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ZIAGEN Oral solution (2018)

Active ingredients: Abacavir

Product Name and Form

Ziagen 20 mg/ml oral solution.

Pharmaceutical form

Oral solution.

The oral solution is clear to slightly opalescent yellowish, aqueous solution which may turn into a brown colour over time.

Qualitative and Quantitative Composition

Each ml of oral solution contains 20 mg of abacavir (as sulfate).

Excipients with known effect:

Sorbitol (E420) 340 mg/ml

Methyl parahydroxybenzoate (E218) 1.5 mg/ml

Propyl parahydroxybenzoate (E216) 0.18 mg/ml

For the full list of excipients see section 6.1.

Chemical substance
Description
Abacavir

Abacavir is a potent selective inhibitor of HIV-1 and HIV-2. The mechanism of action as to HIV, is the inhibition of the enzyme reverse transcriptase of HIV, an event that causes chain termination and stopping the replication cycle of the virus.

List of excipients

Sorbitol 70% (E420)
Saccharin sodium
Sodium citrate
Citric acid anhydrous
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Propylene glycol (E1520)
Maltodextrin
Lactic acid
Glyceryl triacetate
Artificial strawberry and banana flavours
Purified water
Sodium hydroxide and/or hydrochloric acid for pH adjustment

Pack sizes and Marketing

Ziagen oral solution is supplied in high density polyethylene bottles with child-resistant closures, containing 240 ml of oral solution.

The pack also includes a polyethylene syringe-adapter and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.

Marketing authorization holder
Authorization dates

ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Date of first authorisation: 8 July 1999

Date of latest renewal: 21 March 2014

Marketing authorization number:

EU/1/99/112/002