Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
DEXAMETHASONE SODIUM PHOSPHATE
Dopharma Research B.V.
QH02AB02
DEXAMETHASONE SODIUM PHOSPHATE
2 Mg/Ml
Solution for Injection
POM
Bovine, Canine, Equine - Food, Feline, Porcine
Dexamethasone
Corticosteroid
Authorised
2012-10-05
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 15 mg For a 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. 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 29/07/2016_ _CRN 7024235_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS Response to long-term therapy shoul Прочитать полный документ