Viaflo Ringer solution for intravenous infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Viaflo Ringer infusion solution

Active substances: sodium chloride, potassium chloride and calcium chloride dihydrate

Read the entire leaflet carefully before starting administration of this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet.

Leaflet contents:

1. What Viaflo Ringer is and what it is used for

2. What you need to know before administration of Viaflo Ringer

3. How Viaflo Ringer is administered

4. Possible adverse effects

5. How to store Viaflo Ringer

6. Contents of the pack and other information

1. What Viaflo Ringer is and what it is used for

Viaflo Ringer is a solution containing the following substances in water:

• Sodium chloride
• Potassium chloride
• Calcium chloride dihydrate

Viaflo Ringer is used to treat loss of body water (dehydration) and loss of chemical substances (e.g. excessive sweating, kidney disorders).

2. What you need to know before starting administration of Viaflo Ringer

DO NOT administer Viaflo Ringer if you have any of the following clinical conditions

• Premature newborn or full-term newborn (less than 28 days old): your child must not be given an antibiotic called ceftriaxone as an intravenous infusion at the same time as this medicine.

• Excess fluid in the extracellular spaces of the body (extracellular hyperhydration)

• Abnormally high blood volume in the blood vessels (hypervolemia)

• Severe renal failure (when your kidneys do not function properly and you require dialysis)

• If you have uncompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:

  • Shortness of breath
  • Swelling of the ankles

• Excess fluid in the body caused by excessive salts in the blood (hypertonic dehydration)

• If your blood potassium concentration is higher than normal (hyperkalemia)

• If your blood sodium concentration is higher than normal (hypernatremia)

• If your blood calcium concentration is higher than normal (hypercalcemia)

• If your blood chloride concentration is higher than normal (hyperchloremia)

• Very high blood pressure (hypertension)

• Fluid accumulation under the skin affecting the whole body (generalized edema)

• If you have a liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis)

• If you are receiving cardiac glycosides (cardiotonics) used to treat heart failure, such as digitalis or digoxin. (See "Other medicines and Viaflo Ringer")

Warnings and precautions

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

• Respiratory insufficiency (lung disease) (in such cases special monitoring may be required)
• Any type of heart disease or heart failure
• Renal insufficiency
• High blood pressure (hypertension)
• Fluid accumulation under the skin, particularly around the ankles (peripheral edema)
• Fluid accumulation in the lungs (pulmonary edema)
• High blood pressure during pregnancy (pre-eclampsia)
• If you have a condition causing high levels of the hormone aldosterone (aldosteronism)
• Any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (see also "Other medicines and Viaflo Ringer")
• If you have problems with fluid levels in your brain (e.g., due to meningitis, intracranial hemorrhage, or brain injury)
• If you have a condition that may cause elevated levels of vasopressin, a hormone that regulates your body's fluids, such as:
  • A sudden and severe illness or injury
  • Surgery
  • A brain disorder
  • Certain medications you are taking

This may increase the risk of low sodium levels in your blood and may cause headache, nausea, seizures, lethargy, coma, and brain swelling.

Individuals at higher risk of brain swelling include:

Children

Women (especially women of childbearing age)

• If you have a condition in which the glands in your body are not producing enough hormones (adrenocortical insufficiency)
• Loss of water from the body (acute dehydration, for example due to vomiting or diarrhea)
• Extensive tissue damage (such as in severe burns)
• Diseases associated with high levels of vitamin D (sarcoidosis, a disease affecting the skin and internal organs)
• Conditions associated with kidney stones
• Ceftriaxone, an antibiotic, must not be mixed or administered simultaneously with solutions containing calcium when given intravenously. Patients older than 28 days may receive ceftriaxone and calcium-containing solutions sequentially, provided your doctor takes appropriate measures to prevent interaction between the medicines. If you or your child have low blood volume, your doctor will avoid administering ceftriaxone and calcium sequentially.
• Heart failure

While you are receiving this solution, your doctor may take blood and urine samples to monitor:

• The amount of fluid in your body
• Your vital signs
• The levels of chemical substances such as sodium, potassium, calcium, and chlorides in your blood (your plasma electrolytes)

Although Viaflo Ringer contains potassium and calcium, it does not contain enough to:

• Maintain normal levels of these substances
• Treat very low levels of potassium (severe potassium deficiency) and calcium (severe calcium deficiency) in plasma

Once your dehydration has been treated with Viaflo Ringer solution, your doctor will switch you to a different infusion to provide adequate potassium and calcium. Your doctor must consider whether you are receiving parenteral nutrition (nutrition delivered by intravenous infusion). During prolonged treatment with Viaflo Ringer, you will require additional nutritional support.

Calcium chloride can be harmful if injected into tissues. Therefore, Viaflo Ringer must not be administered by intramuscular injection. Your doctor will also take care to prevent the solution from leaking into the tissues around the veins (extravasation).

Viaflo Ringer must not be administered through the same intravenous line used for blood transfusion. This could damage red blood cells or cause them to clump together.

Other medicines and Viaflo Ringer

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

It is particularly important that you inform your doctor if you are taking:

• Ceftriaxone (an antibiotic) administered intravenously (see Warnings and precautions)
• Cardiac glycosides (cardiotonics) such as digitalis or digoxin, used to treat heart failure, which must not be used together with Viaflo Ringer (see section "Do not administer Viaflo Ringer if you have..."). The effects of these medicines may be increased by calcium, which could lead to life-threatening heart rhythm disturbances.

The following medicines may cause the body to retain sodium and water, leading to tissue swelling and high blood pressure:

• Corticosteroids (anti-inflammatory medicines)
• Carbenoxolone (an anti-inflammatory medicine used to treat stomach ulcers)

The following medicines may increase blood potassium levels. This effect can be life-threatening. You are more likely to experience increased blood potassium levels if you have kidney disease:

• Potassium-sparing diuretics (some water tablets, e.g., amiloride, spironolactone, triamterene)

(Note that these drugs may be included in some combination medicines)

• Angiotensin-converting enzyme inhibitors (ACE inhibitors) used to treat high blood pressure
• Angiotensin II receptor antagonists (used to treat high blood pressure)
• Tacrolimus (used to prevent transplant rejection and to treat skin disorders)
• Cyclosporines (used to prevent transplant rejection)

Some medicines may increase the risk of side effects due to low sodium levels in the blood. These medicines may include:

• Water tablets (diuretics)
• Medicines for pain and/or inflammation (also known as non-steroidal anti-inflammatory drugs; NSAIDs)
• Antipsychotics
• Medicines used to treat depression (selective serotonin reuptake inhibitors)
• Medicines that produce effects similar to morphine (opioids)
• Certain medicines used to treat epilepsy (antiepileptics)
• A hormone called oxytocin (used to contract the uterus)
• Medicines used to treat cancer (chemotherapy)
• Medicines used to treat cholesterol
• Medicines used to treat diabetes

Other medicines that may interact with or be affected by Viaflo Ringer include:

• Thiazide diuretics such as hydrochlorothiazide or chlorthalidone
• Vitamin D

Use of Viaflo Ringer with food and drink

Ask your doctor about what you may eat or drink.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medicine.

Viaflo Ringer can be used safely during pregnancy and breastfeeding as long as electrolytes and fluid balance are controlled and monitored by your doctor. Your doctor will take special care if you are receiving oxytocin during labor.

Calcium can pass through the placenta to the fetus and, after birth, through breast milk. Your doctor will monitor your blood electrolyte levels and fluid balance.

However, if another medicine is added to the infusion solution during pregnancy, particularly during labor or breastfeeding, you must:

• Ask your doctor
• Read the package leaflet of the medicine being added

Driving and using machines

Viaflo Ringer does not affect your ability to drive or operate machinery.

3. How Viaflo Ringer is administered

Viaflo Ringer will be administered to you by a doctor or nurse. Your doctor will decide how much you need and when it should be given. This will depend on your age, weight, physical condition, and the reason for treatment. The amount you receive may also be influenced by other treatments you are receiving.

Do not receive Viaflo Ringer if there are particles floating in the solution or if the container is damaged in any way.

Viaflo Ringer is usually administered through a plastic tube connected to a needle inserted into a vein. A vein in the arm is typically used for the infusion. However, your doctor may administer the medicine in another way.

While you are receiving Viaflo Ringer, your doctor will perform blood tests to monitor:

• your blood levels of sodium, potassium, calcium, and chloride
• your fluid levels

Any unused portion of the solution must be discarded. DO NOT receive Viaflo Ringer from a bag that has been partially used.

If you receive more Viaflo Ringer than you should

If you receive too much Viaflo Ringer solution or if it is administered too quickly, you may experience the following symptoms:

• fluid and/or sodium (salt) overload with accumulation of fluid in the tissues (edema), causing swelling

• tingling in the arms and legs (paresthesia)

  • muscle weakness
  • inability to move (paralysis)
  • irregular heartbeats (cardiac arrhythmias)
  • heart block (very slow heartbeats)
  • cardiac arrest (the heart stops beating and life is at risk)
  • confusion
  • loss of appetite (anorexia)

• discomfort (nausea)

• vomiting

• constipation

• abdominal pain

• mental disturbances, such as irritability or depression

• excessive thirst (polidipsia)

• increased urine production (polyuria)

• kidney disease caused by calcium accumulation in the kidneys (nephrocalcinosis)

• kidney stones

• coma (loss of consciousness)

• chalky taste

• redness (flushing)

• dilation of blood vessels in the skin (peripheral vasodilation)

• acidification of the blood (acidosis), leading to fatigue, confusion, lethargy, and increased breathing rate.

If you notice these symptoms, inform your doctor immediately. The infusion will be stopped, and you will receive treatment depending on the symptoms.

If any medicine has been added to Viaflo Ringer before the overdose, that medicine may also cause symptoms. You should read the list of possible side effects in the package leaflet of the added medicine.

If the Viaflo Ringer infusion is interrupted

Your doctor will decide when you should stop receiving this infusion.

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

4. Possible adverse effects

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

The adverse effects are listed in order of frequency.

Very common (occur in more than 1 in 10 patients)

• Variations in blood concentrations of chemical substances (electrolyte disorders).

If you have any heart disease or fluid in the lungs (pulmonary edema):

• Excessive fluid in the body (hyperhydration).
• Heart failure.

Other

• Reactions due to the administration technique:

• Fever (febrile reaction).

• Infection at the infusion site.

• Pain or local reaction (redness or swelling at the infusion site).

• Irritation and inflammation of the vein into which the solution is administered (phlebitis). This may cause redness, pain, burning, and swelling along the vein.

• Formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot.

• Leakage of the infusion solution into the surrounding tissues (extravasation), which may damage tissues and lead to scarring.

• Sodium levels in the blood (hyponatremia).

• Brain swelling that may cause brain damage (hyponatremic encephalopathy).

If a medicine has been added to the infusion solution, it may also cause adverse effects. These adverse effects will depend on the added medicine. You should read the list of possible symptoms in the leaflet of the added medicine.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Viaflo Ringer

Keep this medicine out of the sight and reach of children.

Viaflo Ringer does not require special storage conditions.

Do not use this medicine after the expiry date stated on the bag after EXP. The expiry date refers to the last day of the month indicated.

Do not administer this medicine if you observe particles floating in the solution or if the container is damaged in any way.

6. Package contents and other information

Composition of Viaflo Ringer

The active substances are:

• sodium chloride: 8.60 g per litre
• potassium chloride: 0.30 g per litre
• calcium chloride dihydrate: 0.33 g per litre

The other components are: water for injections, sodium hydroxide

Appearance of the product and contents of the container

Viaflo Ringer is a clear solution, free from visible particles. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is contained within a sealed protective overpouch made of plastic.

The bag sizes are:

• 500 ml
• 1000 ml

The bags are packed in cardboard boxes. Each cardboard box contains one of the following quantities:

• 1 bag of 500 ml
• 20 bags of 500 ml
• 1 bag of 1000 ml
• 10 or 12 bags of 1000 ml

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Baxter S.L.

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

Manufacturer:

Bieffe Medital S.A.

Ctra. Biescas-Senegüé s/n, 22666 Sabiñánigo (Huesca), Spain

or

Baxter S.A.

Av. René Branquart 80, Lessines

Belgium

The most recent revision of this package leaflet was in November 2018

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.gob.es/

This information is intended for healthcare professionals only

Handling and preparation

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

Do not remove the bag from its overpouch 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 entrained from the primary container before completion of administration of the fluid in the secondary container. Pressurizing intravenous solutions in flexible plastic containers to increase flow rates may lead to gas embolism if residual air in the container is not completely evacuated prior to administration. Using an intravenous administration set with a vent filter in the open position may cause gas embolism. Such intravenous administration sets with the vent filter in the open position must not be used with flexible plastic containers.

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

Medications may be added before or during infusion through the medication addition port.

When adding medications, osmolarity must be checked before parenteral administration. It is essential that mixing be carried out under strict aseptic conditions. Solutions containing additives should be used immediately and must not be stored.

The addition of medications or the use of an incorrect administration technique may cause febrile reactions due to possible introduction of pyrogens. In the event of an adverse reaction, the infusion must be stopped immediately.

Discard after single use.

Discard partially used containers.

Do not reconnect partially used bags.

1- To open

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

• Check for small leaks by firmly squeezing the inner bag. If leaks are detected, discard the solution, as it may no longer be sterile.

• 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 materials 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 to prepare the infusion.

• Connect the administration set. Refer to the instructions accompanying the administration set for connection, priming, and administration of the solution.

3- Techniques for adding medication

Warning: Added medications may be incompatible (see section 5 “Incompatibilities of added medications” below)

To add medication before administration

• Disinfect the medication addition port.

• Using a syringe with a 19 G to 22 G needle, pierce the resealable medication addition port and inject.

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

Caution: Do not store bags with added medication.

To add medication during administration

• Close the clamp on the administration set.

• Disinfect the medication addition port.

• Using a syringe with a 19 G to 22 G needle, pierce the resealable medication addition port and inject.

• Remove the container from the IV stand and/or turn it to place it in vertical position.

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

• Mix the solution and medication carefully.

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

1. In-use expiry (with added medications)

Prior to use, the physical and chemical stability of any added medication at the pH of Viaflo Ringer solution in the Viaflo container must be established.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the conditions at the time of use and storage times prior to use are the responsibility of the user and normally should not exceed 24 hours at 2 to 8 °C, unless reconstitution has taken place under controlled and validated aseptic conditions.

5- Incompatibilities of added medications

As with all parenteral solutions, compatibility of added medications with the solution in the Viaflo bag must be verified before addition.

It is the physician's responsibility to assess incompatibility of the added medication by checking for any change in colour and/or precipitation, formation of insoluble complexes, or appearance of crystals. The package leaflet of the medication to be added should be consulted.

Before adding a medication, verify that it is soluble and stable in water at the pH of Viaflo Ringer (pH 5.0 – 7.5).

Calcium salts are known to be incompatible with a wide range of medications, potentially forming complexes that result in precipitation.

• Concomitant administration of ceftriaxone and Viaflo Ringer is contraindicated in premature neonates and full-term neonates (≤ 28 days of age), even if different infusion lines are used.
• In patients of any age, ceftriaxone must not be mixed or administered simultaneously with intravenous solutions containing calcium, even via different infusion lines or different infusion sites.
• If the same infusion line is used for sequential administration, the line must be thoroughly flushed with a suitable fluid between infusions.
• Sequential infusions of ceftriaxone and calcium-containing solutions should be avoided in patients with low blood volume.

The following list serves as a guide to medications incompatible with Viaflo Ringer (non-exhaustive list):

• Amphotericin B
• Cortisone
• Erythromycin lactobionate
• Etamivan
• Ethyl alcohol
• Sodium thiopental
• Disodium edetate

Medications known to be incompatible must not be used.