Folliplan, 4 mg/ml oral solution for pigs

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Altrenogest

Tillgänglig från:

Intervet Ireland Limited

ATC-kod:

QG03DX90

INN (International namn):

Altrenogest

Dos:

4 milligram(s)/millilitre

Läkemedelsform:

Oral solution

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk grupp:

Pigs

Terapiområde:

altrenogest

Terapeutiska indikationer:

Hormone

Bemyndigande status:

Authorised

Tillstånd datum:

2017-04-28

Produktens egenskaper

Health Products Regulatory Authority
15 January 2022
CRN00CHMT
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Folliplan, 4 mg/ml oral solution for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Altrenogest 4.0 mg
EXCIPIENTS:
Butylhydroxytoluene (E321) 0.07 mg
Butylhydroxyanisole (E320) 0.07 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
Clear, yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pig (sexually mature gilts)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the synchronisation and control of oestrus in cycling gilts.
4.3 CONTRAINDICATIONS
Do not use in male pigs.
Do not administer to pregnant sows or those suffering from uterine
infection.
Do not use in cases of hypersensitivity to the active substance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
To use only in sexually mature gilts who had already presented one
oestrus.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
- Women who are, or may be pregnant, should not use the veterinary
medicinal product. Women of childbearing age should
avoid contact with the veterinary medicinal product.
- This veterinary medicinal product should not be handled by persons
with known or suspected progesterone-dependent
tumours or thrombo-embolic disorders.
- Direct contact with the skin should be avoided. Personal protective
clothing (gloves and overalls) must be worn when
handling the veterinary medicinal product. Porous gloves may let this
veterinary medicinal product pass through. Absorption
Health Products Regulatory Authority
15 January 2022
CRN00CHMT
Page 2 of 4
through the skin may be even higher when the area is covered by an
occlusive material, such as latex or rubber gloves.
Accidental spillage on the skin should be washed off immediately with
soap and water.
- Wash hands after treatment and