Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
mifepristone, Quantity: 200 mg
MS Health Pty Ltd
Mifepristone,Misoprostol
Tablet
Excipient Ingredients: maize starch; microcrystalline cellulose; magnesium stearate; povidone; colloidal anhydrous silica
Oral
One (1) Mifepristone Linepharma tablet and four (4) GyMiso tablets per MS-2 Step pack
(S4) Prescription Only Medicine
MS-2 Step is indicated in females of childbearing age for the medical termination of an intrauterine pregnancy, up to 63 days of gestation. It is recommended that the duration of pregnancy (i.e., up to 63 days gestation) be confirmed by ultrasound. In the event that an ultrasound is not possible, extra caution should be exercised. Ultrasound is also useful to exclude ectopic pregnancy.
Visual Identification: White to off-white, 11 mm diameter round biconvex tablet, with "MF" debossed on one side; Container Type: Carton; Container Material: Cardboard; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-06-04
DocuSign Envelope ID: 6C5D7D4A-0CBB-49E5-886F-D62746C4A5B8 Colleen Turnbull 23/4/2020 DocuSign Envelope ID: 6C5D7D4A-0CBB-49E5-886F-D62746C4A5B8 23/4/2020 Colleen Turnbull Przeczytaj cały dokument
_Page 1 of 18_ AUSTRALIAN PRODUCT INFORMATION MS-2-STEP (MIFEPRISTONE AND MISOPROSTOL) TABLETS It is very important that all patients receiving these medications are followed up by a medical practitioner, preferably the prescriber, to ensure that the medication has been effective. Even if no adverse events have occurred all patients must receive follow-up 14 to 21 days after taking mifepristone. Read the SECTION _4.4_ _SPECIAL WARNINGS AND PRECAUTIONS_ _FOR USE_ carefully_. _ This document refers to the use of _MS-2 STEP_, which consists of Mifepristone Linepharma 200 mg tablet and GyMiso® misoprostol 200 microgram tablets in combination. These medicines are indicated in females of childbearing age for the medical termination of an intrauterine pregnancy, up to 63 days of gestation. The Mifepristone Linepharma 200 mg tablet component of this therapy is also used to treat another condition. For information about the treatment of the other condition, refer to the full Product Information for Mifepristone Linepharma 200 mg tablet individual product (AUST R 175671). 1 NAME OF THE MEDICINE Mifepristone and Misoprostol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _MS-2 STEP_ is a composite pack containing: MIFEPRISTONE LINEPHARMA Each tablet contains 200 mg of mifepristone. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. GYMISO ® Each tablet contains 200 micrograms of misoprostol as a 1% dispersion of misoprostol- hypromellose. Misoprostol is a clear, colourless or yellowish oily liquid. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM MIFEPRISTONE LINEPHARMA White to off-white, round biconvex tablets, diameter 11 mm, with “MF” debossed on one side of the tablet. GYMISO® White, flat round tablet with “ML” debossed on one side and “200” on the other side. Product Information - Australia Page 2 of 18 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _MS-2 STEP_ is indicated in females of childbearing age for the medical termination of an intraut Przeczytaj cały dokument