देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
DEXAMETHASONE SODIUM PHOSPHATE
COMEX LTD., ISRAEL
SOLUTION FOR INJECTION
DEXAMETHASONE SODIUM PHOSPHATE 2 MG/ML
I.V, I.M
Required
NORBROOK LABORATORIES LTD, IRELAND
In hosrses, dogs, cats and Cattle . Dexametahsone is a synthetic corticosteroid with a potent anti-inflammatory action. Colvasone can be used for: 1. Intravenous therapy in cases where emergency treatment is indicated, particulaly shock and circulatory collapse, acute mastitis and burns. 2. Inflammatory conditions in all species: the product will suppress inflammation and is indicated in the treatment of arthritis, laminitis, dermatitis etc. 3. Acetonaemia (ketosis) in cattle. Dexamethasone has a marked glucogenic action.
2019-11-30
THIS LEAFLET HAS BEEN REVIEWED AND APPROVED 05/2019 SUMMARY OF PRODUCT CHARACTERISTICS VETERINARY USE ONLY - PRESCRIPTION ONLY MEDICINE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Colvasone Veterinary, 2mg/ml, Solution for injection I.M, I.V injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Dexamethasone Sodium Phosphate 2mg For a full list of excipients, see section 13 “further information” 3. INDICATIONS FOR USE Dexamethasone is a synthetic corticosteroid with a potent anti- inflammatory action. Colvasone can be used for: (1) Intravenous therapy in cases where emergency treatment is indicated, particularly shock and circulatory collapse, acute mastitis and burns. (2) Inflammatory conditions: the product will suppress inflammation and is indicated in the treatment of arthritis, laminitis, dermatitis etc.. (3) Acetonaemia (ketosis) in cattle. Dexamethasone has a marked glucogenic action PHARMACOTHERAPEUTIC GROUP: corticosteroids 4. CONTRAINDICATIONS Systemic corticosteroid therapy is generally contra-indicated in patients with renal disease and diabetes mellitus. 5. ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Steroids themselves, during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism e.g. redistribution of body fat, muscle weakness and wastage and osteoporosis may result. During therapy effective doses suppress the Hypothalamo-Pituitary- Adrenal axis. Following cessation of treatment, symptoms of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal adequately with stressful situations. Consideration should therefore be given to means of minimising problems of adrenal insufficiency following the withdrawal of treatment, e.g. a gradual reductions of dosage (for further discussion see standard texts). - Systemically acting corticosteroids may cause polyuria, polydipsia and polyphagia, particularly during the early stages of therapy. पूरा दस्तावेज़ पढ़ें
THIS LEAFLET HAS BEEN REVIEWED AND APPROVED 05/2019 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Colvasone veterinary I.M, I.V Solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Dexamethasone Sodium Phosphate 2 mg/ml EXCIPIENTS: Benzyl alcohol 20mg/ml. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. A clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses Cattle Dogs Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dexamethasone is a synthetic corticosteroid with a potent anti- inflammatory action. Colvasone can be used for: (1) Intravenous therapy in cases where emergency treatment is indicated, particularly shock and circulatory collapse, acute mastitis and burns. (2) Acetonaemia (ketosis) in cattle. Dexamethasone has a marked glucogenic action. (3) Inflammatory conditions in all species: the product will suppress inflammation and is indicated in the treatment of arthritis, laminitis, dermatitis etc. 4.3 CONTRAINDICATIONS Systemic corticosteroid therapy is generally contra-indicated in patients with renal disease and diabetes mellitus. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Use of the product in horses could induce laminitis and therefore careful observations should be made during treatment. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals 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. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the carton to the p पूरा दस्तावेज़ पढ़ें