Oxytocin Injection BP

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Oxytocin 5 IU/mL equivalent to 8.3 mcg/ml;  

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (International Name):

Oxytocin 5 IU/mL (= 8.3 mcg/ml)

Dosage:

5 IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Oxytocin 5 IU/mL equivalent to 8.3 mcg/ml   Excipient: Glacial acetic acid Sodium acetate Sodium chloride Water for injection

Units in package:

Ampoule, glass, Type I, 5 x 1 ml, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Joint Stock Company "Grindeks"

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, after the delivery of the child. · Prevention and treatment of postpartum uterine atony and haemorrhage.

Product summary:

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)

Authorization date:

2012-05-24

Summary of Product characteristics

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