United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 100 mg - lamivudine tablets (hbv) are indi cat ed for the t r e atm ent of ch ronic h ep atitis b vi rus ( h b v) in f ection asso ci at ed with evid e n ce of h ep atitis b vi ral r epli c ation and active liv er in f l amm ation [s ee clini cal studi es (14.1, 14.2 ) ] . the follo wing points sh ould be consid ered wh en initi ating th era py with lamivudine tablets (hbv): - due to hi gh rat es of resi st an ce d e v elopm ent in t r e at ed p ati ents, initi ation of t reatm ent with lamivudine tablets (hbv) should only be consid e r ed wh en the use of an alt e rn ative ant ivi ral a g ent with a hi gh er g en etic b arri er to r esist an ce is not av ail able or app rop ri a t e. - lamivudine tablets (hbv) h ave not b e en ev alu a t ed in p ati ents co -in fect ed with h i v, h e p atitis c vi rus (hc v), or h e p atitis d elta vi rus. - lamivudine tablets (hbv) h ave not b e en ev alu a t ed in liv er t ra nspl ant recipi ents or in p a ti ents with ch ronic h ep atiti

United States - English - NLM (National Library of Medicine)

american health packaging - 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 population for birth defects in the general p

United States - English - NLM (National Library of Medicine)

direct rx - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - lamivudine and zidovudine tablets usp, a combination of two nucleoside analogues, are 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. 8.1 pregnancy pregnancy category c. fetal risk summary: there are no adequate and well-controlled studies of lamivudine and zidovudine 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 and fetal malformations (zidovudine), and increased embryolethality (lamivudine). lamivudine and zidovudine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetu

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. limitations of use: - the dosage of this product is for hiv-1 and not for hbv. lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine 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 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 population for birth defects in the general population. t

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. limitations of use: the dosage of this product is for hiv-1 and not for hbv. lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263. available data from the antiretroviral pregnancy registry show no difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp). lamivudine produced embryonic toxicity in rabbits at a dose that produced similar human exposures as the recommended clinical

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. limitations of use: the dosage of this product is for hiv-1 and not for hbv. lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263. available data from the antiretroviral pregnancy registry show no difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp). lamivudine produced embryonic toxicity in rabbits at a dose that produced similar human exposures as the recommended clinical

United States - English - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - abacavir sulfate,lamivudine -

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - abacavir sulfate 702.78mg equivalent to abacavir 600 mg;  ; lamivudine 300mg - film coated tablet - active: abacavir sulfate 702.78mg equivalent to abacavir 600 mg   lamivudine 300mg excipient: colloidal silicon dioxide crospovidone magnesium stearate microcrystalline cellulose opadry white 13b58894 purified talc silicified microcrystalline cellulose - antiretroviral combination therapy for the treatment of hiv in adults and adolescents from 12 years of age.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v.  - lamivudine, zidovudine - hiv infections - antivirals for systemic use - lamivudine/zidovudine teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (hiv) infection.