GLYCOPHOS 216 mg/mL CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Glycophos

Do not use Glycophos:

• if you are allergic (hypersensitive) to sodium glycerophosphate or any of the other ingredients of this medicine.
• if you are in a state of dehydration, hypernatremia (high sodium levels in the blood) or hyperphosphatemia (high phosphate levels in the blood).
• if you have severe renal failure or are in a state of shock.

Warnings and precautions

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

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

Glycophos must not be administered undiluted.

Use of other medicines:

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

Note that these instructions may also apply to medicines that you have taken before or may take later.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

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.

There are limited or no data on 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 using machines:

It is not known whether Glycophos has any effects on the ability to drive and use machines.

3. How to use Glycophos

Follow exactly the administration instructions of this medicine given 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 achieved by adding 10-20 ml of Glycophos to the infusion solution or to a mixture whose compatibility has been checked.

Children:

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

The solution will be administered by intravenous infusion. Before use, 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 in need of intravenous nutrition have an increased ability to tolerate glycerophosphates.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Glycophos can cause side effects, although not everybody gets them.

No adverse reactions related to glycerophosphates have been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Glycophos

Keep out of the sight and reach of children.

Store below 25°C. Do not freeze.

Do not use Glycophos after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Do not use this medicine if you notice that the solution is not homogeneous or the vial is damaged.

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 pack and further information

Composition of Glycophos

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

Appearance and packaging

Concentrate for solution for infusion

Glycophos is a clear, colorless or pale yellow solution.

Glycophos is available in polypropylene vials and ampoules.

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Fresenius Kabi España S.A.U.

Marina 16-18

08005 Barcelona (Spain)

Manufacturer

HP Halden Pharma AS

Svinesundveiem 80

1788 Halden

Norway

Date of last revision of this leaflet:March 2020.

This information is intended only for healthcare professionals:

Practical information on preparation and/or handling of the medicinal product

Glycophos must not be administered undiluted.

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

Compatibility

Additions must be made aseptically.

• 120 ml of Glycophos and 48 mmol of calcium (CaCl2) can be added to 1000 ml of Vamin Glucosa, 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.

Infusion time

The infusion time must not be less than 8 hours.

Stability

When additions are made to an infusion solution, the infusion should be administered within 24 hours of preparation to prevent microbial contamination. The remaining contents of opened vials/ampoules should be discarded and not stored for later use.