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, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicinal product has been prescribed for you. 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, please inform 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 is important for 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 impairment;
• 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, discuss it with your doctor or nurse.

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

Glycophos and Other Medicinal Products

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 reported 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product.
The doctor will decide whether to use Glycophos in pregnant or breastfeeding women.

Driving and Using Machines

Glycophos has no influence 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 renal function and in patients on a controlled sodium diet.

3. How to Use Glycophos

This medicinal product is administered only by medical personnel. Do not use it on your own.
In case of doubts, consult your 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.

Use of a Higher Than Recommended Dose of Glycophos

In case of administration of a higher dose than recommended, inform your doctor or nurse immediately.
No symptoms of overdose have been reported.
In case of any further doubts related to the use of this medicinal product, 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 reported due to the use of glycerophosphate.

Reporting of Side Effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 of side effects will allow for more information to be gathered on the safety of the medicinal product.

5. How to Store Glycophos

Store the medicinal product out of the sight and reach of children.
Store in a temperature below 25°C, in the original packaging. Do not freeze.
Do not store any unused contents of an opened vial or ampoule 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. 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 is sodium glycerophosphate.

1 ml of the medicinal product contains:
216 mg of sodium glycerophosphate in the form of 306.1 mg of hydrated sodium glycerophosphate, 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 Contents of the Pack

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

• 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 20. For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Romania, the Country of Export:

Fresenius Kabi AB
Rapsgatan 7, SE 751 74 Uppsala
Sweden

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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76, 03-301 Warsaw
Authorization Number in Romania, the Country of Export:7324/2015/01
7324/2015/02
Parallel Import Authorization Number:399/19

Date of Approval of the Leaflet: 27.09.2024

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 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 to the nutritional 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 adverse reactions have been reported due to overdose. Most patients requiring parenteral nutrition show increased ability to absorb glycerophosphate.

Preparation of the Medicinal Product for Administration

Other medicinal products should be added under aseptic conditions.

Incompatibilities

Glycophos may 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, 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 medicinal products to the infusion solution, the infusion should be completed within 24 hours of preparation; this will prevent microbial contamination.
Do not store any unused contents of an opened vial or ampoule for further use.

Storage Conditions

Store in a temperature below 25°C, in the original packaging. Do not freeze.

Disposal of Unused Medicinal Product

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