AUROFAC GRANULAR 250 MG/G PREMIX FOR MEDICATED FEEDINGSTUFF FOR PIGS AND CHICKENS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CHLORTETRACYCLINE HYDROCHLORIDE

Available from:

Zoetis Ireland Limited

ATC code:

QJ01AA03

INN (International Name):

CHLORTETRACYCLINE HYDROCHLORIDE

Dosage:

250 mg/g

Pharmaceutical form:

Premix for Med.Feedstuffs

Prescription type:

POM

Therapeutic group:

Fowl - Chicken, Porcine

Therapeutic area:

Chlortetracycline

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-12-09

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Aurofac Granular 250 mg/g Premix for medicated feedingstuff for pigs and chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of premix contains:
Active substance(s):
Chlortetracycline hydrochloride
250 mg/g
Excipients:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
Granular yellow powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs and chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE 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
4.5.i): _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 4.5.i): _Escherichia coli, Mycoplasma gallisepticum, Mycoplasma synoviae, Ornithobacterium rhinotracheale,_
_Pasteurella multocida._
4.3 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 case of hypersensitivity to the active substance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Pigs: Use of the product during the period of tooth development may lead to tooth discolouration.
HEALTH PRODUCTS REGULATORY AUTHORITY
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