Australia - englanti - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - macitentan, quantity: 10 mg - tablet, film coated - excipient ingredients: sodium starch glycollate type a; magnesium stearate; microcrystalline cellulose; polysorbate 80; povidone; lactose monohydrate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - opsumit, as monotherapy or in combination with approved pah treatments (phosphodiesterase-5 inhibitors or inhaled prostanoids), is indicated for the treatment of: ?idiopathic pulmonary arterial hypertension ?heritable pulmonary arterial hypertension ?pulmonary arterial hypertension associated with connective tissue disease ?pulmonary arterial hypertension associated with congenital heart disease with repaired shunts in patients with who functional class ii, iii or iv symptoms.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - miglustat, quantity: 100 mg - capsule, hard - excipient ingredients: magnesium stearate; povidone; sodium starch glycollate; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid; potassium hydroxide; industrial methylated spirit; ammonia; sorbitan monolaurate; gelatin; sodium lauryl sulfate - zavesca is indicated for the oral treatment of patients with mild to moderate type 1 gaucher disease, for whom enzyme replacement therapy is not a therapeutic option. zavesca is indicated for the treatment of the progressive neurological manifestations in adult and paediatric patients with niemann-pick type c disease.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - bosentan monohydrate, quantity: 129.08 mg (equivalent: bosentan, qty 125 mg) - tablet, film coated - excipient ingredients: magnesium stearate; ethylcellulose; purified talc; pregelatinised maize starch; iron oxide red; iron oxide yellow; glyceryl behenate; triacetin; maize starch; titanium dioxide; sodium starch glycollate; hypromellose; povidone - tracleer is indicated for the treatment of: idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who functional class ii, iii or iv symptoms.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - bosentan monohydrate, quantity: 64.54 mg (equivalent: bosentan, qty 62.5 mg) - tablet, film coated - excipient ingredients: maize starch; iron oxide yellow; glyceryl behenate; triacetin; iron oxide red; purified talc; magnesium stearate; titanium dioxide; hypromellose; povidone; sodium starch glycollate; ethylcellulose; pregelatinised maize starch - tracleer is indicated for the treatment of: idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who functional class ii, iii or iv symptoms.

Israel - englanti - Ministry of Health

j-c health care ltd - bosentan - film coated tablets - bosentan 62.5 mg - bosentan - bosentan - treatment of pulmonary arterial hypertension (pah) in patients of who functional class ii-iv.reduction in the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer disease

Israel - englanti - Ministry of Health

j-c health care ltd - bosentan as monohydrate - film coated tablets - bosentan as monohydrate 62.5 mg - bosentan - bosentan - treatment of pulmonary arterial hypertension (pah) in patients of who functional class ii-iv.reduction in the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer disease.

Israel - englanti - Ministry of Health

j-c health care ltd - bosentan as monohydrate - film coated tablets - bosentan as monohydrate 125 mg - bosentan - bosentan - treatment of pulmonary arterial hypertension (pah) in patients of who functional class ii-iv.reduction in the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer disease

Yhdysvallat - englanti - 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 populations (8.1)] . opsumit is contraindicated in patients with a history of a hypersensitivity reaction to macitentan or any component of the product [see adverse reactions (6.2)] . risk summary based on data from animal reproduction studies, opsumit may cause embryo-fetal toxicity, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy. there are risks to the mother and the fetus associated with pulmonary arterial hypertension in pregnancy [see clinical considerations] . there are limited data on opsumit use in pregnant women. macitentan was teratogenic in rabbits and rats at all doses tested. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the risk to a fetus [see contraindications (4.1)] . 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 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk in patients with pulmonary arterial hypertension, pregnancy is associated with an increased rate of maternal and fetal morbidity and mortality, including spontaneous abortion, intrauterine growth restriction and premature labor. data animal data 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. risk summary there are no data on the presence of macitentan in human milk, the effects on the breastfed infant, or the effect on milk production. because of the potential for serious adverse reactions in breastfed infants from opsumit advise women not to breastfeed during treatment with opsumit. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating opsumit, monthly during treatment and one month after stopping treatment with opsumit. 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 warnings and precautions (5.1), and dosage and administration (2.2) and contraindication (4.1)] . contraception female patients of reproductive potential must use acceptable methods of contraception during treatment with opsumit and for 1 month after treatment with opsumit. 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 based on findings in animals, opsumit may impair fertility in males of reproductive potential. it is not known whether effects on fertility would be reversible [see warnings and precautions (5.7), adverse reactions (6.1) and nonclinical toxicology (13.1)] . the safety and efficacy of opsumit in children have not been established. of the total number of subjects in the clinical study of opsumit for pah, 14% were 65 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Uusi-Seelanti - englanti - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bosentan 125mg;   - film coated tablet - 125 mg - active: bosentan 125mg   excipient: ethylcellulose glyceryl behenate hypromellose iron oxide red iron oxide yellow magnesium stearate maize starch povidone purified talc sodium starch glycolate starch titanium dioxide triacetin - tracleer® is indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.

Uusi-Seelanti - englanti - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bosentan 62.5mg (as monohydrate);   - film coated tablet - 62.5 mg - active: bosentan 62.5mg (as monohydrate)   excipient: ethylcellulose glyceryl behenate hypromellose iron oxide red iron oxide yellow magnesium stearate maize starch povidone purified talc sodium starch glycolate starch titanium dioxide triacetin - tracleer® is indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.