VIAFLO HARTMANN (RINGER LACTATE) SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Viaflo Hartmann (Lactated Ringer's) Solution for Infusion

Sodium chloride, potassium chloride, calcium chloride dihydrate, and sodium lactate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Viaflo Hartmann (Lactated Ringer's) is and what it is used for
2. What you need to know before you are given Viaflo Hartmann (Lactated Ringer's)
3. How Viaflo Hartmann (Lactated Ringer's) will be given to you
4. Possible side effects
5. Storage of Viaflo Hartmann (Lactated Ringer's)
6. Contents of the pack and further information

This medicinal product is referred to as “Solution for Viaflo Hartmann (Lactated Ringer's) solution for infusion”, but will be referred to as “Viaflo Hartmann (Lactated Ringer's)” throughout the rest of this leaflet.

1. What Viaflo Hartmann (Lactated Ringer's) is and what it is used for

Viaflo Hartmann (Lactated Ringer's) is a solution containing the following substances in water:

• Sodium chloride
• Potassium chloride
• Calcium chloride dihydrate
• Sodium lactate

Sodium, potassium, calcium, chloride, and lactate are chemical substances (electrolytes) found in the blood.

Viaflo Hartmann (Lactated Ringer's) is used to:

• treat loss of water and chemical substances from the body (e.g., excessive sweating, kidney disorders)
• treat you if the volume of blood in your blood vessels is low (hypovolemia) or if you have low blood pressure (hypotension).
• treat metabolic acidosis (when the blood becomes too acidic)

2. What you need to know before you are given Viaflo Hartmann (Lactated Ringer's)

Viaflo Hartmann (Lactated Ringer's) should not be given to you if you have any of the following conditions

• in a newborn (less than 28 days old) who is receiving ceftriaxone (an antibiotic)
• if you are allergic to sodium lactate or any of the components of Viaflo Hartmann (Lactated Ringer's) (listed in section 6).
• when there is too much fluid in the body's extracellular spaces (extracellular hyperhydration)
• when there is too much blood in the blood vessels (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.
• if your blood potassium level is higher than normal (hyperkalemia)
• if your blood calcium level is higher than normal (hypercalcemia)
• if you have a disease where the blood becomes too alkaline (metabolic alkalosis)
• if you have a liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis)
• your blood is too acidic with a risk to your life (severe metabolic acidosis)
• a particular type of metabolic acidosis (lactic acidosis)
• severe liver disease (when the liver does not work well and requires intensive treatment).
• impaired lactate metabolism (this occurs in severe liver disease, as lactate is eliminated by the liver)
• if you are receiving cardiac glycosides (cardiotonics) used to treat heart failure, such as digitalis or digoxin. (See also Other medicines and Viaflo Hartmann (Lactated Ringer's))

Warnings and precautions

Tell your doctor or nurse before you start using Viaflo Hartmann (Lactated Ringer's) if you have or have had any of the following conditions:

• if you are receiving ceftriaxone (an antibiotic) (see also Other medicines and Viaflo Hartmann (Lactated Ringer's))
• heart failure
• respiratory failure (lung disease) (in the above cases, special monitoring may be necessary).
• kidney failure
• if your blood chloride level is higher than normal (hyperchloremia).
• high blood pressure (hypertension)
• fluid accumulation under the skin that affects the whole body (generalized edema).
• 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)
• diseases that cause high levels of the hormone aldosterone (aldosteronism)
• if your blood sodium level is higher than normal (hypernatremia) or 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 Hartmann (Lactated Ringer's)) heart disease of any kind
• any situation that implies you have a higher risk of having high blood potassium levels (hyperkalemia) such as:
• Kidney failure
• Adrenal cortical insufficiency (a disease of the adrenal glands that affects the hormones that control the concentration of substances in the body)
• Acute dehydration (water loss from the body, e.g., due to vomiting or diarrhea)
• Extensive tissue damage (such as severe burns)

Intensive monitoring of your blood potassium levels is required

• diseases associated with high levels of vitamin D (e.g., sarcoidosis, a disease that affects the skin and internal organs)
• kidney stones
• impaired liver function
• diabetes if you have a condition that could cause high levels of vasopressin, a hormone that regulates the fluid in your body. You may have too much vasopressin in your body because, for example:
• you have had a sudden and severe illness,
• you are in pain,
• you have had surgery,
• you have infections, burns, or head injuries
• you have diseases related to your heart, liver, kidneys, or central nervous system,
• you are taking certain medications (see also Other medicines and Viaflo Hartmann (Lactated Ringer's))

This may increase the risk of low sodium levels in the blood and can cause headache, nausea, seizures, lethargy, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. People at higher risk of brain swelling are:

• children
• women (particularly if you are of childbearing age)
• people who have problems with their brain fluid levels, for example, due to meningitis, bleeding in the skull, or a head injury.

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

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

Although Viaflo Hartmann (Lactated Ringer's) contains potassium, it does not contain enough to treat very low potassium levels in the blood (severe hypokalemia)

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

Viaflo Hartmann (Lactated Ringer's) should not be administered with the same needle used for a blood transfusion. The red blood cells could be damaged or clumped.

Since Viaflo Hartmann (Lactated Ringer's) contains lactate (a substance present in the body), it can make the blood too alkaline (metabolic alkalosis).

Viaflo Hartmann (Lactated Ringer's) should be administered with special caution to infants under 6 months.

Your doctor should take into account if you are receiving parenteral nutrition (nutrition received through an infusion into a vein). During prolonged treatment with Viaflo Hartmann (Lactated Ringer's), you will need extra nutrition.

Other medicines and Viaflo Hartmann (Lactated Ringer's)

Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines.

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

• ceftriaxone (an antibiotic), which should not be administered through the same infusion line, unless it is well flushed.
• cardiac glycosides (cardiotonics) such as digitalis or digoxin, used to treat heart failure, as they should not be used with Viaflo Hartmann (Lactated Ringer's) (see section “Viaflo Hartmann (Lactated Ringer's) should not be given to you if you have any of the following conditions”). The effects of these medicines may be increased by the calcium, which could cause dangerous heart rhythm disorders.
• corticosteroids (anti-inflammatory medicines)

These medicines can cause the body to accumulate sodium and water, leading to:

• swelling of tissues due to fluid accumulation under the skin (edema)
• high blood pressure (hypertension)

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 blood 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 (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 act on the vasopressin hormone. These may include:

• antidiabetic medication (chlorpropamide)
• cholesterol medication (clofibrate)
• some anticancer medicines (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• opioids for severe pain relief
• medicines for pain and/or inflammation (also known as NSAIDs)

• medicines that mimic or enhance the effects of vasopressin, such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor)
• antiepileptic medicines (carbamazepine and oxcarbazepine)
• diuretics

Other medicines that may affect or be affected by Viaflo Hartmann (Lactated Ringer's) are:

• thiazide diuretics such as hydrochlorothiazide or chlorthalidone
• vitamin D
• bisphosphonates (used to treat bone diseases, such as osteoporosis)
• fluoride (for teeth and bones)
• fluoroquinolones (a type of antibiotic, such as ciprofloxacin, norfloxacin, ofloxacin)
• tetracyclines (a type of antibiotic, including tetracycline)
• acidic medicines, for example:
• salicylates used to treat inflammation (aspirin)
• barbiturates (sleeping pills)
• lithium (used to treat psychiatric diseases)
• alkaline medicines (basic), for example:
• sympathomimetics (stimulants, such as ephedrine and pseudoephedrine, used in cough and cold preparations)
• other stimulants (e.g., dextroamphetamine, fenfluramine)

Using Viaflo Hartmann (Lactated Ringer's) 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 using this medicine.

Viaflo Hartmann (Lactated Ringer's) can be used safely during pregnancy and breastfeeding.

Your doctor will monitor your blood electrolyte levels and fluid volume.

Calcium can reach the fetus through the placenta and, after birth, through breast milk.

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

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

Driving and using machines

Ask your doctor or pharmacist for advice before driving or using machines.

3. How Viaflo Hartmann (Lactated Ringer's) will be given to you

Viaflo Hartmann (Lactated Ringer's) will be given 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 Hartmann (Lactated Ringer's) if there are particles floating in the solution or if the container is damaged in any way.

Viaflo Hartmann (Lactated Ringer's) is usually given to you 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 give you the medicine in another way.

Before and during the infusion, your doctor will monitor:

• the amount of fluid in your body
• the acidity of the blood and urine
• the amount of electrolytes in your body (particularly sodium, in patients with high vasopressin levels, or those taking other medicines that increase the effect of vasopressin).

Any unused solution should be discarded. DO NOT receive Viaflo Hartmann (Lactated Ringer's) from a bag that has been partially used.

If you receive more Viaflo Hartmann (Lactated Ringer's) than you should

If you receive too much Viaflo Hartmann (Lactated Ringer's) solution or if it is given too quickly, you may experience the following symptoms:

• water or sodium overload and fluid accumulation in the tissues (edema) that causes swelling
• hyperkalemia (high blood potassium level) especially in patients with kidney failure, causing symptoms such as:
• 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
• hypercalcemia (high blood calcium level) that causes symptoms such as:
• loss of appetite (anorexia)
• nausea
• vomiting
• constipation
• abdominal pain
• mental disorders, such as irritability or depression
• excessive thirst (polydipsia)
• excessive urination (polyuria)
• kidney disease caused by calcium accumulation in the kidneys (nephrocalcinosis)
• kidney stones
• coma (loss of consciousness)
• taste of chalk
• flushing (hot flashes)
• dilation of the blood vessels in the skin (peripheral vasodilation)
• hypokalemia (low blood potassium level) and metabolic alkalosis (the blood becomes too alkaline), especially in patients with kidney failure, causing symptoms such as:
• mood changes
• fatigue
• breathing difficulties
• muscle stiffness
• muscle spasms
• muscle contractions

If you notice any of 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 Viaflo Hartmann (Lactated Ringer's) 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.

Stopping the infusion of Viaflo Hartmann (Lactated Ringer's)

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

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

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from them.

If you experience any of the following symptoms, inform your doctor or nurse immediately.

The following symptoms may be signs of a severe or even life-threatening hypersensitivity reaction (allergy) called anaphylactic shock:

• Hives (urticaria), which can be localized to one part of the body or widespread
• Rash
• Redness of the skin (erythema)
• Itching (pruritus)
• Swelling of the skin (angioedema)
• Cough
• Narrowing of the airways that makes breathing difficult (bronchospasm)
• Fast heartbeats (tachycardia)
• Slow heartbeats (bradycardia)
• Decrease in blood pressure
• Discomfort or chest pain
• Anxiety
• Pressure on the chest (making breathing difficult)
• Shortness of breath (dyspnea)
• Flushing
• Irritation of the throat
• Pins and needles (paresthesia)
• Numbness of the mouth (oral hypoesthesia)
• Altered taste (dysgeusia)
• Fever (pyrexia)
• Nausea
• Headache

Higher than normal potassium levels in the blood (hyperkalemia).

Low sodium levels in the blood that can be acquired during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy). Hyponatremia can cause irreversible brain damage and death due to swelling (cerebral edema/inflammation) (see also section 2 "Warnings and Precautions").

Reactions due to the method of administration, manifested by one or more of the following symptoms:

• 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 itching and swelling along the vein in which the solution is administered.
• Rash or itching (pruritus) at the infusion site

Other adverse effects reported with similar products (other solutions containing sodium lactate) include:

• Other manifestations of hypersensitivity/perfusion reactions: nasal congestion, sneezing, swelling of the throat that makes breathing difficult (laryngeal edema, also called Quincke's edema), skin inflammation (angioedema)
• Alterations in blood concentrations of chemicals (electrolyte disorders)
• A greater volume of blood in the blood vessels than there should be (hypervolemia)
• Panic attacks
• Other reactions due to the administration technique: infection at the infusion site, leakage of the infusion solution into the tissues surrounding the vein (extravasation), which can damage tissues and cause scarring and numbness at the infusion site.

If a medicine has been added to the infusion solution, it can 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 that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Viaflo Hartmann (Ringer Lactate)

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

250 ml bag: Do not store at a temperature above 30°C

500 and 1000 ml bags: no special storage conditions are required.

Viaflo Hartmann (Ringer lactate) should NOT be administered after the expiration date CAD that appears on the bag. The expiration date is the last day of the month indicated.

You should not receive Viaflo Hartmann (Ringer lactate) if there are particles floating in the solution or if the container is damaged in any way.

6. Package Contents and Additional Information

Composition of Viaflo Hartmann (Ringer lactate)

The active ingredients are:

• Sodium chloride: 6.00 g per liter
• Potassium chloride: 0.40 g per liter
• Calcium chloride dihydrate: 0.27 g per liter
• Sodium lactate: 3.20 g per liter

The only excipient is water for injectable preparations

Appearance of the Product and Package Contents

Viaflo Hartmann (Ringer lactate) is a clear, particle-free solution. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed protective plastic overbag.

The bag sizes are

• 250 ml
• 500 ml
• 1000 ml

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

• 30 bags of 250 ml per box
• 1 bag of 250 ml
• 20 bags of 500 ml per box
• 1 bag of 500 ml
• 10 bags of 1000 ml per box
• 12 bags of 1000 ml per box
• 1 bag of 1000 ml

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Baxter S.L.

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

Manufacturer:

Bieffe Medital S.A.

Ctra de Biescas, Senegüé

22666 Sabiñanigo (Huesca)

Spain

Baxter SA

Boulevard René Branquart, 80

7860 Lessines

Belgium

Date of the Last Revision of this Leaflet: November 2018

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

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This information is intended only for healthcare professionals

Handling and Preparation

Parenteral solutions should be visually inspected for particles and discoloration before administration, when the solution and container allow it. Do not administer unless the solution is clear and the container is intact.

Do not remove the bag from its overbag until it is ready for use. The inner bag maintains the sterility of the product. Administer immediately after connecting the infusion equipment.

Do not connect plastic containers in series. This type of use can produce gas embolisms due to residual air drawn from the primary container before the liquid contained in the secondary container is completely administered. 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 set with a ventilation filter in the open position could cause a gas embolism. This type of intravenous administration set with a ventilation filter in the open position should not be used with flexible plastic containers.

The solution is for intravenous administration with a sterile administration set using an aseptic technique. The set must be primed with the solution to prevent air from entering the system.

Added medications can be introduced before or during infusion through the injection point.

When medications are added, the isotonicity should be checked before parenteral administration. It is essential that the mixing of products is done under extreme asepsis conditions. Solutions containing added medications should be used immediately and not stored.

The addition of other 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 bags.

Do not reconnect partially used bags.

1. To Open

1. Remove the Viaflo bag from the protective overbag immediately before use.
2. Check for small leaks by squeezing the inner bag firmly. If you detect leaks, discard the solution, as it may not be sterile.
3. Check the transparency of the solution and the absence of foreign particles. Discard the solution if it is not transparent or contains foreign particles.

1. Preparation for Administration

Use sterile material for preparation and administration.

1. Hang the container by the handle
2. 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.
• 1. Use an aseptic technique to prepare the infusion
  2. Connect the administration set. Consult the instructions that accompany the set for connection, priming, and administration of the solution.

1. Techniques for Injecting Added Medication

Warning: Added medications may be incompatible. Check the compatibility of the added medication with the solution and container before use. When medications are added, the isotonicity should be checked before parenteral administration (see section 5 "Incompatibilities of Added Medications").

To Add Medication Before Administration

• Disinfect the injection point
• Using a syringe with a 19 (1.10 mm) to 22 (0.70 mm) gauge needle, puncture the resealable injection point 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.

Caution: do not store bags with added medication.

To Add Medication During Administration

• Close the clamp on the administration set
• Disinfect the injection point
• Using a syringe with a 19 (1.10 mm) to 22 (0.70 mm) gauge needle, puncture the resealable injection point 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
• Return the container to the position of use, reopen the clamp, and continue administration.

1. Expiry Date for Use (Added Medications)

Before use, the physical and chemical stability of any added medication should be established at the pH of the Viaflo Hartmann (Ringer lactate) solution in the Viaflo container.

From a microbiological point of view, the diluted product should be used immediately unless the addition of medications has been carried out under controlled and validated aseptic conditions. If it is not used immediately, the conditions and storage times used before use are the responsibility of the user

1. Incompatibilities of Added Medications

Ceftriaxone should not be mixed with solutions that contain calcium, including Viaflo Hartmann (Ringer lactate)

As with all parenteral solutions, added medications may be incompatible; therefore, the compatibility of added medications with Viaflo Hartmann (Ringer lactate) should be verified before addition.

After adding a medication, the incompatibility of the added medication with Viaflo Hartmann (Ringer lactate) should be visible by a change in color and/or precipitate, insoluble complexes, or appearance of crystals. The leaflet of the medication to be added or any other relevant source should be consulted.

Before adding a medication, verify that it is soluble and/or stable in water at the pH range of Viaflo Hartmann (Ringer lactate) (pH 5.0 - 7.0).

When medications are added to Viaflo Hartmann (Ringer lactate), an aseptic technique should be used. Mix the solution well when added medications have been introduced. Do not store solutions with added medications.

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

• Incompatible medications with Viaflo Hartmann (Ringer lactate):

• Aminocaproic acid
• Amphotericin B
• Metharaminol tartrate
• Cefamandole
• Ceftriaxone
• Cortisone acetate
• Diethylstilbestrol
• Etamivan
• Ethyl alcohol
• Phosphate and carbonate solutions
• Oxytetracycline
• Sodium thiopental
• Disodium edetate

• Medications partially incompatible with Viaflo Hartmann (Ringer lactate)

• Tetracycline stable for 12 hours
• Sodium ampicillin

concentration of 2%-3% stable for 4 hours

concentration >3% should be administered within 1 hour

• Minocycline stable for 12 hours
• Doxycycline stable for 6 hours

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