Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
misoprostol, Quantity: 200 microgram
MS Health Pty Ltd
Misoprostol
Tablet
Excipient Ingredients: hypromellose; microcrystalline cellulose; sodium starch glycollate; hydrogenated castor oil
Oral
Four (4) tablets per pack
Medicine Registered
(S4) Prescription Only Medicine
GyMiso is indicated in females of childbearing age for the medical termination of a developing intrauterine pregnancy in sequential combination with a mifepristone 200 mg tablet, up to 49 days of gestation.
Visual Identification: White, flat round tablet, "ML" debossed on one side, "200" on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-08-29
GyMiso® misoprostol 200 µg tablets Page 1 of 3 GYMISO® EACH TABLET CONTAINS MISOPROSTOL 200 MICROGRAMS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET _ _ This leaflet answers some common questions about GyMiso® tablets. 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 GyMiso® tablets 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 GYMISO® IS USED FOR GyMiso® contains misoprostol. It belongs to a group of medicines called prostaglandins. It acts like prostaglandin E 1 . GyMiso® induces contractions of the smooth muscle and relaxation of the cervix. These properties help open the cervix and push out the contents of the uterus. GyMiso® can therefore be used to terminate a pregnancy. GyMiso® is recommended for the medical termination of pregnancy. It is recommended for use up to 49 days after your last menstrual period. It is given in combination with another medicine called mifepristone, which blocks progesterone, a hormone that is needed for pregnancy to continue. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY GYMISO® HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. _ _ This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN GYMISO® _ _ _WHEN YOU MUST NOT BE GIVEN _ _IT _ YOU SHOULD NOT BE GIVEN GYMISO® IF: you are pregnant and wish to carry your pregnancy to term you have any allergies to misoprostol, or any other prostaglandins or any of the other ingredients listed at the end of this leaflet YOU SHOULD NOT BE GIVEN A MIFEPRISTONE TABLET AND GYMISO® TABLETS IF: you cannot take mifepristone or have any allergies to mifepristone you suffer from chronic adrenal failure you suffer from severe disease where it is necessary to take st Aqra d-dokument sħiħ
PRODUCT INFORMATION - GYMISO® _Version: 18-09-2012 _ _ _ _Page 1 of 13 _ NAME OF THE MEDICINE GyMiso ® , misoprostol 200 microgram tablet Australian Approved Name (AAN): Misoprostol Chemical Structure: O C H 3 OH OMe O O H (±) Molecular formula: C 22 H 38 O 5 Molecular weight: 382.5 The CAS Registry Number: _ _ 59122-46-2 _ _ DESCRIPTION White, flat round tablet with ‘ML’ debossed on one side and ‘200’ on the other side. Each tablet contains 200 micrograms of misoprostol as a 1% dispersion of misoprostol- hypromellose. Misoprostol is a clear, colourless or yellowish oily liquid. GyMiso® contains the following excipients: hypromellose, cellulose - microcrystalline, sodium starch glycollate type A and castor oil - hydrogenated. PHARMACOLOGY PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Other gynecological medicines – prostaglandins. ATC code: G02AD06 _ _ Misoprostol is a synthetic analogue of prostaglandin E1. At the recommended dosages, misoprostol induces contractions of the smooth muscle fibers in the myometrium and relaxation of the uterine cervix. The uterotonic properties of misoprostol should facilitate cervical opening and evacuation of intrauterine debris. In the event of an early termination of pregnancy, the combination of GyMiso® used in a sequential regimen after mifepristone leads to an increase in the success rate and accelerates the expulsion of the conceptus. PRODUCT INFORMATION - GYMISO® _Version: 18-09-2012 _ _ _ _Page 2 of 13 _ Pharmacodynamic studies in early pregnancy have found an increase in uterine tone around 8 minutes after oral and 40 minutes after buccal misoprostol, with sustained contractions achieved by a mean of around 90 minutes and uterine activity peaking prior to 5 hours. Following oral administration uterine activity rises earlier than other routes, but is lower overall. Pretreatment with mifepristone has previously been shown to increase uterine contractility in response to misoprostol. PHARMACOKINETIC PROPERTIES ABSORPTION When administered orally, mis Aqra d-dokument sħiħ