PATIENT INFORMATION LEAFLET

Fosfate dipotassium 1M Fresenius Kabi 174.2 mg/ml concentrate for infusion solution

Fosfate dipotassium

Read this leaflet carefully before you start using the 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 they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor even if they do not appear in this leaflet. See section 4.

1. What is Fosfate dipotassium 1M Fresenius Kabi and what it is used for

2. What you need to know before using Fosfate dipotassium 1M Fresenius Kabi

3. How to use Fosfate dipotassium 1M Fresenius Kabi

4. Possible side effects

5. Storage of Fosfate dipotassium 1M Fresenius Kabi

6. Contents of the pack and additional information

Fosfato dipotásico 1M Fresenius Kabiis a medication that belongs to a group called electrolyte solutions.

It is used for thereplacement of phosphates and potassium in all clinical situations in which it is necessary to maintain an adequate concentration of phosphates and potassium in the blood:

- Prevention and treatment of hypophosphatemia in patients receiving parenteral nutrition and/or in patients in intensive care units.

- Diabetic ketoacidosis as a source of potassium.

No useFosfate dipotassium1M Fresenius Kabi

• if you are allergic (hypersensitive) to dipotassium phosphate or to any of the other components of Fosfate dipotassium 1M Fresenius Kabi.
• if you have severe kidney disease.
• if you have been found to have high levels of phosphate or potassium in your blood.
• if you have episodes of kidney stones composed of ammonium and magnesium phosphate.
• if you have kidney infections caused by microorganisms that break down urea.

Warnings and precautions

Before starting treatment with Fosfate dipotassium 1M Fresenius Kabi, your doctor must take special precautions and evaluate whether to administer or not this medication:

• if you have previously had high levels of phosphates.
• if you have previously had high levels of potassium.
• if you have previously had low levels of calcium.

It is recommended, for all the above, to monitor renal function, frequent ECGs, and periodic determinations of serum calcium, phosphate, potassium, and sodium.

It is essential to avoid exceeding the indicated doses, as it could cause phosphate intoxication and hyperpotasemia (high levels of phosphate and potassium in the blood).

The intravenous perfusion of phosphates in large quantities can lead to hypocalcemia (low levels of calcium in the blood).

In chronic administration, it can cause fluid retention.

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 parenteral use of dipotassium phosphate is not recommended with digitalis glycosides, in digitalized patients, with severe or complete heart block, due to the possible hyperpotasemia (high levels of potassium in the blood).

If dipotassium phosphate is added to patients stabilized on treatments with salicylates, it can cause an increase in plasma levels of these substances to toxic concentrations, as the acidification of the urine by phosphates reduces the excretion of salicylates.

The concomitant administration of dipotassium phosphate and nonsteroidal anti-inflammatory drugs, captopril, ciclosporina, diuretics that spare potassium, enalapril, heparin used chronically, lisinopril, low-sodium milk, salt substitutes, or other medications containing potassium can increase potassium levels in the blood, especially in patients with renal dysfunction.

Use of Fosfate dipotassium 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 dipotassium 1M Fresenius Kabi does not affect the ability to drive or operate machines.

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

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

Fosfate dipotásico 1M Fresenius Kabi is administered through a 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 what dose to administer to you.

Use in children

The normal dose in children is 2-3 mEq/kg/day.

If you use moreFosfate dipotásico 1M Fresenius Kabi than you should

If you receive more Fosfate dipotásico 1M Fresenius Kabi than you should, your blood phosphate and potassium levels may increase, as well as decrease your blood calcium levels.

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

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

Adverse effects are associated with an excessive dose of the medication that can produce elevated levels of potassium in the blood, low levels of calcium in the blood, and phosphate poisoning (tetany, seizures, muscle cramps, numbness, tingling, tremors, and respiratory difficulty).

Elevated levels of potassium in the blood are manifested with confusion, fatigue or weakness, arrhythmia, bradycardia, inexplicable anxiety, weakness or heaviness in the legs.

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

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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 useDipotassium 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 useDipotassium 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 medicines you no longer need. This will help protect the environment.

Composition ofFosfate dipotassium 1M Fresenius Kabi

• The active ingredient is: dipotassium phosphate.Each ml of solution contains 174.2 mg of dipotassium phosphate(electrolytes: K+2 mmol, PO4H2– 1 mmol).

• The other components are: water for injection preparations.

Appearance of the product and contents of the package

Fosfate dipotassium 1M Fresenius Kabieis an intravenous infusion solution, transparent, colorless and without visible particles, contained in 10 ml glass vials.

The contents of the package are 1 vial, 10 vials or 100 vials (clinical packaging).

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

or

Laboratoire Renaudin

Z. A. Errobi

F-64250 Itxassou

This leaflet has been approved in: August 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 dipotassium 1M Fresenius Kabi is by intravenous infusion. The product requires dilution before use, at least with an equal amount of diluent.

The product can be diluted with 5% and 10% glucose solutions, 0.9% and 0.45% NaCl, and 1/6 M sodium lactate. It is also compatible for 24 hours at 22°C with parenteral nutrition solutions.

Dipotassium phosphate should not be dissolved with Ringer's solution, Ringer Lactate, and 10% Dextrose with 0.9% Sodium Chloride.

Do not add dobutamine to the phosphate dipotassium solution, as precipitates form.

Phosphate dipotassium is compatible with the addition of magnesium sulfate, metoclopramide, verapamil, cefalotin, and ceftazidime; in parallel (Y infusion) it is compatible with: ciprofloxacin, diltiazem, enalapril, esmolol, famotidine, labetalol, vinorelbine, and zidovudine.

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.