Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - dolutegravir as sodium; lamivudine - film coated tablets - lamivudine 300 mg; dolutegravir as sodium 50 mg - lamivudine and dolutegravir - dovato is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine and viral load ≤500,000 c/ml.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

macleods pharmaceuticals limited, india - dolutegravir sodium, lamivudine , tenofovovir disoproxil fumarate - oral tablet - dolutegravir 50mg, lamivudine 300mg and tenofovir disoproxil fumerate 300mg

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

remedyrepack inc. - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - abacavir tablets usp 300 mg, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv-1) infection. abacavir tablet is 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)] . - with moderate or severe hepatic impairment [see use in specific populations ( 8.6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir sulfate 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 abacavir 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. the macdp evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks' gestation. the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15% to 20%. the background risk for major birth defects and miscarriage for the indicated population is unknown. in animal reproduction studies, oral administration of abacavir to pregnant rats during organogenesis resulted in fetal malformations and other embryonic and fetal toxicities at exposures 35 times the human exposure (auc) at the recommended clinical daily dose. however, no adverse developmental effects were observed following oral administration of abacavir to pregnant rabbits during organogenesis, at exposures approximately 9 times the human exposure (auc) at the recommended clinical dose (see data) . data human data: based on prospective reports to the apr of exposures to abacavir during pregnancy resulting in live births (including over 1,300 exposed in the first trimester and over 1,300 exposed in second/third trimester), there was no difference between the overall risk of birth defects for abacavir compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of defects in live births was 3.2% (95% ci: 2.3% to 4.3%) following first trimester exposure to abacavir-containing regimens and 2.9% (95% ci: 2.1% to 4.0%) following second/third trimester exposure to abacavir-containing regimens. abacavir has been shown to cross the placenta and concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery [see clinical pharmacology ( 12.3)] . animal data: abacavir was administered orally to pregnant rats (at 100, 300, and 1,000 mg per kg per day) and rabbits (at 125, 350, or 700 mg per kg per day) during organogenesis (on gestation days 6 through 17 and 6 through 20, respectively). fetal malformations (increased incidences of fetal anasarca and skeletal malformations) or developmental toxicity (decreased fetal body weight and crown-rump length) were observed in rats at doses up to 1,000 mg per kg per day, resulting in exposures approximately 35 times the human exposure (auc) at the recommended daily dose. no developmental effects were observed in rats at 100 mg per kg per day, resulting in exposures (auc) 3.5 times the human exposure at the recommended daily dose. in a fertility and early embryo-fetal development study conducted in rats (at 60, 160, or 500 mg per kg per day), embryonic and fetal toxicities (increased resorptions, decreased fetal body weights) or toxicities to the offspring (increased incidence of stillbirth and lower body weights) occurred at doses up to 500 mg per kg per day. no developmental effects were observed in rats at 60 mg per kg per day, resulting in exposures (auc) approximately 4 times the human exposure at the recommended daily dose. studies in pregnant rats showed that abacavir is transferred to the fetus through the placenta. in pregnant rabbits, no developmental toxicities and no increases in fetal malformations occurred at up to the highest dose evaluated, resulting in exposures (auc) approximately 9 times the human exposure at the recommended dose. risk summary the centers for disease control and prevention recommends that hiv-1-infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. abacavir is present in human milk. there is no information on the effects of abacavir on the breastfed infant or the effects of the drug on milk production. because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving abacavir tablets. the safety and effectiveness of abacavir sulfate have been established in pediatric patients aged 3 months and older. use of abacavir sulfate is supported by pharmacokinetic trials and evidence from adequate and well-controlled trials of abacavir sulfate in adults and pediatric subjects [see dosage and administration ( 2.3), adverse reactions ( 6.2), clinical pharmacology ( 12.3), clinical studies ( 14.2)] . clinical trials of abacavir sulfate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, caution should be exercised in the administration of abacavir sulfate in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. a dose reduction is required for patients with mild hepatic impairment (child-pugh class a) [see dosage and administration ( 2.4)] . the safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate or severe hepatic impairment; therefore, abacavir sulfate is contraindicated in these patients [see contraindications ( 4), clinical pharmacology ( 12.3)] .

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

viiv healthcare pty ltd - abacavir sulfate, quantity: 702 mg (equivalent: abacavir, qty 600 mg); lamivudine, quantity: 300 mg; dolutegravir, quantity: 50 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; povidone; magnesium stearate; purified water; mannitol; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - trelavue is indicated for the treatment of human immunodeficiency virus (hiv) infection in adults and adolescents from 12 years of age who are antiretroviral treatment-na?ve or are infected with hiv without documented or clinically suspected resistance to any of the three antiretroviral agents (dolutegravir, abacavir or lamivudine) in trelavue.

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

emcure pharmaceuticals ltd. - dolutegravir (dolutegravir sodium), lamivudine, tenofovir disoproxil fumarate - tablets film-coated - 50mg+ 300mg+ 300mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

emcure pharmaceuticals ltd. - dolutegravir (dolutegravir sodium) - tablets film-coated - 50mg

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - abacavir as sulfate - solution (oral) - abacavir as sulfate 20 mg/ml - abacavir - abacavir - ziagen is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infected .28/10/2018 בקשה לשינוי משטר מינון

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

aurobindo pharma limited - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. abacavir and lamivudine 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)] or lamivudine. • with moderate or severe hepatic impairment [see use in specific populations (8.7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and 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 abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defe

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

burel pharmaceuticals, llc - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. abacavir and lamivudine 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)] or lamivudine. • with moderate or severe hepatic impairment [see use in specific populations (8.7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and 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 abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan atl

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

major pharmaceuticals - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv-1) infection. abacavir tablets are contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir 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 abacavir 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. the macdp evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks’ gestation. the rate of miscarri