Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
tepoxalin
Intervet International B. V.
QM01AE92
tepoxalin
Dogs
Musculo-skeletal system
Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
Revision: 13
Withdrawn
2001-03-13
17 B. PACKAGE LEAFLET Medicinal product no longer authorised 18 PACKAGE LEAFLET Zubrin oral lyophilisates 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: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands MANUFACTURER FOR THE BATCH RELEASE: S-P Veterinary Ltd Breakspear Road South Harefield Uxbridge UB9 6LS United Kingdom 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS ACTIVE SUBSTANCE Tepoxalin 50 mg / oral lyophilisate Tepoxalin 100 mg / oral lyophilisate Tepoxalin 200 mg / oral lyophilisate 4. INDICATIONS Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders. 5. CONTRAINDICATIONS Do not use if your dog • is pregnant or lactating or in bitches intended for breeding • has cardiac or hepatic disease • has had gastrointestinal ulceration or bleeding • is hypersensitive to the product • is dehydrated, hypovolaemic or hypotensive, as there is an increased risk of renal toxicity. Medicinal product no longer authorised 19 6. ADVERSE REACTIONS Vomiting or diarrhoea may occur due to treatment. Alopecia and erythema may also occur occasionally. Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite, lethargy and renal disorders. If there are such undesirable effects, treatment should be discontinued immediately. In rare cases, particularly in older or in sensitive dogs, these undesirable effects may be serious or fatal. During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) occurred in 1 out of 10 animals. If you notice any other side effects, please inform your veterinary surgeon. 7. TARGET S Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Tepoxalin 50 mg / oral lyophilisate Tepoxalin 100 mg / oral lyophilisate Tepoxalin 200 mg / oral lyophilisate For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral lyophilisates 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders. 4.3 CONTRAINDICATIONS Do not use in pregnant or lactating dogs or in bitches intended for breeding. Use is contraindicated in animals suffering from cardiac or hepatic disease, or where there is a history of gastrointestinal ulceration, or bleeding, or where there is hypersensitivity to the product. Do not use in dehydrated, hypovolaemic or hypotensive dogs, as there is an increased risk of renal toxicity. 4.4 SPECIAL WARNINGS Special care should be taken when treating dogs with marked renal insufficiency. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Use in animals less than 6 months of age, with a weight below 5 kg, or in aged animals, may involve additional risk. If such use cannot be avoided, close veterinary supervision to monitor for gastrointestinal blood loss is necessary. If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. The recommended dose should not be exceeded. Medicinal product no longer authorised 3 SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS Tepoxalin is not water-soluble and becomes very sticky upon wetting. If the oral lyophilisate disintegrates prematurely, wash hands thoroughly. In case of ingestion of a number of oral lyophilisates by a person, the advice of a doctor should be sought Aqra d-dokument sħiħ