Oxytobel 10 IU/ml Solution for Injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Oxytocin

MAH:

Bela-Pharm GmbH & Co. KG

ATC_code:

QH01BB02

INN:

Oxytocin

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:

2014-08-06

SPC

Revised: January 2019
AN: 00235/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs,
Sheep, Goats, Dogs
and Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Oxytocin
16.6 µg
(equivalent to 10 IU Oxytocin)
EXCIPIENTS:
Chlorobutanol hemihydrate
3.0 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses (mares), cattle (cows), pigs (sows), sheep (ewes), goats
(nanny), dogs
(bitches) and cats (queen)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In the mare, cow, sow, ewe, nanny, bitch and queen the product is
indicated for:
•
Obstetric use (stimulation of uterine contraction to facilitate
parturition in the
presence of a fully dilated cervix, promotion of involution of the
post partum
uterus, aid in the control of post partum haemorrhage).
•
Promotion of milk let-down in cases of agalactia.
4.3
CONTRAINDICATIONS
Do not use in cases of obstructive dystocia and/or in cases of
non-dilatation of the
uterine cervix.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Revised: January 2019
AN: 00235/2018
Page 2 of 5
Adrenaline at physiological levels markedly reduces the effect of
Oxytocin on the
uterus or mammary gland. For this reason the animal should not be
frightened when
complete
Oxytocin
effect
is
desired
to
cause
either
milk
"let-down"
or
uterine
contractions.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
When the veterinary medicinal product is used as an aid in parturition
cervical dilation
must be confirmed prior to administration to prevent risk of foetal
death and possible
uterine rupture.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Pregnant or lactating women should a