국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Selegiline hydrochloride
Ceva Santé Animale
QN06A
Selegiline hydrochloride
16.74 mg/tablet
Film-coated tablet
POM: Prescription Only Medicine as defined in relevant national legislation
ANTIDEPRESSANTS
Authorised
2002-11-22
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SELGIAN 40 KG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Selegiline (as hydrochloride) 16.74 mg For a tablet of 1020.00 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM White film-coated tablet with two cross-scored lines on one side 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: - 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. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Emotional disorders can mask hierarchical conflicts. In dominant dogs suffering from an emotional disorder, the alleviation of the disorder can sometimes reveal a latent aggressiveness. In such cases, behavioural therapy must be instituted. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In case of accidental ingestion, seek medical advice and show the package insert or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None reported to date. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Cf contra-indications. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None reported to date. 4.9 AMOUNTS TO BE ADMINISTERED AND 전체 문서 읽기