Glycophos

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Glycophos, 216 mg/ml, concentrate for solution for infusion
Natrii glycerophosphas
Please read all of this leaflet carefully before using this medicine because it contains
important information for the patient.

• Keep this leaflet to re-read it if necessary.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Glycophos is and what it is used for
2. Important information before using Glycophos
3. How to use Glycophos
4. Possible side effects
5. How to store Glycophos
6. Contents of the pack and other information

1. What Glycophos is and what it is used for

Glycophos is a medicine containing glycerophosphate, which plays an important role in fat metabolism in the body.
The medicine is administered by intravenous infusion.
Indications:
Glycophos is indicated for use in adult patients and infants as a supplement to meet phosphate requirements in parenteral nutrition.

2. Important information before using Glycophos

When not to use Glycophos
Do not use the medicine:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is dehydrated (has lost a large amount of fluids or blood);
• if the patient has hypernatraemia (increased sodium levels in the blood);
• if the patient has hyperphosphataemia (increased phosphate levels in the blood);
• if the patient has severe renal impairment;
• if the patient is in shock (a life-threatening condition caused by sudden lack of oxygen in the body).

Warnings and precautions
Before starting treatment with Glycophos, discuss this with a doctor or nurse.

• The medicine should be administered with caution in patients with impaired kidney function.
• In patients receiving Glycophos, the doctor will order regular monitoring of blood phosphate levels.

Glycophos and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
No interactions between Glycophos and other medicines have been reported. However, when used concomitantly with carbohydrates (sugars), a decrease in blood phosphate levels may be observed.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The doctor will decide whether Glycophos should be used during pregnancy and while breastfeeding.

Driving and operating machinery
Glycophos has no influence on the ability to drive or operate machinery.

Glycophos contains sodium
1 ml of the medicine contains 2 mmol of sodium. This should be taken into account in patients with impaired kidney function and in patients who are controlling their dietary sodium intake.

3. How to use Glycophos

This medicine is administered only by medical personnel.
Glycophos must not be self-administered.
If in doubt, consult a doctor.
The dosage is determined individually by the doctor for each patient, depending on age, body weight, and phosphate requirements.
The duration of intravenous infusion should not be shorter than 8 hours.

Administration of a higher than recommended dose of Glycophos
If a higher than recommended dose is administered, inform the doctor or nurse immediately.
Symptoms of overdose have not been observed.
If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody experiences them.
No adverse reactions due to the use of glycerophosphate have been reported.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Glycophos

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
After opening, any unused contents of a vial or ampoule must be discarded and must not be stored for later use.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Glycophos contains

• The active substance in this medicinal product is glycerophosphoric acid sodium salt.

1 ml of the medicinal product contains:
216 mg of glycerophosphoric acid sodium salt in the form of 306.1 mg of hydrated glycerophosphoric acid sodium salt, which is
equivalent to 1 mmol of phosphate and 2 mmol of sodium.

• Other components are: hydrochloric acid, water for injections.

The osmolality of the medicinal product is 2760 mOsm/kg of water, pH 7.4.
What Glycophos looks like and contents of the pack
The medicinal product is a concentrate for solution for infusion.
Pack sizes:

• Polypropylene vials containing 20 ml of concentrate for solution for infusion, packed in cardboard boxes containing 10 vials.
• Polypropylene ampoules containing 20 ml of concentrate for solution for infusion, packed in cardboard boxes containing 10 or 20 ampoules.

For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Greece, the country of export:
Fresenius Kabi Hellas A.E.
L. Kifisias 64A, 151 25 Marousi, Attica, Greece
Manufacturer:
Fresenius Kabi Norge AS
Svinesundsveien 80
NO-1788 Halden, Norway
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Greece, the country of export: 61149/4-12-2007
69035/18-07-2022
Parallel import authorisation number: 77/24

Information intended exclusively for medical professionals:

Dosage and administration
Glycophos must not be administered in undiluted form.
Dosage
Adult patients:
Individualized dosing is recommended.
The usual daily dose of phosphates during parenteral nutrition generally ranges from
10 to 20 mmol. This can be achieved by adding 10 to 20 mL of Glycophos to an infusion solution
or to a nutrition mixture with confirmed compatibility.
Infants:
Individualized dosing is recommended.
The recommended dose for infants and neonates is 1.0 to 1.5 mmol/kg body weight/day.
Administration method
Intravenous infusion. The duration of infusion should not be shorter than 8 hours.
Overdose
No adverse effects related to overdose have been reported. Most patients requiring parenteral nutrition demonstrate increased capacity to utilize glycerophosphate.
Preparation of the medicinal product for administration
Other medicinal products should be added under aseptic conditions.
Pharmaceutical incompatibilities
Glycophos may only be added to or mixed with medicinal products whose compatibility has been established.
Added medicinal products
No more than 120 mL of Glycophos and 48 mmol of calcium (as CaCl) may be added to 1000 mL of Vamin 14 Electrolyte-Free, Vamin 18 Electrolyte-Free, or Vaminolact.
No more than 10 mL of Glycophos and 10 mmol of calcium (as CaCl) may be added to 1000 mL of glucose 50 mg/mL.
No more than 20 mL of Glycophos and 20 mmol of calcium (as CaCl) may be added to 1000 mL of glucose 200 mg/mL.
No more than 60 mL of Glycophos and 24 mmol of calcium (as CaCl) may be added to 1000 mL of glucose 500 mg/mL.
Stability
When additional medicinal products are introduced into the infusion solution, the infusion should be completed within 24 hours after preparation of the solution to avoid microbiological contamination.
Any unused content of an opened vial or ampoule must be discarded and must not be stored for later use.
Storage conditions
Store below 25°C. Do not freeze.
Disposal of unused medicinal product
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.