Benelite

Leaflet attached to the packaging: information for the user

Benelyte, solution for infusion

Complex product

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Benelyte and what is it used for
• 2. Important information before using Benelyte
• 3. How to use Benelyte
• 4. Possible side effects
• 5. How to store Benelyte
• 6. Contents of the packaging and other information

1. What is Benelyte and what is it used for

Benelyte is a solution for intravenous infusion (into a vein). It contains mineral components called electrolytes, which affect the amount of water and other essential processes in the body. It also contains carbohydrates.
Benelyte is indicated for use in newborns (from 0 to ≤28 days), infants (from 28 days to ≤2 years), children (from 2 to ≤12 years), and adolescents (from 12 to ≤14 years), because:

• it helps restore the normal fluid and electrolyte (salt) content in the body after surgery; it also contains glucose, which is a source of energy;
• it acts as a plasma volume substitute, used to restore normal blood volume;
• it helps supplement fluid and electrolyte deficiencies;
• it serves as a diluent for other electrolytes and medications.

2. Important information before using Benelyte

When not to use Benelyte

• if the patient is allergic (hypersensitive) to sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, glucose, or any of the other components of this medicine (listed in section 6);
• in preterm and newborn infants (up to 28 days of age): the antibiotic ceftriaxone should not be administered by intravenous infusion simultaneously with this medicine;
• if the patient has an excess of water in the body (overhydration).

Warnings and precautions

Before starting treatment with Benelyte, tell your doctor, pharmacist, or nurse if the patient has:

• low acid levels in the body (metabolic alkalosis);
• high blood sugar levels (hyperglycemia);
• low potassium levels in the blood (hypokalemia);
• high sodium levels in the blood (hypernatremia);
• high chloride levels in the blood (hyperchloremia);
• kidney failure or impaired kidney function;
• treatment with the antibiotic ceftriaxone; it should not be mixed or administered simultaneously with any solutions containing calcium, given by intravenous infusion. Knowing this, the doctor will not recommend administering them to the patient simultaneously, even through different infusion lines or different infusion sites;
• however, in patients over 28 days of age, the doctor may administer calcium and ceftriaxone sequentially, one after the other, if the infusion lines are inserted at different sites or are changed or thoroughly flushed with physiological saline solution between infusions, to avoid precipitate formation. In the case of adult or pediatric patients with low blood volume, the doctor will not recommend administering calcium and ceftriaxone sequentially.

During treatment with Benelyte, the doctor will periodically check the electrolyte levels in the blood, fluid balance, blood glucose levels, and acid-base balance.
Due to the risk of lactic acidosis (increased lactic acid levels in the body), special caution should be exercised when using this medicine in children, especially newborns and infants. This should be taken into account in children with lactic acid metabolism disorders.

Benelyte and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

• Concomitant use of Benelyte with ceftriaxone (an antibiotic) administered intravenously is not recommended (see section Warnings and precautions).

Pregnancy and breastfeeding

Benelyte is intended for use only in children and adolescents (up to 14 years of age).

3. How to use Benelyte

Benelyte will be administered by a doctor or other qualified medical personnel, in the form of an intravenous infusion (drip).

Dosage

The doctor will determine the amount of medicine the patient will receive, based on the patient's age, weight, clinical condition, and other medications being used. When determining the dose, the doctor will take into account the individual need for fluids, electrolytes, and energy. The doctor will decide on the appropriate dose of the medicine for the patient to receive.
This medicine should always be used as directed by the doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Using more than the recommended dose of Benelyte

Since this medicine will be administered by a doctor or other medical personnel, incorrect dosing is unlikely.
Overdose may lead to excess fluid in the body (overhydration) and high blood sugar levels (hyperglycemia).
The doctor will determine the treatment to normalize the patient's condition. Treatment may include discontinuing the infusion, monitoring electrolyte levels in the blood, and using appropriate symptomatic treatment (e.g., diuretics, insulin).

4. Possible side effects

Like all medicines, Benelyte can cause side effects, although not everybody gets them.

Frequency not known (cannot be estimated from the available data)

Local reactions related to the method of administration:

• fever;
• infection at the infusion site;
• irritation and inflammation of the vein at the infusion site; this may cause redness, pain, or burning and swelling along the vein into which the solution is administered;
• formation of a blood clot (thrombophlebitis) at the infusion site, causing pain, swelling, or redness at the clot formation site;
• leakage of the medicine into the surrounding tissues (extravasation); this may lead to tissue damage and scarring.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Benelyte

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or carton after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Use only a clear solution, without visible particles, and when the packaging is not damaged.
Use immediately after opening. From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the user is responsible for the storage time and conditions before use. The storage period should not exceed 24 hours, at a temperature between 2°C and 8°C, unless the opening and storage of the medicine took place in controlled and validated aseptic conditions.
When using with other infusion solutions, consider the current general requirements for mixing medicines (e.g., aseptic conditions, compatibility, and accuracy of the mixture).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Benelyte contains

One ml of Benelyte solution for infusion contains:
sodium chloride
6.429 mg
potassium chloride
0.298 mg
calcium chloride dihydrate
0.147 mg
magnesium chloride hexahydrate
0.203 mg
sodium acetate trihydrate
4.082 mg
glucose monohydrate
11.0 mg
(which corresponds to glucose
10.0 mg)
The other ingredients are: hydrochloric acid 37% (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What Benelyte looks like and what the pack contains

Benelyte is a clear, colorless to slightly yellowish aqueous solution for infusion.
Benelyte is available in LDPE (KabiPac) bottles of 100 ml, 250 ml, and 500 ml with a PE or PE/PP closure, containing a polyisoprene stopper.
Pack sizes:
40 bottles of 100 ml
20 bottles of 250 ml
10 bottles of 500 ml.
Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Polska Sp. z o.o.
ul. Sienkiewicza 25
99-300 Kutno
To obtain more detailed information about this medicine, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
ELO-MEL paediatric Infusionslösung
Belgium
Bulgaria
Croatia
Benelyte oplossing voor infusie/solution pour perfusion/Infusionslösung
Бенелайт инфузионен разтвор
Benelyte solution for infusion
Benelyte otopina za infuzij
Czech Republic
Denmark
Estonia
Benelyte
Benelyte
Benelyte
Finland
Benelyte Infuusioneste, liuos
France
Benelyte, solution pour perfusion
Spain
Benelyte solución para perfusión
Netherlands
Benelyte oplossing voor infusie
Ireland
Latvia
Lithuania
Paedisol solution for infusion
Benelyte šķīdums infūzijām
Benelyte infuzinis tirpalas
Luxembourg
Benelyte Infusionslösung
Germany
Benelyte Infusionslösung
Norway
Benelyte
Poland
Benelyte
Portugal
Romania
Benelyte
Benelyte soluție perfuzabilă
Slovakia
Benelyte
Slovenia
Benelyte raztopina za infundiranje
Sweden
Benelyte
Hungary
Benelyte oldatos infúzió
United Kingdom (Northern Ireland)
Minorsol solution for infusion
Date of last revision of the leaflet:18.06.2025
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Information intended for healthcare professionals only:

To obtain additional information, refer to the Summary of Product Characteristics.

Dosage

Dosage in perioperative intravenous infusion depends on the patient's need for fluids, electrolytes, and glucose: for the first hour, e.g., 10-20 ml/kg body weight/hour, and then as needed, according to the patient's basic and adjusted needs, monitoring the relevant cardiovascular and laboratory parameters.
The need for fluids is determined based on the following reference values:
Newborns (from 0 to ≤28 days), infants (from 28 days to ≤1 year):
100-140 ml/kg body weight per day.
Infants from 1 year to ≤2 years:
80-120 ml/kg body weight per day.
Children from 2 to ≤5 years:
80-100 ml/kg body weight per day.
Children from 5 to ≤10 years:
60-80 ml/kg body weight per day.
Children from 10 to ≤12 years and adolescents from 12 to ≤14 years:
50-70 ml/kg body weight per day.
In the case of short-term supplementation of intravascular volume, the dose should be determined individually, based on the need for fluids.
In the treatment of isotonic dehydration in children and adolescents, the infusion rate and daily dose should be determined individually, based on the nature and severity of the water and electrolyte balance disorders, monitoring the relevant cardiovascular and laboratory parameters.
If Benelyte is used concomitantly with other infusion solutions, the dose for the selected age group should be determined, taking into account the current guidelines for total fluid intake.
Especially in preterm and newborn infants with low birth weight, as well as in other exceptional therapeutic situations, the individual need for water, electrolytes, and carbohydrates should be calculated and modified accordingly. The balancing of needs should be more precise, the greater the degree of prematurity, the younger the patient, and the lower the birth weight.

Method of administration

Intravenous administration.

Administration time

The administration time depends on the patient's need for fluids and electrolytes.

Incompatibilities

Before adding the medicine, check its compatibility with Benelyte.
The following medicines (groups) should not be mixed with Benelyte:

• those that may form poorly soluble precipitates with the solution components (Benelyte contains Ca ions. After addition of inorganic phosphate, bicarbonate/carbonate, or oxalate, precipitate formation may occur),
• those showing poor stability in the acidic pH range, not showing optimal efficacy, or undergoing degradation,
• parenteral nutrition solutions, for which compatibility has not been tested. Glucose-containing infusion solutions should not be administered simultaneously with blood through the same infusion equipment due to the risk of pseudoagglutination.