SODIUM BICARBONATE LAVOISIER 1,4 % S perf Fl/500ml

Solution for infusion

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

For 100 ml of solution for infusion.

Sodium 166,6 mmol/l

Bicarbonates 166,6 mmol/l

Osmolarity 333 mOsm/l

pH between 7 and 8,5

Excipients:

• 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.

• 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 carrying out mixtures of medicinal products to be administered concomitantly in the infusion, and check the clarity and colour of the solution before infusing (see section Interactions).

Precautions for use

Use with caution in cases of sodium and water retention, heart failure, oedematous-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:

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

Associations subject to Precautions for use

• Quinidine-type drugs (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 quinidemia testing: if necessary, adjust the dosage during alkalinising treatment and after its discontinuation.

Pregnancy

In clinical use, no malformative or fetotoxic effect has appeared to date. However, follow-up of pregnancies exposed to intravenous administration of sodium bicarbonate is insufficient to exclude any risk.

Consequently, this product should not be administered during pregnancy unless necessary.

Breast-feeding

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

Fertility

Not applicable.

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 reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr.

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

Pharmacotherapeutic class: alkaline supply product, ATC code: B05XA02

(B: blood and haematopoietic organs).

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

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

• check for any colour change and/or formation of a precipitate, insoluble complex or crystals.
• before adding a drug, check whether the pH range in which it is effective corresponds to that of the sodium bicarbonate solution 1,4 %.

3 years.

Shelf life after opening: the product must be used immediately.

This medicine does not require any particular storage precautions.

For storage conditions of the medicine after first opening, see section Shelf life.

No special requirements for disposal.

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

Marketing authorisation (AMM)

CIP 3400955350651 (12Fl/250ml). CIP 3400930575260 (Fl/500ml). CIP 3400955350712 (12Fl/500ml). CIP 3400930575031 (Fl/250ml). CIP 3400936675902 (10Amp/10ml).

Price:

2,91 euros (bottle/500ml). 2,52 euros (Fl/250ml).

Social security reimbursement at 65% (Fl/500ml, Fl/250ml).
Non Remb Séc soc (10Amp/10ml).
Hospital model(s) (12Fl/250ml, 12Fl/500ml).
Collection.