Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
CHLORTETRACYCLINE HYDROCHLORIDE
Zoetis Belgium S.A.
QJ01AA03
CHLORTETRACYCLINE HYDROCHLORIDE
100 mg/g
Premix for Med.Feedstuffs
POM
Chlortetracycline
Antibacterial
Authorised
2017-03-01
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 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Preberite celoten dokument