SYNTOMETRINE INJECTION

Страна: Сінгапур

мова: англійська

Джерело: HSA (Health Sciences Authority)

Активний інгредієнт:

ERGOMETRINE MALEATE; OXYTOCIN

Доступна з:

PHARMACON PTE LTD

Код атс:

G02AC

Дозування:

0.5 mg/ml

Фармацевтична форма:

INJECTION

Склад:

ERGOMETRINE MALEATE 0.5 mg/ml; OXYTOCIN 5 iu/ml

Адміністрація маршрут:

INTRAVENOUS, INTRAMUSCULAR

Тип рецепту:

Prescription Only

Виробник:

Panpharma GmbH

Статус Авторизація:

ACTIVE

Дата Авторизація:

1989-07-05

інформаційний буклет

SYNTOMETRINE
®

Ergot alkaloids and oxytocin incl. analogues, in combination. 
DESCRIPTION AND COMPOSITION 
PHARMACEUTICAL FORM 
Solution for injection 
The solution is clear, colourless, faintly bluish fluorescent. 
ACTIVE SUBSTANCES 
Each ampoule of 1 mL contains 5 IU of synthetic oxytocin and 0.5
mg of ergometrine 
maleate. 
The ampoules are made of uncoloured glass. 
EXCIPIENTS 
Sodium chloride, maleic acid, water for injection. 
Pharmaceutical formulations may vary between countries.  
INDICATIONS 
•  Active management of the third stage of labour (as a means to
promote separation of the 
placenta and to reduce blood loss) 
•  Prevention and treatment of postpartum haemorrhage associated
with uterine atony 
DOSAGE AND ADMINISTRATION 
Syntometrine should be used under medical supervision only. 
DOSAGE 
GENERAL TARGET POPULATION
_ _
•  Active management of third stage of labour 
1 mL i.m. 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 manually
assisted by applying gentle 
fundal pressure. 

•  Prevention and treatment of postpartum haemorrhage 
1 mL i.m. 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 oxytocine, use is
contraindicated in 
severe hepatic and renal impairment and caution is required in mild
or moderate hepatic and 
renal impairment (see sections CONTRAINDICATIONS, WARNINGS AND 
PRECAUTIONS and CLINICAL PHARMACOLOGY)
.

PAEDIATRIC PATIENTS  
No studies hav

Характеристики продукта

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