CTC ALPHARMA 100 MG/G GRANULAR PREMIX FOR MEDICATED FEEDINGSTUFF
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-12-2015
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Active ingredient:
CHLORTETRACYCLINE HYDROCHLORIDE
Available from:
Zoetis Ireland Limited
ATC code:
QJ01AA03
INN (International Name):
CHLORTETRACYCLINE HYDROCHLORIDE
Dosage:
100 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
CTC Alpharma 100 mg/g Granular Premix for medicated feedingstuff.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g contains:
ACTIVE SUBSTANCE:
Chlortetracycline hydrochloride
100 mg
EXCIPIENTS:
For a 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.
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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_Date Printed 14/12/2015_
_CRN 7022393_
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