SODIUM BICARBONATE 1/6 M MEIN SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for theuser

Sodium Bicarbonate 1/6 M Mein solution for infusion

Sodium Hydrogen Carbonate

(Sodium Bicarbonate)

Read the entire package leaflet carefully beforestarting to usethis medicine, as it contains important information for you.

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

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience side effects, ask your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Sodium Bicarbonate 1/6 M Mein and what is it used for
2. What you need to know before using Sodium Bicarbonate 1/6 M Mein
3. How to use Sodium Bicarbonate 1/6 M Mein
4. Possible side effects
5. Storage of Sodium Bicarbonate 1/6 M Mein
6. Package contents and additional information

1. What is Sodium Bicarbonate 1/6 M Mein and what is it used for

Sodium Bicarbonate 1/6 M Mein is a solution for intravenous infusion belonging to the group of medicines called intravenous solutions that affect the electrolyte balance - Electrolytes.

It is indicated in the following situations:

1. In the treatment of metabolic acidosis, which are clinical situations characterized by a decrease in blood pH.
2. In situations of decreased sodium
3. In case of diarrhea with loss of bicarbonate
4. In case of infant toxicity
5. To increase the pH of the urine

2. What you need to know before using Sodium Bicarbonate 1/6 M Mein

Do not use Sodium Bicarbonate 1/6 M Mein

1. If you are allergic to the active substance or to any of the other components of the medicine
2. If you have alkalosis (increased blood pH), either of metabolic or respiratory origin
3. 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)
4. If you have excessive loss of chloride due to vomiting or gastrointestinal suction or hypochloremic alkalosis caused by diuretic medications
5. If you have respiratory acidosis

Be careful with Sodium Bicarbonate 1/6 M Mein

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

1. During treatment, as the concentration of calcium and potassium in the blood may decrease during therapy with sodium bicarbonate. Your doctor can monitor and, if necessary, correct the levels of these electrolytes.

1. If you have heart and/or kidney diseases, edematous states (excessive fluid accumulation) or other situations related to sodium retention, or if you are taking medications such as corticosteroids and corticotropin that can increase sodium levels in the blood. In these cases, sodium bicarbonate solutions should be administered with extreme caution.

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

1. If you are administered the undiluted sodium bicarbonate solution, as if the fluid comes out of the vein, it can cause necrosis, ulceration, and/or desquamation 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 (decrease in blood pressure) in anesthetized patients.

Use of other medicines

Certain medications may interact with Sodium Bicarbonate 1M Mein. 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 essential that you inform your doctor if you are using any of the following medications:

1. corticosteroids with mineralocorticoid action (such as fludrocortisone) or ACTH (corticotropin) - lithium carbonate.
2. acidic medications such as salicylates and barbiturates.
3. basic medications such as sympathomimetics (ephedrine, pseudoephedrine) and stimulants (amphetamine, dextroamphetamine).

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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.

Important information about some of the components of Sodium Bicarbonate 1/6 M Mein

Patients with low-sodium diets should note that this medication contains 3.84 g (167 mmol) of sodium per liter.

3. How to use Sodium Bicarbonate 1/6 M Mein

Sodium Bicarbonate 1/6 M Mein will be administered to you in a hospital by healthcare professionals via intravenous infusion. The volume and infusion rate at which it is administered will depend on your needs. Your doctor will decide what dose you should receive.

If you are given more Sodium Bicarbonate 1/6 M Mein than you should

Overdose or intoxication 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 (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, the administration of the medicine should be discontinued, and the electrolyte imbalance should be corrected.

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

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

4. Possible side effects

Like all medicines, Sodium Bicarbonate 1/6 M Mein can cause side effects, although not everyone 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:

1. metabolic alkalosis (increased blood pH)
2. paradoxical intracellular and cerebrospinal fluid acidosis (decrease in pH in cells and cerebrospinal fluid)
3. hypokalemia (low potassium levels in the blood)
4. hypocalcemia (low calcium levels in the blood)
5. tetany (prolonged muscle spasms)
6. lactic acidosis (accumulation of lactic acid)
7. hypernatremia (high sodium levels in the blood)
8. hyperosmolar state
9. mood changes
10. irritability
11. hypertonia (extreme muscle tension)
12. cerebral hemorrhage
13. arrhythmia (alteration of heart rhythm)
14. hypotension (decrease in blood pressure)
15. hypoxia (decrease in oxygen levels below normal in blood or tissues)
16. diarrhea
17. muscle weakness
18. fatigue
19. edema (excessive fluid accumulation)
20. 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 1/6 M Mein.

1. If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

5. Storage of Sodium Bicarbonate 1/6 M Mein

Keep out of the reach and sight of children.

Your doctor/hospital healthcare staff are responsible for the correct storage, use, and disposal of Sodium Bicarbonate 1/6 M Mein.

No special storage conditions are required.

Do not use Sodium Bicarbonate 1/6 M Mein after the expiration date stated on the package.

Once the treatment is finished, any remaining solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Sodium Bicarbonate 1/6 M Mein

The active substance is sodium hydrogen carbonate (sodium bicarbonate). Each 100 ml of solution contains 1.4 g of sodium hydrogen carbonate.

The other components are: water for injection.

Appearance of the product and package contents

Sodium Bicarbonate 1/6 M Mein is a clear and colorless solution, without visible particles, packaged in a glass container. It is available in 250 ml and 500 ml containers.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi España S.A.U

C/ Marina 16-18.

08005-Barcelona (Spain)

Manufacturer:

Fresenius Kabi Italia, S.r.l.

Via Camagre, 41

I-37063 Isola della Scala - Verona

This package leaflet was revised in

January 2011

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This information is intended only for doctors or 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. Complete and rapid correction to normal pH levels (7.30-7.40) can lead to overdose problems.

This medicine will always be administered by specialized personnel. It will be administered by infusion, through a central or peripheral vein.

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

The contents of each container are for a single infusion; the unused fraction must be discarded.

Use an aseptic method to administer the solution and when preparing mixtures.

Before adding medications to the solution or administering them simultaneously with other medications, 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, acid salts, and many alkaloid salts, but the incompatibility depends on different factors such as the concentration of the drugs, 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 containing 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), as the bicarbonate, being an alkaline solution, can inactivate the catecholamines.

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