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

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Dipotassium Phosphate

Read the entire 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.

Leaflet contents:

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

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

Fosfato dipotásico 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 an adequate concentration of phosphates and potassium in the blood:

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

2. What you need to know before using Fosfato dipotásico 1M Fresenius Kabi

Do not use Fosfato dipotásico 1M Fresenius Kabi

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

Warnings and precautions

Before starting treatment with Fosfato dipotásico 1M Fresenius Kabi, your doctor must exercise special caution and evaluate whether or not to administer this medicine:

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

For the above reasons, monitoring of renal function, frequent ECGs, and periodic determinations of serum calcium, phosphate, potassium, and sodium are recommended.

Care should be taken not to exceed the recommended doses, as phosphate intoxication and hyperkalemia (elevated levels of phosphate and potassium in blood) could occur.

Intravenous infusion of phosphates in large amounts may lead to hypocalcemia (low calcium levels in blood).

With chronic administration, fluid retention may occur.

Use of other medicines

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

Parenteral use of dipotassium phosphate is not recommended together with digitalis glycosides in patients receiving digitalis, or in those with severe or complete cardiac block, due to the risk of hyperkalemia (elevated potassium levels in blood).

If dipotassium phosphate is added to patients stabilized on salicylate therapy, it may cause an increase in plasma salicylate levels to toxic concentrations, since phosphate-induced acidification of urine reduces salicylate excretion.

Concomitant administration of dipotassium phosphate and non-steroidal anti-inflammatory drugs, captopril, cyclosporine, potassium-sparing diuretics, enalapril, chronically used heparin, lisinopril, low-salt milk, salt substitutes, or other medications containing potassium may increase potassium blood levels, especially in patients with renal dysfunction.

Use of Fosfato dipotásico 1M Fresenius Kabi with food and drink

No interaction with food and drink is known.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

Fosfato dipotásico 1M Fresenius Kabi does not affect the ability to drive or operate machinery.

3. How to use Fosfato dipotásico 1M Fresenius Kabi

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

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

Fosfato dipotásico 1M Fresenius Kabi is administered by slow injection into a vein (intravenous infusion). The rate as well as the amount administered will depend on your individual needs and the condition 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 2–3 mEq/kg/day.

If you use more Fosfato dipotásico 1M Fresenius Kabi than you should

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

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

4. Possible adverse effects

Like all medicines, Fosfato dipotásico 1M Fresenius Kabi may cause adverse effects, although not everyone experiences them.

Adverse effects are associated with an excessive dose of the medicine, which may lead to high levels of potassium in the blood, low levels of calcium in the blood, and phosphate intoxication (hypocalcemic tetany, with seizures, cramps, numbness, tingling, tremors, and respiratory difficulty).

High levels of potassium in the blood manifest as confusion, fatigue or weakness, cardiac arrhythmia, bradycardia, unexplained anxiety, weakness or heaviness in the legs.

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

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

5. Storage of Fosfato dipotásico 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 Fosfato dipotásico 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 Fosfato dipotásico 1M Fresenius Kabi if the solution is not clear and free from particles, 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 pack and other information

Composition of Fosfate dipotásico 1M Fresenius Kabi

• The active substance is: dipotassium phosphate. Each ml of solution contains 174.2 mg of dipotassium phosphate (electrolytes: K+ 2 mmol, H2PO4– 1 mmol).

• The other components are: water for injections.

Appearance of the product and contents of the pack

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

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

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

or

Laboratoire Renaudin

• A. Errobi

F-64250 Itxassou

This summary of product characteristics was approved in: August 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 exclusively for physicians or healthcare professionals:

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

The product may 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 must not be dissolved in Ringer's solution, Ringer-Lactate solution or 10% Dextrose with 0.9% Sodium Chloride.

Dobutamine must not be added to the dipotassium phosphate solution, as precipitates may form.

Dipotassium phosphate is compatible with the addition of magnesium sulfate, metoclopramide, verapamil, cephalothin and ceftazidime; when administered simultaneously via Y-site infusion, it is compatible with: ciprofloxacin, diltiazem, enalapril, esmolol, famotidine, labetalol, vinorelbine and zidovudine.

Use only if the solution is clear.

Disposal of unused medicinal product and of all materials which have been in contact with it must be carried out in accordance with local regulations.