1. NAME OF THE MEDICINAL PRODUCT
ZINC-NICKEL-COBALT OLIGOSOL, drinkable solution in ampoule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc gluconate ......................................................................................................................... 0,470 mg (corresponding amount of zinc ................................................................................................. 0,0674 mg) Nickel gluconate ....................................................................................................................... 0,555 mg (corresponding amount of nickel .............................................................................................. 0,0726 mg) Cobalt gluconate ....................................................................................................................... 0,553 mg (corresponding amount of cobalt .............................................................................................. 0,0726 mg) For one ampoule of 2 ml For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution in ampoule.
4. CLINICAL DATA
4.1 Therapeutic indications Used as a soil modifier, particularly in the case of weight loss diets. 4.2. Dosage and method of administration Oral administration Sublingual administration is recommended. RESERVED FOR ADULTS. 2 to 3 phials per day. The ampoules should be taken: - preferably in the morning on an empty stomach, - possibly 15 minutes before a meal or in the evening at bedtime. Keep the contents of the ampoule 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 components of the solution. 4.4. Special warnings and precautions for use Treatment with these trace minerals does not dispense with any specific treatment. This medicine contains glucose. Its use is not recommended in patients with glucose and galactose malabsorption syndrome. 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. Adverse reactions Skin and subcutaneous tissue disorders under treatment but not known to be true allergies. The frequency of occurrence is not determinable. 4.9. Overdose No cases of overdose have been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties Pharmacotherapeutic class: OLIGOTHERAPY (V: Miscellaneous) Trace minerals 5.2. Pharmacokinetic properties Not given. 5.3. Preclinical safety data Not provided.
6. PHARMACEUTICAL DATA
6.1. List of excipients Anhydrous glucose, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 5 years. 6.4. Special precautions for storage A. Store below 25°C. 6.5. Nature and contents of outer packaging 2 ml colourless type I glass ampoule with two self-closing tips. Box of 14 or 28. 6.6. Special precautions for disposal and handling 2 ml colourless glass ampoule with two self-closing tips. Box of 14 or 28.
7. MARKETING AUTHORISATION HOLDER
LABCATAL 7, RUE ROGER SALENGRO BP 305 92541 MONTROUGE CEDEX
8. MARKETING AUTHORISATION NUMBER(S)
- 307 526-3: 2 ml in ampoule (colourless glass), box of 14. - 375 478-0: 2 ml ampoule (colourless 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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