GLYCOPHOS

Land: Indonesië

Taal: Indonesisch

Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Werkstoffen:

SODIUM GLYCEROPHOSPHATE HYDRATED

Beschikbaar vanaf:

FRESENIUS KABI COMBIPHAR - Indonesia

INN (Algemene Internationale Benaming):

SODIUM GLYCEROPHOSPHATE HYDRATED

farmaceutische vorm:

INFUS

Eenheden in pakket:

DUS, 20 AMPUL @ 20 ML

Geproduceerd door:

FRESENIUS KABI NORGE AS - Norway

Autorisatie datum:

2019-12-22

Productkenmerken

GLYCOPHOS
TM
Concentrate for solution for infusion
DESCRIPTION
Glycophos is a sterile concentrate for solution containing sodium
glycerophosphate for
addition to infusion solutions.
COMPOSITION
The active substance is sodium glycerophosphate hydrated corresponding
to 216 mg sodium
glycerophopshate anhydrous.
Osmolality: 2760 mosm/kg water.
The active ingredients in 1 ml of Glycophos corresponds to 1 mmol of
phosphate and 2 mmol
of sodium.
INDICATIONS
Glycophos is indicated in adult patients and infants as a supplement
in intravenous nutrition
to meet the requirement of phosphate.
CONTRAINDICATIONS
•
state of dehydration,
•
hypernatraemia,
•
hyperphosphataemia,
•
severe renal insufficiency,
•
shock.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Glycophos should be used with caution in patients with impaired renal
function. The
phosphate status of all patients should be monitored regularly.
Glycophos must not be given
undiluted.
INTERACTIONS
No interactions with other drugs have been observed, but a moderate
fall in serum phosphate
can be seen during carbohydrate infusions.
PREGNANCY AND LACTATION
Animal reproduction studies or clinical investigations during
pregnancy have not been carried
out with Glycophos. However, the requirements of phosphate in a
pregnant woman are
slightly increased compared to non-pregnant women.
No adverse events are to be expected when Glycophos is administered
during pregnancy.
PHARMACODYNAMIC PROPERTIES
Glycerophosphate is a metabolic intermediate in fat metabolism and any
pharmacodynamic
effects other than maintaining the normal metabolic pathways are
unlikely.
Disetujui oleh BPOM: 03/12/2019
ID: EREG10024311800009
PHARMACOKINETIC PROPERTIES
To become available it is necessary for the phosphate group to be
hydrolysed from the
glycerophosphate molecule. The hydrolysis occurs maximally at a plasma
concentration of
>0.7 mmol/l. Assuming that all hydrolysis of glycerophosphate takes
place in plasma, about
12-15 mmol of sodium glycerophosphate will be hydrolysed each day in
individuals