Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Fentanyl
Eurovet Animal Health B.V.
QN02AB03
Fentanyl
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Neurological Agent analgesic
Authorized
2012-02-27
Revised: March 2017 AN: 00451/2016 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fentadon 50 microgram/ml solution for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each1 ml solution contains: ACTIVE SUBSTANCE: Fentanyl 50 microgram (equivalent to fentanyl citrate 78.5 microgram) EXCIPIENTS: Methyl parahydroxybenzoate (E218) 1.6 mg Propyl parahydroxybenzoate 0.2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 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 or renal dysfunction. Refer to sections 4.7 and 4.8. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Revised: March 2017 AN: 00451/2016 Page 2 of 7 The use of this veterinary 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 animals This veterinary medicinal product should be titrated for the individual animal to an effective dose that provides adequate analgesia and minimises undesirable effects. Animals should be carefully monitored until an effective dose is reached. Due to individual differences in pain sensitivity, the effects of fentanyl may be variable. Older animals may tend to titrate to a lower effective dose than younger animals. It is important when estimating the required dose for intra-operative analgesia to assess t Read the complete document