Syntometrine Injection 5IU1ML Ampoule

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ERGOMETRINE MALEATE; OXYTOCIN

Available from:

RIGEL PHARMA SDN. BHD.

INN (International Name):

ERGOMETRINE MALEATE; OXYTOCIN

Units in package:

10ampoule Ampoules

Manufactured by:

Panpharma GmbH

Summary of Product characteristics

1 NAME OF THE MEDICINAL PRODUCT
Syntometrine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml ampoule contains 500 micrograms ergometrine maleate and 5IU
oxytocin.
Excipient with known effect: Sodium chloride 7.000 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
The solution is clear, colourless, faintly bluish fluorescent.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
• Active management of the third stage of labour (in order to
facilitate separation of the
placenta and to reduce blood loss)
• Prevention and treatment of postpartum haemorrhage associated with
uterine atony
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Syntometrine should be used under medical supervision only.
Dosage
General target population
• Active management of third stage of labour
1 mL IM following delivery of the anterior shoulder or immediately
after delivery of the child.
Expulsion of the placenta — usually 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 IM 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 2 hours.
The total dose given within 24 hours should not exceed 3 mL.
Special populations
Renal impairment / Hepatic impairment
No studies have been performed in patients with renal or hepatic
impairment. However
considering the metabolic pathway of ergometrine and oxytocin, use is
contraindicated in
severe hepatic and renal impairment and caution is required in mild or
moderate hepatic and
renal impairment (see sections 4.3 Contraindications, 4.4 Special
warnings and precautions
for use and 5.2 Pharmacokinetic properties).
Paediatric population: No data are available.
Elderly: Not applicable.
METHOD OF ADMINISTRATION
Intramuscular injection is the recommended route. Intravenous
administration of
Syntometrine (0.5 to 1 mL by s