Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
TRIZIVIR 300 mg/150 mg/300 mg film-coated tablets.
Pharmaceutical Form |
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Film-coated tablet (tablet). Blue-green capsule-shaped film-coated tablets engraved with “GX LL1” on one side. |
Each film-coated tablet contains 300 mg of abacavir (as sulfate), 150 mg lamivudine and 300 mg zidovudine.
Excipient(s) with known effect: Each 300 mg/150 mg/300 mg tablet contains 2.7 mg sodium.
For the full list of excipients see section 6.1.
Active Ingredient | Description | |
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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. |
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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. |
|
Zidovudine |
Zidovudine is an antiviral agent which is highly active in vitro against retroviruses including the Human Immunodeficiency Virus (HIV). |
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Zidovudine, Lamivudine and Abacavir |
Abacavir, lamivudine and zidovudine are all NRTIs, and are potent selective inhibitors of HIV-1 and HIV-2.All three medicinal products are metabolised sequentially by intracellular kinases to the respective 5′-triphosphate (TP). Lamivudine-TP, carbovir-TP (the active triphosphate form of abacavir) and zidovudine-TP are substrates for and competitive inhibitors of HIV reverse transcriptase (RT). However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination. Abacavir, lamivudine and zidovudine triphosphates show significantly less affinity for host cell DNA polymerases. |
List of Excipients |
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Tablet core: Microcrystalline cellulose Tablet coating Opadry Green 03B11434 containing: hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow. |
Trizivir tablets are available in opaque white PCTFE/PVC-Al blister packs or child-resistant foil PVC/PCTFE/PVC-Al/Paper blister packs containing 60 tablets, or child resistant HDPE bottles containing 60 tablets.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
EU/1/00/156/002 – opaque white PCTFE/PVC-Al Blister pack (60 Tablets)
EU/1/00/156/003 – Bottle pack (60 Tablets)
EU/1/00/156/004 – child-resistant foil PVC/PCTFE/PVC-Al/Paper Blister pack (60 Tablets)
Date of first authorisation: 28 December 2000
Date of latest renewal: 29 November 2010
Drug | Countries | |
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TRIZIVIR | Austria, Australia, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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