Oxytocin APOTEX

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Oxytocin 10 IU/mL equivalent to 16.7 microgram/mL

Available from:

Apotex NZ Ltd

INN (International Name):

Oxytocin 10 IU/mL (equivalent to 16.7 microgram/mL)

Dosage:

10 IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Oxytocin 10 IU/mL equivalent to 16.7 microgram/mL Excipient: Acetic acid Chlorobutanol hemihydrate Water for injection

Prescription type:

Prescription

Manufactured by:

Joint Stock Company "Grindeks"

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. - Oxytocin 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, glass, Type I colourless glass ampoules 1 mL - 5 dose units - 15 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.

Authorization date:

2017-10-02

Patient Information leaflet

OXYTOCIN APOTEX SOLUTION FOR INJECTION
1
OXYTOCIN APOTEX
SOLUTION FOR INJECTION
_Contains the active ingredient synthetic oxytocin_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 IN AUSTRALIA OR
09 444 2073 IN NEW ZEALAND_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about oxytocin solution for
injection. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
http://www.medsafe.govt.nz/Medicin
es/infoSearch.asp
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
This leaflet should be kept with your
medicine, in case you may want to
read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Oxytocin APOTEXSolution for
Injection. It contains the active
ingredient synthetic oxytocin.
Oxytocin can be used to bring on
(induce) labour. It can also be used
during and immediately after
delivery to help the birth and to
prevent or treat excessive bleeding.
Oxytocin is not suitable in all
situations - for example, if the baby
or placenta are in the wrong position
or if you have had a previous
Caesarean section or other surgery
involving the uterus. Your doctor can
give you more information on the
suitability of oxytocin in your
particular case.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may hav

Summary of Product characteristics

NEW ZEALAND DATA SHEET
OXYTOCIN APOTEX
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 12
1. OXYTOCIN APOTEX (5 IU/ML & 10 IU/ML INJECTION)
OXYTOCIN APOTEX Oxytocin Injection 5 IU/ml
OXYTOCIN APOTEX Oxytocin Injection 10 IU/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytocin Injection 5 IU/ml and 10 IU/ml
Chemical Name:
L-cysteinyl-L-tyrosyl-L-isoleucyl-L-glutaminyl-L-asparaginyl-L-cysteinyl-
Lprolyl-L-leucylglycinamide cyclic (1
6) disulphide
Oxytocin is a white or
almost
white fluffy powder
hygroscopic.
Its molecular
formula is
C
43
H
66
N
12
O
12
S
2
which corresponds to a molecular weight of 1007.20.
Chemical Structure:
NEW ZEALAND DATA SHEET
OXYTOCIN APOTEX
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 12
EXCIPIENT(S) OF KNOWN EFFECT
Oxytocin APOTEX does not contain Glucose and lactose.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for Injection. A colourless solution contained in transparent
1 mL glass ampoules.
4. CLINICAL PARTICULARS
4.1 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.
•
Oxytocin 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.
4.2 DOSE AND METHOD OF ADMINISTRATION
INDUCTION OR ENHANCEMENT OF LABOUR
Oxytocin 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 Oxytocin
be added to 500 mL of a physiological electrolyte solution (such as
sodium chloride 0.9%). For
patients in whom infusion of so