Aurofac Granular 250 mg/g Premix for medicated feedingstuff for pigs and chickens

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Chlortetracycline hydrochloride

Disponible depuis:

Zoetis Belgium S.A.

Code ATC:

QJ01AA03

DCI (Dénomination commune internationale):

Chlortetracycline hydrochloride

Dosage:

250 milligram(s)/gram

forme pharmaceutique:

Premix for medicated feeding stuff

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Chickens, Pigs

Domaine thérapeutique:

chlortetracycline

indications thérapeutiques:

Antibacterial

Statut de autorisation:

Authorised

Date de l'autorisation:

2013-12-09

Résumé des caractéristiques du produit

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Aurofac
®
Granular 250 mg/g Premix for medicated feeding stuff for pigs and
chickens [IE, PT, SI]
Aurofac
®
250 mg/g premezcla medicamentosa para porcino y aves [ES]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Chlortetracycline hydrochloride
250 mg/g
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Carmellose sodium
Calcium sulfate dihydrate
Premix for medicated feeding stuff.
Granular yellow powder.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs and chickens
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Pigs:
As an aid in the treatment and control of swine respiratory disease
complex associated with
chlortetracycline-sensitive organisms. The following pathogens in pigs
are generally considered as
sensitive to chlortetracycline (refer to section 3.5):
_Actinobacillus pleuropneumoniae_
,
_Bordetella _
_bronchiseptica_
,
_Erysipelothrix rhusiopathiae_
,
_Escherichia coli_
,
_Haemophilus parasuis_
,
_Leptospira _
spp.,
_Lawsonia intracellularis_
,
_Mycoplasma _
spp.,
_Pasteurella multocida_
,
_Streptococcus suis_
.
Chickens:
As an aid in the treatment and control of respiratory and systemic
infections associated with
chlortetracycline-sensitive organisms. The following pathogens in
chickens are generally considered
as sensitive to chlortetracycline (refer to section 3.5):
_Escherichia coli_
,
_Mycoplasma gallisepticum_
,
_Mycoplasma synoviae_
,
_Ornithobacterium rhinotracheale_
,
_Pasteurella multocida_
.
3.3
CONTRAINDICATIONS
Do not use in adult ruminants.
Do not use in animals where resistance to the active substance is
known to occur.
Do not use in cases of hypersensitivity to the active substance.
3
3.4
SPECIAL WARNINGS
Pigs: Use of the veterinary medicinal product during the period of
tooth development may lead to
tooth discolouration
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Use of the veterinary medicinal product should be based on
susceptibility testing o