GRANIONS MANGANESE 30 vials
1. NAME OF THE MEDICINAL
Granions MANGANESE 0.1 mg / 2 ml oral solution in ampoule.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Manganese sulphate monohydrate ........................................................................... ..0,306 mg
Amount corresponding to 0.100 mg manganese element ...............................................................
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 especially in allergic conditions.
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
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 were reported during use of Granions MANGANESE 0.1 mg / 2 ml oral solution in ampoule.
4.9. Overdose
No case of overdose has been reported with the specialty.
In chronic administration of high doses, neurological symptoms were observed with the manganese.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: oligotherapy
(V: Other)
Trace element mineral.
5.2. Pharmacokinetic properties
Unknown.
5.3. Preclinical safety data
Unknown.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Amyloidosis, glycerol, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Retention period
2 years.
6.4. Special precautions for storage
No special storage conditions.
6.5. Nature and contents of container
Bulb (glass) 2 ml of 10 boxes or 30 bulbs.
6.6. Special precautions for disposal and handling
No special requirements.
7. HOLDER OF MARKETING AUTHORISATION
LABORATORY Granions
7, rue industry
The Mercator
98000 MONACO
MONACO
8. NUMBER (S) MARKETING AUTHORIZATION
341 480-2: 2 ml ampoule (glass); box of 10 bulbs
375 459-6: 2 ml ampoule (glass); box of 30 bulbs
9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION
31 July 1996/31 July 2006
10. DATE OF REVISION OF THE TEXT
June 17, 2010
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. : 023624