Label: Information for the User

Viaflo Hartmann (Ringer lactate) in 5% glucose solution for infusion

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

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

This medication is referred to as “Viaflo Hartmann (Ringer lactate) in 5% glucose solution for infusion”, but will be referred to as “Viaflo Hartmann (Ringer lactate) in 5% glucose” in the rest of this label.

Viaflo Hartmann (Ringer lactate) in 5% glucose is a solution of the following substances in water:

• Sugar (glucose)
• Sodium chloride
• Potassium chloride
• Calcium chloride dihydrate
• Sodium lactate

Glucose is one of the body's energy sources. This solution provides 200 kilocalories per liter. Sodium, potassium, calcium, chlorides, and lactate are chemical substances (electrolytes) found in the blood.

Viaflo Hartmann (Ringer lactate) in 5% glucose is used as a source of carbohydrates (sugar) in the following situations:

• To treat a loss of body water and chemical substances (for example, excessive sweating, renal alterations)
• To treat if the volume of blood in your blood vessels is low (hypovolemia) or if you have low blood pressure (hypotension).
• In metabolic acidosis (when the blood becomes too acidic)

You should not be administered Viaflo Hartmann (Ringer lactada) in 5% glucose if you have any of the following clinical situations

• in a newborn (less than 28 days) who is receiving ceftriaxona (an antibiotic)
• if you are allergic to sodium lactate or any of the components of Viaflo Hartmann (Ringer lactada) in 5% glucose
• when there is a lot of fluid in the extracellular spaces of the body (extracellular hyperhydration)
• when there is a greater 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.
• 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 in which the blood becomes too alkaline (metabolic alkalosis)
• if you have a liver disease that causes accumulation of fluid in the abdomen (ascitic cirrhosis)
• if your blood is too acidic and poses a risk to life (severe metabolic acidosis)
• in a particular type of metabolic acidosis (lactic acidosis)
• severe liver disease (when the liver does not function 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 digitals or digoxin. (See "Other medications and Viaflo Hartmann (Ringer lactada) in 5% glucose")
• uncontrolled diabetes, allowing your blood sugar levels to be higher than normal (uncontrolled diabetes)
• states of glucose intolerance, for example:
• metabolic stress (when the body's metabolism does not function correctly, for example, due to a serious illness)
• hyperosmolar coma (loss of consciousness). This is a type of coma that can occur if you have diabetes and do not receive enough medication.
• higher than normal blood glucose levels (hyperglycemia)
• higher than normal blood lactate levels (hyperlactatemia)

Warnings and precautions

Viaflo Hartmann (Ringer lactada) in 5% glucose is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating how much solution to administer

Consult your doctor or nurse before starting to use Viaflo Hartmann (Ringer lactada) in 5% glucose if you have or have had any of the following clinical situations:

• if you are receiving ceftriaxona (an antibiotic) (see also "Other medications and Viaflo Hartmann (Ringer lactada) in 5% glucose")
• heart failure
• respiratory insufficiency (lung disease) (in the above cases, special monitoring may be required)
• renal insufficiency
• if your blood chloride level is higher than normal (hyperchloremia).
• high blood pressure (hypertension)
• generalized edema (accumulation of fluid under the skin affecting the entire body)
• peripheral edema (accumulation of fluid under the skin, particularly under the ankles)
• pulmonary edema (accumulation of fluid in the lungs)
• high blood pressure during pregnancy (pre-eclampsia)
• diseases that cause high levels of aldosterone hormone (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 steroid treatment (see also "Other medications and Viaflo Hartmann (Ringer lactada) in 5% glucose")
• diabetes (your blood sugar level will be carefully controlled and may need to be modified with insulin)
• any type of heart disease
• any situation that implies you have a higher risk of having high potassium levels in the blood (hyperkalemia) such as:

• renal failure
• adrenocortical insufficiency (this disease of the adrenal glands affects the hormones that control the concentration of substances in the body)
• acute dehydration (a loss of water from the body, for example, by vomiting or diarrhea)
• extensive tissue damage (such as in 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
• increased intracranial pressure (hypertension intracraneal)
• stroke due to a blood clot in a blood vessel (cerebral ictus)
• if you have had a head injury within the last day

• If you have a condition that could cause high levels of vasopresin, a hormone that regulates the fluid in your body. You may have too much vasopresin in your body because, for example:

• you have had a sudden and severe illness,
• you have pain,
• you have been operated on,
• you have infections, burns or brain injury
• you have diseases related to your heart, liver, kidneys or central nervous system,
• you are taking certain medications (see "Other medications and Viaflo Hartmann (Ringer lactada) in 5% glucose").

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

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

When you are being administered this solution, your doctor will be able to take blood and urine samples to control:

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

Although Viaflo Hartmann (Ringer lactada) in 5% glucose contains potassium, it does not contain enough to treat very low potassium levels in plasma (severe potassium deficiency)

Calcium chloride can be harmful if injected into tissues. Therefore, Viaflo Hartmann (Ringer lactada) in 5% glucose should not be injected into muscle (intramuscular injection). Your doctor will take this into account to avoid the solution penetrating into the tissues around the veins.

Viaflo Hartmann (Ringer lactada) in 5% glucose should not be administered with the same syringe used for a blood transfusion. The red blood cells may be damaged or clumped.

As Viaflo Hartmann (Ringer lactada) in 5% glucose contains lactate (a substance present in the body), it can make the blood too alkaline (metabolic alkalosis).

Viaflo Hartmann (Ringer lactada) in 5% glucose contains sugar (glucose), and can cause high blood sugar levels (hyperglycemia). If this occurs, your doctor may:

• adjust the infusion rate
• administer insulin to reduce your blood sugar level

This is very important if you have diabetes.

Children

Viaflo Hartmann in 5% glucose should be administered with caution in children. Newborns, especially premature and low birth weight babies, have a higher risk of developing high or low blood sugar levels (hypoglycemia or hyperglycemia), which can lead to complications.

Your doctor should take into account if you are receiving parenteral nutrition (nutrition received by infusion through a vein). During prolonged treatments with Viaflo Hartmann (Ringer lactada) in 5% glucose, you will need additional nutrition.

Other medications and Viaflo Hartmann (Ringer lactada) in 5% glucose

Inform your doctor or nurse if you are using or 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), which should not be administered through the same infusion route, unless the route is well flushed.
• cardiac glycosides (cardiotonics) such as digitals or digoxin, used to treat heart failure, as they should not be used together with Viaflo Hartmann (Ringer lactada) in 5% glucose (See section "You should not be administered Viaflo Hartmann (Ringer lactada) in 5% glucose if you have any of the following clinical situations"). The effects of those medications may be increased by calcium, which could cause dangerous heart rhythm disturbances.
• corticosteroids (anti-inflammatory medications)

These medications 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 medications can increase the concentration of potassium in the blood. This effect can be life-threatening. You are more likely to experience an increase in blood potassium levels if you have kidney disease.

• potassium-sparing diuretics (some tablets that help eliminate water, e.g. amiloride, spironolactone, triamterene)

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

• 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)
• ciclosporins (used to prevent transplant rejection)

Some medications act on the vasopressin hormone. These may include:

• diabetic medication (chlorpropamide)
• cholesterol-lowering medication (clofibrate)
• some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• opioids for severe pain
• medications for pain and/or inflammation (also known as NSAIDs)
• medications that mimic or enhance the effects of vasopresin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat bleeding in the esophagus) and oxytocin (used to induce labor)
• antiepileptic medications (carbamazepine and oxcarbazepine)
• diuretics

Other medications that may affect or be affected by Viaflo Hartmann (Ringer lactada) in 5% glucose are:

• thiazide diuretics such as hydrochlorothiazide or chlortalidone
• 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 medications, for example:
• salicylates used to treat inflammation (aspirin)
• barbiturates (sleeping pills)
• lithium (used to treat psychiatric disorders)
• alkaline medications (basic), for example:
• sympathomimetics (stimulants, such as ephedrine and pseudoephedrine, used in cough and cold preparations)
• other stimulants (e.g. dexfenfluramine, fenfluramine)

Use of Viaflo Hartmann (Ringer lactada) in 5% glucose with food and drinks

Ask your doctor or nurse 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 Hartmann (Ringer lactada) in 5% glucose 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 medication is added to the infusion solution during pregnancy or breastfeeding, you should:

• ask your doctor or nurse
• read the medication's leaflet

Driving and operating machinery

Ask your doctor or pharmacist before driving or operating machinery.

Ringer's Lactate Solution in 5% Glucose will be administered by a doctor or a nurse.

Your doctor will decide how much you need and when to receive 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.

Do not receive Ringer's Lactate Solution in 5% Glucose if there are particles floating in the solution or if the container is damaged in any way.

Ringer's Lactate Solution in 5% Glucose is usually administered through a plastic tube connected to a needle inserted into a vein. A vein in the arm is often used to administer the infusion. However, your doctor may administer the medication in another way.

Before and during the infusion, your doctor will monitor:

- the amount of fluid in your body

- the acidity of your blood and urine

- the amount of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin, or those taking other medications that increase the effect of vasopressin).

Any remaining solution not used should be discarded. Do not receive Ringer's Lactate Solution in 5% Glucose from a bag that has been partially used.

If you receive more Ringer's Lactate Solution in 5% Glucose than you should

If you receive too much Ringer's Lactate Solution in 5% Glucose or if it is administered too quickly, you may experience the following symptoms:

• fluid overload or sodium overload and accumulation of fluid in tissues (edema) causing swelling
• hyperkalemia (elevated potassium levels in the blood), especially in patients with renal insufficiency, causing symptoms such as:
• tingling in the arms and legs (paresthesia)
• muscle weakness
• inability to move (paralysis)
• irregular heartbeats (arrhythmias)
• cardiac arrest (heart stops beating and life is at risk)
• confusion
• hypercalcemia (elevated calcium levels in the blood), causing symptoms such as:
• loss of appetite (anorexia)
• nausea
• vomiting
• constipation
• abdominal pain
• mental disturbances, such as irritability or depression
• excessive thirst (polydipsia)
• excessive urine production (polyuria)
• renal disease caused by calcium accumulation in the kidneys (nephrocalcinosis)
• kidney stones
• coma (loss of consciousness)
• metallic taste
• flushing (hot flashes)
• dilation of peripheral blood vessels (vasodilation)
• hypokalemia (low potassium levels in the blood) and metabolic alkalosis (blood becomes too alkaline), especially in patients with renal insufficiency, causing symptoms such as:
• mood changes
• fatigue
• difficulty breathing
• muscle stiffness
• muscle cramps
• muscle contractions
• hyperosmolarity (excessive concentration of blood)
• dehydration (loss of water from the body)
• high blood sugar levels (hyperglycemia)
• glucosuria (glucose in the urine)
• increased urine production (osmotic diuresis)

If you experience any of 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 to Ringer's Lactate Solution in 5% Glucose before the excessive administration, the medication may also cause symptoms. Read the list of possible symptoms in the medication's package insert.

If you interrupt the infusion of Ringer's Lactate Solution in 5% Glucose

Your doctor will decide when to stop receiving this infusion.

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

Like all medications, Viaflo Hartmann (Ringer lactate) with 5% glucose may cause side effects, although not everyone will experience them.

Inform your doctor or nurse immediately if you experience any of the following symptoms.

The following symptoms may be signs of a severe and potentially life-threatening allergic reaction called anaphylactic shock:

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

Some reactions may be due to the administration technique:

• Skin rash or itching at the infusion site
• Pain or local reaction (redness or swelling at the infusion site)
• Numbness at the infusion site

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

• Other manifestations of hypersensitivity/reactions due to infusion: laryngeal edema (Quincke's edema), slow heart rate (bradycardia), rapid heart rate (tachycardia), decreased blood pressure, respiratory difficulty, flushing, throat irritation, skin inflammation, paresthesias, decreased oral sensitivity (hypogeusia), altered taste (dysgeusia), anxiety, headache, nasal congestion, sneezing
• Alterations in blood concentrations of chemical substances (electrolyte disturbances)
• High levels of potassium in the blood (hyperkalemia)
• Increased blood volume in the blood vessels (hypervolemia)
• Panic attacks
• Other reactions due to administration technique: infection at the infusion site, phlebitis, extravasation, inflammation, swelling, rash, pain, or burning at the infusion site.

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

If you experience side effects, consult your doctor or nurse, even if they do not appear in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

DO NOT use this medication after the expiration date that appears on the bag after CAD. The expiration date is the last day of the month indicated.

Do not administer Viaflo Hartmann (Ringer lactate) in 5% glucose if there are particles floating in the solution or if the container is damaged in any way.

Composition of Viaflo Hartmann (Ringer lactate) in 5% glucose

The active principles are:

• Sugar (glucose): 50.00 g per liter
• 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 injection

Appearance of the product and contents of the package

Viaflo Hartmann (Ringer lactate) in 5% glucose is a transparent, particle-free solution. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed plastic protective 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
• 20 bags of 500 ml
• 10 bags of 1000 ml
• 12 bags of 1000 ml

Not all packages 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. de Biescas, Senegüé

22666 Sabiñanigo (Huesca)

Spain

Baxter SA

Boulevard René Branquart, 80

7860 Lessines

Belgium

Last review date of this leaflet: April 2018

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals

Handling and preparation

Parenteral solutions must be visually inspected for particles and discoloration before administration when the solution and container permit. Do not administer unless the solution is transparent and the container is intact.

Do not remove the bag from its protective 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 may produce 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 lead to gas embolism if the residual air in the container is not completely evacuated before administration. The use of an intravenous administration set with a ventilation filter in the open position may cause gas embolism. Such administration sets with ventilation filters in the open position should not be used with flexible plastic containers.

The solution is for intravenous administration using a sterile administration set and aseptic technique. The equipment must be primed with the solution to prevent air entry into the system.

Medicaments may be added before or during infusion through the injection port.

It is essential that the mixing of products be carried out in extreme aseptic conditions. Solutions containing added medicaments should be used immediately and not stored.

The addition of other medicaments or the use of an incorrect administration technique may cause the appearance of febrile reactions due to the possible introduction of pyrogens. In the event 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

1. Remove the Viaflo bag from the protective overbag immediately before use.
2. Check for small leaks by compressing the inner bag firmly. If leaks are detected, 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 hanger
2. 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 cap and turn.

- The cap will come off.

1. Use aseptic technique to prepare the infusion
2. Connect the administration equipment. Consult the instructions accompanying the equipment for connection, priming, and administration of the solution.

1. Techniques for injecting added medicaments

Warning: Added medicaments may be incompatible.Check the compatibility of the added medicament with the solution and the container before use (see the following section 5 “Incompatibilities of added medicaments”)

To add medicaments before administration

• Disinfect the injection port

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

• Mix the medicament and solution carefully. For high-density medicaments, such as potassium chloride, gently move the tubes while in the vertical position and mix.

Caution: Do not store bags with added medicaments.

To add medicaments during administration

• Close the clamp on the equipment
• Disinfect the injection port
• Using a syringe with a 19 (1.10 mm) to 22 (0.70 mm) gauge needle, pierce the resellable injection port and inject.
• Remove the container from the intravenous support and/or turn it to the vertical position.
• Empty both tubes by gently tapping them while the container is in the vertical position.
• Mix the solution and medicament carefully.
• Replace the container in the use position, reopen the clamp, and continue administration.

1. Expiry in use (added medicaments)

Before use, the physical and chemical stability of any additional medicament to the pH of Viaflo Hartmann (Ringer lactate) in 5% glucose in the Viaflo container must be established.

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

1. Incompatibilities of added medicaments

Ceftriaxone should not be mixed with solutions containing calcium, including Viaflo Hartmann (Ringer lactate) in 5% glucose.

As with all parenteral solutions, added medicaments may be incompatible, so the compatibility of added medicaments with Viaflo Hartmann (Ringer lactate) in 5% glucose must be verified before addition.

After adding a medicament, the incompatibility of the added medicament with Viaflo Hartmann (Ringer lactate) in 5% glucose should be visible by a change in color and/or precipitation, insoluble complexes, or the appearance of crystals. The product insert of the medicament to be added or any other relevant source should be consulted.

Before adding a medicament, verify that it is soluble and/or stable in water within the pH range of Viaflo Hartmann (Ringer lactate) in 5% glucose (pH 4.0 – 6.5) is appropriate.

When adding medicaments to Viaflo Hartmann (Ringer lactate) in 5% glucose, use aseptic technique. Mix the solution well when the added medicaments have been introduced. Do not store solutions with added medicaments.

The following list of incompatible medicaments with Viaflo Hartmann (Ringer lactate) in 5% glucose (non-exhaustive list):

• Medicaments incompatible with Viaflo Hartmann (Ringer lactate) in 5% glucose:

• Aminocaproic acid
• Anfotericin B
• Ceftriaxone
• Cortisone acetate
• Dietilestilbestrol
• Etamiván
• Ethyl alcohol
• Phosphate and carbonate solutions
• Oxitetraciclina
• Potassium tiopental
• Sodium versenate

• Medicaments partially incompatible with Viaflo Hartmann (Ringer lactate) in 5% glucose:

• Tetracycline stable for 12 hours
• Ampicillin sodium

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

Those medicaments known to be incompatible should not be used.