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34 views2 pages

Public Summary

Uploaded by

Rado
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Public Summary

Summary for ARTG Entry: 230396 ALPHACLAV DUO FORTE 875/125 amoxicillin 875 mg (as trihydrate) and clavulanic acid 125 mg (as
potassium) tablet blister pack

ARTG entry for Medicine Registered

Sponsor Alphapharm Pty Ltd


Postal Address PO Box R1462, ROYAL EXCHANGE, NSW, 1225
Australia
ARTG Start Date 16/10/2015
Product Category Medicine
Status Active
Approval Area Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods Under
Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered or
Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1 . ALPHACLAV DUO FORTE 875/125 amoxicillin 875 mg (as trihydrate) and clavulanic acid 125 mg (as

Public Summary
potassium) tablet blister pack
Product Type Single Medicine Product Effective Date 30/09/2020

Permitted Indications
No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Short-term treatment of bacterial infections at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing
organisms: Skin and skin structure infections. Urinary tract infections (complicated and uncomplicated). Upper respiratory tract infections, such as sinusitis,
otitis media and recurrent tonsillitis. Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic
bronchitis.
Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to
amoxycillin/clavulanic acid tablet preparations. However, when there is reason to believe an infection may involve any of the beta-lactamase producing
organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptible studies. Once
these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections cause by amoxycillin susceptible organisms and
beta-lactamase producing organisms susceptible to amoxycillin/clavulanic acid tablet preparations should not require the addition of another antibiotic due
to the amoxycillin content of these products.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type Material Life Time Temperature Closure Conditions


Blister Pack Al/Al 2 Years Store below 25 Not recorded Protect from Moisture
degrees Celsius

Pack Size/Poison information

Pack Size Poison Schedule


10 tablets (S4) Prescription Only Medicine

Components
1 . Medicine Component

Dosage Form Tablet, film coated

Page 1 of 2 Produced at 03.10.2020 at 04:11:16 AEST


This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
Route of Administration Oral
Visual Identification White to pale yellow, oblong, biconvex, film-coated tablets, scored on both sides.

Active Ingredients

amoxicillin trihydrate 1005 mg


Equivalent: amoxicillin 875 mg
Equivalent: amoxicillin 875 mg
potassium clavulanate 149 mg
Equivalent: amoxicillin 875 mg
Equivalent: clavulanic acid 125 mg

Other Ingredients (Excipients)

croscarmellose sodium
ethylcellulose
hypromellose
magnesium stearate
microcrystalline cellulose
povidone
purified talc

Public Summary
silicon dioxide
titanium dioxide
triethyl citrate

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Page 2 of 2 Produced at 03.10.2020 at 04:11:16 AEST


This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information

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