1. NAME OF THE MEDICINAL
Granions COPPER 0.3 mg / 2 ml oral solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Copper .......................................................................................................................................... 0.3 mg
To a 2 ml ampoule.
Excipients: sodium hydrosulfite, sodium sulfite.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
4. CLINICAL PARTICULARS
4.1. Indications
Used as a modifier of the land especially during infectious and viral states of flu symptoms, the course of inflammatory rheumatic diseases and in osteoarthritis.
4.2. Dosage and method of administration
RESERVED FOR ADULTS.
2-3 ampoules per day: It is recommended to absorb the contents of the vials diluted in a glass of water without food.
OA: the dosage is 1 bulb 3 times daily.
4.3. Cons-indications
This drug is cons-indicated in patients who
· Hypersensitivity to any component of the solution.
4.4. Special warnings and precautions for use
Treatment with this mineral trace element does not exempt of any specific treatment.
4.5. Interaction with other medicinal products and other forms of interaction
Not applicable.
4.6. Pregnancy and lactation
In the absence of experimental and clinical data and as a precaution, the use of this drug should be avoided during pregnancy and lactation.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Adverse reactions
This medicine contains "sulphite" and can cause severe allergic reactions and bronchospasm.
4.9. Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Oligotherapy.
(V: miscellaneous)
Trace element mineral.
5.2. Pharmacokinetic properties
Not specified.
5.3. Preclinical safety data
Not specified.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Amyloidosis, glycerol, disodium phosphate dihydrate, potassium dihydrogen phosphate anhydrous, sodium hydrosulfite, sodium sulfite, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Retention period
2 years.
6.4. Special precautions for storage
Store at a temperature below 25 ° C.
6.5. Nature and contents of container
Dropping two points breakable brown glass type II 2ml. Box of 10 or 30 bulbs.
6.6. Special precautions for disposal and handling
No special requirements.
7. HOLDER OF MARKETING AUTHORISATION
Laboratory Granions
7, rue de l'Industrie
The Mercator
98000 MONACO
8. NUMBER (S) MARKETING AUTHORIZATION
· 304 623-8: 2 ml ampoule (glass). Box of 10 bulbs.
· 375 460-4: 2 ml ampoule (glass). Box of 30 bulbs.
9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION
January 26, 1998 / January 26, 2008
10. DATE OF REVISION OF THE TEXT
June 2, 2006.
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND DELIVERY
Medicinal product not subject to medical prescription.
Réf. : 023622