מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
Oxytocin; Ergometrine maleate
Novartis Pharmaceuticals Australia Pty Ltd
Medicine Registered
SYNTOMETRINE ® _synthetic oxytocin/ergometrine maleate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Syntometrine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. Some more recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you having Syntometrine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT SYNTOMETRINE IS USED FOR Syntometrine can be used during and immediately after delivery of a baby to help the birth and to prevent or treat excessive bleeding. Syntometrine works by stimulating the muscles of the uterus (womb) to produce rhythmic contractions. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SYNTOMETRINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. Syntometrine is only available with a doctor's prescription. It is not addictive. BEFORE YOU ARE GIVEN SYNTOMETRINE _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN SYNTOMETRINE IF YOU ARE ALLERGIC TO: • oxytocin • ergometrine • any of the other ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. IF YOU THINK YOU MAY BE ALLERGIC TO SYNTOMETRINE, ASK YOUR DOCTOR FOR ADVI קרא את המסמך השלם
1 SYNTOMETRINE ® (SYNTHETIC OXYTOCIN/ERGOMETRINE MALEATE) NAME OF THE MEDICINE Active ingredient oxytocin ergometrine maleate Chemical name l-cysteinyl-l-tyrosyl-l-isoleucyl-l- glutamyl-l-asparaginyl-l-cysteinyl-l- prolyl-l-leucylglycinamide cyclic (1→6)-disulfide 6aR,9R)-N-[(S)-2-hydroxy-1- methylethyl]-7-methyl- 4,6,6a,7,8,9-hexahydro- indolo[4,3-fg]quinoline-9- carboxamide (Z)-butenedioate CAS number 50-56-6 129-51-1 Molecular weight 1007 441.5 Molecular formula C 43 H 66 N 12 O 12 S 2 C 19 H 23 N 3 O 2 .C 4 H 4 O 4 Chemical structure DESCRIPTION Syntometrine injection is a sterile, clear, colourless solution, faintly bluish fluorescent, containing synthetic oxytocin 5 I.U/mL and ergometrine maleate 0.5 mg/mL. Syntometrine injection also contains maleic acid, sodium chloride, and water for injections, buffered to pH 3.2. PHARMACOLOGY PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Ergot alkaloids and oxytocin incl. analogues, in combination; ATC code: G02AC. Syntometrine combines the rapid uterine action of oxytocin, a nonapeptide hormone released by the posterior lobe of the pituitary, with the sustained uterotonic effect of ergometrine. 2 PHARMACOKINETICS Following intramuscular administration, the latent period for the occurrence of the uterine response is considerably shorter with Syntometrine (about 2½ min) than with ergometrine given alone (about 7 min) whereas the uterotonic effect of Syntometrine lasts for several hours, compared with only ½-1 hour when oxytocin is given alone. These properties make Syntometrine i.m. suitable for the active management of the third stage of labour (see 'Dosage') and for the prevention or treatment of postpartum haemorrhage, particularly in situations where for any reason the intravenous administration קרא את המסמך השלם