Forcyl for the treatment of respiratory infections in cattle-Hyperdrug

Special precautions for use in animals Official and local antimicrobial policies should be taken into account when this product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other class of antimicrobials. Wherever possible, use of the product should only be based on susceptibility testing. Use of the product deviating from the instructions given in this SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to (fluoro)quinolones should avoid any contact with the product. If the product comes into contact with the skin or eyes, rinse with copious amounts of water. Care should be taken to avoid accidental self-injection. In the event of accidental self-administration, the user should immediately seek professional medical care. Accidental self-injection can induce a slight irritation. Other precautions None 4.6 Adverse reactions (frequency and seriousness) Administration by the intramuscular route may cause rare transient local reactions such as pain and swelling at the injection site which may persist up to 7 days after injection. Fluoroquinolones are known to induce arthropathies. In cattle, such lesions were observed after a three days treatment with the 16% marbofloxacin solution. These lesions did not induce clinical signs and should be reversible, particularly if they were to be observed after a single administration. No other adverse effect was observed on cattle. 4.7 Use during pregnancy, lactation or lay Studies in laboratory animals (rats, rabbits) did not show any evidence of a teratogenic, embryotoxic or maternotoxic effect associated with the use of marbofloxacin. Safety of the product at 10 mg/kg has not been determined in pregnant cows or in suckling calves when used in cows. Use therefore according to the benefit/risk assessment carried out by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction None known. 4.9 Amounts to be administered and administration route The recommended dosage is 10 mg/kg body weight i.e. 10 ml /160 kg body weight in a single intramuscular injection. If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites. To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing. Where there is slight cloudiness or visible particles present, such cloudiness or particles disappear when the bottle is shaken before use. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Lesions of the joint cartilage were observed in some animals treated at 10 mg/kg or 30 mg/kg for three times the recommended treatment duration, but did not induce clinical signs. Moreover, no sign of overdosage was observed throughout this study. Overdosage may cause signs such as acute neurological disorders which should be treated symptomatically. 4.11 Withdrawal period(s) Meat and offal: 5 days Milk : 48 hours 5. PHARMACOLOGICAL PROPERTIES ATC Vet code: QJ01MA93 Pharmacotherapeutic group: antibacterials for systemic use 5.1 Pharmacodynamic properties Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group, which acts by inhibition of DNA gyrase. It has a broad-spectrum activity in vitro against mycoplasma, Gram-positive and Gram-negative bacteria. The marbofloxacin in vitro activity against pathogens isolated in 2007 from bovine respiratory diseases is good: MIC values are comprised between 0.008 and 0.5 µg/ml for M. haemolytica (MIC90 = 0.139 µg/ml; MIC50 = 0.021 µg/ml), between 0.004 and 0.5 µg/ml for P. multocida (MIC90 = 0.028 µg/ml; MIC50 = 0.012 µg/ml). Strains with MIC ≤ 1 µg/ml are sensitive to marbofloxacin whereas strains with MIC ≥ 4 µg/ml are resistant to marbofloxacin. Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: decrease of the bacterial wall permeability, expression of efflux pump or mutation of enzymes responsible for molecule binding. 5.2 Pharmacokinetic particulars After a single intramuscular administration in cattle at the recommended dose of 10 mg/kg, the maximum plasma concentration of marbofloxacin (Cmax) is 7.915 µg/ml reached in 1.28 h (Tmax). Marbofloxacin is extensively distributed. Binding to plasma proteins is about 30%. Marbofloxacin is eliminated slowly (T1/2z = 17.50 h) predominantly as the active form in urine and faeces. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Benzyl alcohol Glucono-delta-lactone Water for injection 6.2 Incompatibilities In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. 6.3 Shelf life Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 28 days 6.4. Special precautions for storage This veterinary medicinal product does not require any special storage conditions. 6.5 Nature and composition of immediate packaging Details of the primary packaging: Amber type II glass vials Chlorobutyl rubber stopper Aluminium cap or flip cap Pack sizes: Cardboard box containing one 50 ml vial Cardboard box containing one 100 ml vial Cardboard box containing one 250 ml vial Not all pack sizes may be marketed.

Forcyl 160mg/ml Solution for Injection for cattle 100ml