Label: information for the user

Benelyte perfusion solution

(sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate and glucose monohydrate)

Read this label carefully before starting to use the medication, as it contains important information for you.

-Keep this label, as you may need to refer to it again.

-If you have any questions, consult your doctor, pharmacist or nurse.

-If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this label. See section 4.

1. What Benelyte is and how it is used

2. What you need to know before starting to use Benelyte

3. How to use Benelyte

4. Possible adverse effects

5. Storage of Benelyte

6. Contents of the container and additional information

Benelyte is an intravenous infusion solution (given through a vein). It contains minerals called electrolytes that affect the amount of water in your body and other important processes. It also contains carbohydrates.

Benelyte is used innewborns (0 to ≤28 days), infants (28 days to ≤2 years), children (2 to ≤12 years), and adolescents (12 to ≤14 years) for:

• To help restore fluid levels and normal electrolyte balance (salt) after surgery. It also contains glucose that provides a source of energy.
• As a plasma volume expander used to restore blood volume.
• To help restore fluid and electrolyte deficiencies.

It is used as a transport solution for other electrolytes and medications.

Do not use Benelyte

• If your child is allergic (hypersensitive) to sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, glucose, or any of the other components of this medication (listed in section 6).
• For premature newborns and neonates (≤28 days old): Your child should not receive a certain antibiotic called ceftriaxona as an intravenous infusion at the same time as this medication.
• If your child has excess water in their body (hyperhydration)

Warnings and precautions

Consult your doctor, pharmacist, or nurse before administering Benelyte to your child if your child has:

• Low levels of acid in the body (metabolic alkalosis)
• Abnormally high blood sugar levels (hyperglycemia)
• Abnormally low potassium levels in the blood (hypokalemia)
• Abnormally high sodium levels in the blood (hypernatremia)
• Abnormally high chloride levels in the blood (hyperchloremia)
• Renal insufficiency or decreased renal function
• Been treated with a certain antibiotic called ceftriaxona; do not mix or administer simultaneously with any solution containing calcium administered by intravenous infusion. Your doctor knows this and will not administer them together, either through different infusion lines or different infusion sites.
• • However, in children over 28 days old, your doctor may administer calcium and ceftriaxona sequentially one after the other if used through different infusion sites or if the infusion lines are replaced or flushed completely with physiological saline solution between infusions, to avoid precipitation. If you or your child suffer from low blood volume, your doctor will avoid administering calcium and ceftriaxona sequentially

While your child is receiving this medication, their serum electrolyte levels, water balance, blood glucose levels, and acid-base status should be monitored occasionally.

Care should be taken when administering the medication in children, especially in newborns and infants, as it may cause lactic acidosis (increased lactic acid in the body). This should be considered in children born with problems using lactate.

Use of Benelyte with other medications

Inform your doctor or pharmacist if your child is using, has used recently, or may need to use any other medication.

The concurrent use with ceftriaxona (an antibiotic) is not recommended when administered intravenously (see section Warnings and precautions).

Pregnancy and breastfeeding

Benelyte is only for use in children (under 14 years old).

Your child's doctor or other healthcare professional will administer this medication to your child through a vein (intravenous infusion).

Dosage

The doctor will determine the amount of medication to be administered to your child, which will depend on their age, weight, clinical condition, and any other treatment they are receiving. Their individual needs for fluids, electrolytes, and energy will be taken into account. The doctor will decide on the correct dosage for your child.

Follow exactly the administration instructions for Benelyte as indicated by your child's doctor or pharmacist. If in doubt, consult your child's doctor or pharmacist again.

If you use more Benelyte than you should

It is unlikely that your child will be given an incorrect dose, as the medication will be administered by a doctor or other healthcare professional.

A overdose may cause an excess of fluids in the body (hyperhydration) and an excess of sugar in the blood (hyperglycemia).

The doctor will determine the appropriate treatment to normalize your child's condition, which may include stopping the infusion, controlling your child's blood salt levels, and administering appropriate medications to treat your child's symptoms (e.g., diuretics, insulin).

If you have any other questions about the use of this medication, ask your child's doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Unknown Frequency(cannot be estimated from available data)

Local reactions at the injection site due to the administration technique:

• fever (febrile response)
• infection at the perfusion site
• irritation and inflammation of the vein in which the solution is infused (phlebitis). This may cause redness, pain, or burning and inflammation along the vein in which the solution is being administered
• formation of a blood clot (venous thrombosis) at the perfusion site, causing pain, swelling, or redness in the area of the clot
• escape of the perfusion solution into the surrounding tissues of the vein (extravasation). This may damage the tissues and cause scarring.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label or on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Use only if the solution is transparent, free of visible particles, and if the container is not damaged.

Use immediately after the first opening. From a microbiological standpoint, the product must be used immediately. If not used immediately, storage times and conditions in use are the responsibility of the user and are normally not to exceed 24 hours at 2°C-8°C, unless storage and opening are performed in controlled and validated aseptic conditions.

When combined with other infusion solutions, the current general requirements for medication mixing (e.g. aseptic conditions, compatibility, and complete mixing) must be taken into account.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Benelyte:

Each ml of Benelyte infusion solution contains:

Sodium chloride6,429 mg

Potassium chloride0,298 mg

Calcium chloride dihydrate0,147 mg

Magnesium chloride hexahydrate0,203 mg

Sodium acetate trihydrate4,082 mg

Glucose monohydrate11,0 mg

(equivalent to Glucose10,0 mg)

The other components are: hydrochloric acid 37% (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injection preparations.

Appearance of the product and contents of the container

Benelyte is a transparent, colorless to slightly yellowish aqueous infusion solution.

Benelyte is available in low-density polyethylene bottles (KabiPac) of 100 ml, 250 ml, and 500 ml as primary closed containers with a polyethylene or polyethylene/polypropylene stopper with a polyisoprene seal.

Container sizes:

40 x 100 ml bottles

20 x 250 ml bottles

10 x 500 ml bottles

Only some container sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Fresenius Kabi España, S.A.U.

Marina 16-18,

08005-Barcelona

Manufacturer responsible

Fresenius Kabi Polska Sp. z o.o.

ul. Sienkiewicza 25,

PL-99-300 Kutno

Poland

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet: August 2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/).

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This information is intended solely for healthcare professionals

For more information, please consult the technical data sheet.

Dosage

The dose for intravenous perioperative infusion therapy depends on the patient's fluid, electrolyte, and glucose needs:

During the first hour, for example, 10 to 20 ml/kg/hour, and then adjust the infusion rate according to the patient's basic and corrective needs, with monitoring of relevant cardiovascular and laboratory parameters.

The following reference values apply for fluid needs:

Newborns (0 to ≤28 days), infants (28 days to ≤1 year):

100 - 140 ml/kg of body weight/day

Infants 1 to ≤ 2 years:

80 - 120 ml/kg of body weight/day

Children 2 to ≤ 5 years:

80 - 100 ml/kg of body weight/day

Children 5 to ≤ 10 years:

60 - 80 ml/kg of body weight/day

Children 10 to ≤12 years and adolescents 12 to ≤14 years:

50 - 70 ml/kg of body weight/day

The dose should be administered individually according to the patient's fluid needs for short-term intravascular volume replacement.

The infusion rate and daily dose should be determined individually according to the nature and severity of the fluid and electrolyte imbalance, with monitoring of relevant cardiovascular and laboratory parameters, for the treatment of isotonic dehydration in pediatric patients.

If Benelyte is used in combination with other infusion solutions, the current guidelines on total fluid administration should be considered for calculating the dose of the corresponding age group.

The individual needs for water, electrolytes, and carbohydrates should be calculated and replaced accordingly; particularly in premature infants and low-birth-weight infants, and also in all other exceptional therapeutic situations. The balance needs to be more exact in premature infants, the youngest, and those with low birth weight.

Administration

Route of administration: intravenous.

Duration of administration:

The duration of administration depends on the patient's fluid and electrolyte needs.

Incompatibilities

The compatibility of the medications to be added to Benelyte should be evaluated before addition. In general, the following medications (groups) should not be mixed with Benelyte:

• Medications that may form insoluble precipitates with the constituents of the solution. (The preparation contains Ca2+ ions. Precipitation may occur with the addition of inorganic phosphate, hydrogen carbonate/carbonate, or oxalate).
• Medications that are not stable in an acidic pH range or do not have optimal efficacy or decompose

Infusion solutions containing glucose should not be administered simultaneously in the same infusion set with blood due to the possibility of pseudo-agglutination.