Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 160 mg

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

avera mckennan hospital - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

avera mckennan hospital - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 120 mg

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg

Kanada - Englisch - Health Canada

merck canada inc - doravirine - tablet - 100mg - doravirine 100mg - nonnucleoside reverse transcriptase inhibitors

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

a-s medication solutions - doravirine (unii: 913p6lk81m) (doravirine - unii:913p6lk81m) - pifeltro™ is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 35 kg: - with no prior antiretroviral treatment history; or - to replace the current antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine [see clinical studies (14)] . pifeltro is contraindicated when co-administered with drugs that are strong cytochrome p450 (cyp)3a enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of pifeltro [see warnings and precautions (5.1), drug interactions (7.1), and clinical pharmacology (12.3)] . these drugs include, but are not limited to, the following: - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the androgen

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

a-s medication solutions - doravirine (unii: 913p6lk81m) (doravirine - unii:913p6lk81m) - pifeltro® is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 35 kg: - with no prior antiretroviral treatment history; or - to replace the current antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine [see clinical studies (14)] . pifeltro is contraindicated when co-administered with drugs that are strong cytochrome p450 (cyp)3a enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of pifeltro [see warnings and precautions (5.1), drug interactions (7.1), and clinical pharmacology (12.3)] . these drugs include, but are not limited to, the following: - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the androgen receptor inhibitor enzalutamide - the antimycobacterials rifampin, rifapentine - the cytotoxic agent mitotane - st. john's wort (hypericum perforatum) pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to pifeltro during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary no adequate human data are available to establish whether or not pifeltro poses a risk to pregnancy outcomes. in animal reproduction studies, no adverse developmental effects were observed when doravirine was administered at exposures ≥8 times the exposure in humans at the recommended human dose (rhd) of pifeltro (see data ). the background rate of major birth defects is 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp). the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in the clinically recognized pregnancies in the u.s. general population is 15-20%. methodological limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates individuals and infants from the limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation. data animal data doravirine was administered orally to pregnant rabbits (up to 300 mg/kg/day on gestation days (gd) 7 to 20) and rats (up to 450 mg/kg/day on gd 6 to 20 and separately from gd 6 to lactation/postpartum day 20). no significant toxicological effects on embryo-fetal (rats and rabbits) or pre/post-natal (rats) development were observed at exposures (auc) approximately 9 times (rats) and 8 times (rabbits) the exposure in humans at the rhd. doravirine was transferred to the fetus through the placenta in embryo-fetal studies, with fetal plasma concentrations of up to 40% (rabbits) and 52% (rats) that of maternal concentrations observed on gd 20. risk summary the centers for disease control and prevention recommend that hiv-1-infected mothers in the united states not breastfeed their infants to avoid risking potential transmission of hiv-1 infection. it is unknown whether doravirine is present in human milk, affects human milk production, or has effects on the breastfed infant. doravirine is present in the milk of lactating rats (see data ). because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving pifeltro. data doravirine was excreted into the milk of lactating rats following oral administration (450 mg/kg/day) from gd 6 to lactation day 14, with milk concentrations approximately 1.5 times that of maternal plasma concentrations observed 2 hours post dose on lactation day 14. the safety and efficacy of pifeltro for the treatment of hiv-1 infection have been established in pediatric patients weighing at least 35 kg [see indications and usage (1) and dosage and administration (2.1)]. use of pifeltro in this group is supported by evidence from adequate and well-controlled trials in adults and an open-label trial in virologically-suppressed or treatment-naïve pediatric subjects 12 to less than 18 years of age. the safety, efficacy, and exposure of doravirine in these pediatric subjects were similar to that in adults. [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.3).] safety and efficacy of pifeltro in pediatric patients weighing less than 35 kg have not been established. clinical trials of pifeltro did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. in general, caution should be exercised in the administration of pifeltro in elderly patients, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)] . no dosage adjustment of pifeltro is required in patients with mild, moderate, or severe renal impairment. pifeltro has not been adequately studied in patients with end-stage renal disease and has not been studied in dialysis patients [see clinical pharmacology (12.3)] . no dosage adjustment of pifeltro is required in patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. pifeltro has not been studied in patients with severe hepatic impairment (child-pugh class c) [see clinical pharmacology (12.3)] .

Kanada - Englisch - Health Canada

merck canada inc - doravirine; lamivudine; tenofovir disoproxil fumarate - tablet - 100mg; 300mg; 300mg - doravirine 100mg; lamivudine 300mg; tenofovir disoproxil fumarate 300mg - nonnucleoside reverse transcriptase inhibitors

Singapur - Englisch - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - doravirine - tablet, film coated - doravirine 100.0mg