Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Florfenicol
Laboratorios Hipra S.A.
QJ01BA90
Florfenicol
300 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
florfenicol
Antibacterial
Authorised
2008-02-15
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SELECTAN 300 mg/ml solution for injection for cattle and swine. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH ML CONTAINS: Active substance Florfenicol …………………………………………………………………………… 300 mg Excipient N-methyl pyrrolidone ……………………………………………...………………… 308 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A slightly yellowish and clear solution. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cattle and swine. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Diseases caused by florfenicol susceptible bacteria: Cattle: Therapeutic treatment of respiratory tract infections in cattle due to _ Mannheimia haemolytica, _ _Pasteurella_ _multocida,_ and _ Histophilus somni. _ Swine: Treatment of acute outbreaks of respiratory disease caused by strains of _Actinobacillus _ _pleuropneumoniae _ and _ Pasteurella multocida_ . 4.3. CONTRAINDICATIONS Do not administer to adult bulls or boars intended for breeding purposes. Do not administer to animals with known hypersensitivity to the active substance or to any of the excipients. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5. SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Do not use in piglets of less than 2 kg. Swab the septum before removing each dose. Use a dry, sterile syringe and needle. Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local antimicrobial policies. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the florfenicol and may decrease the effectiveness of treatment with other amfenicols, due to the potential for crossresistance. _ _ SPECIAL PRECAUTION TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS Care should be taken to avoid accidental Baca dokumen lengkapnya