VIAFLO RINGER INTRAVENOUS INFUSION SOLUTION

2. What you need to know before taking Viaflo Ringer

Viaflo Ringer must not be administeredif you suffer from any of the following clinical situations

• Premature or full-term newborn (less than 28 days): your child must not be given a type of antibiotic called ceftriaxone as a drip into a vein at the same time as this medicine.
• when there is too much fluid in the body's extracellular spaces (extracellular hyperhydration)
• when there is more blood volume in the blood vessels than there should be (hypervolemia)
• severe kidney failure (when your kidneys do not work well and require dialysis)
• if you have uncompensated heart failure. This is heart failure that is not receiving proper treatment and causes symptoms such as:
• breathing difficulties
• swelling of the ankles.
• when there is too much fluid in the body caused by too much salt in the blood (hypertonic dehydration)
• if the blood potassium level is higher than normal (hyperkalemia)
• if the blood sodium level is higher than normal (hypernatremia).
• if the blood calcium level is higher than normal (hypercalcemia)
• if the blood chloride level 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 that causes 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

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

• Respiratory failure (lung disease) (in the above cases, special monitoring may be necessary).
• Any type of heart disease or heart failure.
• Kidney failure.
• High blood pressure (hypertension).
• Fluid accumulation under the skin, particularly under the ankles (peripheral edema)
• Fluid accumulation in the lungs (pulmonary edema).
• High blood pressure during pregnancy (pre-eclampsia)
• If you have a disease that causes 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, bleeding in the skull, or a brain injury.)
• If you have a condition that can cause high levels of vasopressin, a hormone that regulates body fluids, such as:
• a severe and sudden illness
• a surgical operation
• a brain disease
• certain medications you are taking

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

People at higher risk of brain swelling are:

Children

Women (especially of childbearing age)

• If you have a condition where the body's glands are not producing enough of certain hormones (adrenal insufficiency).
• An acute loss of body water (dehydration, e.g., due to vomiting or diarrhea).
• Extensive tissue damage (such as 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.
• Ceftriaxone, an antibiotic, must not be mixed or administered at the same time with solutions containing calcium when given into a vein. Patients over 28 days old may receive ceftriaxone and a calcium solution one after the other, as long as your doctor takes measures to prevent the medicines from interacting. If you or your child have low blood volume, your doctor will avoid giving you ceftriaxone and calcium sequentially.
• Heart failure.

When you are being given this solution, your doctor may take blood and urine samples to monitor:

• The amount of fluid in your body.
• your vital signs.
• the amount of chemicals 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 the levels of these chemicals,
• 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 consider whether you are receiving parenteral nutrition (nutrition received through a vein). During prolonged treatment with Viaflo Ringer, you will need extra nutrition.

Calcium chloride can be harmful if injected into tissues. Therefore, Viaflo Ringer must not be injected into a muscle (intramuscular injection). Your doctor will also take this into account to prevent the solution from penetrating the tissues around the veins.

Viaflo Ringer must not be administered with the same needle used for a blood transfusion. The red blood cells could be damaged or clump together.

Other medicines and Viaflo Ringer

Tell your doctor or nurse if you are using, have recently used, or might use any other medicine.

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

• Ceftriaxone (an antibiotic) given into a vein (see Warnings and precautions),
• cardiac glycosides (cardiotonics) such as digitalis or digoxin, used to treat heart failure, as they must not be used with Viaflo Ringer (see section "Viaflo Ringer must not be administered if you suffer..."). The effects of these medicines can be increased by calcium, which could cause life-threatening heart rhythm disorders.

The following medicines can cause the body to retain sodium and water, leading to swelling of tissues and high blood pressure:

• corticosteroids (anti-inflammatory medicines)
• carbenoxolone (an anti-inflammatory medicine used to treat stomach ulcers).

The following medicines can increase the potassium level in the blood. This effect can be life-threatening. It is more likely that you will suffer from high potassium levels if you have kidney disease.

• potassium-sparing diuretics (some water pills, e.g., amiloride, spironolactone, triamterene),

(Note that these medicines 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 treat skin disorders),
• cyclosporins (used to prevent transplant rejection).

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

• water pills (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 those of morphine (opioids);
• certain medicines used to treat epilepsy (antiepileptics):
• a hormone called oxytocin (used to stimulate uterine contractions);
• medicines used to treat cancer (chemotherapy);
• medicines used to treat cholesterol;
• medicines used to treat diabetes.

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

• thiazide diuretics such as hydrochlorothiazide or chlorthalidone,
• vitamin D.

Using 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 are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

Viaflo Ringer can be used safely during pregnancy and breastfeeding, provided that electrolyte and fluid balance are controlled and monitored by your doctor. Your doctor will take special precautions if you are taking oxytocin during labor.

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

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

• ask your doctor,
• read the package leaflet of the medicine to be added.

Driving and using machines

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

3. How Viaflo Ringer will be administered

Viaflo Ringer will be administered by a doctor or nurse. Your doctor will decide how much you need and when it should be administered. 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.

You must not receive Viaflo Ringerif there are particles floating in the solution or if the packaging is damaged in any way.

Generally, Viaflo Ringer will be administered through a plastic tube attached 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 medicine in another way.

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

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

Any unused solution must be discarded. You must not receive Viaflo Ringer from a partially used bag.

If you receive more Viaflo Ringer than you should

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

• fluid overload and/or sodium (salt) with fluid accumulation in 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 disorders, such as irritability or depression
• need to drink a lot of water (polydipsia)
• production of more urine than usual (polyuria)
• kidney disease caused by calcium accumulation in the kidneys (nephrocalcinosis)
• kidney stones
• coma (loss of consciousness)
• chalky taste
• flushing (hot flashes)
• dilation of blood vessels in the skin (peripheral vasodilation)
• acidification of the blood (acidosis) leading to fatigue, confusion, lethargy, and increased respiratory rate.

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

If a medicine has been added to the Viaflo Ringer solution before the excessive administration, that medicine may also cause symptoms. You should read the list of possible symptoms in the package leaflet of the added medicine.

If you stop the Viaflo Ringer infusion

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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are listed by frequency.

Very common(affects more than 1 in 10 people)

• changes in blood levels of chemicals (electrolyte disorders).

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

• excess fluid in the body (hyperhydration).
• heart failure.

Others

• reactions due to the 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 where the solution is administered (phlebitis). This can cause redness, pain, or itching and swelling along the vein where the solution is administered.
• formation of a blood clot (venous thrombosis) at the infusion site, which can cause pain, swelling, or redness in the area of the clot.
• leakage of the infusion solution into the tissues surrounding the vein (extravasation), which can damage tissues and cause scarring.
• low sodium levels in the blood (hyponatremia);
• brain swelling that can cause brain damage (hyponatremic encephalopathy).

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

Reporting side effects:

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 is the last day of the month shown.

You must not receive this medicine if you notice particles floating in the solution or if the packaging is damaged in any way.

6. Container Contents and Additional Information

Composition ofViaflo Ringer

The active ingredients are:

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

The other components are: water for injectable preparations, sodium hydroxide

Appearance of the Product and Container Contents

Viaflo Ringer is a clear, particle-free solution. It is presented in polyolefin/polyamide plastic bags (Viaflo). Each bag is packaged in a sealed 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 packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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 last revision of thisleaflet was in November 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

Handling and Preparation

Use only if the solution is clear, free of visible particles, and if the container is not damaged. Administer immediately after connecting the infusion equipment.

Do not remove the bag from its 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 can produce gas embolisms due to residual air dragged from the primary container before the administration of the liquid contained in the secondary container is completed. The pressurization of intravenous solutions in flexible plastic containers to increase flow rates can lead to a gas embolism if the residual air in the container is not fully evacuated before administration. The use of an intravenous administration device with a ventilation filter in the open position could cause a gas embolism. This type of intravenous administration device with the ventilation filter in the open position should not be used with flexible plastic containers.

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.

Added medications can be introduced before or during infusion through the medication addition port.

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

The addition of medications or the use of an incorrect administration technique can 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.

Discard after a single use.

Discard partially used containers.

Do not reconnect partially used bags.

1- To open

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

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

• 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.

• Hang the container by the tab

• Remove the plastic protector from the outlet port at the bottom of the container.
  • Hold the small wing of the outlet tube neck with one hand.
  • Hold the large wing of the closure cap with the other hand and turn.
  • The cap will come off.

• Use an aseptic technique to prepare the infusion

• 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 (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, puncture the resealable medication addition port and inject.

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

Precaution: do not store bags with added medication.

To add medication during administration

• Close the equipment clamp

• Disinfect the medication addition port

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

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

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

• Mix the solution and medication carefully

• Put the container back in the operating position, reopen the clamp, and continue administration.

1. Expiry date for use (added medications)

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

From a microbiological point of view, the product should be used immediately. If it is not used immediately, the conditions at the time of use and the storage times used before use are the responsibility of the user and should not normally 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 solution in the Viaflo bag must be verified before addition.

It is the responsibility of the physician to judge the incompatibility of the added medication to Viaflo Ringer by examining any eventual change in color and/or precipitate, insoluble complexes, or appearance of crystals. The 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)

It is known that calcium salts are incompatible with a wide range of medications, which can form complexes resulting in the formation of a precipitate.

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

The following list serves as a guide for 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 should not be used.