Label:information for theuser

Hyperlite Concentrate for infusion solution

Read the entire label carefully before starting to use the medication.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

Hyperliteis a concentrated solution for perfusion(which is administered diluted by intravenous route via an infusion set) thatis used as anelectrolyte carrier (salts such as sodium, calcium, magnesium…)during normal parenteral nutrition (direct feeding into a vein).

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

Do not use Hyperlite:

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

Use in children:

The composition of Hyperlite does not make it advisable to use in children.

Be especially careful with Hyperlite:

If you have:

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

Use of other medications

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

It is essential to inform your doctor if you use any of the following medications:

-Corticosteroids/steroids and carbenoxolone (a type of anti-inflammatory)

-Lithium carbonate (a depressant of the nervous system)

-Diuretics (increase urine elimination) that save potassium (such as amiloride, spironolactone, triamterene) alone or in combination

-Anti-hypertensive medications of the type angiotensin-converting enzyme inhibitors (ACE inhibitors) (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)

-Medications used to prevent rejection in transplants such as tacrolimus and cyclosporine (with nephrotoxicity)

-Suxamethonium (a type of muscle relaxant used in combination with anesthesia in operations)

-Thiazide diuretics such as hydrochlorothiazide, altizide, mebutizide, bendroflumethiazide (to increase the normal amount of urine eliminated) or vitamin D

-Medications such as barbiturates, narcotics or hypnotics (tranquilizers)

-Cardiotonic glucosides (digoxin, methyldigoxin) used in heart disorders

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Hyperlite can be administered during pregnancy and lactation as long as it is done with caution.

This medication will always be administered by healthcare personnel.

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

Your doctor will decide on the correct dose and frequency at which the solution will be administered to you, and this will depend on your age, weight, and clinical condition.

Follow exactly the administration instructions for Hyperlite indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you use more Hyperlite than you should

It is unlikely that this will happen since your doctor will ensure that you receive the correct amount. However, if you received more Hyperlite than you should, this could cause:

• fluid accumulation, with increased blood pressure

If this happens, administration should be stopped immediately and, depending on the severity of the situation, the necessary corrective measures should be taken at the doctor's discretion. It may be necessary to administer insulin.

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount used.

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

If the administration of the solution is made according to the indications of this prospectus, no adverse effects are expected to occur.

There may be fever, decreased fluid volume in the body, and reactions due to the administration method 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 the leakage of liquid from blood vessels (extravasation).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about 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:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Hyperlite after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not use Hyperlite if you observe that the solution is not transparent or contains particles at the bottom of the packaging, or if the packaging shows visible signs of deterioration.

Drugs and materials that have come into contact with it should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Hyperlite:

The other components are: water for injection preparations.

Appearance of the product and contents of the packaging

Hyperlite is a clear and colorless perfusion solution that is presented in presentations of 10 x 75 ml and 20 x 75 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

This prospectus was approved in February 2019

The detailed information of this medication is available on the website ofthe Spanish Agency of Medicines and Medical Devices.

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This information is intended solely for doctors or healthcare professionals:

Single-use containers. Dispose of any remaining unused content after completing the perfusion.

Use the sterile administration set for administration. Do not use the same infusion equipment used or to be used for the administration of blood, as there is a possibility of agglutination.

Before mixing the solution with other medications, consider the possible incompatibilities.

Special attention should be given to:

• The patient's clinical status and laboratory parameters (electrolytes in blood and urine, as well as acid-base balance, hematocrit) during the use of this solution.
• The patient's plasma potassium level (particularly in patients at risk of hyperkalemia).
• Patients with advanced age, as they may have impaired renal, hepatic, or cardiac function.
• Patients at risk of cerebral edema or intracranial hypertension.
• Hyperlite does not contain phosphates. Patients undergoing total parenteral nutrition with concentrated glucose solutions may require additional phosphates.

If administered via peripheral vein, avoid continuous administration in the same injection site due to the risk of thrombophlebitis.

Daily monitoring of possible signs of inflammation or infection at the perfusion site is recommended.

Hyperlite is a highly hypertonic solution and should not be administered in any case without dilution.