Glycophos

Glycophos

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Sodium glycerophosphate.
Description
1 mL solution contains Sodium glycerophosphate pentahydrate 306.1 mg (corresponds to sodium glycerophosphate 216 mg).
Glycophos contains 1 mmol glycerophosphate and 2 mmol sodium per mL.
Osmolality: 2800 mOsm per kg water.
pH: 7.4.
Excipients/Inactive Ingredients: Hydrochloric acid, water for injection solution.
Action
Pharmacotherapeutic group: Electrolyte solution, ATC code: B05XA14.
Pharmacology: Pharmacodynamics: Glycophos is a concentrated additive solution of phosphate and sodium.
Glycerophosphate is a metabolic intermediate in fat metabolism and any pharmacodynamic effects other than maintaining the normal metabolic pathways are unlikely.
Pharmacokinetics: 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 with normal serum alkaline phosphatase.
No pharmacokinetic data is available for neonates. However, hyperphosphatemia is unlikely at the recommended dosage.
Indications/Uses
Meets phosphate needs of adults and children when receiving intravenous nutrition.
Dosage/Direction for Use
Dosage is individual. Must be diluted.
The infusion duration should be at least 8 hours.
Adults: The daily phosphate need of adults receiving intravenous nutrition is normally 10-30 mmol. The phosphate need can normally be covered with 10-20 ml Glycophos.
Children: The recommended dose for children and neonates is 1.0–1.5 mmol per kg of bodyweight per day.
Contraindications
Severe renal insufficiency, shock and dehydration.
Special Precautions
Glycophos should be used with caution in patients with impaired renal function.
The phosphate status of all patients should be monitored regularly.
Effects on Ability to Drive and Use Machines: None known.
Use In Pregnancy & Lactation
Pregnancy: No adverse risks to the foetus are expected when Glycophos is administered at the recommended dosage.
Lactation: No adverse effects are expected for a nursing child.
Adverse Reactions
No known side effects.
Caution For Usage
Compatibility: Glycophos may only be mixed with other medicinal products for which compatibility has been documented. See "Special precautions for use, disposal and other handling" as follows.
Special Precautions for Use, Disposal and Other Handling: Additions must be made aseptically.
Compatibility: Up to 120 mmol glycerophosphate (as sodium glycerophosphate) and 48 mmol calcium (as CaCl2) can be added to 1000 mL Vamin Glucose, Vamin 14 gN/l, Vamin 14 g N/l electrolyte free or Vamin 18 g N/l electrolyte free.
Up to 10 mmol glycerophosphate and 10 mmol calcium (as CaCl2) can be added to 1000 mL Glucose 50 mg/mL, 20 mmol glycerophosphate and 20 mmol calcium can be added to 1000 mL Glucose 200 mg/mL and up to 60 mmol glycerophosphate and 24 mmol calcium to 1000 mL Glucose 500 mg/mL.
Compatibility data and data on physical stability for a number of mixtures, for addition to phthalate-free bag and for addition to TPN solutions is available upon request from the manufacturer.
Storage
No special precautions.
Shelf life:
3 years.
The mixture must be used immediately after preparation due to the risk of microbial contamination arising from additions to the infusion solution on the ward. Any excess solution in an opened package must be discarded, and must not be saved for later use.
MIMS Class
Parenteral Nutritional Products
ATC Classification
B05XA14 - sodium glycerophosphate ; Belongs to the class of electrolyte solutions used in I.V. solutions.
Presentation/Packing
Form
Glycophos conc for soln for infusion 216 mg/20 mL
Packing/Price
20 mL x 20 × 1's
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