MAGNESIUM SULFATE KALCEKS 50 %

देश: इसराइल

भाषा: अंग्रेज़ी

स्रोत: Ministry of Health

सक्रिय संघटक:

MAGNESIUM SULFATE HEPTAHYDRATE

थमां उपलब्ध:

A.L. MEDI-MARKET LTD.

ए.टी.सी कोड:

A12CC02

फार्मास्यूटिकल फॉर्म:

SOLUTION FOR INJECTION / CONCENTRATE FOR SOLUTION FOR INJ/INF

रचना:

MAGNESIUM SULFATE HEPTAHYDRATE 500 MG / 1 ML

प्रशासन का मार्ग:

I.M, I.V

प्रिस्क्रिप्शन प्रकार:

Required

द्वारा बनाया गया:

HBM PHARMA S.R.O., SLOVAKIA

चिकित्सीय क्षेत्र:

MAGNESIUM SULFATE

चिकित्सीय संकेत:

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

प्राधिकरण की तारीख:

2020-10-20

उत्पाद विशेषताएं

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