Oxytocin 10units/1ml solution for infusion ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxytocin

Available from:

Esteve Pharmaceuticals Ltd

ATC code:

H01BB02

INN (International Name):

Oxytocin

Dosage:

10unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07010100; GTIN: 5039021008950 5039021008905

Patient Information leaflet

LATEX ALLERGY
The active substance in Oxytocin 10 IU/ml Solution
for infusion might cause a severe allergic reaction
(anaphylaxis) in patients with latex allergy. Please tell
your doctor if you know you are allergic to latex.
06/2018
Intrapharm Laboratories Limited,
The Courtyard Barns, Choke Lane,
Cookham Dean, Maidenhead,
Berks, SL6 6PT, United Kingdom

Summary of Product characteristics

OBJECT 1
OXYTOCIN 10 IU/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 06-Jul-2018 | Intrapharm
Laboratories Limited
1. Name of the medicinal product
Oxytocin 10 IU/ml Solution for 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 infusion.
Colourless, clear liquid with characteristic odour.
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
membranes, pregnancy-induced hypertension (pre-eclampsia).
– Stimulation of labour in hypotonic uterine inertia.
– Early stages of pregnancy as adjunctive therapy for the management
of incomplete, inevitable, or
missed abortion.
_Postpartum _
– During caesarean section, following delivery of the child.
– Prevention and treatment of postpartum uterine atony and
haemorrhage.
4.2 Posology and method of administration
Posology
_INDUCTION OR ENHANCEMENT OF LABOUR: _Oxytocin should not be started
for 6 hours following
administration of vaginal prostaglandins.
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 (8.3 micrograms) of
Oxytocin 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 section 4.4). 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 2 to 8 drops/minute (1 to 4
milliunits/minute). It may be
gradually increased at intervals not shorter than 20 minutes and
increments of not more than 1 to 2
milliunits/minute, until a contraction pattern similar to