SODIUM HYDROGEN CARBONATE B.Braun 8.4% glass
Pack size:5 x 20 ml Dosage form:Infusion solution concentrate
Sodium bicarbonate 8.4% B. Braun, concentrate. Indications: Used to: correct excessive blood acidity (metabolic acidosis), raise the pH of the urine (urine alkalization) in cases of poisoning with weak organic acids (e.g. barbiturates, acetylsalicylic acid), raise the pH of the urine (urine alkalization) to improve the solubility of medications that are poorly soluble in neutral and acidic environments (e.g. methotrexate, sulfonamides), and raise the pH of the urine (urine alkalization) in cases of red blood cell breakdown (hemolysis).
For information on risks and side effects, read the package insert and ask your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium bicarbonate 8.4% B. Braun, concentrate for solution for infusion
Active ingredient: sodium bicarbonate
Read the entire package leaflet carefully before you start using this medicine.
- Keep this leaflet. You may want to read it again later.
- If you have any further questions, ask your doctor or pharmacist.
- If any of the side effects listed affect you seriously or if you notice side effects not listed in this leaflet, please inform your doctor or pharmacist.
This package leaflet contains:
- WHAT IS SODIUM HYDROGEN CARBONATE 8.4% B. BRAUN CONCENTRATE AND WHAT IS IT USED FOR?
- WHAT SHOULD YOU CONSIDER BEFORE USING SODIUM HYDROGEN CARBONATE 8.4% B. BRAUN CONCENTRATE?
- HOW SHOULD SODIUM HYDROGEN CARBONATE 8.4% B. BRAUN CONCENTRATE BE USED?
- WHAT SIDE EFFECTS ARE POSSIBLE?
- HOW SHOULD SODIUM HYDROGEN CARBONATE 8.4% B. BRAUN CONCENTRATE BE STORED?
- MORE INFORMATION
1. WHAT IS SODIUM BIOXIDE CARBONATE 8.4% B. BRAUN CONCENTRATE AND WHAT IS IT USED FOR?
Sodium bicarbonate 8.4% B. Braun concentrate is a solution for raising blood pH (alkalization) by administering bicarbonate. Sodium bicarbonate 8.4% B. Braun concentrate is used to: correct excessive acidity of the blood (metabolic acidosis), raise the pH of the urine (urine alkalization) in cases of poisoning with weak organic acids (e.g. barbiturates, acetylsalicylic acid), raise the pH of the urine (urine alkalization) to improve the solubility of medications that are poorly soluble in neutral and acidic environments (e.g. methotrexate, sulfonamides), and raise the pH of the urine (urine alkalization) in cases of red blood cell breakdown (hemolysis). Sodium bicarbonate 8.4% B. Braun concentrate is a medicine that will be administered to you by a doctor or medical professional.
2. WHAT SHOULD YOU CONSIDER BEFORE USING SODIUM HYDROGEN CARBONATE 8.4% B. BRAUN CONCENTRATE?
Sodium bicarbonate 8.4% B. Braun concentrate must not be used in the following cases:
- Excess alkali in the blood (alkalosis),
- low potassium levels in the blood (hypokalemia),
- increased sodium levels in the blood (hypernatremia).
Special care is required when using sodium bicarbonate 8.4% B. Braun concentrate in the following cases:
- slowed or shallow breathing (hypoventilation),
- low calcium levels in the blood (hypocalcaemia),
- Conditions associated with increased concentration of salts in the blood (hyperosmolarity),
- Diseases that require a limited sodium intake, such as heart failure, fluid accumulation in the tissues (generalized edema), fluid accumulation in the lungs (pulmonary edema), high blood pressure (hypertension), pregnancy-related conditions with high blood pressure, cramps and fluid accumulation in the tissues (eclampsia), severe kidney dysfunction (renal insufficiency).
Monitoring of serum electrolytes, fluid balance, and acid-base status is required. Administration of sodium bicarbonate 8.4% B. Braun concentrate can lead to high sodium and fluid load. Alkalizing therapy can cause the potassium level in the blood to fall below normal levels (hypokalemia). In cases of low potassium or calcium levels in the blood (hypokalemia or hypocalcemia, respectively), the potassium or calcium deficiency should be corrected before alkalizing therapy. Particular care must be taken with strict intravenous administration, as accidental administration into an artery can lead to shock and loss of the affected limb. If not used as directed, sodium bicarbonate 8.4% B. Braun concentrate can cause vein wall irritation with subsequent phlebitis and thrombophlebitis if applied undiluted or too quickly into veins of the limbs (peripheral veins) due to the alkaline pH value and the high concentration of the active ingredient. If accidentally administered next to the vein (paravenously) into the surrounding tissue, tissue destruction (necrosis) can occur.
When using sodium bicarbonate 8.4% B. Braun concentrate with other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken or used any other medicines, including medicines obtained without a prescription. In particular, please inform your doctor if you are receiving or taking the following medicines:
–%%% adrenal cortex hormones,
–%%% androgens (male sex hormones),
–%%% diuretics that increase potassium excretion.
The increase in the pH value (alkalization) of the urine by bicarbonate causes accelerated excretion of acidic drugs (e.g., acetylsalicylic acid) and delayed excretion of basic drugs. Due to its alkaline pH value, Sodium Bicarbonate 8.4% B. Braun Concentrate is physically and chemically incompatible with most medications. In particular, combination with solutions containing calcium, magnesium, and phosphate can lead to precipitation. Pregnancy
and breastfeeding:
Please inform your doctor of a possible pregnancy or if you are breastfeeding before treatment with Sodium Bicarbonate 8.4% B. Braun Concentrate.
Sodium bicarbonate can be administered to you via infusion during pregnancy if your doctor considers this absolutely necessary after carefully weighing up the benefits and risks. Due to the high sodium content of the solution, special caution is required in pregnancy-related illnesses with high blood pressure, cramps and fluid retention in the tissues (eclampsia) (see section "Special care is required when using Sodium Bicarbonate 8.4% B. Braun Concentrate"%%%).
Breastfeeding:
During breastfeeding, Sodium Bicarbonate 8.4% B. Braun Concentrate should only be used with caution after carefully weighing up the benefits and risks.
Ability to drive and operate machinery:
Sodium Bicarbonate 8.4% B. Braun Concentrate has no influence on the ability to drive or operate machinery.
3. HOW SHOULD SODIUM BIcarbonatE 8.4% B. BRAUN CONCENTRATE BE USE?
This medicine will be administered to you by a doctor or medical professional.
Dosage:
Adults:
When correcting metabolic acidosis, the dosage depends on the extent of the acid-base imbalance. The amount to be administered is calculated according to the blood gas analysis values using the following formula: ml 1 molar sodium bicarbonate 8.4% B. Braun concentrate = base deficit (-BE) × kg body weight × 0.3 (The factor 0.3 corresponds to the proportion of extracellular fluid in relation to total fluid.)
Children:
Your doctor will determine the dosage for your child individually. Initially, a dosage of up to 1 mmol/kg body weight can be selected, which is administered to your child slowly into a vein (iv).
Newborns and children under 2 years of age:
Your doctor will ensure that the dose to be administered does not exceed 5 mmol/kg body weight per day. The solution is then administered to your child slowly into a vein and is generally diluted. Your doctor will ensure that a 4.2% (or lower) sodium bicarbonate solution should generally be used in this age group.
Example of use:
A determined base deficit (BE) of, for example, -5 with a body weight of 70 kg results in: 5 × 70 × 0.3 = 105 ml of sodium bicarbonate 8.4% B. Braun concentrate. Since acidosis correction should not occur too quickly, i.e., complete compensation of the base deficit should not be sought, it is recommended to initially administer half of the calculated amount of sodium bicarbonate 8.4% B. Braun concentrate and base the next dose on the results of further blood gas analyses.
Maximum daily dose:
The maximum daily dose depends on the correction required.
Maximum infusion rate:
Up to approximately 1.5 ml of sodium bicarbonate 8.4% B. Braun concentrate per kg of body weight per hour. For urine alkalinization, the dosage is based on the desired pH value in the urine and is carried out under control of the acid-base, water and electrolyte balance. The maximum infusion rate specified above must not be exceeded.
Method of administration:
Intravenous use, i.e. administration as an infusion into a vein. Only use diluted as an additive to infusion solutions! In general, the calculated amount of sodium bicarbonate 8.4% B. Braun concentrate is administered in 250 ml of fluid. In the event of fluid deficiency, larger volumes can be selected as a carrier solution. For peripheral venous administration, sodium bicarbonate 8.4% B. Braun concentrate must be diluted so that a total osmolarity of 800 mOsm/l is not exceeded. Sodium bicarbonate 8.4% B. Braun concentrate may only be injected immediately before starting the infusion under strictly sterile precautions. The infusion bottle should then be shaken gently.
If you have received more sodium bicarbonate 8.4% B. Braun concentrate than you should:
An overdose can lead to excess alkali in the blood (alkalosis), increased sodium levels in the blood (hypernatremia), and increased osmolarity of the blood (hyperosmolarity). If excessive acidosis of the blood is corrected too quickly, particularly in the case of respiratory disorders, the rapid release of CO2 can temporarily intensify excessive acidification of the brain (cerebral acidosis).
Countermeasures:
Alkalosis therapy depending on the severity: administration of isotonic sodium chloride solution, potassium supplementation, in the case of pronounced alkalosis, infusion of L-arginine hydrochloride or hydrochloric acid.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, sodium bicarbonate 8.4% B. Braun concentrate can cause side effects, although not everybody experiences them. The frequency of side effects is based on the following categories:
| The following categories are used to indicate the frequency of side effects: | |
| Very common: | more than 1 in 10 treated patients |
| Frequently: | 1 to 10 treated patients out of 100 |
| Occasionally: | 1 to 10 patients treated in 1,000 |
| Rarely: | 1 to 10 treated patients out of 10,000 |
| Very rare: | less than 1 in 10,000 treated |
| Not known: | Frequency cannot be estimated based on the available data. |
Possible side effects:
Metabolism and nutritional disorders:
Not known: Use may lead to increased sodium levels in the blood (hypernatremia) and excessive salt concentration in the blood.
Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW SHOULD SODIUM HYDROGEN CARBONATE 8.4% B. BRAUN CONCENTRATE BE STORED?
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and container after “%%%Use by”%%% or “%%%Exp. by:”%%%. The expiry date refers to the last day of that month. Storage conditions: Sodium hydrogen carbonate 8.4% B. Braun concentrate is an almost saturated solution. It should therefore not be stored below room temperature. Any crystals can be dissolved by heating. Shelf life after opening or preparation: No multi-dose container! Opened solutions must be used immediately. Any leftovers must be discarded. Only use if the container is undamaged and the solution is clear.
6. FURTHER INFORMATION
What Sodium hydrogen carbonate 8.4% B. Braun concentrate contains:
The active ingredient is sodium hydrogen carbonate (sodium bicarbonate). 100 ml of concentrate for solution for infusion contains 8.4 g of sodium hydrogen carbonate (sodium bicarbonate). The other ingredient is water for injections. Electrolyte concentration: 1 ml contains 1 mmol sodium ion and 1 mmol bicarbonate ion. Theoretical osmolarity: 2000 mOsm/l. Titration acidity (pH 7.4): approx. 80 mmol/l. pH value 7.0 – 8.5.
What Sodium Bicarbonate 8.4% B. Braun Concentrate looks like and contents of the pack:
Sodium Bicarbonate 8.4% B. Braun is a concentrate for solution for infusion, i.e. a solution for administration via a cannula into a vein after dilution. It is a clear, colorless aqueous solution. It is usually available in 20 ml glass ampoules, in packs of 5 ampoules, and in packs of 10 ampoules. Not all pack sizes may be marketed.
Pharmaceutical entrepreneur and manufacturer:
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Postal address:
34209 Melsungen
This leaflet was last revised in July 2025.
Source: Information from the package leaflet
. Version: 08/2025
Areas of application: is used to: correct hyperacidity of the blood (metabolic acidosis), raise the pH value of the urine (urine alkalization) in case of poisoning with weak organic acids (e.g. barbiturates, acetylsalicylic acid), raise the pH value of the urine (urine alkalization) to improve the solubility of drugs that are difficult to dissolve in neutral and acidic environments (e.g. methotrexate, sulfonamides) and to raise the pH value of the urine (urine alkalization) in case of breakdown of the red blood cells (hemolysis).