Metabolic acidosis, salicylate poisoning, SODIUM HYDROGEN CARBONATE 8.4% 1 mol glass

Pack size:20 x 100 ml Dosage form:Infusion solution

Sodium bicarbonate 1 molar 8.4%, infusion solution. 

Indications: Metabolic acidosis, alkalization in barbiturate and salicylate poisoning.

For risks and side effects, read the package insert and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium bicarbonate 1 molar 8.4%, infusion solution.

This package insert contains:

1. WHAT IS SODIUM HYDROGEN CARBONATE 1 MOLAR 8.4% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SODIUM HYDROGEN CARBONATE 1 MOLAR 8.4%?
3. HOW SHOULD SODIUM HYDROGEN CARBONATE 1 MOLAR 8.4% BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SODIUM HYDROGEN CARBONATE 1 MOLAR 8.4% BE STORED?
6. MORE INFORMATION

1. WHAT IS SODIUM HYDROGEN CARBONATE 1 MOLAR 8.4% AND WHAT IS IT USED FOR?

Substance or indication group:
Solution for the correction of acidosis.

Indications:

• Metabolic acidosis,
• Alkalization in barbiturate and salicylate poisoning.

2. WHAT SHOULD YOU CONSIDER BEFORE USING SODIUM HYDROGEN CARBONATE 1 MOLAR 8.4%?

Contraindications:

• alkalosis,
• hypernatremia,
• Hypokalemia.

Precautions for use and warnings:
Paravenous application can result in necrosis. Acid-base balance and serum ionogram monitoring are required. Caution in cases of hypokalemia. Risk of hypocalcemic tetany if the dose is exceeded.

Interactions with other drugs:
Do not use with calcium- and magnesium-containing solutions. Do not mix with phosphate-containing solutions.

3. HOW SHOULD SODIUM HYDROGEN CARBONATE 1 MOLAR 8.4% BE USED?

Dosage instructions:
Unless otherwise prescribed, continuous drip up to a maximum of 25 drops/minute and 100 ml/day, taking acid-base balance into account. The dosage should be based on the following dosage formula: ml sodium bicarbonate solution 8.4% = bicarbonate deficit (mval/l x kg body weight x 0.3). Sodium bicarbonate 1 molar 8.4% can be infused undiluted or diluted with 5% glucose solution in the same volume ratio.

Method of administration:
For intravenous infusion.

If you have any questions regarding the use of this medicine, consult your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

If the contraindications and instructions are followed, side effects are not known.

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, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

Additional information for healthcare professionals:
Reporting of suspected side effects:
Reporting suspected side effects after authorization is very important. It enables continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare professionals are requested to report any suspected adverse reactions to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn

5. HOW SHOULD SODIUM HYDROGEN CARBONATE 1 MOLAR 8.4% BE STORED?

Do not use after the expiry date printed on the container and outer packaging! Use only clear solutions in undamaged containers! Keep out of the sight and reach of children!

6. FURTHER INFORMATION

Composition:
1000 ml of infusion solution contains: Active ingredient: Sodium bicarbonate 84.0 g. Other ingredients: Water for injections, sodium edetate (Ph. Eur.). Na+ 1000 mmol/l, HCO3- 1000 mmol/l. Theoretical osmolarity: 2000 mOsm/l. pH: 7.0 - 8.5.

Dosage form:
Infusion solution, glass bottle: 100 ml, 250 ml.

Pharmaceutical entrepreneur and manufacturer:
Serag-Wiessner GmbH & Co. KG
Zum Kugelfang 8 - 12
95119 Naila

This package leaflet was last revised in October 2024.

Source: Information from the package leaflet
, as of: 03/2025

Indications: metabolic acidosis, alkalization in barbiturate and salicylate poisoning.

Metabolic acidosis, salicylate poisoning