Glycophos

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is 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 you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your 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 this 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 failure;
• if the patient is in shock (a life-threatening condition caused by acute inadequate tissue perfusion).

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

• This medicine should be administered with caution in patients with impaired kidney function.
• In patients receiving Glycophos, the physician 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 take.
No interactions between Glycophos and other medicines have been reported. However, when administered concomitantly with carbohydrates (sugars), a decrease in blood phosphate levels may occur.

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 decision to use Glycophos in pregnant women or during breastfeeding will be made by the physician.

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 renal function and in patients who are controlling sodium intake in their diet.

3. How to use Glycophos

This medicine is administered exclusively by medical personnel.
You must not use this medicine on your own.
If in doubt, 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 shorter than 8 hours.
Use of a higher than recommended dose of Glycophos
If a higher than recommended dose of Glycophos 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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
No adverse reactions related to the use of glycerophosphate have been reported.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Glycophos

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging. Do not freeze.
Any unused portion of an opened vial or ampoule must be discarded; do not store 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Glycophos contains

• The active substance is glycerophosphoric acid sodium salt.

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

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

The osmolality of the medicinal product is 2760 mOsm/kg 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 concentrate for solution for infusion, packed in cardboard boxes of 10 vials.
• Polypropylene ampoules containing 20 ml concentrate for solution for infusion, packed in cardboard boxes of 20 ampoules. For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation 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 in:
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
Marketing Authorisation numbers in Romania, the country of export: 7324/2015/01
7324/2015/02
Parallel import licence number: 399/19

Information intended exclusively for healthcare professionals:

Dosage and method of 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 is generally
10 to 20 mmol. This can be achieved by using 10 to 20 ml of Glycophos added to an infusion solution
or to a nutritionally balanced mixture whose compatibility has been confirmed.

Infants:
Individualized dosing is recommended.
The recommended dose for infants and neonates is 1.0 to 1.5 mmol/kg body weight/day.

Method of administration
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 be added or mixed only with medicinal products whose compatibility has been established.

Medicinal products to be added

• Up to 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.
• Up to 10 ml of Glycophos and 10 mmol of calcium (as CaCl) may be added to 1000 ml of glucose 50 mg/ml.
• Up to 20 ml of Glycophos and 20 mmol of calcium (as CaCl) may be added to 1000 ml of glucose 200 mg/ml.
• Up to 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 from an opened vial or ampoule must be discarded and must not be stored for subsequent use.

Storage conditions
Store below 25°C in the original packaging. Do not freeze.

Disposal of unused medicinal product or waste
Any unused residues of the medicinal product or waste material must be disposed of in accordance with local regulations.