OXYTOCIN PANPHARMA INJECTION 10 I.U.ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OXYTOCIN

Available from:

PHARMALOGIC LTD

ATC code:

H01BB02

Pharmaceutical form:

SOLUTION FOR INJECTION / INFUSION

Composition:

OXYTOCIN 10 IU/ML

Administration route:

I.V, I.M

Prescription type:

Required

Manufactured by:

PANPHARMA GMBH, GERMANY

Therapeutic group:

OXYTOCIN

Therapeutic indications:

Induction of labour for medical reasons stimulation of labour in hypotonic uterine inertia during caesarian section following the delivery ot the child prevention and treatment of postpartum uterine atony and haemorrhage.Oxytocin injection may also be indicated in early stages of pregnancy as an adjunctive therapy for the management of incomplete inevitable or missed abortion.

Authorization date:

2022-02-28

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
OXYTOCIN PANPHARMA INJECTION 10 I.U./ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytocin.
1 ml solution for injection contains 10 IU oxytocin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
For I.M., I.V Injection and I.V. Infusion
A clear, colourless sterile solution in 1 ml clear glass ampoules
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxytocin PANPHARMA may be used for:
•
Induction of labour for medical reasons;
•
Stimulation of labour in hypotonic uterine inertia;
•
During Caesarean section following the delivery of the child;
•
Prevention and treatment of postpartum uterine atony and haemorrhage.
Oxytocin
PANPHARMA 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
Oxytocin should be used only in a clinical setting and only under
medical supervision. For
the individual dosage, careful monitoring of the birth is required
(CTG, blood pressure and
pulse of the mother).
Induction or enhancement of labour:
For labour induction or to increase contractions, Oxytocin PANPHARMA
may only be
administered as an intravenous continuous infusion and never as
subcutaneous,
intramuscular or intravenous bolus injection.
Oxytocin PANPHARMA should be administered as an intravenous drip
infusion or,
preferably, using a variable-speed infusion pump. For drip infusion,
it is recommended
that 10 lU of Oxytocin PANPHARMA should be added to 1000 mL of an
isotonic sodium
chloride solution.
For patients in whom infusion of sodium chloride must be avoided, 5%
dextrose sodium
may be used as the diluent (see section 4.4 Special warnings and
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 mU/min (2-8 drops/min).
It may be gradually
increased at intervals not shorter than 20 min, until a contract