Glicophos

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

GLYCOPHOS, 216 mg/ml, concentrate for solution for infusion

Sodium glycerophosphate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is GLYCOPHOS and what is it 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 is GLYCOPHOS and what is it used for

GLYCOPHOS is a medicine that contains glycerophosphate, which is important for fat metabolism in the body.
The medicine is administered by intravenous infusion.

Indications for use:

GLYCOPHOS is indicated for use in adult patients and infants as a supplement to 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 any of the other ingredients of this medicine (listed in section 6);
• if the patient is dehydrated (has lost a lot of fluids or blood);
• if the patient has hypernatremia (elevated sodium levels in the blood);
• if the patient has hyperphosphatemia (elevated phosphate levels in the blood);
• if the patient has severe renal failure;
• if the patient is in shock (a life-threatening condition caused by sudden lack of oxygen in the body).

Warnings and precautions

Before starting to use GLYCOPHOS, discuss it with your doctor or nurse.

• The medicine should be administered with caution if the patient has kidney function disorders.
• In patients using GLYCOPHOS, the doctor will order regular blood phosphate level tests. Page 1 5

GLYCOPHOS and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to use.
No interaction between GLYCOPHOS and other medicines has been found, but when used concurrently with carbohydrates (sugars), a decrease in blood phosphate levels may be observed.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The doctor will decide whether to use GLYCOPHOS in pregnant or breastfeeding women.

Driving and using machines

GLYCOPHOS has no effect on the ability to drive and use machines.

GLYCOPHOS contains sodium

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

3. How to use GLYCOPHOS

This medicine is administered only by medical personnel. The medicine must not be used by itself.
In case of doubts, consult a doctor.
The dosage is determined by the doctor individually for each patient, depending on age, body weight, and phosphate requirements.
The duration of intravenous infusion should not be less than 8 hours.

Using a higher dose of GLYCOPHOS than recommended

In case of using a higher dose of the medicine than recommended, tell your doctor or nurse immediately.
No symptoms of overdose have been found.
In case of any further doubts about using this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, GLYCOPHOS can cause side effects, although not everybody gets them.
No side effects due to glycerophosphate have been found.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 (22) 49 21 301, fax: +48 (22) 49 21 309, website: https://smz.ezdrowie.gov.pl
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Reporting side effects will help gather more information on the safety of the medicine.

5. How to store GLYCOPHOS

Store the medicine out of sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not store unused contents of an opened vial or ampoule for further use.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What GLYCOPHOS contains

• The active substance of the medicine is sodium glycerophosphate.

1 ml of the medicine contains:
216 mg of sodium glycerophosphate in the form of 306.1 mg of hydrated sodium glycerophosphate, equivalent to 1 mmol of phosphate and 2 mmol of sodium.

• The other excipients are: hydrochloric acid, water for injections.

The osmolality of the medicine is 2760 mOsm/kg of water, pH 7.4.

What GLYCOPHOS looks like and what the pack contains

The medicine is a concentrate for solution for infusion.
Pack sizes:

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

For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Fresenius Kabi Nederland B.V., Amersfoortseweg 10 E, 3712BC Huis ter Heide, Netherlands

Manufacturer:

Fresenius Kabi Norge AS, P.O. Box 430, N-1753 Halden, Norway

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Netherlands, country of export, authorization number: RVG 16431
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Parallel import authorization number: 237/22 Date of leaflet approval: 01.06.2022

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Information intended for healthcare professionals only:

Dosage and administration

GLYCOPHOS must not be administered undiluted.
Dosage
Adult patients:
Individual dosing is recommended.
The recommended daily dose of phosphates during parenteral nutrition is usually 10 to 20 mmol.
This can be achieved by using 10 to 20 ml of GLYCOPHOS added to the infusion solution or nutrient mixture, whose compatibility has been confirmed.
Infants:
Individual dosing is recommended.
The recommended dose for infants and newborns is 1.0 to 1.5 mmol/kg body weight/day.
Administration route
Intravenous infusion.
The duration of the infusion should not be less than 8 hours.

Overdose

No side effects due to overdose have been found. Most patients requiring parenteral nutrition show increased ability to absorb glycerophosphate. See also section 4.3 of the Summary of Product Characteristics.

Preparation of the medicine for use

Other medicines should be added under aseptic conditions.

Incompatibilities

GLYCOPHOS can be added or mixed only with medicines whose compatibility has been established.
Added medicines
Up to 1000 ml of Vamin 14 Electrolyte-Free, Vamin 18 Electrolyte-Free, or Vaminolact, no more than 120 ml of GLYCOPHOS and 48 mmol of calcium (in the form of CaCl2) can be added.
Up to 1000 ml of glucose 50 mg/ml, no more than 10 ml of GLYCOPHOS and 10 mmol of calcium (in the form of CaCl2) can be added.
Up to 1000 ml of glucose 200 mg/ml, no more than 20 ml of GLYCOPHOS and 20 mmol of calcium (in the form of CaCl2) can be added.
Up to 1000 ml of glucose 500 mg/ml, no more than 60 ml of GLYCOPHOS and 24 mmol of calcium (in the form of CaCl2) can be added.
Stability
When adding other medicines to the infusion solution, the infusion should be completed within 24 hours of preparation; this will prevent microbial contamination.
Do not store unused contents of an opened vial or ampoule for further use.
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Storage conditions

Do not store above 25°C. Do not freeze.

Disposal of unused medicine

Any unused medicine or waste should be disposed of in accordance with local regulations.
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