Država: Njemačka
Jezik: engleski
Izvor: HMA (Heads of Medicines Agencies)
fentanyl citrate 78.5 µg/ml
Eurovet Animal Health
QN02AB03
Solution for injection
fentanyl
Dogs Non Food
2012-01-20
Page 1 / 10 LABELLING AND PACKAGE LEAFLET Page 2 / 10 A. LABELLING Page 3 / 10Pročitajte cijeli dokument {OUTER CARTON/5/10/20/25/30/50/100 ML} {LABEL/100 ML} 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fentadon 50 microgram/ml, solution for injection for dogs SE, DK: Fentadon Vet. 50 microgram/ml, solution for injection for dogs NO: Fentadon vet 50 microgram/ml, solution for injection for dogs Fentanyl 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each ml contains: ACTIVE SUBSTANCE: Fentanyl 50 microgram (equivalent to fentanyl citrate 78.5 microgram) EXCIPIENT(S): Methyl parahydroxybenzoate (E218) 1.6 mg Propyl parahydroxybenzoate (E216) 0.2 mg 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless 4. PACKAGE SIZE 5/10/20/25/30/50/100 ml 5. TARGET SPECIES Dogs 6. INDICATION(S) --- 7. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 8. WITHDRAWAL PERIOD Not applicable 9. SPECIAL WARNING(S), IF NECESSARY Page 4 / 10 Accidental injection is dangerous. Read the package leaflet before use. 10. EXPIRY DATE EXP {month/year} Once broached, use by .. 11. SPECIAL STORAGE CONDITIONS Do not freeze. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Any unused product or waste materials should be disposed of in accordance with local requirements. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUP
Page 1 / 6 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 / 6 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fentadon 50 microgram/ml, solution for injection for dogs SE, DK: Fentadon Vet. 50 microgram/ml, solution for injection for dogs NO: Fentadon vet 50 microgram/ml, solution for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per ml solution: ACTIVE SUBSTANCE: Fentanyl 50 microgram (equivalent to fentanyl citrate 78.5 microgram) EXCIPIENTS: Methyl parahydroxybenzoate (E 218) 1.6 mg Propyl parahydroxybenzoate(E 216) 0.2 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For intra-operative analgesia during surgical procedures such as soft tissue- and orthopaedic surgery. For the control of post-operative pain associated with major orthopaedic and soft tissue surgery. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance, or to any of the excipients. Do not use in dogs with cardiac failure, hypotension, hypovolaemia, obstructive airway disease, respiratory depression, hypertension or with a history of epilepsy. Do not use in animals with severe liver and renal dysfunction. Refer to section 4.7. and 4.8. 4.4 SPECIAL WARNINGS The use of this medicinal product must be preceded by a thorough clinical examination. Atropine may be used to block the vagal effects. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN Pročitajte cijeli dokument