Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
fentanyl
Eli Lilly and Company Limited
QN02AB03
fentanyl
Dogs
Nervous system
For the control of pain associated with orthopaedic and soft tissue surgery in dogs.
Revision: 4
Withdrawn
2011-10-06
Medicinal product no longer authorised 19 B. PACKAGE LEAFLET Medicinal product no longer authorised 20 PACKAGE LEAFLET RECUVYRA 50 MG/ML TRANSDERMAL SOLUTION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Eli Lilly & Company Ltd Elanco Animal Health Lilly House Priestley Road Basingstoke, Hampshire RG24 9NL United Kingdom Manufacturer for batch release: McGregor Cory Cherwell 2 Middleton Close Banbury, Oxfordshire, OX16 4RS United Kingdom. 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Recuvyra 50 mg/ml transdermal solution for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Recuvyra is a clear, colourless to light yellow solution containing 50 mg of fentanyl (the active substance) per ml of solution. Recuvyra also contains octyl salicylate and isopropyl alcohol. Recuvyra is supplied to your veterinarian in an amber glass bottle containing 10 ml of product. 4. INDICATION(S) Recuvyra controls pain in dogs that have undergone major orthopaedic or soft tissue surgery. 5. CONTRAINDICATIONS Your dog should not be given Recuvyra if it: Has broken, damaged or diseased skin at the treatment site. Has heart failure, low or high blood pressure, low blood volume, impaired breathing, has a history of epilepsy, non-aged related corneal pathology or has or might have a partial or completely stationary bowel. Has an allergy to the active substance (fentanyl) or to any of the excipients. Is lactating, pregnant or a dog used for breeding. Medicinal product no longer authorised 21 Your veterinarian should not administer Recuvyra: Except as a single dose at the recommended dose rate. To anywhere except between your dogs shoulder blades. To your dog if it has already had a dose of Recuvyra within the last 7 days. It is important that you do not allow any other dogs or pets you may have to lick or come into contact with the area between your dog’s Lire le document complet
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Recuvyra 50 mg/ml transdermal solution for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Fentanyl 50 mg/ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal solution. Clear, colourless to light yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the control of post-operative pain associated with major orthopaedic and soft tissue surgery in dogs. 4.3 CONTRAINDICATIONS Do not administer to skin that does not have an intact _stratum corneum_ due to injury or disease. Do not administer to areas other than the dorsal scapular region. Do not use in dogs with cardiac failure, hypotension, hypovolaemia, respiratory depression, hypertension, a history of epilepsy, non age related corneal pathology or those who have or are suspected of having a paralytic ileus. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not give a second dose of the veterinary medicinal product within 7 days. Accumulation of fentanyl following repeated administration could result in severe adverse reactions, including death. Do not give more than the recommended dose of the veterinary medicinal product. Do not allow the dog or other animals to lick the site of application as oral bioavailability following licking is high in the first five minutes after application. Do not allow other animals contact with the application site for at least 72 hours after application. The veterinary medicinal product should not come into direct contact with the oral cavity or mucous membranes of dogs. Mild side effects such as sedation, may occur after a single accidental oral administration of more than 20 µg/kg of fentanyl (0.4 µl/kg Recuvyra). Higher oral doses may induce anaesthetic effects and cardiopulmonary depression. Medicin Lire le document complet