[Title Page-Start]

Product Monograph
Including Patient Medication Information
(For Pharmaceuticals)
[Scheduling Symbol] [BRAND NAME] [Trademarking symbol(s) optional]
[Non-proprietary name of the drug product(s)]
[Dosage Form (if not evident from the non-proprietary name of the drug product)]
For [Route(s) of Administration] use
[Strength(s)] of [Non-proprietary name of the drug substance(s)]
[Pharmaceutical Standard (if applicable)]
[Therapeutic Classification]
(For Biologics)
[Scheduling Symbol] [BRAND NAME] [Trademarking symbol(s) optional]
[Non-proprietary name of the drug product(s)]
[Biological origin of active substance (nature of cellular system(s) used for production and if relevant,
the use of recombinant DNA should be specified)]
[Dosage Form] by Route(s) of Administration] from [Presentation(s)]
[Strength(s)] of [Non-proprietary name of the drug substance(s)]
[Pharmaceutical Standard (if applicable)]
[Therapeutic Classification]
(For Schedule C drugs)
[BRAND NAME] [Trademarking symbol(s) optional]
[Non-proprietary name of the drug product(s) following International Non-Proprietary Name (INN)
nomenclature]
[Product description for cold kits such as Kit for the preparation of [radiopharmaceutical name],
description for generators such as Production of [radiopharmaceutical name]]
[Dosage Forms(s)] in [Drug Product Presentation(s)] administered by [Route(s) of Administration]
[Strength(s)] in Radioactivity and Radionuclide(s) used in [Reconstituted Kit, radiopharmaceutical or
Generator(s)]
[Pharmaceutical Standard (if applicable)]
[Therapeutic/Diagnostic Classification such as Therapeutic Radiopharmaceutical (Kit), Diagnostic
Radiopharmaceutical (Kit) or Radioactive Generator]
[For products that have been authorized under the Notice of Compliance with Conditions (NOC/c)
policy, include the following boxed statement:]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 1 of 42

“[BRAND NAME], indicated for:
-[]
has been issued market authorization with conditions, pending the results of trials to verify its clinical
benefit. Patients should be advised of the nature of the authorization. For further information for
[BRAND NAME] please refer to Health Canada’s Notice of Compliance with conditions - drug products
web site.“

[For market authorizations without conditions]

“[BRAND NAME], indicated for:
-[]
has been issued market authorization without conditions.”

[Sponsor Name] Date of Authorization:

[YYYY-MM-DD]
[Sponsor Address]

[Canadian Distributor / Importer Name (if applicable)]

[Canadian Distributor / Importer Address (if applicable)]

Control Number: [control number]

[Trademark declaration optional]
[Title Page – End]

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 For all products authorized under the Notice of Compliance with Conditions policy, include the
following information:

What is a Notice of Compliance with Conditions (NOC/c)?

A NOC/c is a form of market approval granted to a product on the basis of promising

evidence of clinical effectiveness following review of the submission by Health Canada.

Products authorized under Health Canada’s NOC/c policy are intended for the treatment,
prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They
have demonstrated promising benefit, are of high quality and possess an acceptable safety
profile based on a benefit/risk assessment. In addition, they either respond to a serious
unmet medical need in Canada or have demonstrated a significant improvement in the
benefit/risk profile over existing therapies. Health Canada has provided access to this product
on the condition that sponsors carry out additional clinical trials to verify the anticipated
benefit within an agreed upon time frame.

Recent Major Label Changes

[Section number and heading], [Subsection number and [YYYY-MM]

subheading]
[Approval, retain for 24
months]
[Section number and heading], [Subsection number and [YYYY-MM]
subheading]
[Approval, retain for 24
months]

Table of Contents

Sections and their headings should not be omitted, with the exception of 3 Serious Warnings and
Precautions Box (i.e., only if there are no serious warnings and precautions), 12 Special Handling
Instructions (i.e., only if there are no special handling instructions or cautionary statements), 15
Microbiology (i.e., if no microbiological information is required), and 17 Supporting Product
Monographs (i.e., if there are no supporting product monographs).
Subsections and subheadings not applicable to a specific drug product may be deleted. For example,
"4.8 Radiation Dosimetry" may be deleted if the product is not a radiopharmaceutical, and non-
applicable subheadings under 7 Warnings and Precautions should be omitted.
The remaining sections and subsections must not be renumbered or modified as they are expected to
be consistent across all product monographs (e.g., Dosage and Administration is always section number
4; Indications, Pediatrics is always subsection 1.1). The following statement should be included before
the Table of Contents:
Certain sections or subsections that are not applicable at the time of the preparation of the
most recent authorized product monograph are not listed.

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When product specific requirements do not fit into existing subsections, additional subsections may be
added as required, after the existing Master Template subsections.
[To update, right-click anywhere in the Table of Contents and select “Update Field,” “Update entire
table,” and click OK.]

Recent Major Label Changes....................................................................................................3

Table of Contents....................................................................................................................3
Part 1: Healthcare Professional Information............................................................................7
1. Indications........................................................................................................................7
1.1. Pediatrics................................................................................................................... 7
1.2. Geriatrics....................................................................................................................8
2. Contraindications.............................................................................................................8
3. Serious Warnings and Precautions Box.............................................................................8
4. Dosage and Administration...............................................................................................9
4.1. Dosing Considerations................................................................................................9
4.2. Recommended Dose and Dosage Adjustment...........................................................9
4.3. Reconstitution............................................................................................................9
4.4. Administration......................................................................................................... 10
4.5. Missed Dose.............................................................................................................10
4.6. Image Acquisition and Interpretation......................................................................10
4.7. Instructions for Preparation and Use of Radiopharmaceuticals...............................10
4.8. Radiation Dosimetry.................................................................................................11
5. Overdose........................................................................................................................12
6. Dosage Forms, Strengths, Composition, and Packaging...................................................12
6.1. Physical Characteristics............................................................................................13
6.2. External Radiation....................................................................................................13
7. Warnings and Precautions..............................................................................................14
General................................................................................................................................. 14
Carcinogenesis and Genotoxicity..........................................................................................14
Cardiovascular...................................................................................................................... 14
Contamination......................................................................................................................15
Dependence, Tolerance and/or Abuse Liability....................................................................15

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 Driving and Operating Machinery........................................................................................15
Ear/Nose/Throat.................................................................................................................. 16
Endocrine and Metabolism.................................................................................................. 16
Gastrointestinal.................................................................................................................... 16
Genitourinary....................................................................................................................... 16
Hematologic......................................................................................................................... 16
Hepatic/Biliary/Pancreatic....................................................................................................16
Immune................................................................................................................................ 16
Monitoring and Laboratory Tests.........................................................................................16
Musculoskeletal....................................................................................................................16
Neurologic............................................................................................................................ 16
Ophthalmologic....................................................................................................................16
Perioperative Considerations...............................................................................................16
Psychiatric............................................................................................................................ 17
Renal.................................................................................................................................... 17
Reproductive Health.............................................................................................................17
Respiratory........................................................................................................................... 17
Sensitivity/Resistance...........................................................................................................17
Skin....................................................................................................................................... 17
7.1. Special Populations..................................................................................................18
7.1.1. Pregnancy.......................................................................................................18
7.1.2. Breastfeeding..................................................................................................18
7.1.3. Pediatrics........................................................................................................19
7.1.4. Geriatrics........................................................................................................ 19
8. Adverse Reactions..........................................................................................................19
8.1. Adverse Reaction Overview.....................................................................................19
8.2. Clinical Trial Adverse Reactions................................................................................19
8.2.1. Clinical Trial Adverse Reactions – Pediatrics ..................................................20
8.3. Less Common Clinical Trial Adverse Reactions.........................................................20
8.3.1. Less Common Clinical Trial Adverse Reactions – Pediatrics ...........................20

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 8.4. Abnormal Laboratory Findings: Hematologic, Clinical Chemistry, and Other
Quantitative Data.................................................................................................................21
8.5. Post-Market Adverse Reactions...............................................................................21
9. Drug Interactions............................................................................................................21
9.1. Serious Drug Interactions.........................................................................................21
9.2. Drug Interactions Overview.....................................................................................22
9.3. Drug-Behaviour Interactions....................................................................................22
9.4. Drug-Drug Interactions............................................................................................ 22
9.5. Drug-Food Interactions............................................................................................22
9.6. Drug-Herb Interactions............................................................................................23
9.7. Drug-Laboratory Test Interactions...........................................................................23
10. Clinical Pharmacology.....................................................................................................24
10.1. Mechanism of Action...............................................................................................24
10.2. Pharmacodynamics..................................................................................................24
10.3. Pharmacokinetics.....................................................................................................24
10.4. Immunogenicity.......................................................................................................25
11. Storage, Stability, and Disposal.......................................................................................25
12. Special Handling Instructions..........................................................................................26
Part 2: Scientific Information.................................................................................................27
13. Pharmaceutical Information...........................................................................................27
14. Clinical Trials...................................................................................................................27
14.1. Clinical Trials by Indication.......................................................................................27
14.2. Comparative Bioavailability Studies.........................................................................29
15. Microbiology..................................................................................................................31
16. Non-Clinical Toxicology...................................................................................................31
17. Supporting Product Monographs....................................................................................32
Patient Medication Information.............................................................................................33

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Part 1: Healthcare Professional Information

For biosimilar biologic drugs (hereafter referred to as biosimilars), include the following statement:

[Biosimilar BRAND NAME (Non-proprietary name of the drug product(s))] is a biosimilar

biologic drug (biosimilar) to [Reference biologic drug BRAND NAME (Non-proprietary name
of the drug product(s))]. A biosimilar is a biologic drug that was granted authorization based
on a demonstration of similarity to a version previously authorized in Canada, known as the
reference biologic drug.

1. Indications
[BRAND NAME] (Non-proprietary name of the drug product(s)) is indicated for:
 [text]
 [text]
[narrative]

For NOC/c indications: include a brief statement regarding the uncertainties and/or limitations of the
indications.
Special restrictions with respect to the distribution of the drug product should be declared in this
section.

1.1. Pediatrics

One of the following or similar statements should be used:

Pediatrics (age range): Based on the data submitted and reviewed by Health Canada, the
safety and efficacy of [BRAND NAME] in pediatric patients has been established. Therefore,
Health Canada has authorized an indication for pediatric use (include cross-reference to
relevant sections).
or
Pediatrics (age range): No data are available to Health Canada; therefore, Health Canada
has not authorized an indication for pediatric use.
or
Pediatrics (age range): Based on the data submitted and reviewed by Health Canada, the
safety and efficacy of [BRAND NAME] in pediatric patients has not been established;
therefore, Health Canada has not authorized an indication for pediatric use (include cross-
reference to relevant sections).

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 7 of 42

1.2. Geriatrics

One of the following or similar statements may be used:

Geriatrics (age range): No data are available to Health Canada; therefore, Health Canada
has not authorized an indication for geriatric use.
or
Geriatrics (age range): Evidence from clinical studies and experience suggests that use in the
geriatric population is associated with differences in safety or effectiveness.

2. Contraindications
 [narrative]

Describe absolute contraindications, meaning those situations in which the drug should not be used
because the risk outweighs any potential therapeutic benefit. For example:

[BRAND NAME] with [Non-proprietary name of co-administered drug] is contraindicated. Co-

administration may result in increased concentrations of [Non-proprietary name of co-
administered drug] due to inhibition of CYP3A, which may lead to QT interval prolongation
and torsades de pointes (see 7 Warnings and Precautions and 9 Drug Interactions).

For hypersensitivity reactions, the following or similar statement should be used:

[BRAND NAME or Non-proprietary name of the drug product(s), as applicable] is

contraindicated in patients who are hypersensitive to this drug or to any ingredient in the
formulation, including any non-medicinal ingredient, or component of the container. For a
complete listing, see 6 Dosage Forms, Strengths, Composition, and Packaging.

3. Serious Warnings and Precautions Box

 [text]
 [text]

Clinically significant or serious (i.e., life-threatening) safety hazards when taking the drug should be
placed in this box, with a cross-reference to the relevant section(s) for more detailed information.
Generally, this text should not exceed 20 lines.
For all radiopharmaceuticals, the Serious Warnings and Precautions Box should contain the following
or similar statement:
Radiopharmaceuticals should be used only by those healthcare professionals who are
appropriately qualified in the use of radioactive prescribed substances in or on humans.
In the absence of a serious warning or precaution identified at the time of authorization, this box is
omitted, along with the heading 3 Serious Warnings and Precautions Box.

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 8 of 42

4. Dosage and Administration

4.1. Dosing Considerations

 [tables, bullets and/or narrative]

Briefly list all safety issues to consider that may affect dosing of the drug (e.g., renal or hepatic
disease, concomitant therapy, changing from intravenous to oral therapy, lab values prior to
infusion, rule out pregnancy prior to administration, pre-medication is required, duration of effect,
imaging time post-injection).

4.2. Recommended Dose and Dosage Adjustment

 [tables, bullets and/or narrative]

Include detailed dosage information for each indication, route of administration and/or dosage form,
dosage schedules, booster doses, initial dose, titration of dose, dosage range, maximum daily dose,
maintenance dosage, duration of treatment and drug discontinuance, considerations for special
populations.
For drugs that may cause clinically relevant signs and/or symptoms upon abrupt discontinuation or
dosage reduction, the addition of a new subsection 4.2.1 titled “Discontinuing Treatment” should be
considered. This new subsection should contain detailed information related to drug discontinuation,
anticipated discontinuation symptoms, and instructions for tapering of the drug and treatment (if
known or available) to mitigate symptoms. Refer to the XML PM Guidance for formatting rules. In
the absence of a Health Canada authorized pediatric indication, the following or similar statement
should be used, with a cross-reference to relevant sections, if applicable:
Health Canada has not authorized an indication for pediatric use.

4.3. Reconstitution

Oral Solutions:

 [narrative and/or table]

List all recommended diluents for reconstitution. Directions should include the volume and type of
diluents to be added and the approximate volume and concentration of the resulting product.
(Include cross-reference to 11 Storage, Stability, and Disposal)

Parenteral Products:

 [table and/or narrative, as appropriate]

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 For intravenous use, information should be separately described for direct intravenous injection,
intermittent infusion, and continuous infusion; use of in-line filters, etc.
(Include cross-reference to 11 Storage, Stability, and Disposal)
(For radiopharmaceutical kits, cross-reference to 4.7 Instructions for Preparation and Use of
Radiopharmaceuticals)

Table [#] – Reconstitution

Vial Size Volume of Diluent To Approximate

Concentration Per mL
Be Added to Vial Available Volume

4.4. Administration
[narrative and/or table]

Include details concerning methods of administration. Specify any special considerations (e.g., do not
crush, do not split if not scored, capsule contents can be sprinkled).

For radiopharmaceuticals, if applicable, include the following or similar statement:

The patient dose should be measured by a suitable radioactivity calibration system prior to
administration.

4.5. Missed Dose

[narrative]

Include actions to be taken in the event that a patient misses a dose. If no action needs to be taken,
a statement to this effect should be included.

4.6. Image Acquisition and Interpretation

[narrative and/or table]

This subsection applies to certain radiopharmaceuticals only, otherwise delete this subheading.
Include specific requirements for image acquisition and interpretation such as type of equipment
and calibration scanning or imaging time post injection, location of views, and frequency of images.

4.7. Instructions for Preparation and Use of Radiopharmaceuticals

[narrative and/or list]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 10 of 42

 This subsection applies to radiopharmaceuticals only, otherwise delete this subheading. The
following or similar statement should be included:

The components of the reagent vial are sterile and nonpyrogenic. It is essential that the user
follows the directions carefully and adheres to strict aseptic technique.
or
Use aseptic technique and wear waterproof gloves throughout the entire preparation
procedure.
or
Make all transfers of radioactive solutions with an adequately shielded syringe and maintain
adequate shielding around the vial during the useful life of the radioactive product.

4.8. Radiation Dosimetry

[This is an example of acceptable presentation of Dose Estimate Data:]
[narrative]

This subsection applies to radiopharmaceuticals only, otherwise delete this subheading. Include
narrative description of the study used to estimate the final dose, including the model and method
of calculation.

Table [#] – Final Dose Estimates [The model and method of calculation should be specified]

Organ Absorbed dose per unit Calculated absorbed dose for

radioactivity (mGy/MBq) [XX MBq] administered (mGy)
Adrenals
Brain
Breasts
Gallbladder Wall
LLI Wall
Small Intestine
Stomach
ULI Wall
Heart Wall
Kidneys
Liver
Lungs
Muscle
Ovaries
Pancreas

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 11 of 42

 Organ Absorbed dose per unit Calculated absorbed dose for
radioactivity (mGy/MBq) [XX MBq] administered (mGy)
Red Marrow
Bone Surfaces
Skin
Spleen
Testes
Thymus
Thyroid
Urinary Bladder
Uterus
Total Body

Effective Dose Equivalent (mSv/MBq) (rem/mCi)

Effective Dose (mSv/MBq) (rem/mCi)

5. Overdose
[narrative]

Include the following information:

 A description of the acute and/or long-term signs and symptoms of overdose;
 Potential sequelae/complications which may occur with the drug (e.g., organ toxicity);
 Current recommended management of overdose (e.g., monitoring, use of
agonist/antagonist/antidotes, method to increase elimination and/or other clinical
interventions); and
 Procedures that, by experience with this or similar type drugs, are known or reasonably
expected to be unnecessary or unsuitable (e.g., those that may be hazardous to the patient).

For the most recent information in the management of a suspected drug overdose, contact your
regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-
7669).

6. Dosage Forms, Strengths, Composition, and Packaging

Include the following information as applicable:

To help ensure the traceability of biologic products, healthcare professionals should record both the
brand name and the non-proprietary (active ingredient) name as well as other product-specific
identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product
supplied.

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 To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety
monitoring, healthcare professionals should record the time and date of administration, quantity of
administered dose (if applicable), anatomical site and route of administration, brand name and
generic name of the vaccine, the product lot number, and expiry date.

Table [#] – Dosage Forms, Strengths, and Composition

Route of Dosage Form/

Non-Medicinal Ingredients
Administration Strength/Composition
[oral] [tablet 5 mg, 10 mg] [List all non-medicinal ingredients in
alphabetical order]

[text]

Description
[narrative]

Include a narrative description of the physical characteristics of each authorized dosage form
including any identifiable markings (e.g., score lines, embossing, logos). A description of the type and
size of all authorized packaging formats, including healthcare professional samples that differ from
their commercial package sizes, should also be provided. If applicable, any additional packaging
information (e.g., external components required for product administration) that may impact patient
safety, drug product administration, or drug product quality characteristics should also be provided.
For biosimilars, include a narrative description of the biosimilar biologic drug that is similar to the
narrative in the product monograph of the reference biologic drug. Incorporate changes as necessary
where there are descriptive differences between the biosimilar and the reference biologic drug due
to, for example, differences in formulation.

6.1. Physical Characteristics

[table]

This subsection applies to radiopharmaceuticals only, otherwise delete this subheading. Include a
brief description of physical characteristics including physical half-life, principle radiation emission
data, physical decay chart (tabular format), parent and daughter radionuclides data.

6.2. External Radiation

[table]

This subsection applies to radiopharmaceuticals only. Include specific gamma ray constant for the
radioisotope, radiation attenuation by lead shielding (tabular format), parent and daughter
radionuclides data.

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 13 of 42

7. Warnings and Precautions

If applicable, include one of the following statements:

See 3 Serious Warnings and Precautions Box.
For blood products:
This product is prepared from large pools of human plasma. Thus, there is a possibility it may
contain causative agents of viral or other undetermined diseases.
For all radiopharmaceuticals:
The product should be administered under the supervision of a healthcare professional who
is experienced in the use of radiopharmaceuticals. Appropriate management of therapy and
complications is only possible when adequate diagnostic and treatment facilities are readily
available.
The radiopharmaceutical product may be received, used, and administered only by
authorized persons in designated clinical settings. Its receipt, storage, use, transfer, and
disposal are subject to the regulations and/or appropriate licenses of local competent official
organizations.
As in the use of any other radioactive material, care should be taken to minimize radiation
exposure to patients consistent with proper patient management, and to minimize radiation
exposure to occupational workers.

[Subheadings to be included as applicable, in alphabetical order (with the exception of General):]

General

Include information that does not fall under the subheadings listed below. Where applicable, genetic
polymorphisms should be specified under the appropriate subheading.

For products derived from plasma, the inherent risks of the product should be explained.

[narrative]

Carcinogenesis and Genotoxicity

Include human data where there is evidence that the drug is carcinogenic or genotoxic. In the
absence of human data, include pertinent animal data with a cross-reference to 16 Non-clinical
Toxicology.

[narrative]

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Cardiovascular

Includes QTc prolongation (cross-reference to 10.2 Pharmacodynamics as required).

[narrative]

Contamination

For radiopharmaceuticals, include practical information for the patient to minimize the
contamination potential after receiving the drug. This information must also appear in the Patient
Medication Information.

[narrative]

Dependence, Tolerance and/or Abuse Liability

Discuss the drug’s potential for physical and/or psychological dependence, tolerance and/or abuse
and the potential effects or harms from these risks. The amount of drug, duration of time taking the
drug, and characteristics of the dependence, tolerance and/or withdrawal should be described.
Discuss the potential for rebound effects and the need for tapering. Treatment of the effects of the
dependence should be provided if known.
Where human or animal studies have been conducted to assess the above risks, provide a cross-
reference to these studies in 10.2 Pharmacodynamics and 16 Non-clinical Toxicology, Special
Toxicology.
For drugs that have not been systematically studied for the above risks, but the risks cannot be ruled
out, include the following or similar statement:
[BRAND NAME] has not been studied for its potential to cause dependence, tolerance and/or
abuse; however, there may be a theoretical risk of the occurrence of one or more of these
risks. Healthcare professionals should consider the patient’s history of drug use and monitor
appropriately.
Where there is a theoretical basis of concern (e.g., the medication crosses the blood-brain barrier;
the mechanism of action is similar to other medications with known dependence, tolerance or abuse
liability), include a statement elaborating on the basis of this concern.

[narrative]

Driving and Operating Machinery

Include any effects that may impair performance of a task requiring attention, physical coordination,
or unimpaired reaction times and decision-making, including driving and operating machinery. If the
effects are known, describe the risks and include the following or similar statement:

While taking [BRAND NAME], patients should be cautioned not to drive, operate dangerous
machinery or engage in activities that require alertness or physical coordination if they are

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 15 of 42

 experiencing any of these effects.

[narrative]

Ear/Nose/Throat
[narrative]

Endocrine and Metabolism

[narrative]

Gastrointestinal
[narrative]

Genitourinary
[narrative]

Hematologic
[narrative]

Hepatic/Biliary/Pancreatic

When possible, idiopathic versus metabolic liver failure should be described.

[narrative]

Immune
[narrative]

Monitoring and Laboratory Tests

[narrative]

Musculoskeletal
[narrative]

Neurologic
[narrative]

Ophthalmologic
[narrative]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 16 of 42

Perioperative Considerations

Include information on management before, during, and after surgery.

[narrative]

Psychiatric

Behavioural changes or potential (e.g., suicidal ideation) should be stated.

[narrative]

Renal
[narrative]

Reproductive Health

Cross-reference to other relevant sections (e.g., 2 Contraindications, 7.1.1 Pregnancy, 10.3

Pharmacokinetics, 16 Non-clinical Toxicology) as required; consider contraception for both females
and males.

 Fertility

Include a summary of relevant information of effects of the drug on fertility from animal or
human exposure. In the absence of information, clearly state that no data exist.

[narrative]
 Function

Include effects on sexual desire, erection, orgasm, and ejaculation.

[narrative]

Respiratory
[narrative]

Sensitivity/Resistance
[narrative]

Skin

Include information on serious and/or severe local injection site reactions, human photosensitivity

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 17 of 42

 where applicable, etc.

[narrative]

7.1. Special Populations

7.1.1. Pregnancy

Include information related to Pregnancy Registries if applicable. This information should also be
included in the Patient Medication Information. Teratogenic and other developmental adverse
effects on the reproductive system/embryo/fetus/neonate should be included. In the absence of
human data, include a brief description of adverse developmental effects observed in animal toxicity
studies with a cross-reference to section 16 Non-Clinical Toxicology. If information on birth defects
and miscarriage is available for the patient population for whom the drug is labelled, it must also be
included, along with the following, when available:
 Disease-associated maternal and/or fetal risk
 Maternal adverse reactions
 Embryo/fetal/neonatal adverse reactions
 Labour and/or delivery
The extent of exposure in pregnancy during clinical trials should be included:
Wide: > 1,000 pregnancies
Limited: < 1,000 pregnancies
Very Limited: individual cases only
No experience

For radiopharmaceuticals, the following or similar statement should be included:

In women of childbearing potential, examinations using radiopharmaceuticals should ideally
be performed during the first ten days following the onset of menses, or after ensuring the
woman is not pregnant. The benefit of using a diagnostic radiopharmaceutical should be
weighed against the possible risk to an embryo or a fetus.

[narrative]

7.1.2. Breastfeeding

If studies have shown that the drug is not excreted in human breast milk, it should be stated. In the
absence of human data, pertinent animal data should be included along with the following or similar
statement:

It is unknown if [Non-proprietary name of the drug product] is excreted in human milk.

Precaution should be exercised because many drugs can be excreted in human milk.

For radiopharmaceuticals, the following or similar statement should be included:

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 18 of 42

 Nursing mothers who are using radiopharmaceuticals should switch their child to formula for
the duration of treatment and until their healthcare professional advises them that it is safe
to reintroduce breastfeeding.

[narrative]

7.1.3. Pediatrics

In the absence of a Health Canada authorized pediatric indication, the following statement should be
used:
Pediatrics (age range): No data are available to Health Canada; therefore, Health Canada
has not authorized an indication for pediatric use.
or
Pediatrics (age range): Based on the data submitted and reviewed by Health Canada, the
safety and efficacy of [BRAND NAME] in pediatric patients has not been established;
therefore, Health Canada has not authorized an indication for pediatric use (include cross-
reference to relevant sections).

[narrative]

7.1.4. Geriatrics
[narrative]

8. Adverse Reactions

8.1. Adverse Reaction Overview

[narrative]

Provide information on the most serious and/or most frequently occurring adverse reactions, or
those where there have been reports of particularly severe cases. Frequencies to be stated as
accurately as possible. It should not be a summary of the safety database.
Refer to Section 8: Adverse Reactions and the Glossary of the Product Monograph Guidance
document for the definitions of “Adverse Reaction” and “Adverse Event.”

8.2. Clinical Trial Adverse Reactions

Clinical trials are conducted under very specific conditions. Therefore, the frequencies of adverse
reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and
should not be compared to frequencies reported in clinical trials of another drug.
[Include a brief description of data sources]
[narrative]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 19 of 42

Table [#] – [Title of Table]
System organ class/preferred [Non-proprietary name of the [Placebo/comparator (if
term drug product] applicable)]
[Use MedDRA terms for n = [#] n = [#]
headings, as applicable] (%) (%)

System organ class

Preferred term
System organ class
Preferred term

[narrative]

A brief narrative should follow the table to explain or supplement the information provided in the
table where applicable. Separate tables may be required for different indications (e.g., oncology and
a non-oncology indication) or different formulations (e.g., oral, intravenous) or different drug
combinations.

Adverse reactions may also be related to genetically determined product metabolism. Subjects or
patients deficient in the specific enzyme may experience a different frequency or severity of adverse
reactions. This should be mentioned where relevant and correlated with data from clinical trials.

8.2.1. Clinical Trial Adverse Reactions – Pediatrics

[narrative]

From pediatric studies include: age characteristics, any clinically relevant differences (i.e.,
seriousness or reversibility of adverse reaction) between safety profiles in adult and pediatric
populations, or any relevant age groups, uncertainties due to limited experience. If the observed
safety profile is consistent in pediatrics and adults, this could be stated.

8.3. Less Common Clinical Trial Adverse Reactions

[list]

Present as a list, categorized by System Organ Class, alphabetically: e.g.,

Cardiovascular: [text]
Gastrointestinal: [text]

8.3.1. Less Common Clinical Trial Adverse Reactions – Pediatrics

[list]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 20 of 42

 Present as a list, categorized by System Organ Class, alphabetically: e.g.,
Cardiovascular: [text]
Gastrointestinal: [text]

8.4. Abnormal Laboratory Findings: Hematologic, Clinical Chemistry, and Other Quantitative
Data

Clinical Trial Findings

[table (and narrative, if applicable)]

Outline any differences between adult, geriatric, and pediatric patients as necessary with regard to
abnormal laboratory findings.

Post-Market Findings
[table (and narrative, if applicable)]

Outline any differences between adult, geriatric, and pediatric patients as necessary with regard to
post-market abnormal laboratory findings.

8.5. Post-Market Adverse Reactions

[narrative and/or table]

List Canadian and international post-market adverse reactions including serious and/or unexpected
adverse reactions that are reported through post-market surveillance and/or identified in Phase IV
clinical trials. Adverse reactions already listed in the Clinical Trial Adverse Reactions section should
not be repeated in this section unless there are changes in the nature, severity or frequency.

9. Drug Interactions

9.1. Serious Drug Interactions

 [text]
 [text]

Serious (e.g., life-threatening) drug interactions should be highlighted in this box, with a cross-
reference to detailed information in 9.4 Drug-Drug Interactions. The text should generally not exceed
20 lines. If a drug interaction is included in 2 Contraindications or 3 Serious Warnings and
Precautions Box it must also be included in this box.

If there are no serious drug interactions at the time of authorization, this box is omitted, along with

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 21 of 42

 the heading 9.1 Serious Drug Interactions.

9.2. Drug Interactions Overview

[narrative]

9.3. Drug-Behaviour Interactions

[narrative]

Briefly present known or potential interactions in terms of individual behavioural risks including, but
not limited to, dietary behaviours, alcohol consumption, sexual activity, and nicotine or cannabis use
(e.g., smoking, vaping, etc.) which may result in adverse events or unfavourable treatment
outcomes.

Where no interaction data is known, the following or similar statement may be included:
The interaction of [BRAND NAME] with individual behavioural risks (e.g. cigarette smoking,
cannabis use, and/or alcohol consumption) has not been studied.

9.4. Drug-Drug Interactions

The following or similar statement should precede the table:

The drugs listed in this table are based on either drug interaction case reports or studies, or
potential interactions due to the expected magnitude and seriousness of the interaction (i.e.,
those identified as contraindicated).

Where no interaction data is known the following or similar statement should be included:
Interactions with other drugs have not been established.

Table [#] – Established or Potential Drug-Drug Interactions

[Non-proprietary
Source of
name(s) of the drug Effect Clinical comment
evidence
product(s)]
[drug A] [Level/source of [drug A] conc [Caution is warranted and therapeutic
evidence, see concentration monitoring is
legend] recommended]
Legend: C = Case Study; CT = Clinical Trial; T = Theoretical; PBPK = Physiologically based
pharmacokinetic modeling; popPK = Population pharmacokinetic modeling

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 22 of 42

9.5. Drug-Food Interactions
[narrative]

Briefly present known or potential interactions with food or beverages (e.g., grapefruit, caffeine).
Cross-referencing to 4 Dosage and Administration may be required when the timing of food
consumption should be considered.
When it has been established that there is no interaction, the following or similar statement should
be included:
This drug may be taken with or without food.
When it has been established that there is no interaction, however administration under specific
conditions (e.g., with food) is recommended for reasons of safety/tolerability, the following or
similar statement should be included:

Although a significant drug-food interaction has not been observed, for safety/tolerability
reasons, this drug should be taken with food as recommended in 4 Dosage and
Administration.
Where no interaction data are available to Health Canada or interactions with food cannot be
established based on the data submitted and reviewed by Health Canada, the following or similar
statement should be included:

Interactions with food have not been established.

9.6. Drug-Herb Interactions

[narrative]

Briefly present known or potential interactions with herbal products and practical guidance for the
healthcare professional.
Where no interaction data is known, the following or similar statement should be included:
Interactions with herbal products have not been established.

9.7. Drug-Laboratory Test Interactions

[narrative]

Briefly present laboratory tests affected by the presence of the drug, such as interfering with the
accuracy of the test results or methods (e.g., antihistamines diminish the positive reactions to
dermal reactivity indicators).
Where no interaction data is known, the following or similar statement should be included:
Interactions with laboratory tests have not been established.

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 23 of 42

10. Clinical Pharmacology

10.1. Mechanism of Action

[narrative]

10.2. Pharmacodynamics
[narrative]

Include cardiac electrophysiology study findings related to QT prolongation.

10.3. Pharmacokinetics
[narrative]

Description on how pharmacokinetic studies were assessed.

Table [#] – Summary of [Non-proprietary name of the drug product(s)] pharmacokinetic parameters
in [specific patient population]

Cmax Tmax t½ (h) AUC0-∞ CL Vd

Single Dose
Mean

Absorption
[text]
Distribution
[text]
Metabolism
[text]
Elimination
[text]
Duration of effect

This subsection applies specifically to vaccines and should describe the duration of effect of the
recommended dose (e.g., duration of detectable levels of antibodies and/or conferred immunity
status).

[text]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 24 of 42

Special populations and conditions
[text]
 Pediatrics [text]
 Geriatrics [text]
 Sex [text]
 Pregnancy and breastfeeding [text]
 Genetic polymorphism [text]
 Ethnic origin [text]
 Hepatic Insufficiency [text]
 Renal Insufficiency [text]
 Obesity [text]

10.4. Immunogenicity

For biologics, the following or similar statements should be included:

All therapeutic proteins have the potential for immunogenicity.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the
assay. Additionally, the observed incidence of antibody (including neutralizing antibody)
positivity in an assay may be influenced by several factors including assay methodology, sample
handling, timing of sample collection, concomitant medications, and underlying disease. For
these reasons, comparison of incidence of antibodies in the studies described below with the
incidences of antibodies in other studies or to other products may be misleading.

For biologics, also include:

 The proportion of participants that were positive for binding and neutralizing antibodies
(expressed as % [positive participants/total participants]) in the main clinical trials as well as
relevant study details (e.g. duration, time point[s], patient population[s], etc.).
 A concise summary of the clinical impact of ADAs (i.e. on pharmacokinetics, efficacy, and
safety) or if clinical significance is not known, a statement to that effect.
 A cross-reference to applicable sections (e.g., 7 Warnings and Precautions – Immune), as
necessary, for more detailed discussion of the clinical effect(s) and pertinent clinical
recommendations.

For vaccines, as immunogenicity may be a surrogate marker of efficacy, these data may be most
appropriately included in section 14.1 Clinical Trials by Indication.

[narrative]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 25 of 42

11. Storage, Stability, and Disposal
[narrative]

Include recommended storage conditions for each dosage form as supported by stability studies.
For reconstituted products, including parenterals, the recommended storage period and conditions
should be stated.
Disposal instructions should be included for all drug products. Include a cross-reference to more
detailed safe disposal instructions under 12 Special Handling Instructions where appropriate.
For radiopharmaceutical kits, include the following or similar statement:
Do not use the kit beyond the expiration date stamped on the box. After preparation
[product] should be stored at room temperature until administration, within [x] hours of
radiolabelling.

12. Special Handling Instructions

Remove this section and heading if it is not applicable to the drug product.
[narrative]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 26 of 42

Part 2: Scientific Information

13. Pharmaceutical Information

Drug Substance
Non-proprietary name of the drug substance(s): [text]
Chemical name: [text]
Molecular formula and molecular mass: [text]
Structure (for biologics)/Structural formula: [image]
Physicochemical properties: [text]
Pharmaceutical standard: [text]
Product Characteristics:
[narrative]

For radiopharmaceuticals, provide detailed information of product characteristics that are in

addition to those mentioned under 6.1 Physical Characteristics.
For biologics, this subsection should describe the method of manufacture. The description should
include information about human or animal biological source material of the active substance
[nature of cellular system(s) used for production and if relevant, the use of recombinant DNA should
be specified]. Sponsors are not expected to supply proprietary information, but they must provide
enough detail to provide healthcare professionals with an understanding of how the product is
prepared.

Viral Inactivation
[narrative]

For products derived from plasma, detail the viral reduction steps. Include information on selection
criteria for donors, if applicable.

14. Clinical Trials

14.1. Clinical Trials by Indication

 Information on the design and results for each study should be presented together. Studies
should be organized under subheadings for each indication. The subheading for each specific
indication should be written out in Title Case font (i.e., with only the first letter of each word
capitalized), and should be included in the Table of Contents. The subheadings should not be
numbered.

Example layout: (repeat for additional indications)

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 27 of 42

[Subheading for Indication 1]

Table [#] – Summary of Patient Demographics for Clinical Trials in [Specific Indication 1]

Dosage, route of
Study subjects
Study # Study design administration Age (range) Sex
(n)
and duration

[Provide a brief narrative describing the study design and demographic characteristics of the study
population:]
[narrative]
The table of results should include only key endpoints with corresponding responses in each
treatment group (e.g., response rate for binary outcomes, or mean for continuous
outcomes), point estimates of relevant treatment effect metrics, corresponding confidence
intervals, and p-values, if applicable. If statistical significance is achieved on the primary
endpoint, other clinically relevant endpoints may be considered for product labelling in
consultation with Health Canada. Type 1 error should be controlled across these other
clinically relevant endpoints to provide statistical support for their inclusion in the product
monograph.

Table [#] – Results of Key Endpoints at Duration [X] in Subjects with [X] in Studies [X] and [Y]
Study [X] Study [Y]
a
[Drug] [Comparator Adjusted [Drug] [Comparator Adjusteda
(N = [#]) ] (N = [#]) treatment (N = [#]) ] treatment
difference (N = [#]) difference
(95% CI) (95% CI)
Primary endpoint
[Primary ()b ()b
endpoint]

Key secondary endpoints

[Secondary ()b ()b
endpoints]

a. Based on [method] adjusted for randomization stratification factors

b. Statistically significant under multiplicity control for [drug] vs [comparator] comparison (p < 0.05)

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 28 of 42

14.2. Comparative Bioavailability Studies
[narrative]

This subsection is not applicable to biosimilar biologic drugs.

Provide a narrative outlining the design of the comparative bioavailability study. At a minimum, the
narrative should include the following:
 General study design (crossover, replicate crossover, semi-replicate crossover, parallel)
 Number of treatment groups
 Identity of the products that were compared
 Dose and dose units administered [e.g., single unit dose (30 mg dose as 1 x 30 mg) or
multiple unit dose (30 mg dose as 2 x 15 mg)]
 Conditions of administration [e.g., administered under fasting conditions, administered
under fed conditions (high-fat high-calorie, low-fat low-calorie, etc.)]
 Sex of the study population
 Ethnicity of the study population if it impacts the pharmacokinetics of the drug
 Health status of the study population (healthy subjects or patients)
 Number of subjects/patients included in the statistical analysis
If the study drug was co-administered with a booster, the booster, its dose and frequency of dosing
should be identified.
If the data in the Summary Table of the Comparative Bioavailability Data is metabolite data, the
narrative should identify the measured metabolite and state that the data is metabolite data.
Additional Instructions for preparation of the summary table of the comparative bioavailability
data
Drugs with a half-life greater than 24 hours
 Replace AUCT with AUC0-72h.
If AUCI and T½ cannot be accurately estimated, it may be acceptable to omit these rows from the
Summary Table of the Comparative Bioavailability Data. In this case, the following statement should
be included as the last footnote:
Due to the long elimination half-life of [analyte name], AUCI and T½ could not be accurately
calculated from the data obtained in this study.
Highly variable drug products:
If the bioequivalence limits were expanded based on reference scaling, the following statement
should be included as the last footnote:
Bioequivalence acceptance limits were scaled to within subject variability of the reference
product [AUCT or AUC0-72h].

Multiple dose studies:

 Replace AUCT with AUCtau;
 Omit the AUCI and T½ rows;

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 29 of 42

  Add a row for Cmin immediately after the row for Cmax.
Units of measurement and data formatting:
 Present the AUC parameters with the following formatting and units: (xx·h/mL). “xx” may be
mcg, ng, or pg;
 Present the Cmax parameter (and Cmin in the case of multiple dose studies) with the following
formatting and units: (xx/mL). “xx” may be mcg, ng, or pg;
 Present the % Ratio of Geometric Means and 90% Confidence Intervals to one decimal point
only. All other data should be rounded to no more than two decimal points and presented in
a consistent format throughout the table;
 If the analysis of a primary pharmacokinetic parameter (e.g., AUCT, AUC0-72h or Cmax) includes
data from a different number of subjects than stated in the narrative, the number of subjects
for the parameter should be denoted by a footnote.
Combination products:
A Summary Table of the Comparative Bioavailability Data should be presented for each drug in the
combination (whether administered as a fixed dose combination or two or more drug products given
concomitantly).

Biopharmaceutics Classification System-based biowaivers:

When a drug product is approved based on a Biopharmaceutics Classification System-based
biowaiver, the Table of the Comparative Bioavailability Data and accompanying narrative should be
replaced with the following statement:
[BRAND NAME of test product, dosage form, strength(s)] have satisfied the criteria for a
Biopharmaceutics Classification System (BCS)-based biowaiver in comparison to the
respective strength(s) of [BRAND NAME of reference product, Non-proprietary name of the
drug product(s) including salt form, market authorization holder].

Table [#] – Summary Table of the Comparative Bioavailability Data

Analyte name
(Number of units x strength)
Geometric mean
Arithmetic mean (CV %)
% Ratio of 90% Confidence
Parameter Test1 Reference2
geometric means Interval
AUCT
(units)
AUCI
(units)
CMAX
(units)

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 30 of 42

 Analyte name
(Number of units x strength)
Geometric mean
Arithmetic mean (CV %)
% Ratio of 90% Confidence
Parameter Test1 Reference2
geometric means Interval
TMAX3
(h)
T½4
(h)

1
BRAND NAME of the test product [Non-proprietary name of the drug product(s) including salt form], dosage form, strength
and market authorization holder.
2
BRAND NAME of the reference product, [Non-proprietary name of the drug product(s) including salt form], dosage form,
strength and market authorization holder and country of origin.
3
Expressed as the median (range) only.
4
Expressed as the arithmetic mean (CV %) only.

15. Microbiology
[narrative]
[table]

For drugs with no antimicrobial properties, include one of the following or similar statements:
No microbiological information is required for this drug product.
or
[BRAND NAME] is not an antimicrobial drug.
Alternatively, this section can be omitted if microbiological information is not required.

16. Non-Clinical Toxicology

Only use a table if presentation will be more concise. The following or similar statements should be
included where applicable:

No long-term animal studies have been performed to evaluate the carcinogenic potential of
[Non-proprietary name of the drug product].

No studies have been performed to evaluate the genotoxic potential of [Non-proprietary

name of the drug product].

No dedicated animal fertility studies have been performed for [Non-proprietary name of the
drug product].

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 31 of 42

 As with other radiopharmaceuticals that distribute intracellularly, there may be increased
risk of chromosome damage from Auger electrons if nuclear uptake occurs.

Presentation: narrative where possible. Table format only if presentation will be more concise.
Information should only be presented once, either in narrative or table format.

General toxicology [narrative]

Genotoxicity [narrative]
Carcinogenicity [narrative]
Reproductive and developmental toxicology [narrative]
Juvenile toxicity [narrative]
Special toxicology [narrative]

17. Supporting Product Monographs

[numbered list:]
[BRAND NAME] [dosage form, strength], control [number], product monograph, [Sponsor]. (YYYY-MM-
DD)

List only Health Canada authorized product monographs that were supportive in the development of
the product monograph (e.g., Canadian Reference Product for a generic or Reference Biologic Drug
for a biosimilar biologic drug). For subsequent entry products, the product monograph for the
Canadian Reference Product should remain listed even if it is in dormant status or has been
discontinued from marketing in Canada. All strengths and dosage forms listed on the title page of the
supportive product monograph should be included, even if the subsequent entry product is not
authorized for the strength or dosage form of the drug. For a fixed-dose combination product (FDC),
the list should include the product monographs of the Canadian Reference Product for the FDC as
well as those for each individual drug. For an innovator FDC product, the list should include the
product monographs for each of the individual innovator drugs.

Where there are no such supporting product monographs, this section, including heading, should be
omitted.

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 32 of 42

Patient Medication Information

The Patient Medication Information section should be written in plain language at the grade 6-8
reading literacy level.

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

[Scheduling symbol] [BRAND NAME] [Trademarking symbol(s) (optional)]

[Non-proprietary name of the drug product(s)]

This Patient Medication Information is written for the person who will be taking [BRAND NAME]. This
may be you or a person you are caring for. Read this information carefully. Keep it as you may need to
read it again.
This Patient Medication Information is a summary. It will not tell you everything about this medication.
If you have more questions about this medication or want more information about [BRAND NAME],
talk to a healthcare professional.

For biosimilars include the following statement:

[BRAND NAME] is a biosimilar biologic drug (biosimilar) to the reference biologic drug
[reference biologic drug BRAND NAME]. A biosimilar is authorized based on its similarity to a
reference biologic drug that was already authorized for sale in Canada.

Serious warnings and precautions box

 [text]
 [text]

The box should contain a bullet listing of each serious warning and precaution in 3 Serious Warnings
and Precautions Box. Delete this box along with the section heading if there are no serious warnings
and precautions.

What [BRAND NAME] is 1used for:

 [text]
 [text]
[For products that have been authorized under the Notice of Compliance with Conditions (NOC/c)
policy, include the following boxed statement:]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 33 of 42

 “For the following indication(s) [BRAND NAME] has been approved with conditions (NOC/c). This
means it has passed Health Canada’s review and can be bought and sold in Canada, but the
manufacturer has agreed to complete more studies to make sure the drug works the way it should.
For more information, talk to your healthcare professional.”
[Provide a bullet listing of the indications from 1 Indications]
 [text]
[If the Indications section includes lifestyle recommendations as part of the therapy, they should be
included here]
“For the following indication(s) [BRAND NAME] has been approved without conditions. This means it
has passed Health Canada’s review and can be bought and sold in Canada.”
[Provide a bullet listing of the indications from 1 Indications]
 [text]
[If the Indications section includes lifestyle recommendations as part of the therapy, they should be
included here]

For products that have been authorized under the NOC/c policy, the following text must be included:
What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in
Canada.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious
or life-threatening illness. The drug must show promising proof that it works well, is of high
quality, and is reasonably safe. Also, the drug must either respond to a serious medical need
in Canada, or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an
NOC/c, to complete more testing to make sure the drug works the way it should, to actively
monitor the drug’s performance after it has been sold, and to report their findings to Health
Canada.

How [BRAND NAME] works:

[narrative]

In one or two sentences, summarize the information in 10 Clinical Pharmacology to describe how the
drug works—explaining the mechanism of action of the drug, in plain language, how long it takes to
work and how to know if it is working (e.g., improved symptomatology).

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 34 of 42

The ingredients in [BRAND NAME] are:
Medicinal ingredient(s): [List all medicinal ingredient(s)]
Non-medicinal ingredients: [List all non-medicinal ingredients 1in alphabetical order]

[BRAND NAME] comes in the following dosage form(s):

[dosage form(s) and strength(s)]

List all authorized dosage forms followed by strengths in increasing order, as listed in 6 Dosage
Forms, Strengths, Composition, and Packaging.

Do not use [BRAND NAME] if:

 [text]
 [text]

Provide a bullet listing of the contraindications listed from 2 Contraindications.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you
take [BRAND NAME]. Talk about any health conditions or problems you may have, including if you:
 [text]
 [text]

Provide a bullet listing of items listed in 7 Warnings and Precautions that relate to pre-existing
conditions for which there is a medical history. Do not repeat items from 3 Serious Warning and
Precautions Box.

1Other warnings you should know about:

 [text]

Provide general information that would not appear in 3 Serious Warning and Precautions Box or
other existing headings. Otherwise, this heading is not required.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins,
minerals, natural supplements or alternative medicines.
Serious drug interactions:

Serious drug interactions with [BRAND NAME] include:

 [text]
 [text]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 35 of 42

 The box should contain a bullet listing of serious or significant interactions provided in 9.1 Serious
Drug Interactions.
Delete this box, along with the section heading, if there are no serious drug interactions.

The following may [also] interact with [BRAND NAME]:

 [list]

Provide a bullet listing of each relevant interaction listed in 9 Drug Interactions. Do not repeat
interactions that are listed in the Serious Drug Interactions Box.

Include information to ensure patients are aware of any medications, foods (e.g., citrus, dairy),
beverages (e.g., alcohol) or natural health products (e.g., St. John’s wort) known to interact with this
medication.

If there is no “Serious Drug Interactions” subsection, use the following heading for this section:

The following may interact with [BRAND NAME]:

If there is a “Serious Drug Interactions” section included, use the following heading for this section:

The following may also interact with [BRAND NAME]:

Delete this section heading if there are no interactions to include.

How to take [BRAND NAME]:

 [text]

Relevant information should be included from 4 Dosage and Administration and 12 Special Handling
Instructions. Text should include when to take the drug, how to take the drug and other related
details.
Consider the following or similar statements as required:
Do not use this medication if it looks cloudy or is leaking.
or
[BRAND NAME] will be given to you by a healthcare professional in a healthcare setting.
or
[for radiopharmaceuticals:] [product] will be given to you by a healthcare professional who is
experienced in the use of radiopharmaceuticals.

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 36 of 42

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 37 of 42
Usual dose:
[text]

From 4 Dosage and Administration, provide the usual dose and other related details about the dose.

Overdose:
[text]

If you think you, or a person you are caring for, have taken too much [BRAND NAME], contact a
healthcare professional, hospital emergency department, regional poison control centre or Health
Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no
signs or symptoms.

From 5 Overdose, provide information on what to do if the individual has taken too much
medication including accidental ingestion. The boxed message may be modified to provide the most
appropriate advice according to current standards of care for this drug product.

Missed dose:
[text]

Include information from 4.5 Missed Dose. The following or similar statement should be included,
which is most appropriate for the drug/dosing regimen:
If you missed a dose of this medication, take it as soon as you remember. But if it is almost
time for your next dose, skip the missed dose and continue with your next scheduled dose. Go
back to the regular dosing schedule. Do not take two doses at the same time.
or
If you missed a dose of this medication, you do not need to make up the missed dose. Skip
the missed dose and continue with your next scheduled dose. Do not take two doses at the
same time.

Possible side effects from using [BRAND NAME]:

1These are not all the possible side effects you may have when taking [BRAND NAME]. If you
experience any side effects not listed here, tell your healthcare professional.
[text]

Self-limiting side effects should be described in the text section only. Those listed in 3 Serious
Warnings and Precautions Box must be listed in the serious side effects table. Each side effect should

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 38 of 42

 appear only once, in text or in the table, to avoid duplication.

Only one bulleted list of self-limiting side effects and one table of serious side effects should appear
in this section for all indications and active ingredients for the drug product.

If there are no serious side effects, delete the table along with the heading “Serious Side Effects and
What To Do About Them.”

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 39 of 42

Serious side effects and what to do about them
Talk to your healthcare professional [Stop taking this
drug and get
immediate medical
Frequency/Side Effect/Symptom
Only if severe In all cases help] OR [Get
immediate medical
help]
Very common
Clinical term (plain language
description): symptoms
Clinical term (plain language
description): symptoms
Common
Clinical term (plain language
description): symptoms
Clinical term (plain language
description): symptoms
Uncommon
Clinical term (plain language
description): symptoms
Clinical term (plain language
description): symptoms
Rare
Clinical term (plain language
description): symptoms
Clinical term (plain language
description): symptoms
Very rare
Clinical term (plain language
description): symptoms
Clinical term (plain language
description): symptoms
Unknown
Clinical term (plain language
description): symptoms
Clinical term (plain language
description): symptoms

If you have a troublesome symptom or 1side effect that is not listed here or becomes bad enough to
interfere with your daily activities, tell your healthcare professional.

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 40 of 42

 Reporting side effects

You can report any suspected side effects associated with the use of health products to Health
Canada by:

 Visiting the Web page on Adverse Reaction Reporting ([Link]/drug-device-reporting) for

information on how to report online, by mail or by fax; or
 Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side
effects. The Canada Vigilance Program does not provide medical advice.

Reporting suspected side effects for vaccines

For the general public: Should you experience a side effect following immunization, please report it to
your healthcare professional.
Should you require information related to the management of the side effect, please contact your
healthcare professional. The Public Health Agency of Canada (PHAC), Health Canada (HC), and
[Sponsor Name] cannot provide medical advice.

For healthcare professionals: If a patient experiences a side effect following immunization, please
complete the Adverse Events Following Immunization (AEFI) Form appropriate for your
province/territory (Reporting Adverse Events Following Immunization (AEFI) in Canada) and send it to
your local Health Unit.

Choose the reporting box option that is most appropriate for this product.

Storage:
[text]
Keep out of reach and sight of children.

Include information from 11 Storage, stability, and disposal. For drugs that are exclusively
administered by healthcare professionals and stored in a healthcare setting, it is not necessary to
include the above statement.

Where applicable, include relevant information provided in 12 Special handling instructions.

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 41 of 42

If you want more information about [BRAND NAME]:
 Talk to your healthcare professional
 Find the full product monograph that is prepared for healthcare professionals 1and includes the
Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug
Product Database: Access the database); the manufacturer’s website [website]; or by calling
[phone number].
This leaflet was prepared by [Sponsor Name] [Sponsor address optional].
[Canadian distributor/importer name and address optional]
Date of Authorization: [YYYY-MM-DD]

[Trademark statements optional]

<BRAND NAME><Non-proprietary name of the drug product(s)> Page 42 of 42