देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
ambrisentan, Quantity: 5 mg
Cipla Australia Pty Ltd
Ambrisentan
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; allura red AC aluminium lake; polyvinyl alcohol; macrogol 3350; lecithin
Oral
10 tablets, 30 tablets
(S4) Prescription Only Medicine
CIPLA AMBRISENTAN is indicated for the treatment of: - idiopathic pulmonary arterial hypertension (PAH), - pulmonary artrial hypertension associated with connective tissue disease (PAH-CTD),,in patients with WHO functional class II, III or IV symptoms.
Visual Identification: Pale pink, square shaped, biconvex film coated tablets debossed with CL on one side and 5 on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-09-14
CIPLA AMBRISENTAN 1 CIPLA AMBRISENTAN Consumer Medicine Information (CMI) summary The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. Why am I using Cipla Ambrisentan? Cipla Ambrisentan contains the active ingredient ambrisentan. Cipla Ambrisentan is used to treat adults with pulmonary arterial hypertension (PAH). For more information, see Section 1. Why am I using Cipla Ambrisentan? in the full CMI. 2. What should I know before I use Cipla Ambrisentan? Do not use if you have ever had an allergic reaction to ambrisentan or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Cipla Ambrisentan? in the full CMI. 3. What if I am taking other medicines? Some medicines may interfere with Cipla Ambrisentan and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. How do I use Cipla Ambrisentan? • The usual dose of Cipla Ambrisentan is 5 mg, once a day More instructions can be found in Section 4. How do I use Cipla Ambrisentan? in the full CMI. 5. What should I know while using Cipla Ambrisentan? Things you should do • Remind any doctor, dentist or pharmacist you visit that you are using Cipla Ambrisentan. • You must use reliable birth control (contraception) while using Cipla Ambrisentan and for 3 months after you stop taking it. Use at least two reliable forms of birth control (contraception). • If you are a male, you should avoid exposing your partner to your semen by use of appropriate contraception e.g. condoms. Things you should not do • Do not stop using this medicine suddenly or lower the dosage without checking with your doctor. Driving or using machines • Do not drive or operate machines if you're feeling unwell. Drinking alcohol • N पूरा दस्तावेज़ पढ़ें
AUSTRALIAN PRODUCT INFORMATION – CIPLA AMBRISENTAN (ambrisentan) TERATOGENICITY Cipla Ambrisentan may cause birth defects and is contraindicated in pregnancy (see section 4.3 CONTRAINDICATIONS). 1 NAME OF THE MEDICINE Cipla Ambrisentan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cipla Ambrisentan 5 mg film-coated tablets Each film-coated tablet contains 5 mg ambrisentan Excipients with known effect: Contains sugars as lactose Cipla Ambrisentan 10 mg film-coated tablets Each film-coated tablet contains 10 mg ambrisentan Excipients with known effect: Contains lactose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Cipla Ambrisentan 5 mg film-coated tablets Cipla Ambrisentan 5 mg tablets are pale pink, square shaped, biconvex, film-coated tablets debossed with “CL” on one side and “5” on the other side. Cipla Ambrisentan 10 mg film-coated tablets Cipla Ambrisentan 10 mg tablets are pink, oval shaped, biconvex, film-coated tablets debossed with “CL” on one side and “10” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cipla Ambrisentan 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. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment should only be initiated by a physician experienced in the treatment of PAH. Cipla Ambrisentan is for oral use and can be administered with or without food. Dose Cipla Ambrisentan as a single agent Cipla Ambrisentan 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 sections 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS) and 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials]. Limited data suggest that the abrupt discontinuation of ambrisentan is not associated with rebound worsening of PAH. Use with ciclosporin When co-administered with ciclosporin, the dose पूरा दस्तावेज़ पढ़ें