Venofusin sodium bicarbonate 1 M solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Venofusin Sodium Bicarbonate 1M Solution for infusion

Sodium hydrogen carbonate

(Sodium bicarbonate)

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Venofusin Sodium Bicarbonate 1M is and what it is used for
2. What you need to know before using Venofusin Sodium Bicarbonate 1M
3. How to use Venofusin Sodium Bicarbonate 1M
4. Possible side effects
5. How to store Venofusin Sodium Bicarbonate 1M
6. Contents of the pack and other information

1. What VENOFUSIN SODIUM BICARBONATE 1M is and what it is used for

Venofusin Sodium Bicarbonate 1M is an intravenous infusion solution belonging to the group of medicines known as intravenous electrolyte solutions affecting electrolyte balance.

It is indicated in the following situations:

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

• To increase urinary pH in the treatment of acute intoxications with certain drugs 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 VENOFUSIN SODIUM BICARBONATE 1M

Do not use Venofusin Sodium Bicarbonate 1M

• If you are allergic to the active substance or to any of the other components of this medicine
• If you have alkalosis (increased blood pH), whether of metabolic or respiratory origin
• If you have low levels of calcium in the blood (hypocalcemia), since administration of 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

Exercise special caution with Venofusin Sodium Bicarbonate 1M:

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

• During treatment, since blood levels of calcium and potassium may decrease during therapy with sodium bicarbonate. Your doctor may monitor and, if necessary, correct the levels of these electrolytes.

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

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

• If the sodium bicarbonate solution is administered undiluted, since leakage of the liquid outside the vein may cause necrosis, ulceration, and/or peeling at the injection site.

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

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

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

Using Venofusin Sodium Bicarbonate 1M with other medicines

Certain medicines may interact with Venofusin Sodium Bicarbonate 1M. 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:

• Mineralocorticoid-acting corticosteroids (such as fludrocortisone) or ACTH (corticotropin).
• Lithium carbonate.
• Acidic drugs such as salicylates and barbiturates.
• Basic drugs such as sympathomimetics (ephedrine, pseudoephedrine) and stimulants (amphetamine, dexamphetamine).

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist 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 outweigh the potential risks to the fetus or infant.

Driving and using machines

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

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

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

3. How to use VENOFUSIN SODIUM BICARBONATE 1M

Venofusin Sodium Bicarbonate 1M is normally administered by infusion, diluted to isotonicity in other intravenous administration fluids with which it is physically compatible. However, the undiluted solution may also be administered by slow injection. In cases of extreme emergency, such as cardiac arrest (a clinical condition associated with lactic acidosis), the medication may even be initially administered by rapid direct intravenous injection. When administering the hypertonic solution, a central route must be used.

This medicine will be used in a hospital setting by qualified healthcare personnel. If administered via a peripheral route, the medication must be diluted with a compatible solution.

Your doctor will determine the duration and dosing regimen for treatment with Venofusin Sodium Bicarbonate 1M based on the severity of the 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, frequent monitoring of the acid-base status is recommended during therapy, allowing adjustment of the dose according to the patient's 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.

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 a 7.5% or 8.4% sodium bicarbonate injection with 5% glucose injection (final solution at 4.2%) is recommended, not exceeding 8 mEq/kg per day.

If you are given more Venofusin Sodium Bicarbonate 1M than you should

Toxicity or overdose during sodium bicarbonate therapy may occur when drug administration is excessive or too rapid, or in patients with renal insufficiency, and may lead to the development of 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 medication 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 pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

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

Possible adverse effects include:

• 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 (irregular heart rhythm)
• hypotension (low blood pressure)
• hypoxia (reduced 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 above are not established, as there are no clinical studies conducted with Venofusin Sodium Bicarbonate 1M.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VENOFUSIN SODIUM BICARBONATE 1M

Keep out of the sight and reach of children.

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

No special storage conditions are required.

Do not use Venofusin Sodium Bicarbonate 1M after the expiry date stated on the container.

After completion of treatment, any remaining solution must be discarded.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venofusin Sodium Bicarbonate 1M

The active substance 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 injections.

Appearance of the medicinal product and contents of the pack

Venofusin Sodium Bicarbonate 1M is a clear, colourless solution free from visible particles, contained in a glass container. It is available in 250 ml packs.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Fresenius Kabi España S.A.U
C/ Marina 16-18.
08005-Barcelona (Spain)

Manufacturer:

Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria

or

Fresenius Kabi Deutschland GmbH
Freseniusstrasse 1 (Friedberg)
D-61169 - Germany

Date of the most recent revision of this leaflet: December 2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only:

The treatment of metabolic acidosis should focus on correcting or improving the underlying disorder responsible. Generally, administration of sodium bicarbonate is only necessary in severe cases of metabolic acidosis (arterial pH below 7.20), or when the cause of the 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) with sodium bicarbonate carries the risk of overdosage.

This medicine must always be administered by trained healthcare personnel. It is given by intravenous infusion via a central or peripheral vein. It may be administered undiluted via central line or diluted in a compatible solution for peripheral administration.

Venofusin Sodium Bicarbonate 1M 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.

The solution must be clear and free from precipitates. Do not administer if this is not the case.

The contents of each container are intended for a single infusion; any unused portion must be discarded.

Use aseptic techniques when administering the solution and when preparing mixtures.

Before adding any medicinal products to the solution or administering them simultaneously with other drugs, compatibility must be verified.

Sodium bicarbonate has been shown to be physically and/or chemically incompatible with many drugs, including acids, acidic salts, and numerous alkaloidal salts. However, incompatibility depends on various factors such as drug concentration, diluent used, resulting pH, and temperature. In many cases, incompatibility arises due to the alkaline nature of the sodium bicarbonate solution.

In general, sodium bicarbonate solutions must not be mixed with acids in aqueous solutions, due to the release of CO₂ that occurs when bicarbonate reacts with acidic solutions, nor with solutions containing calcium salts, because insoluble complexes may form as a result of such combinations.

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

As with other parenteral solutions, compatibility tables should be consulted before adding any medicinal products to the solution.