País: Regne Unit
Idioma: anglès
Font: HMA (Heads of Medicines Agencies)
marbofloxacin 100 mg/ml
INDUSTRIAL VETERINARIA S.A.
QJ01MA93
Solution for injection
marbofloxacin
Cattle Food, Pigs Food
2013-01-23
Page 1 of 12 LABELLING AND PACKAGE LEAFLET Page 2 of 12 A. LABELLING Page 3 of 12 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Boflox, 100 mg/ml solution for injection for cattle and pigs Marbofloxacin 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance: Marbofloxacin 100 mg/ml Excipients: Disodium edetate Monothioglycerol Metacresol 3. PHARMACEUTICAL FORM Solution for injection 4. PACKAGE SIZE 100 ml 250 ml 6 x 100 ml 6 x 250 ml 10 x 100 ml 10 x 250 ml 12 x 100 ml 12 x 250 ml 5. TARGET SPECIES Cattle, pigs (sows) 6. INDICATION(S) Read the package leaflet before use. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: IM, SC or IV use Pigs (sows): IM use Read the package leaflet before use. 8. WITHDRAWAL PERIOD CATTLE: 8 mg/kg on a single occasion (IM) Page 4 of 12 Meat and offal: 3 days Milk: 72 hours 2 mg/kg for 3 to 5 days (IV/SC/IM) Meat and offal: 6 days Milk: 36 hours PIG (SOWS): Meat and offal: 4 days 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP Shelf-life after first opening the container: 28 days. Once broached, use by… 11. SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Dispose of waste material in accordance with local requirements. 13. THE WORDS “FOR ANIMAL TR Llegiu el document complet
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Boflox, 100 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains: ACTIVE SUBSTANCE: Marbofloxacin 100 mg EXCIPIENTS: Disodium edetate 0.10 mg Monothioglycerol 1 mg Metacresol 2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Yellow greenish to yellow brownish, clear solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs (sows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle: - treatment of respiratory infections caused by strains of _Histophilus somni_, _Mannheimia _ _haemolytica_, _Mycoplasma bovis, Pasteurella multocida_ susceptible to marbofloxacin._ _ - treatment of acute mastitis caused by strains of _Escherichia coli_ susceptible to marbofloxacin during the lactation period. In pigs: - treatment of Postpartum Dysgalactia Syndrome –PDS-(Metritis Mastitis Agalactia syndrome), caused by bacterial strains susceptible to marbofloxacin. 4.3 CONTRAINDICATIONS Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). Do not use in animals with known hypersensitivity to the active substance or to any other quinolone or to any of the excipients. Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Official and local antimicrobial policies should be taken into account when the p Llegiu el document complet