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

vifor (international) inc. - epoetin (unii: 64fs3bfh5w) (epoetin - unii:64fs3bfh5w) - retacrit is indicated for the treatment of anemia due to chronic kidney disease (ckd), including patients on dialysis and not on dialysis to decrease the need for red blood cell (rbc) transfusion. retacrit is indicated for the treatment of anemia due to zidovudine administered at ≤ 4,200 mg/week in patients with hiv-infection with endogenous serum erythropoietin levels of ≤ 500 munits/ml. retacrit is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. retacrit is indicated to reduce the need for allogeneic rbc transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dl who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. retacrit is not indicated for patients who are willing to donate autologous blood pre-operatively. retacrit has not been shown to improv

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

vifor (international) inc. - methoxy polyethylene glycol-epoetin beta (unii: lr3uxn0193) (methoxy polyethylene glycol-epoetin beta - unii:lr3uxn0193) - methoxy polyethylene glycol-epoetin beta 30 ug in 0.3 ml - mircera is indicated for the treatment of anemia associated with chronic kidney disease (ckd) in: limitations of use mircera is not indicated and is not recommended: mircera has not been shown to improve symptoms, physical functioning, or health-related quality of life. mircera is contraindicated in patients with: risk summary available data from a small number of published case reports and postmarketing experience with mircera use in pregnancy are insufficient to identify a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. chronic kidney disease is associated with maternal and embryo-fetal risks (see clinical considerations) . in animal reproduction studies, administration of methoxy polyethylene glycol-epoetin beta to rats and rabbits during pregnancy and lactation adversely affected offspring at doses 17-fold and greater than the recommended human dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populatio

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

vifor (international) inc. - difelikefalin acetate (unii: 0p70ar5byb) (difelikefalin - unii:na1u919mro) - korsuva is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (ckd-ap) in adults undergoing hemodialysis (hd). limitations of use korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population. none risk summary the limited human data on use of korsuva in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. in animal reproduction studies, intravenous injection of difelikefalin to pregnant rats and rabbits during the period of organogenesis at doses 711 and 10 times the maximum recommended human dose (mrhd), respectively, resulted in no adverse effects in either rats or rabbits (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in an embryofetal development study, difelikefalin was administered by intravenous injection to pregnant rats at doses of 0.25, 2.5, and 25 mg/kg/day during the period of organogenesis. difelikefalin was not associated with embryofetal lethality or fetal malformations. difelikefalin increased the incidences of skeletal variations (wavy ribs and incompletely ossified ribs) at the dose of 25 mg/kg/day (711 times the mrhd based on auc comparison). in an embryofetal development study, difelikefalin was administered by intravenous injection to pregnant rabbits at doses of 0.025, 0.05, and 0.1 mg/kg/day during the period of organogenesis. maternal toxicity evidenced by decreased maternal body weight gain was noted in all dose groups. difelikefalin was not associated with embryofetal lethality or fetal malformations at doses up to 0.1 mg/kg/day (10 times the mrhd based on auc comparison). in a prenatal and postnatal development study, difelikefalin was administered by intravenous injection to pregnant rats at doses of 0.6, 2.5, and 10 mg/kg/day beginning on gestation day 7 and continuing through lactation day 20. persisting effects on decreased maternal body weight and/or maternal body weight gain as well as food consumption were noted at doses greater than or equal to 2.5 mg/kg/day (68 times the mrhd based on auc comparison). no maternal effects were observed at 0.6 mg/kg/day (14 times the mrhd based on auc comparison). no difelikefalin-related effects on postnatal developmental, neurobehavioral, or reproductive performance of offspring were noted at doses up to 10 mg/kg/day (282 times the mrhd based on auc comparison). risk summary there are no data regarding the presence of korsuva in human milk or effects on the breastfed infant or on milk production. studies in rats showed difelikefalin was transferred into the milk in lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for korsuva and any potential adverse effects on the breastfed child from korsuva or from the underlying maternal condition. data animal data difelikefalin was administered to lactating rats by intravenous injection at doses of 0.6, 2.5, or 10 mg/kg/day from gestation day 7 through lactation day 14. difelikefalin was detected in the milk of the lactating rats with the concentration ratio for milk:plasma of 0.04 to 0.05 across the doses. there was no measurable difelikefalin in the plasma of nursing pups. the safety and effectiveness of korsuva in pediatric patients have not been established. of the 848 subjects in the placebo-controlled studies who received korsuva, 278 subjects (32.8%) were 65 years of age and older and 98 subjects (11.6%) were 75 years of age and older. no overall differences in safety or effectiveness of korsuva have been observed between patients 65 years of age and older and younger adult subjects, with the exception of the incidence of somnolence which was higher in korsuva-treated subjects 65 years of age and older (7.0%) than in korsuva-treated subjects less than 65 years of age (2.8%), and was comparable in both placebo age groups (3.0% and 2.1%, respectively). no differences in plasma concentrations of korsuva were observed between subjects 65 years of age and older and younger adult subjects [see clinical pharmacology ( 12.3)] . the influence of mild-to-moderate hepatic impairment on the pharmacokinetics of korsuva was evaluated in a population pharmacokinetic analysis which concluded that no korsuva dosage adjustments are needed in these populations [see clinical pharmacology ( 12.3)] . the influence of severe hepatic impairment on the pharmacokinetics of korsuva in subjects undergoing hd has not been evaluated; therefore, use of korsuva in this population is not recommended.

Singapore - English - HSA (Health Sciences Authority)

vifor pharma asia pacific pte. ltd. - hydroxide polymaltose complex eqv iron - syrup - 10mg/ml - hydroxide polymaltose complex eqv iron 50mg/5ml

Singapore - English - HSA (Health Sciences Authority)

vifor pharma asia pacific pte. ltd. - iron hydroxide polymaltose eqv iron - solution - 50 mg/ml - iron hydroxide polymaltose eqv iron 50 mg/ml

Singapore - English - HSA (Health Sciences Authority)

vifor pharma asia pacific pte. ltd. - ferric carboxymaltose 180 mg eqv iron - injection, solution - 50mg - ferric carboxymaltose 180 mg eqv iron 50 mg/ml

Israel - English - Ministry of Health

cts ltd - iron as sucroferric oxyhydroxide - chewable tablets - iron as sucroferric oxyhydroxide 500 mg - sucroferric oxyhydroxide - velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (ckd) patients on haemodialysis (hd) or peritoneal dialysis (pd).velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin d3 or one of its analogues, or calcimimetics to control the development of renal bone disease.

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

m/s. aspiro pharma limited - remdesivir - powder lyophilized for solution for infusion - 100mg

Singapore - English - HSA (Health Sciences Authority)

vifor pharma asia pacific pte. ltd. - iron(iii)-hydroxide polymaltose complex 357mg eqv iron (iii) - tablet, film coated - iron(iii)-hydroxide polymaltose complex 357mg eqv iron (iii) 100mg

Israel - English - Ministry of Health

cts ltd - ferric carboxymaltose - solution for injection / infusion - ferric carboxymaltose 1800 mg/vial - ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. the diagnosis must be based on laboratory tests.