ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Metacam, Solution for injection 1

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metacam 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Metacam solution for injection contains; 2.1 Active substance(s) Meloxicam 5 mg 2.2 Excipient(s) knowledge of which is essential for the proper administration of the veterinary medicinal product Ethanol, absolute 150 mg 3. PHARMACEUTICAL FORM Solution for injection 4. PHARMACOLOGICAL PROPERTIES - Pharmacodynamic 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 effects. Meloxicam has also been shown to inhibit production of thromboxane B 2 induced by intravenous E-coli endotoxin administration in calves. - Pharmacokinetic properties: Absorption After a single subcutaneous dose of 0.5 mg/kg of meloxicam in calves, a maximum mean plasma concentration of 2.1 µg/ml was reached after 6-8 hours. Distribution More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to be found in liver followed by kidney and bile. Comparatively low concentrations are detectable in skeletal muscle and fat. Metabolism Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive. Elimination Meloxicam is eliminated with a half-life of 26 hours. Approximately 50 % of the administered dose is eliminated via urine and the remainder via the faeces. Metacam, Solution for injection 2

3 5. CLINICAL PARTICULARS 5.1 Target species Cattle (calves and young cattle). 5.2 Indications for use, specifying the target species For use in acute respiratory infection in combination with appropriate antibiotic therapy to reduce clinical symptoms in calves and young cattle. 5.3 Contra-indications Do not use in pregnant or lactating animals. Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of individual hypersensitivity to the product. 5.4 Undesirable effects (frequency and seriousness) Subcutaneous as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the animals treated in clinical studies. 5.5 Special precaution(s) for use None. 5.6 Use during pregnancy and lactation The safety for use in pregnant or lactating animals has not been established. 5.7 Interaction with other veterinary medicinal products and other forms of interaction Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs, or with anti-coagulant agents. 5.8 Posology and method of administration Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10 ml/100 kg body weight) in combination with appropriate antibiotic therapy. 5.9 Overdose (symptoms, emergency procedures, antidotes) In the case of overdosage symptomatic treatment should be initiated Special warnings for each target species None 5.11 Withdrawal period Meat and offal: 15 days 5.12 Special precautions to be taken by the person administering the veterinary medicinal product to animals. Metacam, Solution for injection 3

4 Accidental self injection may give rise to pain. Individuals sensitive to NSAIDs should avoid contact with the product. Metacam, Solution for injection 4

5 6. PHARMACEUTICAL PARTICULARS 6.1 Incompatibilities (major) None known 6.2 Shelf life, when necessary after reconstitution of the veterinary medicinal product or when the container is opened for the first time Unopened vial: Broached vial: 24 months 28 days 6.3. Special precautions for storage Store at or below 25 C. Protect from light. 6.4 Nature and contents of container Colourless glass injection vials of 100 ml. 6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from such medicinal products, if appropriate Any unused product or waste material should be disposed of in accordance with local requirements. 7. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH Ingelheim am Rhein Germany 8. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10. DATE OF REVISION OF THE TEXT Metacam, Solution for injection 5

6 ANNEX II THE MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE AND CONDITIONS OF THE MARKETING AUTHORISATION Metacam, Solution for injection 6

7 A. MANUFACTURING AUTHORISATION HOLDER(S) Manufacturer(s) responsible for batch release BASF Labiana S.A. Polig. Ind. Can Parellada Les Fonts de Terrassa Barcelona Spain Manufacturing Authorisation issued on 3 November 1981 by Ministerio de Agricultura, Pesca Y Alimentacion Subdireccion General de Sanidad Animal C/Velazquez no. 147, 2a planta E Madrid B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. C. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable D. STATEMENT OF THE MRLs WHICH MAY BE ACCEPTED IN ACCORDANCE WITH COUNCIL REGULATION (EEC) No 2377/90 The Committee for Veterinary Medicinal Products has recommended the inclusion of meloxicam in Annex III of Council Regulation (EEC) No 2377/90 in accordance with the following table : Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Meloxicam Meloxicam Bovine 60 µg/kg 35 µg/kg 25 µg/kg Liver Kidney Muscle Provisional MRLs expire on Metacam, Solution for injection 7

8 STATEMENT OF THE MRLs WHICH ARE ACCEPTED IN ACCORDANCE WITH COUNCIL REGULATION (EEC) No 2377/90 Annex II of Council Regulation (EEC) No 2377/90 Pharmacologically active substance(s) Ethanol 5 Poloxomer Sodium Chloride 7 Glycine 8 Sodium Hydroxide 9 Water for injection 10 Nitrogen 11 Animal species All food producing species All food producing species All food producing species All food producing species All food producing species All food producing species All food producing species Other provisions The Committee considered that at the concentration of the dose in the product to be administered to the target species, the excipient glycofurol was not pharmacologically active. It therefore concluded, in accordance with its recent position paper on pharmacologically active excipients, that an MRL was not required to be established for this substance. For meglumine, as this substance is contained in veterinary medicinal products licensed in all Member States prior to the entry into force of Council Regulation (EEC) No. 2377/90, no MRLs need to be established prior to 1 January OJ No. L 143 of OJ No. L 290 of OJ No. L 290 of OJ No. L 272 of OJ No. L 272 of OJ No. L 143 of OJ No. L 272 of Metacam, Solution for injection 8

9 ANNEX III LABELLING AND PACKAGE INSERT Metacam, Solution for injection 9

10 A. LABELLING Metacam, Solution for injection 10

11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE OR, WHERE THERE IS NO OUTER PACKAGE, ON THE IMMEDIATE PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metacam Solution for injection meloxicam 5 mg/ml for cattle 2. STATEMENT OF ACTIVE SUBSTANCE(S) 5 mg meloxicam/ml 3. PHARMACEUTICAL FORM Solution for injection 4. PACKAGE SIZE 100 ml injection vial 5. TARGET SPECIES Cattle (calves and young cattle) 6. INDICATION Non steroidal anti-inflammatory drug for use in acute respiratory infection in combination with appropriate antibiotic therapy. 7. METHOD AND ROUTE(S) OF ADMINISTRATION For single subcutaneous or intravenous injection. 8. WITHDRAWAL PERIOD Meat and offal: 15 days 9. SPECIAL WARNING(S), IF NECESSARY Do not use in pregnant or lactating animals. For further information refer to the package insert. 10. EXPIRY DATE (month/year) Metacam, Solution for injection 11

12 11. SPECIAL STORAGE CONDITIONS Store at or below 25 C. Protect from light. Shelf-life of opened vial: 28 days 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements. 13. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only 14. THE WORDS KEEP OUT OF REACH OF CHILDREN Keep out of reach of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH Ingelheim am Rhein Germany Manufacturer BASF Labiana S.A. Polig. Ind. Can Parellada Les Fonts de Terrassa Barcelona - Spain 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS 17. MANUFACTURER S BATCH NUMBER 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Metacam, Solution for injection 12

13 B. PACKAGE INSERT Metacam, Solution for injection 13

14 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metacam Solution for injection meloxicam 5 mg/ml for cattle 2. STATEMENT OF THE ACTIVE SUBSTANCE(S) 5 mg meloxicam/ml 3. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH Ingelheim am Rhein Germany Manufacturer BASF Labiana S.A. Polig. Ind. Can Parellada Les Fonts de Terrassa Barcelona - Spain 4. TARGET SPECIES Cattle (calves and young cattle). 5. INDICATION(S) Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class and acts by inhibition of prostaglandin synthesis thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic properties. For use in acute respiratory infection in combination with appropriate antibiotic therapy to reduce clinical symptoms. 6. DOSAGE FOR EACH SPECIES Single administration of 0.5 mg meloxicam/kg body weight (i.e. 10 ml /100 kg). 7. METHOD AND ROUTE(S) OF ADMINISTRATION Single subcutaneous or intravenous injection 8. ADVICE ON CORRECT ADMINISTRATION None. Metacam, Solution for injection 14

15 9. CONTRA-INDICATIONS Do not use in pregnant or lactating animals. Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of individual hypersensitivity to the product. 10. UNDESIRABLE EFFECTS Subcutaneous as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the animals treated in clinical studies. 11. WITHDRAWAL PERIOD Meat and offal: 15 days 12. SPECIAL STORAGE CONDITIONS, IF ANY Store at or below 25 C. Protect from light. Shelf-life of opened vial: 28 days 13. SPECIAL WARNING(S), IF NECESSARY Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs, or with anti-coagulant agents. In the case of overdosage symptomatic treatment should be initiated. Accidental self injection may give rise to pain. Individuals sensitive to NSAIDs should avoid contact with the product. 14. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements. 15. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED Metacam, Solution for injection 15

16 16. OTHER INFORMATION Veterinary Medicinal Product subject to prescription. 100 ml injection vial For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder. Belgique/Belgi n.v. Boehringer Ingelheim s.a Division Vétérinaire Arianelaan / 16 Av. Ariane Brussel 1200 Bruxelles Tel.: Danmark Boehringer Ingelheim Danmark A/S Stødamuej København ø Tel.: Deutschland Boehringer Ingelheim Vetmedica GmbH KG Ingelheim Tel.: ÅëëÜäá Boehringer Ingelheim ÅëëÜò Á.Å. Åëëçíéêïý Åëëçíéêü - ÁèÞíá ôçë.: Espa a Boehringer Ingelheim España, S.A. División Veterinaria Pablo Alcover, Barcelona Tel: France Boehringer Ingelheim France Département Vétérinaire 12, rue André Huet - B.P Reims Cedex Tel.: Luxembourg n.v. Boehringer Ingelheim s.a Division Vétérinaire Arianelaan / 16 Av. Ariane Brussel 1200 Bruxelles Nederland Boehringer Ingelheim bv Berenkoog BJ Alkmaar Tel.: sterreich Richter Pharma C. Richter Ges.m.b.H & Co KG Feldgasse Wels Tel.: Portugal Vetlima Sociedade Distribuidora de Productos Agro- Pecuarios Lda. Av. 5 de Outubro, 35 3 Esq Lisboa Codex Tel: Suomi Vetcare Oy PL Salo Tel.: Sverige BIVet Regementsgatan 52 B Malmö Tel.: Metacam, Solution for injection 16

17 Ireland Boehringer Ingelheim Limited Bracknell, Berkshire RG12 8YS Tel.: (00 44) United Kingdom Boehringer Ingelheim Limited Bracknell, Berkshire RG12 8YS Tel.: Italia Boehringer Ingelheim Italia s.p.a. Divisione Veterinaria Via Pellicceria, Firenze Tel.: Metacam, Solution for injection 17