Σιγκαπούρη - Αγγλικά - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - selexipag - tablet, film coated - selexipag 1.2 mg

Σιγκαπούρη - Αγγλικά - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - selexipag - tablet, film coated - selexipag 1.4 mg

Σιγκαπούρη - Αγγλικά - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - selexipag - tablet, film coated - selexipag 1.6 mg

Σιγκαπούρη - Αγγλικά - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - selexipag - tablet, film coated - selexipag 0.4 mg

Σιγκαπούρη - Αγγλικά - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - selexipag - tablet, film coated - selexipag 0.6 mg

Σιγκαπούρη - Αγγλικά - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - selexipag - tablet, film coated - selexipag 0.8 mg

Σιγκαπούρη - Αγγλικά - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - epoprostenol sodium 0.531mg eqv epoprostenol - injection, powder, for solution - epoprostenol sodium 0.531mg eqv epoprostenol 0.5mg

Σιγκαπούρη - Αγγλικά - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - epoprostenol sodium 1.593mg eqv epoprostenol - injection, powder, for solution - epoprostenol sodium 1.593mg eqv epoprostenol 1.5mg

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

actelion pharmaceuticals us, inc. - macitentan (unii: z9k9y9wmvl) (macitentan - unii:z9k9y9wmvl), tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - opsynvi is the combination of macitentan and tadalafil indicated for the chronic treatment of adults with pulmonary arterial hypertension (pah, who group i and who functional class (fc) ii–iii). individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability [see clinical studies (14.1)] . opsynvi may cause fetal harm when administered to a pregnant woman. opsynvi is contraindicated in females who are pregnant. macitentan was consistently shown to have teratogenic effects when administered to animals. if opsynvi is used during pregnancy, advise the patient of the potential risk to a fetus [see warnings and precautions (5.1) and use in specific populations (8.1)] . opsynvi is contraindicated in patients with a history of a hypersensitivity reaction to macitentan, tadalafil, or any component of the product. hypersensitivity reactions have been reported. stevens-johnson syndrome and exfoliative dermatitis have been reported with tadalafil [see adverse reactions (6.2)]. opsynvi is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the last dose of opsynvi. tadalafil potentiates the hypotensive effect of nitrates. this potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cgmp pathway [see clinical pharmacology (12.2)]. coadministration of gc stimulators such as riociguat with opsynvi is contraindicated. tadalafil may potentiate the hypotensive effects of gc stimulators. risk summary based on data from animal reproduction studies, opsynvi is contraindicated during pregnancy. macitentan, a component of opsynvi, may cause embryo-fetal toxicity, including birth defects and fetal death, when administered to a pregnant female. the available data from opsynvi pharmacovigilance reports and published case reports on macitentan are insufficient to evaluate the potential risk of embryo-fetal toxicity. macitentan was teratogenic in rabbits and rats at all doses tested. available data from a randomized controlled trial, observational studies, and case series with tadalafil use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in tadalafil animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats and mice during organogenesis at exposures 7 times the maximum recommended human dose (mrhd) of 40 mg/day (see data) . there are risks to the mother and the fetus associated with pah in pregnancy (see clinical considerations) . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise pregnant women of the potential risk to a fetus [see contraindications (4.1) and warnings and precautions (5.1)]. the 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 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk in patients with pah, pregnancy is associated with an increased rate of maternal and fetal morbidity and mortality, including heart failure, stroke, spontaneous abortion, intrauterine growth restriction, premature labor, and preterm birth. data animal data macitentan in both rabbits and rats, there were cardiovascular and mandibular arch fusion abnormalities. administration of macitentan to female rats from late pregnancy through lactation caused reduced pup survival and impairment of the male fertility of the offspring at all dose levels tested. tadalafil tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day during organogenesis based on auc. in one of two perinatal/postnatal developmental studies in rats, a reduction of postnatal pup survival was observed at dose levels of 60, 200 and 1000 mg/kg. the no-observed-effect-level (noel) for developmental toxicity was 30 mg/kg, which provided maternal exposure to unbound tadalafil concentrations approximately 5 times the exposure at the mrhd based on auc. signs of maternal toxicity occurred at doses greater than 200 mg/kg/day, which produced aucs greater than 8 times the exposure at the mrhd. surviving offspring had normal development and reproductive performance. risk summary there are no data on the presence of tadalafil, macitentan, and/or their metabolites in human milk, the effects on the breastfed infant, or the effect on milk production. tadalafil and/or its metabolites are present in the milk of lactating rats (see data) . when a drug is present in animal milk, it is likely that the drug will be present in human milk. because of the potential for serious adverse reactions in breastfed infants from opsynvi, advise women not to breastfeed during treatment with opsynvi. data tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-times that found in the plasma. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating opsynvi, monthly during treatment and one month after stopping treatment with opsynvi. the patient should contact her physician immediately for pregnancy testing if onset of menses is delayed or pregnancy is suspected. if the pregnancy test is positive, the physician and patient must discuss the risks to her, the pregnancy, and the fetus [see dosage and administration (2.2) and contraindications (4.1)]. contraception female patients of reproductive potential must use acceptable methods of contraception during treatment with opsynvi and for 1 month after treatment with opsynvi. patients may choose one highly effective form of contraception (intrauterine devices (iud), contraceptive implants or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). if a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling [see warnings and precautions (5.1)] . infertility males macitentan based on findings in animals, macitentan may impair fertility in males of reproductive potential. it is not known whether effects on fertility would be reversible [see warnings and precautions (5.11), clinical pharmacology (12.2), and nonclinical toxicology (13.1)]. tadalafil based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. this effect was not seen in the study of 20 mg tadalafil taken for 6 months. there was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone. the clinical significance of the decreased sperm concentrations in the two studies is unknown. there have been no studies evaluating the effect of tadalafil on fertility in men or women [see clinical pharmacology (12.2) and nonclinical toxicology (13.1)] . the safety and efficacy of opsynvi in children has not been established. of the total number of subjects in the clinical study of opsynvi for pah, 20% were 65 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. the use of opsynvi is not recommended in patients undergoing dialysis. avoid use of opsynvi in patients with severe renal impairment (creatinine clearance 15–29 ml/min) because of increased tadalafil exposure (auc), lack of clinical experience and the lack of ability to influence clearance by dialysis. for patients with mild (creatinine clearance 51–80 ml/min) to moderate (creatinine clearance 30–50 ml/min) renal impairment, the recommended dose should be consistent with the adult dosing [see dosage and administration (2.1) and clinical pharmacology (12.3)]. opsynvi was not studied in severe hepatic impairment patients defined as a model for end-stage liver disease score ≥19. opsynvi must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the upper limit of normal at baseline (> 3 × uln). for patients with mild to moderate hepatic impairment (child pugh class a or b) the recommended dose should be consistent with the adult dosing see dosage and administration (2.1) [see warnings and precautions (5.3) and clinical pharmacology (12.3)].

Ηνωμένα Αραβικά Εμιράτα - Αγγλικά - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

modern pharmaceutical company switzerland - 30's (15's blister x 2) - tablet - 10 mg/tablet - cardiovascular system-hypertension , heart failure