9 mg / ml solution for infusion
sodium chloride
What Sodium Chloride B. Braun is and what it is used for
This medicine is a sodium chloride solution given to you through a tube in a vein ( intravenous drip). The drug contains a concentration of sodium chloride that is similar to the concentration of salts in your blood.
- Sodium chloride B. Braun is used to restore the fluid and electrolyte balance in the body after salt and fluid losses (dehydration) caused by e.g. severe vomiting or diarrhea, hot weather, extreme sweating, burns or permanent sores, kidney disease or through fistulas or serous cavities.
- Sodium chloride B. Braun can be used as a short-term replacement in case of blood loss.
- Your doctor may also prescribe Sodium Chloride B. Braun for reconstitution or dilution of other medicines included in your treatment.
Sodium chloride contained in Sodium Chloride B. Braun may also be approved for the treatment of other conditions 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.
What you need to know before you use Sodium Chloride B. Braun
Do not use Sodium Chloride B. Braun
- if you have too much fluid in your body (overhydration)
- if you have been informed that the level of sodium or chloride in your blood is significantly elevated (severe hypernatremia or severe hyperchloraemia ).
Warnings and cautions
Talk to your doctor or nurse before using Sodium Chloride B. Braun if you have any of the following:
- 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 ( hyperchloraemia )
- any disease that requires you to limit your intake of sodium , such as heart disease ( heart failure ), severe kidney disease (severe kidney function), swollen tissue due to accumulation of fluid in the tissues , water in the lungs ( pulmonary edema ), high blood pressure ( hypertension ) ) or preeclampsia , a disease that can occur during pregnancy and causes high blood pressure , cramps and swelling ( edema )
- a disease in which the adrenal glands produce too much of a hormone called aldosterone (hyperaldosteronism).
While you are receiving this medicine, your serum electrolyte concentrations, fluid balance, and acid-base balance will be checked from time to time.
If rapid infusion of the solution is required, your heart and lung function will be monitored.
To prevent brain damage (osmotic demyelinating syndrome), your doctor will make sure that the increase in sodium levels in your blood does not increase too quickly.
If the solution is used as a vehicle solution (carrier) for other electrolytes or medicines, your doctor will consider the safety information for the medicine to be dissolved or diluted in Sodium Chloride B. Braun.
Children
Premature or full-term infants can retain too much sodium due to undeveloped kidney function. Repeated infusions of sodium chloride should therefore only be given by your doctor after your serum sodium concentration has been determined.
Other drugs and Sodium chloride B. Braun
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will take special care if you are taking medicines that cause the body to retain sodium (eg corticosteroids, corticotropins, or non-steroidal anti-inflammatory drugs) as these may cause fluid to accumulate in body tissues ( edema ).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Particular caution will be exercised if you have preeclampsia, a disease that can occur during pregnancy and that causes high blood pressure, seizures, and swelling.
Breast-feeding
Sodium chloride B. Braun can be used during breastfeeding.
Driving and using machines
Sodium chloride B. Braun does not affect the ability to drive or use machines.
How to use Sodium Chloride B. Braun
This medicine is for intravenous use.
Dosage
Adults
The amount of medicine you receive depends on your need for water and salts ( electrolytes ).
Maximum dose:
You will gain up to 40 ml per kg of body weight per day. This means that you get up to 6 mmol sodium per kg body weight per day.
E.g. fever, diarrhea, or vomiting, the doctor will compensate the additional losses according to the volume and composition of the lost fluids.
The rate at which the medicine is given depends on your need for water and salts ( electrolytes ).
Elderly people will be closely monitored. In the elderly, the dose may need to be adjusted to avoid circulatory and renal problems caused by fluid supply.
In case of an urgent need for volume replacement in case of blood loss, the solution can in exceptional cases be given quickly by pressure infusion. In such cases, all air will be carefully removed from containers and tubing before starting an infusion.
Use for children
The doctor will determine the dose individually for your child.
If you take more Sodium Chloride B. Braun than you should
Overdose can lead to abnormally high fluid and abnormally high levels of sodium and chloride in the blood, accumulation of fluid in tissues ( edema ), and/or high levels of acidic substances in the blood (the blood becomes acidic). The first signs of overdose may be thirst, confusion, sweating, headache, weakness, drowsiness, or high heart rate (palpitations).
If the sodium concentration increases too fast, the brain can be damaged (osmotic demyelinating syndrome).
In such cases, the infusion will be stopped immediately. You can also get diuretics to increase urine output. The electrolyte concentration in your blood will be monitored continuously. The doctor decides on any additional medicines or measures to normalize the electrolyte concentration, the water balance, and the acid-base balance.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people):
- central pontine myelinolysis (a disorder of the central nervous system that can be severe or life-threatening).
Has been reported (occurs in an unknown number of users):
- excess fluid, too much sodium in the blood (if your heart and / or kidneys are not working properly) or too much acid in the blood.
- swelling of the veins (blood clot), reaction, pain, irritation, venous inflammation and / or infection at the injection site, that the medicine is not injected into a vein but into the surrounding tissue (extravasation) ( side effects caused by the way the medicine is given).
How to store Sodium Chloride B. Braun
No special storage instructions.
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 bottle and the outer carton after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if the solution looks cloudy or colored, if the solution contains particles or if the package leaks.
The solution should be used immediately after opening the package.
The packages are for single use only. Dispose of the packaging and any unused contents after use.
After dilution or admixture of additives
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user and would normally not be longer than 24 hours at 2-8 ° C.
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.
Contents of the pack and other information
Content declaration
- The active substance is sodium chloride. 1000 ml of solution contains 9.0 g of sodium chloride.
- The other ingredients are water for injections
What the medicine looks like and contents of the pack
Sodium chloride B. Braun is a clear, colorless solution of sodium chloride in water.
Available in the following packages:
Plastic packaging (Ecoflac plus): 20×50 ml, 20×100 ml, 10×250 ml, 10×500 ml, 10×1000 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Manufacturer:
B. Braun Melsungen AG
Carl-Braun-Strasse 1,
34212 Melsungen, Germany
OR
B. Braun Medical SA
Carreterra de Terrassa 121
08191 Rubi, Barcelona, Spain
OR
B. Braun Avitum AG
Schwarzenberger Weg 73-79
34212 Melsungen, Germany
Local representative:
B. Braun Medical AB
Box 110
182 12 Dandery