Leaflet: information for the user

Glycophos 216 mg/ml concentrate for solution for infusion

Sodium glycerophosphate

Glycophos is a concentrate for solution for perfusion, which belongs to the group of medications known as electrolyte solutions, additives for intravenous solutions.

Glycophos is indicated in adult and pediatric patients as a supplement in intravenous nutrition to cover phosphate needs.

Glycophos is a medication that will be administered by a doctor or healthcare professional.

Do not use Glycophos:

• if you are allergic (hypersensitive) to sodium glycerophosphate or any of the other components of this medication.
• if you are dehydrated, have hypernatremia (high sodium levels in the blood) or hyperphosphatemia (high phosphate levels in the blood).
• if you have severe renal insufficiency or are in shock.

Warnings and precautions

Consult your doctor before starting to use this medication. If you have renal insufficiency, your doctor will regularly monitor your blood phosphate levels.

Glycophos may only be added or mixed with other medicinal products whose compatibility has been documented.

Glycophos should not be administered without dilution.

Use of other medications:

No interactions with other medications have been observed, although a moderate decrease in serum phosphate has been seen during carbohydrate infusions.

Be aware that these instructions may also apply to medications that have been taken before or may be taken afterwards.

Inform your doctor or pharmacist if you are taking, have recently taken or may need to take any other medication, including those obtained without a prescription.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

There are no data or these are limited regarding the use of Glycophos in pregnant women.

The use of Glycophos during pregnancy may be considered in cases where it is clinically indicated.

Driving and operating machinery:

The effects of Glycophos on the ability to drive and operate machinery are unknown.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults:

The recommended dosage is individual. The recommended daily dose of phosphate during intravenous nutrition is about 10 – 20 mmol. This can be obtained by adding 10 – 20 ml of Glycophos to the infusion solution or to the mixture whose compatibility has been confirmed.

Children:

The recommended dosage is individual. The recommended dose for children and newborns is 1.0-1.5 mmol/kg of body weight/day.

The solution will be administered via intravenous infusion. Before using, check that the solution is homogeneous and that the vial is not damaged.

If you use more Glycophos than you should:

No adverse effects have been observed due to overdosing. Most patients requiring intravenous nutrition have an increase in their ability to accept glycerophosphates.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Glycophos may produce adverse effects, although not all people will experience them.

No adverse reactions related to glycerophosphates have been reported.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Store below 25°C. Do not freeze.

Do not use Glycophos after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the solution is not homogeneous or the vial is damaged.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition of Glycophos

• The active principle is sodium glycerophosphate pentahydrate. 1 ml of Glycophos contains 306.1 mg of active principle (equivalent to 216 mg of anhydrous sodium glycerophosphate).
• The electrolytes in 1 ml are phosphate (1 mmol) and sodium (2 mmol).
• The other components are hydrochloric acid (to adjust the pH) and water for injectable preparations.

Aspect of the product and content of the package

Concentrate for perfusion solution

Glycophos is a transparent, colorless or pale yellow solution.

Glycophos is available in polypropylene vials and ampoules.

The containers contain 10 vials of 20 ml and 20 ampoules of 20 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España S.A.U.

Marina 16-18

08005 Barcelona (Spain)

Responsible for manufacturing

HP Halden Pharma AS

Svinesundveiem 80

1788 Halden

Norway

Last review date of this leaflet:March 2020.

This information is intended solely for doctors or healthcare professionals:

Practical information on the preparation and/or manipulation of the medication

Glycophos should not be administered without dilution.

Before use, check that the solution is homogeneous and that the vial is not damaged.

Compatibility

Admixtures should be made aseptically.

• 120 ml of Glycophos and 48 mmol of calcium (CaCl2) can be added to 1000 ml of Vamin Glucose, Vamin 14, Vamin 14 without electrolytes, and Vamin 18 without electrolytes.
• 10 ml of Glycophos and 10 mmol of calcium (CaCl2) can be added to 1000 ml of Glucose 50 mg/ml.
• 20 ml of Glycophos and 20 mmol of calcium (CaCl2) can be added to 1000 ml of Glucose 200 mg/ml.
• 60 ml of Glycophos and 24 mmol of calcium (CaCl2) can be added to 1000 ml of Glucose 500 mg/ml.

Perfusion time

The perfusion time should not be less than 8 hours

Stability

When admixtures are made to a perfusion solution, the perfusion should be administered within 24 hours of preparation to prevent microbial contamination. The remaining contents of opened vials/franklin/ampoules should be discarded and cannot be stored for later use.