Ketink 100 mg/ml solution for injection 100ml

ment of Postpartum Dysgalactia Syndrome -PDS- (Metritis Mastitis Agalactia Syndrome) and respiratory diseases. Horses: Anti-inflammatory and analgesic treatment of diseases in the musculoskeletal system and joints. Symptomatic analgesic treatment for colic. Postoperative pain and swelling. 4.3. Contraindications Do not use in case of hypersensitivity to the active substance, or to any of the excipients. Donot use in animals suffering from gastro-intestinal lesions, haemorrhagic diathesis, blood dyscrasia, impaired hepatic, cardiac or renal function. Do not use in foals in their first month of life. Do not useother non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. 4.4. Special warnings for each target species None. 4.5. Special precautions for use Special precautions for use in animals Use in animals 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 intra-arterial injection. Do not exceed the stated dose or duration of treatment. Use with caution in dehydrated, hypovolemic or hypotensive animals as there is a potential risk of increased renal toxicity. In the case of colic a supplementary dose may only be given after a thorough clinical examination. Sufficient drinking water must be supplied at all times during treatment. Special precautions to be taken by the person administering the veterinary medicinal product to animals Take care to avoid accidental self injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. People with known hypersensitivity to ketoprofen or benzyl alcohol should avoid contact with the veterinary medicinal product. Avoid splashes on the skin and eyes. Rinse thoroughly with water should this occur. If irritation persists seek medical advice. Wash hands after use. 4.6. Adverse reactions (frequency and seriousness) In very rare cases these signs can be observed: • temporary irritation after repeated intramuscular injections • gastric and intestinal irritation or ulceration (due to ketoprofen mechanism of action including inhibition of prostaglandin synthesis) • reversible inappetence after repeated administration to swine. • allergic reactions. 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 according to a benefit/risk assessment by the responsible veterinarian. 4.8. Interaction with other medicinal products and other forms of interaction The veterinary medicinal product must not be administered in conjunction with, or within 24 hours of administration of other NSAIDs and glucocorticoids. Concurrent administration of diuretics, nephrotoxic drugs and anticoagulative drugs should be avoided. Ketoprofen is highly bound to plasma proteins, and may displace or be displaced by other highly protein bound medicines, such as anticoagulants. Due to the fact that ketoprofen may inhibit platelet aggregation and cause gastrointestinal ulceration, it should not be used with other medicines that have the same profile of adverse drug reactions.
Vat Rate: 20%