Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Oxytocin 5 IU/mL equivalent to 8.33 microgram/mL
Apotex NZ Ltd
Oxytocin 5 IU/mL (equivalent to 8.33 microgram/mL)
5 IU/mL
Solution for injection
Active: Oxytocin 5 IU/mL equivalent to 8.33 microgram/mL Excipient: Acetic acid Chlorobutanol hemihydrate Water for injection
Prescription
Joint Stock Company "Grindeks"
Antepartum: - Induction of labour for medical reasons, e.g. in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia). - Enhancement of labour in selected cases of uterine inertia. - Oxytocin may also be indicated in early stage of pregnancy, as adjunctive therapy for management of incomplete, inevitable or missed abortion.
Package - Contents - Shelf Life: Ampoule, glass, Type I colourless glass ampoules 1 mL - 5 dose units - 15 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.
2017-10-02
OXYTOCIN APOTEX SOLUTION FOR INJECTION 1 OXYTOCIN APOTEX SOLUTION FOR INJECTION _Contains the active ingredient synthetic oxytocin_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 IN AUSTRALIA OR 09 444 2073 IN NEW ZEALAND_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about oxytocin solution for injection. 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 last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from http://www.medsafe.govt.nz/Medicin es/infoSearch.asp All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. This leaflet should be kept with your medicine, in case you may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Oxytocin APOTEXSolution for Injection. It contains the active ingredient synthetic oxytocin. Oxytocin can be used to bring on (induce) labour. It can also be used during and immediately after delivery to help the birth and to prevent or treat excessive bleeding. Oxytocin is not suitable in all situations - for example, if the baby or placenta are in the wrong position or if you have had a previous Caesarean section or other surgery involving the uterus. Your doctor can give you more information on the suitability of oxytocin in your particular case. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may hav Read the complete document
NEW ZEALAND DATA SHEET OXYTOCIN APOTEX Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 12 1. OXYTOCIN APOTEX (5 IU/ML & 10 IU/ML INJECTION) OXYTOCIN APOTEX Oxytocin Injection 5 IU/ml OXYTOCIN APOTEX Oxytocin Injection 10 IU/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Oxytocin Injection 5 IU/ml and 10 IU/ml Chemical Name: L-cysteinyl-L-tyrosyl-L-isoleucyl-L-glutaminyl-L-asparaginyl-L-cysteinyl- Lprolyl-L-leucylglycinamide cyclic (1 6) disulphide Oxytocin is a white or almost white fluffy powder hygroscopic. Its molecular formula is C 43 H 66 N 12 O 12 S 2 which corresponds to a molecular weight of 1007.20. Chemical Structure: NEW ZEALAND DATA SHEET OXYTOCIN APOTEX Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 2 of 12 EXCIPIENT(S) OF KNOWN EFFECT Oxytocin APOTEX does not contain Glucose and lactose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for Injection. A colourless solution contained in transparent 1 mL glass ampoules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ANTEPARTUM: • Induction of labour for medical reasons, e.g. in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia). • Enhancement of labour in selected cases of uterine inertia. • Oxytocin may also be indicated in early stage of pregnancy, as adjunctive therapy for management of incomplete, inevitable or missed abortion. POSTPARTUM: • During caesarean section, but after the delivery of the child. • Prevention and treatment of postpartum uterine atony and haemorrhage. 4.2 DOSE AND METHOD OF ADMINISTRATION INDUCTION OR ENHANCEMENT OF LABOUR Oxytocin should be administered as an intravenous (i.v.) drip infusion or, preferably, by means of a variable-speed infusion pump. For drip infusion it is recommended that 5 IU of Oxytocin be added to 500 mL of a physiological electrolyte solution (such as sodium chloride 0.9%). For patients in whom infusion of so Read the complete document