Land: Cypern
Sprog: græsk
Kilde: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες
GRANTED
QB03BA04
COBAMAMIDE 10.000 μg/ 20ml
GRANTED
FATRO SpA ITALY
LYOPHILISATE AND SOLVENT FOR SOLUTION FOR INJECTION
N. A. CHANCE TRADING CO
Withdrawal period: CATTLE HORSES PIGS DOGS CATS; Distributor: ANTIANEMIC PREPARATIONS
ΠΑΡΑΡΤΗΜΑ Ι ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT COENZILE 10,000µg/20ml, lyophilised, and solvent for solution for injection for cattle, horses, swine, dogs and cats. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _One bottle of lyophilisate contains:_ ACTIVE SUBSTANCE: cobamamide.........................................10,000 µg For a complete list of excipients, see section 6.1. _One bottle of solvent contains:_ Water for injections.....................................20 ml 3. PHARMACEUTICAL FORM Lyophilisate and solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES_ _ Cattle, horses, swine, dogs and cats. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In all states regarding retarded growth, insufficient or difficult weight gain, convalescence, hyporexia and anorexia. As stimulant in fatigue with poor performance in sporting animals. As an adjuvant in anaemia, hepatopathies and neuropathies. As Vitamin B 12 in Vitamin B 12 avitaminosis and dysvitaminosis with a deficiency of this vitamin. 4.3. CONTRAINDICATIONS None. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5. SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS None. 4.6. ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None reported. 1/12 4.7. USE DURING PREGNANCY, LACTATION OR LAY COENZILE may be used during pregnancy and lactation. 4.8. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.9. AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Administer by the intramuscular route CALVES, FOALS: 5-10ml (2,500 - 5,000µg) per day for 3-6 days. PIGLETS: 2.5ml (1,250µg) per day, for 3 days. ADULT CATTLE AND HORSES:10-20ml (5,000 - 10,000µg) per day, for 2-4 days. ADULT SWINE: 5-10ml (2,500 - 5,000µg) per day, for 2-4 days. DOGS AND CATS: 2.5-5ml (1,250 - 2,500µg Læs hele dokumentet