Label: information for theuser

Sodium Bicarbonate 1/6 M Mein solution for perfusion

Hydrogen Carbonate of sodium

(Sodium Bicarbonate)

Read this label carefully beforestarting to usethis medication, because 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 pharmacist..

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

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

1. What isSodium Bicarbonate 1/6 M Meinand what is it used for

2. What you need to know before starting to useSodium Bicarbonate 1/6 M Mein

3. How to useSodium Bicarbonate 1/6 M Mein

4. Possible adverse effects

5. Storage ofSodium Bicarbonate 1/6 M Mein

6. Contents of the package and additional information

Sodium Bicarbonate 1/6 M Mein is an intravenous solution that belongs to a group of medications called intravenous solutions that affect the electrolyte balance-Electrolytes.

It is indicated in the following situations:

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

Do not use Sodium Bicarbonate 1/6 M Mein

1. If you are allergic to the active ingredient or any of the other components of the medication
2. If you have alkalosis (elevated blood pH), whether of metabolic or respiratory origin
3. 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)
4. If you have excessive chloride loss through vomiting or gastrointestinal suction or alkalosis caused by diuretic medications
5. If you have respiratory acidosis

Be especially careful with Sodium Bicarbonate 1/6 M Mein

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

1. 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

1. 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. In these cases, bicarbonate solutions should be administered with extreme caution

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

1. If you are administered undiluted bicarbonate solution, as if the liquid comes out of the vein, it may cause necrosis, ulceration, and/or desquamation at the injection site

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

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

Use of other medications

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

1. Corticosteroids with mineralocorticoid activity (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)

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription

Pregnancy and lactation

Consult your doctor or pharmacist before using any 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 beneficial effects justify the possible risks to the fetus or infant

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

Sodium Bicarbonate 1/6 M Mein will be administered in a hospital by healthcare professionals via intravenous infusion. The volume and rate of infusion 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 overmedication with sodium bicarbonate can occur when the medication is administered in excess or too quickly, or in patients with renal insufficiency and may lead to the development of metabolic alkalosis, hypocalcemia, hypokalemia (low potassium levels in the blood), 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, administration of the medication should be discontinued and 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 product, ask your doctor or pharmacist

Like all medications, Sodium Bicarbonate 1/6 M Mein may produce adverse effects, although not all people will experience them.

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

The possible adverse effects are:

1. Metabolic alkalosis (elevated blood pH)
2. Paradoxical intracellular and cerebrospinal fluid acidosis (decreased pH in cells and cerebrospinal fluid)
3. Hypokalemia (low potassium levels in blood)
4. Hypocalcemia (low calcium levels in blood)
5. Tetany (prolonged muscle spasms)
6. Lactic acidosis (accumulation of lactic acid)
7. Hypernatremia (high sodium levels in blood)
8. Hyperosmolar state
9. Mood changes
10. Irritability
11. Extreme muscle tension
12. Cerebral hemorrhage
13. Arrhythmia (alteration of heart rhythm)
14. Hypotension (decreased blood pressure)
15. Hypoxia (decreased oxygen levels below normal in blood or tissues)
16. Diarrhea
17. Muscle weakness
18. Fatigue
19. Edema (excessive accumulation of fluids)
20. 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 1/6 M Mein.

1. If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

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

No special conservation conditions are required.

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

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

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Sodium Bicarbonate 1/6 M Mein

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

The other components are: injection water.

Appearance of the product and contents of the package

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

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 Italia, S.r.l.

Vía Camagre, 41

I-37063 Isola della Scala - Verona

This leaflet has been reviewed in

January 2011

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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.

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, 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 through 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.