Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
oxytocin, Quantity: 5 IU; ergometrine maleate, Quantity: 0.5 mg
Phebra Pty Ltd
Injection, solution
Excipient Ingredients: sodium chloride; maleic acid; water for injections; acetic acid; sodium acetate trihydrate; chlorobutanol hemihydrate
Intramuscular, Intravenous
5 x 1 mL
(S4) Prescription Only Medicine
Active management of the third stage of labour. Prevention and treatment of post-partum haemorrhage associated with uterine atony.
Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1991-08-21
SYNTOMETRINE ® VERSION 04 1 SYNTOMETRINE ® _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.PHEBRA.COM. 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 ADV Lue koko asiakirja
PRODUCT INFORMATION Australian Product Information – Syntometrine Injection Page 1 of 9 Version 03 SYNTOMETRINE ® (OXYTOCIN/ERGOMETRINE MALEATE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Oxytocin, ergometrine maleate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Syntometrine injection contains synthetic oxytocin 5 IU/mL and ergometrine maleate 500 microgram/mL. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Solution for injection. Syntometrine injection is a sterile, clear, colourless solution, faintly bluish fluorescent solution. It is buffered to pH 3.2. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS • Active management of the third stage of labour. • Prevention and treatment of post-partum haemorrhage associated with uterine atony. 4.2 D OSE AND METHOD OF ADMINISTRATION ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR: 1 mL intramuscularly following delivery of the anterior shoulder, or immediately after delivery of the child. Expulsion of the placenta, which is normally separated by the first strong uterine contraction following the injection of Syntometrine should be assisted by controlled cord traction. PREVENTION AND TREATMENT OF POST-PARTUM HAEMORRHAGE: 1 mL intramuscularly following expulsion of the placenta, or when bleeding occurs. If necessary, the injection of 1 mL may be repeated after an interval of no less than two hours. The total dose given within 24 hours should not exceed 3 mL. Intravenous administration of Syntometrine (0.5 - 1 mL by slow injection) is possible, but not generally recommended. It is advisable to monitor blood pressure during intravenous administration. 4.3 C ONTRAINDICATIONS • Hypersensitivity to oxytocin, ergometrine, or to any of the components in the formulation. PRODUCT INFORMATION SYNTOMETRINE INJECTION Australian Product Information – Syntometrine Injection Page 2 of 9 Version 03 • Pregnancy, labour (except in second stage of labour following the delivery of the anterior shoulder) (see Section 4.6 Fertility, Pregna Lue koko asiakirja