PATIENT INFORMATION LEAFLET

Fresenius Kabi Sodium Phosphate 1M 120 mg/ml Concentrate for Solution for Infusion

Sodium Phosphate

Read 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet (see section 4).

1. What isFresenius Kabi Sodium Phosphate 1Mand what it is used for

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

3. How touse Fresenius Kabi Sodium Phosphate 1M

4. Possible side effects

5. Storage ofFresenius Kabi Sodium Phosphate 1M

6. Contents of the pack and additional information

Phosphate Monosodium 1M Fresenius Kabiis a medication that belongs to a group called electrolyte solutions.

It is used for thereplacement of phosphates in clinical situations of hypophosphatemia.

Do not use Fosfate monosódico 1M Fresenius Kabi

• if you are allergic (hypersensitive) to monosodium phosphate or to any of the other components of Fosfate monosódico 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, which are accompanied by infection, of phosphate and magnesium stones in the kidney.
• if you have kidney infections caused by microorganisms that break down urea.
• if you are following a low-sodium diet.

Warnings and precautions

Before starting treatment with Fosfate monosódico 1M Fresenius Kabi, your doctor must take special precautions and evaluate the administration or not of this medication:

• if you have high levels of phosphate, high levels of sodium, or low levels of calcium.
• if you have problems with your heart, liver, or kidneys.
• 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 of other medications

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

The simultaneous administration of this medication with other medications containing sodium may promote fluid accumulation in your body.

Your use with medications containing calcium, including dietary supplements and antacids, may increase the risk of calcium accumulation in some tissue of your body.

This medication should not be used simultaneously with other medications containing phosphates.

Use of Fosfate monosódico 1M Fresenius Kabi with food and beverages

No interactions with food and beverages are known.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

Fosfate monosódico 1M Fresenius Kabi does not affect your ability to drive or operate machines.

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

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

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

Your doctor will decide on the dose to be administered to you.

Use in children

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

Using more Fosfate Monosodico 1M Fresenius Kabi than prescribed

If you receive more Fosfate Monosodico 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 Fosfate Monosodico 1M Fresenius Kabi. If the dose is too high for you, your doctor will immediately stop your administration and provide you with appropriate treatment.

Like all medications,Fosfate monosódico 1M Fresenius Kabimay cause adverse effects, although not everyone will experience them.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

There may be fluid retention in chronic administration.

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects 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.

No requires special conservation conditions. Store in the original packaging to protect it from light.

Keep out of sight and reach of children.

Do not useMonosodium Phosphate 1M Fresenius Kabiafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not useMonosodium Phosphate 1M Fresenius Kabiif you observe that the solution is not transparent, free of particles, or the packaging 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 ofFosfate monosodium 1M Fresenius Kabi

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

• The other components are: water for injection preparations.

Appearance of the product and content of the container

Fosfate monosodium 1M Fresenius Kabieis a solution for intravenous infusion, transparent, colorless and without visible particles, contained in 10 ml glass ampoules.

The content of the container is 1 ampoule, 10 ampoules or 100 ampoules.

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

Responsible for manufacturing

Labesfal- Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

This leaflet was approved in July 2020

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

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

There are controversies about the administration in parallel perfusion (in Y) of phosphates and ciprofloxacin, since 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 elimination of unused medication and all materials that have been in contact with it, will be carried out in accordance with local regulations.