SUMMARY OF PRODUCT CHARACTERISTICS
ANSM - Updated on: 01/08/2023
1. NAME OF THE MEDICINE
MANGANESE-COPPER-COBALT OLIGOSOL, oral solution in ampoule form
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Manganese gluconate.................................................................................................. 0.590 mg
(Corresponding amount of manganese.......................................................................... 0.0728 mg)
Copper gluconate........................................................................................................... 0.518 mg
(Corresponding amount of copper.................................................................................. 0.0726 mg)
Cobalt gluconate........................................................................................................... 0.553 mg
(Corresponding amount of cobalt................................................................................. 0.0726 mg)
Per ampoule of 2 ml.
Excipient with known effect: glucose (100 mg per 2 ml ampoule).
For the complete list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution in ampoule form.
4. CLINICAL DATA
4.1. Therapeutic indications
Used as a terrain modifier, particularly during asthenic conditions.
4.2. Posology and method of administration
Dosage
FOR ADULTS ONLY.
1 to 2 ampoules per day.
The ampoules should be taken:
- preferably in the morning on an empty stomach,
- or 15 minutes before a meal, or at bedtime.
Method of administration
Oral route. Sublingual administration is recommended: keep the contents of the ampoule under the tongue for 1 to 2 minutes before swallowing.
4.3. Contraindications
Hypersensitivity to the active substances or any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
This medicine contains glucose. Its use is not recommended in patients with glucose-galactose malabsorption syndrome (a rare hereditary condition).
Treatment with these trace minerals does not exempt from any specific treatment.
4.5. Interactions with other medicines and other forms of interaction
The available data do not suggest any clinically significant interactions.
4.6. Fertility, pregnancy, and breastfeeding
In the absence of experimental and clinical data, and as a precautionary measure, the use of this medicine should be avoided during pregnancy and breastfeeding.
4.7. Effects on the ability to drive and use machines
MANGANESE-COPPER-COBALT OLIGOSOL, oral solution in ampoule form has no effect on the ability to drive vehicles or use machines.
4.8. Undesirable effects
No notable undesirable effects have been reported with the use of MANGANESE-COPPER-COBALT OLIGOSOL, oral solution in ampoule form.
Reporting suspected adverse reactions
Reporting suspected adverse reactions after the authorization of the medicine is important. It allows for continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals should report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the Regional Pharmacovigilance Centers network - Website: www.signalement-sante.gouv.fr
4.9. Overdose
No cases of overdose have been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class: OLIGOTHERAPY (V: various).
Trace minerals.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Preclinical safety data in animals are insufficient to evaluate the toxicity of manganese gluconate, copper gluconate, and cobalt gluconate concerning reproductive functions.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Monohydrated glucose and purified water.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store at a temperature not exceeding 25°C.
6.5. Nature and contents of the outer packaging
2 ml ampoule with two breakable tips, made of colorless type I glass. Box of 14 or 28 ampoules.
6.6. Special precautions for disposal and handling
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
LABCATAL
1198 AVENUE DU DOCTEUR MAURICE DONAT
ZAC DU FONT DE L’ORME
06250 MOUGINS, France
8. MARKETING AUTHORIZATION NUMBER(S)
- 34009 307 518 0 0: 2 ml ampoule (colorless glass), box of 14.
- 34009 301 406 7 3: 2 ml ampoule (colorless glass), box of 28.
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
[To be completed later by the holder]
10. DATE OF TEXT REVISION
[To be completed later by the holder]
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS FOR PRESCRIPTION AND DISPENSING
Medicine not subject to medical prescription.
