Oxytocin-S, 10 iu/ml, Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Oxytocin Synthetic

Available from:

Kernfarm B.V.

ATC code:

QH01BB02

INN (International Name):

Oxytocin Synthetic

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Cattle, Dogs, Goats, Horses, Pigs, Sheep

Therapeutic area:

Hormone

Authorization status:

Authorized

Authorization date:

2017-05-23

Summary of Product characteristics

Unlimited renewal: April 2023
AN: 03903/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxytocin-S, 10 iu/ml, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Oxytocin acetate 0.018mg
(equivalent to 10iu oxytocin at 560iu per mg)
Excipient
Chlorbutanol hemihydrate 5.254mg
(equivalent to 5mg Chlorbutanol)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for Injection
Clear aqueous solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, horses, pigs, sheep, goats, cats and dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Injections with this product will initiate strong, regular and
purposeful
contractions of the uterine muscle especially in the later stages of
pregnancy
and post-partum. It also evokes the 'let-down' of milk although it has
no action
on the smooth muscles of the gut or urinary bladder, nor is it
effective in the
treatment of diabetes insipidus. The absence of vasopressor and
antidiuretic
effects make it particularly suitable for obstetric use (stimulation
of parturition,
promotion of uterine involution and control of post-partum
haemorrhage) and
the treatment of agalactia.
The product is indicated for:
-
stimulation of uterine contraction to facilitate parturition in the
presence of a
fully dilated cervix
-
to promote involution of the post-parturient uterus and thus aid the
passage of
retained placenta
-
to aid in control of post-partum haemorrhage
-
promotion of milk 'let-down' in cases of agalactia and to facilitate
‘stripping
out’ of infected quarters in the treatment of mastitis in cows.
Unlimited renewal: April 2023
AN: 03903/2022
Page 2 of 5
4.3
CONTRA-INDICATIONS
1.
When the product is used as an aid to parturition, cervical dilation
must
be confirmed prior to administration to prevent the risk of foetal
death
and possible uterine rupture.
2.
The product is contra-indicated in any form of obstructive dystocia.
3.
Excessive doses of the produ