PATIENT INFORMATION LEAFLET

VIAFLO SODIUM BICARBONATE 1.4% SOLUTION FOR INFUSION

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. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

1.What Viaflo Sodium Bicarbonate 1.4% is and what it is used for

2.Before using Viaflo Sodium Bicarbonate 1.4%

3.How to use Viaflo Sodium Bicarbonate 1.4%

4.Possible side effects

5.Storage of Viaflo Sodium Bicarbonate 1.4%

6.Further information

Viaflo Sodium Bicarbonate 1,4%is a solution for infusion that is used:

• For metabolic acidosis (when the blood becomes too acidic).

For the treatment of phenobarbital poisoning.

You should not be administered Viaflo Bicarbonato sódico 1,4% if you suffer from any of the following conditions:

• if you are allergic to sodium bicarbonate or any of the other components listed at the end of this prospectus
• if you have a condition in which the blood becomes too alkaline (metabolic or respiratory alkalosis)
• if you have a condition in which the blood becomes too acidic due to respiratory insufficiency (respiratory acidosis)
• if your blood presents levels of calcium lower than normal (hypocalcemia)
• if your blood presents levels of chlorides lower than normal (hypochloremia)

Be especially careful with Viaflo Bicarbonato sódico 1,4%:

Inform your doctor if you have or have had any of the following clinical situations:

• Any condition that indicates you are more prone to having low levels of potassium in the blood (hypokalemia)
• Any situation that indicates you retain water and salt (hydrosodic retention)
• Heart disease (heart failure)
• Renal disease or impaired renal function (renal failure)
• Any situation in which you receive corticosteroids (for example, if you have an inflammatory disease such as arthritis or asthma)
• Any situation that indicates the existence of an increase in the concentration of carbon dioxide in your blood (hypercapnia)
• Any situation that indicates the existence of a severe liver disorder (cirrhosis) and the storage of fluid in the body (ascitic-edematous syndrome)

When you are administered this solution, the doctor will take blood samples to determine:

• The amount of chemical substances, such as sodium and potassium, present in the blood (your plasma electrolytes)
• The acidity of the blood and urine (your acid-base balance and plasma pH)

When you are administered this solution, the doctor will regularly check:

• The proper functioning of your heart, lungs, and kidneys

If your blood is too acidic (metabolic acidosis), your doctor will analyze the cause. Sodium bicarbonate is only effective if this is also treated.

Use of other medications

Sodium bicarbonate may increase the concentration in the blood of certain medications such as: quinidine, flecainide, amphetamine, dextroamphetamine, ephedrine, pseudoephedrine, or memantine.

Sodium bicarbonate may decrease the concentration in the blood of certain medications such as salicylates, phenobarbital, or lithium.

You should inform your doctor if you are taking these medications while using Viaflo Bicarbonato sódico 1,4%.

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

Your doctor will check if the mixtures of other medications (that you may be administered intravenously) can be used with Viaflo Bicarbonato sódico 1,4%

Pregnancy and lactation

It is not recommended to administer Viaflo Bicarbonato sódico 1,4% during pregnancy or lactation.

Consult your doctor or pharmacist before using any medication.

Inform your doctor before administration if:

• You are pregnant or expect to be.
• If you are breastfeeding.

Your doctor will decide the amount and frequency of administration needed based on your condition.

Viaflo Sodium Bicarbonate 1.4% should be administered as a slow intravenous infusion. A needle is inserted into a vein and the medication flows slowly into the body.

If you receive more than the recommended amount of 1.4% sodium bicarbonate

You may develop:

• high blood alkalinity (metabolic alkalosis)
• respiratory problems (respiratory acidosis)
• low potassium levels in the blood (hypokalemia)
• heart failure (heart failure) or cardiac arrhythmias
• acute inflammation and/or fluid accumulation in the lungs (pulmonary edema)
• painful muscle spasms and tremors (seizures)
• bleeding in the brain (intracranial hemorrhage) due to increased carbon dioxide concentration in the blood (hypercapnia), especially in newborns and premature infants

Seek immediate medical attention if you experience any of these symptoms.

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

Like all medications, Viaflo Sodium Bicarbonate 1.4% may produce adverse effects, although not everyone will experience them.

• High blood alkalinity (metabolic or respiratory alkalosis)
• Low blood potassium concentration (hypokalemia)
• Low blood calcium concentration (hypocalcemia)
• High blood sodium concentration (hypernatremia)
• Deterioration at the infusion site (tissue destruction may occur at the injection site after extravasation)
• Fluid accumulation in the ankles (edema)
• Mood changes and/or irritability
• Decreased blood pressure (hypotension)

If you consider any of the adverse effects you are experiencing to be 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.

Viaflo Sodium Bicarbonate 1.4% MUST NOT be administered after the expiration date appearing on the bag. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Use only if the solution is transparent, free of visible particles, and if the container is not damaged.

Do not remove the bag from its overbag until ready for use.

The inner bag maintains the sterility of the product.

Medicines must not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Viaflo Bicarbonate Sodium 1.4%

The active ingredient is:

Bicarbonate sodium 1.4 g

Per 100 ml.

1 ml of solution contains 14 mg of bicarbonate sodium.

Sodium167 mmol/l

Carbonate167 mmol/l

pH = 7.0 - 8.5

Osmolarity: 334 mOsm/l

The other components are: water for injection and carbon dioxide.

Appearance of Viaflo Bicarbonate Sodium 1.4% and packaging contents

Viaflo Bicarbonate Sodium 1.4% is a perfusion solution that is presented in a 500 ml plastic bag.

Each bag is packaged in a sealed plastic protective overbag,whose sole functionis to protect it.

The product is marketed in boxes of 20 bags of 500 ml.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Baxter, S.L.

Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia)

Manufacturer responsible:

Baxter SA

Boulevard René Branquart, 80

7860 Lessines

Belgium

Bieffe Medital S.A.

Ctra de Biescas, Senegüé

22666 Sabiñánigo (Huesca)

Spain

This leaflet was approved in April 2011

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.gob.es/

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This information is intended solely for doctors or healthcare professionals

Viaflo Bicarbonate Sodium 1.4% allows the regulation of plasma acid-base balance. However, the correction of metabolic acidosis with sodium bicarbonate does not provide any benefit without correcting the underlying cause.

This medication may exacerbate or reveal hypokalemia.

Check for the absence of hypokalemia. If present, administer a potassium salt.

Be aware of sodium administration.

The alkalinity of the solution is a cause of numerous incompatibilities.

Check the integrity of the bag and the transparency of the solution before use.

Due to the alkalinity of this solution, check compatibility before mixing medications to be administered concomitantly in the perfusion and check the transparency and color of the solution before perfusion.

When mixing medications administered by perfusion, be aware of the pH of the solution (alkaline) and the presence of bicarbonate and sodium ions.

Typical examples of chemical incompatibility: All medications with an acidic reaction in solution (including chlorohydrates, insulin, etc.) and those whose basic form is insoluble (alkaloids, antibiotics, etc.).

Combination requiring caution for use:

Quinidine:increase in quinidine in plasma and risk of overdose (decrease in renal excretion of quinidine due to alkaline urine).

Clinical monitoring, electrocardiogram, and possibility of monitoring quinidine concentration if necessary, adjust dosage during and after alkalizing treatment.

Method of use of the VIAFLO bag

The perfusion solution must be visually controlled before use.

Use only if the solution is transparent, without visible particles, and if the container is not damaged. Administer immediately after connecting the perfusion equipment.

Do not remove the bag from its protective overbag until it is ready for use.

The inner bag maintains the sterility of the product.

Do not connect in series plastic containers. This type of use may produce gas embolisms due to residual air carried from the primary container before the administration of the liquid contained in the secondary container is completed.

The solution must be administered with sterile equipment using an aseptic technique. The equipment must be primed with the solution to prevent air entry into the system.

Adjuvants may be introduced before or during perfusion through the injection point.

When adding adjuvants, check isotonicity before parenteral administration. It is essential that the mixture of products be made in extreme asepsis conditions. Solutions containing adjuvants must be used immediately and not stored

The addition of medications or the use of an incorrect administration technique may cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, the perfusion must be interrupted immediately.

Dispose of after a single use.

Dispose of partially used containers.

Do not reconnect partially used bags.

1-To open

a.Remove the Viaflo bag from the protective overbag immediately before use.

b.Check for the absence of small leaks by pressing the inner bag firmly. If leaks are detected, discard the solution, as it may not be sterile.

c.Check the transparency of the solution and the absence of foreign particles. Discard the solution if it is not transparent or contains foreign particles.

2-Preparation for administration

Use sterile material for preparation and administration.

a.Hang the container by the hanger

b.-Remove the plastic protector from the outlet in the lower part of the container.

-Hold one hand on the small handle of the outlet tube.

-Hold the other hand on the large handle of the closure cap and turn.

-The cap will come off.

c.Use an aseptic technique to prepare the perfusion

d.Connect the administration equipment. Consult the instructions accompanying the equipment for connection, priming, and administration of the solution.

3-Techniques for injecting added medication

Warning: Added medications may be incompatible.

To add medication before administration

a.Disinfect the injection point

b.Using a syringe with a 19(1.10 mm)to 22(0.70 mm)gauge needle, prick the resellable injection point and inject.

c.Mix the medication and solution carefully. For high-density medications, such as potassium chloride, move the tubes gently while in the vertical position and mix.

Attention: do not store bags with added medication.

To add medication during administration

a.Close the clamp of the equipment.

b.Disinfect the injection point.

c.Using a syringe with a 19(1.10 mm)to 22(0.70 mm)gauge needle, prick the resellable injection point and inject.

d.Remove the container from the intravenous support and/or turn it to put it in the vertical position.

e.Empty both tubes by gently tapping them while the container is in the vertical position.

f.Mix the solution and medication carefully.

g.Put the container back in the use position, reopen the clamp, and continue administration.