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Melovem mg/ml solution for injection for cattle and pigs 2.QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance


Melovem mg/ml solution for injection for cattle and pigs 2.QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Meloxicam 5 mg Excipient(s): Benzyl alcohol 50 mg For the full list of excipients, see section 6.1. 3.PHARMACEUTICAL FORM Solution for injection. Clear, greenish yellow solution. 4.CLINICAL PARTICULARS 4.1Target species Cattle (calves and young cattle) and pigs. 4.2Indications for use, specifying the target species Cattle: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. For the relief of post-operative pain following dehorning in calves. Pigs: For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For the relief of post operative pain associated with minor soft tissue surgery such as castration. 4.3Contraindications Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. Do not use in case of hypersensitivity to the active substance or to any of the excipients. For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age. Do not use in pigs less than 2 days old. 4.4Special warnings for each target species Treatment of calves with Melovem 20 minutes before dehorning reduces post-operative pain. Melovem alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed. Treatment of piglets with Melovem before castration reduces post operative pain. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed. To obtain the best possible pain relieving effect post surgery Melovem should be administered 30 minutes before surgical intervention. 4.5Special precautions for use Special precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity. Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6Adverse reactions (frequency and seriousness) Transient swelling at the injection site was commonly reported in clinical studies following subcutaneous administration in cattle. Injection site swelling may be painful. Transient swelling at the injection site was observed in clinical studies following intramuscular administration in pigs. In very rare cases anaphylactoid reactions, which may be serious (including fatal), 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 displaying adverse reactions 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). 4.7Use during pregnancy, lactation or lay Cattle: Can be used during pregnancy. For lactating animals see section 4.11. Pigs: Can be used during pregnancy and lactation. 4.8Interaction with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents. 4.9Amounts to be administered and administration route Cattle: Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate. Pigs: Locomotor disorders: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight). If required, a second administration of meloxicam can be given after 24 hours. It is recommended to administer the second injection at a different site since local tolerance has been assessed after single injection only. Reduction of post-operative pain: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery. Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of body weight. Avoid introduction of contamination during use. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary In the case of overdosage symptomatic treatment should be initiated. 4.11 Withdrawal periods Cattle: Meat and offal: 15 days. Not authorised for use in animals producing milk for human consumption. Pigs: Meat and offal: 5 days. 5.PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06. 5.1Pharmacodynamic properties Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic properties. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves and pigs.https://enongvetmedication.com/


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