PROSPECTO: INFORMATION FOR THE USER

Viaflo Ringer solution for perfusion

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

Read this prospectus carefully beforeinitiating the administration of this medicationbecause it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• Ifyou experienceadverse effects, consult yourdoctor or nurse,evenifthey do not appearin this prospectus.

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

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

3.How Viaflo Ringer will be administered

4.Possible adverse effects

5.Storage of Viaflo Ringer

6.Contents of the package and additional information

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

• Sodium chloride
• Potassium chloride
• Calcium chloride dihydrate

Viaflo Ringer is used to treat a loss of body water (dehydration) and of chemical substances (for example excessive sweating, renal alterations).

No Viaflo Ringer will be administered if you suffer from any of the following clinical situations

• Preterm or full-term newborn (less than 28 days): your child should not receive a type of antibiotic called ceftriaxona as an intravenous drip at the same time as this medication.
• When there is a lot of fluid in the extracellular spaces of the body (hyperhydration extracellular)
• When there is a higher volume of blood in the blood vessels than there should be (hypervolemia)
• Severe renal insufficiency (when your kidneys do not function well and require dialysis)
• If you have uncompensated heart failure. This is heart failure that does not receive adequate treatment and causes symptoms such as:
• Difficulty breathing
• Swelling of the ankles.
• When there is too much fluid in the body caused by too many 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)
• Generalized edema (swelling of the body)

• If you have liver disease that causes fluid accumulation in the abdomen (cirrhosis ascítica)
• If you are receiving cardiac glycosides (cardiotonics) used to treat heart failure, such as digitals or digoxin. (See "Other medications and Viaflo Ringer")

Warnings and precautions

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

• Respiratory insufficiency (lung disease) (in the above cases, special monitoring may be required)
• Any type of heart disease or insufficiency
• Renal insufficiency
• High blood pressure (hypertension)
• Peripheral edema (swelling of the legs)
• Pulmonary edema (fluid accumulation in the lungs)
• High blood pressure during pregnancy (pre-eclampsia)
• If you have a disease that causes high levels of the hormone aldosterone (aldosteronismo)
• Any other condition associated with sodium retention (when the body retains too much sodium), such as steroid treatment (see also "Other medications and Viaflo Ringer")
• If you have problems with fluid levels in your brain (for example, due to meningitis, bleeding in the skull or a brain injury)
• If you have a condition that may cause high levels of vasopressin, a hormone that regulates the fluids in your body, such as:
• A sudden and severe illness or injury
• Surgery
• Brain disease
• Certain medications you are taking

This may increase the risk of having low sodium levels in the blood and may cause headaches, nausea, convulsions, lethargy, coma, and brain inflammation.

People at higher risk of brain inflammation are:

Infants

Women (especially in fertile age)

• If you have a condition in which the glands of the body are not producing enough of some hormones (adrenal insufficiency)
• Acute dehydration (for example, due to vomiting or diarrhea)
• Extensive tissue damage (such as can occur in severe burns)
• Diseases associated with high levels of vitamin D (sarcoidosis, a disease that affects the skin and internal organs)
• Diseases associated with kidney stones
• Ceftriaxona, an antibiotic, should not be mixed or administered at the same time as solutions containing calcium when administered intravenously. Patients over 28 days of age may receive ceftriaxona and a calcium solution, one after the other, as long as their doctor takes the necessary measures to prevent the medications from reacting with each other. If you or your child have a low blood volume, your doctor will avoid administering ceftriaxona and calcium sequentially.
• Heart failure

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

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

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

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

Once your dehydration has been treated with the Viaflo Ringer solution, your doctor will give you a different infusion to provide you with enough potassium and calcium.Your doctor must take into account if you are receiving parenteral nutrition (nutrition received by intravenous infusion). During prolonged treatments with Viaflo Ringer, you will need extra nutrition.

The calcium chloride can be harmful if injected into the tissues. Therefore, Viaflo Ringer should not be injected into muscle (intramuscular injection). Your doctor will also take this into account to avoid the solution penetrating the tissues around the veins.

Viaflo Ringer should not be administered with the same needle used for a blood transfusion. The red blood cells may be damaged or clumped.

Other medications and Viaflo Ringer

Inform your doctor or nurse if you are using, have used recently or may need to use any other medication.

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

• Ceftriaxona (an antibiotic) administered intravenously (see Warnings and precautions),
• Cardiac glycosides (cardiotonics) such as digitals or digoxin, used to treat heart failure, as they should not be used with Viaflo Ringer (See section "No Viaflo Ringer will be administered if you suffer...."). The effects of those medications may be increased by the calcium, which could cause dangerous heart rhythm alterations.

The following medications may cause the body to accumulate sodium and water, causing tissue swelling and high blood pressure:

• Corticosteroids (anti-inflammatory medications)
• Carbenoxolona (an anti-inflammatory medication used in the treatment of stomach ulcers)

The following medications may increase the concentration of potassium in the blood. This effect may be life-threatening. It is more likely that you will suffer from an increase in blood potassium levels if you have kidney disease.

• Diuretics that save potassium (some tablets that help eliminate water, e.g. amilorida, espirolactona, triamtereno),

(Note that these medications may be included in some combinations of medications)

- Inhibitors of the angiotensin-converting enzyme (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 treat skin disorders),

- Cyclosporins (used to prevent transplant rejection).

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

• Diuretics that help eliminate water (diuretics);
• Medications for pain and/or inflammation (also known as non-steroidal anti-inflammatory drugs; NSAIDs);
• Antipsychotics;
• Medications used to treat depression (selective serotonin reuptake inhibitors);
• Medications that produce effects similar to those of morphine (opioids);
• Certain medications used to treat epilepsy (antiepileptics):
• A hormone called oxytocin (used to contract the uterus);
• Medications used to treat cancer (chemotherapy);
• Medications used to treat cholesterol;
• Medications used to treat diabetes.

Other medications that may affect or be affected by Viaflo Ringer are:

• Thiazide diuretics such as hydrochlorothiazide or clortalidona,
• Vitamin D.

Use of Viaflo Ringer with food and drinks

Ask your doctor about what you can eat or drink.

Pregnancy, breastfeeding, and fertility

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

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

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

However, if another medication is added to the infusion solution during pregnancy, especially during delivery or breastfeeding, you should:

• Ask your doctor,
• Read the medication's prospectus.

Driving and using machines

Viaflo Ringer does not affect your ability to drive or use machines.

Viaflo Ringerwill be administered by a doctor or a nurse. Your doctor will decide how much you need and when to administer it. 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.

Noshould receiveViaflo Ringerif there are particles floating in the solution or if the container is damaged in any way.

Generally, Viaflo Ringerwill be administered through a plastic tube connected to a needle inserted into a vein. A vein in the arm is usually used to administer the infusion. However, your doctor may administer the medication in another way.

When you are administeredViaflo Ringer, your doctor will perform blood tests to monitor:

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

Any remaining solution should be discarded. Do not receive Viaflo Ringer from a used partially used bag.

If you receive moreViaflo Ringerthan you should

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

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

-tingling in the arms and legs (paresthesia)

• muscle weakness
• inability to move (paralysis)
• irregular heartbeats (cardiac arrhythmias)
• cardiac block (very slow heartbeats)
• cardiac arrest (the heart stops beating and life is in danger)
• confusion
• decreased appetite (anorexia)

• uncomfort (nausea)
• vomiting
• constipation
• abdominal pain
• mental disorders, such as irritability or depression
• excessive thirst (polydipsia)
• excessive urine production (polyuria)
• kidney disease caused by calcium accumulation in the kidneys (nephrocalcinosis)
• kidney stones
• coma (loss of consciousness)
• metallic taste
• flushing (flushing)
• dilation of peripheral blood vessels in the skin (peripheral vasodilation)
• blood acidification (acidosis) leading to fatigue, confusion, lethargy, and increased respiratory rate.

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

If a medication has been added toViaflo Ringerbefore the excessive administration, the medication may also cause symptoms. You should read the list of possible symptoms in the medication's package insert.

If you interrupttheinfusionofViaflo Ringer

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

If you have any other questions about the use of this medication, ask your doctoror nurse.

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Adverse effects are listed in order of frequency.

Very Frequent(occur in more than one patient in every ten)

• Changes in blood chemistry substance concentrations (electrolyte disorders).

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

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

Others

• Reactions due to administration technique:

• Fever (febrile response).
• Infection at the infusion site.
• Pain or local reaction (redness or swelling at the infusion site).
• Irritation and inflammation of the vein in which the solution is administered (phlebitis). This can cause redness, pain, or burning and swelling along the vein in which the solution is administered.
• Formation of a blood clot (venous thrombosis), at the infusion site, which causes pain, swelling, or redness in the clot area.
• Leakage of the infusion solution into the surrounding tissues (extravasation), which can damage the tissues and cause the appearance of scars.
• Low sodium levels in the blood (hyponatremia);
• Swelling of the brain that can cause brain damage (hypnatremic encephalopathy).

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Viaflo Ringerdoes not require special conditions for conservation.

Do not usethis medicationafter the expiration date that appears on the bag after CAD. The expiration date is the last day of the month indicated.

Do not receivethis medicationif you observe particles floating in the solution or if the container is damaged in any way.

Composition ofViaflo Ringer

The active principles are:

• sodium chloride:8.60 gper liter
• potassium chloride:0.30 gper liter
• calcium chloride dihydrate:0.33 gper liter

The other components are: water for injection, sodium hydroxide

Appearance of the product and contents of the container

Viaflo Ringeris a transparent, particle-free solution. It is presented in polyolefin/polyamide plastic bags (Viaflo). Each bag is packaged in a protective plastic overbag.

The bag sizes are

• 500 ml
• 1000 ml

The bags are packaged 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 some sizes of containers may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder

Baxter S.L.

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

Responsible for manufacturing:

Bieffe Medital S.A.

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

or

Baxter S.A.

Av.René Branquart 80, Lessines

Belgium

Last review of thisleaflet was in November 2018

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/

This information is intended solely for healthcare professionals

Handling and preparation

Use only if the solution is transparent, particle-free, and the container is not damaged. Administer immediately after connecting the infusion 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 plastic containers in series. This type of use may cause gas embolism due to residual air carried from the primary container before the secondary container is completed. Pressurizing intravenous solutions in flexible plastic containers to increase flow rates may cause gas embolism if the residual air in the container is not completely evacuated before administration.The use ofan intravenous administrationequipmentwith a ventilation filter in open positionmay cause agas embolism. This type ofintravenous administrationequipmentwith the ventilation filter in open positionshould not be used withflexible plasticcontainers.

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

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

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

The addition of medicines or the use of an incorrect administration technique may cause the appearance of febrile reactions due to the possible introduction of pyrogens. In case of an adverse reaction, the infusion should be interrupted immediately.

Dispose of after 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 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 infusion

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

3-Techniques for injection of added medication

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

To add medication before administration

a.Disinfect the medication addition port

b.Using a syringe with a 19 Gto 22 G needle, pierce the medication addition port resellable and inject.

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

Caution: Do not store bags with added medication.

To add medication during administration

a.Close the clamp of the equipment

b.Disinfect the medication addition port

c.Using a syringe with a 19 Gto 22 G needle, pierce the medication addition port resellable and inject.

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

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

f.Mix the solution and medication carefully

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

4.Expiry in use (added medications)

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

From a microbiological point of view, the product must be used immediately. If not used immediately, the conditions at the time of use and the storage times used before use are the responsibility of the userand normally should not exceed 24 hours between 2 and 8 ° C, unless reconstitution has taken place in controlled and validated aseptic conditions.

5-Incompatibilities of added medications

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

It is the responsibility of the doctor to judge the incompatibility of the added medication with Viaflo Ringerby examining any eventual change in color and/or precipitation, insoluble complexes, or appearance of crystals. The prospectus of the medication to be added should be consulted.

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

It is known that calcium salts are incompatible with a wide range of medications, which may formcomplexes that result in the formation of a precipitate.

The following list of medications is incompatible with Viaflo Ringer(non-exhaustive list):

• Anfotericina B
• Cortisona
• Eritromicina lactobionato
• Etamiván
• Alcohol etílico
• Tiopental sódico
• Edetato disódico

Medications that are known to be incompatible should not be used.