MAGNESIUM SULFATE KALCEKS 50 %

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

MAGNESIUM SULFATE HEPTAHYDRATE

Saatavilla:

A.L. MEDI-MARKET LTD.

ATC-koodi:

A12CC02

Lääkemuoto:

SOLUTION FOR INJECTION / CONCENTRATE FOR SOLUTION FOR INJ/INF

Koostumus:

MAGNESIUM SULFATE HEPTAHYDRATE 500 MG / 1 ML

Antoreitti:

I.M, I.V

Prescription tyyppi:

Required

Valmistaja:

HBM PHARMA S.R.O., SLOVAKIA

Terapeuttinen alue:

MAGNESIUM SULFATE

Käyttöaiheet:

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

Valtuutus päivämäärä:

2020-10-20

Valmisteyhteenveto

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