PATIENT INFORMATION LEAFLET

Venofusin Sodium Bicarbonate 1M solution for infusion

Sodium Hydrogenocarbonate

(Sodium Bicarbonate)

Read this leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Venofusin Bicarbonato sódico 1M is a solution for intravenous infusion that belongs to the group of medications known as intravenous solutions that affect the electrolyte balance-Electrolytes.

It is indicated in the following situations:

• For 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)

Do not use Sodium Bicarbonate 1M

• If you are allergic to the active ingredient or any of the other components of the medication
• If you have alkalosis (elevated blood pH), either of metabolic or respiratory origin
• If you have low levels of calcium in the blood (hypocalcemia), as administration of this medication in these situations may lead to tetany (prolonged muscle spasms)

• prolonged)
• If you have excessive chloride loss through vomiting or gastrointestinal suction or alkalosis caused by diuretic medications
• If you have respiratory acidosis

Warnings and Precautions

Be especially careful with Sodium Bicarbonate 1M:

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

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

• If you have heart and/or kidney diseases, edematous states (excessive accumulation of liquids) 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. In these cases, bicarbonate solutions should be administered with extreme caution.

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

• If you are administered the undiluted bicarbonate solution, as it may cause necrosis, ulceration, and/or desquamation 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.

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

Using Sodium Bicarbonate 1M with other medications

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

In general, it is recommended to avoid concurrent administration of bicarbonate with any medication that presents or may present renal toxicity, 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 or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Pregnancy and breastfeeding

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

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

Driving and operating machinery:

There is no indication that this medication may affect the ability to drive vehicles or operate complex machinery.

Important information about some of the components of Sodium Bicarbonate 1M

Patients with low-sodium diets should be aware that this medication contains 22.9 g (1000 mmol) of sodium per liter.

Sodium Bicarbonate 1M is usually administered by infusion, diluted to isotonicity in other intravenous administration liquids 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. In the case of administering a hypertonic solution, the central route should be used.

This medication will be used in a hospital by the corresponding healthcare personnel. In the case of peripheral administration, the medication must be diluted with a compatible solution.

Your doctor will indicate the duration and administration schedule of the treatment with Sodium Bicarbonate 1M 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, as the degree of response of the body 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.

Use in children and adolescents

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

If they administer more Sodium Bicarbonate 1M than they 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 (decreased pH in cells and cerebrospinal fluid), hypotension, hypernatremia (high sodium levels in the blood), and hyperosmolality (see section 4).

In case of overdose, the administration of the medication should be suspended and the correction of the electrolyte imbalance initiated.

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 pharmacist.

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)

- Intracellular and cerebrospinal fluid paradoxical acidosis and (decrease in pH in cells and in the 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)

- Diarrhea

- Muscle weakness

- Fatigue

- Edema (excessive accumulation of liquids)

- 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 Venofusin Sodium Bicarbonate 1M.

Reporting Adverse Effects:

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

Keep out of the sight and reach of children.

Your doctor and hospital healthcare staff are responsible for the correct storage, use, and disposal of Sodium Bicarbonate Venofusin 1M.

No special conservation conditions are required.

Do not use Sodium Bicarbonate Venofusin 1M after the expiration date shown on the packaging.

After treatment is completed, any remaining solution must be discarded.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medicines. This will help protect the environment.

Composition of Venofusin Bicarbonate Sodium 1M

The active ingredient is sodium hydrogen carbonate (sodium bicarbonate). Each 100 ml of solution contains 8.4 g of sodium hydrogen carbonate.

The other components are: sodium edetate and water for injection preparations.

Appearance of the product and contents of the package

Venofusin Bicarbonate Sodium 1M is a transparent and colorless solution, without visible particles, packaged in a glass container. It is presented in 250 ml containers.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España S.A.U

C/ Marina 16-18.

08005-Barcelona (Spain)

Responsible for manufacturing:

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

8055 Graz

Austria

or

Fresenius kabi Deutschland GmbH

Freseniusstrasse 1 (Friedberg)

D-61169 - Germany

Last review date of this leaflet: December 2016

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

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This information is intended solely for doctors or 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.

This medication will always be administered by specialized personnel. It will be administered by infusion, through a central or peripheral vein. It can be administered undiluted through a central vein or diluted with a compatible solution through a peripheral vein.

Venofusin Bicarbonate Sodium 1M is administered intravenously, usually diluted in other liquids to be administered by infusion, although it can also be administered undiluted through a direct injection of the hypertonic solution.

The solution must be transparent and not contain precipitates. Do not administer otherwise.

The contents of each container are for a single infusion, discard the unused portion.

Use an aseptic method to administer the solution and in case of preparation of mixtures.

Before adding medications to the solution or administering simultaneously with other medications, check 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, 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 containing calcium salts due to the formation of insoluble complexes that may result from these combinations.

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

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