Monosodium phosphate 1M Fresenius Kabi 120 mg/ml concentrate for infusion solution

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fosfato monosódico 1M Fresenius Kabi 120 mg/ml concentrate for solution for infusion

Monosodium phosphate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Fosfato monosódico 1M Fresenius Kabi is and what it is used for

Fosfato monosódico 1M Fresenius Kabi is a medicine that belongs to a group called electrolyte solutions.

It is used for phosphate replacement in clinical situations of hypophosphatemia.

2. What you need to know before using Monosodium Phosphate 1M Fresenius Kabi

Do not use Monosodium Phosphate 1M Fresenius Kabi

• if you are allergic (hypersensitive) to monosodium phosphate or to any of the other components of Monosodium Phosphate 1M Fresenius Kabi.
• if you have severe kidney disease.
• if you have been diagnosed with high levels of phosphate in the blood.
• if you have episodes, associated with infection, of kidney stones composed 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 Monosodium Phosphate 1M Fresenius Kabi, your doctor must take special care and evaluate whether or not 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 in your lungs.

Use with other medicines

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

Concomitant administration of this medicine with other products containing sodium may promote fluid retention in your body.

Its use together with medicines containing calcium, including dietary supplements and antacids, may increase the risk of calcium deposition in body tissues.

It must not be used simultaneously with other medicines containing phosphates.

Use of Monosodium Phosphate 1M Fresenius Kabi with 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

Monosodium Phosphate 1M Fresenius Kabi does not affect the ability to drive or operate machinery.

3. How to use Monosodium Phosphate 1M Fresenius Kabi

Follow exactly the administration instructions for Monosodium Phosphate 1M Fresenius Kabi as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

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

Your doctor will decide the appropriate dose for you.

Use in children

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

If you are given more Monosodium Phosphate 1M Fresenius Kabi than you should

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

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

4. Possible adverse effects

Like all medicines, Fosfato monosódico 1M Fresenius Kabi can produce adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

With chronic administration, fluid retention may occur.

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it involves possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Monosodium 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 Monosodium Phosphate 1M Fresenius Kabi after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Do not use Monosodium Phosphate 1M Fresenius Kabi if the solution is not clear and particle-free, or if the container is damaged.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Fosfate monosódico 1M Fresenius Kabi

• The active substance is: monosodium phosphate. Each ml of solution contains 120 mg of monosodium phosphate (electrolytes: Na+ 1 mmol, H2PO4– 1 mmol).

• The other components are: water for injections.

Appearance of the product and contents of the container

Fosfato monosódico 1M Fresenius Kabi is a solution for intravenous infusion, transparent, colourless and free from visible particles, contained in 10 ml glass vials.

The pack contents are: 1 vial, 10 vials or 100 vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 summary of product characteristics was approved in July 2020

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

This information is intended for healthcare professionals only:

Fosfato monosódico 1M Fresenius Kabi is administered by intravenous infusion. The product must be diluted before use, with at least an equal volume of diluent.

There is controversy regarding the simultaneous administration (via Y-site) of phosphate solutions and ciprofloxacin, as some authors have reported precipitation of both preparations.

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

Use only if the solution is clear.

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