SODIUM HYDROGEN CARBONATE 4.2% solution for infusion

Pack size:10 x 250 ml Dosage form:Infusion solution Sodium bicarbonate 4.2% B. Braun infusion solution. 

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), 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 4.2% B. Braun infusion solution
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:

1. WHAT IS SODIUM HYDROGEN CARBONATE 4.2% B. BRAUN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SODIUM HYDROGEN CARBONATE 4.2% B. BRAUN?
3. HOW SHOULD SODIUM HYDROGEN CARBONATE 4.2% B. BRAUN BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SODIUM HYDROGEN CARBONATE 4.2% B. BRAUN BE STORED?
6. MORE INFORMATION

1. WHAT IS SODIUM BIcarbonate 4.2% B. Braun AND WHAT IS IT USED FOR?

Sodium Bicarbonate 4.2% B. Braun is a solution for raising blood pH (alkalinization) by administering bicarbonate. Sodium Bicarbonate 4.2% B. Braun is used for:

• Correction of hyperacidity of the blood (metabolic acidosis),
• Increase in the pH value of the urine (urine alkalization) in case of poisoning with weak organic acids (e.g. barbiturates, acetylsalicylic acid),
• Raising the pH value of the urine (urine alkalization) to improve the solubility of drugs that are poorly soluble in neutral and acidic environments (e.g. methotrexate, sulfonamides),
• Increase in the pH value of the urine (urine alkalization) when red blood cells break down (hemolysis).

Sodium bicarbonate 4.2% B. Braun is a medicine that will be administered to you by a doctor or healthcare professional.

2. WHAT MUST YOU CONSIDER BEFORE USING SODIUM BIcarbonate 4.2% B. Braun?

Sodium bicarbonate 4.2% B. Braun should not be used if:

• 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 4.2% B. Braun in the following cases:

• slowed or shallow breathing (hypoventilation)
• low calcium levels in the blood (hypocalcemia)
• 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 4.2% B. Braun can lead to high sodium and fluid load. Alkalizing therapy can cause the potassium level in the blood to fall below normal values (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.

Newborns and children under 2 years of age:
Rapid infusions (up to 1 ml/min) of hypertonic sodium bicarbonate solutions can cause excessively high concentrations of sodium in the blood (hypernatremia) and, in premature infants, cerebral hemorrhage. Therefore, your doctor will ensure that doses of > 5 mmol per kg body weight per day should not be administered (see also section 4.2). If used improperly, sodium bicarbonate 4.2% B. Braun may cause vein wall irritation with subsequent phlebitis and thrombophlebitis if applied too quickly into veins of the extremities (peripheral veins) due to its alkaline pH. If accidentally administered next to the vein (paravenously), tissue destruction (necrosis) may occur.

When using sodium bicarbonate 4.2% B. Braun 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 using the following medicines:

• Adrenal cortex hormones,
• Androgens (male sex hormones),
• diuretics that increase potassium excretion.

The increase in urine pH (alkalization) caused by bicarbonate accelerates the excretion of acidic drugs (e.g., acetylsalicylic acid) and delays the excretion of basic drugs. Due to its alkaline pH, Sodium Bicarbonate 4.2% B. Braun is physically and chemically incompatible with most drugs. In particular, combination with solutions containing calcium, magnesium, and phosphate can lead to precipitation.

Pregnancy and breastfeeding:
Please inform your doctor if you are pregnant or breastfeeding before treatment with Sodium Bicarbonate 4.2% B. Braun

. Pregnancy:
Sodium bicarbonate can be administered to you via infusion during pregnancy if your doctor considers this absolutely necessary after careful risk-benefit assessment. 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 caution is required when using Sodium Bicarbonate 4.2% B. Braun”).

Breastfeeding:
During breastfeeding, Sodium Bicarbonate 4.2% B. Braun should only be used with caution after careful benefit/risk assessment.

Ability to drive and operate machinery:
Sodium Bicarbonate 4.2% B. Braun has no influence on the ability to drive or operate machinery.

3. HOW SHOULD SODIUM BIOCHEMICAL CARBONATE 4.2% B. BRAUN BE USED?

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 disturbance in the acid-base status. Based on the blood gas analysis, the amount to be administered is calculated using the following formula: ml 0.5 molar sodium bicarbonate 4.2% B. Braun infusion solution = base deficit (-BE) × kg body weight × 0.3 × 2 (The factor 0.3 corresponds to the proportion of extracellular fluid in relation to total fluid, "KG", = body weight.)

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 slowly into a vein (IV).

Newborns and children under 2 years:
Your doctor will ensure that the dosage to be administered does not exceed 5 mmol/kg body weight per day. The solution will then be given slowly into your child's vein and is generally diluted. Your doctor will ensure that a 4.2% (or less concentrated) 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 × 2 = 210 ml Sodium Bicarbonate 4.2% B. Braun Infusion Solution. Since acidosis correction should not occur too quickly, i.e. full compensation of the base deficit should not be sought, it is recommended that half of the calculated amount of Sodium Bicarbonate 4.2% B. Braun Infusion Solution be administered initially and the next dose dependent 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 3 ml of sodium bicarbonate 4.2% B. Braun infusion solution per kg 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 stated above must not be exceeded.

Method of administration:
Intravenous use, i.e. administration as an infusion into a vein.

If you use more sodium bicarbonate 4.2% B. Braun infusion solution than you should:
An overdose can lead to an excess of alkali in the blood (alkalosis), an increased sodium level in the blood (hypernatremia) and an increased salt concentration in the blood (hyperosmolarity). If excessive acidification of the blood (acidosis) is compensated for 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 severe 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. POSSIBLE SIDE EFFECTS?

Like all medicines, Sodium Bicarbonate 4.2% B. Braun Infusion Solution can cause side effects, although not everybody experiences them. The following categories are used to estimate the frequency of side effects:

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 4.2% B. BRAUN SOLUTION FOR INFUSION 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 the container after “EXP”. The expiry date refers to the last day of the month. Storage conditions: This medicinal product does not require any special storage conditions. Information on shelf life after opening or preparation: For single use! Discard any remainder! Only use if the container is undamaged and the solution is clear.

6. FURTHER INFORMATION

What Sodium Hydrogen Carbonate 4.2% B. Braun Infusion Solution contains:
The active ingredient is sodium hydrogen carbonate (sodium bicarbonate). 1000 ml of infusion solution contains 42.0 g of sodium hydrogen carbonate (sodium bicarbonate). The other ingredients are: Disodium edetate (Ph. Eur.) 25 mg/1000 ml, water for injections. Electrolytes: 500 mmol/l sodium ion, 500 bicarbonate ion. Theoretical osmolarity: 1000 mOsm/l. Titration acidity (pH 7.4): approx. -35 mmol/l. pH value: 7.0 – 8.5.

What Sodium Bicarbonate 4.2% B. Braun Infusion Solution looks like and what the pack contains:
Sodium Bicarbonate 4.2% B. Braun Infusion Solution is an infusion solution, i.e., a solution for administration via a cannula into a vein. It is a clear, colorless, aqueous solution. It is supplied in 250 ml glass bottles, in packs of 1 x 250 ml and 10 x 250 ml.

Pharmaceutical Entrepreneur and Manufacturer:
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen

Postal Address:
34209 Melsungen


This package leaflet was last revised in July 2025.

Source: Information from the package leaflet
, as of: 08/2025

Areas of application: is used to correct hyperacidity of the blood (metabolic acidosis), to raise the pH value of the urine (urine alkalization) in cases of poisoning with weak organic acids (e.g. barbiturates, acetylsalicylic acid), to raise the pH value of the urine (urine alkalization) to improve the solubility of medications that are difficult to dissolve in neutral and acidic environments (e.g. methotrexate, sulfonamides), to raise the pH value of the urine (urine alkalization) in cases of red blood cell breakdown (hemolysis).

For the correction of metabolic acidosis