DIPOTASSIUM PHOSPHATE 1M FRESENIUS KABI 174.2 mg/mL INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dipotassium phosphate 1M Fresenius Kabi 174.2 mg/ml concentrate for solution for infusion

Dipotassium 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Dipotassium phosphate 1M Fresenius Kabi is and what it is used for

Dipotassium phosphate 1M Fresenius Kabi is a medicine that belongs to a group called electrolyte solutions.

It is used for the replacement of phosphates and potassium in all clinical situations where it is necessary to maintain adequate phosphate and potassium concentrations in the blood:

• Prevention and treatment of hypophosphatemia in patients under parenteral nutrition and/or in patients in intensive care units.
• Diabetic ketoacidosis as a source of potassium.

2. What you need to know before you use Dipotassium phosphate 1M Fresenius Kabi

Do not useDipotassium phosphate 1M Fresenius Kabi

• if you are allergic (hypersensitive) to dipotassium phosphate or any of the other components of Dipotassium phosphate 1M Fresenius Kabi.
• if you have severe kidney disease.
• if you have been detected with high levels of phosphate or potassium in the blood.
• if you have episodes of kidney stones of ammonium and magnesium phosphates.
• if you have kidney infections caused by microorganisms that hydrolyze urea.

Warnings and precautions

Before starting treatment with Dipotassium phosphate 1M Fresenius Kabi, your doctor should take special precautions and assess the administration or not of this medicine:

• 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 of the above, to monitor renal function, frequent ECGs, and periodic determinations of calcium, phosphorus, potassium, and sodium in the blood.

It should be ensured that the indicated doses are not exceeded, as phosphate poisoning and hyperkalemia (high levels of phosphate and potassium in the blood) may occur.

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

In chronic administration, fluid retention may occur.

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

If dipotassium phosphate is added to patients stabilized on salicylate treatments, it may produce an elevation of plasma levels of these to toxic concentrations, since the acidification of the urine by phosphates reduces the excretion of salicylates.

The concomitant administration of dipotassium phosphate and non-steroidal anti-inflammatory drugs, captopril, cyclosporine, diuretics that spare potassium, enalapril, heparin used chronically, lisinopril, low-sodium milk, salt substitutes, or other medicines that contain potassium may increase potassium levels in the blood, especially in patients with renal dysfunction.

Use ofDipotassium phosphate 1M Fresenius Kabiwith food and drinks

No interaction with food and drinks is known.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Dipotassium phosphate 1M Fresenius Kabi does not affect the ability to drive or use machines.

3. How to use Dipotassium phosphate 1M Fresenius Kabi

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

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

Dipotassium phosphate 1M Fresenius Kabi is administered by slow injection into a vein (intravenous perfusion). The speed and amount administered will depend on your needs and the disorder to be 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 moreDipotassium phosphate 1M Fresenius Kabithan you should

If you receive more Dipotassium phosphate 1M Fresenius Kabi than you should, your phosphate and potassium levels in the blood may rise, as well as reduce your calcium levels in the blood.

Your doctor must ensure that you receive the correct amount of Dipotassium phosphate 1M Fresenius Kabi. In case 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, Dipotassium phosphate 1M Fresenius Kabi can cause side effects, although not everybody gets them.

Side effects are associated with an excessive dose of the medicine that can produce high levels of potassium in the blood, low levels of calcium in the blood, and phosphate poisoning (hypocalcemic tetany, with convulsions, cramps, numbness, tingling, tremors, and difficulty breathing).

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

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

If you experience any type of side effect, talk to 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 Dipotassium phosphate 1M Fresenius Kabi

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

Keep out of the sight and reach of children.

Do not use Dipotassium 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 Dipotassium phosphate 1M Fresenius Kabi if you notice that the solution is not transparent, 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 medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition ofDipotassium phosphate 1M Fresenius Kabi

• The active principle 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 injectable preparations.

Appearance of the product and contents of the pack

Dipotassium phosphate 1M Fresenius Kabi is an intravenous perfusion solution, transparent, colorless, and without visible particles, contained in 10 ml glass ampoules.

The pack contains 1 ampoule, 10 ampoules, or 100 ampoules (clinical packaging).

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

or

Laboratoire Renaudin

• A. Errobi

F-64250 Itxassou

This leaflet was approved in: August 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

-----------------------------------------------------------------------------------------------------------------------

This information is intended only for doctors or healthcare professionals:

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

The product can be diluted with 5% and 10% glucose solutions, 0.9% and 0.45% sodium chloride, 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, Ringer's Lactate, and 10% Dextrose plus 0.9% Sodium Chloride solutions.

The dipotassium phosphate solution should not be added with dobutamine, as precipitates are formed.

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

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.