Syntocinon

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Oxytocin 5 IU/mL (added as 200 IU/mL solution.);  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Oxytocin 5 IU/mL (added as 200 IU/mL solution.)

Dosage:

5 IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Oxytocin 5 IU/mL (added as 200 IU/mL solution.)   Excipient: Acetic acid Chlorobutanol Ethanol Sodium acetate trihydrate Water for injection

Units in package:

Ampoule, 1mL, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

Therapeutic indications:

Antepartum: · Induction of labour for medical reasons, e.g. in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia). · Enhancement of labour in selected cases of uterine inertia. · Syntocinon may also be indicated in early stage of pregnancy, as adjunctive therapy for management of incomplete, inevitable or missed abortion.

Product summary:

Package - Contents - Shelf Life: Ampoule, 1mL - 5 dose units - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months from date of manufacture stored at or below 30°C

Authorization date:

1969-12-31

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
1
SYNTOCINON
®
_(synthetic oxytocin) _
5IU/1mL solution for infusion/injection
10IU/1mL solution for infusion/injection
WHAT IS IN THIS LEAFLET
Read all of this leaflet carefully before you start taking this
medicine.
This leaflet answers some common questions about SYNTOCINON. It does
not contain all
the available information. It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you being given
SYNTOCINON against the benefits your doctor expects it to provide.
This medicine has been
prescribed only for you. Do not give it to anybody else or use it for
any other illnesses.
If any of the side effects affects you seriously, or if you notice any
side effect not listed in this
leaflet, please tell your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on
the final page. More
recent information on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP
TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET
FROM WWW.MEDSAFE.GOVT.NZ
Keep this leaflet. You may need to read it again.
WHAT SYNTOCINON IS
SYNTOCINON contains an active substance called oxytocin. It belongs to
a group of
medicines called oxytocics that stimulate contraction of the womb
(uterus). It is identical with
oxytocin, a natural hormone released by the pituitary gland.
The other ingredients are: Sodium acetate trihydrate, glacial acetic
acid, chlorobutanol,
ethanol 94%, water for injections.
WHAT SYNTOCINON IS USED FOR
BEFORE CHILDBIRTH (ANTEPARTUM)
•
To bring on (induce) or enhance contractions of the womb (labour)
•
To correct sluggish contractions (uterine inertia) during labour
•
To manage incomplete, inevitable or missed miscarriage
AFTER CHILDBIRTH (POSTPARTUM)
•
To help the womb contract during caesarean section, after delivery of
the baby and
placenta
•
To prevent and treat b

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
SYNTOCINON
®
SYNTHETIC OXYTOCIN
5 IU/ML AND 10 IU/ML
CONCENTRATE FOR SOLUTION FOR INFUSION; SOLUTION FOR INJECTION
PRESENTATION(S)
ACTIVE SUBSTANCE: synthetic oxytocin.
PHARMACEUTICAL FORM: Concentrate for solution for infusion; Solution
for injection containing
5 IU/mL or 10 IU/mL. One ampoule contains 1 mL solution.
EXCIPIENTS: Sodium acetate trihydrate, acetic acid glacial,
chlorobutanol, ethanol 94% w/w,
water for injections.
INDICATIONS
ANTEPARTUM:

Induction of labour for medical reasons, e.g. in cases of post-term
gestation, premature
rupture of the membranes, pregnancy-induced hypertension
(pre-eclampsia).

Enhancement of labour in selected cases of uterine inertia.

Syntocinon
®
may also be indicated in early stage of pregnancy, as adjunctive
therapy for
management of incomplete, inevitable or missed abortion.
POSTPARTUM:

During caesarean section, but after the delivery of the child.

Prevention and treatment of postpartum uterine atony and haemorrhage.
DOSAGE AND ADMINISTRATION
INDUCTION OR ENHANCEMENT OF LABOUR
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 physiological 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 Warnings and precautions)_. To ensure
even mixing, the bottle
or bag must be turned upside down several times before use.
2
The initial infusion rate should be set at 1 to 4 milliunits/minute (2
to 8 drops/minute). It may be
increased gradually at intervals not shorter than 20 minutes and
increments of not more than 1
to 2 milliunits/minute until a contraction pattern similar to that of
normal labour is established. In
pregnancy near term, this can often be achieved with an infusion of
less than 10 milliunits/
minute (20 drops/minute), and the recommended m