MAGNASPARTATE Powder for oral solution Ref.[7306] Active ingredients: Magnesium aspartate

Posology

Adults (>18 years)

1-2 sachets daily (243-486 mg magnesium or 10-20 mmol magnesium)

Children and adolescents: 10 to 18 years

1 sachet daily, (243 mg magnesium or 10 mmol magnesium)

Children: 4-10 years

One level 5ml spoon daily (109 mg magnesium) or One sachet daily (243 mg magnesium).

Children: 2 to 4 years

One level 5ml spoon daily. (109 mg magnesium or 4.5mmol magnesium)

The safety and efficacy of Magnaspartate in children below 2 years has not been established

Renal patients

Magnaspartate 243 mg is contraindicated in patients with severe renal impairment (see section 4.3).

There is no dose adjustment necessary in patients with mild to moderate renal impairment.

Elderly

No dose adjustment is necessary.

Method of administration

For oral use after solution in water, tea or orange juice.

Magnaspartate can be dissolved in 50-200mL water, tea or orange juice.

Stir until the solution in water is cloudy to transparent. In orange juice or tea inactive particles will be visible. The solution should be taken immediately after being prepared.

Discard any remaining content of the sachet.

Note: If necessary, Magnaspartate in 200ml water can be administered via a gastric, duodenal, and nasal feeding tube. This should be administered immediately after preparation.

In the case of intact renal function, magnesium toxication due to oral overdose of magnesium is not expected. Only in the case of severe renal insufficiency a cumulation of magnesium may arise in combination with a manifested intoxication.

In general, plasma concentrations up to 2 mmol/l are well tolerated.

Intoxication symptoms:

• Blood pressure fall, nausea, vomiting, hyporeflexia, somnolence, changes in the electrocardiogram, respiratory depression and cardiac arrest.

Intoxication therapy:

• Intravenous administration of calcium and slow intravenous administration of 0.5–2 mg neostigmine methylsulfate;
• Intravenous and per-oral administration of isotonic sodium chloride solution; ventilatory and circulatory support;
• In case of renal insufficiency: haemodialysis.

Shelf life: 3 years.

Use immediately following reconstitution.

Do not store above 25°C.

Sachets.

Laminated foil (Paper/Aluminium/Polyethylene).

10 sachets.

No special requirements.