Magnesium sulfate Kalceks 500mgml solution for injection infusion

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

MAGNESIUM SULFATE,HEPTAHYDRATE

Tilgjengelig fra:

EUCOGEN SDN BHD

INN (International Name):

MAGNESIUM SULFATE,HEPTAHYDRATE

Enheter i pakken:

10 ampoules x 10 ml

Produsert av:

HBM PHARMA S.R.O.

Preparatomtale

Font size 11 pt, as measure in Times New Roman
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Magnesium sulfate Kalceks 500 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium sulfate heptahydrate (2 mmol Mg
2+
in 1 ml).
Each 1 ml of solution contains 2 mmol Mg
2+
(equivalent to 500 mg magnesium sulfate heptahydrate).
Each 10 ml ampoule contains 20 mmol Mg
2+
(equivalent to 5 g magnesium sulfate heptahydrate).
The concentrations of magnesium ions (Mg
2+
) in millimoles are given as approximate values.
For the full list of excipients, see
_List of excipients_
.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear colourless solution, free from visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
‒
Parenteral administration of magnesium sulfate is indicated in the
treatment of acute
hypomagnesaemia.
‒
Magnesium salts are also indicated to prevent hypomagnesaemia in
patients receiving total
parenteral nutrition.
‒
Magnesium sulfate is also indicated in the prevention and treatment of
life-threatening seizures
in the treatment of toxaemias of pregnancy (pre-eclampsia and
eclampsia).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Magnesium sulfate Kalceks solution may be administered by intravenous
or intramuscular routes (see
Method of administration below).
Posology
Magnesium sulfate heptahydrate 1 g = 98.6 mg or 8.1 mEq or
approximately 4 mmol magnesium
(Mg
2+
).
Therapeutic levels are reached almost immediately with appropriate
intravenous doses and within
60 minutes following intramuscular injection.
HYPOMAGNESAEMIA
Mild hypomagnesemia (ADULT): 1 g magnesium sulfate (8 mEq) IM every 6
hours for 4 doses.
Severe hypomagnesemia (ADULT): 0.25 g/kg IM over 4 hours. Alternative
dose of 5 g may be given
by slow intravenous infusion over 3 hours.
Hypomagnesemia (CHILDREN): Must be diluted prior to administration in
children. Magnesium
sulfate Kalceks may be given by intravenous or intramuscular routes.
The dose strictly is individual