LAVOISIER MAGNESIUM CHLORIDE 10 % (1 g/10 ml) S inj in ampoule IV 10Ampoule/10ml

Magnesium chloride hexahydrate ........................................................................................ 1,00 g

Corresponding quantity of elemental magnesium ..................................................................... 0,12 g

For one ampoule.

Elemental magnesium: 492 mmol/L, i.e. 12 g/L

Total osmolarity of the solution: 1476 mOsm/L

• Curative treatment of torsades de pointes

• Treatment of acute hypokalaemia associated with hypomagnesaemia

• Magnesium supply during hydroelectrolytic rebalancing

• Magnesium supply in parenteral nutrition

• Preventive and curative treatment of eclamptic seizures.

Dosage

Curative treatment of torsades de pointes

Intravenous bolus of 8 mmol of magnesium cation, i.e. 1,6 g of magnesium chloride, by slow intravenous injection, followed by a continuous infusion of 0,012 to 0,08 mmol of magnesium cation per minute, i.e. 2,5 to 16,5 mg/minute of magnesium chloride.

Treatment of acute hypokalaemia associated with hypomagnesaemia

Intravenous infusion of 24 to 32 mmol of magnesium cation per day, i.e. 5 to 6,5 g of magnesium chloride every 24 hours, with potassium as a supplement.

The supplemental potassium will be administered in a container separate from that of the magnesium.

Treatment will be discontinued once magnesaemia is normalised.

Magnesium supply during hydro-electrolytic rebalancing and parenteral nutrition

Intravenous infusion of 6 to 8 mmol of magnesium cation every 24 hours, i.e. 1,2 to 1,6 g of magnesium chloride.

In children, the usual dosage is 0,1 to 0,3 mmol/kg of magnesium cation, i.e. 20 to 60 mg/kg of magnesium chloride every 24 hours.

Preventive and curative treatment of eclamptic seizures

Slow intravenous route.

To prevent an eclamptic seizure or when one occurs, administer an intravenous infusion of 16 mmol of magnesium cation, i.e. 3,5 g of magnesium chloride, over 20 to 30 minutes.

If the seizure persists, administer again an intravenous infusion of 16 mmol of magnesium cation, i.e. 3,5 g of magnesium chloride, without exceeding the maximum cumulative dose of 32 mmol of magnesium cation, i.e. 6,5 g of magnesium chloride during the first hour of treatment.

Thereafter, continuous infusion of 8 to 12 mmol of magnesium cation, i.e. 1,5 to 2 g of magnesium chloride per hour, for the 24 hours following the last seizure.

As a general rule in adults, to avoid potentially lethal hypermagnesaemia, the intravenous infusion must never exceed 120 mg/minute, i.e. 0,6 mmol/minute.

Method of administration

The magnesium chloride solution must be administered:

• as a slow intravenous injection in a supine subject, direct intravenous (bolus) injection being reserved for the treatment of torsades de pointes and to be performed in a specialised setting,

• diluted in a glucose or saline solution.

This medicine must never be prescribed in cases of severe renal insufficiency (creatinine clearance below 30 ml/min/1, 73 m2).

HYPERTONIC SOLUTION TO BE INJECTED SLOWLY.

• The first intravenous administrations are to be carried out in a hospital setting.

• Comply with an infusion rate not exceeding 0.6 mmol of magnesium cation per minute, i.e. 120 mg/min of magnesium chloride.

• Monitoring of blood pressure during intravenous injection and continuous infusion.

• Monitoring of magnesaemia; interrupt treatment once it has normalised.

• Reduce the dosage in renally impaired patients, with increased monitoring of renal function, blood pressure and magnesaemia.

• Do not administer concomitantly with a calcium salt (antagonistic effect).

Combinations not recommended

+ Quinidine-type agents

Increased plasma levels of quinidine and risk of overdose (decreased renal excretion of quinidine due to urinary alkalinisation).

Associations requiring precautions for use

+ Curarising agents

Possible prolongation of neuromuscular blockade.

Pregnancy

In clinical use, the use of magnesium during a limited number of pregnancies has apparently not revealed any particular malformative or foetotoxic effect to date.

However, additional studies are needed to assess the consequences of exposure during pregnancy.

Consequently, the use of magnesium should be considered during pregnancy only if necessary.

Breast-feeding

Due to the passage of magnesium into breast milk, avoid breastfeeding during treatment.

• Pain at the injection site, vasodilation with a sensation of warmth,

• Potentially lethal hypermagnesaemia in cases of severe renal insufficiency or too rapid injection.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

The first signs of hypermagnesaemia are inhibition of the patellar reflexes, a feeling of warmth, drowsiness, speech disorders, muscular paralysis with respiratory difficulties and, at the extreme, respiratory and cardiac arrest.

Treatment:

• rehydration, forced diuresis, assisted ventilation;

• IV injection of 1 g of calcium gluconate;

• haemodialysis or peritoneal dialysis in case of renal failure.

Pharmacotherapeutic class: Magnesium salt solutions (B05CB)

(B: blood and blood-forming organs)

Physiological aspects

Magnesium is a predominantly intracellular cation. It decreases neuronal excitability and neuromuscular transmission and is involved in numerous enzymatic reactions.

As a constituent element, half of the body's magnesium store is in the bones.

Clinically, a serum magnesium level:

• between 12 and 17 mg/L (1 to 1,4 mEq/L or 0,5 to 0,7 mmol/L), indicates a moderate magnesium deficiency;

• below 12 mg/L (1 mEq/L or 0,5 mmol/L), indicates a severe magnesium deficiency.

Magnesium deficiency may be:

• primary due to a congenital metabolic abnormality (chronic congenital hypomagnesaemia),

• secondary to:

• insufficient intake (severe malnutrition, alcoholism, exclusive parenteral nutrition),
• digestive malabsorption (chronic diarrhoea, digestive fistulas, hypoparathyroidism),
• excessive renal losses (tubulopathies, significant polyuria, diuretic misuse, chronic pyelonephritis, primary hyperaldosteronism, treatment with cisplatin).

Excretion is mainly urinary.

Magnesium chloride solution may precipitate when mixed with solutions containing:

• high-concentration alcohol,

• carbonates, bicarbonates, alkali hydroxides,

• calcium salts,

• tartrates, salicylates,

• procaine,

• clindamycin phosphate,

• hydrocortisone sodium succinate.

Glass and polypropylene ampoule: 3 years.

After opening: the product must be used immediately.

This medicinal product does not require any special storage precautions before opening.

For storage conditions of the medicinal product after reconstitution, dilution or first opening, see section Shelf life.

No special requirements.