HYPERLITE CONCENTRATE FOR INFUSION SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hyperlite Concentrate for solution for infusion

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Hyperlite is and what it is used for
2. Before using Hyperlite
3. How to use Hyperlite
4. Possible side effects
5. Storage of Hyperlite
6. Additional information

1. What Hyperlite is and what it is used for

Hyperlite is a concentrate for infusion solution (administered intravenously in diluted form via an infusion set) used as a source of electrolytes (salts such as sodium, calcium, magnesium, etc.) during standard parenteral nutrition (feeding directly into the vein).

Parenteral nutrition consists of delivering nutrients to the body via the intravenous route (directly into the vein). It is used in patients who are unable to ingest orally the nutrients required to meet their nutritional needs, due to an inability to use their digestive system.

2. Before using Hyperlite

Do not use Hyperlite:

• if you are allergic (hypersensitive) to the active substances in Hyperlite.
• if you have:
• excess fluid in the body (hyperhydration)
• excess sodium, potassium, calcium, magnesium, or acetate in the blood
• anuria (absence of urine production)
• kidney disorders
• liver disorders
• heart disorders
• fluid accumulation (edema) in the lungs or brain.

Use in children:

The composition of Hyperlite is not considered suitable for use in children.

Take special care with Hyperlite:

If you have:

• hypertension (high blood pressure) or other conditions associated with sodium retention
• diseases or conditions that predispose to potassium retention

Use of other medicines

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

It is important that you inform your doctor if you are taking any of the following medicines:

• A type of anti-inflammatory drugs called corticosteroids/steroids and carbenoxolone
• Lithium carbonate (a central nervous system depressant)
• Potassium-sparing diuretics (increase urine elimination), such as amiloride, spironolactone, triamterene, used alone or in combination
• Antihypertensive drugs of the angiotensin-converting enzyme (ACE) inhibitor type (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)
• Medicines used to prevent transplant rejection, such as tacrolimus and cyclosporine (with kidney toxicity)
• Suxamethonium (a type of muscle relaxant used in combination with anesthesia during surgery)
• Thiazide diuretics such as hydrochlorothiazide, altizide, mebutizide, bendroflumethiazide (to increase the normal amount of urine excreted) or vitamin D
• Medicines such as barbiturates, narcotics, or hypnotics (tranquilizers)
• A type of medicine used in heart disorders called cardiac glycosides (digoxin, methyldigoxin).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Hyperlite may be administered during pregnancy and breastfeeding, provided it is used with caution.

3. How to use Hyperlite

This medicine will always be administered by healthcare professionals.

This solution must never be injected directly into the patient. It should only be used diluted (mixed) in other solutions.

Your doctor will decide the correct dose and how often you will receive the solution, based on your age, weight, and clinical condition.

Follow exactly the administration instructions for Hyperlite provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

If you are given more Hyperlite than you should

This is unlikely to occur, as your doctor will ensure you receive the correct amount. However, if you were to receive more Hyperlite than required, it could cause you:

• fluid accumulation, leading to increased blood pressure

If this occurs, administration must be stopped immediately and, depending on the severity of the situation, corrective measures should be taken at the physician's discretion. Insulin administration may be necessary.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number (91) 562 04 20, indicating the medication and the amount taken.

4. Possible adverse effects

Like all medicines, Hyperlite may produce adverse effects, although not everyone will experience them.

If the solution is administered according to the instructions in this leaflet, adverse effects are not expected to occur.

Possible effects include fever, decreased fluid volume in the body, and reactions related to the route of administration such as: infection at the injection site, formation of a blood clot in a blood vessel, inflammation of a vein (phlebitis), and reactions due to leakage of fluid from blood vessels (extravasation).

Reporting of adverse effects

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

5. Storage of Hyperlite

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Hyperlite after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Do not use Hyperlite if you notice that the solution is not clear or contains particles at the bottom of the container, or if the container shows visible signs of deterioration.

Medicines and materials that have been in contact with it must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Hyperlite:

The other components are: water for injections.

Appearance of the medicinal product and contents of the container

Hyperlite is a clear, colourless solution for infusion, supplied in pack sizes of 10 x 75 ml and 20 x 75 ml.

Marketing Authorization Holder and Manufacturer

Holder

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

This patient information leaflet was approved in February 2019

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS).

This information is intended exclusively for physicians or healthcare professionals:

Single-use containers. Discard any unused residual contents after completion of the infusion.

Use a sterile administration set for administration. Do not use the same infusion equipment used or intended for use with blood, due to the risk of agglutination.

Before mixing this solution with other medicinal products, possible incompatibilities must be considered.

Special attention should be paid to:

• The patient's clinical condition and laboratory parameters (blood and urine electrolytes, acid-base balance, hematocrit) during the use of this solution.
• The patient's plasma potassium levels (particularly in patients at risk of hyperkalemia).
• Use in elderly patients, as they may have impaired renal, hepatic, or cardiac function.
• Patients at risk of cerebral edema or increased intracranial pressure.
• Hyperlite does not contain phosphates. Patients receiving total parenteral nutrition with concentrated glucose solutions may require additional phosphate supplementation.

If administered via peripheral vein, continuous infusion at the same injection site should be avoided due to the risk of thrombophlebitis.

The infusion site should be monitored daily for possible signs of inflammation or infection.

Hyperlite is a highly hypertonic solution and must never be administered undiluted.