OXYTOCIN - GRINDEKS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OXYTOCIN

Available from:

A.L. MEDI-MARKET LTD.

ATC code:

H01BB02

Pharmaceutical form:

SOLUTION FOR INJECTION / INFUSION

Composition:

OXYTOCIN 10 IU / 1 ML

Administration route:

I.V, I.M

Prescription type:

Required

Manufactured by:

JSC GRINDEKS, LATVIA

Therapeutic area:

OXYTOCIN

Therapeutic indications:

- Induction of labour for medical reasons;- Stimulation of labour in hypnotic uterine inertia;- During Caesarean section following the delivery of the child;- Prevention and treatment of postpartum uterine atony and hemorrhage.- In early stages of pregnancy as an adjunctive therapy for the management of incomplete, inevitable of missed abortion.

Authorization date:

2020-10-14

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Oxytocin - Grindeks, Solution for Injection/Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 10 IU (16.7 micrograms) oxytocin.
Each 1 ml ampoule also contains 2.99 mg (0.13 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection/ Infusion.
For I.M., I.V Injection and I.V. Infusion.
Clear colourless liquid .
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
Oxytocin -Grindeks 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- Grindeks 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 -Grindeks
may only be administered as an
intravenous continuous infusion and never as subcutaneous,
intramuscular or intravenous bolus
injection.
Oxytocin -Grindeks should be administered as an intravenous drip
infusion or, preferably, using a
variable-speed infusion pump. For drip infusion, it is recommended
that 10 IU of Oxytocin -Grindeks
should be added to 1000 mL of a physiological electrolyte solution
(such as sodium chloride solution
0.9%).
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