Страна: Израел
Език: английски
Източник: Ministry of Health
MAGNESIUM SULFATE AS HEPTAHYDRATE
INOVAMED LTD
A12CC02
SOLUTION FOR INJECTION / CONCENTRATE FOR SOLUTION FOR INJ/INF
MAGNESIUM SULFATE AS HEPTAHYDRATE 500 MG / 1 ML
I.V, I.M
Required
DEMO S.A. PHARMACEUTICAL IND., GREECE
MAGNESIUM SULFATE
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
2020-05-04
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 Прочетете целия документ