SODIUM MONOPHOSPHATE 1M FRESENIUS KABI 120 MG/ML CONCENTRATE FOR PERFUSION SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Phosphate 1M Fresenius Kabi 120 mg/ml concentrate for solution for infusion

Sodium Phosphate

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Sodium Phosphate 1M Fresenius Kabi is and what it is used for
2. What you need to know before you use Sodium Phosphate 1M Fresenius Kabi
3. How to use Sodium Phosphate 1M Fresenius Kabi
4. Possible side effects
5. Storage of Sodium Phosphate 1M Fresenius Kabi
6. Contents of the pack and other information

1. What Sodium Phosphate 1M Fresenius Kabi is and what it is used for

Sodium Phosphate 1M Fresenius Kabi is a medicine that belongs to a group called electrolyte solutions.

It is used for the replacement of phosphates in clinical situations of hypophosphatemia.

2. What you need to know before you use Sodium Phosphate 1M Fresenius Kabi

Do not useSodium Phosphate 1M Fresenius Kabi

• if you are allergic (hypersensitive) to sodium phosphate or any of the other ingredients of Sodium Phosphate 1M Fresenius Kabi.
• if you have severe kidney disease.
• if you have been found to have high levels of phosphate in your blood.
• if you have episodes of infection-related kidney stones of ammonium and magnesium phosphates.
• if you have kidney infections caused by microorganisms that hydrolyze urea.
• if you are on a low-sodium diet.

Warnings and precautions

Before starting treatment with Sodium Phosphate 1M Fresenius Kabi, your doctor should take special precautions and assess whether to administer this medicine:

• if you have high levels of phosphates, high levels of sodium, or low levels of calcium.
• if you have heart, liver, or kidney problems.
• if you have high blood pressure.
• if you have high blood pressure during pregnancy.
• if you have fluid accumulation in your body or lungs.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

The simultaneous administration of this medicine with others that contain sodium may favor fluid accumulation in your body.

Its use with medicines that contain calcium, including dietary supplements and antacids, may increase the risk of calcium accumulation in some tissue of your body.

It should not be used simultaneously with other medicines that contain phosphates.

Use ofSodium Phosphate 1M Fresenius Kabiwith food and drinks

No interaction with food and drinks is known.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Sodium Phosphate 1M Fresenius Kabi does not affect the ability to drive or use machines.

3. How to use Sodium Phosphate 1M Fresenius Kabi

Follow exactly the administration instructions of Sodium Phosphate 1M Fresenius Kabi indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Sodium Phosphate 1M Fresenius Kabi will always be administered under the direct supervision of your doctor, who will closely monitor the administered dose.

Sodium Phosphate 1M Fresenius Kabi is administered by slow injection into a vein (intravenous infusion). The speed and amount administered will depend on your needs and the disorder being treated, taking into account the recommended maximum daily dose.

Your doctor will decide what dose to administer to you.

Use in children

The normal dose in children is 1.5 to 2 mmol/kg/day.

If you use moreSodium Phosphate 1M Fresenius Kabithan you should

If you receive more Sodium Phosphate 1M Fresenius Kabi than you should, your phosphate and sodium levels in the blood may rise.

Your doctor should ensure that you receive the correct amount of Sodium Phosphate 1M Fresenius Kabi. If the dose is too high for you, your doctor will immediately stop its administration and administer appropriate treatment.

4. Possible side effects

Like all medicines, Sodium Phosphate 1M Fresenius Kabi can cause side effects, although not everybody gets them.

If you consider that any of the side effects you suffer is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

With chronic administration, there may be fluid retention.

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them 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 Sodium Phosphate 1M Fresenius Kabi

No special storage conditions are required. Keep in the original packaging to protect from light.

Keep out of sight and reach of children.

Do not use Sodium Phosphate 1M Fresenius Kabi after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not use Sodium Phosphate 1M Fresenius Kabi if you notice that the solution is not clear, free of particles, or the packaging is damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition ofSodium Phosphate 1M Fresenius Kabi

• The active ingredient is: sodium phosphate. Each ml of solution contains 120 mg of sodium phosphate (electrolytes: Na+ 1 mmol, PO4H2- 1 mmol).

• The other ingredients are: water for injections.

Appearance of the product and packaging contents

Sodium Phosphate 1M Fresenius Kabi is a solution for intravenous infusion, clear, colorless, and free of visible particles, contained in 10 ml glass ampoules.

The packaging contents are 1 ampoule, 10 ampoules, or 100 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi España S.A.U.

Marina 16-18,

08005 – Barcelona

Manufacturer

Labesfal- Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

This leaflet was approved in July 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

The administration of Sodium Phosphate 1M Fresenius Kabi is by intravenous infusion. The product requires dilution before use, with at least an equal amount of diluent.

There are controversies about the administration in parallel infusion (in Y) of phosphates and ciprofloxacin, as some authors have found precipitation of both preparations.

Phosphates may be incompatible with metal ions such as magnesium and calcium when added to parenteral nutrition solutions.

Use only if the solution is clear.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.