Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Ergometrine maleate 0.5 mg/mL; Oxytocin 5 IU/mL ((8.5 µg) added as 200 IU/mL solution.)
Max Health Limited
Ergometrine maleate 0.5 mg/mL
Solution for injection
Active: Ergometrine maleate 0.5 mg/mL Oxytocin 5 IU/mL ((8.5 µg) added as 200 IU/mL solution.) Excipient: Carbon dioxide Chlorobutanol hemihydrate Glacial acetic acid Maleic acid Sodium acetate trihydrate Sodium chloride Water for injection
Ampoule, glass, 1mL, 5 dose units
Prescription
Prescription
Teva Czech Industries s.r.o.
Active management of the third stage of labour (as a means to promote separation of the placenta and to reduce blood loss).
Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
1969-12-31
SYNTOMETRINE ® _Injection _ _5 IU synthetic oxytocin / 0.5mg ergometrine maleate _ NEW ZEALAND 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.MEDSAFE.GOVT.NZ . 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. • Latex 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 T Soma hati kamili
NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 1 of 11 1 PRODUCT NAME SYNTOMETRINE ® 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substances: Each 1 mL ampoule of injectable solution contains: Synthetic Oxytocin 5 IU/mL ((8.5 µg) added as 200 IU/mL solution) and Ergometrine maleate 0.5 mg/mL 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 structures Excipient(s) with known effect For the full list of excipients, refer section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection Description SYNTOMETRINE® injection is a sterile, clear, colourless solution, faintly bluish fluorescent. It is buffered to pH 3.2. The ampoules have two blue identification rings. NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 2 of 11 4 CLINICAL PARTICULARS 4.1 Therapeutic indications • Active management of the third stage of labour (as a means to promote separation of the placenta and to reduce blood loss). • Prevention and treatment of postpartum haemorrhage associated with uterine atony. 4.2 Dose 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 postpartum haemorrhage: 1 mL i.m. following expulsion of the placenta, or when bleeding occurs. If necessary, the injection of 1 mL may be repeated after an interval of not less than 2 hours. The total dose given Soma hati kamili