Enzaprost Bovis 12.5 mg/ml Solution for Injection for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Dinoprost

Available from:

Ceva Animal Health Ltd

ATC code:

QG02AD01

INN (International Name):

Dinoprost

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Prostaglandin

Authorization status:

Authorized

Authorization date:

2019-08-23

Summary of Product characteristics

Revised: September 2022
AN: 01513/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enzaprost Bovis 12.5 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Dinoprost (as dinoprost trometamol)
12.5 mg
EXCIPIENTS:
Benzyl alcohol (E1519)
16.5 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to pale brownish yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (heifers and cows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The veterinary medicinal product is used in the following indications:
- Induction of oestrus,
- Controlled breeding in normally-cycling dairy cows:
- oestrus synchronisation,
- ovulation synchronisation in combination with GnRH or GnRH analogues
as part of
timed artificial insemination protocols.
- Treatment of sub-oestrus or silent heat in cows which have a
functional corpus
luteum,
- As supportive treatment of endometritis with the presence of
functional corpus
luteum and pyometra,
- Induction of abortion,
- Induction of parturition, including cases with complications such as
hydrops amnii,
etc,
- Expulsion of mummified foetuses.
Revised: September 2022
AN: 01513/2022
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in animals suffering from either acute or sub-acute
disorders of the
vascular system, gastro-intestinal tract or respiratory system.
Do not use in pregnant cows unless abortion or parturition is
intended.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not administer by the intravenous route.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not administer more than 2 ml per single injection.
The veterinary medicinal product is ineffective when administered
prior to day 5 after
ovulation in cattle.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Pregnancy status should be determined prior to injection since the
veter