Pays: Pays-Bas
Langue: anglais
Source: HMA (Heads of Medicines Agencies)
phenobarbital 100 mg
Desitin Arzneimittel GmbH
QN03AA02
Tablet
Phenobarbital
Dogs Non Food
2010-09-29
Desitin Arzneimittel GmbH Phenobarbital, 100 mg tablets DE/V/0141/002 PART 1B: PRODUCT INFORMATION 06/2013 C O N F I D E N T I A L Page 1/8 1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS _Phenobarbital _ _100 mg _ _tablets _ Desitin Arzneimittel GmbH Phenobarbital, 100 mg tablets DE/V/0141/002/ E/001 PART 1B: PRODUCT INFORMATION 06/2013 C O N F I D E N T I A L Page 2/8 1. NAME OF THE VETERINARY MEDICINAL PRODUCT (DE) Luminal vet, 100 mg tablets for dogs (AT, BE, DK, ES, FR, NL, PT, SE) Epirepress 100 mg, tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Phenobarbital 100 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, round, flat faceted tablets, diameter 9 mm, with DN imprinted on one side and a cross breakline on the other side. The tablet can be divided into equal halves (each 50 mg phenobarbital). 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Prevention of seizures due to generalised epilepsy in dogs. 4.3 CONTRAINDICATIONS Do not use in the case of hypersensitivity to the active substance or to any other barbiturates or to any of the excipients. Do not use in animals with severe impaired hepatic function. Do not use in animals with serious renal and/or cardiovascular/respiratory disorders. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The decision to start antiepileptic drug therapy with phenobarbital should be evaluated for each individual case and depends on number, frequency, durati Lire le document complet