Label: information for the user

Bicarbonato Sódico 1M Grifols Injectable Solution

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.

-If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

6. Contents of the container and additional information

Bicarbonato Sódico 1M Grifols is an injectable solution that belongs to the group of medications known as Intravenous Solution Additives - Electrolyte Solutions.

Bicarbonato Sódico 1M Grifols is indicated in the following situations:

-In the treatment of acute severe metabolic acidosis, which are clinical situations characterized by a decrease in blood pH and may be caused by a loss of bicarbonate, such as after a severe diarrhea or in renal tubular acidosis (kidney disorder that does not allow for proper bicarbonate regulation), or by an excessive accumulation of acids in the body such as in ketoacidosis (accumulation of ketone bodies) or in situations of lactic acidosis (accumulation of lactic acid).

-To increase the pH of the urine in the treatment of acute poisoning with certain medications such as barbiturates or salicylates, in order to eliminate them quickly through the kidneys, or to reduce the toxic effects on the kidneys that can occur after hemolytic reactions (reactions that cause the destruction of red blood cells).

No useBicarbonato Sódico 1M Grifols:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6)
• If you have alkalosis (elevated blood pH), whether of metabolic or respiratory origin
• If you have low levels of calcium in your blood (hypocalcemia), as administration of this medication in these situations may lead to tetany (prolonged muscle spasms)
• If you experience excessive loss of chloride through vomiting or gastrointestinal suction or alkalosis caused by diuretic medications
• If you have respiratory acidosis

Warnings and Precautions

Consult your doctor or nurse before starting to use Bicarbonato Sódico 1M Grifols.

During treatment, administration of sodium bicarbonate requires adequate pulmonary ventilation to correctly eliminate the formed carbon dioxide (CO2).

The concentration of calcium and potassium in the blood may decrease during sodium bicarbonate therapy. Your doctor will be able to monitor and, if necessary, correct the levels of these electrolytes.

Solutions of sodium bicarbonate should be administered with extreme caution if you have heart or kidney disease, edematous states (excessive accumulation of fluids) or other situations related to sodium retention, or if you are receiving medications such as corticosteroids and corticotropin that may increase sodium levels in the blood.

If you are elderly, your kidneys, lungs, or heart may not function correctly.

If the undiluted sodium bicarbonate solution comes out of the vein when administered, necrosis, ulceration, and/or desquamation may occur at the injection site.

Sodium bicarbonate administration should always be performed under strict medical control, with periodic appropriate tests (such as blood analysis).

Sodium bicarbonate may induce hypotension (decreased blood pressure) in anesthetized patients.

Use of Bicarbonato Sódico 1M Grifols with other medications

Certain medications may interact with Bicarbonato Sódico 1M Grifols. In this case, it may be necessary to change the dose or discontinue treatment of one of the medications.

In general, the administration of sodium bicarbonate with any medication that presents or may present renal toxicity should be avoided, as it may cause fluid and electrolyte retention.

It is essential to inform your doctor if you are using any of the following medications:

• Corticosteroids with mineralocorticoid action (such as fludrocortisone) or ACTH (corticotropin)
• Lithium carbonate
• Acidic medications such as salicylates and barbiturates
• Basic medications such as sympathomimetics (ephedrine, pseudoephedrine) and stimulants (amphetamine, dextroamphetamine)

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant,consult your doctor before using this medication.

The safety of its use during pregnancy and lactation has not been established. Therefore, it should be used only when clearly necessary and when the benefits justify the possible risks to the fetus or infant.

Bicarbonato Sódico 1M Grifols contains sodium

This medication contains 230 mg of sodium (main component of table salt) in each ampule. This is equivalent to 11.5% of the recommended daily maximum sodium intake for an adult.

Sodium Bicarbonate 1M Grifols is usually administered by infusion, diluted to isotonicity in other intravenous administration fluids with which there is physical compatibility, although it can also be administered undiluted by slow injection. In cases of extreme need, such as cardiac arrest(a clinical situation that runs with lactic acidosis), the medication can even be administered initially by direct rapid intravenous injection.

This medication will be used in a hospital by the corresponding healthcare personnel.

Your doctor will indicate the duration and administration schedule of the treatment with Sodium Bicarbonate 1M Grifols based on the intensity of the acidosis, laboratory determinations, and your age, weight, and clinical condition.

It is recommended that the initial dose of sodium bicarbonate not exceed 50% of the calculated deficit since the degree of response of the organism to a given dose of sodium bicarbonate is not always predictable, due to the delayed action of physiological compensation mechanisms. For this reason, it is recommended to frequently monitor the acid-base state during therapy, modifying the dose accordingly.

As a general guideline, in adult patients in cardiac arrest, a dose of 1 mEq/kg of intravenous sodium bicarbonate can be administered, always ensuring adequate pulmonary ventilation.

In pediatric patients, an initial dose of 1 mEq/kg administered by slow intravenous injection is recommended. In neonates, a 1:1 dilution of a 7.5 or 8.4% sodium bicarbonate injection and a 5% glucose injection (final solution at 4.2%) is recommended, without exceeding 8 mEq/kg per day.

For severe acidosis in less critical cases,the recommended initial dose of sodium bicarbonate for children and adults is 2-5 mEq/kg administered by infusion over 4-8 hours. Subsequent doses will be determined based on the patient's response through appropriate laboratory determinations (arterial pH, arterial pCO2, and serum electrolytes).

If you receive moreSodium Bicarbonate 1M Grifols than you should

Overdose or overmedication in a treatment with sodium bicarbonate can occur when the administration of the drug is excessive or too rapid, or in patients with renal insufficiency and can lead to the development of metabolic alkalosis, hypocalcemia, hypokalemia(low potassium levels in the blood), paradoxical intracellular and cerebrospinal fluid acidosis (decrease in pH in cells and cerebrospinal fluid), hypotension, hypernatremia(high sodium levels in the blood), and hyperosmolarity (see section 4).

In case of overdose, discontinue medication administration and initiate correction of the electrolyte imbalance.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915 620 420.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects that may occur are due to the administration of sodium bicarbonate at high doses or at too high a speed.

The possible adverse effects are:

• Metabolic alkalosis (increase in blood pH)
• Paradoxical intracellular and cerebrospinal fluid acidosis (decrease in pH in cells and cerebrospinal fluid)
• Hypokalemia (low levels of potassium in the blood)
• Hypocalcemia (low levels of calcium in the blood)
• Tetany (prolonged muscle spasms)
• Lactic acidosis (accumulation of lactic acid)
• Hypernatremia (high levels of sodium in the blood)
• Hyperosmolar state
• Mood changes
• Irritability
• Extreme muscle tension
• Cerebral hemorrhage
• Arrhythmia (alteration of heart rhythm)
• Hypotension (decrease in blood pressure)
• Hypoxia (decrease in oxygen levels below normal in the blood or tissues)
• Diarrea
• Muscle weakness
• Fatigue
• Edema (excessive accumulation of fluids)
• Necrosis, ulcer, and/or desquamation at the injection site.

The frequencies of the possible adverse reactions described are not established, as there are no clinical studies conducted with Sodium Bicarbonate 1M Grifols.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No requires special conservation conditions.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging.

Do not use this medication if you observe that the solution is not transparent or contains precipitates.

Once the packaging is opened, the solution must be used immediately.

Composition of Sodium Bicarbonate 1M Grifols

The active ingredient is sodium hydrogen carbonate (sodium bicarbonate). Each 10 ml ampule contains840 mg ofsodium hydrogen carbonate.

The other components (excipients) are: disodium EDTA, carbon dioxide (for pH adjustment)andwater forparenteral preparations.

Appearance of the product and contents of the package

Sodium Bicarbonate 1M Grifolsis a transparent and colorless injectable solution, presented in 10 ml glass ampules.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Date of the last review of this leaflet:January 2020

Other sources of information

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals

The treatment of metabolic acidosis should be directed at correcting or improving the underlying disorder. Generally, the administration of sodium bicarbonate is only necessary in severe cases of metabolic acidosis (arterial pH below 7.20) or when it is not possible to determine or correct the cause of the acidosis.

The amount of sodium bicarbonate to be administered should not aim to completely correct the acidosis. Sodium bicarbonate should be administered only to partially correct the pH to levels that do not pose a serious threat to life (in the order of 7.20-7.30), allowing the physiological compensation mechanisms to complete the correction. Full and rapid correction to normal pH levels (7.30-7.40) leads to problems of overdosing.

Sodium Bicarbonate 1M Grifols is administered intravenously, usually diluted in other fluids for administration by infusion, although it can also be administered undiluted by direct injection of the hypertonic solution.

Before diluting Sodium Bicarbonate 1M Grifols in a large volume parenteral solution, it should be checked that there are no incompatibilities.

Sodium bicarbonate has been shown to be physically and/or chemically incompatible with many drugs, including acids, acidic salts, and many alkaloid salts, but incompatibility depends on various factors such as the concentration of the drugs, the diluent used, the resulting pH, or the temperature. In many cases, incompatibility is a consequence of the alkaline nature of the sodium bicarbonate solution.

In general, sodium bicarbonate solutions should not be mixed with acids in aqueous solutions, due to the release of CO2that occurs when the bicarbonate is reduced by the acidic solution, nor with solutions containing calcium salts due to the formation of insoluble complexes that may result from these combinations.

Sodium bicarbonate solutions should also not be mixed or administered in the same intravenous line with catecholamines (adrenaline) due to the fact that bicarbonate, being an alkaline solution, can inactivate catecholamines.

Like other parenteral solutions, before adding medications, consult the compatibility tables.

Once the package is opened, the solution should be used immediately. Discard the unused portion.

The sodium bicarbonate solution should be transparent and not contain precipitates. Do not administer otherwise.

When diluting Sodium Bicarbonate 1M Grifols and when administering the final solution, maximum asepsis should be maintained.