HYPERLITE CONCENTRATED SOLUTION FOR PERFUSION

Introduction

Leaflet:information for theuser

Hyperlite Concentrate for solution for infusion

Read the entire leaflet carefully before starting to use the 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 to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

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

1. What is Hyperlite and what is it used for

Hyperlite is a concentrate for solution for infusion (which is administered diluted by intravenous route through a drip) used as a supply of electrolytes (salts such as sodium, calcium, magnesium...) during normal parenteral nutrition (feeding directly into a vein).

Parenteral nutrition consists of the administration of nutrients to the body through the intravenous route. It is used in all those patients who are unable to ingest the necessary nutrients orally to cover their nutritional needs, due to the inability to use their digestive system.

2. Before using Hyperlite

Do not use Hyperlite:

• if you are allergic (hypersensitive) to the active ingredients of 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 lung or brain.

Use in children:

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

Be careful with Hyperlite:

If you have:

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

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, even those purchased without a prescription.

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

• A type of anti-inflammatory called corticosteroids/steroids and carbenoxolone
• Lithium carbonate (central nervous system depressant)
• Diuretics (increase urine elimination) that save potassium (such as amiloride, spironolactone, triamterene) alone or in combination
• Antihypertensives of the type angiotensin-converting enzyme inhibitors (ACE inhibitors) (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)
• Medicines used to prevent rejection in transplants such as tacrolimus and cyclosporin (with kidney toxicity)
• 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
• Medicines such as barbiturates, narcotics or hypnotics (tranquilizers)
• A type of medicines used in heart disorders called digitalis cardiac glycosides (digoxin, methyldigoxin).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Hyperlite can be administered during pregnancy and breastfeeding, provided it is done with caution.

3. How to use Hyperlite

This medicine will always be administered by healthcare personnel.

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

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

Follow the administration instructions of Hyperlite indicated by your doctor exactly. 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 were to receive more Hyperlite than you should, this could cause you:

• water accumulation, with increased blood pressure

If this happens, the administration should be interrupted 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 Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount used.

4. Possible side effects

Like all medicines, Hyperlite can cause side effects, although not everyone gets them.

If the administration of the solution is done according to the instructions of this leaflet, it is not expected to appear side effects.

There may be fever, decreased fluid volume in the body, and reactions due to the method of administration such as infection at the injection site, formation of a thrombus in a blood vessel, inflammation of a vein (phlebitis), and reactions due to the leakage of fluid from the blood vessels (extravasation).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing 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 expiration date stated on the packaging. The expiration date is the last day of the month indicated.

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

Medicines and materials that have come into contact with them should not be thrown away through the sewers or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of Hyperlite:

The other components are: water for injectable preparations.

Appearance of the product and packaging content

Hyperlite is a clear and colorless solution for infusion, which is presented in 10 x 75 ml and 20 x 75 ml packaging.

Marketing authorization holder and manufacturer

Holder

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

This leaflet was approved in February 2019

Detailed information about this medicine is available on the website of theSpanish Agency for Medicines and Health Products.

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

This information is intended only for doctors or healthcare professionals:

Single-use containers. Discard any unused contents after finishing the infusion.

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

Before mixing the solution with other medicines, possible incompatibilities should be considered.

Special attention should be paid

• To the patient's clinical condition and laboratory parameters (electrolytes in blood and urine as well as acid-base balance, hematocrit) during the use of this solution.
• To the patient's plasma potassium level (particularly in patients at risk of hyperkalemia).
• If used in elderly patients, due to the fact that they may have impaired renal, hepatic, or cardiac function.
• Patient with 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, continuous administration at the same injection site should be avoided due to the risk of thrombophlebitis.

Possible signs of inflammation or infection at the infusion site should be checked daily.

Hyperlite is a highly hypertonic solution, so it should never be administered undiluted under any circumstances.