PART 1 B1 SUMMARY OF PRODUCT CHARACTERISTICS (SPC)

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1 PART 1 B1 SUMMARY OF PRODUCT CHARACTERISTICS (SPC) SPC for Acticarp SA 50 mg/ml Solution for injection for dogs and cats presented in subsequent pages,

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AT: Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen BE: Acticarp SA 50 mg/ml Oplossing voor injectie voor honden en katten CZ: Acticarp SA 50 mg/ml Injekční roztok pro psy a kočky DE: Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen LU: Acticarp SA 50 mg/ml Solution injectable pour chiens et chats NL: Acticarp SA 50 mg/ml Oplossing voor injectie voor honden en katten PT: Acticarp SA 50 mg/ml Solução injectável para cães e gatos SK: Acticarp SA 50 mg/ml Injekĉný roztok pre psov a mačky 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains : Active substance: Carprofen Excipients: Benzyl alcohol 50 mg 10 mg For a full list of excipients, see section PHARMACEUTICAL FORM A clear pale yellow to yellowish solution for injection. 4. CLINICAL PARTICULARS 4.1 Target species Dogs and cats (cats as from the age of 5 months). 4.2 Indications for use, specifying the target species Dogs: For the reduction of post-operative pain and inflammation following orthopaedic and soft tissue (including intra-ocular) surgery. Cats: For the control of post-operative pain after small surgical procedures 4.3 Contraindications Do not use in animals suffering from cardiac, hepatic or renal disease or gastrointestinal problems, where there is a possibility of gastrointestinal ulceration or bleeding, or hypersensitivity to carprofen or any other NSAIDs or any excipients of this product. As with other NSAIDs there is a risk of rare renal or idiosyncratic hepatic adverse events. Do not administer by intramuscular injection. Do not use after surgery which was associated with considerable blood loss. Do not use in cats on repeated occasions. Do not use in cats less than 5 months of age. Do not use in dogs less than 10 weeks of age. 4.4 Special warnings for each target species None.

3 4.5 Special precautions for use Special precautions for use in animals Do not exceed the recommended dose or duration of treatment. Use in aged dogs and cats, may involve additional risk. If such use cannot be avoided, such animals may require a reduced dosage and careful clinical management. Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided. NSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be instigated. Special precautions to be taken by the person administering the veterinary medicinal product to animals Carprofen, in common with other NSAIDs, has been shown to exhibit photosensitising potential in laboratory studies. Avoid skin contact with the product. Should this occur, wash the affected areas immediately. Care should be taken to avoid accidental self-injection. In case of accidental injection, seek medical advice immediately and show the package leaflet to the physician. 4.6 Adverse reactions (frequency and seriousness) Typical undesirable effects associated with NSAIDs such as vomiting, soft faeces/diarrhoea, faecal occult blood, loss of appetite and lethargy have been reported. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. If adverse reactions occur, use of the product should be stopped and the advice of a veterinarian should be sought. As with other NSAIDs there is a risk of rare renal or idiosyncratic hepatic adverse events. Occasionally reactions at the injection site may be observed following subcutaneous injection. 4.7 Use during pregnancy, lactation or lay Laboratory studies in laboratory animals (rat, rabbit) have shown evidence of foetotoxic effects of carprofen at doses close to the therapeutic dose. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use in dogs or cats during pregnancy or lactation.

4 4.8 Interaction with other medicinal products and other forms of interaction Carprofen should not be administered concurrently, or within 24 hours of another NSAID, or in conjunction with glucocorticosteroids. Some NSAIDs highly bind to plasma proteins and are competitive to other substances which bind the same proteins. The latter may result in toxic effects. Hence, concurrent administration with potentially nephrotoxic substances should be avoided. 4.9 Amounts to be administered and administration route Dogs: The recommended dosage is 4 mg/kg bodyweight (1 ml/12.5 kg bodyweight) by intravenous or subcutaneous injection, best given pre-operatively, either at the time of premedication or induction of anaesthesia. Cats: The recommended dosage is 4 mg/kg bodyweight (0.08 ml/kg bodyweight) by intravenous or subcutaneous injection, best given pre-operatively, either at the time of premedication or induction of anaesthesia. Due to the longer half life in cats and narrower therapeutic index particular care should be taken not to exceed the recommended dose and not to repeat the administration. The use of a 1 ml graduated syringe is recommended to measure the dose accurately. The stopper can be punctured safely up to 24 times Overdose (symptoms, emergency procedures, antidotes), if necessary In case of overdose, no other adverse reactions than those mentioned in section 4.6 are expected. There is no specific antidote for carprofen overdosage but general supportive therapy, as applied to clinical overdosage with NSAID s, should be applied Withdrawal period(s) Not applicable 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Antiflammatory and antirheumatic products, non steroids, propionic acid derivates ATCvet code: QM01AE Pharmacodynamic properties Carprofen is a member of the 2-arylpropionic acid group of non-steroidal antiinflammatory drugs (NSAIDs), and possesses anti-inflammatory, analgesic and antipyretic activity. Carprofen, like most other NSAIDs is an inhibitor of the enzyme cyclo-oxygenase of the arachidonic acid cascade. However, the inhibition of prostaglandin synthesis by carprofen is slight in relation to its anti-inflammatory and analgesic potency. At therapeutic doses in the dog and cat, inhibition of the products of cyclo-oxygenase (prostaglandins and thromboxanes) or lipoxygenase (leucotrienes) has been absent or slight.

5 5.2 Pharmacokinetic particulars The absorption is rapid and complete. Following a single subcutaneous dose of 4 mg carprofen/kg the maximum plasma concentration (Cmax) of 16 μg/ml was reached after (Tmax) approximately 4.5 hours in dogs and 26 μg/ml after approximately 3.4 hours in cats. The volume of distribution is small. Carprofen is highly protein bound. The bioavailability is 85% in dogs and more than 90% in cats. Carprofen has a plasma elimination half-life of 10 hours in dogs and 20 hours in cats. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients L-Arginine Glycocholic acid Soyphosphtidyl choline (Lecithin) Benzyl alcohol Sodium hydroxide Hydrochloric acid Water for Injections 6.2 Incompatibilities In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. 6.3 Shelf life Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening of the immediate packaging: 28 days 6.4. Special precautions for storage Store in a refrigerator (2 to 8 C). Do not freeze. Once broached, the product is stable at temperatures up to 25 C for 28 days. 6.5 Nature and composition of immediate packaging 20 ml Type I molded amber glass vial closed with Fluorotec Plus rubber stopper and aluminium flip off yellow seal, packed in a cardboard box. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local/national requirements. 7. MARKETING AUTHORISATION HOLDER Ecuphar NV Legeweg 157-i 8020 Oostkamp Belgium

6 8. MARKETING AUTHORISATION NUMBER 9. DATE OF THE FIRST AUTHORISATION 10 DATE OF REVISION OF THE TEXT

7 Proposal for labelling English labelling - Enclosed -

8 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard Box 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AT: Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen BE: Acticarp SA 50 mg/ml Oplossing voor injectie voor honden en katten CZ: Acticarp SA 50 mg/ml Injekční roztok pro psy a kočky DE: Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen LU: Acticarp SA 50 mg/ml Solution injectable pour chiens et chats NL: Acticarp SA 50 mg/ml Oplossing voor injectie voor honden en katten PT: Acticarp SA 50 mg/ml Solução injectável para cães e gatos SK: Acticarp SA 50 mg/ml Injekĉný roztok pre psov a mačky Carprofen 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml solution for injection contains 50 mg Carprofen and Benzyl alcohol 3. PHARMACEUTICAL FORM Solution for Injection 4. PACKAGE SIZE 1 vial of 20 ml 5. TARGET SPECIES Dogs and cats (cats as from the age of 5 months) 6. INDICATION(S) Dogs: For the reduction of post-operative pain and inflammation following orthopaedic and soft tissue (including intra-ocular) surgery. Cats: For the control of post-operative pain after small surgical procedures 7. METHOD AND ROUTE(S) OF ADMINISTRATION Dogs: 4 mg/kg bodyweight (1 ml/12.5 kg) Cats: 4 mg/kg bodyweight (0.08 ml/kg) For intravenous or subcutaneous injection, preferably given pre-operatively, either at the time of premedication or induction of anaesthesia. 8. WITHDRAWAL PERIOD

9 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP Once broached, use within 28 days. 11. SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 to 8 C). Do not freeze. Once broached, the product is stable at temperatures up to 25 C for 28 days. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local/national requirements. 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only. To be supplied only on veterinary prescription. 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 Ecuphar NV Legeweg 157-i 8020 Oostkamp Belgium 16. MARKETING AUTHORISATION NUMBER(S) 17. MANUFACTURER S BATCH NUMBER Lot

10 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AT: Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen BE: Acticarp SA 50 mg/ml Oplossing voor injectie voor honden en katten CZ: Acticarp SA 50 mg/ml Injekční roztok pro psy a kočky DE: Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen LU: Acticarp SA 50 mg/ml Solution injectable pour chiens et chats NL: Acticarp SA 50 mg/ml Oplossing voor injectie voor honden en katten PT: Acticarp SA 50 mg/ml Solução injectável para cães e gatos SK: Acticarp SA 50 mg/ml Injekĉný roztok pre psov a mačky Carprofen 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) Carprofen: 50 mg/ml Benzyl alcohol 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml 4. ROUTE(S) OF ADMINISTRATION Dogs / cats: 4 mg/kg IV or SC 5. WITHDRAWAL PERIOD 6. BATCH NUMBER Lot: 7. EXPIRY DATE EXP Once broached, use within 28 days 8. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. To be supplied only on veterinary prescription.

11 Proposal for package insert English PIL - Enclosed

12 PACKAGE LEAFLET AT: Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen BE: Acticarp SA 50 mg/ml Oplossing voor injectie voor honden en katten CZ: Acticarp SA 50 mg/ml Injekční roztok pro psy a kočky DE: Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen LU: Acticarp SA 50 mg/ml Solution injectable pour chiens et chats NL: Acticarp SA 50 mg/ml Oplossing voor injectie voor honden en katten PT: Acticarp SA 50 mg/ml Solução injectável para cães e gatos SK: Acticarp SA 50 mg/ml Injekĉný roztok pre psov a mačky 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing Authorization Holder: Ecuphar NV Legeweg 157-i 8020 Oostkamp Belgium Manufacturing authorization holder responsible for batch release: Ecuphar NV Legeweg 157-i 8020 Oostkamp Belgium or Accord Healthcare Limited Sage House 319, Pinner Road North Harrow Middlesex HA1 4HF United Kingdom 2. NAME OF THE VETERINARY MEDICINAL PRODUCT AT: Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen BE: Acticarp SA 50 mg/ml Oplossing voor injectie voor honden en katten CZ: Acticarp SA 50 mg/ml Injekční roztok pro psy a kočky DE: Acticarp SA 50 mg/ml Injektionslösung für Hunde und Katzen LU: Acticarp SA 50 mg/ml Solution injectable pour chiens et chats NL: Acticarp SA 50 mg/ml Oplossing voor injectie voor honden en katten PT: Acticarp SA 50 mg/ml Solução injectável para cães e gatos SK: Acticarp SA 50 mg/ml Injekĉný roztok pre psov a mačky Carprofen

13 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per ml solution for injection : Active substance: Carprofen 50 mg Excipients: Benzyl alcohol 4. INDICATION(S) Dogs: Cats: For the reduction of post-operative pain and inflammation following orthopaedic and soft tissue (including intra-ocular) surgery. For the control of post-operative pain after small surgical procedures. 5. CONTRAINDICATIONS Do not use in animals suffering from cardiac, hepatic or renal disease or gastrointestinal problems, where there is a possibility of gastrointestinal ulceration or bleeding, or hypersensitivity to carprofen or any other NSAIDs or any excipients of this product. As with other NSAIDs there is a risk of rare renal or idiosyncratic hepatic adverse events. Do not administer by intramuscular injection. Do not use after surgery which was associated with considerable blood loss. Do not use in cats on repeated occasions. Do not use in cats less than 5 months of age. Do not use in dogs less than 10 weeks of age. 6. ADVERSE REACTIONS Typical undesirable effects associated with NSAIDs such as vomiting, soft faeces/diarrhoea, faecal occult blood, loss of appetite and lethargy have been reported. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. If adverse reactions occur, use of the product should be stopped and the advice of a veterinarian should be sought. As with other NSAIDs there is a risk of rare renal or idiosyncratic hepatic adverse events. Occasionally reactions at the injection site may be observed following subcutaneous injection. 7. TARGET SPECIES Dogs and cats (cats as from the age of 5 months).

14 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION The product should be given as a single subcutaneous or intravenous injection. Dosage: Dogs: 4 mg/kg bodyweight (1 ml/12.5 kg bodyweight) Cats: 4 mg/kg bodyweight (0.08 ml/kg bodyweight) Due to the longer half life in cats and narrower therapeutic index particular care should be taken not to exceed the recommended dose and not to repeat the administration. 9. ADVICE ON CORRECT ADMINISTRATION The product should best be given pre-operatively, either at the time of premedication or induction of anaesthesia. The use of a 1 ml graduated syringe is recommended to measure the dose accurately. The stopper can be punctured safely up to 24 times. 10. WITHDRAWAL PERIOD Not applicable. 11. SPECIAL STORAGE PRECAUTIONS Store in a refrigerator (2 to 8 C). Do not freeze. Once broached, the product is stable at temperatures up to 25 C for 28 days. Keep out of reach and sight of children. Do not use after the expiry date stated on the outer carton and immediate label. 12. SPECIAL WARNING(S) Special precautions for use in animals Do not exceed the recommended dose or duration of treatment. Use in aged dogs and cats, may involve additional risk. If such use cannot be avoided, such animals may require a reduced dosage and careful clinical management. Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided. NSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be instigated.

15 Interaction with other medicinal products and other forms of interaction Carprofen should not be administered concurrently, or within 24 hours of another NSAID, or in conjunction with glucocorticosteroids. Some NSAIDs highly bind to plasma proteins and are competitive to other substances which bind the same proteins. The latter may result in toxic effects. Hence, concurrent administration with potentially nephrotoxic substances should be avoided. Incompatibilities In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. Overdose In case of overdose, no other adverse reactions than those mentioned in section 6 are expected. There is no specific antidote for carprofen overdosage but general supportive therapy, as applied to clinical overdosage with NSAID s, should be applied. Use during pregnancy, lactation or lay Laboratory studies in laboratory animals (rat, rabbit) have shown evidence of foetotoxic effects of carprofen at doses close to the therapeutic dose. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use in dogs or cats during pregnancy or lactation. Special precautions to be taken by the person administering the veterinary medicinal product to animals Carprofen, in common with other NSAIDs, has been shown to exhibit photosensitising potential in laboratory studies. Avoid skin contact with the product. Should this occur, wash the affected areas immediately. Care should be taken to avoid accidental self-injection. In case of accidental injection, seek medical advice immediately and show the package leaflet to the physician. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local/national requirements. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be supplied only on veterinary prescription. For animal treatment only.

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