Country: Indonesia
Language: Indonesian
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SODIUM GLYCEROPHOSPHATE HYDRATED
FRESENIUS KABI COMBIPHAR - Indonesia
SODIUM GLYCEROPHOSPHATE HYDRATED
INFUS
DUS, 1 AMPUL @ 20 ML
FRESENIUS KABI NORGE AS - Norway
2021-02-16
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 Read the complete document