GRANIONS BISMUTH 10 vials
1. NAME OF THE MEDICINAL
Granions BISMUTH 2 mg / 2 ml oral solution in ampoule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BISMUTH NITRATE ....................................................................................... .. 4, 64 mg
(Corresponding amount of bismuth ........................................................................ 2.00 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 land especially during viral infectious states of ENT, of flu symptoms.
4.2. Dosage and method of administration
RESERVED FOR ADULTS.
Oral use.
1-2 ampoules per day, diluted in a glass of water without food.
4.3. Cons-indications
This drug is cons-indicated in patients with hypersensitivity to any component.
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
Unknown.
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
Granions® Bismuth 2 mg / 2 ml oral solution in ampoule has no effect on ability to drive and use machines.
4.8. Adverse reactions
Unknown.
4.9. Overdose
Unknown.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Oligotherapy (V: miscellaneous)
Trace element mineral.
5.2. Pharmacokinetic properties
Not indicated.
5.3. Preclinical Safety Data
Not indicated.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Amyloidosis, glycerol, 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
The Mercator
7 rue Industry
Z.I. Fontvieille
98000 MONACO
8. NUMBER (S) MARKETING AUTHORIZATION
3400930462218 2 ml ampoule (brown glass), box of 10.
9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION
January 29, 1998 / January 29, 2008.
10. DATE OF REVISION OF THE TEXT
Not applicable.
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
Réf. : 023621