United States - English - 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

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

actelion pharmaceuticals us, inc. - macitentan (unii: z9k9y9wmvl) (macitentan - unii:z9k9y9wmvl) - macitentan 10 mg - opsumit is an endothelin receptor antagonist (era) indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to reduce the risks of disease progression and hospitalization for pah. effectiveness was established in a long-term study in pah patients with predominantly who functional class ii–iii symptoms treated for an average of 2 years. patients had idiopathic and heritable pah (57%), pah caused by connective tissue disorders (31%), and pah caused by congenital heart disease with repaired shunts (8%) [see clinical studies (14.1)] . opsumit may cause fetal harm when administered to a pregnant woman. opsumit is contraindicated in females who are pregnant. opsumit was consistently shown to have teratogenic effects when administered to animals. if opsumit is used during pregnancy, advise the patient of the potential risk to a fetus [see warnings and precautions (5.1) and use in specific popul

United States - English - 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

United States - English - 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

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

actelion pharmaceuticals us, inc. - mechlorethamine (unii: 50d9xsg0vr) (mechlorethamine - unii:50d9xsg0vr) - mechlorethamine 0.012 g in 60 g - valchlor is an alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous t-cell lymphoma in patients who have received prior skin-directed therapy. the use of valchlor is contraindicated in patients with known severe hypersensitivity to mechlorethamine. hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine. pregnancy category d [see warnings and precautions (5.5) ] risk summary mechlorethamine can cause fetal harm when administered to a pregnant woman. there are case reports of children born with malformations in pregnant women systemically administered mechlorethamine. mechlorethamine was teratogenic in animals after a single subcutaneous administration. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5) ]. animal data mechlorethamine caused fetal malformat

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

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

United States - English - 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

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

actelion pharmaceuticals us, inc. - non-medicated valchlor® demonstration gel does not contain mechlorethamine (the medicine in valchlor). the purpose of valchlor demonstration gel is to show healthcare providers and patients how to properly apply valchlor. this will also allow the user to experience the consistency of valchlor and how it may feel on the skin. this information does not take the place of talking to your healthcare provider about your condition or your treatment. how should valchlor demonstration gel be used? - use valchlor demonstration gel on clean and dry, healthy skin - if you take a bath or shower, be sure to use the gel after your skin is dry (at least 30 minutes after bathing or showering) how to use valchlor demonstration gel: some important do's and don'ts about valchlor demonstration gel: - when applying valchlor demonstration gel, avoid the eyes, mouth, and nose. - valchlor demonstration gel should only be used on healthy skin since it is non-medicated. - the 5g tube of valchlor demonstration gel is meant for single

United Arab Emirates - English - 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

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

modern pharmaceutical company switzerland - 60's (10's blister x 6) - tablet - 800 microgram/tablet - cardiovascular system-hypertension , heart failure