Combivir

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Lamivudine 150mg;  ; Zidovudine 300mg

Dostupné z:

GlaxoSmithKline NZ Limited

INN (Medzinárodný Name):

Lamivudine 150 mg

Dávkovanie:

150 mg/300 mg

Forma lieku:

Film coated tablet

Zloženie:

Active: Lamivudine 150mg   Zidovudine 300mg Excipient: Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Opadry white YS-1-7706-G Purified water Sodium starch glycolate

Počet v balení:

Blister pack, PVC & aluminium, 60 tablets

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

Mylan Laboratories Limited

Terapeutické indikácie:

Indicated for the treatment of HIV infected adults and adolescents over the age of 12 years, with progressive immunodeficiency (CD4 = Count = < 500 cells/mm3).

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 60 tablets - 24 months from date of manufacture stored at or below 30°C

Dátum Autorizácia:

1997-11-18

Súhrn charakteristických

1 
NEW ZEALAND DATA SHEET 
COMBIVIR
®
  TABLETS 
_LAMIVUDINE 150MG & ZIDOVUDINE 300MG TABLETS _

PRESENTATION 
COMBIVIR film-coated tablets contain 150mg lamivudine and 300mg 
zidovudine. 
COMBIVIR film-coated tablets are white to off-white capsule-shaped 
engraved with GXFC3 on one side. 
Do not halve tablet. 
USES 
_ACTIONS _
Pharmacotherapeutic group - nucleoside analogue. 
Lamivudine and zidovudine are potent, selective inhibitors of HIV-1
and HIV-
2. Lamivudine has been shown to be highly synergistic with
zidovudine, 
inhibiting the replication of HIV in cell culture. Both active
substances are 
metabolised sequentially by intracellular kinases to the
5’-triphosphate (TP). 
Lamivudine-TP and zidovudine-TP are substrates for and competitive 
inhibitors of HIV reverse transcriptase.  However, their main
antiviral activity is 
through incorporation of the monophosphate form into the viral DNA
chain, 
resulting in chain termination. Lamivudine and zidovudine
triphosphates show 
significantly less affinity for host cell DNA polymerases. 
_In vitro_, lamivudine demonstrates low cytotoxicity to peripheral
blood 
lymphocytes, to established lymphocyte and monocyte-macrophage cell
lines, 
and to a variety of bone marrow progenitor cells in vitro. Lamivudine
therefore 
has, in vitro, a high therapeutic index. 
HIV-1 resistance to lamivudine involves the development of a M184V
amino 
acid change close to the active site of the viral reverse
transcriptase (RT). 
This variant arises both _in vitro_ and in HIV-1 infected patients
treated with 
lamivudine-containing antiretroviral therapy.  M184V mutants display
greatly 
reduced susceptibility to lamivudine and show diminished viral
replicative 
capacity _in vitro_._ In vitro_ studies indicate
that zidovudine-resistant virus 
isolates can become zidovudine sensitive when they simultaneously
acquire 
resistance to lamivudine.  The clinical relevance of such findings
remains, 
however, not well defined. 
2 
Cros