Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Dexamethasone isonicotinate
Emdoka
QH02AB02
Dexamethasone isonicotinate
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
dexamethasone
Authorised
2021-11-12
Health Products Regulatory Authority 12 November 2021 CRN009Q98 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Trovex 1 mg/ml suspension for injection for cattle, horses, pigs, cats and dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Dexamethasone isonicotinate 1.00 mg (equivalent to 0.79 mg dexamethasone) EXCIPIENTS: Methylparahydroxybenzoate (E218) 1.35mg Propylparahydroxybenzoate 0.15mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection White to yellowish white suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horses, pigs, cats and dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Horses, cattle, pigs, dogs and cats: Treatment of inflammatory skin conditions, diseases of the locomotor system and diseases of the respiratory system. Cattle: Treatment of ketosis (acetonaemia). 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 use in animals with known cases of hypersensitivity to the active substance, to corticosteroids and to any other ingredient of the product. See also section 4.7. Do not use for the treatment of laminitis in horses, where there is the possibility that such treatment could worsen the condition. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Health Products Regulatory Authority 12 November 2021 CRN009Q98 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals During a course of treatment the situation should be reviewed frequently by close veterinary supervision. Care should be taken not to overdose Channel Island breeds of cattle. Use of Đọc toàn bộ tài liệu