1. NAME OF THE MEDICINAL PRODUCT
SELENIUM OLIGOSOL 100 micrograms/2 ml, drinkable solution in ampoule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium selenite pentahydrate ............... 0,3331 mg Quantity corresponding to selenium ......... 100 micrograms For one 2 ml ampoule. For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
4. CLINICAL DATA
4.1 Therapeutic indications Used as a soil modifier, particularly in muscular and skin disorders. 4.2. Posology and method of administration FOR ADULTS ONLY. Oral use. 1 ampoule per day, to be taken in the morning on an empty stomach or 15 minutes before a meal. Sublingual administration is recommended: keep the solution under the tongue for 1 to 2 minutes before swallowing. 4.3. Contraindications This medicine is contraindicated in case of hypersensitivity to any of the ingredients. 4.4. Special warnings and precautions for use Not applicable. 4.5. Interactions 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 precautionary measure, the use of this medicinal product should be avoided during pregnancy and lactation. 4.7. Effects on ability to drive and use machines Not applicable. 4.8. Undesirable effects Not applicable. 4.9. Overdose No cases of overdose have been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties OLIGOTHERAPY (V: Miscellaneous) Trace mineral element. 5.2. Pharmacokinetic properties Not known. 5.3. Preclinical safety data Not provided.
6. PHARMACEUTICAL DATA
6.1. List of excipients Purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 2 years. 6.4. Special precautions for storage No special precautions for storage. 6.5. Nature and contents of packaging 2 ml in ampoule (glass). Box of 14 or 28. 6.6. Special precautions for disposal and handling No special requirements.
7. MARKETING AUTHORISATION HOLDER
LABCATAL 7, RUE ROGER SALENGRO BP 305 92541 MONTROUGE CEDEX
8. MARKETING AUTHORISATION NUMBER(S)
- 375 475-1: 2 ml in ampoule (glass). Box of 28.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
[To be completed by the holder]
10. DATE OF UPDATE OF THE TEXT
[to be completed by the holder] 11.
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND SUPPLY
Not subject to medical prescription.
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