Folltropin 700 IU Powder and Solvent for Solution for Injection

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Follicle Stimulating Hormone (porcine)

Disponibil de la:

Vetoquinol UK Ltd

Codul ATC:

QG03GA90

INN (nume internaţional):

Follicle Stimulating Hormone (porcine)

Forma farmaceutică:

Powder and solvent for solution for injection

Tip de prescriptie medicala:

POM-V - Prescription Only Medicine – Veterinarian

Grupul Terapeutică:

Cattle

Zonă Terapeutică:

Hormone sex

Statutul autorizaţiei:

Authorized

Data de autorizare:

2004-11-08

Caracteristicilor produsului

Revised: August 2018
AN: 00537/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Folltropin 700 IU Powder and Solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of lyophilized product contains:
ACTIVE SUBSTANCE
Follicle Stimulating Hormone (FSH)
700 IU
One vial of solventcontains:
EXCIPIENTS
Benzyl alcohol (E1519)
360 mg
One ml of reconstituted solution contains:
ACTIVE SUBSTANCE:
Follicle Stimulating Hormone (FSH)
35 IU
EXCIPIENTS
Benzyl alcohol (E1519)
18 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Powder: Freeze dried off-white powder
Solvent: Clear, colourless solution
Reconstituted solution: Clear, slightly pink solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (reproductively mature females).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To induce superovulation in reproductively mature heifers or cows.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in males and reproductively immature female cattle.
Do not use in pregnant cattle.
Revised: August 2018
AN: 00537/2018
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product should only be used in clinically healthy cows and mature
heifers, which are
cycling normally. There is a wide range in response to superovulation
between animals.
There may be a small proportion of non-responders in any group
treated.
Collection of embryo is normally started on day 7 following observed
oestrus or first
breeding. Prior to breeding and the collection of fertilized embryo
from these animals,
oestrus will have to be induced with prostaglandin F2α or a
prostaglandin F2α analogue.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Care should be taken when handling the product to av