MAGNESIUM SULFATE 50 % WV INOVAMED

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

MAGNESIUM SULFATE AS HEPTAHYDRATE

Disponibil de la:

INOVAMED LTD

Codul ATC:

A12CC02

Forma farmaceutică:

SOLUTION FOR INJECTION / CONCENTRATE FOR SOLUTION FOR INJ/INF

Compoziție:

MAGNESIUM SULFATE AS HEPTAHYDRATE 500 MG / 1 ML

Calea de administrare:

I.V, I.M

Tip de prescriptie medicala:

Required

Produs de:

DEMO S.A. PHARMACEUTICAL IND., GREECE

Zonă Terapeutică:

MAGNESIUM SULFATE

Indicații terapeutice:

Magnesium Sulfate 50%w/v Inovamed is indicated for:1. the treatment of Magnesium deficiency in hypomagnesaemia. 2. the prevention and treatment of hypomagnesaemia in patients receiving total parenteral nutrition. 3. the control and prevention of seizures in severe pre-eclampsia. 4. the control and prevention of recurrent seizures in eclampsia

Data de autorizare:

2020-05-04

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
MAGNESIUM SULFATE 50%W/V INOVAMED
solution for injection or concentrate for solution for injection or
infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL ampoule contains 5 g magnesium sulfate heptahydrate
(500mg/mL).
1mL contains 2 mmol (49 mg = 4 mEq) magnesium ions.
1g of magnesium sulfate heptahydrate provides 4.1 mmol (8.2 mEq) of
elemental magnesium.
For the full list of excipients, see section 6.1
.
3. PHARMACEUTICAL FORM
Solution for injection or concentrate for solution for injection or
infusion, with a pH of between 5.5 and 7 and osmolality of
2000 mOsm/kg approximately
.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Magnesium Sulfate 50% w/v Inovamed solution is indicated for:
1) the treatment of magnesium deficiency in hypomagnesaemia.
2) the prevention and treatment of hypomagnesaemia in patients
receiving total parenteral nutrition.
3) the control and prevention of seizures in severe pre-eclampsia.
4) the control and prevention of recurrent seizures in eclampsia.
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 Mg
2+
.
_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 Mg
2+
) 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