Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
pregabalin
Orion Corporation
QN03AX16
pregabalin
Cats
Antiepileptics
Alleviation of acute anxiety and fear associated with transportation and veterinary visits.
Authorised
2021-07-13
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: BONQAT 50 MG/ML ORAL SOLUTION FOR CATS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Orion Corporation Orionintie 1 FI-02200 Espoo Finland Manufacturer responsible for batch release: Orion Corporation Orion Pharma Tengströminkatu 8 FI-20360 Turku Finland 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Bonqat 50 mg/ml oral solution for cats pregabalin 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains: ACTIVE SUBSTANCE: Pregabalin 50 mg EXCIPIENT: Sodium benzoate (E211) 2 mg Clear, colourless solution. 4. INDICATION(S) Alleviation of acute anxiety and fear associated with transportation and veterinary visits. 5. CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 16 6. ADVERSE REACTIONS Signs of sedation (characterised by tiredness, difficulties in perception of the position and movement of the body, and problems with balance) and vomiting have been observed commonly in clinical studies. Muscle tremor, dilatated pupils, loss of appetite, weight loss and reduced number of white blood cells have been reported uncommonly in clinical studies. Salivation has been reported rarely in clinical studies. Typically, clinical signs are mild and transient. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1 000 animals treated) - rare (more than 1 but less than 10 animals in 10 000 animals treated) - very rare (less than 1 animal in 10 000 animals treated, including isolated reports). If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterin Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bonqat 50 mg/ml oral solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Pregabalin 50 mg EXCIPIENT: Sodium benzoate (E211) 2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear, colourless solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Alleviation of acute anxiety and fear associated with transportation and veterinary visits. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The safety of the veterinary medicinal product has not been established in cats weighing less than 2 kg, younger than 5 months and older than 15 years. Use only according to the benefit-risk assessment by the responsible veterinarian. The safety of the veterinary medicinal product has only been established in healthy cats or those with mild systemic illness. It has not been established in animals with moderate or severe systemic disease e.g. moderate to severe renal, liver, or cardiovascular disease. Use only according to the benefit-risk assessment by the responsible veterinarian. 3 Always assess the cat’s health status before prescribing the veterinary medicinal product. The veterinary medicinal product may cause slight reduction in heart rate, respiratory rate and body temperature. As a reduction of body temperature can occur after the administration, the treated animal should be kept at a suitable ambient temperature. Monitor the cat carefully for any symptoms of respiratory depression and sedation when a CNS depressant is used concomitantly with pregabalin. The prescribing veterinarian should advise the owner to always inform the attending veterinarian if the veterinary medicinal product has been administered Les hele dokumentet