supplied with its solvent for more practical use

Transcription

1 TISSUE Friendly l From 1-14 days following injection, no clinical signs like pain, swelling, erythema and induration have been reported l No macroscopic lesions were observed l Moreover, Cevaxel did not impair general behaviour, appetite and weight gain less stress for lactating cows CATTLE neck muscle 24h after injection of Cevaxel (15) less stress for suckling piglets pig neck muscle 24h after injection of Cevaxel (16) EXClusively supplied with its solvent SOLVENT Reconstitution of the product for more practical use POWDER Fill the syringe with the required quantity of solvent 2. inject the solvent into the vial of powder until resistance builds in the plunger 3. EASE PRESSURE on plunger to allow air back into the syringe 4. Re-inject the rest of the solvent After reconstitution the product can be used for 7 days when stored in a refrigerator (2ºC - 8ºC) or for up to 12 hours if stored below 25ºC.

2 CEFTIOFUR IN POWDER FOR INJECTABLE SOLUTION You no longer have to pay for exclusivity

3 CEFTIOFUR IN POWDER FOR INJECTABLE SOLUTION You no longer have to pay for exclusivity

4 Less expensive - cost effective Zero milk withdrawal Two day meat withdrawal in cattle Differences in cost of milk discard between products in the UK Treatment Treatment time Milk withdrawal times Difference in cost compared to CEVAXEL CEVAXEL 3-5 days 0 0 danofloxacin 3 days 48 hours enrofloxacin 3 days 72 hours marbofloxacin 3-5 days 36 hours oxytetracycline LA 1 injection 8 days tylosin 3-5 days 108 hours Based on 25litres/day/cow and 20 pence/litre milk

5 CEVA Santé Animale, undeniable expertise in anti-infectives BIOEQUIVALENCE TO REFERENCE PRODUCT 6 Evolution of plasma concentrations in cows after injection of 2 different preparations of ceftiofur 1 5 A = CEVAXEL B = reference product Plasma Conc. (mg/l) Treatment A (Test item) Treatment B (Reference item) Time (h) Evolution of plasma concentrations in pigs after injection of 2 different preparations of ceftiofur 2 Plasma Conc. (mg/l) Treatment A (Test item) 8 Treatment B (Reference item) Time (h) A = CEVAXEL B = reference product CEVA has a long EXPerience in manufacturing injectable anti-infectives in its modern GMP plant including colistin, erythromycin, florfenicol, spectinomycin and tiamulin.

6 CEFTIOFUR Ceftiofur: A WIDE RANGE OF ACTIONS Good extracellular diffusion and total bioavailability of ceftiofur l Ceftiofur belongs to the 3 rd generation of cephalosporins l With bactericidal properties related to the inhibition of bacteria cell wall synthesis l Wide spectrum against Gram + and Gram - bacteria (3) susceptibility OF the main isolated pathogens Pasteurella multocida (82 isolated strains) Pasteurella multocida (171 isolated strains) Cattle Pigs Mannheimia haemolytica (72) Actinobacillus pleuropneumoniæ (133) Haemophilus somnus (62) Streptococcus suis (117) Fusobacterium necrophorum (27) 0 % 20 % 40 % 60 % 80 % 100 % Ref. 4,5,6 Comparison of antimicrobial activity Anaerobiae Gram + Cl. Perfringens Anaerobiae Gram - Enterobacter (E.Coli) Actinobacillus pleuropneumoniae Pasteurella multocida Streptococcus suis Ceftiofur X X X X X X tulathromycin X X No X X X Spectinomycin X X +/- X +/- +/- enrofloxacin +/- +/- X X X X Ref. 1,7,8,9

7 CEFTIOFUR (10) Bovine Respiratory Disease eg Pasteurella multocida and Mannheimia haemolytica BRD = THE Most common cause of morbidity and mortality This multifactorial complex involves different agents including bacteria. Antimicrobials are known to reduce illness and death rate in case of BRD. Porcine Respiratory Disease eg Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis Pasteurella multocida typical secondary bacteria contributing to the development of complicated enzootic pneumonia of growing and fattening pigs. Actinobacillus pleuropneumoniae (APP) a frequent worldwide spread primary infection, which can cause significant direct and indirect losses. The mortality after infection of susceptible animals can reach 50% (11). Streptococcus suis most common pathogen involved in mixed respiratory viral and bacterial coinfections (12). (13) Foot rot interdigital necrobacillosis in which Fusobacterium necrophorum and Bacteroides melaninogenicus are involved. Foot rot is known to have a severe impact on reproductive function by reducing oestrus expression. Interdigital phlegmon has also been associated with a 10% decrease in milk production (14).

8 Xero powder with zero milk CEFTIOFUR IN POWDER FOR INJECTABLE SOLUTION SPECIES ADMINISTRATION ROUTE DOSAGE Cattle IM 1mg/kg/day 1ml/50kg/day Pigs IM 3mg/kg/day 1ml/16kg/day Daily for 3-5 days Daily for 3 days CEVAXEL 50mg/ml: Powder and solvent for solution for injection for cattle and pigs. COMPOSITION: Powder vials contain: Ceftiofur (as sodium) 1 g or 4 g. One ml solvent contains: Water for injection 1ml. INDICATIONS: Cattle: Treatment of bacterial respiratory disease associated with Pasteurella multocida and Mannheimia haemolytica sensitive to ceftiofur.treatment of cattle with interdigital necrobacillosis (foot rot) in which Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica) sensitive to ceftiofur are involved. Pigs: Treatment of bacterial respiratory disease in which Pasteurella multocida, Actinobacillus pleuropneumonia and Streptococcus suis sensitive to ceftiofur are involved. DOSAGE FOR EACH SPECIES, ROUTE OF ADMINISTRATION: Intramuscular use. Cattle: For respiratory disease:1 mg ceftiofur (as sodium) per kg bodyweight per day for 3 to 5 days, i.e. 1 ml of reconstituted solution per 50 kg bodyweight per day for 3 to 5 days. For interdigital necrobacillosis: 1 mg ceftiofur (as sodium) per kg bodyweight per day for 3 days, i.e. 1 ml of reconstituted solution per 50 kg bodyweight per day for 3 days. Pigs: 3 mg ceftiofur (as sodium) per kg bodyweight per day for 3 days, i.e. 1 ml of reconstituted solution per 16 kg bodyweight per day for 3 days. The dose should be given once daily at 24 hour intervals. Do not administer more than 10 ml per injection site. WITHDRAWAL PERIODS: Meat and offal: Cattle: 2 days, pigs: 2 days. Milk: zero day. CONTRAINDICATIONS: Do not use in animals previously found to be hypersensitive to ceftiofur or other beta-lactamines. ADVERSE REACTIONS: Fleeting symptoms of pain may be observed at the injection site. In local tolerance studies conducted in cattle and swine, mild and transient swelling were observed at the injection site in a few pigs six hours after injection. No signs of swelling at the palpation of the injection site were observed 24 hours after injection. Hypersensitivity reactions can occasionally occur. In the case of an allergic reaction, treatment should be stopped. PRECAUTIONS: Special precautions for use in animals: In case of repeated administrations, precautions must be taken, such as injections on both sides of the neck. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Penicillins and cephalosporins may cause hypersensitivity following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. People with known hypersensitivity should avoid contact with the veterinary medicinal product. In case of development of a skin rash following exposure, seek medical advice. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention. Wash hands after use. LEGAL CATEGORY: POM-V PACK SIZES: Box containing 1 vial of CEVAXEL 50 mg/ml, 1 g and box containing a vial of 20 ml solvent / Box containing 1 vial of CEVAXEL 50 mg/ml, 4 g and box containing a vial of 80 ml solvent. Not all pack sizes may be marketed. Vm 15052/ : Mas (2006) Study report. CEVA Santé Animale MPK/475R0/ : Guyonnet (2006) Study report CEVA Santé Animale MPK/475R0/ : Sarah A. et al (1996) In vitro activity of ceftiofur and its primary metabolite, desfuroylceftiofur, against organisms of veterinary importance. J Vet Diagn Invest. 8(3): : Manco, B. (2008) Ceftiofur susceptibility surveillance with respect to Histophilus somni (Haemophilus somnus), Pasteurella multocida and Mannheimia haemolytica bovine isolates. Study report CEVA Santé Animale MIC/475/ : Manco, B. (2008) Ceftiofur susceptibility surveillance with respect to Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis swine isolates. Study report CEVA Santé Animale MIC/475/ : Manco, B. (2008) Ceftiofur susceptibility surveillance with respect to Fusobacterium necrophorum bovine isolates. Study report CEVA Santé Animale MIC/475/ : Wallman, J. et al (2006) Results of an interlaboratory test on antimicrobial susceptibility tests of bacteria from animals by broth microdilution. International Journal of Antimicrobial Agents, 27, : Burton, P.J. et al (1996) Interpretive criteria for antimicrobial susceptibility testing of ceftiofur against bacteria associated with swine respiratory disease. J Vet Diagn Invest. 8, : Coutinho, T.A. et al (2008) Antimicrobial susceptibility of Pasteurella multocida isolated from lungs of swine with pneumonia in south of Brazil. Proceedings of the 20th IPVS Congress, Durban, S Africa June. 10: Zwald A.G. et al (2004) Management practices and reported antimicrobial usage on conventional and organic dairy farms. J Dairy Sci. 87(1): : Broes A. et al (2007) Dealing with unexpected Actinobacillus pleuropneumoniae serological results. J of Swine Health and Production 15(5): : Wisselink H.J. et al (2006) Quantitative susceptibility of Streptococcus suis strains isolated from diseased pigs in seven european countries to antimicrobial agents licenced in veterinary medicine. Vet Mic.113: : Kausche F.M. and Robb, E.J. (2003) A comprehensive review of ceftiofur sodium and hydrochloride formulations for treatment of acute bovine foot rot. Vet Ther. 4(1): : Hernandez J. et al (2002) Effect of lameness on milk yield in dairy cows. J Am Vet Med Assoc. 220(5): : Study report. CEVA Santé Animale ST- MPK/475R0/ : Study report. CEVA Santé Animale ST- MPK/475R0/0535. Dec 2009 Further information is available from: CEVA ANIMAL HEALTH LTD 90 The Broadway, Chesham, Bucks HP5 1EG Tel: Fax: