Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
bosentan monohydrate, Quantity: 64.541 mg
Alphapharm Pty Ltd
bosentan monohydrate
Tablet, film coated
Excipient Ingredients: sodium lauryl sulfate; glyceryl behenate; povidone; maize starch; pregelatinised maize starch; magnesium stearate; sodium starch glycollate type A; titanium dioxide; hypromellose; purified talc; triacetin; purified water; strong ammonia solution; ethylcellulose; oleic acid; medium chain triglycerides
Oral
60
(S4) Prescription Only Medicine
BOSENTAN VIATRIS 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: A white to off-white, film coated, round, biconvex, beveled edge tablet debossed with 'M' on one side of the tablet and 'BN1' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2016-12-19
BOSENTAN MYLAN _contains the active ingredient bosentan (as monohydrate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bosentan Mylan. 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 TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT BOSENTAN MYLAN IS USED FOR Bosentan Mylan 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 Mylan 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 MYLAN _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 three 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 cyclosporine A (a medicine used after a transplant or to treat psoriasis) • being treated with glibenclamide (a medicine used for diabetes) DO NOT TAKE BOSENTAN MYLAN IF YOU ARE ALLER Preberite celoten dokument
AUSTRALIAN PRODUCT INFORMATION BOSENTAN MYLAN _Bosentan (as monohydrate) film-coated tablet _ 1 NAME OF THE MEDICINE Bosentan (as monohydrate) _._ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bosentan monohydrate, a white to off-white powder, is practically insoluble at low pH (0.1 mg/100 mL at pH 1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility increases at higher pH values (43 mg/100 mL at pH 7.5). In the solid state, bosentan monohydrate is very stable, is not hygroscopic and shows no light sensitivity. BOSENTAN MYLAN 62.5 mg film coated tablets each contain 64.5411 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan, as the active ingredient. BOSENTAN MYLAN 125 mg film-coated tablets each contain 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan, as the active ingredient. Excipients of Known effects: BOSENTAN MYLAN also contains traces of sulfites For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM BOSENTAN 62.5 mg white to off-white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side of the tablet and “BN1” on the other side. BOSENTAN MYLAN 125 mg white to off-white, film-coated, oval, biconvex, beveled edge tablet debossed with “M” on one side of the tablet and “BN2” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BOSENTAN MYLAN 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. 4.2 DOSE AND METHOD OF ADMINISTRATION BOSENTAN MYLAN may 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 reporte Preberite celoten dokument