Syntometrine 500 micrograms/5 IU solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ERGOMETRINE MALEATE; Oxytocin

Available from:

Alliance Pharma (Ireland) Limited

ATC code:

G02AC; G02AC01

INN (International Name):

ERGOMETRINE MALEATE; Oxytocin

Dosage:

500 micrograms/5 international unit(s)

Pharmaceutical form:

Solution for injection

Therapeutic area:

Ergot alkaloids and oxytocin incl. analogues, in combination; methylergometrine and oxytocin

Authorization status:

Marketed

Authorization date:

2014-02-07

Patient Information leaflet

Syntometrine PIL IE 008
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYNTOMETRINE
®
500 MICROGRAMS/5IU SOLUTION FOR INJECTION
ergometrine maleate and oxytocin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU HAVE THIS MEDICINE
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or midwife.

If you get any side effects, talk to your doctor, nurse or midwife.
This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Syntometrine is and what it is used for
2. What you need to know before you have Syntometrine
3. How to have Syntometrine
4. Possible side effects
5.
How to store Syntometrine
6.
Contents of the pack and other information
1. WHAT SYNTOMETRINE IS AND WHAT IT IS USED FOR
The name of your medicine is Syntometrine 500micrograms/5IU Solution
for
Injection (called Syntometrine in this leaflet). Syntometrine contains
two active
substances called ergometrine maleate and oxytocin.
Syntometrine is used:

to help deliver your placenta after giving birth to your baby

to control bleeding after giving birth.
It works by making the muscles in your womb (uterus) contract.
Syntometrine should be used under medical supervision only.
2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE SYNTOMETRINE
DO NOT HAVE SYNTOMETRINE IF:

you are allergic (hypersensitive) to ergometrine maleate, oxytocin or
to any
of the other ingredients of this medicine listed in Section 6

you are pregnant or you are in an early stage of labour and your
baby’s
shoulder has not yet been delivered you have severe high blood
pressure
Syntometrine PIL IE 008

you have a problem with your circulation

you have a severe heart, liver or kidney problem

you have an infection
Do not have Syntometrine if any of the above apply to you. If you are
not sure,
talk to your doctor, nurse or midwife before having Syntometrine.
WARNINGS AND PRECAUTIONS
Check with your doctor, nurse or

Summary of Product characteristics

Health Products Regulatory Authority
26 February 2019
CRN008KJX
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Syntometrine 500 micrograms/5 IU Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml ampoule contains 500 micrograms of Ergometrine Maleate and 5
International Units (equivalent to 8.5 micrograms)
of Oxytocin.
Excipient with known effect:
Contains 2.76 mg/ml (0.120 mmol/ml) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
Clear glass ampoules containing a clear colourless, solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Syntometrine is indicated in the active management of the third stage
of labour (as a means to promote separation of the
placenta and to reduce blood loss) or, routinely, following the birth
of the placenta, to prevent or treat postpartum
haemorrhage in those patients who have not recently received a pressor
agent.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Syntometrine should only be administered by a healthcare professional.
Adults
_Active management of third stage of labour: _Intramuscular injection
of 1 ml to be administered to the mother following delivery
of the baby's anterior shoulder or immediately after delivery of the
baby. 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:_ Intramuscular
injection of 1 ml to be administered to the mother
following expulsion of the placenta, or when bleeding occurs.
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.