البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
DEXAMETHASONE AS PHENYLPROPIONATE; DEXAMETHASONE AS SODIUM PHOSPHATE
INTERVET ( ISRAEL) LTD
SUSPENSION FOR INJECTION
DEXAMETHASONE AS PHENYLPROPIONATE 2 MG/ML; DEXAMETHASONE AS SODIUM PHOSPHATE 1 MG/ML
I.M
Required
VET PHARMA FRIESOYTHE GMBH, GERMANY
For the treatment of primary ketosis, various inflammatory conditions like arthritis and other orthopedic conditions, shock, stress, allergic conditions in horses, cattle, dogs and cats.
2019-03-18
CONSUMER PACKAGE INSERT FOR VETERINARY MEDICINAL PRODUCT The medicine is dispensed with a veterinarian's prescription only For animal use only 1. NAME OF THE MEDICINAL PRODUCT: DEXAFORT VETERINARY Suspension for injection 2. COMPOSITION: Each ml contains: Active substances: Dexamethasone (as sodium phosphate) 1 mg Dexamethasone (as phenylpropionate) 2 mg Preservative: Benzyl alcohol 10.4 mg For the full list of excipients, see section 13 – “Additional information”. 3. WHAT IS THE MEDICINAL PRODUCT INTENDED FOR: For the treatment of primary ketosis (acetonaemia), in various inflammatory conditions like arthritis and other orthopedic conditions, shock, stress, allergic conditions in horses, cattle, dogs and cats. Therapeutic group: glucocorticoids 4. CONTRAINDICATIONS: Do not use in case of sensitivity to the active substance or to any of the excipients listed in section 13. Except in emergency situations the product should not be used in animals suffering from: •Diabetes •Chronic nephritis •Renal disease •Congestive heart failure •Osteoporosis •Viral infections during the viraemic stage 5. SIDE EFFECTS: Anti-inflammatory corticosteroids, such as dexamethasone, are known to exert a wide range of side-effects. Whilst single high doses are generally well tolerated, they may induce severe side-effects in long term use and when esters possessing a long duration of action are administered. Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms. Steroids themselves, during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism. For example, redistribution of body fat, muscle weakness and wastage and osteoporosis may result. During therapy, effective doses suppress the hypothalamopituitreal-adrenal axis (HPA axis). Following cessation of treatment, symptoms of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal ade اقرأ الوثيقة كاملة
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Dexafort Veterinary 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substances: Dexamethasone (as sodium phosphate) 1mg Dexamethasone (as phenylpropionate) 2mg Excipients: Benzyl alcohol 10.4 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection. White to off-white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, cattle, dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of primary ketosis, various inflammatory conditions like arthritis and other orthopedic conditions, shock, stress, allergic conditions in horses, cattle, dogs and cats. 4.3 CONTRA-INDICATIONS Except in emergency situations the product should not be used in animals suffering from diabetes, chronic nephritis, renal disease, congestive heart failure, osteoporosis and in viral infections during the viraemic stage. Do not use in case of hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNING FOR EACH TARGET SPECIES See 4.6 below. Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE (i) Special precautions for use in animals Shake vial well before use. See 4.3 above and 4.6 below. (ii) Special precautions to be taken by the person administering the medicinal product to the animals. Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician. To avoid the risk of self-injection, pregnant women should not handle the veterinary medicinal product. Avoid contact with skin and eyes. In the event of accidental eye or skin contact, wash/irrigate the area with clean running water. Seek medical attention if irritation persists. Wash hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Anti-inflammatory corticosteroids, such as dexamethasone, are known to exert a wide range o اقرأ الوثيقة كاملة