1. NAME OF THE MEDICINAL
Granions GOLD 0.2 mg / 2 ml oral solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Gold .................................................................................................................................. 0, 20 mg
To a 2 ml ampoule.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
4. CLINICAL DATA
4.1. Indications
Used as a modifier of the field in particular during inflammatory rheumatic diseases.
4.2. Dosage and method of administration
RESERVED FOR ADULTS.
1-2 ampoules per day. It is recommended to absorb the contents of the vials diluted in a glass of water without food.
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
The data available to date do not suggest the existence of clinically significant interactions.
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
No adverse effects have been reported with the use of Granions d'Or 0.2 mg / 2 ml oral solution. Treatment with gold may cause hypersensitivity reactions.
4.9. Overdose
No case of overdose has been reported, however, an overdose may cause a worsening of side effects. Treatment is symptomatic.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Oligotherapy
(V: miscellaneous)
Trace element mineral.
5.2. Pharmacokinetic properties
Unknown
5.3. Preclinical safety data
Unknown.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Amyloidosis, glycerol, sodium hydrosulfite, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Retention period
3 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.
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
MONACO
8. NUMBER (S) MARKETING AUTHORIZATION
304 627-3: 2 ml ampoule (brown glass), box of 10.
394 386-0 394 386 or 34009 03: 2 ml ampoule (brown glass), 30 box.
9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION
January 26, 1998 / January 26, 2008
10. DATE OF REVISION OF THE TEXT
December 22, 2011.
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.