GRANIONS SELENIUM 30 vials
1. NAME OF THE MEDICINAL
Granions SELENIUM, 0.96 mg / 2 ml oral suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Selenium ............................................................................................................................0,96 mg
To a 2 ml ampoule.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension.
4. CLINICAL DATA
4.1. Indications
Used as a modifier of the land especially during muscle and skin conditions.
4.2. Dosage and method of administration
RESERVED FOR ADULTS.
1 ampoule 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
At recommended doses, there were no reports of adverse effects to date.
4.9. Overdose
No case of overdose has been reported, though a chronic overdose may cause hair loss, irritability, brittle nails and fatigue.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: 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
Amylose, carrageenans (Satiagum X3), glycerol, xanthan gum (Satiaxane CX91), 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
304 630-4: 2 ml ampoule (brown glass), box of 10.
366 673-9: 2 ml ampoule (brown glass); box of 30.
9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION
January 29, 1998 / January 29, 2008
10. DATE OF REVISION OF THE TEXT
December 23, 2011.
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
Réf. : 023627