Sodium bicarbonate 1M Grifols solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sodium Bicarbonate 1M Grifols Solution for injection

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or nurse.

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

Leaflet contents

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

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

3. How to use Sodium Bicarbonate 1M Grifols

4. Possible side effects

5. How to store Sodium Bicarbonate 1M Grifols

6. Contents of the pack and other information

1. What Bicarbonato Sódico 1M Grifols is and what it is used for

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

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

• In the treatment of severe acute metabolic acidosis, which are clinical conditions characterized by a decreased blood pH and may be caused by a loss of bicarbonate, as occurs after severe diarrhea or in renal tubular acidosis (a kidney disorder that impairs proper bicarbonate regulation), or by excessive accumulation of acids in the body, as occurs in ketoacidosis (accumulation of ketone bodies) or in conditions of lactic acidosis (accumulation of lactic acid).

• To increase urinary pH in the treatment of acute intoxications with certain medications such as barbiturates or salicylates, in order to promote their rapid elimination through the kidneys, or to reduce renal toxic effects that may occur following hemolytic reactions (reactions causing destruction of red blood cells).

2. What you need to know before using Bicarbonato Sódico 1M Grifels

Do not use Bicarbonato Sódico 1M Grifels:

• 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), whether of metabolic or respiratory origin
• if you have low levels of calcium in the blood (hypocalcemia), as administering this medicine in such cases may lead to tetany (prolonged muscle spasms)
• if you have excessive chloride loss 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 Bicarbonato Sódico 1M Grifels.

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

Blood calcium and potassium levels may decrease during sodium bicarbonate therapy. Your doctor may monitor and, if necessary, correct the levels of these electrolytes.

Sodium bicarbonate solutions must be administered with extreme caution if you have heart and/or kidney disease, edematous conditions (excessive fluid accumulation), or other conditions associated with sodium retention, or if you are receiving medications such as corticosteroids and corticotropin that may increase blood sodium levels.

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

If the undiluted bicarbonate solution leaks outside the vein during administration, necrosis, ulceration, and/or sloughing may occur at the injection site.

Administration of sodium bicarbonate must always be under strict medical supervision, with periodic appropriate tests (such as blood tests) performed.

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

Use of Bicarbonato Sódico 1M Grifels with other medicines

Certain medicines may interact with Bicarbonato Sódico 1M Grifels. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

In general, concomitant administration of sodium bicarbonate with any medicine that has or may have renal toxicity should be avoided, as it may cause fluid and electrolyte retention.

It is important that you inform your doctor if you are taking any of the following medicines:

• corticosteroids with mineralocorticoid activity (such as fludrocortisone) or ACTH (corticotropin)
• lithium carbonate
• acidic drugs such as salicylates and barbiturates
• basic drugs such as sympathomimetics (ephedrine, pseudoephedrine) and stimulants (amphetamines, dexamphetamines).

Inform your doctor if you are taking, have recently taken, or might need to take any other medicine.

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 potential benefits outweigh the possible risks to the fetus or infant.

Bicarbonato Sódico 1M Grifels contains sodium

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

3. How to use Bicarbonate Sodium 1M Grifols

Bicarbonate Sodium 1M Grifols is usually administered by infusion, diluted to isotonicity in other intravenous administration fluids with which it is physically compatible. However, it may also be given undiluted by slow injection. In extreme emergencies, such as cardiac arrest (a clinical condition associated with lactic acidosis), the medicine may even be initially administered by direct rapid intravenous injection.

This medicine will be used in a hospital setting by appropriate healthcare personnel.

Your doctor will determine the duration and dosing regimen of treatment with Bicarbonate Sodium 1M Grifols based on the severity of acidosis, laboratory test results, and your age, weight, and clinical condition.

It is recommended that the initial dose of sodium bicarbonate should not exceed 50% of the calculated deficit, since the body's response to a given dose of sodium bicarbonate is not always predictable due to the delayed action of physiological compensatory mechanisms. For this reason, it is recommended that acid-base status be frequently monitored during therapy, allowing adjustment of the dose according to response.

As a general guideline, in adult patients experiencing cardiac arrest, an initial dose of 1 mEq/kg of intravenous sodium bicarbonate may 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 with 5% glucose injection is recommended (final solution at 4.2%), without exceeding 8 mEq/kg per day.

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

If you receive more Bicarbonate Sodium 1M Grifols than you should

Toxicity or overdose during treatment with sodium bicarbonate may occur when drug administration is excessive or too rapid, or in patients with renal insufficiency, and may lead to metabolic alkalosis, hypocalcemia, hypokalemia (low blood potassium levels), paradoxical intracellular and cerebrospinal fluid acidosis (decreased pH within cells and in the fluid surrounding the brain and spinal cord), hypotension, hypernatremia (high blood sodium levels), and hyperosmolarity (see section 4).

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

In case of overdose or accidental ingestion, contact 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 adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

The possible adverse effects are:

• metabolic alkalosis (increased blood pH)
• paradoxical intracellular and cerebrospinal fluid acidosis (decreased pH within cells and in the fluid surrounding the brain and spinal cord)
• hypokalaemia (low potassium levels in blood)
• hypocalcaemia (low calcium levels in blood)
• tetany (prolonged muscle spasms)
• lactic acidosis (accumulation of lactic acid)
• hypernatraemia (high sodium levels in blood)
• hyperosmolar state
• mood changes
• irritability
• hypertonia (extreme muscle tension)
• cerebral haemorrhage
• arrhythmia (disturbance in heart rhythm)
• hypotension (decrease in blood pressure)
• hypoxia (reduction in oxygen levels below normal in blood or tissues)
• diarrhoea
• muscle weakness
• fatigue
• oedema (excessive fluid accumulation)
• necrosis, ulceration and/or desquamation at the injection site.

Frequencies of the possible adverse reactions described are not established, as there are no clinical studies conducted with Bicarbonato Sódico 1M Grifols.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 expiry date stated on the container.

Do not use this medicine if the solution is not clear or contains precipitates.

Once the container has been opened, the solution must be used immediately.

6. Contents of the container and other information

Composition of Bicarbonato Sódico 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 injections.

Appearance of the product and contents of the container

Bicarbonato Sódico 1M Grifols is a clear, colourless injectable solution supplied in 10 ml glass ampoules.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS GRIFOLS, S.A.
Can Guasch, 2
08150 Parets del Vallès, Barcelona (SPAIN)

Date of the most recent revision of this leaflet: January 2020

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only

The treatment of metabolic acidosis should aim at correcting or improving the underlying disorder. Generally, administration of sodium bicarbonate is only necessary in severe cases of metabolic acidosis (arterial pH below 7.20) or when the cause of acidosis cannot be identified or corrected.

The amount of sodium bicarbonate administered should not aim at complete correction of the acidosis. Sodium bicarbonate should be administered only to partially correct the pH to levels that do not pose a serious threat to life (approximately 7.20–7.30), thereby allowing physiological compensatory mechanisms to complete the correction. Full and rapid correction to normal pH levels (7.30–7.40) may lead to problems associated with overdosage.

Bicarbonato Sódico 1M Grifols is administered intravenously, usually diluted in other fluids for infusion, although it may also be given undiluted as a direct injection of the hypertonic solution.

Before diluting Bicarbonato Sódico 1M Grifols in a large-volume parenteral solution, compatibility must be verified.

Sodium bicarbonate has been shown to be physically and/or chemically incompatible with many drugs, including acids, acid salts, and numerous alkaloid salts, although incompatibility depends on various factors such as drug concentration, the diluent used, the resulting pH, and temperature. In many cases, incompatibility results from 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 CO₂ that occurs when bicarbonate is acidified, nor with solutions containing calcium salts, because insoluble complexes may form as a result of these combinations.

Sodium bicarbonate solutions should also not be mixed or administered through the same intravenous line as catecholamines (e.g. adrenaline), since the alkaline nature of bicarbonate may inactivate catecholamines.

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

After opening the container, the solution should be used immediately. Any unused portion should be discarded.

The sodium bicarbonate solution should be clear and free from precipitates. Do not administer if otherwise.

Maximum aseptic precautions must be observed when diluting Bicarbonato Sódico 1M Grifols and when administering the final solution.