Syntocinon Ampoules 5 IU/ml Concentrate for solution for infusion or Solution for intramuscular injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxytocin

Available from:

Alfasigma S.p.A

ATC code:

H01BB; H01BB02

INN (International Name):

Oxytocin

Dosage:

5 international unit(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Oxytocin and analogues; oxytocin

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

INFORMATION FOR PATIENTS
SYNTOCINON
®
AMPOULES 5 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION OR SOLUTION FOR
INTRAMUSCOLAR
INJECTION
SYNTOCINON
®
AMPOULES 10 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION OR SOLUTION
FOR
INTRAMUSCOLAR INJECTION
OXYTOCIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.

If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Syntocinon
is and what it is used for.
2.
What you need to know before you use Syntocinon
3.
How to use Syntocinon
4.
Possible side effects
5.
How to store Syntocinon
6.
Contents of the pack and other information
1.
WHAT SYNTOCINON IS AND WHAT IT IS USED FOR
Syntocinon is an injection, which causes contraction of the muscles of
the womb. It is identical with
oxytocin, a natural hormone released by the pituitary gland.
It may be used:

To start or help contractions of the womb during labor.

In patients who are having a miscarriage.

In the prevention and control of bleeding after delivery.

During a cesarean section.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SYNTOCINON
THE INDUCTION OF LABOR BY MEANS OF OXYTOCIN SHOULD BE ATTEMPTED ONLY
WHEN STRICTLY NECESSARY FOR
MEDICAL REASONS. ADMINISTRATION SHOULD ONLY BE UNDER HOSPITAL
CONDITIONS AND QUALIFIED MEDICAL
SUPERVISION.
DO NOT USE SYNTOCINON:

If you are allergic (hypersensitive) to oxytocin or to any of the
other ingredients of this medicine (listed
in section 6).

IF YOUR DOCTOR THINKS THAT INDUCING OR ENHANCING CONTRACTIONS WOULD BE
UNSUITABLE FOR YOU. FOR
EXAMPLE:
-
If your contractions of the womb are unusually strong. (hypertonic)
-
If any obstructions may prevent delivery.
-
If your doctor advises against normal labor or vaginal delivery.
-
If your baby is suffering from fetal distress.

If you have

Summary of Product characteristics

Health Products Regulatory Authority
27 January 2021
CRN00C4J5
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Syntocinon Ampoules 5 IU/ml Concentrate for solution for infusion or
Solution for intramuscular injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: synthetic oxytocin.
Each 1 ml ampoule contains 5 IU oxytocin as a concentrate for solution
for infusion or solution for intramuscular injection.
Excipients with known effect: each 1 mL ampoule contains 0.2 mg sodium
and 5 mg ethanol 94% w/w.
For a full list of excipients, see section 6.1 List of Excipients.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion or solution for intramuscular
injection.
Clear colourless, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Induction of labor for medical reasons; stimulation of labour in
hypotonic uterine inertia; during cesarean section, following the
delivery of the child; prevention and treatment of postpartum uterine
atony and hemorrhage.
Syntocinon may also be indicated in early stages of pregnancy as an
adjunctive therapy for the management of incomplete,
inevitable, or missed abortion.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Induction or enhancement of labor: _Syntocinon should be administered
as an intravenous (i.v.) drip infusion or, preferably, by
means of a variable-speed infusion pump. For drip infusion it is
recommended that 5 IU of Syntocinon be added to 500 ml of
a physiologic electrolyte solution (such as sodium chloride 0.9%). For
patients in whom infusion of sodium chloride must be
avoided, 5% dextrose solution may be used as the diluent (see section
4.4, special warnings and special precautions for use).
To ensure even mixing, the bottle or bag must be turned upside down
several times before use.
The initial infusion rate should be set at 1-4 milliunits/minute (2-8
drops/minute). It may be gradually increased at intervals not
shorter than 20 minutes and increments of not more than 1–2
milliunits/minute, until