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| HEALTH & LIFESTYLE Brands: |
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Tot’hema® ampoules contain an iron supplement in liquid form. The formulation includes Copper and
Manganese which enhance its action. Tot’hema is indicated in iron deficiency anaemias, iron deficiency
prophylaxis in pregnancy, newborns with an iron-deficient mother, and when adequate amounts of iron cannot be supplied by food intake. Drinkable solution, ampoules.
| Composition: |
List of Excipients: |
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• Iron gluconate: quantity equivalent in iron to 50.00 mg
• Manganese gluconate: quantity equivalent in Manganese to 1.33 mg
• Copper gluconate: quantity equivalent in copper to 0.70 mg
Excipients (glycerol, glucose, sucrose, anhydrous citric acid, sodium citrate, sodium benzoate, polysorbate 80, caramel colouring TPS (E 150 b), tutti frutti aroma, demineralized water) q.s.f. one drinkable ampoule of 10 ml.
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LIST OF EXCIPIENTS WHICH EFFECTS SHOULD BE WELL-KNOWN FOR A SAFE USE IN SOME PATIENTS: glucose, sucrose, glycerol, sodium citrate, sodium benzoate. |
| Indication: |
Contra indications: |
This drug is an iron supply • it is recommended for treatment of iron deficiency anaemia. |
Anaemia not related to iron deficiency. |
| Precautions for use: |
Contraindication: |
Drinking large quantities of tea inhibits iron absorption. Take into account the supply of 3 g of sucrose per ampoule in the daily food intake. Prevention of deficiency in infants is based upon diversified food intake. INFORM YOUR PHYSICIAN OR YOUR PHARMACIST SYSTEMATICALLY ABOUT ALL CURRENT TREATMENT.
ALWAYS KEEP OUT OF REACH OF CHILDREN. |
Total pyrexial disease. |
| Dosage and method of use: |
Side effects: |
Oral route, ampoules are drunk after dilution in sweetened water or not, or in any other soft drink. Take preferably the ampoule before meals but sometimes the time of the intake and the dosage must be adapted in accordance with digestive tolerance.
• Curative treatment: • in adults: 100 to 200 mg of metal iron per day that is to say 2 to 4 ampoules of TOT’HEMA® • In infants over 1 month and children: 5 to 10 mg of metal iron per kg and per day.
• Preventive treatment: pregnant women: 50 mg of metal iron per day that is to say 1 ampoule of TOT’HEMA® during the last two quarters of pregnancy (or from the 4th month).
• Duration of treatment: it must be sufficient to correct anaemia and to restore iron reserves which, in the adult are 600 mg in the woman and 1 200 mg in the man. Anaemia due to iron deficiency: 3 to 6 months depending on the depletion of reserves, but may be prolonged further if the cause of anaemia is not controlled. The control of efficacy is only useful after at least 3 months of treatment: it should consist of determining the correction of anaemia (Hb, MCV) and the restoration of iron stores (seric iron and transferrin saturation). Respect strictly the duration of treatment.
IN ALL CASES FOLLOW STRICTLY THE PHYSICIAN’S PRESCRIPTION. |
Normal coloration of stools in black – digestive symptoms : gastric burns, nausea, constipation, diarrhoea. |
| Presentation: |
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DO NOT EXCEED THE LIMIT DATE OF USE INDICATED ON THE PACKING.
Date of revision of the leaflet: February 1998 |
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