For the use only of Registered Medical Practitioners or a Hospital or a Laboratory

BOOSTRIX

Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, Reduced

Antigens Content) Ph. Eur.

1. NAME OF THE MEDICINAL PRODUCT

Diphtheria, Tetanus and Pertussis (Acellular, Component) Vaccine (Adsorbed, reduced

antigens content) Ph. Eur.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 dose (0.5 mL) contains:

Diphtheria toxoid1 not less than 2 International Units (IU) (2.5Lf)

Tetanus toxoid1 not less than 20 International Units (IU) (5 Lf)

Bordetella pertussis antigens:

Pertussis toxoid1 8 micrograms
Filamentous Haemagglutinin1 8 micrograms
Pertactin1 2.5 micrograms
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.3 milligrams Al3+
and aluminium phosphate (AlPO4) 0.2 milligrams Al3+

The vaccine may contain traces of formaldehyde which is used during the manufacturing
process (see section 4.3 Contraindications).

For the full list of excipients, see section 6.1 List of Excipients.

3. PHARMACEUTICAL FORM

Suspension for injection.

BOOSTRIX is a turbid white suspension.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

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BOOSTRIX is indicated for booster vaccination against diphtheria, tetanus and pertussis in
individuals aged 4 years and above who have previously completed primary vaccination with
DPT.

The administration of BOOSTRIX should be based on official recommendations.

4.2 Posology and method of administration

Posology

A single 0.5 ml dose of the vaccine is recommended.

BOOSTRIX may be administered from the age of 4 years onwards.

BOOSTRIX should be administered in accordance with official recommendations and/or local

practice regarding the use of vaccines with reduced content of diphtheria, tetanus and pertussis
antigens.

BOOSTRIX can be administered to pregnant women during the second or the third trimester in
accordance with official recommendations (see sections 4.6 Pregnancy and lactation and 5.1
Pharmacodynamic Properties).

BOOSTRIX may also be administered to adolescents and adults with unknown vaccination
status or incomplete vaccination against diphtheria, tetanus and pertussis as part of an
immunisation series against diphtheria, tetanus and pertussis. Based on data in adults, two
additional doses of a diphtheria and tetanus containing vaccine are recommended one and six
months after the first dose to maximize the vaccine response against diphtheria and tetanus (see
section 5.1 Pharmacodynamic Properties).

BOOSTRIX can be used in the management of tetanus prone injuries in persons who have
previously received a primary vaccination series of tetanus toxoid vaccine and for whom a
booster against diphtheria and pertussis is indicated. Tetanus immunoglobulin should be
administered concomitantly in accordance with official recommendations.

Repeat vaccination against diphtheria, tetanus and pertussis should be performed at intervals
as per official recommendations (generally 10 years).

Paediatric population

The safety and efficacy of BOOSTRIX in children below 4 years of age have not been
established.

Method of administration

BOOSTRIX is for deep intramuscular injection preferably in the deltoid region (see section 4.4
Special warnings and precautions for use).
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4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 List of
excipients or formaldehyde.

Hypersensitivity after previous administration of a diphtheria, tetanus or pertussis vaccines.

BOOSTRIX is contraindicated if the subject has experienced an encephalopathy of unknown

aetiology occurring within 7 days following a previous vaccination with pertussis-containing
vaccine. In these circumstances, pertussis vaccination should be discontinued and the
vaccination course should be continued with diphtheria and tetanus vaccines .

BOOSTRIX should not be administered to subjects who have experienced transient

thrombocytopenia or neurological complications (for convulsions or hypotonic-hyporesponsive
episodes, see section 4.4 Special warnings and precautions for use) following an earlier
immunisation against diphtheria and/or tetanus.

As with other vaccines, administration of BOOSTRIX should be postponed in subjects suffering

from acute severe febrile illness. The presence of a minor infection is not a contra-indication.

4.4 Special warnings and precautions for use

Vaccination should be preceded by a review of the medical history (especially with regard to
previous vaccination and possible occurrence of undesirable events).

If any of the following events are known to have occurred in temporal relation to receipt of
pertussis-containing vaccine, the decision to give doses of pertussis-containing vaccines should
be carefully considered:
- Temperature of ≥ 40.0°C within 48 hours of vaccination, not due to another identifiable
cause.
- Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of
vaccination.
- Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
- Convulsions with or without fever, occurring within 3 days of vaccination.

There may be circumstances, such as a high incidence of pertussis, when the potential benefits
outweigh possible risks.

As for any vaccination, the risk-benefit of immunising with BOOSTRIX or deferring this
vaccination should be weighed carefully in a child suffering from a new onset or progression of
a severe neurological disorder.

As with all injectable vaccines, appropriate medical treatment and supervision should always
be readily available in case of a rare anaphylactic reaction following the administration of the
vaccine.
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BOOSTRIX should be administered with caution to subjects with thrombocytopenia (see section
4.3 Contraindications) or a bleeding disorder since bleeding may occur following an
intramuscular administration to these subjects. The vaccine may be administered
subcutaneously to these subjects. With both routes of administration, firm pressure should be
applied to the injection site (without rubbing) for at least two minutes.

BOOSTRIX should in no circumstances be administered intravascularly .

A history or a family history of convulsions and a family history of an adverse event following
DTP vaccination do not constitute contraindications.

Human Immunodeficiency Virus (HIV) infection is not considered as a contra-indication. The

expected immunological response may not be obtained after vaccination of immunosuppressed
patients.

Syncope (fainting) can occur following, or even before, any vaccination especially in
adolescents as a psychogenic response to the needle injection. This can be accompanied by
several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic
limb movements during recovery. It is important that procedures are in place to avoid injury
from faints.

As with any vaccine, a protective immune response may not be elicited in all vaccinees.

Excipients

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially
‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

Use with other vaccines or immunoglobulins

BOOSTRIX may be administered concomitantly with human papilloma virus vaccine with no
clinically relevant interference with antibody response to any of the components of either
vaccine.

BOOSTRIX can be given concomitantly with meningococcal serogroups A, C, W-135 and Y

(MenACWY) conjugate vaccines. Clinical studies in subjects aged 9 to 25 years demonstrated
that the immune responses to the tetanus, diphtheria and meningococcal antigens were
unaffected. Lower geometric mean concentrations (GMCs) were observed for the pertussis
antigens; however, these data do not suggest clinically relevant interference.

BOOSTRIX can be given concomitantly with unadjuvanted inactivated seasonal influenza

vaccines. When BOOSTRIX was co-administered with a trivalent inactivated influenza vaccine
in subjects aged between 19 and 64 years, clinical data demonstrated that the immune responses
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to the tetanus, diphtheria, pertussis toxoid (PT) and influenza antigens were unaffected. Lower
GMCs were observed for the pertussis filamentous haemagglutinin (FHA) and pertactin (PRN)
antigens; however, these data do not suggest clinically relevant interference. No differences
were observed in a predefined exploratory cohort when the vaccines were given concomitantly
or separately to subjects aged 65 years and older.

Concomitant administration of BOOSTRIX with other vaccines or with immunoglobulins has

not been studied.

It is unlikely that co-administration with other inactivated vaccines or with immunoglobulins

will result clinically relevant in interference with the immune responses.

According to generally accepted vaccine practices and recommendations, if concomitant

administration of BOOSTRIX with other vaccines or immunoglobulins is considered necessary,
the products should be given at separate sites.

Use with immunosuppressive treatment

As with other vaccines, patients receiving immunosuppressive therapy may not achieve an
adequate response.

4.6 Pregnancy and lactation

Fertility

No human data from prospective clinical studies are available. Animal studies do not indicate
direct or indirect harmful effects on female fertility (see section 5.3 Preclinical safety data).

Pregnancy

BOOSTRIX can be used during the second or third trimester of pregnancy in accordance with
official recommendations.

For data relating to the prevention of pertussis disease in infants born to women vaccinated
during pregnancy, see section 5.1 Pharmacodynamic Properties.

Safety data from a randomised controlled clinical trial (341 pregnancy outcomes) and from a
prospective observational study (793 pregnancy outcomes), where BOOSTRIX was
administered to pregnant women during the third trimester, have shown no vaccine related
adverse effect on pregnancy or on the health of the foetus/newborn child.

Safety data from prospective clinical studies on the use of BOOSTRIX or BOOSTRIX POLIO
during the first and second trimester of pregnancy are not available.

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Data from passive surveillance where pregnant women were exposed to BOOSTRIX or to
BOOSTRIX POLIO (dTpa-IPV vaccine) in the 3rd or 2nd trimester have shown no vaccine-
related adverse effect on pregnancy or on the health of the foetus/newborn child.

As with other inactivated vaccines, it is not expected that vaccination with BOOSTRIX harms
the foetus at any trimester of pregnancy.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,
embryonal/foetal development, parturition or post-natal development (see section 5.3
Preclinical safety data).

Lactation

The effect of administration of BOOSTRIX during lactation has not been assessed. Nevertheless,
as BOOSTRIX contains toxoids or inactivated antigens, no risk to the breastfed infant should be
expected. The benefits versus the risk of administering BOOSTRIX to breastfeeding women
should carefully be evaluated by the health-care providers.

4.7 Effects on Ability to Drive and Use Machines

The vaccine is unlikely to produce an effect on the ability to drive and use machines.

4.8 Undesirable Effects

Summary of the safety profile

The safety profile presented below is based on data from clinical trials where BOOSTRIX was
administered to 839 children (from 4 to 8 years of age) and 1931 adults, adolescents and children
(from 10 to 76 years of age) (Table 1).

The most common events occurring after BOOSTRIX administration in both groups were local
injection site reactions (pain, redness and swelling) reported by 23.7 – 80.6% of subjects in each
trial. These usually had their onset within the first 48 hours after vaccination. All resolved
without sequelae.

Tabulated list of adverse reactions

Adverse reactions reported are listed according to the following frequency:

Very common: (≥1/10)

Common: (≥ 1/100 to < 1/10)
Uncommon: (≥ 1/1,000 to < 1/100)
Rare: (≥ 1/10,000 to < 1/1,000)
Very rare: (< 1/10,000)

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Within each frequency grouping, undesirable effects are presented in order of decreasing
seriousness.

Clinical trials

Table 1: Adverse reactions reported in clinical trials with BOOSTRIX

Adverse reactions
Subjects aged 4 - 8 Subjects aged 10 - 76
System Organ Class Frequency
years years
(N=839) (N = 1931)
Infections and Uncommon upper respiratory tract upper respiratory tract
infestations infection infection, pharyngitis
Blood and lymphatic Uncommon lymphadenopathy
system disorders
Metabolism and Common anorexia
nutrition disorders
Psychiatric disorders Very irritability
common
Nervous system Very common somnolence headache
disorders
Common headache dizziness

Uncommon disturbances in syncope

attention
Eye disorders Uncommon conjunctivitis

Respiratory, thoracic Uncommon cough

and mediastinal
disorders
Gastrointestinal Common diarrhoea, vomiting, nausea, gastrointestinal
disorders gastrointestinal disorders
disorders
Uncommon diarrhoea, vomiting
Skin and Uncommon rash hyperhidrosis, pruritus,
subcutaneous tissue rash
disorders
Musculoskeletal and Uncommon arthralgia, myalgia, joint
connective tissue stiffness,
disorders musculoskeletal
stiffness
General disorders and Very injection site reactions injection site reactions
administration site common (such as redness and/or (such as redness and/or
conditions swelling), injection site swelling), malaise,
pain, fatigue fatigue, injection site
pain
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 Adverse reactions
Subjects aged 4 - 8 Subjects aged 10 - 76
System Organ Class Frequency
years years
(N=839) (N = 1931)
Common pyrexia (fever ≥ pyrexia (fever ≥
37.5°C including fever 37.5°C), injection site
> 39.0°C), extensive reactions (such as
swelling of vaccinated injection site mass and
limb (sometimes injection site abscess
involving the adjacent sterile)
joint)
Uncommon other injection site pyrexia (fever >
reactions (such as 39.0°C), influenza like
induration), pain illness, pain

Reactogenicity after repeat dose

Data on 146 subjects suggest that there might be a small increase in local reactogenicity (pain,
redness, swelling) with repeated vaccination according to a 0, 1, 6 months schedule in adults
(>40 years of age).

Data suggest that in subjects primed with DTP in childhood a second booster dose might give
an increase of local reactogenicity.

Post-marketing surveillance

Because these events were reported spontaneously, it is not possible to reliably estimate their
frequency.

Table 2: Adverse reactions reported with BOOSTRIX during post-marketing surveillance

System Organ Class Frequency Adverse reactions

Immune system disorders unknown Allergic reactions, including anaphylactic and
anaphylactoid reactions
Nervous system disorders unknown Hypotonic-hyporesponsiveness episodes,
convulsions (with or without fever)
Skin and subcutaneous tissue unknown Urticaria, angioedema
disorders
General disorders and unknown Asthenia
administration site conditions

Following administration of tetanus toxoid containing vaccines, there have been very rare
reports of adverse reactions on the central or peripheral nervous systems, including ascending
paralysis or even respiratory paralysis (e.g. Guillain-Barré syndrome).
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 4.9 Overdose

Cases of overdose have been reported during post-marketing surveillance. Adverse events
following overdosage, when reported, were similar to those reported with normal vaccine
administration.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Bacterial vaccines, pertussis vaccines; ATC code: J07AJ52.

Immune response

Approximately one month following booster vaccination with BOOSTRIX, the following
seroprotection / seropositivity rates were observed (Table 3):

Table 3: Immune response in children, adolescents and adults

Adults and
Children from the
adolescents from
age of 4 years
the age of 10 years
onwards
Antigen Response(1) onwards
ATP(2)
ATP(2)
N=415
N=1694
(% vaccinees)
(% vaccinees)
Diphtheria ≥ 0.1 IU/ml 97.2% 99.8%
Tetanus ≥ 0.1 IU/ml 99.0% 100.0%
Pertussis:
- Pertussis toxoid 97.8% 99.0%
- Filamentous haemagglutinin ≥ 5 EL.U/ml 99.9% 100.0%
- Pertactin 99.4% 99.8%
(1)
Response: where, at the specified time point, a concentration of antibodies against diphtheria and tetanus ≥
0.1 IU/ml was considered as seroprotection and a concentration of antibodies against pertussis ≥ 5 EL.U/ml
was considered as seropositivity.
(2)
ATP: According to protocol – includes all eligible subjects, who had received a single booster dose of
BOOSTRIX, for whom immunogenicity data was available for at least one antigen at the specified time-point.
N: the minimum number of subjects with available data for each antigen.

In adolescents and adults, comparative trials have demonstrated that one month post-
vaccination, diphtheria antibody titres are similar to adult-type Td vaccines with the same
antigen content as BOOSTRIX; lower tetanus antibody titres were seen as compared to adult-
type Td vaccines.

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 As with other adult-type Td vaccines, BOOSTRIX induces higher titres of both anti-D and anti-
T antibodies in children and adolescents as compared to adults.

Persistence of the immune response

Three to 3.5 years, 5 to 6 years and 10 years following a first vaccination with BOOSTRIX, the
following seroprotection/seropositivity rates were observed in subjects vaccinated according to
protocol (ATP1) (Table 4):

Table 4: Persistence of immune response in children, adolescents and adults

Antigen Response Children from the age

(2) Adults and adolescents from the age of 10 years onwards
of 4 years onwards
(% vaccinees)
(% vaccinees)
3-3.5
3-3.5 years 10 years years 5 to 6 years
5 years persistence
persistence persistence persisten persistence
ce
Adult(3) Adole- Adult(3) Adole- Adult(3) Adole-
(N=309 scent(3) (N=232 scent(3) (N=158 scent(3) (N=118) (N=68)
) (N=261) ) (N=250) ) (N=74)
Diphtheria ≥ 0.1
71.2% 91.6% 84.1% 86.8% 64.6% 82.4% 97.5 % 94.2 %
IU/ml
≥ 0.016 Not
97.4% 100% 94.4% 99.2% 89.9% 98.6% 100 %
IU/ml(4) determined
≥ 0.1
Tetanus 94.8% 100% 96.2% 100% 95.0% 97.3% 98.4 % 98.5 %
IU/ml
Pertussis
Pertussis toxoid 90.6% 81.6% 89.5% 76.8% 85.6% 61.3% 58.7 % 51.5 %
Filamentous ≥5
Haemagglutinin EL.U/ml 100% 100% 100% 100% 99.4% 100% 100 % 100 %
Pertactin 94.8% 99.2% 95.0% 98.1% 95.0% 96.0% 99.2 % 100 %
(1)
ATP: According to protocol –includes all eligible subjects who had received a single booster dose of
BOOSTRIX for whom immunogenicity data was available for at least one antigen at the specified time-point.
(2)
Response: Where, at the specified time point, a concentration of antibodies against diphtheria and tetanus ≥
0.1 IU/ml was considered as seroprotection and, a concentration of antibodies against pertussis ≥ 5 EL.U/ml
was considered as seropositivity.
(3)
The terms ‘adult’ and ‘adolescent’ reflect the ages at which subjects received their first vaccination with
BOOSTRIX.
(4)
Percentage of subjects with antibody concentrations associated with protection against disease (≥ 0.1 IU/ml
by ELISA assay or ≥ 0.016 IU/ml by an in-vitro Vero-cell neutralisation assay).
N = the minimum number of subjects with available data for each antigen.

Efficacy in protecting against pertussis

The pertussis antigens contained in BOOSTRIX are an integral part of the paediatric acellular
pertussis combination vaccine (INFANRIX), for which efficacy after primary vaccination has
been demonstrated in a household contact efficacy study. The antibody titres to all three
pertussis components following vaccination with BOOSTRIX are higher than those observed
during the household contact efficacy trial. Based on these comparisons, BOOSTRIX would

10
provide protection against pertussis, however the degree and duration of protection afforded by
the vaccine are undetermined.

Passive protection against pertussis in infants (below 3 months of age) born to mothers
vaccinated during pregnancy

In a randomised, cross-over, placebo-controlled study, higher pertussis antibody concentrations

were demonstrated at delivery in the cord blood of babies born to mothers vaccinated with
BOOSTRIX (dTpa group; N=291) versus placebo (control group; N=292) at 27-36 weeks of
pregnancy. The cord blood geometric mean concentrations of antibodies against the pertussis
antigens PT, FHA and PRN were 46.9, 366.1 and 301.8 IU/ml in the dTpa group, and 5.5, 22.7
and 14.6 IU/ml in the control group. This corresponds to antibody titres that are 8, 16 and 21
times higher in the cord blood of babies born to vaccinated mothers versus controls. These
antibody titres may provide passive protection against pertussis as shown by observational
effectiveness studies.

Immunogenicity in infants and toddlers born to mothers vaccinated during pregnancy

The immunogenicity of INFANRIX HEXA (diphtheria, tetanus, pertussis, hepatitis B,

inactivated poliovirus, Haemophilus influenzae type b conjugate vaccine) in infants and toddlers
born to healthy mothers vaccinated with BOOSTRIX at 27-36 weeks of pregnancy was evaluated
in two clinical studies.

INFANRIX HEXA was co-administered with a 13-valent pneumococcal conjugate vaccine to

infants for primary vaccination (n=268); and to the same infants/toddlers from 11 to 18 months
as booster dose (n=229).

Post-primary and post-booster vaccination, immunological data did not show clinically relevant
interference of maternal vaccination with BOOSTRIX on the infant’s and toddler’s responses to
diphtheria, tetanus, hepatitis B, inactivated poliovirus, Haemophilus influenzae type b or
pneumococcal antigens.

Lower antibody concentrations against pertussis antigens post-primary (PT, FHA and PRN) and
post-booster (PT, FHA) vaccination were observed in infants and toddlers born to mothers
vaccinated with BOOSTRIX during pregnancy. The fold-increases of anti-pertussis antibody
concentrations from the pre-booster to the 1-month post-booster time point were in the same
range for infants and toddlers born to mothers vaccinated with BOOSTRIX or with placebo,
demonstrating effective priming of the immune system. In the absence of correlates of
protection for pertussis, the clinical relevance of these observations remains to be fully
understood. However, current epidemiological data on pertussis disease following the
implementation of dTpa maternal immunisation do not suggest any clinical relevance of this
immune interference.

Effectiveness in the protection against pertussis disease in infants born to women vaccinated
during pregnancy.

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BOOSTRIX or BOOSTRIX POLIO vaccine effectiveness (VE) was evaluated in three
observational studies, in UK, Spain and Australia. The vaccine was used during the third
trimester of pregnancy to protect infants below 3 months of age against pertussis disease, as
part of a maternal vaccination programme.

Details of each study design and results are provided in Table 5.

Table 5: VE against pertussis disease for infants below 3 months of age born to mothers
vaccinated during the third trimester of pregnancy with BOOSTRIX / BOOSTRIX POLIO:

Study location Vaccine Study design Vaccination Effectiveness

UK BOOSTRIX Retrospective, screening 88% (95% CI: 79, 93)
POLIO method
Spain BOOSTRIX Prospective, matched case- 90.9% (95% CI: 56.6, 98.1)
control
Australia BOOSTRIX Prospective, matched case- 69% (95% CI: 13, 89)
control
CI: confidence interval

If maternal vaccination occurs within two weeks before delivery, vaccine effectiveness in the
infant may be lower than the figures in the table.

Immune response after a repeat dose of BOOSTRIX

The immunogenicity of BOOSTRIX administered 10 years after a previous booster dose with
reduced-antigen content diphtheria, tetanus and acellular pertussis vaccine(s) has been
evaluated. One month post vaccination, > 99 % of subjects were seroprotected against
diphtheria and tetanus and seropositive against pertussis.

Immune response in subjects without prior or with unknown vaccination history

After administration of one dose of BOOSTRIX to 83 adolescents aged from 11 to 18 years,

without previous pertussis vaccination and no vaccination against diphtheria and tetanus in the
previous 5 years, all subjects were seroprotected against tetanus and diphtheria.

The seropositivity rate after one dose varied between 87% and 100% for the different pertussis
antigens.

After administration of one dose of BOOSTRIX to 139 adults ≥ 40 years of age that had not
received any diphtheria and tetanus containing vaccine in the past 20 years, more than 98.5%
of adults were seropositive for all three pertussis antigens and 81.5% and 93.4% were
seroprotected against diphtheria and tetanus respectively. After administration of two additional
doses one and six months after the first dose, the seropositivity rate was 100% for all three
pertussis antigens and the seroprotection rates for diphtheria and tetanus reached 99.3% and
100% respectively.

5.2 Pharmacokinetic Properties

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Evaluation of pharmacokinetic properties is not required for vaccines.

5.3 Preclinical Safety Data

Reproductive toxicology

Fertility

Non-clinical data obtained with BOOSTRIX reveal no specific hazard for humans based on
conventional studies of female fertility in rats and rabbits.

Pregnancy

Non-clinical data obtained with BOOSTRIX reveal no specific hazard for humans based on
conventional studies of embryo-foetal development in rats and rabbits, and also of parturition
and postnatal toxicity in rats (up to the end of the lactation period).

Animal toxicology and/or pharmacology

Preclinical data reveal no special hazard for humans based on conventional studies of safety
and of toxicity.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Sodium chloride, water for injections.

For adjuvants, see section 2. Qualitative and quantitative composition.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other
medicinal products.

6.3 Shelf Life

48 months.

The expiry date of the vaccine is indicated on the label and packaging.

6.4 Special Precautions for Storage

Store in a refrigerator (+2 to +8°C).

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Stability data indicate that BOOSTRIX is stable at temperatures up to 37°C for 7 days. At the
end of this period BOOSTRIX should be used or discarded. These data are intended to guide
healthcare professionals in case of temporary temperature excursion only.

Do not freeze.

Store in the original package in order to protect from light.

Keep out of reach of children.

6.5 Nature and contents of Container

0.5 ml of suspension a in pre-filled syringe (type I glass) with a plunger stopper (butyl rubber)
and with a rubber tip cap. Pack sizes of 1 and 10, with or without needles

The tip cap and rubber plunger stopper of the pre-filled syringe and the stopper of the vial are
made with synthetic rubber.

All presentations may not be marketed in the country.

6.6 Special precautions for disposal and other handling

Prior to use, the vaccine should be at room temperature, and well shaken in order to obtain a
homogeneous turbid white suspension. Prior to administration, the vaccine should be visually
inspected for any foreign particulate matter and/or variation of physical aspect. In the event of
either being observed, do not administer the vaccine.

Instructions for the pre-filled syringe

Luer Lock Adaptor

Hold the syringe by the barrel, not by the
plunger.

Plunger Unscrew the syringe cap by twisting it

Barrel anticlockwise.
Cap

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 Needle hub To attach the needle, connect the hub to the
Luer Lock Adaptor and rotate a quarter turn
clockwise until you feel it lock.
Do not pull the syringe plunger out of the
barrel. If it happens, do not administer the
vaccine.

Disposal:

Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Pharmaceuticals Limited.

Registered Office
Dr. Annie Besant Road, Worli
Mumbai 400 030,
India

8. MARKETING AUTHORISATION NUMBER(S)

Import Permission No.: Import - 6056/05(B).

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorization (Form 45): 3rd August, 2005.

Trademarks are owned by or licensed to the GSK group of companies.

Version BTX/PI/IN/2023/01 dated 19-Jul-2023

Adapted from EU SPC dated 19-Dec-2022 [GDS 16 / IPI 17 dated 15-Aug-2022].

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