Kelaprofen 100 mg/ml Solution for Injection 100ml

4.1 Target species Horses, cattle, pigs. 4.2 Indications for use, specifying the target species Horse - the alleviation of inflammation and pain associated with musculoskeletal disorders; - the alleviation of visceral pain associated with colic. Cattle - the supportive treatment of parturient paresis associated with calving; - reducing the pyrexia and distress associated with bacterial respiratory disease when used in conjunction with antimicrobial therapy as appropriate; - improving the recovery rate in acute clinical mastitis, including acute endotoxin mastitis, caused by Gram-negative micro-organisms, in conjunction with antimicrobial therapy; - reducing oedema of the udder associated with calving. Pigs - reducing the pyrexia and respiratory rate associated with bacterial or viral respiratory disease when used in conjunction with antimicrobial therapy as appropriate; - the supportive treatment of Mastitis Metritis Agalactia Syndrome in sows, in conjunction with antimicrobial therapy as appropriate. 4.3 Contraindications Do not use in animals with known hypersensitivity to the active substances or to any of the excipients. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other, corticosteroids, diuretics and anticoagulants. Do not use in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, or where there is evidence of blood dyscrasia. 4.4 Special warnings for each target species None. 4.5 Special precautions for use (i) Special precautions for use in animals The use of ketoprofen is not recommended in foals under the age of 15 days. Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful management. Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity. Avoid intra-arterial injection. Do not exceed the stated dose or duration of treatment. (ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to the active substance and/or benzyl alcohol should avoid contact with the veterinary medicinal product. In case of accidental self-injection, seek medical advice and show the package leaflet or the label to the physician. Wash hands after use. Avoid splashes on the skin and eyes. Wash affected area thoroughly with water should this occur. If irritation persists seek medical advice. 4.6 Adverse reactions (frequency and seriousness) In very rare cases, due to the action of inhibition of prostaglandin synthesis, there can be the possibility in certain individuals of gastric or renal intolerance. In very rare cases allergic reactions may occur. The frequency of adverse reactions is defined using the following convention: - Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment). - Common (more than 1 but less than 10 animals in 100 animals). - Uncommon (more than 1 but less than 10 animals in 1,000 animals). - Rare (more than 1 but less than 10 animals in 10,000 animals). - Very rare (less than 1 animal in 10,000 animals, including isolated reports). 4.7 Use during pregnancy, lactation or lay The safety of Ketoprofen has been investigated in pregnant laboratory animals (rats, mice and rabbits) and in cattle, and showed no teratogenic or embryotoxic effects. The product may be given to pregnant and to lactating cattle and to lactating sows. As the effects of ketoprofen on the fertility, pregnancy or foetal health of horses have not been determined, the product should not be administered to pregnant horses. As the safety of ketoprofen has not been assessed in pregnant sows, the product should be used in these cases only according to a benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction Do not administer with other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other, corticosteroids, diuretics or anticoagulants. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. Concurrent administration with nephrotoxic drugs should be avoided.