Gestavet 400/200 IU Lyophilisate and Solvent for Solution for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Chorionic Gonadotrophin, Serum Gonadotrophin

Available from:

Laboratorios Hipra SA

ATC code:

sQG03GA9

INN (International Name):

Chorionic Gonadotrophin, Serum Gonadotrophin

Pharmaceutical form:

Lyophilisate and solvent for solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Hormone sex

Authorization status:

Authorized

Authorization date:

2009-07-01

Summary of Product characteristics

Revised: April 2015
AN. 01585/2013
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GESTAVET 400/200 IU lyophilisate and solvent for solution for
injection for pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Liophilisate vial contains:
ACTIVE SUBSTANCES:
Equine Serum Gonadotrophin (PMSG) ………………. 400 IU
Chorionic Gonadotrophin (HCG) …………………….. 200 IU
EXCIPIENTS, q.s.
Solvent vial (5 ml) contains:
EXCIPIENTS, q.s.
One ml of reconstituted solution contains:
ACTIVE SUBSTANCES:
Equine Serum Gonadotrophin (PMSG) ………………. 80 IU
Chorionic Gonadotrophin (HCG) …………………….. 40 IU
EXCIPIENTS, q.s.
Each reconstituted 5 ml dose contains:
ACTIVE SUBSTANCES:
Equine Serum Gonadotrophin (PMSG) ………………. 400 IU
Chorionic Gonadotrophin (HCG) …………………….. 200 IU
EXCIPIENTS, q.s.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for solution for injection.
White, fragile, lyophilisate with clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (sows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Revised: April 2015
AN. 01585/2013
Page 2 of 5
SOWS: Induction and synchronization of heat.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substances or to any
of the excipients.
Do not use in sows with polycystic ovaries.
Do not use in pregnant animals.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment during the primary luteinized phase or in the middle of the
cycle may
increase the development of ovarian cysts.
The administration of this veterinary medicinal product induces heat
between 3 and
6 days after treatment.
Do not adjust the dose. High doses do not increase the efficacy of the
veterinary
medicinal product.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not inject into the subcutaneous fat.
Shake the vial well to obtain a homogenous solution.
Special
precautions
to
b