Finadyne Transdermal 50mg/ml pour-on solution for cattle 250ml

Target species Cattle Indications for use For the reduction of pyrexia associated with bovine respiratory disease. For the reduction of pyrexia associated with acute mastitis. For the reduction of pain and lameness associated with interdigital phlegmon, interdigital dermatitis and digital dermatitis. Contraindications Do not use in animals suffering from cardiac, hepatic or renal disease, or where there is evidence of gastrointestinal ulceration or bleeding. Do not use in severely dehydrated, hypovolaemic animals as there is a potential risk of increased renal toxicity. Do not use the product within 48 hours before expected parturition in cows. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Special warnings for each target species Apply only to dry skin and prevent exposure to wetting for at least 6 hours after application. In case of bacterial infections, concurrent antibiotic therapy should be considered. Special precautions for use See also section “Use during pregnancy, lactation or lay”. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are known to have the potential to delay parturition through a tocolytic effect by inhibiting prostaglandins that are important in signalling the initiation of parturition. The use of the product in the immediate post-partum period may interfere with uterine involution and expulsion of foetal membranes resulting in retained placentae. Safety studies have not been conducted in bulls intended for breeding. Laboratory studies in rats have not shown any evidence of reproductive toxicity. Use only in accordance with a benefit/risk assessment by the responsible veterinarian. Use in pre-ruminating and in aged animals may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful clinical management. Apply only to undamaged skin. Operator warnings Non-Steroidal Anti-inflammatory Drugs (NSAIDs) may cause hypersensitivity (allergy). People with known hypersensitivity to NSAIDs should avoid contact with the product. The product has been shown to cause severe and irreversible eye damage and to cause slight skin irritation. Ingestion of, or dermal contact with the product may be harmful. Avoid contact with eyes, including hand-to-eye contact. Avoid contact with the skin. Avoid contact with the treated area (allowing for spreading of the product) without protective gloves, for at least three days or until the application site is dry (if longer). Avoid children getting access to the product or treated animals. Personal protective equipment consisting of impermeable gloves, protective clothing and approved safety glasses should be worn when using this product. In case of accidental ingestion or mouth contact, immediately rinse the mouth with plenty of water and seek medical advice. In case of eye contact, rinse eyes immediately with copious amounts of clean water and seek medical advice. In case of skin contact, wash thoroughly with soap and water. Do not smoke, eat or drink while handling the product. Wash hands after use. Adverse reactions Transient swelling, erythema, dandruff, broken/brittle hair, hair thinning, alopecia or skin thickening have been commonly reported at the application site. No specific treatment is generally required. Some animals may display temporary signs of irritation, agitation or discomfort following application of the product. In very rare cases anaphylactic reactions, which may be serious, may occur and should be treated symptomatically. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). Use during pregnancy or lactation Can be used during pregnancy and lactation except for 48 hours prior to parturition. Due to an increased risk of retained placentae, the product should only be administered within the first 36 hours post-partum following a benefit/risk assessment performed by the responsible veterinarian and treated animals should be monitored for retained placentae. Interactions Do not administer other NSAIDs concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. Concurrent administration of potentially nephrotoxic drugs should be avoided.