Magnesium sulfate Kalceks 500mgml solution for injection infusion

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

MAGNESIUM SULFATE,HEPTAHYDRATE

Disponible depuis:

EUCOGEN SDN BHD

DCI (Dénomination commune internationale):

MAGNESIUM SULFATE,HEPTAHYDRATE

Unités en paquet:

10 ampoules x 10 ml

Fabriqué par:

HBM PHARMA S.R.O.

Résumé des caractéristiques du produit

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