Altresyn 4 mg/ml oral solution for pigs

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Altrenogest

Dostępny od:

Ceva Santé Animale

Kod ATC:

QG03DX90

INN (International Nazwa):

Altrenogest

Dawkowanie:

4 milligram(s)/millilitre

Forma farmaceutyczna:

Oral solution

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Pigs

Dziedzina terapeutyczna:

altrenogest

Wskazania:

Hormone

Status autoryzacji:

Authorised

Data autoryzacji:

2009-02-06

Charakterystyka produktu

Health Products Regulatory Authority
17 April 2019
CRN008SM5
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Altresyn 4 mg/ml oral solution for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains :
ACTIVE SUBSTANCE:
Altrenogest
........................................................................................
4.00 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
............................................................. 0.07 mg
Butylhydroxytoluène (E321)
............................................................. 0.07 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, pale yellow, odourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (sexually mature gilts).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the synchronisation of oestrus in sexually mature gilts.
4.3 CONTRAINDICATIONS
Do not administer to animals suffering from uterine infection.
Do not administer to male animals.
See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Add the veterinary medicinal product to the feed immediately before
feeding. Discard any uneaten medicated feed
To use only in sexually mature gilts who had already presented one
oestrus.
Part consumed feed must be safely disposed of and not given to any
other animal.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Direct contact with the skin should be avoided_._ Personal protective
clothing (gloves and overalls) must be worn when handling
the product.
Porous gloves may let this product pass through to the skin. If the
product makes contact with the skin underneath the glove,
occlusive materials such as latex or rubber in gloves may enhance
transcutaneous absorption of the product.
Accidental spillage on the skin or eyes should be washed off
immediately with plenty of water.
Health Products Regulatory Authority
17 April 2