País: Regne Unit
Idioma: anglès
Font: VMD (Veterinary Medicines Directorate)
Dexamethasone
Dopharma Research B.V.
QH02AB02
Dexamethasone
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Cattle, Dogs, Horses, Pigs
Anti Inflammatory corticosteroid
Authorized
2012-08-24
Revised: July 2017 AN: 01391/2016 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per ml: _ACTIVE SUBSTANCE:_ Dexamethasone 2 mg as dexamethasone sodium phosphate 2.63 mg _EXCIPIENTS_: Benzyl alcohol (E1519) 15 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horses, pigs, dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Horses, cattle, pigs, dogs and cats: Treatment of inflammatory or allergic conditions. Cattle: Induction of parturition. Treatment of primary ketosis (acetonaemia). Horses: Treatment of arthritis, bursitis or tenosynovitis. 4.3 CONTRAINDICATIONS Except in emergency situations, do not use in animals suffering from diabetes mellitus, renal insufficiency, cardiac insufficiency, hyperadrenocorticism or osteoporosis. Do not use in viral infections during the viraemic stage or in cases of systemic mycotic infections. Do not use in animals suffering from gastrointestinal or corneal ulcers, or demodicosis. Do not administer intra-articularly where there is evidence of fractures, bacterial joint infections and aseptic bone necrosis. Revised: July 2017 AN: 01391/2016 Page 2 of 7 Do not use in known cases of hypersensitivity to the active substance, to corticosteroids and to any other ingredient of the product. See also section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.Use of corticosteroids in horses has been reported to induce laminitis. Therefore horses treated with such preparations should be monitored frequently during the treatment period. Because of the pharmacological properties of the active ingredie Llegiu el document complet