Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
ceftiofur
Zoetis Belgium SA
QJ01DD90
ceftiofur
Pigs; Cattle
Antibacterials for systemic use
PigsTreatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.CattleTreatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot.Treatment of acute post-partum (puerperal) metritis in cattle, in cases where treatment with another antimicrobial has failed.
Revision: 15
Authorised
2005-05-19
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: NAXCEL 100 MG/ML SUSPENSION FOR INJECTION FOR PIGS 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: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 100 mg/ml suspension for injection for pigs ceftiofur 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One ml contains: ACTIVE SUBSTANCE: Ceftiofur (as crystalline free acid) 100 mg. 4. INDICATION(S) Treatment of bacterial respiratory disease associated with _Actinobacillus pleuropneumoniae_ , _Pasteurella multocida_ , _Haemophilus parasuis_ and _Streptococcus suis_ . Treatment of septicaemia, polyarthritis or polyserositis associated with _Streptococcus suis _ infection. 5. CONTRAINDICATIONS Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, or to any of the excipients. 6. ADVERSE REACTIONS Occasionally, transient local swelling may occur following intramuscular injection. Mild tissue reactions at the injection site, such as small areas (less than 6 cm²) of discolouration and small cysts have been observed for up to 42 days after injection. Resolution has been observed at 56 days post-injection. In very rare cases anaphylactic type reactions may occur following administration of the product. 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) 27 - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). If you notice any side effects, even those not already listed in this package leafle Прочетете целия документ
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 100 mg/ml suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Ceftiofur (as crystalline free acid) 100 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Opaque white to light brown suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of bacterial respiratory disease associated with _Actinobacillus pleuropneumoniae_ , _Pasteurella multocida_ , _Haemophilus parasuis_ and _Streptococcus suis_ . Treatment of septicaemia, polyarthritis or polyserositis associated with _Streptococcus suis _ infection. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, 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 For systemically administered broad spectrum cephalosporins (3 rd and 4 th generation, such as ceftiofur), it should be reflected that these are to be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to less critical antimicrobials. Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of bacteria resistant to ceftiofur. Official, national and regional antimicrobial policies should be taken into account when the product is used. Whenever possible, cephalosporins should only be used based on susceptibility testing. When considering the treatment strategy, it is appropriate to consider improvement of the herd management practice and use supporting treatment with suitable local products (e.g. disinfectants). 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals Penicillins and cephalosporins such as cefti Прочетете целия документ