Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Selegiline hydrochloride
Ceva Animal Health Limited
QN06A
Selegiline hydrochloride
16.74 mg/tablet
Film-coated tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
ANTIDEPRESSANTS
Neurological Preparations
Authorised
2002-11-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT SELGIAN 40kg, Film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a 1020 mg tablet Active substance: Selegiline (as hydrochloride) 16.74 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (from 26 kg to 86 kg). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES - Treatment of behavioural disorders of purely emotional origin: depression, dysthymia, anxiety. - In combination with behaviour therapy, treatment of disorders of emotional origin found in hypersensibility/hyperactivity, separation anxiety, deprivation syndrome and generalised phobia. 4.3 CONTRAINDICATIONS Owing to its MAOI properties, selegiline may act on prolactin secretion. For want of specific studies, the product should not be administered to pregnant and lactating bitches. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The use of a dosage less than the recommended dosage may result in exacerbation of the dog’s aggressiveness in case of latent hierarchy conflict. If no clinical improvement is observed after 2 months, it is useless to continue the treatment. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _8_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _4_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _9_ _2_ _4_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Emotional disorders can m Olvassa el a teljes dokumentumot