50 mg/ml, buffered infusion solution
Glucose, sodium chloride, sodium acetate trihydrate

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

In this leaflet you will find information about:
1. What Glucose Braun 50 mg/ml buffered is and what it is used for
2. What you need to know before you get Glucose Braun 50 mg/ml buffered
3. How to get Glucose Braun 50 mg / buffered
4. Possible side effects
5. How to store Glucose Braun 50 mg/ml buffered
6. Contents of the packaging and other information

1. What Glucose Braun 50 mg / ml buffered is and what it is used for

Glucose Braun 50 mg/ml buffered is an aqueous solution containing glucose, sodium chloride, and sodium acetate trihydrate. You will receive this medicine to add fluid during the day of surgery.

You can also get it to prevent or treat dehydration.

Glucose, sodium chloride, and sodium acetate trihydrate contained in Glucose Braun 50 mg/ml buffered may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you receive Glucose Braun 50 mg / ml buffered

Warnings and cautions

Talk to your doctor or nurse before receiving Glucose Braun 50 mg/ml buffered

  • if you have diabetes
  • if you have impaired kidney function
  • if you have heart problems
  • if you have any condition that causes the accumulation of fluid and sodium
  • if you have problems with the liquid level in the brain (for example, because of hjärnhinne- inflammation , bleeding within the skull or brain injury)
  • if you have a disease / condition that can cause high levels of vasopressin , a hormone that regulates fluid levels in the body, such as:
    • an acute and serious illness or injury
    • you have recently had surgery
    • disease of the brain
    • you are taking certain medicines (see section Other medicines and Glucose Braun 50 mg / ml buffered).

This can increase the risk of low sodium levels in the blood and can lead to headaches, nausea, seizures, fatigue, coma, and swelling of the brain.

Your fluid balance and your levels of glucose, sodium, and other electrolytes may need to be checked before and during treatment. You may therefore be allowed to submit blood samples before and during treatment.

Other medicines and Glucose Braun 50 mg / ml buffered

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

It is especially important that you tell your doctor if you are taking any of the following medicines, as they may increase the risk of side effects due to low levels of sodium in your blood (see section Warnings and precautions):

  • diuretics
  • certain cancer drugs
  • selective serotonin reuptake inhibitors (used to treat depression)
  • certain medicines for mental illness (antipsychotics)
  • morphine-like drugs ( opioids )
  • medicines for pain and / or inflammation (also called non-steroidal anti-inflammatory drugs ( NSAIDs ))
  • certain medicines for epilepsy
  • oxytocin (used to initiate labor, by caesarean section, to control postpartum haemorrhage, miscarriage or miscarriage).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

This medicine has no or negligible effect on the ability to drive and use machines.

3. How to get Glucose Braun 50 mg / ml buffered

Glucose Braun 50 mg/ml buffered is given to you by a doctor or nurse according to your clinical condition. Dose one of Glucose Braun 50 mg/ml buffered is determined by your doctor and depends on your condition, your age, and your body weight.

The drug is given in the form of a drip into a vein ( intravenous infusion ). The infusion rate is adapted to your condition.

If you are given too much Glucose Braun 50 mg / ml buffered

This is unlikely to happen because this medicine is given by healthcare professionals.

Overdose or too rapid infusion can lead to fluid overload with symptoms such as fluid retention ( edema ), especially at the ankles (swollen ankles), or in the lungs (may cause difficulty breathing), and electrolyte disturbances. If any of these occur, tell your doctor or nurse immediately. The infusion rate will be adjusted and, if necessary, the infusion will be stopped completely. Additional treatment depends on what symptoms you have.

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

4. Possible side effects

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

The following side effects have been reported:

Common (may affect up to 1 in 10 people):

  • inflammation with thrombosis ( thrombophlebitis ) in a blood vessel

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

  • low sodium levels in the blood ( hyponatremia )
  • swelling of the brain which can cause brain damage (hyponatremic encephalopathy )

Reporting of side effects

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. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Glucose Braun 50 mg / ml buffered

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. The expiration date is the last day of the specified month. The unused solution in an opened container should be discarded.

Do not use this medicine if the solution is not clear or if the container or its closure is damaged.

No special storage instructions.

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 are:

  • glucose (in the form of glucose monohydrate, 55.0 g): 50.0 g per liter
  • sodium chloride: 2.6 g per liter
  • sodium acetate trihydrate: 3.4 g per liter

The other ingredients are hydrochloric acid and water for injections.

Electrolyte content:

Sodium 70 mmol / l
Chloride 45 mmol / l
Acetate 25 mmol / l
Calorie value: 835 kJ (200 kcal)
Osmolarity 440 mOsm / l
pH ca 6
Acidimetric titration (to pH 7) about 2 mmol / l

What the medicine looks like and contents of the pack

Glucose Braun 50 mg/ml is a buffered solution for infusion.

It is a colorless or almost colorless aqueous solution.

Pack size: Ecoflac Plus polyethylene container 10 x 1,000 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

B. Braun Melsungen AG

34209 Melsungen

Germany

Manufacturer:

B. Braun Melsungen AG

34209 Melsungen, Germany

B. Braun Medical SA

Carretera de Terrassa 121

08191 Rubi, Barcelona, ​​Spain

Information provided by:

B. Braun Medical AB

Box 110

182 12 Danderyd

Muhammad Nadeem

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