Χώρα: Κύπρος
Γλώσσα: Ελληνικά
Πηγή: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες
GRANTED
QH02AB02
DEXAMETHASONE 1 MG/ML
GRANTED
FATRO SpA ITALY
SOLUTION FOR INJECTION
N. A. CHANCE TRADING CO
Withdrawal period: CATTLE PIGS HORSES DOGS CATS; Distributor: CORTICOSTEROIDS FOR SYSTEMIC USE
ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FATROCORTIN 1 mg/ml solution for injection for cattle, swine, horses, dogs and cats. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml bottle 1 ml contains: ACTIVE SUBSTANCE: dexamethasone............1 mg EXCIPIENTS q.s. to….....................................1 ml For a complete list of the excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, swine, horses, dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dexamethasone is indicated in the treatment of inflammatory and metabolic syndromes and allergic phenomena in cattle, swine, horse, dogs and cats, particularly in cases of: acetonemia (ketosis) - rheumatoid arthritis - inflammatory disorders in general, articular or tendinous in particular (bursitis, synovitis, hydrarthrosis, hygroma, tendonitis) - edema disease of piglets - allergies and pruritus “sine materia” - dermatosis in the dog - control of inflammatory and stressful phenomena (in combination with antibiotic treatment) in the course of infectious bacterial diseases - acute mastitis in the cow and sow. 4.3 CONTRAINDICATIONS Administration of dexamethasone or of glucocorticoids in general is contraindicated in subjects affected by diabetes mellitus, osteoporosis, renal disorders, cardiac insufficiency, corneal, gastric or duodenal ulcers, glaucoma. Infectious diseases must not be treated with corticosteroids, unless concurrent specific antiinfectious therapy is also conducted. Do not use in animals in cases of known hypersensitivity to the active substance or to any of the excipients. 1/14 Dexamethasone must not be administered in cases of systemic thrombocytopenia. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In cases of intra-articular use, administration of the medicinal product must be performed by a veterinary surgeon. The corticosteroids can cause immuno-s Διαβάστε το πλήρες έγγραφο