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doc_0 | Revised: October 2022 AN: 01667/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT KETOFEN 20mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ketoprofen 20 mg per tablet For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet: White uncoated tablets with a break line on one side. The score line is intended to facilitate ease of swallowing and not divide into equal doses. 4. CLINICAL PARTICULARS 4.1 Target species Dogs and cats. 4.2 Indications for use (specifying the target species) For the relief of acute pain and inflammation associated with musculo-skeletal and other painful disorders in the dog and cat. For the relief of pain in dogs associated with chronic osteoarthritic conditions. 4.3 Contraindications Do not administer with diuretics or anti-coagulants. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product. 4.4 Special warnings (for each target species) Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity. Use in any animal less than 6 weeks of age or in aged animals may | |
doc_1 | there is a potential risk of increased renal toxicity. Use in any animal less than 6 weeks of age or in aged animals may require a reduced dosage and careful clinical management. 4.5 Special precautions for use (i) Special precautions for use in animals When treating acute pain or inflammation, do not exceed the stated dose of 1mg/kg or 5 day duration of treatment. (ii) Special precautions for use to be taken by the person administering the medicinal product to the animals Wash hands after use. In the event of accidental ingestion, seek medical advice and show the doctor what has been taken. 4.6 Adverse reactions (frequency and seriousness) Vomiting and diarrhoea rarely but occasionally occur following treatment. These signs disappear rapidly when treatment is discontinued. 4.7 Use during pregnancy, lactation or lay Do not administer to pregnant animals. 4.8 Interaction with other medicinal products and other forms of interaction Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. Concurrent administration with nephrotoxic drugs should be avoided. 4.9 Amount(s) to be administered and administration route For acute indications in dogs and cats, the recommended dosage is 1 mg of ketoprofen per kg body weight administered orally once daily for up to 5 days. Ketofen tablets may be given on the day following administration of Ketofen 1% injection to maintain treatment for up to a total of 5 days. For chronic pain in dogs, the recommended dosage is 0.25 mg of | |
doc_2 | of Ketofen 1% injection to maintain treatment for up to a total of 5 days. For chronic pain in dogs, the recommended dosage is 0.25 mg of recommended duration of treatment is up to 30 days. If continued treatment is indicated beyond the thirty days, the animal should first be re-examined by the veterinarian. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary The product is well tolerated by dogs and cats at three times the recommended dose of 1 mg/kg, i.e., at 3 mg/kg. Ketoprofen is well tolerated in dogs at five times the recommended dose of 0.25 mg/kg for up to 90 days, i.e., at 1.25 mg/kg. 4.11 Withdrawal period(s) Not applicable. 5. PHARMACOLOGICAL PROPERTIES SUMMARY PRESENTATION OF THE ACTIVE SUBSTANCE Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) belonging to the propionic acid subclass of carbonylic acid derivatives. The primary metabolism. ATC Vet Code: QM01AE03 5.1 Pharmacodynamic properties Ketoprofen exerts three main pharmacological effects, which are Ketoprofen has been shown to have potent activity against acute, inflammation. 5.2 Pharmacokinetic properties For single administration of ketoprofen to dogs and cats by oral route, parameters appear to be good with rapid resorption and bioavailability. Oral administration in cats is generally represented by a two-compartment model, with the dogs represented by a one-compartment | |
doc_3 | model, with the dogs represented by a one-compartment model. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Microcrystalline Cellulose Maltodextrine Saccharose Magnesium Stearate Lactose Monohydrate 6.2 Major incompatibilities None observed. 6.3 Shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time. 3 years. 6.4 Special precautions for storage Do not store above 250C. 6.5 Nature and composition of immediate packaging Cartons containing 5 aluminium foil blister packs of 10 tablets. Cartons containing 10 aluminium foil blister packs of 10 tablets. Not all pack sizes may be marketed. Revised: October 2022 AN: 01667/2022 Page 5 of 5 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 product or waste material should be disposed of in accordance with national requirements. 7. MARKETING AUTHORISATION HOLDER Ceva Animal Health Ltd Explorer House Mercury Park Wycombe Lane Wooburn Green High Wycombe Buckinghamshire HP10 0HH United Kingdom 8. MARKETING AUTHORISATION NUMBER Vm 15052/4148 9. DATE OF FIRST AUTHORISATION 29 April 1992 10. DATE OF REVISION OF THE TEXT October 2022 | |
doc_4 | administration in cats is generally represented by a two-compartment model, with the dogs represented by a one-compartment Revised: October 2022 AN: 01667/2022 Page 4 of 5 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Microcrystalline Cellulose Maltodextrine Saccharose Magnesium Stearate Lactose Monohydrate 6.2 Major incompatibilities None observed. 6.3 Shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time. 3 years. 6.4 Special precautions for storage Do not store above 250C. 6.5 Nature and composition of immediate packaging Cartons containing 5 aluminium foil blister packs of 10 tablets. Cartons containing 10 aluminium foil blister packs of 10 tablets. Not all pack sizes may be marketed. 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 product or waste material should be disposed of in accordance with national requirements. Revised: October 2022 AN: 01667/2022 Page 5 of 5 7. MARKETING AUTHORISATION HOLDER Ceva Animal Health Ltd Explorer House Mercury Park Wycombe Lane Wooburn Green High Wycombe Buckinghamshire HP10 0HH United Kingdom 8. MARKETING AUTHORISATION NUMBER Vm 15052/4147 9. DATE OF FIRST AUTHORISATION 30 April 1992 10. DATE OF REVISION OF THE TEXT October 2022 Approved 14 October 2022 | |
doc_5 | Oral administration in cats is generally represented by a two-compartment model, with the dogs represented by a one-compartment. Revised: October 2022 AN: 01667/2022 Page 4 of 5 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Microcrystalline Cellulose Maltodextrine Saccharose Magnesium Stearate Lactose Monohydrate 6.2 Major incompatibilities None observed. 6.3 Shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time. 3 years. 6.4 Special precautions for storage Do not store above 25掳C. 6.5 Nature and composition of immediate packaging Cartons containing 5 aluminium foil blister packs of 10 tablets. Cartons containing 10 aluminium foil blister packs of 10 tablets. Not all pack sizes may be marketed. 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 product or waste material should be disposed of in accordance with local requirements. Revised: October 2022 AN: 01667/2022 Page 5 of 5 7. MARKETING AUTHORISATION HOLDER Ceva Animal Health Ltd Explorer House Mercury Park Wycombe Lane Wooburn Green High Wycombe Buckinghamshire HP10 0HH United Kingdom 8. MARKETING AUTHORISATION NUMBER Vm 15052/4147 9. DATE OF FIRST AUTHORISATION 30 April 1992 10. DATE OF REVISION OF THE TEXT October 2022 Approved 14 October 2022 |