Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
robenacoxib
Elanco GmbH
QM01AH91
robenacoxib
Dogs; Cats
Anti-inflammatory and anti-rheumatic products, non-steroids, Coxibs
Cats (tablets):For the treatmentRelief of pain and inflammation associated with acute andor chronic musculo-skeletal disorders.For the reduction of moderate pain and inflammation associated with orthopaedic surgery.Dogs (tablets):For the Ttreatment of pain and inflammation associated with chronic osteoarthritis.For the treatment of pain and inflammation associated with soft tissue surgery.Cats and dogs (solution for injection):For the Ttreatment of pain and inflammation associated with orthopaedic or soft tissue surgery.
Revision: 14
Authorised
2008-12-16
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: ONSIOR 6 MG TABLETS FOR CATS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany Manufacturer responsible for the batch release: Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Onsior 6 mg tablets for cats Robenacoxib 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains 6 mg robenacoxib. Tablets are round, beige to brown, non-divisible and with imprints “NA” on one side and “AK” on the other side. Onsior tablets are easy to administer and well accepted by most cats. 4. INDICATION(S) For the treatment of pain and inflammation associated with acute and chronic musculoskeletal disorders in cats. For the reduction of moderate pain and inflammation associated with orthopaedic surgery in cats. 5. CONTRAINDICATIONS Do not use in cats suffering from ulceration in the digestive tract. Do not use together with non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, medicines commonly used in the treatment of pain, inflammation and allergies. Do not use in case of hypersensitivity to robenacoxib or to any of the constituents of the tablets. Do not use in pregnant or lactating cats or cats used for breeding because the safety of this product has not been established in these animals. 6. ADVERSE REACTIONS Mild and transient diarrhoea, soft faeces or vomiting were commonly reported in clinical trials with treatment up to 6 days. Lethargy may be observed in very rare cases. In addition, elevated renal parameters (creatinine, BUN and SDMA), and renal insufficiency have been reported very rarely in post marketing safety experience, more commonly in older cats and with concomitant use of anaesthetic or 36 sedative agents (see also Sections: Special precautions for use, Interaction with other medicina Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Onsior 6 mg tablets for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Robenacoxib 6 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Round, beige to brown tablets with imprints “NA” on one side and “AK” on the other side. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of pain and inflammation associated with acute or chronic musculoskeletal disorders in cats. For the reduction of moderate pain and inflammation associated with orthopaedic surgery in cats. 4.3 CONTRAINDICATIONS Do not use in cats suffering from gastrointestinal ulceration. Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in pregnant and lactating animals (see section 4.7). _ _ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The safety of the veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age. Use in cats with impaired cardiac, renal or hepatic function or in cats that are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these cats require careful monitoring. 3 Response to treatment should be monitored at regular intervals by a veterinary surgeon. Clinical field studies showed that robenacoxib was well-tolerated by most cats for up to 12 weeks. Use this veterinary medicinal product under strict veterinary monitoring in cats with a risk of gastrointestinal ulcers, or if the cat previously displayed intolerance to other NSAIDs. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use of the veterinary m Przeczytaj cały dokument