ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Zubrin EN 1/42

Transcription

1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Zubrin EN 1/42

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 30 mg oral lyophilisates for dogs Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance Tepoxalin Tepoxalin Tepoxalin Tepoxalin 30 mg / oral lyophilisate 50 mg / oral lyophilisate 100 mg / oral lyophilisate 200 mg / oral lyophilisate List of excipients Excipients to Excipients to Excipients to Excipients to 36 mg (Zubrin 30 mg) 60 mg (Zubrin 50 mg) 120mg (Zubrin 100 mg) 240 mg (Zubrin 200 mg) 3. PHARMACEUTICAL FORM Oral lyophilisates 4. PHARMACOLOGICAL PROPERTIES 4.1 Pharmacodynamic properties Pharmacotherapeutic group: Anti-inflammatory Products, Non Steroids ATCvet code: QM01A Tepoxalin is a dual cyclooxygenase / 5-lipoxygenase inhibitor with anti-inflammatory activity. Oral administration of 10 mg tepoxalin / kg bodyweight results in inhibition of prostaglandin and leukotriene synthesis. 4.2 Pharmacokinetic properties Tepoxalin is rapidly (T max of approximately 2 hours) absorbed after oral administration in dogs. At a therapeutic dose of 10 mg/kg, the C max of tepoxalin was 1.08 ± 0.37 µg/ml in dogs fed a low fat meal and 1.19 ± 0.29 µg/ml in dogs fed a high fat meal.. Absorption of tepoxalin is facilitated via administration to dogs in a fed state. Tepoxalin is extensively converted to its acid metabolite. The acid metabolite is a potent, active cyclooxygenase inhibitor and prolongs the activity of the parent compound. Plasma concentrations of the acid metabolite are higher than those of the parent compound in the dog. No accumulation of tepoxalin or its acid metabolite was detected after multiple dosing over Zubrin EN 2/42

3 a broad dose range. Tepoxalin and its metabolites are highly protein-bound, more than 98%. Tepoxalin and its metabolites are excreted in the faeces (99%). Zubrin EN 3/42

4 5. CLINICAL PARTICULARS 5.0 Target species Dogs 5.1 Indications for use Reduction of inflammation and relief of pain caused by acute musculoskeletal disorders or acute exacerbation of chronic musculoskeletal disorders. 5.2 Contraindications Do not use in pregnant or lactating dogs or in bitches intended for breeding. Use is contraindicated in animals suffering from cardiac or hepatic disease, or where there is a history of gastrointestinal ulceration, or bleeding, or where there is hypersensitivity to the product. Do not use in dehydrated, hypovolaemic or hypotensive dogs, as there is an increased risk of renal toxicity. 5.3 Undesirable effects Vomiting or diarrhoea may occur following treatment. Alopecia and erythema may occur occasionally. Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite and lethargy. If undesirable effects persist or are severe, treatment should be discontinued. During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) was 10%. 5.4 Special precaution(s) for use Use in animals less than 6 months of age, with a weight below 3 kg, or in aged animals, may involve additional risk. If such use cannot be avoided, close veterinary supervision to monitor for gastrointestinal blood loss is necessary. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. The recommended dose or duration of treatment should not be exceeded. 5.5 Pregnancy and lactation Do not use in pregnant or lactating bitches. 5.6 Interaction with other veterinary medicinal products and other forms of interaction Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Other NSAIDs, diuretics, anticoagulants and substances with high plasma protein binding may compete for binding leading to potentially toxic effects. 5.7 Posology and method of administration 10 mg tepoxalin per kg bodyweight once daily for a maximum period of 7 days. Zubrin EN 4/42

5 The weight of the animal should be accurately determined before start of treatment. Peel back foil to reveal a single oral lyophilisate in the form of a round tablet. Ensure hands are dry to prevent the tablet from sticking to fingers. Push the bottom of the blister and the tablet will pop out. Place the tablet in the dog s mouth. The tablet will disintegrate upon contact with moisture. Keep the mouth of the dog closed for a few seconds to ensure complete tablet wetting. When possible, administer to dogs in a fed state (within 1 2 hours after eating). Do not administer Zubrin in water or food, including treats. 5.8 Overdose At doses of 30 mg/kg and above, oral administration of tepoxalin is associated with discoloured faeces ranging in colour from white to yellow, which is the result of unabsorbed drug. NSAID overdosage is characterised by vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite and lethargy. In the case of overdosage discontinue therapy. If gastrointestinal bleeding is suspected, administer gastric protectants. If vomiting continues, administer anti-emetics. Monitor the hematocrit frequently. Maintain the animal on intravenous fluids and, if necessary, administer whole blood. 5.9 Special warnings for each target species Special care should be taken when treating dogs with marked renal insufficiency 5.10 Withdrawal period Not applicable 5.11 Special precautions to be taken by the person administering the veterinary medicinal product to animals Tepoxalin is not water-soluble and becomes very sticky upon wetting. If the oral lyophilisate disintegrates prematurely, wash hands thoroughly. In case of ingestion of a number of oral lyophilisates, the advice of a doctor should be sought immediately. 6. PHARMACEUTICAL PARTICULARS 6.1 Incompatibilities Not applicable 6.2 Shelf life 18 months 6.3 Special precautions for storage No special precautions for storage 6.4 Nature and contents of container Zubrin EN 5/42

6 Zubrin oral lyophilisates are supplied in boxes with foil blisters. Each blister contains 8 oral lyophilisates. The oral lyophilisates are available in the following pack sizes: 30 mg: 1 box containing 1 blister. 50 mg, 100 mg: 1 box containing 1 or 4 blisters. 200 mg: 1 box containing 1, 2 or 4 blisters. Zubrin EN 6/42

7 6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from such veterinary medicinal products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 7. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable 8. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom 9. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/00/028/ DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 11. DATE OF REVISION OF THE TEXT Zubrin EN 7/42

8 ANNEX II A. THE MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE C. PROHIBITION OF SALE, SUPPLY AND/OR USE D. STATEMENT OF THE MRLs Zubrin EN 8/42

9 A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE Manufacturer responsible for batch release in the EEA Schering-Plough (Bray) Boghall Road Bray Co Wicklow Ireland Manufacturing Authorisation issued on 27 January 2000 by the Irish Medicines Board. B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING 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 Not applicable Zubrin EN 9/42

10 ANNEX III LABELLING AND PACKAGE INSERT Zubrin EN 10/42

11 A. LABELLING Zubrin EN 11/42

12 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 Zubrin 30 mg oral lyophilisates for dogs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin Excipients to 36 mg 30 mg / oral lyophilisate 3. PHARMACEUTICAL FORM Oral lyophilisates 4. PACKAGE SIZE 1 box containing 1 blister with 8 oral lyophilisates 5. TARGET SPECIES Dogs 6. INDICATION(S) Reduction of inflammation and relief of pain caused by acute musculoskeletal disorders or acute exacerbation of chronic musculoskeletal disorders. 7. METHOD AND ROUTE(S) OF ADMINISTRATION 10 mg/kg of body weight once daily for a maximum period of 7 days. The weight of the animal should be accurately determined before start of treatment. Do not administer Zubrin in water or food, including treats. Read the package insert before use. 8. WITHDRAWAL PERIOD Not applicable Zubrin EN 12/42

13 9. SPECIAL WARNING(S), IF NECESSARY Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers Do not use in pregnant or lactating dogs or in bitches intended for breeding. The recommended dose or duration of treatment should not be exceeded. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. For further information please see package insert. 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS No special precautions for storage 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 13. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing Authorisation Holder Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom Zubrin EN 13/42

14 Manufacturing Authorisation Holder Responsible for Batch Release: Schering-Plough (Bray) Boghall Road Bray Co. Wicklow Ireland 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/00/028/ MANUFACTURER S BATCH NUMBER Batch {number} 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Zubrin EN 14/42

15 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 Zubrin 50 mg oral lyophilisates for dogs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin Excipients to 60 mg 50 mg / oral lyophilisate 3. PHARMACEUTICAL FORM Oral lyophilisates 4. PACKAGE SIZE 1 box containing 1 blister with 8 oral lyophilisates 5. TARGET SPECIES Dogs 6. INDICATION(S) Reduction of inflammation and relief of pain caused by acute musculoskeletal disorders or acute exacerbation of chronic musculoskeletal disorders. 7. METHOD AND ROUTE(S) OF ADMINISTRATION 10 mg/kg of body weight once daily for a maximum period of 7 days. The weight of the animal should be accurately determined before start of treatment. Do not administer Zubrin in water or food, including treats. Read the package insert before use. 8. WITHDRAWAL PERIOD Not applicable Zubrin EN 15/42

16 9. SPECIAL WARNING(S), IF NECESSARY Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers Do not use in pregnant or lactating dogs or in bitches intended for breeding. The recommended dose or duration of treatment should not be exceeded. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. For further information please see package insert. 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS No special precautions for storage 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 13. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing Authorisation Holder Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom Zubrin EN 16/42

17 Manufacturing Authorisation Holder Responsible for Batch Release: Schering-Plough (Bray) Boghall Road Bray Co. Wicklow Ireland 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/00/028/ MANUFACTURER S BATCH NUMBER Batch {number} 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Zubrin EN 17/42

18 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 Zubrin 50 mg oral lyophilisates for dogs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin Excipients to 60 mg 50 mg / oral lyophilisate 3. PHARMACEUTICAL FORM Oral lyophilisates 4. PACKAGE SIZE 1 box containing 4 blisters with 8 oral lyophilisates 5. TARGET SPECIES Dogs 6. INDICATION(S) Reduction of inflammation and relief of pain caused by acute musculoskeletal disorders or acute exacerbation of chronic musculoskeletal disorders. 7. METHOD AND ROUTE(S) OF ADMINISTRATION 10 mg/kg of body weight once daily for a maximum period of 7 days. The weight of the animal should be accurately determined before start of treatment. Do not administer Zubrin in water or food, including treats. Read the package insert before use. 8. WITHDRAWAL PERIOD Not applicable Zubrin EN 18/42

19 9. SPECIAL WARNING(S), IF NECESSARY Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers Do not use in pregnant or lactating dogs or in bitches intended for breeding. The recommended dose or duration of treatment should not be exceeded. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. For further information please see package insert. 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS No special precautions for storage 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 13. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing Authorisation Holder Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom Zubrin EN 19/42

20 Manufacturing Authorisation Holder Responsible for Batch Release: Schering-Plough (Bray) Boghall Road Bray Co. Wicklow Ireland 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/00/028/ MANUFACTURER S BATCH NUMBER Batch {number} 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Zubrin EN 20/42

21 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 Zubrin 100 mg oral lyophilisates for dogs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin Excipients to 100 mg / oral lyophilisate 120 mg 3. PHARMACEUTICAL FORM Oral lyophilisates 4. PACKAGE SIZE 1 box containing 1 blister with 8 oral lyophilisates 5. TARGET SPECIES Dogs 6. INDICATION(S) Reduction of inflammation and relief of pain caused by acute musculoskeletal disorders or acute exacerbation of chronic musculoskeletal disorders. 7. METHOD AND ROUTE(S) OF ADMINISTRATION 10 mg/kg of body weight once daily for a maximum period of 7 days. The weight of the animal should be accurately determined before start of treatment. Do not administer Zubrin in water or food, including treats. Read the package insert before use. 8. WITHDRAWAL PERIOD Not applicable Zubrin EN 21/42

22 9. SPECIAL WARNING(S), IF NECESSARY Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers Do not use in pregnant or lactating dogs or in bitches intended for breeding. The recommended dose or duration of treatment should not be exceeded. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. For further information please see package insert. 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS No special precautions for storage 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 13. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing Authorisation Holder Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom Zubrin EN 22/42

23 Manufacturing Authorisation Holder Responsible for Batch Release: Schering-Plough (Bray) Boghall Road Bray Co. Wicklow Ireland 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/00/028/ MANUFACTURER S BATCH NUMBER Batch {number} 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Zubrin EN 23/42

24 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 Zubrin 100 mg oral lyophilisates for dogs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin Excipients to 100 mg / oral lyophilisate 120 mg 3. PHARMACEUTICAL FORM Oral lyophilisates 4. PACKAGE SIZE 1 box containing 4 blisters with 8 oral lyophilisates 5. TARGET SPECIES Dogs 6. INDICATION(S) Reduction of inflammation and relief of pain caused by acute musculoskeletal disorders or acute exacerbation of chronic musculoskeletal disorders. 7. METHOD AND ROUTE(S) OF ADMINISTRATION 10 mg/kg of body weight once daily for a maximum period of 7 days. The weight of the animal should be accurately determined before start of treatment. Do not administer Zubrin in water or food, including treats. Read the package insert before use. 8. WITHDRAWAL PERIOD Not applicable Zubrin EN 24/42

25 9. SPECIAL WARNING(S), IF NECESSARY Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers Do not use in pregnant or lactating dogs or in bitches intended for breeding. The recommended dose or duration of treatment should not be exceeded. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. For further information please see package insert. 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS No special precautions for storage 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 13. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing Authorisation Holder Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom Zubrin EN 25/42

26 Manufacturing Authorisation Holder Responsible for Batch Release: Schering-Plough (Bray) Boghall Road Bray Co. Wicklow Ireland 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/00/028/ MANUFACTURER S BATCH NUMBER Batch {number} 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Zubrin EN 26/42

27 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 Zubrin 200 mg oral lyophilisates for dogs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin Excipients to 200 mg / oral lyophilisate 240 mg 3. PHARMACEUTICAL FORM Oral lyophilisates 4. PACKAGE SIZE 1 box containing 1 blister with 8 oral lyophilisates 5. TARGET SPECIES Dogs 6. INDICATION(S) Reduction of inflammation and relief of pain caused by acute musculoskeletal disorders or acute exacerbation of chronic musculoskeletal disorders. 7. METHOD AND ROUTE(S) OF ADMINISTRATION 10 mg/kg of body weight once daily for a maximum period of 7 days. The weight of the animal should be accurately determined before start of treatment. Do not administer Zubrin in water or food, including treats. Read the package insert before use. 8. WITHDRAWAL PERIOD Not applicable Zubrin EN 27/42

28 9. SPECIAL WARNING(S), IF NECESSARY Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers Do not use in pregnant or lactating dogs or in bitches intended for breeding. The recommended dose or duration of treatment should not be exceeded. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. For further information please see package insert. 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS No special precautions for storage 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 13. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing Authorisation Holder Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom Zubrin EN 28/42

29 Manufacturing Authorisation Holder Responsible for Batch Release: Schering-Plough (Bray) Boghall Road Bray Co. Wicklow Ireland 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/00/028/ MANUFACTURER S BATCH NUMBER Batch {number} 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Zubrin EN 29/42

30 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 Zubrin 200 mg oral lyophilisates for dogs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin Excipients to 200 mg / oral lyophilisate 240 mg 3. PHARMACEUTICAL FORM Oral lyophilisates 4. PACKAGE SIZE 1 box containing 2 blisters with 8 oral lyophilisates 5. TARGET SPECIES Dogs 6. INDICATION(S) Reduction of inflammation and relief of pain caused by acute musculoskeletal disorders or acute exacerbation of chronic musculoskeletal disorders. 7. METHOD AND ROUTE(S) OF ADMINISTRATION 10 mg/kg of body weight once daily for a maximum period of 7 days. The weight of the animal should be accurately determined before start of treatment. Do not administer Zubrin in water or food, including treats. Read the package insert before use. 8. WITHDRAWAL PERIOD Not applicable Zubrin EN 30/42

31 9. SPECIAL WARNING(S), IF NECESSARY Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers Do not use in pregnant or lactating dogs or in bitches intended for breeding. The recommended dose or duration of treatment should not be exceeded. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. For further information please see package insert. 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS No special precautions for storage 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 13. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing Authorisation Holder Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom Zubrin EN 31/42

32 Manufacturing Authorisation Holder Responsible for Batch Release: Schering-Plough (Bray) Boghall Road Bray Co. Wicklow Ireland 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/00/028/ MANUFACTURER S BATCH NUMBER Batch {number} 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Zubrin EN 32/42

33 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 Zubrin 200 mg oral lyophilisates for dogs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin Excipients to 200 mg / oral lyophilisate 240 mg 3. PHARMACEUTICAL FORM Oral lyophilisates 4. PACKAGE SIZE 1 box containing 4 blisters with 8 oral lyophilisates 5. TARGET SPECIES Dogs 6. INDICATION(S) Reduction of inflammation and relief of pain caused by acute musculoskeletal disorders or acute exacerbation of chronic musculoskeletal disorders. 7. METHOD AND ROUTE(S) OF ADMINISTRATION 10 mg/kg of body weight once daily for a maximum period of 7 days. The weight of the animal should be accurately determined before start of treatment. Do not administer Zubrin in water or food, including treats. Read the package insert before use. 8. WITHDRAWAL PERIOD Not applicable Zubrin EN 33/42

34 9. SPECIAL WARNING(S), IF NECESSARY Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers Do not use in pregnant or lactating dogs or in bitches intended for breeding. The recommended dose or duration of treatment should not be exceeded. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. For further information please see package insert. 10. EXPIRY DATE EXP {month/year} 11. SPECIAL STORAGE CONDITIONS No special precautions for storage 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 13. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing Authorisation Holder Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom Zubrin EN 34/42

35 Manufacturing Authorisation Holder Responsible for Batch Release: Schering-Plough (Bray) Boghall Road Bray Co. Wicklow Ireland 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/00/028/ MANUFACTURER S BATCH NUMBER Batch {number} 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Zubrin EN 35/42

36 MINIMUM PARTICULARS TO APPEAR ON BLISTER 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 30 mg oral lyophilisates for dogs Tepoxalin 2. NAME OF THE MARKETING AUTHORISATION HOLDER Schering-Plough Limited 3. EXPIRY DATE EXP {month/year} 4. BATCH NUMBER Batch {number} Zubrin EN 36/42

37 MINIMUM PARTICULARS TO APPEAR ON BLISTER 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 50 mg oral lyophilisates for dogs Tepoxalin 2. NAME OF THE MARKETING AUTHORISATION HOLDER Schering-Plough Limited 3. EXPIRY DATE EXP {month/year} 4. BATCH NUMBER Batch {number} Zubrin EN 37/42

38 MINIMUM PARTICULARS TO APPEAR ON BLISTER 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 100 mg oral lyophilisates for dogs Tepoxalin 2. NAME OF THE MARKETING AUTHORISATION HOLDER Schering-Plough Limited 3. EXPIRY DATE EXP {month/year} 4. BATCH NUMBER Batch {number} Zubrin EN 38/42

39 MINIMUM PARTICULARS TO APPEAR ON BLISTER 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 200 mg oral lyophilisates for dogs Tepoxalin 2. NAME OF THE MARKETING AUTHORISATION HOLDER Schering-Plough Limited 3. EXPIRY DATE EXP {month/year} 4. BATCH NUMBER Batch {number} Zubrin EN 39/42

40 B. PACKAGE INSERT Zubrin EN 40/42

41 PACKAGE INSERT 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 30 mg oral lyophilisates for dogs Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates for dogs 2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) Active substance Tepoxalin Tepoxalin Tepoxalin Tepoxalin 30 mg / oral lyophilisate 50 mg / oral lyophilisate, 100 mg / oral lyophilisate 200 mg / oral lyophilisate List of excipients Excipients to Excipients to Excipients to Excipients to 36 mg (Zubrin 30 mg) 60 mg (Zubrin 50 mg) 120mg (Zubrin 100 mg) 240 mg (Zubrin 200 mg) 3. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing Authorisation Holder Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom Manufacturing Authorisation Holder Responsibility for Batch Release: Schering-Plough (Bray) Boghall Road Bray Co. Wicklow Ireland 4. TARGET SPECIES Zubrin EN 41/42

42 Dogs Zubrin EN 42/42

43 5. INDICATIONS Reduction of inflammation and relief of pain caused by acute musculoskeletal disorders or acute exacerbation of chronic musculoskeletal disorders. 6. DOSAGE FOR EACH SPECIES 10 mg/kg once daily for a maximum period of 7 days. 7. METHOD AND ROUTE OF ADMINISTRATION The weight of the animal should be accurately determined before start of treatment. Peel back foil to reveal a single oral lyophilisate in the form of a round tablet. Push the bottom of the blister and the tablet will pop out. Place the tablet in the dog s mouth. The tablet will disintegrate upon contact with moisture. Keep the mouth of the dog closed for a few seconds to ensure complete tablet wetting. When possible, administer to dogs in a fed state (within 1 2 hours after eating). Do not administer Zubrin in water or food, including treats. 8. ADVICE ON CORRECT ADMINISTRATION Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers. Tepoxalin is not water-soluble and becomes very sticky upon wetting. If the oral lyophilisate disintegrates prematurely, wash hands thoroughly. 9. CONTRAINDICATIONS Do not use in pregnant or lactating dogs or in bitches intended for breeding. Use is contraindicated in animals suffering from cardiac or hepatic disease, or where there is a history of gastrointestinal ulceration, or bleeding, or where there is hypersensitivity to the product. Do not use in dehydrated, hypovolaemic or hypotensive dogs, as there is an increased risk of renal toxicity. 10. UNDESIRABLE EFFECTS Vomiting or diarrhoea may occur following treatment.. Alopecia and erythema may occur occasionally. Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite and lethargy. If undesirable effects persist or are severe, treatment should be discontinued. During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) was 10%. If you notice any other side effects, please inform your veterinary surgeon. 11. WITHDRAWAL PERIOD Not applicable Zubrin EN 43/42

44 12. SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children. No special precautions for storage. Do not use after the expiry date stated on the blister. 13. SPECIAL WARNINGS The recommended dose or duration of treatment should not be exceeded. Use in animals less than 6 months of age, with a weight below 3 kg, or in aged animals, may involve additional risk. If such use cannot be avoided, close veterinary supervision to monitor for gastrointestinal blood loss is necessary. Special care should be taken when treating dogs with marked renal insufficiency Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids..other NSAIDs, diuretics, anticoagulants and substances with high plasma protein binding may compete for binding leading to potentially toxic effects. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. In case of ingestion of a number of oral lyophilisates, the advice of a doctor should be sought immediately. 14. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 15. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED 16. OTHER INFORMATION For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder. België/Belgique/Belgien 73, Rue de Stalle/Stallestraat 73, B-1180 Bruxelles/Brussel Danmark Postbox 297, Hvedemarken 12 DK-3520 Farum Luxembourg/Luxemburg 73, Rue de Stalle/Stallestraat, 73 B-1180 Bruxelles/Brussel Belgique/België Nederland Maarssenbroeksedijk 4 NL-3606 AN Maarssen Zubrin EN 44/42

45 Deutschland Thomas-Dehler-Str. 27 D München Ελλαδα Αγίου ηµητρίον Αλιµος Αθήνα España Km 36, Carretera Nacional N San Agustin de Guadalix Madrid France 92, rue Baudin Levallois-Perret cedex Ireland Boghall Road Bray Co Wicklow Ísland Borgartúni Reykjavík Norge Ankerveien Eiksmarka Österreich Thomas-Dehler-Str. 27 D München Deutschland Portugal Casal Colaride - Agualva 2735 Cacém Suomi/Finland Riihitontuntie 14A FIN Espoo/Esbo Sverige Tegeluddsvägen 31 S Stockholm United Kingdom Breakspear Road, South Harefield, UB9 6LS Italia Centro Direzionale Milano 2 Palazzo Borromini I Segrate MI Milano Zubrin EN 45/42