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ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
COENZILE 10,000 µg/20 ml, lyophilised, and solvent for solution for injection for cattle, horses, swine, dogs and cats.
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
PHARMACEUTICAL FORM
Lyophilisate and solvent for solution for injection.
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
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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.
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
Piglets :
: 5-10 ml (2,500 - 5,000 µg) per day for 3-6 days.
2.5 ml (1,250 µg) per day, for 3 days.
Adult cattle and horses : 10-20 ml (5,000 - 10,000 µg) per day, for 2-4 days.
Adult swine : 5-10 ml (2,500 - 5,000 µg) per day, for 2-4 days.
Dogs and cats : 2.5-5 ml (1,250 - 2,500 µg) per day, for 1-2 weeks.
The doses indicated may be increased at the discretion of the Veterinary surgeon, who will also regulate the duration of the treatment on the basis of the therapeutic response and the desired clinical effects.
4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary
No symptoms due to overdose are known.
4.11. Withdrawal periods
Meat and offal: 0 days.
Milk: 0 hours.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Vitamin B
12
(cyanocobalamin and analogues)
ATC Vet Code: QB03BA04
5.1.
Pharmacodynamic properties
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COENZILE consists of cobamamide or coenzyme B
12
, the principal active metabolite into which cyanocobalamin or vitamin B
12
is transformed in the liver.
Its metabolic function is essential for the integrity of all tissues in which synthesis of nucleic acids, proteins and nucleoproteins takes place; it also intervenes in lipid metabolism.
Cobamamide is thus essential for haemopoiesis, to maintain the integrity of cells in general (e.g. epithelial, muscle, brain and pancreatic cells) and particularly the functional integrity of the cells of the central and peripheral nervous systems.
Cobamamide is used as a adjuvant in cases of retarded growth or to restore normal weight conditions after diseases or other debilitating situations in both young and in adult animals, leading to an improvement in the general state of health and an increase in appetite; it is also useful in treatment of fatigue in sporting animals (dogs, horses).
Cobamamide, the physiological form of Vitamin B
12
, shows no toxicity and has no contraindications.
5.2. Pharmacokinetic particulars
Cobamamide, administered by the intramuscular route, is rapidly absorbed and distributes to all tissues, particularly to the liver. Any excess is excreted principally by the renal route.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
One bottle of lyophilisate contains: mannitol
One bottle of solvent contains: water for injections
6.2.
Incompatibilities
In the absence of stability studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3. Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years
After reconstitution, the product must be used immediately and not stored.
6.4. Special precautions for storage
Store protected from sources of heat and, given the particular photosensitivity of cobamamide, store protected from light and prepare the solution immediately prior to use.
6.5. Nature and composition of immediate packaging
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20 ml type-I glass bottles, amber-coloured for the lyophilisate and neutral for the solvent, with an elastomer stopper and aluminium collar in a cardboard box.
Not all pack sizes may be marketed.
6.6.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
FATRO S.p.A. - Via Emilia, 285 - Ozzano dell'Emilia - Bologna - Italy.
10309
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21/11/1985
Date of renewal: 22/11/2012
10. DATE OF REVISION OF THE TEXT
22/11/2012
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
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