SODIUM BICARBONATE 1M GRIFOLS INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Sodium Bicarbonate 1M Grifols Injectable Solution

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.

• If you experience side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sodium Bicarbonate 1M Grifols and what is it used for
2. What you need to know before you start using Sodium Bicarbonate 1M Grifols
3. How to use Sodium Bicarbonate 1M Grifols
4. Possible side effects
5. Storage of Sodium Bicarbonate 1M Grifols

1. Contents of the pack and further information

1. What is Sodium Bicarbonate 1M Grifols and what is it used for

Sodium Bicarbonate 1M Grifols is an injectable solution belonging to the group of medicines called Intravenous Solution Additives - Electrolyte Solutions.

Sodium Bicarbonate 1M Grifols is indicated in the following situations:

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

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

2. What you need to know before you start using Sodium Bicarbonate 1M Grifols

Do not useSodium Bicarbonate 1M Grifols:

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6)
• if you have alkalosis (increased blood pH), either of metabolic or respiratory origin
• if you have low calcium levels in the blood (hypocalcemia), as the administration of this medicine in these situations can lead to tetany (prolonged muscle spasms)
• if you have excessive loss of chloride due to vomiting or gastrointestinal suction or hypochloremic alkalosis caused by diuretic medications
• if you have respiratory acidosis.

Warnings and Precautions

Consult your doctor or nurse before starting to use Sodium Bicarbonate 1M Grifols.

During treatment, the 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 therapy with sodium bicarbonate. Your doctor may monitor and, if necessary, correct the levels of these electrolytes.

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

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

If, when administering the sodium bicarbonate solution without diluting the liquid, it comes out of the vein, necrosis, ulceration, and/or desquamation may occur at the injection site.

The administration of sodium bicarbonate should always be done under strict medical control, with periodic tests (such as blood tests) performed.

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

Using Sodium Bicarbonate 1M Grifols with other medicines

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

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

It is important that you 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, dexamphetamine)

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

Pregnancy and Breastfeeding

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

The safety of its use during pregnancy and breastfeeding has not been established. Therefore, it should only be used when clearly necessary and when the beneficial effects justify the potential risks to the fetus or baby.

Sodium Bicarbonate 1M Grifols contains sodium

This medicine contains 230 mg of sodium (main component of table salt) per ampoule. This is equivalent to 11.5% of the maximum recommended daily sodium intake for an adult.

3. How to use Sodium Bicarbonate 1M Grifols

Sodium Bicarbonate 1M Grifols is normally administered by perfusion, 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 necessity, such as cardiac arrest (clinical situation characterized by lactic acidosis), the medication can even be administered initially by rapid intravenous injection.

This medicine 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 tests, 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 body to a given dose of sodium bicarbonate is not always predictable, due to the delayed action of the physiological compensation mechanisms. For this reason, it is recommended that during therapy, the acid-base state be frequently monitored, modifying the dose according to the response.

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

In pediatric patients, an initial dose of 1 mEq/kg is recommended, administered by slow intravenous injection. In neonates, a 1:1 dilution of a sodium bicarbonate injection at 7.5 or 8.4% and a 5% glucose injection (final solution at 4.2%) is recommended, not 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 perfusion over 4-8 hours. Subsequent doses will be determined based on the patient's response through appropriate laboratory tests (arterial pH, arterial pCO2, and serum electrolytes).

If you receive moreSodium Bicarbonate 1M Grifols than you should

Overdose or poisoning during 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, hypotension, hypernatremia (high sodium levels in the blood), and hyperosmolarity (see section 4).

In case of overdose, administration of the medicine should be discontinued and correction of the electrolyte imbalance initiated.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects that may occur are due to the administration of sodium bicarbonate at high doses or too quickly.

The possible side effects are:

• metabolic alkalosis (increased blood pH)
• paradoxical intracellular and cerebrospinal fluid acidosis (decrease in pH in cells and cerebrospinal fluid)
• hypokalemia (low potassium levels in the blood)
• hypocalcemia (low calcium levels in the blood)
• tetany (prolonged muscle spasms)
• lactic acidosis (accumulation of lactic acid)
• hypernatremia (high sodium levels in the blood)
• hyperosmolar state
• mood changes
• irritability
• hypertonia (extreme muscle tension)
• cerebral hemorrhage
• arrhythmia (alteration of heart rhythm)
• hypotension (decreased blood pressure)
• hypoxia (decrease in oxygen levels below normal in blood or tissues)
• diarrhea
• muscle weakness
• fatigue
• edema (excessive fluid accumulation)
• necrosis, ulceration, and/or desquamation at the injection site.

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

Reporting of side effects

If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sodium Bicarbonate 1M Grifols

No special storage conditions are required.

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

Do not use this medicine after the expiration date stated on the packaging.

Do not use this medicine if you notice that the solution is not transparent or contains precipitates.

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

6. Contents of the pack and further information

Composition of Sodium Bicarbonate 1M Grifols

The active substance is sodium hydrogen carbonate (sodium bicarbonate). Each 10 ml ampoule contains 840 mg of sodium hydrogen carbonate.

The other components (excipients) are: disodium edetate, carbon dioxide (for pH adjustment), and water for injectable preparations.

Appearance of the product and pack contents

Sodium Bicarbonate 1M Grifols is a clear and colorless injectable solution, presented in 10 ml glass ampoules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Date of last revision of this leaflet:January 2020

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals

Treatment of metabolic acidosis should be aimed 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 (around 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) involves problems of overdose.

Sodium Bicarbonate 1M Grifols is administered intravenously, normally diluted in other fluids for administration by perfusion, 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 medications, including acids, acid salts, and many alkaloid salts, but the incompatibility depends on different factors such as the concentration of the medications, the diluent used, the resulting pH, or the temperature. In many cases, the incompatibility is due to the alkaline nature of the sodium bicarbonate solution.

Generally, sodium bicarbonate solutions should not be mixed with acids in aqueous solutions, due to the release of CO2 that occurs when the bicarbonate is reduced by the acidic solution, nor with solutions that contain calcium salts due to the formation of insoluble complexes that can result from these combinations.

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

As with other parenteral solutions, compatibility tables should be consulted before adding medications.

Once the packaging is opened, the solution should be used immediately. Discard the unused fraction.

The sodium bicarbonate solution should be transparent and not contain precipitates. Do not administer if this is not the case.

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