Infusion solution 
sodium chloride solution, 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. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Benelyte is and what it is used for 
2. What you need to know before you use 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 Benelyte is and what it is used for

Benelyte is a solution for intravenous infusion (drip into a vein). It contains minerals called electrolytes which affect the amount of water in the body and other important processes. It also contains carbohydrates.

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

  • It helps to restore fluid levels and the normal electrolyte (salt) balance after surgery. It also contains glucose which is a source of energy.
  • It acts as a plasma volume substitute used to restore blood volume.
  • It helps to recover fluid and electrolyte deficiencies.
  • It is used as a carrier solution for other electrolytes and drugs.

2. What you need to know before using Benelyte

Do not use Benelyte

  • if your child is allergic to sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, glucose, or any of the other ingredients of this medicine (listed in section 6),
  • if your child has too much water in the body (hyperhydration).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before giving your child Benelyte if your child has:

  • less acid in the body than normal ( metabolic alkalosis )
  • abnormally high blood sugar (hyperglycemia)
  • abnormally low level of potassium in the blood ( hypokalaemia )
  • abnormally high level of sodium in the blood ( hypernatremia )
  • abnormally high level of chloride in the blood ( hyperchloremia )

While your child is taking this medicine, serum electrolyte levels, water balance, blood sugar ( glucose ), and acid-base status will be checked from time to time.

Caution is required with children, especially with newborns and infants, when administering this medicine. This is because lactic acidosis (increased lactic acid in the body) can occur. This should be taken into account for children born with problems digesting and utilizing lactate.

Other medicines and Benelyte

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

Pregnancy, breastfeeding, and fertility

Benelyte is only intended for children (under 14 years).

3. How to use Benelyte

Your doctor or other healthcare professional will give your child this medicine by infusion into a vein ( intravenous drip).

Dosage

The amount of medicine that your child will be given is determined by the doctor and depends on the child’s age, weight, clinical condition, and what other treatment your child is receiving. The individual needs of fluids, electrolytes, and energy will be taken into account. Your doctor will determine the right dose for your child.

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

If you take more Benelyte than you should

It is unlikely that your child will receive too much because doctors or other healthcare professionals will give it.

An overdose can lead to too much fluid in the body (hyperhydration) and high blood sugar ( hyperglycemia ).

Any treatment to normalize your child’s condition will be determined by your doctor. It could mean an end of the infusion, one, checking your child’s level of salt in the blood, and your child is given adequate medication to treat the symptoms (such as diuretics ( diuretic drug), insulin ).

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

4. Possible side effects

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

Has been reported (occurs in an unknown number of users)

Local reactions due to administration technique (how the medicine is given):

  • fever,
  • injection site infection,
  • irritation and inflammation in the vein where the solution is given ( phlebitis ). This can cause redness, pain or burning sensation, and swelling along the vein in which the solution is given.
  • the formation of a blood clot ( venous thrombosis ) at the infusion site, which causes pain, swelling, or redness in the area where the blood clot is located,
  • leakage of infusion fluid into the tissues around the vein (extravasation). This can damage the tissues and cause scarring.

5. How to store Benelyte

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

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

Use only if the solution is clear, without visible particles and if the container is undamaged.

Use immediately after opening. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8 ° C, unless opening and storage have been performed under controlled and validated aseptic conditions.

When mixing with other infusion solutions, the general requirements for miscibility of medicinal products must be taken into account (eg aseptic conditions, compatibility, and thorough mixing ).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances in 1 ml of Benelyte solution for infusion are:

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
(corresponding 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 the medicine looks like and the contents of the pack

Benelyte is a clear, colorless to the pale yellow solution ( aqueous solution ).

Benelyte is available in 100 ml, 250 ml, and 500 ml low-density polyethylene bottles which are closed with a polyethylene or polyethylene/polypropylene cap containing a polyisoprene stopper.

Pack sizes:

40 x 100 ml bottles

20 x 250 ml bottles

10 x 500 ml bottles

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer

Fresenius Kabi Polska Sp. z oo

ul. Sienkiewicza 25

99-300 Kutno

Poland

Muhammad Nadeem

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