Posology : מינונים

4.2 Posology and method of administration
Magnesium Sulfate 50% w/v Inovamed solution may be administered by the intravenous (preferred method) or intramuscular (painful, avoid if possible) routes (see below for method of administration and section 4.4).

Posology
Dosage should be tailored according to the individual’s needs and responses and should be reduced in renal impairment.
Plasma magnesium concentrations should be measured to determine the rate and duration of infusion and should be monitored throughout therapy.
1 g Magnesium sulfate heptahydrate = 98.6 mg or 8.2 mEq or 4.1 mmol Mg2+.

Treatment of magnesium deficiency in hypomagnesaemia

Adults:
Intravenous Route:
Up to 80 mL Magnesium sulfate 50% w/v Inovamed solution (corresponding to 160 mmol ≈ 4 g Mg2+) diluted should be administered by slow intravenous infusion over a period of up to five days and titrated to clinical need. The usual regimen is 16 – 24 mL Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 32-48 mmol ≈0.8 – 1.2 g Mg2+) diluted in the first 24 hours followed by 8 – 12 mL Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 16 – 24 mmol ≈ 0.4 – 0.6 g
Mg2+) diluted per day for 3 or 4 days.

Intramuscular Route:
2 – 4 mL Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 4 – 8 mmol ≈ 0.1 – 0.2 g Mg2+) undiluted or 4 – 8 mL of Magnesium sulfate 50% w/v Inovamed solution diluted to 25% w/v solution can be given intramuscularly every 6 hours for 24 hours (a total of 4 doses).

Children and adolescents:
Neonate
0.2 mL/kg Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 0.4 mmol/kg ≈ 0.01 g/kg Mg2+) diluted to 20% w/v solution (i.e. 0.5 mL/kg of a 20% w/v solution) every 6 – 12 hours as required, to be given by intravenous injection over at least 10 minutes.
Child 1 month – 11 years
0.1 mL/kg Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 0.2 mmol/kg ≈ 0.005 g/kg Mg2+) diluted to 20% w/v solution (i.e. 0.25 mL/kg of a 20% w/v solution) every 12 hours as required, to be given by intravenous injection over at least 10 minutes.
Adolescent 12 – 17 years
2 mL Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 4 mmol ≈ 0.1 g Mg2+) diluted to 20% w/v solution
(i.e. 5 mL of a 20% w/v solution) every 12 hours as required, to be given by intravenous injection over at least 10 minutes.

Elderly:
There are no specific recommendations for dosage in elderly adults. Magnesium Sulfate 50% w/v Inovamed solution should be used with caution in elderly because of often renal impairment in this age group.

Prevention of hypomagnesaemia in patients receiving total parenteral nutrition 
Adults:
5 – 10 mL Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 10 – 20 mmol ≈ 0.25 – 0.5 g Mg2+) diluted daily, usual dose 6 mL Magnesium sulfate 50% w/v Inovamed solution (corresponding to 12 mmol ≈ 0.3 g Mg2+) diluted daily, by intravenous infusion or intramuscular injection.

Neonates and infants (up to 12 months):
0.1 mL/kg Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 0.2 mmol/kg ≈ 0.005 g/kg Mg2+) diluted daily by intravenous infusion.

Children (1 – 13 years) and adolescents (14 – 18 years):
0.05 mL/kg Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 0.1 mmol/kg ≈ 0.0025 g/kg Mg2+) diluted daily by intravenous infusion.

Control and prevention of recurrent seizures in severe pre-eclampsia and eclampsia 
Adult women:
Loading dose: An initial IV loading dose of approximately 8 – 10 mL Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 16 – 20 mmol ≈ 0.4 – 0.5 g Mg2+) diluted to an appropriate volume is administered over 5 – 15 minutes, followed either by maintenance intravenous infusion or regular IM injections for 24 hours, as follows: 
IV Maintenance Regimen
The IV loading dose (above) is followed by an infusion of approximately 2 mL Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 4 mmol ≈ 0.1 g Mg2+) diluted per hour for at least 24 hours after the last fit.

IM Maintenance Regimen
The IV loading dose (above) is immediately followed by deep IM injection of 10 mL Magnesium sulfate 50% w/v Inovamed solution (corresponding to 20 mmol ≈ 0.5 g Mg2+) undiluted.

Maintenance therapy is a further 10 mL Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 20 mmol ≈ 0.5 g Mg2+) undiluted IM every four hours, continued for 24 hours after the last fit (provided respiratory rate is > 16/min, urine output > 25mL/min and knee jerks are present).

Recurrent convulsions: In both IV and IM regimens, a further 4 – 8 mL Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 8 – 16 mmol ≈ 0.2 – 0.4 g Mg2+) diluted depending on body weight [if less than 70 kg 4 mL Magnesium sulfate 50% w/v Inovamed solution (corresponding to 8 mmol ≈0.2 g Mg2+) diluted] are given IV over a period of 5 minutes.

Renal impairment
Magnesium Sulfate 50% w/v Inovamed solution is contraindicated in patients with severe renal impairment (see section 4.3) Magnesium Sulfate 50% w/v Inovamed solution should be used with caution in mild to moderate renal impairment. A reduction in dosage to 40 mL Magnesium Sulfate 50% w/v Inovamed solution (corresponding to 80 mmol ≈ 2 g Mg2+) diluted over 48 hours may be given.

Patients with impaired liver function
There are no recommended special dosage instructions for patients with impaired liver function because of insufficient data.

Method of administration
Intravenous use in adults and adolescents
Intravenous infusion:
For the intravenous route, the 50% w/v solution requires dilution to a concentration of not more than 20% (≤ 200 mg/mL magnesium sulfate heptahydrate) – with a suitable diluent, such as Glucose 5% or sodium chloride 0.9%. Infuse via a volumetric infusion device at a rate appropriate to the indication (see posology above).

Intravenous injection:
Give by slow IV injection at a rate appropriate to the indication (see posology above).

Intravenous use in children:
Rate of administration should not exceed 0.02 mL/kg/min of appropriately diluted Magnesium sulfate 50% w/v Inovamed solution (corresponding to 0.04 mmol/kg/min ≈ 0.001 g/kg/min Mg2+).

Deep Intramuscular injection (adults only)
For the intramuscular route, the 50% w/v solution should be used undiluted or diluted to 25% w/v. If the total dose to be administered exceeds 5 mL, the injection volume should be divided between more than one deep muscular injection site.