SUMMARY OF PRODUCT CHARACTERISTICS. Bottle of powder: Active substance: ceftiofur sodium mg equivalent to ceftiofur...
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1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT WONDERCEF powder and solvent for solution for injection for horses not intended for the production of foods for human consumption. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION WONDERCEF 1 g Bottle of powder: Active substance: ceftiofur sodium mg equivalent to ceftiofur mg Bottle of solvent: water for injections ml WONDERCEF 4 g Bottle of powder: Active substance: ceftiofur sodium mg equivalent to ceftiofur mg Bottle of solvent: water for injections ml 1 ml of solution thus obtained contains ceftiofur 50 mg For a full list of excipients, see section PHARMACEUTICAL FORM Powder and solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 Target species Horses not intended for the production of foods for human consumption. 4.2 Indications for use, specifying the target species WONDERCEF is indicated for the treatment of infections to the respiratory system of horses due to bacteria sensitive to ceftiofur, associated with Streptococcus zooepidemicus, Streptococcus equi and Pasteurella spp. 4.3 Contraindications Do not use in animals with ascertained hypersensitivity to the active substance or to any one of the excipients. Do not use in poultry (including layers) due to the risk of the spread of antimicrobial resistance to humans. 1/5
2 4.4 Special warnings for each target species The product must not be administered to horses intended for the production of foods for human consumption. Administration of antimicrobial agents to horses under stress conditions may be associated with acute diarrhoea, which may be fatal. In case of acute diarrhoea, suspend administration of the veterinary medicinal product and perform suitable therapy. 4.5 Special precautions for use Special precautions for use in animals WONDERCEF selects resistant strains as bacterial vectors of extended spectrum betalactamases (ESBL) and may constitute a risk for human health if these strains spread to man, for example through foods. For this reason, WONDERCEF must be limited to the treatment of clinical condition which have responded reply, or which it is considered may respond, poorly (referring to very acute cases in which treatment must be started without bacteriological diagnosis) to the first-line treatment. During use of the product, please comply with the official national and regional regulations on the use of antimicrobial products. More frequent use, including use of this product other than according to the instructions supplied in the SPC, may lead to an increase in the incidence of this type of resistance. Where possible, WONDERCEF must be used exclusively on the basis of sensitivity testing. WONDERCEF is intended for the treatment of individual animals. Do not use for the prevention of diseases or as part of health programmes for breeding establishments. The treatment of groups of animals must be rigorously limited to ongoing epidemics, according to the approved conditions of use. Special precautions to be taken by the person administering the veterinary medicinal product to animals Ceftiofur may cause mild irritation to excoriated skin, particularly after frequent contacts. Antimicrobial drugs, including penicillin and the cephalosporins, may cause allergic reactions in sensitive subjects. Therefore, in cases of known hypersensitivity, do not handle the product. To reduce the possibility of these reactions, it is recommended that direct contact of the skin and the mucosae with the medicinal product be avoided. The occurrence of severe symptoms such as swelling of the face, lips and eyes or respiratory difficulty require rapid treatment by a doctor. Care must be taken during administration of the product to avoid accidental self-injection. In case of accidental self-injection, see a doctor immediately and show him the package leaflet or label of the product. 4.6 Adverse reactions (frequency and severity) In the horse, a mild local muscle irritation has been found at the injection site. The lesions evolve towards a muscle regeneration and, in a number of cases, small necrotic foci remain. Cases of anaphylactic reactions have been reported, with massive urticaria. Prolonged use of the medicinal product may lead to a change to the intestinal bacterial flora, with symptoms of colic. 2/5
3 4.7 Use during pregnancy and lactation Data in the horse are not available. In rats, after oral administration, teratogenic effects, cases of abortion or effects on reproductive capacity were not observed. In any event, use only after an evaluation of the risk/benefit ratio by the attending veterinarian. 4.8 Interaction with other veterinary medicinal products and other forms of interaction The bactericidal properties of the cephalosporins are antagonised by the concurrent administration of bacteriostatic antibiotics (macrolides, sulfonamides and tetracyclines). 4.9 Amounts to be administered and administration route Reconstitute the solution of WONDERCEF, transferring the contents of the solvent bottle to the bottle containing the powder, then shake. Reconstitution must be performed rapidly. Administer by the intramuscular route, taking the usual aseptic precautions, at the following amounts to be administered: 1 ml/25 kg b.w. (equivalent to 2.2 mg of ceftiofur per kg b.w.) once a day for 10 consecutive days at 24-hourly intervals. To ensure correct dosage, the body weight must be determined as precisely as possible, to avoid underdosing Overdose (symptoms, emergency procedures, antidotes) In horses, dosages 5 times greater than those recommended, administered for 30 days, were well tolerated Withdrawal periods Not applicable. The product must not be administered to horses intended for the production of foods for human consumption. For horses not intended for the production of foods for human consumption. 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: third generation cephalosporins - antibacterial agents for systemic use ATC Vet Code: QJ01DD Pharmacodynamic properties WONDERCEF is a veterinary medicinal product based on ceftiofur, a broad spectrum, third-generation cephalosporin. Ceftiofur, interfering with the synthesis of the bacterial cell wall, acts bactericidally against Gram-positive and Gram-negative bacteria, including beta-lactamase producing strains Its solubility in water is conditioned by the ph (with a ph higher than 5.5 it is greater than 400 mg/ml). 3/5
4 Ceftiofur is active, both in vivo and in vitro, against Streptococcus zooepidemicus, Streptococcus equi and Pasteurella spp., microorganisms involved in infections to the respiratory system in horses. 5.2 Pharmacokinetic particulars In the horses, the product distributes very rapidly to the tissues. After intramuscular administration of 2.2 mg of ceftiofur/kg of body weight the maximum plasma concentration of 4.46 µg/ml (Cmax.) is reached in 1.25 hours (Tmax.), with a half-life of 3.15 hours (T 1/2). The plasma and pulmonary concentrations, 24 hours after administration, are still higher than the MICs of the microorganisms responsible for respiratory disorders in the horse. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Potassium phosphate monobasic Water for injections 6.2 Incompatibilities Do not mix with other veterinary medicinal products. 6.3 Shelf-life Shelf-life of the veterinary medicinal product as packaged for sale: - powder: 2 years - solvent: 4 years. The shelf-life refers to the individual bottles of powder and solvent. The box containing both the bottle of powder and the bottle of solvent has the shorter shelf-life of 2 years. Shelf-life after reconstitution according to directions: - 12 hours if stored at temperature between 15 C and 30 C; - 7 days if stored in a refrigerator (2-8 C). 6.4 Special precautions for storage Store in a refrigerator (2-8 C) protected from light. After reconstitution: to be used within 12 hours if stored at a temperature between 15 C and 30 C and 7 days if stored in a refrigerator (2 C - 8 C). 6.5 Nature and composition of the immediate packaging Powder: 30 ml and 100 ml bottles in Type II glass with elastomer cap sealed with an aluminium collar. 4/5
5 Solvent: 20 ml and 100 ml bottles in Type II glass with elastomer cap sealed with an aluminium collar. Not all pack sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused product or waste materials should be disposed of in accordance with national requirements. 7. MARKETING AUTHORISATION HOLDER FATRO S.p.A. - Via Emilia, Ozzano dell'emilia - Bologna - Italy 8. MARKETING AUTHORISATION NUMBERS Box containing 1 x 1 g bottle of powder + 1 x 20 ml bottle of solvent - Marketing Authorisation no Box containing 1 x 4 g bottle of powder + 1 x 80 ml bottle of solvent - Marketing Authorisation no DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: Date of renewal: DATE OF REVISION OF THE TEXT Dispensing November 2015 Medicinal product subject to non-renewable veterinary medical prescription in one copy. 5/5
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