Viaflo sodium bicarbonate 1.4%, solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

VIAFLO SODIUM BICARBONATE 1.4% solution for infusion

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 others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet.

Leaflet contents:

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

2. Before you use Viaflo Sodium Bicarbonate 1.4%

3. How to use Viaflo Sodium Bicarbonate 1.4%

4. Possible adverse effects

5. How to store Viaflo Sodium Bicarbonate 1.4%

6. Further information

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

Viaflo Sodium Bicarbonate 1.4% is an infusion solution used:

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

In the treatment of phenobarbital intoxication.

2. Before using Viaflo Sodium Bicarbonate 1.4%

Do not administer Viaflo Sodium Bicarbonate 1.4% if you have any of the following conditions:

• if you are allergic to sodium bicarbonate or to any of the other ingredients listed at the end of this leaflet
• 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 failure (respiratory acidosis)
• if your blood has lower than normal calcium levels (hypocalcemia)
• if your blood has lower than normal chloride levels (hypochloremia)

Take special care with Viaflo Sodium Bicarbonate 1.4%:

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

• Any condition indicating that you may be prone to low blood potassium levels (hypokalemia)
• Any condition indicating that you retain water and salt (water and sodium retention)
• Heart disease (heart failure)
• Kidney disease or impaired kidney function (renal failure)
• Any condition for which you are receiving corticosteroids (e.g., if you have an inflammatory disease such as arthritis or asthma)
• Any condition indicating elevated carbon dioxide levels in your blood (hypercapnia)
• Any condition indicating severe liver disorder (cirrhosis) and fluid accumulation in the body (ascites-edema syndrome)

When this solution is administered, your doctor will take blood samples to monitor:

• The levels of certain chemicals, such as sodium and potassium, in your blood (your plasma electrolytes)
• The acidity of your blood and urine (your acid-base balance and plasma pH)

While this solution is being administered, your doctor will regularly monitor:

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

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

Use of other medicines

Sodium bicarbonate may increase blood concentrations of certain medicines such as: quinidine, flecainide, amphetamine, dexamphetamine, ephedrine, pseudoephedrine, or memantine.

Sodium bicarbonate may decrease blood concentrations of certain medicines such as salicylates, phenobarbital, or lithium.

You must inform your doctor if you are taking any of these medicines while using Viaflo Sodium Bicarbonate 1.4%.

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

Your doctor will check whether mixtures of other medicines (which may be administered to you intravenously) are compatible with Viaflo Sodium Bicarbonate 1.4%.

Pregnancy and breastfeeding

Administration of Viaflo Sodium Bicarbonate 1.4% is not recommended during pregnancy or breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Inform your doctor before administration if:

• You are pregnant or suspect you may be pregnant.
• You are breastfeeding.

3. How to use Viaflo Sodium Bicarbonate 1.4%

Your doctor will determine the required dose and frequency of administration depending on your condition.

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

If you receive more 1.4% sodium bicarbonate than you should

You may develop:

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

Contact a doctor immediately if you experience any of these symptoms.

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

4. Possible adverse effects

Like all medicines, Viaflo Sodium Bicarbonate 1.4% can cause adverse effects, although not everybody will experience them.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Viaflo Sodium Bicarbonate 1.4%

Keep out of the reach and sight of children.

Viaflo Sodium Bicarbonate 1.4% must not be used after the expiry date stated on the bag. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Use only if the solution is clear, free from visible particles, and the container is undamaged.

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

The inner bag maintains the sterility of the product.

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

6. Information for Healthcare Professionals

Composition of Viaflo Sodium Bicarbonate 1.4%

The active substance is:

Sodium bicarbonate 1.4 g

per 100 ml.

1 ml of solution contains 14 mg of sodium bicarbonate.

Sodium 167 mmol/l
Carbonate 167 mmol/l
pH = 7.0 – 8.5
Osmolarity: 334 mOsm/l

Other components: water for injections and carbon dioxide.

Appearance of Viaflo Sodium Bicarbonate 1.4% and pack contents

Viaflo Sodium Bicarbonate 1.4% is an infusion solution supplied in a 500 ml plastic bag.

Each bag is individually packed in a sealed protective overwrap, which serves only as a protective layer.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Baxter, S.L.
Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia), Spain

Manufacturer:

Baxter SA
Boulevard René Branquart, 80
7860 Lessines, Belgium

Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca), Spain

This summary of product characteristics was approved in April 2011

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended exclusively for physicians and healthcare professionals

Viaflo Sodium Bicarbonate 1.4% allows regulation of plasma acid-base balance. However, correction of metabolic acidosis with sodium bicarbonate provides no benefit unless the underlying cause is also corrected.

This medicinal product may worsen or unmask hypokalaemia.

Check for absence of hypokalaemia. If present, administer potassium salts.

Take into account the administration of sodium.

The alkalinity of the solution causes numerous incompatibilities.

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

Due to the alkalinity of this solution, check compatibility before mixing with other drugs intended for concomitant administration via infusion, and verify the clarity and colour of the solution before infusion.

When mixing drugs for infusion, consider the pH of the solution (alkaline) and the presence of bicarbonate and sodium ions.

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

Combination requiring precautions in use:

Quinidine: increased plasma quinidine levels and risk of overdose (reduced renal excretion of quinidine due to urinary alkalinization).

Clinical monitoring, electrocardiogram, and possible monitoring of quinidine concentration if necessary; adjust dosage during and after alkalinizing treatment.

Instructions for use of VIAFLO bag

The infusion solution should be visually inspected before use.

Use only if the solution is clear, free from visible particles, and the container is undamaged. Administer immediately after connecting the infusion set.

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

The inner bag maintains the sterility of the product.

Do not connect plastic containers in series. This type of use may result in gas embolism due to residual air being drawn from the primary container before complete administration of the fluid in the secondary container.

The solution must be administered using a sterile set and aseptic technique. The administration set should be primed with the solution to prevent air from entering the system.

Additives may be introduced before or during infusion through the resealable injection port.

When additives are added, isotonicity must be verified prior to parenteral administration. Mixing must be performed under strict aseptic conditions. Solutions containing additives should be used immediately and must not be stored.

The addition of medications or incorrect administration techniques may lead to febrile reactions due to possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately.

Single-use only.

Discard partially used containers.

Do not reconnect partially used bags.

1- Opening the bag

• Remove the Viaflo bag from the protective overwrap immediately before use.

• Check for small leaks by firmly squeezing the inner bag. If leaks are detected, discard the solution, as sterility may be compromised.

• Check the clarity of the solution and absence of foreign particles. Discard the solution if it is not clear or contains foreign particles.

2- Preparation for administration

Use sterile equipment for preparation and administration.

• Hang the container by the eyelet.

• Remove the plastic protector from the outlet port at the bottom of the container.

  • Hold the small fin on the neck of the outlet tube with one hand.
  • Hold the large fin on the closure cap with the other hand and twist.
  • The cap will detach.

• Use aseptic technique when preparing the infusion.

• Connect the administration set. Refer to the instructions provided with the administration set for connection, priming, and solution administration.

3- Techniques for adding medication

Warning: Added medications may be incompatible.

To add medication before administration

• Disinfect the injection site.

• Using a syringe with a needle gauge 19 (1.10 mm) to 22 (0.70 mm), puncture the resealable injection port and inject the medication.

• Mix the medication and solution thoroughly. For high-density medications such as potassium chloride, gently move the tubes while in vertical position to ensure mixing.

Caution: Do not store bags with added medication.

To add medication during administration

• Close the clamp on the administration set.

• Disinfect the injection site.

• Using a syringe with a needle gauge 19 (1.10 mm) to 22 (0.70 mm), puncture the resealable injection port and inject the medication.

• Remove the container from the IV pole and/or turn it to vertical position.

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

• Mix the solution and medication thoroughly.

• Return the container to its normal position, reopen the clamp, and continue administration.