SYNTOMETRINE INJECTION [SIN03588P]

Product Info

SYNTOMETRINE INJECTION

[SIN03588P]

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 slow injection) is possible, but should be limited to use only in cases of severe haemorrhage due to uterine atony.

4.3 Contraindications

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Pregnancy and labour (induction of labour, first stage labour and second stage labour prior to the delivery of the anterior shoulder) due to the risk of uterine hypertonus and associated foetal complications (see section 4.6 Fertility, pregnancy and lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Primary or secondary uterine inertia

• Severe hypertension, pre-eclampsia, eclampsia

• Severe cardiac disorders

• Severe hepatic or renal impairment

• Occlusive vascular disease

• Sepsis