Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
bosentan monohydrate, Quantity: 129.08 mg (Equivalent: bosentan, Qty 125 mg)
Generic Health Pty Ltd
bosentan monohydrate
Tablet, film coated
Excipient Ingredients: maize starch; pregelatinised maize starch; sodium starch glycollate type A; povidone; magnesium stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red
Oral
14 tablets in blister pack, 56 tablets in blister pack, 112 tablets in blister pack
(S4) Prescription Only Medicine
BOSENTAN GH 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.
Visual Identification: Orange-white, oval, biconvex, film-coated tablets, debossed with IB2 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-03-22
CONSUMER MEDICINE INFORMATION BOSENTAN GH (BOSENTAN MONOHYDRATE) FILM COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bosentan GH. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT BOSENTAN GH IS USED FOR Bosentan GH is used for the treatment of high blood pressure in the blood vessels between the heart and the lungs. This condition is called pulmonary arterial hypertension. This medicine acts to reduce abnormally high blood pressure by widening these blood vessels. It belongs to the class of medicines known as endothelin receptor antagonists. Your doctor however, may prescribe Bosentan GH for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE BOSENTAN GH _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU ARE: • PREGNANT OR INTEND TO BECOME PREGNANT. YOU MUST STOP TAKING THE MEDICINE AT LEAST 3 MONTHS BEFORE TRYING TO BECOME PREGNANT. It is known that this medicine causes harm to the developing baby if you take it during pregnancy and in the 3 months before becoming pregnant. • BREASTFEEDING. Tell your doctor immediately if you are breastfeeding. You are advised to stop breastfeeding if this medicine is prescribed for you because it is not known if this drug passes into the milk in women who are taking this medicine. • Being treated with ciclosporin (a medicine used after a transplant or to treat psoriasis). • Being treated with glibenclamide (a medicine used for diabetes). DO NOT TAKE BOSENTAN GH IF YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED A Baca dokumen lengkap
AUSTRALIAN PRODUCT INFORMATION – BOSENTAN GH (BOSENTAN MONOHYDRATE) FILM COATED TABLET WARNINGS: Cause birth defects and is contraindicated in pregnancy (see SECTION 4.3 CONTRAINDICATIONS and SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Rare cases of hepatic cirrhosis and hepatic failure have been reported in patients using bosentan (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 1 NAME OF THE MEDICINE Bosentan monohydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bosentan GH tablet contains 64.54 mg bosentan monohydrate is equivalent to 62.5 mg bosentan. Bosentan GH tablet contains 129.08 mg bosentan monohydrate is equivalent to 125 mg bosentan. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Bosentan GH 62.5 mg: Orange-white, round, biconvex, film-coated tablets, debossed with “IB1” on one side and plain on other side. Bosentan GH 125 mg: Orange-white, oval, biconvex, film-coated tablets, debossed with “IB2” on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bosentan GH 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. Bosentan GH v3.0 Page 2 of 27 (bosentan monohydrate) film coated tablet 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL Bosentan GH should be administered under the supervision of a physician experienced in the management of pulmonary arterial hypertension. Bosentan GH treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks. Efficacy was demonstrated in clinical trial subjects who increased to a maintenance dose of 125 mg twice daily. Doses above 125 mg twice daily did not appear to confer additional benefit sufficient to offset the in Baca dokumen lengkap