B. Braun

Concentrate for solution for infusion 4 mmol / ml 
(clear, colorless)

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 is Addens’ Sodium Chloride B. Braun and what it is used for 
2. What you need to know before you get Addens’ Sodium Chloride B. Braun 
3. How to use Addens’ Sodium Chloride B. Braun 
4. Possible side effects 
5. How to store Addens’ Sodium Chloride B. Braun 
6. Contents of the packaging and other information 

What Additive Sodium Chloride B. Braun is and what it is used for

This medicine is a concentrated sodium chloride solution used as a salt additive. It is given to you after dilution in an infusion solution through a tube placed in a vein ( intravenous drip).

You will receive the medicine:

  • if you have low levels of sodium in your blood
  • as a sodium additive to infusion fluids used to deliver fluid and to cover sodium needs if you get all your nutrition directly in a vein (complete parenteral nutrition)
  • if you have suffered from dehydration ( hypotonic hyperhydration) in connection with a prostate operation (so-called TUR syndrome)

Sodium chloride contained in Addens-Sodium chloride B. Braun may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

2. What you need to know before you get Addens-Sodium Chloride B. Braun

Do not use Addens-Sodium Chloride B. Braun:

  • if you have too much sodium or chloride in your blood.

Warnings and cautions

Talk to your doctor before using Addens-Sodium Chloride B. Braun if you have:

  • abnormally low level of potassium in the blood ( hypokalaemia )
  • heart failure
  • swelling in the arms or legs due to fluid accumulation in the body tissues(generalized edema )
  • water in the lungs ( pulmonary edema )
  • high blood pressure
  • diseases during pregnancy that are associated with high blood pressure
  • severe renal impairment
  • abnormally high levels of acids in the blood ( acidosis ).

Your serum electrolyte level, water balance, and acid-base balance will be checked regularly during treatment.

Other medicines and Addens-Sodium chloride B. Braun

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

Corticosteroids (“cortisone”) and adrenocorticotropic hormone can lead to accumulation of fluid and salt, which can lead to swelling and high blood pressure. Your doctor should therefore know if you are using these medicines.

Pregnancy and breastfeeding

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

Particular caution will be exercised if you suffer from diseases during pregnancy that is associated with high blood pressure.

Addens-Sodium Chloride B. Braun can be used during breast-feeding.

Driving and using machines

Addens-Sodium Chloride B. Braun has no effect on the ability to drive and use machines.

How to use Addens’ Sodium Chloride B. Braun

The medicine will be given to you as an infusion into a vein after dilution in a suitable infusion solution.

Your doctor will decide on the amount of medicine you will receive. The amount will be calculated based on the measured sodium level in your blood and also taking into account your body weight, age, and acid-base balance in your blood.

If the level of sodium in your blood has been low for a long time, your doctor will give you Addens-Sodium Chloride B. Braun at a lower infusion rate to avoid brain damage (see also section If you have been given too much Addens-Sodium Chloride B. Braun).

If you take more Addens Sodium Chloride B. Braun than you should

Signs of overdose

Too much of this medicine can lead to accumulation of fluid in the body, abnormally high levels of sodium and chloride in the blood, and to the blood becoming too concentrated.

Too fast an infusion can cause volume overload. You may experience fluid retention in your arms, legs, or lungs as well as high blood pressure. Diarrhea and increased urine flow can also occur due to abnormally high salt concentration in the blood.

If your sodium levels have been low for a long time and now increase rapidly, your brain can be damaged (osmotic demyelinating syndrome).

Measures to be taken in case of overdose

If any of the above occur, contact your doctor or nurse immediately. The infusion rate will be reduced or will the infusion a discontinued immediately. In addition, you can get drugs that increase urine flow. The electrolyte levels in the blood will be monitored continuously. Your doctor will decide on additional medication or other measures to normalize your electrolyte levels, water balance, and acid-base balance

4. Possible side effects

Solutions with high sodium content can cause irritation or inflammation in the vein in which the tube has been placed.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Addens’ Sodium Chloride B. Braun

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 label and carton. 

Do not use this medicine if the solution is cloudy or discolored, if you see particles in the solution or if the ampoule or its closure is damaged. 

No special storage instructions. 

For single use only. Dispose of the packaging and any unused contents after use.

6. Contents of the packaging and other information

Content declaration

  • The active substance is sodium chloride. 
    1 ml concentrate for solution for infusion contains 234 mg sodium chloride.
  • 1 ml concentrate for solution for infusion contains 4 mmol sodium and 4 mmol chlorides.
  • The other ingredients are water for injections.
  • Theoretical osmolarity is 8000 mOsmol / l and pH 4.5–7.0.

What the medicine looks like and the contents of the pack

Addens-Sodium Chloride B. Braun 4 mmol/ml concentrate for solution for infusions a clear, colorless solution containing sodium chloride in water.

It is available in plastic ampoules containing 10 ml or 20 ml solution.

Pack sizes: 20 x 10 ml, 20 x 20 ml.

Marketing Authorization Holder and Manufacturer

B. Braun Melsungen AG

34209 Melsungen

Germany

This leaflet was last modified on 08/08/2018

The following information is intended for healthcare professionals only:

Method of administration

Intravenous use after dilution with a suitable infusion solution. In normal cases, the calculated amount of sodium chloride is added to 250 ml of liquid. In the case of dehydration, larger volumes of diluent can be used. For infusion into peripheral veins, the solution must be diluted so as not to exceed an osmolarity of 800 mOsm / l. The sodium chloride concentrate should be added to the infusion solution under strictly aseptic conditions immediately before starting the infusion. The infusion bottle should then be gently shaken.

Incompatibilities

80 ml (4 ampoules) can be added to 1,000 ml of most common infusion fluids such as amino acid solution, glucose, glucose – electrolyte – and electrolyte solutions.

Shelf life in broken packaging

The product should be used immediately.

Shelf life after dilution

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

Management

The packages are for single use only. Dispose of the packaging and any unused contents after use.

Use only if the solution is clear, colorless, and particle-free and if the package, ampoule, and its closure are undamaged.

Muhammad Nadeem

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