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 Medicinal Product

You should carefully read the leaflet before using the medicinal product, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicinal product has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 medicinal product containing glycerophosphate, which plays an essential role in fat metabolism in the body.
The medicinal product 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 medicinal product:

• if you are allergic to the active substance or to any of the other ingredients of this medicinal product (listed in section 6);
• if you are dehydrated (have lost a lot of fluids or blood);
• if you have hypernatremia (elevated sodium levels in the blood);
• if you have hyperphosphatemia (elevated phosphate levels in the blood);
• if you have severe renal failure;
• if you are in shock (a life-threatening condition caused by sudden lack of oxygen in the body).

Warnings and Precautions

Before starting treatment with Glycophos, you should discuss it with your doctor or nurse.

• The medicinal product should be administered with caution if you have kidney function disorders.
• In patients treated with Glycophos, the doctor will order regular monitoring of phosphate levels in the blood.

Glycophos and Other Medicinal Products

You should tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, as well as any medicinal products you plan to use.
No interactions have been found between Glycophos and other medicinal products. However, when used concomitantly with carbohydrates (sugars), a decrease in phosphate levels in the blood may be observed.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicinal product.
Your 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 medicinal product contains 2 mmol of sodium. This should be taken into account in patients with reduced kidney function and in patients on a controlled sodium diet.

3. How to Use Glycophos

This medicinal product is administered only by medical personnel. You should not use it on your own.
In case of doubts, you should consult your 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 less than 8 hours.

Using More Than the Recommended Dose of Glycophos

In case of using a higher dose than recommended, you should immediately tell your doctor or nurse.
No symptoms of overdose have been found.
In case of any further doubts related to the use of this medicinal product, you should consult your doctor or nurse.

4. Possible Side Effects

Like all medicinal products, Glycophos can cause side effects, although not everybody gets them.
No side effects have been found related to the use of glycerophosphate.

Reporting Side Effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance, 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.
Reporting side effects will help gather more information on the safety of the medicinal product.

5. How to Store Glycophos

The medicinal product should be stored out of sight and reach of children.
Do not store above 25°C. Do not freeze.
Any unused contents of an opened ampoule should be discarded, and not stored for further use.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicinal products should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicinal products that are 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 medicinal product is sodium glycerophosphate. 1 ml of the medicinal product contains: 216 mg of sodium glycerophosphate in the form of 306.1 mg of sodium glycerophosphate hydrate, which is equivalent to 1 mmol of phosphate and 2 mmol of sodium.
• The other ingredients 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 What the Pack Contains

The medicinal product is a concentrate for solution for infusion.
Pack size:

• Polypropylene ampoules containing 20 ml of concentrate for solution for infusion, packed in cartons of 20. For more detailed information, you should contact 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Netherlands Marketing Authorization Number, the Country of Export:RVG 16431

Parallel Import Authorization Number: 207/22 Date of Approval of the Leaflet: 12.05.2022

Information Intended for Healthcare Professionals Only:

Dosage and Administration

Glycophos should not be administered undiluted.
Dosage
Adult patients:
Individual dosing is recommended.
The recommended daily dose of phosphate during parenteral nutrition is usually 10 to 20 mmol. This can be achieved by adding 10 to 20 ml of Glycophos 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
Intravenous infusion. The duration of the infusion should not be less than 8 hours.

Overdose

No side effects have been found related to overdose. 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 Medicinal Product for Administration

Other medicinal products should be added under aseptic conditions.

Incompatibilities

Glycophos can be added or mixed only with medicinal products whose compatibility has been established.
Medicinal products to be added
Up to 1000 ml of Vamin 14 Electrolyte-Free, Vamin 18 Electrolyte-Free, or Vaminolact, a maximum of 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, a maximum of 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, a maximum of 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, a maximum of 60 ml of Glycophos and 24 mmol of calcium (in the form of CaCl2) can be added.
Stability
When adding other medicinal products to the infusion solution, the infusion should be completed within 24 hours of preparation; this will prevent microbiological contamination.
Any unused contents of an opened ampoule should be discarded, and not stored for further use.

Storage Conditions

Do not store above 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 requirements.