AMPROLINE 400 mg/mL solution for use in drinking water for chickens and turkeys

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Amprolium hydrochloride

Saatavilla:

HUVEPHARMA SA

ATC-koodi:

QP51AX09

INN (Kansainvälinen yleisnimi):

Amprolium hydrochloride

Annos:

400 milligram(s)/millilitre

Lääkemuoto:

Solution for use in drinking water

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen alue:

amprolium

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2019-08-30

Valmisteyhteenveto

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amproline 400 mg/mL solution for use in drinking water for chickens
and turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains:
ACTIVE SUBSTANCE(S):
Amprolium..................................400.0 mg
(equivalent to amprolium hydrochloride 452.4 mg)
EXCIPIENT(S):
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Sorbic acid (E200)
0.5 mg
Purified water
Solution for use in drinking water
Clear and yellow solution
3.
CLINICAL INFORMATION
3.1. TARGET SPECIES
Chickens (broilers, pullets, layers and breeder hens), turkeys.
3.2. INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of intestinal coccidiosis caused by
_Eimeria _
spp.
3.3. CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4. SPECIAL WARNINGS
As with any antimicrobial, frequent and repeated use of antiprotozoal
agents of the same class can lead
to resistance development. Cross-resistance has been shown between
amprolium and anticoccidial
drugs having the same mode of action. Use of the veterinary medicinal
product/amprolium should be
carefully considered when susceptibility testing has shown resistance
to amprolium/anticoccidials
because its effectiveness may be reduced. As with all anticoccidials,
prolonged use may result in the
development of resistant strains.
In case of detection of lack of efficacy during treatment, communicate
it to competent national
authorities.
3.5. SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species
The veterinary medicinal product is not intended for prophylaxis.
This veterinary medicinal product should be reserved in case of
coccidiosis outbreaks due to non-
availability of vaccine, in case of lack of efficacy of vaccine and in
vaccinated flocks if a severe
coccidial challenge is diagnosed before immunity has fully developed.
Use of the veterin