Suifertil 4 mg/ml oral solution for pigs

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Altrenogest

Dostupné z:

aniMedica GmbH

ATC kód:

QG03DX90

INN (Medzinárodný Name):

Altrenogest

Dávkovanie:

4.0 milligram(s)/millilitre

Forma lieku:

Oral solution

Typ predpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Pigs

Terapeutické oblasti:

altrenogest

Terapeutické indikácie:

Hormone

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2016-03-16

Súhrn charakteristických

Health Products Regulatory Authority
04 April 2018
CRN000Y6T
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Suifertil 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
​
Butylhydroxytoluene (E321)
​
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
Pigs (nulliparous mature sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Synchronisation of oestrous in nulliparous mature sows.
4.3 CONTRAINDICATIONS
Do not use in boars.
Do not administer to pregnant sows (see section 4.7) or those
suffering from uterine
infection.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
04 April 2018
CRN000Y6T
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The medicated feed is to be given to the nulliparous mature sows, once
the product
has been added.
Part consumed feed must be safely disposed and not given to any other
animals.
To use only in nulliparous mature sows that have had at least one
oestrous cycle.
Ensure the correct dose is administered daily as under dosing can lead
to the
formation of cystic follicles.
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.
Wash hands after t