Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Kivexa 600 mg/300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side. |
Each film-coated tablet contains 600 mg of abacavir (as sulfate) and 300 mg lamivudine.
Excipient(s) with known effect: Each 600 mg/300 mg tablet contains 1.7 mg sunset yellow FCF (E110) and 2.31 mg sodium.
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. |
|
| Lamivudine |
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription. |
|
| Lamivudine and Abacavir |
Abacavir and lamivudine are NRTIs, and are potent selective inhibitors of HIV-1 and HIV-2 (LAV2 and EHO) replication. Both abacavir and lamivudine are metabolised sequentially by intracellular kinases to the respective 5'-triphosphate (TP) which are the active moieties. Their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination. |
| List of Excipients |
|---|
|
Tablet Core: Magnesium stearate Tablet Coating: Opadry Orange YS-1-13065-A containing: Hypromellose |
30 tablets in opaque white (PVC/PVDCAluminium/Paper) child-resistant blister packs Multipacks containing 90 (3 packs of 30) tablets in opaque white (PVC/PVDC-Aluminium/Paper) child-resistant blister packs.
Not all pack sizes may be marketed.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
EU/1/04/298/002
EU/1/04/298/003
Date of first authorization: 17 December 2004
Date of latest renewal: 17 November 2014
| Drug | Countries | |
|---|---|---|
| KIVEXA | Austria, Australia, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, South Africa |
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