BIOSEDRA SODIUM BICARBONATE 1,4 % S for injection/infusion Vial/500ml

Sodium bicarbonate................................................................................................................................ 1,40 g

Sodium...................................................................................................................................................................... 166,6 mmol/l

Bicarbonates............................................................................................................................................................ 166,6 mmol/l

Osmolarity................................................................................................................................................................ 333 mOsm/l

Osmolality................................................................................................................................................................. 300 mOsm/kg

pH............................................................................................................................................................................... between 7 and 8,3

• Metabolic acidosis.
• Phenobarbital poisoning.

Dosage

The dosage is variable and must be adjusted in quantity according to the etiology, the patient's condition, and the extent of disturbances in the acid-base balance.

Method of administration

IV route, by slow infusion.

Hypersensitivity to the active substance or to any of the excipients listed in section Composition .

• Metabolic alkalosis
• Respiratory acidosis

Special warnings

The administration of this solution may worsen hypokalemia or unmask it.

Due to the alkalinity of the solution, check compatibility before mixing medicines to be administered concomitantly in the infusion, and check the clarity and color of the solution before infusing (see section Interactions).

Precautions for use

Use with caution in cases of sodium and water retention, heart failure, or edematous-ascitic syndrome of cirrhosis.

Perform frequent monitoring of electrolytes and blood acid-base balance.

In case of hypokalaemia, combine with a potassium salt.

Take into account the sodium intake.

When preparing mixtures of medicines administered intravenously, take into account the alkaline pH of the solution and the presence of sodium and bicarbonate ions.

The most frequent incompatibilities are due to:

• medicines giving an acidic reaction in solution (hydrochlorides, insulin, etc.);
• medicines whose base form is insoluble (alkaloids, antibiotics, etc.).

Associations subject to Precautions for use

+ Quinidine-type medicines (hydroxyquinidine, quinidine):

Increase in plasma concentrations of quinidine and risk of overdose (decreased renal excretion of quinidine due to urinary alkalinisation).

Clinical monitoring, ECG and possibly monitoring of quinidaemia: if necessary, adjust the dosage during alkalinising treatment and after its discontinuation.

Pregnancy

In clinical practice, no malformative or foetotoxic effect has appeared to date. However, follow-up of pregnancies exposed to intravenous administration of sodium bicarbonate is insufficient to rule out any risk.

Consequently, this product should be administered during pregnancy only if necessary.

Breast-feeding

In the absence of data on possible passage into breast milk, it is preferable to avoid breastfeeding during treatment.

SODIUM BICARBONATE 1,4% BIOSEDRA, solution for infusion has no or negligible effect on the ability to drive vehicles and use machines.

Metabolic alkalosis and hypokalaemia in case of excessive intake.

Risk of sodium overload in case of insufficient renal or extra-renal sodium elimination.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.ansm.sante.fr.

Metabolic alkalosis and respiratory depression, hypokalaemia, cardiac insufficiency, acute pulmonary oedema.

Pharmacotherapeutic class: ALKALINISING AGENT, ATC code: B05XA02.

(B: blood and blood-forming organs).

The sodium bicarbonate solution makes it possible to regulate the acid-base balance of the plasma.

Elimination

Excretion is mainly urinary.

No particular data, sodium bicarbonate being a physiological compound of plasma.

Numerous incompatibilities due to the alkalinity of the solution.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

3 years.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Not applicable.