Stany Zjednoczone - angielski - NLM (National Library of Medicine)

actelion pharmaceuticals us, inc. - epoprostenol (unii: dcr9z582x0) (epoprostenol - unii:dcr9z582x0) - epoprostenol 500000 ng in 10 ml - veletri is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise capacity. studies establishing effectiveness included predominantly patients with nyha functional class iii–iv symptoms and etiologies of idiopathic or heritable pah or pah associated with connective tissue diseases. a large study evaluating the effect of epoprostenol on survival in nyha class iii and iv patients with congestive heart failure due to severe left ventricular systolic dysfunction was terminated after an interim analysis of 471 patients revealed a higher mortality in patients receiving epoprostenol plus conventional therapy than in those receiving conventional therapy alone. the chronic use of veletri in patients with congestive heart failure due to severe left ventricular systolic dysfunction is therefore contraindicated. some patients with pulmonary hypertension have developed pulmonary edema during dose initiation, which may be associated with pulmonary veno-occlusive disease. vele

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

actelion pharmaceuticals us, inc. - iloprost (unii: jed5k35ygl) (iloprost - unii:jed5k35ygl) - iloprost 0.01 mg in 1 ml - ventavis is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (nyha class), and lack of deterioration. studies establishing effectiveness included predominately patients with nyha functional class iii–iv symptoms and etiologies of idiopathic or heritable pah (65%) or pah associated with connective tissue diseases (23%) [see clinical studies (14)] . none. risk summary limited published data from case series and case reports with ventavis in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with pulmonary arterial hypertension (see clinical considerations) . in animal reproductive studies, administration of continuous intravenous iloprost to pregnant han-wistar rats during organogenesis at doses 2-times the recommended human dose on a mg/m2 basis resulted in adverse develo

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

actelion pharmaceuticals us, inc. - miglustat (unii: adn3s497az) (miglustat - unii:adn3s497az) - miglustat 100 mg - zavesca is indicated as monotherapy for the treatment of adult patients with mild to moderate type 1 gaucher disease for whom enzyme replacement therapy is not a therapeutic option (e.g. due to allergy, hypersensitivity, or poor venous access). none. risk summary based on findings from animal reproduction studies, zavesca may cause fetal harm when administered to a pregnant woman. available data from postmarketing case reports with zavesca use in pregnancy are insufficient to assess a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks associated with symptomatic type i gaucher disease in pregnancy, including hepatosplenomegaly and thrombocytopenia (see clinical considerations). advise pregnant women of the potential risks to the fetus. in animal reproduction studies, miglustat was maternally toxic in rabbits at exposures near the expected human therapeutic dose and caused embryo-fetal toxicitie

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

actelion pharmaceuticals us, inc. - epoprostenol sodium (unii: 4k04iq1of4) (epoprostenol - unii:dcr9z582x0) - epoprostenol sodium 1500000 ng in 10 ml

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

actelion pharmaceuticals us, inc. - selexipag (unii: 5exc0e384l) (selexipag - unii:5exc0e384l) - selexipag 200 ug - uptravi is indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to delay disease progression and reduce the risk of hospitalization for pah. effectiveness of uptravi tablets was established in a long-term study in pah patients with who functional class ii–iii symptoms. patients had idiopathic and heritable pah (58%), pah associated with connective tissue disease (29%), pah associated with congenital heart disease with repaired shunts (10%) [see clinical studies (14.1)] . hypersensitivity to the active substance or to any of the excipients. concomitant use of strong inhibitors of cyp2c8 (e.g., gemfibrozil) [see drug interactions (7.1) and clinical pharmacology (12.3)] . risk summary there are no adequate and well-controlled studies with uptravi in pregnant women. animal reproduction studies performed with selexipag showed no clinically relevant effects on embryofetal developmen

Kanada - angielski - Health Canada

taro pharmaceuticals inc - bosentan (bosentan monohydrate) - tablet - 62.5mg - bosentan (bosentan monohydrate) 62.5mg - vasodilating agents

Kanada - angielski - Health Canada

taro pharmaceuticals inc - bosentan (bosentan monohydrate) - tablet - 125mg - bosentan (bosentan monohydrate) 125mg - vasodilating agents

Singapur - angielski - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - macitentan (micronized) - tablet, film coated - macitentan (micronized) 10.00mg

Singapur - angielski - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - selexipag - tablet, film coated - selexipag 0.2 mg

Singapur - angielski - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - selexipag - tablet, film coated - selexipag 1.0 mg