Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
ambrisentan, Quantity: 10 mg
Alphapharm Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; allura red AC aluminium lake; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake
Oral
30
(S4) Prescription Only Medicine
AMBRISENTAN VIATRIS is indicated for the treatment of:,- idiopathic pulmonary arterial hypertension (PAH),,- pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD), in patients with WHO functional class II, III or IV symptoms.
Visual Identification: A pink, film-coated, capsule shaped, biconvex tablet debossed with M on one side of the tablet and AN1 on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-04-01
AMBRISENTAN MYLAN _Ambrisentan_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING AMBRISENTAN MYLAN. This leaflet answers some common questions about AMBRISENTAN 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 benefits and risks. Your doctor has weighed the risks of you taking AMBRISENTAN MYLAN against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT AMBRISENTAN MYLAN IS USED FOR AMBRISENTAN MYLAN contains the active ingredient ambrisentan which is a type of medicine called an endothelin receptor antagonist (ERA). It is used to treat adults with pulmonary arterial hypertension (PAH), which is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. This causes people to become tired, dizzy and short of breath. This medicine works by widening the pulmonary arteries, making it easier for your heart to pump blood through them. This lowers the blood pressure and relieves your symptoms. AMBRISENTAN MYLAN is not recommended for use in children and patients under 18 years of age as there have been no studies of its effects in this age group. AMBRISENTAN MYLAN must not be used for the treatment of idiopathic pulmonary fibrosis (IPF) and must not be used in patients who have IPF with or without secondary pulmonary hypertension. AMBRISENTAN MYLAN is available as 5 mg and 10 mg tablets. This medicine is available only with a doctor's prescription BEFORE YOU TAKE AMBRISENTAN MYLAN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE AMBRISENTAN MYLAN IF YOU HAVE AN ALLERGY TO: • any medicine containing ambrisentan • any of the ingredients listed at the end of this leaflet Baca dokumen lengkap
AMBRISENTAN MYLAN_ Pg. 1 AUSTRALIAN PRODUCT INFORMATION AMBRISENTAN MYLAN _ambrisentan_ TERATOGENICITY AMBRISENTAN MYLAN MAY CAUSE BIRTH DEFECTS AND IS CONTRAINDICATED IN PREGNANCY (SEE SECTION 4.3 CONTRAINDICATIONS). 1. NAME OF THE MEDICINE Ambrisentan 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg or 10 mg of ambrisentan as the active ingredient. Excipients with known effect: Lactose. For the full list of excipients, see _Section 6.1 List of Excipients._ 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) AMBRISENTAN MYLAN 5 mg tablets are pink, round biconvex tablets debossed with ‘M’ on one side and ‘AN’ on the other. AMBRISENTAN MYLAN 10 mg tablets are pink, capsule shaped biconvex tablets debossed with ‘M’ on one side and ‘AN1’ on the other. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS AMBRISENTAN MYLAN is indicated for treatment of: • idiopathic pulmonary arterial hypertension (PAH), • pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD), in patients with WHO functional class II, III or IV symptoms. 4.2. DOSE AND METHOD OF ADMINISTRATION Treatment should only be initiated by a physician experienced in the treatment of PAH. AMBRISENTAN MYLAN is for oral use and can be administered with or without food. It is recommended that the tablet is swallowed whole and should not be split, crushed or chewed. AMBRISENTAN MYLAN should be taken orally at a dose of 5 mg once daily. Additional benefit may be obtained by increasing the dose to 10 mg (see _ Section 4.8 Adverse Effects (Undesirable Effects) _ and _5.1 Pharmacodynamic Properties,_ _Clinical Trials_ ). AMBRISENTAN MYLAN_ Pg. 2 AMBRISENTAN MYLAN – PRODUCT INFORMATION Limited data suggest that the abrupt discontinuation of ambrisentan is not associated with rebound worsening of PAH. USE WITH CICLOSPORIN A When co-administered with ciclosporin A, the dose of ambrisentan should be limited to 5 mg once daily (see _Section 4.5_ _Interactions with Other Medicines and Other Forms of Inte Baca dokumen lengkap