Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
mifepristone, Quantity: 200 mg
MS Health Pty Ltd
Mifepristone
Tablet, uncoated
Excipient Ingredients: maize starch; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; povidone
Oral
Single
(S4) Prescription Only Medicine
Mifepristone Linepharma 200 mg tablet is indicated in females of childbearing age for preparation for the action of registered prostaglandin analogues that are indicated for the termination of pregnancy for medical reasons beyond the first trimester.
Visual Identification: White/off-white, 11 mm diameter, round, biconvex tablet, "MF" debossed on 1 side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2012-08-29
Mifepristone Linepharma 200 mg Tablet _Version 09 Sept 2022_ Page 1 of 4 MIFEPRISTONE LINEPHARMA 200 MG TABLET EACH TABLET CONTAINS MIFEPRISTONE 200 MG CONSUMER MEDICINE INFORMATION This medication is for use in termination of pregnancy for medical reasons beyond the first trimester. For medical termination of pregnancy up to 63 days gestation, a different product should be used (MS-2 Step (mifepristone and misoprostol). It is important that all patients receiving this medication are followed up by a medical practitioner to ensure the medication has been effective. Even if no adverse events have occurred all patients must receive follow up after taking mifepristone. WHAT IS IN THIS LEAFLET _ _ This leaflet answers some common questions about Mifepristone Linepharma 200 mg tablet. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Mifepristone Linepharma 200 mg tablet against the expected benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET. You may need to read it again. WHAT MIFEPRISTONE LINEPHARMA 200 MG TABLET IS USED FOR Mifepristone Linepharma is an anti- hormone. It acts by blocking the effects of progesterone, a hormone which is needed for pregnancy to continue. Mifepristone Linepharma can therefore be used to terminate a pregnancy. Mifepristone Linepharma is recommended for: The medical termination of a pregnancy beyond the first trimester (the first three months). Mifepristone Linepharma is used in combination with a second medication called a prostaglandin analogue. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MIFEPRISTONE LINEPHARMA 200 MG TABLET HAS BEEN PRESCRIBED FOR YOU. _ _ This medicine is available only with a doctor’s prescription, and will be given to you under the care of an appropriately trained doctor. The required prostaglandin analogue will be administered in a hospi Baca dokumen lengkap
Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION MIFEPRISTONE LINEPHARMA (MIFEPRISTONE) 200 MG TABLET This medication is only for use in termination of pregnancy for medical reasons beyond the first trimester. Medical termination of pregnancy up to 63 days gestation requires the use of MS-2 Step (mifepristone, misoprostol). This medication should only be prescribed by medical practitioners with appropriate obstetric qualifications and training to provide termination of pregnancy beyond the first trimester. Published guidelines should be consulted for appropriate prostaglandin regimens that should only be provided in appropriately equipped facilities. It is important that all patients receiving this medication are followed up by a medical practitioner to ensure the medication has been effective. Even if no adverse events have occurred all patients must receive follow up after taking mifepristone. Read the SECTION 4.4 _SPECIAL WARNINGS AND PRECAUTIONS FOR _ _USE_ carefully. 1 NAME OF THE MEDICINE Mifepristone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of mifepristone. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Tablet, uncoated. Mifepristone Linepharma white to off-white, round biconvex tablets, diameter 11 mm, with MF debossed on one side of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mifepristone Linepharma 200 mg tablet is indicated in females of childbearing age for: Preparation for the action of registered prostaglandin analogues that are indicated for the termination of pregnancy for medical reasons beyond the first trimester. 4.2 DOSE AND METHOD OF ADMINSTRATION _Preparation for the action of prostaglandin analogues during the termination of pregnancy for _ _medical reasons beyond the first trimester_. The method of administration is as follows: 200 mg of mifepristone (1 tablet containing 200 mg) orally, followed 36 to 48 hours later by the scheduled prostaglandin analogue administration, which will be repeated as often Baca dokumen lengkap