Glicophos

Package Leaflet: Information for the User

GLYCOPHOS, 216 mg/ml, Concentrate for Solution for Infusion

Sodium Glycerophosphate

Read All of This Leaflet Carefully Before Using This Medicine.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medicine 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, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Contents of the Package Leaflet

• 1. What GLYCOPHOS Is and What It Is Used For
• 2. Important Information Before You Use GLYCOPHOS
• 3. How to Use GLYCOPHOS
• 4. Possible Side Effects
• 5. How to Store GLYCOPHOS
• 6. Contents of the Package and Other Information

1. What GLYCOPHOS Is and What It Is Used For

GLYCOPHOS Is a Medicine That Contains Glycerophosphate, Which Plays an Important Role in 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 You Use GLYCOPHOS

When Not to Use GLYCOPHOS

Do Not Use the Medicine:

• If You Are Allergic to the Active Substance or to Any of the Other Ingredients of This Medicine (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 to Use GLYCOPHOS, Discuss It with Your Doctor or Nurse.

• The Medicine Should Be Administered with Caution If You Have Renal Impairment.
• In Patients Receiving GLYCOPHOS, the Doctor Will Prescribe Regular Monitoring of Phosphate Levels in the Blood.

GLYCOPHOS and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.
No Interactions Have Been Found Between GLYCOPHOS and Other Medicines, but 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 Medicine.
The Doctor Will Decide Whether to Use GLYCOPHOS in Women During Pregnancy and Breastfeeding.

Driving and Using Machines

GLYCOPHOS Has No Influence 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 Renal Function and in Patients Controlling Their Sodium Intake.

3. How to Use GLYCOPHOS

This Medicine Is Administered Only by Medical Personnel. Do Not Use the Medicine Yourself.
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.

Using More Than the Recommended Dose of GLYCOPHOS

If You Have Used More Than the Recommended Dose of the Medicine, Tell Your Doctor or Nurse Immediately.
No Symptoms of Overdose Have Been Found.
If You Have Any Further Questions About the Use of This Medicine, Ask Your Doctor or Nurse.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.
No Side Effects Have Been Found to Be Associated with the Use of Glycerophosphate.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, Tell Your Doctor, Pharmacist, or Nurse. Side Effects Can Be Reported Directly to the Department of Pharmacovigilance 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
Side Effects Can Also Be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help to Gather More Information on the Safety of This Medicine.

5. How to Store GLYCOPHOS

Keep the Medicine Out of the Sight and Reach of Children.
Store in a Temperature Below 25°C. Do Not Freeze.
Do Not Use the Medicine After the Expiry Date Stated on the Packaging.
The Expiry Date Refers to the Last Day of the Month Stated.
Medicines Should Not Be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This Will Help Protect the Environment.

6. Contents of the Package and Other Information

What GLYCOPHOS Contains

• The Active Substance 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, 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 Medicine Is 2760 Moom/Kg Water, pH 7.4.

What GLYCOPHOS Looks Like and Contents of the Package

The Medicine Is a Concentrate for Solution for Infusion.
Pack Sizes:
­ Polypropylene Vials Closed with Bromobutyl Stoppers Containing 20 Ml of Concentrate for Solution for Infusion, Packaged in 10 Pieces in a Cardboard Box.
­ Polypropylene Ampoules Containing 20 Ml of Concentrate for Solution for Infusion, Packaged in 20 Pieces in a Cardboard Box.
Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi AB
S-751 74 Uppsala
Sweden

Manufacturer

HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
NorwayFresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Phone: +48 22 345 67 89
Date of Last Revision of the Leaflet:01.03.2024

Information Intended for Healthcare Professionals Only:

Dosage and Administration

GLYCOPHOS Must Not Be Administered Undiluted.
Dosage
Adult Patients:
Individual Dosage 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 Dosage 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 Infusion Should Not Be Less Than 8 Hours.

Overdose

No Side Effects Have Been Found to Be Associated with 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 Medicine for Administration

Other Medicines Should Be Added Under Aseptic Conditions.

Incompatibilities

GLYCOPHOS Can Be Added or Mixed Only with Medicines Whose Compatibility Has Been Established.
Medicines 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
In the Event of Adding Other Medicines to the Infusion Solution, the Infusion Should Be Completed Within 24 Hours of Preparation of the Solution; This Will Help Prevent Microbiological Contamination.
Do Not Store the Unused Contents of an Open Vial or Ampoule for Further Use.

Storage Conditions

Store in a Temperature Below 25°C. Do Not Freeze.

Disposal of Unused Medicinal Products

Any Unused Medicinal Products or Waste Materials Should Be Disposed of in Accordance with Local Requirements.