País: Israel
Língua: inglês
Origem: Ministry of Health
MAGNESIUM SULFATE HEPTAHYDRATE
A.L. MEDI-MARKET LTD.
A12CC02
SOLUTION FOR INJECTION / CONCENTRATE FOR SOLUTION FOR INJ/INF
MAGNESIUM SULFATE HEPTAHYDRATE 500 MG / 1 ML
I.M, I.V
Required
HBM PHARMA S.R.O., SLOVAKIA
MAGNESIUM SULFATE
Magnesium Sulfate Kalceks 50% solution for injection or infusion is indicated for: the treatment of Magnesium deficiency in hypomagnesaemiathe prevention and treatment of hypomagnesaemia in patients receiving total parenteral nutritionthe control and prevention of seizures in severe pre-eclampsiathe control and prevention of recurrent seizures in eclampsia
2020-10-20
1. NAME OF THE MEDICINAL PRODUCT Magnesium Sulfate Kalceks 50% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1mL contains 500 mg magnesium sulfate heptahydrate (2 mmol =49 mg or 4 mEq) magnesium ( Mg2+) . Each 2 ml ampoule contains 1 g magnesium sulfate heptahydrate. Each 10 ml ampoule contains 5 g magnesium sulfate heptahydrtae. 1g of magnesium sulfate heptahydrate provides 4 mmol (8.1 mEq) of elemental magnesium ( Mg2+) . The concentrations of magnesium ions (Mg 2+ ) in millimoles are given as approximate values. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or infusion, with a pH of between 5.5 and 7. Clear colourless solution, free from visible particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Magnesium Sulfate Kalceks 50% 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 Kalceks 50% 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 8.1 mEq or 4 mmol Mg_ _2+_ _. _ _ _ _TREATMENT OF MAGNESIUM DEFICIENCY IN HYPOMAGNESAEMIA _ Adults: _Intravenous Route: _ Up to 80 mL Magnesium sulfate Kalceks 50% (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 Magn Leia o documento completo