USA - engelska - NLM (National Library of Medicine)

lupin limited - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s), abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - lamivudine 150 mg - abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. limitations of use: - limited data exist on the use of abacavir, lamivudine and zidovudine tablets alone in patients with higher baseline viral load levels (greater than 100,000 copies per ml) [see clinical studies (14)] . abacavir, lamivudine and zidovudine tablets are contraindicated in patients: - who have the hla-b*5701 allele [see warnings and precautions (5.1)]. - with prior hypersensitivity reaction to abacavir [see warnings and precautions (5.1)], lamivudine, or zidovudine. - with moderate or severe hepatic impairment [see use in specific populations (8.7)] . teratogenic effects pregnancy category c: there are no adequate and well-controlled studies of abacavir, lamivudine and zidovudine tablets in pregnant women. reproduction studies with abacavir, lamivudine, and zidovudine have been p

USA - engelska - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - lamivudine and zidovudine tablets a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (hiv-1) infection.    lamivudine and zidovudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine. pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine and zidovudine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the overall risk of birth defects for lamivudine or zidovudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see data). the apr uses the macdp as the u.s. reference populatio

Australien - engelska - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - lamivudine,zidovudine -

Australien - engelska - Department of Health (Therapeutic Goods Administration)

viiv healthcare pty ltd - zidovudine, quantity: 250 mg - capsule, hard - excipient ingredients: gelatin; maize starch; microcrystalline cellulose; sodium starch glycollate; magnesium stearate; indigo carmine; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid; potassium hydroxide - retrovir is indicated for: . treatment of adult patients with severe symptomatic human immunodeficiency virus infection (aids or advanced aids related complex); . treatment of other hiv-positive adult patients with less than 500 cd4 cells/mm3. notes: (1) the limited available data currently support the extended use of retrovir (indication 2 above). (2) the optimal dosage for these indications has not been established. . combination therapy in advanced hiv infection. the addition of hivid (zalcitabine) may be considered for the management of adult patients with advanced hiv infection and cd4 + cell counts less than or equal to 200/mm3, who have received retrovir monotherapy for less than 12 months. retrovir monotherapy is still indicated as initial therapy for adult patients with hiv infection who fulfil the approved indications. new indications approved 7th february 1997: retrovir (zidovudine) is indicated for the treatment of hiv infection, alone and in combination with other antiretroviral therapies. the optimum dosage for this indication has not been established.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

viiv healthcare pty ltd - zidovudine, quantity: 100 mg - capsule - excipient ingredients: sodium starch glycollate; microcrystalline cellulose; maize starch; magnesium stearate; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid; potassium hydroxide - retrovir is indicated for: . treatment of adult patients with severe symptomatic human immunodeficiency virus infection (aids or advanced aids related complex); . treatment of other hiv-positive adult patients with less than 500 cd4 cells/mm3. notes: (1) the limited available data currently support the extended use of retrovir (indication 2 above). (2) the optimal dosage for these indications has not been established. . combination therapy in advanced hiv infection. the addition of hivid (zalcitabine) may be considered for the management of adult patients with advanced hiv infection and cd4 + cell counts less than or equal to 200/mm3, who have received retrovir monotherapy for less than 12 months. retrovir monotherapy is still indicated as initial therapy for adult patients with hiv infection who fulfil the approved indications. new indications approved 7th february 1997: retrovir (zidovudine) is indicated for the treatment of hiv infection, alone and in combination with other antiretroviral therapies. the optimum dosage for this indication has not been established.

Tanzania - engelska - Tanzania Medicinces & Medical Devices Authority

mylan laboratories limited, india - lamivudine , zidovudine - tablet, dispersible - lamivudine 30mg/zidovudine 60mg

Kenya - engelska - Pharmacy and Poisons Board

mylan laboratories limited c/o surgilinks ltd mylan laboratories limited r&d center plot no. - lamivudine usp zidovudine usp - film-coated tablet - lamivudine usp 150mg zidovudine usp 300mg - antivirals for systemic use: combinations of

Kenya - engelska - Pharmacy and Poisons Board

mylan laboratories limited c/o surgilinks ltd mylan laboratories limited r&d centre plot no. - lamivudine usp zidovudine usp - dispersible tablet - lamivudine usp 30mg zidovudine usp 60mg - antivirals for systemic use: combinations of

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

milpharm ltd - lamivudine; zidovudine - tablet - 150mg ; 300mg

USA - engelska - NLM (National Library of Medicine)

exelan pharmaceuticals inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - lamivudine and zidovudine tablet, usp a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of hiv-1 infection. lamivudine and zidovudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, stevens-johnson syndrome) to any of the components of the product. teratogenic effects: pregnancy category c. fetal risk summary: there are no adequate and well-controlled studies of lamivudine and zidovudine tablet in pregnant women. clinical trial data demonstrate that maternal zidovudine treatment during pregnancy reduces vertical transmission of hiv-1 infection to the fetus. animal reproduction studies performed with lamivudine and zidovudine showed increased embryotoxicity fetal malformations (zidovudine), and increased embryolethality (lamivudine). lamivudine and zidovudine tablet should be used during pregnancy only if the potential benefit justifies the potential ris