Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
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. |
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
Propylene glycol (E1520) 50 mg/ml
For the full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Abacavir |
Abacavir is a NRTI. It is a potent selective inhibitor of HIV-1 and HIV-2. Abacavir is metabolised intracellularly to the active moiety, carbovir 5'-triphosphate (TP). In vitro studies have demonstrated that its mechanism of action in relation to HIV is inhibition of the HIV reverse transcriptase enzyme, an event which results in chain termination and interruption of the viral replication cycle. |
| List of Excipients |
|---|
|
Sorbitol 70% (E420) |
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.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
EU/1/99/112/002
Date of first authorisation: 8 July 1999
Date of latest renewal: 21 March 2014
| Drug | Countries | |
|---|---|---|
| ZIAGEN | Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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