Land: Singapore
Språk: engelska
Källa: HSA (Health Sciences Authority)
BOSENTAN MONOHYDRATE 129.082MG EQV BOSENTAN
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
C02KX01
125 mg
TABLET, FILM COATED
BOSENTAN MONOHYDRATE 129.082MG EQV BOSENTAN 125 mg
ORAL
Prescription Only
PATHEON INC
ACTIVE
2004-05-06
TRACLEER® _COMPOSITION _ Active substance: Bosentan (as monohydrate) (62.5 mg or 125 mg). Excipients: maize starch, pregelatinised maize starch, sodium starch glycollate, povidone, glyceryl behenate, magnesium stearate, hypromellose, glycerol triacetate, talc, titanium dioxide, iron oxide yellow, iron oxide red, ethylcellulose _PHARMACEUTICAL FORM AND WEIGHT OF ACTIVE SUBSTANCE PER DOSAGE UNIT _ Film-coated tablets 62.5mg (orange white, round, biconvex, with «62.5» stamped on one side) and 125 mg (orange white, oval, biconvex, with «125» stamped on one side) _ _ _INDICATIONS / AREAS OF USE _ Treatment of pulmonary arterial hypertension (PAH) in patients with WHO functional class III or IV symptoms, to improve exercise ability and decrease the rate of clinical worsening. Some improvements have also been shown in patients with PAH WHO functional class II Reduction in the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer disease. _POSOLOGY AND METHOD OF ADMINISTRATION _ Treatment should only be initiated and monitored by a doctor with experience in the treatment of pulmonary arterial hypertension and systemic sclerosis. Tracleer should be taken in the morning and evening, with or without food. The film-coated tablets are to be swallowed with water. _Pulmonary arterial hypertension (PAH) _ Treatment with Tracleer should be started at a dosage of twice daily 62.5 mg over a period of four weeks, followed by an increase to a maintenance dose of twice daily 125 mg. _Systemic sclerosis with active digital ulcer disease _ Treatment with Tracleer should be started at a dosage of 62.5 mg twice daily over a period of four weeks, followed by an increase to a maintenance dose of 125 mg twice daily. Experience from controlled clinical trials in this i Läs hela dokumentet
1 TRACLEER ® _COMPOSITION _ Active substance: Bosentan (as monohydrate) (62.5 mg or 125 mg). Excipients: maize starch, pregelatinised maize starch, sodium starch glycollate, povidone, glyceryl behenate, magnesium stearate, hypromellose, glycerol triacetate, talc, titanium dioxide, iron oxide yellow, iron oxide red, ethylcellulose _PHARMACEUTICAL FORM AND WEIGHT OF ACTIVE SUBSTANCE PER DOSAGE UNIT _ Film-coated tablets 62.5mg (orange white, round, biconvex, with «62.5» stamped on one side) and 125 mg (orange white, oval, biconvex, with «125» stamped on one side) _ _ _INDICATIONS / AREAS OF USE _ Treatment of pulmonary arterial hypertension (PAH) in patients with WHO functional class III or IV symptoms, to improve exercise ability and decrease the rate of clinical worsening. Some improvements have also been shown in patients with PAH WHO functional class II. Reduction in the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer disease. _POSOLOGY AND METHOD OF ADMINISTRATION _ Treatment should only be initiated and monitored by a doctor with experience in the treatment of pulmonary arterial hypertension and systemic sclerosis. Tracleer ® should be taken orally in the morning and evening, with or without food. The film- coated tablets are to be swallowed with water. Patients must be urged to refrain from swallowing the desiccant in the white high density polyethylene bottle. _Pulmonary arterial hypertension (PAH) _ Treatment with Tracleer ® should be started at a dosage of twice daily 62.5 mg over a period of four weeks, followed by an increase to a maintenance dose of twice daily 125 mg. _Systemic sclerosis with active digital ulcer disease _ Treatment with Tracleer ® should be started at a dosage of 62.5 mg twice daily over a period of four weeks, followed by an increase to a maintenance dose of 125 mg twice daily. Experience from controlled clinical trials in this indication is limited to a period of 6 months. Response to treatment and the necessity of continuing treat Läs hela dokumentet