Sodium Glycerophosphate 21.6 % concentrate for solution for infusion

Sodium Glycerophosphate 21.6 % is indicated in adult patients as a supplement in intravenous nutrition to meet the requirements of phosphate.

Posology

Adults

The recommended dosage is individual.

Maximum daily dose:

The recommended daily dosage of phosphate during intravenous nutrition would normally be 10-20 mmol.

This can be met by using 10-20 ml of Sodium Glycerophosphate 21.6 % added to the infusion solution or to the admixture for which compatibility has been proved.

Infusion rate:

The infusion rate of the diluted product is mainly determined by the infusion of the parenteral nutrition regime (Sodium Glycerophosphate 21.6 % is added to) and infusion time should generally not be less than 8 hours.

Method of administration

Intravenous use

Only to be administered by infusion after dilution in suitable infusion solutions.

For instructions on dilution of the medicinal product before administration, see section 6.6.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Sodium Glycerophosphate 21.6 % must not be administered to patients in states of
● dehydration
● hypernatraemia
● hyperphosphataemia
● severe renal insufficiency
● shock

Sodium Glycerophosphate 21.6 % should only be administered with caution in patients with:
● impaired renal function
The phosphate status of all patients should be monitored regularly.

Sodium Glycerophosphate 21.6 % must not be given undiluted.

No interactions with other drugs have been observed, but a moderate fall in serum phosphate can be seen during carbohydrate infusions.

Pregnancy

Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Sodium Glycerophosphate 21.6 %. 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 Sodium Glycerophosphate 21.6 % is administered during pregnancy.

Sodium Glycerophosphate 21.6 % can be used as indicated during pregnancy if clinically needed and under careful monitoring.

Lactation

At therapeutic doses of Sodium Glycerophosphate 21.6 % no effects on the breastfed newborns/infants are anticipated. Sodium Glycerophosphate 21.6 % concentrate for solution for infusion can be used during breast-feeding, if required.

Fertility

No data available

Sodium Glycerophosphate 21.6 % has no or negligible influence on the ability to drive and use machines.

None known if used according to the instructions given.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Pay or Apple App Store

No adverse effects of an overdose have been reported. Most patients in need of intravenous nutrition have an increased capacity to handle glycerophosphate. See also 4.3 “Contraindications”.

Pharmacotherapeutic group: Sodium Glycerophosphate

ATC code: B05X A14

Glycerophosphate is a metabolic intermediate in fat metabolism and any pharmacodynamic effects other than maintaining the normal metabolic pathways are unlikely.

Absorption

As the solution is administered by intravenous infusion the bioavailability of the solution is 100 %.

Distribution

Intravenously administered phosphate is not taken up by the tissue.

Biotransformation

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.

Elimination

Phosphate is excreted almost entirely in the urine.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

Phosphoric acid, concentrated

Water for injections

Sodium Glycerophosphate 21.6 % may only be added to or mixed with other medicinal products for which compatibility has been documented.

Unopened

3 years

After first opening

The product should be used immediately after opening the container

After dilution

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ° C, unless dilution has taken place in controlled and validated aseptic conditions.

Do not store above 30 °C. Do not freeze.

For storage conditions after dilution of the medicinal product, see section 6.3.

The product is supplied in

● polyethylene bottles,
 containing: 500 ml

 available in packs of 1 × 500 ml, 10 × 500 ml

Not all pack sizes may be marketed.

500 ml containers are bulk source containers used in automated parenteral compounding systems in the pharmacy and must not be used for direct intravenous infusion. Not for manual dispensing.

Discard container and any unused content after use.

Do not use if the solution is not clear, colourless or the container or its closure show visible signs of damage.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

No additions should be made to the product.