Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
florfenicol, meloxicam
CEVA Santé Animale
QJ01BA99
florfenicol, meloxicam
Cattle
Amphenicols, combinations, Antibacterials for systemic use
For therapeutic treatment of bovine respiratory disease (BRD) associated with pyrexia due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to florfenicol.
Authorised
2017-05-15
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET ZELERIS 400 MG/ML + 5 MG/ML SOLUTION FOR INJECTION FOR CATTLE 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle florfenicol / meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 ml contains 400 mg of florfenicol and 5 mg of meloxicam. Clear yellow solution. 4. INDICATION For therapeutic treatment and of bovine respiratory disease (BRD) associated with pyrexia due to _Mannheimia haemolytica_ , _Pasteurella multocida _ and _Histophilus somni_ susceptible to florfenicol. 5. CONTRAINDICATIONS Do not use in adult bulls intended for breeding. Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or when there is evidence of ulcerogenic gastrointestinal lesions. Do not use in case of hypersensitivity to the active substances or to any of the excipients. 6. ADVERSE REACTIONS Injection site reactions (mostly swelling, induration, heat and pain) were very commonly observed after subcutaneous administration of the product. These effects were transitory and usually resolved without any treatment within 5 to 15 days, but could persist up to 49 days. During injection of this product animals may exhibit signs of moderate pain, manifested as movement of the head or neck. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 a Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCES: Florfenicol 400 mg Meloxicam 5 mg. EXCIPIENTS: For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Clear yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For therapeutic treatment of bovine respiratory disease (BRD) associated with pyrexia due to _Mannheimia haemolytica_ , _Pasteurella multocida _ and _Histophilus somni_ susceptible to florfenicol. 4.3 CONTRAINDICATIONS Do not use in adult bulls intended for breeding. Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or when there is evidence of ulcerogenic gastrointestinal lesions. Do not use in case of hypersensitivity to the active substances 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 Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing. Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used. Avoid use in severely dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of renal toxicity. In the absence of safety data it is not recommended to use the product in calves less than 4 weeks old. 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals The product is slightly irritant to the eye. Rinse any splashes from eyes immediately with plenty of water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. People with known hypersensitivity to florfenicol, meloxicam or to any of th Przeczytaj cały dokument