Benelyte solution for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Benelyte infusion solution

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

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Benelyte is and what it is used for

Benelyte is an intravenous infusion solution (into 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 in newborns (0 to ≤28 days), infants (28 days to ≤2 years), children (2 to ≤12 years), and adolescents (12 to ≤14 years) for:

• Helping to restore fluid levels and normal electrolyte (salt) balance after surgery. It also contains glucose, which provides an energy source.
• Acting as a plasma volume substitute used to restore blood volume.
• Helping to correct fluid and electrolyte deficiencies.

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

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

Do not use Benelyte

• if your child is allergic (hypersensitive) to sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, glucose, or to any of the other components of this medicine (listed in section 6).
• For premature and neonatal infants (≤28 days of age): Your child must not receive a certain antibiotic called ceftriaxone as an intravenous infusion at the same time as this medicine.
• if your child has excess water in the body (hyperhydration)

Warnings and precautions

Consult your doctor, pharmacist, or nurse before your child is given Benelyte if your child has:

• less acid in the body than normal (metabolic alkalosis)
• abnormally high blood sugar level (hyperglycemia)
• abnormally low blood potassium level (hypokalemia)
• abnormally high blood sodium level (hypernatremia)
• abnormally high blood chloride level (hyperchloremia)
• renal failure or reduced kidney function
• been treated with a certain antibiotic called ceftriaxone; it must not be mixed or administered simultaneously with any calcium-containing solution given by intravenous infusion. Your doctor is aware of this and will not administer them together, even through different infusion lines or at different infusion sites.
  • However, in children older than 28 days, your doctor may administer calcium and ceftriaxone sequentially, one after the other, if different infusion sites are used, or if the infusion lines are replaced or thoroughly flushed with physiological saline solution between infusions, to prevent precipitation. If you or your child have low blood volume, your doctor will avoid administering calcium and ceftriaxone sequentially.

While your child is receiving this medicine, serum electrolyte levels, fluid balance, blood glucose levels, and acid-base status should be monitored periodically.

Caution should be exercised when administering this medicine to children, especially newborns and infants, as lactic acidosis (increased lactic acid in the body) may occur. This should be considered in children born with lactate utilization disorders.

Use of Benelyte with other medicines

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines.

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

Pregnancy and breastfeeding

Benelyte is intended for use in children only (under 14 years of age).

3. How to use Benelyte

Your doctor or other healthcare professional will administer this medicine to your child as an intravenous infusion (intravenous drip).

Dosage

The dose your child will receive will be determined by the doctor and will depend on your child's age, weight, clinical condition, and any other treatments being received. Therefore, your child's individual requirements for fluids, electrolytes, and energy will be taken into account. Your doctor will decide the correct dose for your child.

Always follow exactly the instructions for administration of Benelyte provided by your doctor or pharmacist. If you have any doubts, consult your 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 medicine will be administered by a doctor or other healthcare professional.

An overdose may cause excess fluid in the body (fluid overload) and high blood sugar levels (hyperglycaemia).

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Frequency not known (cannot be estimated from available data)

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

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

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 via 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. Benelyte Storage

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

Do not use this medicine after the expiry date stated on the label or the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Use only if the solution is clear, free from visible particles, and the container is undamaged.

Use immediately after first opening. From a microbiological standpoint, the product should be used immediately. If immediate use is not possible, the duration and conditions of in-use storage are the responsibility of the user and normally should not exceed 24 hours at 2°C–8°C, unless the storage and opening have been carried out under controlled and validated aseptic conditions.

When combined with other infusion solutions, current general requirements for mixing medications must be observed (e.g. aseptic conditions, compatibility, and complete mixing).

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Benelyte:

Each ml of Benelyte infusion solution 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

(equivalent to Glucose 10.0 mg)

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

Appearance of the product and contents of the container

Benelyte is a clear, colourless 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 containers closed with a polyethylene or polyethylene/polypropylene stopper and a polyisoprene seal.

Pack sizes:

40 x 100 ml bottles

20 x 250 ml bottles

10 x 500 ml bottles

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España, S.A.U.

Marina 16-18,

08005-Barcelona

Manufacturer

Fresenius Kabi Polska Sp. z o.o.

ul. Sienkiewicza 25,

PL-99-300 Kutno

Poland

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

Date of the last review of this summary: August 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only

For further information, please refer to the summary of product characteristics.

Dosage

The dose for perioperative intravenous infusion therapy depends on fluid, electrolyte, and glucose requirements:

During the first hour, for example, 10 to 20 ml/kg/hour, followed by adjustment of the infusion rate according to basic and corrective requirements, with monitoring of relevant cardiovascular and laboratory parameters.

The following reference values apply for fluid requirements:

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

100 - 140 ml/kg body weight/day

Infants from 1 to ≤2 years:

80 - 120 ml/kg body weight/day

Children from 2 to ≤5 years:

80 - 100 ml/kg body weight/day

Children from 5 to ≤10 years:

60 - 80 ml/kg body weight/day

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

50 - 70 ml/kg body weight/day

For short-term intravascular volume replacement, the dose must be individually administered according to fluid requirements.

For the treatment of isotonic dehydration in the pediatric population, the infusion rate and daily dose must be individually determined based on the nature and severity of the fluid and electrolyte imbalance, with monitoring of relevant cardiovascular and laboratory parameters.

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

Individual requirements for water, electrolytes, and carbohydrates should be calculated and replaced accordingly, particularly in premature and low-birth-weight newborns, as well as in all other exceptional therapeutic situations. More precise balance management is required in premature infants, younger patients, and those with low body weight.

Method of administration

Intravenous route.

Duration of administration

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

Incompatibilities

Compatibility of drugs intended to be added to Benelyte must be evaluated prior to addition. In general, the following drugs (groups) should not be mixed with Benelyte:

• Drugs that may form poorly soluble precipitates with components of the solution. (The formulation contains Ca2+ ions. Precipitation may occur upon addition of inorganic phosphate, bicarbonate/carbonate, or oxalate).
• Drugs that are not stable in an acidic pH range, do not exhibit optimal efficacy, or that decompose under such conditions.

Infusion solutions containing glucose must not be administered simultaneously through the same infusion set with blood due to the risk of pseudo-agglutination.