Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Oxytocin 5 IU/mL equivalent to 8.3 mcg/ml;
Boucher & Muir (New Zealand) Limited t/a BNM Group
Oxytocin 5 IU/mL (= 8.3 mcg/ml)
5 IU/mL
Solution for injection
Active: Oxytocin 5 IU/mL equivalent to 8.3 mcg/ml Excipient: Glacial acetic acid Sodium acetate Sodium chloride Water for injection
Ampoule, glass, Type I, 5 x 1 ml, 5 dose units
Prescription
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 Injection BP may also be indicated in early stage of pregnancy, as adjunctive therapy for management of incomplete, inevitable or missed abortion. Postpartum: · During Caesarean section, after the delivery of the child. · Prevention and treatment of postpartum uterine atony and haemorrhage.
Package - Contents - Shelf Life: Ampoule, glass, Type I, 1 ml - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months unopened stored at or below 25°C. Discard afterwards. Do not return to refrigerator. 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2012-05-24
1 OXYTOCIN INJECTION BP OXYTOCIN INJECTION 5 IU/ML/ 10 IU/ML NEW ZEALAND DATA SHEET 1 PRODUCT NAME OXYTOCIN INJECTION BP 5 IU/mL solution for injection OXYTOCIN INJECTION BP 10 IU/mL solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxytocin Injection BP 5 IU/mL solution for injection 1 mL ampoule contains 5 IU oxytocin (equivalent to 8.3 mcg/mL) Oxytocin Injection BP 10 IU/mL solution for injection 1 mL ampoule contains 10 IU oxytocin (equivalent to 16.6 mcg/mL) EXCIPIENT(S) WITH KNOWN EFFECT: Oxytocin Injection BP contains sodium but less than 1 mmol (23 mg) sodium per ampoule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oxytocin Injection BP is a clear and colourless solution for injection containing oxytocin and is packaged in a clear colourless glass ampoule. 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 Injection BP 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. 2 OXYTOCIN INJECTION BP OXYTOCIN INJECTION 5 IU/ML/ 10 IU/ML 4.2 DOSE AND METHOD OF ADMINISTRATION Oxytocin Injection BP is administered via intramuscular (i.m.) or intravenous (i.v.) injection, or as an i.v. infusion, in accordance with the instructions below. DOSE _INDUCTION OR ENHANCEMENT OF LABOUR _ Oxytocin Injection BP should be administered as an 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 s Prečítajte si celý dokument