Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
imepitoin
Boehringer Ingelheim Vetmedica GmbH
QN03AX90
imepitoin
Dogs
Other antiepileptics, Antiepileptics
For the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs for use after careful evaluation of alternative treatment options.
Revision: 6
Authorised
2013-02-25
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: PEXION 100 MG TABLETS FOR DOGS PEXION 400 MG TABLETS FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Pexion 100 mg tablets for dogs Pexion 400 mg tablets for dogs imepitoin 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) White, oblong, half-scored tablets with embedded logo “I 01” (100 mg) or “I 02” (400 mg) on one side. The tablet can be divided into equal halves. One tablet contains: Imepitoin 100 mg Imepitoin 400 mg 4. INDICATION(S) For the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs for use after careful evaluation of alternative treatment options. _ _ For the reduction of anxiety and fear associated with noise phobia in dogs. 5. CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs with severely impaired hepatic function, severe renal or severe cardiovascular disorders. 6. ADVERSE REACTIONS IDIOPATHIC EPILEPSY The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia (loss of coordination), emesis (vomiting), polyphagia (increased appetite) at the beginning of treatment, somnolence (drowsiness) (very common); hyperactivity (much more active than usual), apathy, polydipsia (increased thirst), diarrhoea, disorientation, anorexia (loss of appetite), hypersalivation (increased saliva production), polyuria (increased urine production) (common); prolapsed nictitating membrane (visible third eyelid) and decreased sight (isolated reports). In epileptic dogs, aggression has been uncommonly reported, and increased sensitivit Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pexion 100 mg tablets for dogs Pexion 400 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: ACTIVE SUBSTANCE: Imepitoin 100 mg Imepitoin 400 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, oblong, half-scored tablets with embedded logo “I 01” (100 mg) or “I 02” (400 mg) on one side. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs for use after careful evaluation of alternative treatment options. _ _ For the reduction of anxiety and fear associated with noise phobia in dogs. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs with severely impaired hepatic function, severe renal or severe cardiovascular disorders. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES IDIOPATHIC EPILEPSY The pharmacological response to imepitoin may vary and efficacy may not be complete. On treatment, some dogs will be free of seizures, in other dogs a reduction of the number of seizures will be observed, whilst others will be non-responders. For this reason, careful consideration should be given before deciding to switch a stabilized dog onto imepitoin from a different treatment. In non- responders, an increase in seizure frequency may be observed. _ _ Should seizures not be adequately controlled, further diagnostic measures and other antiepileptic treatment should be considered. When transition between different antiepileptic therapies is medically required, this should be done gradually and with appropriate clinical supervision. 3 The efficacy of the veterinary medicinal product in dogs with status epilepticus and cluster seizures has not been investigated. Therefore, imepitoin should not be u Pročitajte cijeli dokument