Glucosalino Braun 5% solution for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Glucosalino Braun 5% solution for infusion

Sodium chloride, glucose

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Glucosalino Braun 5% is and what it is used for
2. What you need to know before receiving Glucosalino Braun 5%
3. How to use Glucosalino Braun 5%
4. Possible adverse effects
5. Storage of Glucosalino Braun 5%
6. Package contents and additional information

1. What Glucosalino Braun 5% is and what it is used for

This medicine contains common salt and glucose. It will be administered to you via an intravenous infusion (drip).

It will be given to you:

• if you are lacking water
• if you are lacking both water and salts
• if you have lost chloride
• as a partial source of calories to meet your energy requirements

It may also be used to dilute or dissolve medicines that are administered to you via an intravenous infusion.

2. What you need to know before starting Glucosalino Braun 5%

Do not use Glucosalino Braun 5%:

• if you have excess water in your body tissues (hyperhydration)
• if you have abnormally high levels of electrolytes in your body fluids and tissues due to water loss (hypertonic dehydration)
• if your blood is too acidic (lactic acidosis)
• if you have an abnormally high blood sugar level that only responds to high doses of insulin or glucose intolerance
• if you have fluid in the lungs or brain
• if you have very high levels of sodium or chloride in the blood
• if you have heart failure

Special caution with this medicine is required if you have any of the following conditions:

• high levels of sodium or chloride in the blood
• disorders requiring restriction of sodium and fluid intake, for example:
  • heart failure
  • swelling in the limbs
  • high blood pressure
  • pre-eclampsia (see section “Pregnancy and breastfeeding”)
  • severe kidney problems

If you are suffering from an acute stroke and have excessively high blood sugar levels, your doctor will exercise special caution: your blood glucose level will be corrected before you receive this medicine.

If you have low potassium levels in the blood, your doctor will exercise special caution.

At the beginning and during treatment with this medicine, your doctor will monitor your fluid balance, electrolyte levels (especially potassium), blood acidity, and blood glucose levels. If you have very low sodium levels in the blood, your doctor will ensure they do not rise too rapidly.

An adequate supply of vitamins (particularly vitamin B1) will be ensured.

If your child is receiving this medicine, your doctor will exercise special caution.

Note: If this solution is used to dilute or dissolve medications to be administered via an infusion set, your doctor will take into account the safety information of the additive.

Other medicines and Glucosalino Braun 5%

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Your doctor will adjust your dose if you are receiving medicines that cause sodium and fluid retention (e.g., corticosteroids or non-steroidal anti-inflammatory drugs) or that affect how your body uses glucose (e.g., corticosteroids).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before receiving this medicine.

Pregnancy

Your doctor will administer this medicine only with caution and while monitoring your blood glucose levels. Special caution is required if you have a specific disorder that may occur during pregnancy called pre-eclampsia, characterized by the following symptoms: high blood pressure, seizures, and swelling.

Glucose-containing solutions may have harmful effects on newborns (low blood sugar) when administered during labour.

Breastfeeding

This medicine may be administered during breastfeeding.

Driving and using machines

The effect of this medicine on the ability to drive and operate machinery is none or negligible.

3. How to use Glucosalino Braun 5%

The medicine will be administered to you via an infusion drip into a vein.

Dosage

Adults

Your doctor will determine the amount of medicine you will receive based on your age, weight, clinical condition, blood acidity, and concomitant treatments. Therefore, your individual requirements for fluids, electrolytes, and energy will be taken into account.

The normal maximum dose for an adult is 40 ml/kg body weight per day. The maximum infusion rate is 5 ml per kg of body weight per hour.

If you have diarrhoea or vomiting, your doctor will decide whether you need to receive more of the medicine.

Children

Children will receive a reduced dose according to their age, weight, and clinical condition. Therefore, your child's individual daily requirements for fluids, electrolytes, and energy will be considered.

If your child has diarrhoea or vomiting, your doctor will decide whether they need to receive more of the medicine.

Elderly patients

The dosage is basically the same as for adults. However, your doctor will take precautions if you have other conditions commonly associated with advanced age, such as heart failure or renal failure.

Other special patient groups

Particular care will be taken if you have impaired glucose tolerance (e.g. after surgery, severe injury, lack of oxygen, organ failure, etc.). In these cases, your blood glucose level will be monitored while you receive this solution.

If you use more Glucosalino Braun 5% than you should

This is unlikely to occur, as your doctor, pharmacist, or nurse will control the infusion.

Symptoms

An overdose may cause fluid overload, which may lead to:

• Increased skin turgor
• Blood congestion
• Swelling
• Fluid accumulation in the lungs and brain
• Electrolyte and acid-base imbalances

It may also cause:
• High blood sugar levels and glucose in the urine

Treatment

Your doctor will determine the appropriate treatment. This may include stopping the infusion, monitoring blood electrolyte levels, and administering suitable medications to treat the observed symptoms (e.g. diuretics, insulin). In extreme situations, dialysis may also be necessary.

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

4. Possible adverse effects

Like all medicines, Glucosalino Braun 5 % may produce adverse effects, although not everyone will experience them.

You may experience:

• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (may occur in patients allergic to maize)
• pain and swelling at the infusion site

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 through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucosalino Braun 5 %

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

Do not use this medicine after the expiry date stated on the label and outer packaging. The expiry date is the last day of the month indicated.

This medicine is for single use only. After use, dispose of the container and any unused medicine.

Do not reconnect partially used containers.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the solution is not clear and colourless, or if the container or its closure is damaged.

6. Contents of the pack and other information

• The active substances are sodium chloride and glucose.

1,000 ml of the solution contain:

Sodium chloride 9.0 g

Glucose 50.0 g (as glucose monohydrate 55.0 g)

Electrolytes

Sodium 154 mmol/l

Chloride 154 mmol/l

The other components are water for injections.

Energy: 837 kJ/l – 200 kcal/l

Theoretical osmolarity: 586 mOsm/l

Acidity (up to pH 7.4): < 0.5 mmol/l

pH: 3.5–5.5

Appearance of the product and pack contents:

Sterile, clear and colourless solution of sodium chloride and glucose in water.

It is supplied in plastic bottles (Ecoflac Plus) of 250, 500, and 1000 ml (not all sizes may be marketed).

Marketing Authorization Holder and Manufacturing Responsible Party

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Date of the most recent review of this package leaflet: June 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices.

This information is intended for healthcare professionals only:

Method of administration:

The solution must not be administered through the same infusion set simultaneously, before, or after blood administration due to the risk of pseudoagglutination.

Hypertonic solutions should be administered through a central or large peripheral vein to reduce the risk of irritation.

Dosing:

Partial coverage of energy requirements, i.e., replacement of mandatory daily glucose requirements, is only possible with the maximum dose indicated above.