Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
enrofloxacin 100 mg/ml
Universal Farma S.L.
QJ01MA90
Oral solution
enrofloxacin
Chicken Food, Rabbit Food
2011-05-08
B.2. PROPOSAL FOR PACKAGING, LABELLING AND PACKAGE INSERT Label-leaflet ENROFLOXACIN UNIVERSAL 100 MG/ML ORAL SOLUTION FOR CHICKENS AND RABBITS [ES] Enrofloxacin LEVOFLOK ® 100 MG/ML ORAL SOLUTION FOR CHICKENS AND RABBITS [EL, IT, PT] Enrofloxacin 1-L BOTTLES 5-L BARRELS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: [ES]: UNIVERSAL FARMA, S.L. Gran Vía Carlos III, 98 – 7ª 08028 – BARCELONA Spain [EL, IT, PT]: VETPHARMA ANIMAL HEALTH, S.L. Les Corts, 23 08028 – BARCELONA Spain Manufacturer for the batch release: LABORATORIOS KARIZOO, S.A. Polígono Industrial La Borda Mas Pujades, 11-12 08140 – CALDES DE MONTBUI (Barcelona) Spain SP VETERINARIA SA. Ctra. Reus-Vinyols Km 4.1. 43330 Riudoms (Tarragona) Distributed by: 2. NAME OF THE VETERINARY MEDICINAL PRODUCT ENROFLOXACIN UNIVERSAL 100 mg/ml Oral solution for chickens and rabbits [ES] Enrofloxacin LEVOFLOK ® 100 mg/ml Oral solution for chickens and rabbits [EL, IT, PT] Enrofloxacin 3. STATEMENT OF ACTIVE AND OTHER SUBSTANCES ACTIVE SUBSTANCE: Enrofloxacin .......................................... 10.0 g EXCIPIENTS: Benzyl Alcohol ........................................ 1.4 ml Excipients to ........................................... 100 ml 4. PHARMACEUTICAL FORM Oral solution to be administered in drinking water 5. TARGET SPECIES Chickens (broilers) and rabbits 6. INDICATIONS CHICKENS (BROILERS): Treatment of infections due to _E.coli_, _Salmonella spp_. and _Mycoplasma spp_. RABBITS: Treatment of respirator Read the complete document
B.1. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ENROFLOXACIN UNIVERSAL 100 mg/ml Oral solution for chickens and rabbits [ES] LEVOFLOK ® 100 mg/ml Oral solution for chickens and rabbits [EL, IT, PT] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin ....................................... 100.0 mg EXCIPIENTS: Benzyl Alcohol (E 1519)................... 0.014 ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution to be administered in drinking water 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Chickens (broilers) Rabbits 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CHICKENS (BROILERS): Treatment of infections due to _E.coli_, _Salmonella spp_. and _Mycoplasma spp_. RABBITS: Treatment of respiratory infections due to _P.multocida_. If there is no clinical improvement within three days from the beginning of therapy, the chosen therapy should be considered. 4.3. CONTRAINDICATIONS Renal and hepatic failure. Do not use in animals with cartilage growth disorders. Infections caused by micro-organisms resistants to quinolones. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES Not permitted for use in laying birds producing eggs for human consumption. 4.5. SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical co Read the complete document