Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
Vigabatrin
Sanofi-Aventis Australia Pty Ltd
Medicine Registered
SABRIL ® _vigabatrin_ CONSUMER MEDICINES INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sabril. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Sabril against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SABRIL IS USED FOR Sabril is a medicine used to help control epilepsy, a condition where you have repeated fits or convulsions. Sabril is used in addition to other medicines to treat epilepsy. Sabril is an anticonvulsant. It works by stopping the breakdown of an important chemical transmitter ("messenger") in the brain and this helps reduce seizure activity. Your doctor, however, may have prescribed Sabril for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE SABRIL IF YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing. DO NOT TAKE IT IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. It may affect your developing baby if you take it during pregnancy. DO NOT TAKE IT IF YOU ARE BREAST- FEEDING OR PLANNING TO BREAST-FEED. Sabril passes into breast milk and there is a possibility your baby may be affected. DO NOT TAKE IT AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. If you take this medicine after the expiry date has passed, it may not work as well. DO NOT TAKE IT IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. _BEFORE YOU START TO TAKE IT_ TELL YOUR Đọc toàn bộ tài liệu
Sabril PI CCDSv11 PIv9 1 Oct 13 Page 1 PRODUCT INFORMATION SABRIL ® TABLETS 500 MG / SABRIL ® SACHETS 500 MG NAME OF THE MEDICINE NON-PROPRIETARY NAME Vigabatrin CHEMICAL STRUCTURE H 2 C = CH ─ CH ─ CH 2 ─ CH 2 ─ COOH | NH 2 CAS NUMBER 60643-86-9 DESCRIPTION Sabril sachets contain the inactive ingredient povidone EP. Sabril tablets contain the following inactive ingredients: povidone BP, cellulose microcrystalline EP, sodium starch glycollate USNF, magnesium stearate EP, hydroxypropyl methylcellulose EP, titanium dioxide BP and polyethylene glycol 8000. PHARMACOLOGY CLASS Actions: Anticonvulsant PHARMACODYNAMICS The mechanism of action is attributed to dose-dependent enzyme inhibition of GABA- transaminase (GABA-T) and consequent increased levels of the inhibitory neurotransmitter, GABA. In mice, decreased GABA-T levels in the brain persisted for 5 days following a single intraperitoneal dose (1500 mg/kg) and was accompanied by a marked rise in brain GABA concentration. Animal safety studies carried out in rat, mouse, dog and monkey have indicated that vigabatrin has no significant adverse effects on the liver, kidney, lung, heart or gastrointestinal tract. In the brain, microvacuolation has been observed in white matter tracts of rat, mouse and dog at doses of 30-50 mg/kg/day. This effect is caused by a separation of the outer lamellar sheath of myelinated fibres, a change characteristic of intramyelinic oedema. In both rat and dog (mouse, not tested), the intramyelinic oedema was reversible on stopping vigabatrin tre Đọc toàn bộ tài liệu