Singapur - angličtina - HSA (Health Sciences Authority)

organon singapore pte. ltd. - hydrochlorothiazide; losartan potassium - tablet, film coated - 12.5 mg - hydrochlorothiazide 12.5 mg; losartan potassium 50 mg

Singapur - angličtina - HSA (Health Sciences Authority)

organon singapore pte. ltd. - amlodipine camsylate 7.84mg eqv to amlodipine; losartan 91.52mg eqv to losartan potassium - tablet, film coated - 5mg - amlodipine camsylate 7.84mg eqv to amlodipine 5mg; losartan 91.52mg eqv to losartan potassium 100.00mg

Singapur - angličtina - HSA (Health Sciences Authority)

organon singapore pte. ltd. - amlodipine camsylate 7.84mg eqv to amlodipine; losartan 45.76mg eqv to losartan potassium - tablet, film coated - 5mg - amlodipine camsylate 7.84mg eqv to amlodipine 5mg; losartan 45.76mg eqv to losartan potassium 50.00mg

Malta - angličtina - Medicines Authority

anfarm hellas s.a. 4 achaias str. & trizinias 14564 kifissia, attiki, greece - enalapril maleate - tablet - enalapril maleate 5 mg - agents acting on the renin-angiotensin system

Malta - angličtina - Medicines Authority

anfarm hellas s.a. 4 achaias str. & trizinias 14564 kifissia, attiki, greece - enalapril maleate - tablet - enalapril maleate 20 mg - agents acting on the renin-angiotensin system

Evropská unie - angličtina - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren - hypertension - agents acting on the renin-angiotensin system - treatment of essential hypertension

Velká Británie - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol laboratories ltd - ramipril - oral capsule - 1.25mg

Spojené státy - angličtina - NLM (National Library of Medicine)

lexicon pharmaceuticals, inc. - sotagliflozin (unii: 6b4zbs263y) (sotagliflozin - unii:6b4zbs263y) - inpefa is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: - heart failure or - type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors inpefa is contraindicated in patients with a history of serious hypersensitivity reaction to inpefa. risk summary based on animal data showing renal effects, inpefa is not recommended during the second and third trimesters of pregnancy. available data with inpefa in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with untreated heart failure in pregnancy [see clinical considerations] . in rats, renal changes were observed when sotagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. exposure approximately 5 times the clinical exposure at the maximum recommended human dose (mrhd) of 400 mg once daily caused increased kidney weights and renal pelvis and tubule dilatations that were partially reversible [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk pregnant women with congestive heart failure are at increased risk for preterm birth. clinical classification of heart disease may worsen with pregnancy and lead to maternal death. data animal data in embryo-fetal development studies in rats and rabbits, sotagliflozin was administered for intervals coinciding with the first trimester period of organogenesis in humans. sotagliflozin was not teratogenic when administered at doses up to 100 mg/kg/day in pregnant rats during embryonic organogenesis (40 times the human exposure at the mrhd). higher exposures (350 mg/kg or 161 times the human exposure at the mrhd) resulted in embryo-lethality, effects on fetal growth, and cardiovascular and skeletal fetal abnormalities commensurate with maternal toxicity. sotagliflozin was not teratogenic when administered at doses up to 200 mg/kg/day in pregnant rabbits (9 times the human exposure at the mrhd). in a prenatal and postnatal development study in pregnant and lactating rats, sotagliflozin was administered at oral doses up to 100 mg/kg/day from gestation day 6 through to lactation day 20 (weaning). an increased incidence of dilated kidneys with discoloration and dilated ureters was observed at doses ≥ 30 mg/kg (≥ 4 times the human exposure at the mrhd). sotagliflozin did not adversely affect developmental landmarks, sexual maturation, or reproductive performance of the offspring at doses up to 40 times the human exposure at the mrhd. sotagliflozin dosed directly to juvenile rats from postnatal day (pnd) 21 until pnd 90 at doses of 3, 10, 30, and 75 mg/kg/day caused dose-related increased kidney weights for males given ≥ 10 mg/kg/day and females given ≥ 30 mg/kg/day and was correlated with renal tubular and pelvis dilation for animals given ≥ 30 mg/kg/day. these findings were fully or partially reversed after a 29-day recovery period. these outcomes occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimesters of human development. risk summary there are no data on the presence of inpefa in human milk, the effects on the breastfed infant, or the effects on milk production. sotagliflozin is present in rat milk (see data). when a drug is present in animal milk, it is likely to be present in human milk. since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. because of the potential for serious adverse reactions in a breastfed infant, advise women that breastfeeding is not recommended while taking inpefa. data in rats, after a single oral dose of radiolabeled sotagliflozin to dams on gestation day 13 or 18, low to moderate levels of radioactivity were present in fetal tissues. in rat milk, the mean milk/plasma concentration ratios ranged from 0.5 to 2. exposure to radioactivity was approximately 30% greater in milk than in plasma based on auc0-inf values. the safety and effectiveness of inpefa in pediatric patients under 18 years of age have not been established. no inpefa dosage change is recommended based on age. in the soloist study, a total of 241 (40%) patients treated with inpefa were between 65 and < 75 years of age, and 174 (29%) were ≥ 75 years of age. in the scored study, a total of 2,470 (47%) patients treated with inpefa were between 65 and < 75 years of age, and 1,240 (23%) were ≥ 75 years of age. no overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension. in patients ≥ 65 years of age, a higher proportion of patients treated with inpefa had adverse reactions of volume depletion [see warnings and precautions (5.2) and adverse reactions (6.1)]. inpefa was evaluated in 5,292 patients with chronic kidney disease (egfr 25 to 60 ml/min/1.73 m2 ) in the scored study and in 426 patients with heart failure with egfr < 60 ml/min/1.73 m2 in the soloist study. the safety profile of inpefa across egfr subgroups in these studies was consistent with the known safety profile. there was an increase in volume-related adverse events (e.g., hypotension, dizziness) in patients with egfr < 30 ml/min/1.73 m2 relative to the overall safety population [see warnings and precautions (5.2) and adverse reactions (6.1)]. efficacy and safety studies with inpefa did not enroll patients with an egfr less than 25 ml/min/1.73 m2 or on dialysis. after starting therapy in these studies, patients were discontinued if egfr fell below 15 ml/min/1.73 m2 or were initiated on chronic dialysis. in a clinical pharmacology study in patients with hepatic impairment, the exposure in mild hepatic impairment was not increased, but was approximately 3-fold as high in moderate and approximately 6-fold as high in severely hepatic-impaired subjects compared to subjects with normal hepatic function [see clinical pharmacology (12.3)] . no dosage adjustment is necessary in patients with mild hepatic impairment. the safety and efficacy of inpefa have not been established in patients with moderate or severe hepatic impairment [see clinical pharmacology (12.3)] . inpefa is not recommended in patients with moderate or severe hepatic impairment.

Singapur - angličtina - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - hydrochlorothiazide; irbesartan - tablet, film coated - 25.00mg - hydrochlorothiazide 25.00mg; irbesartan 300.00mg

Singapur - angličtina - HSA (Health Sciences Authority)

servier (s) pte ltd - perindopril arginine 10mg eqv to perindopril - tablet, film coated - 6.790 mg - perindopril arginine 10mg eqv to perindopril 6.790 mg