VIAFLO HARTMANN (RINGER LACTATE) 5% GLUCOSE SOLUTION FOR INFUSION

2. What you need to know before you are given Viaflo Hartmann (Lactated Ringer's) in 5% Glucose

Viaflo Hartmann (Lactated Ringer's) in 5% Glucose must not be given to you if you have any of the following conditions

• In a newborn (less than 28 days) who is receiving ceftriaxone (an antibiotic)
• If you are allergic to sodium lactate or any of the components of Viaflo Hartmann (Lactated Ringer's) in 5% Glucose
• 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:

• 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 condition where the blood becomes too alkaline (metabolic alkalosis)
• If you have a liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis)
• If your blood is too acidic with risk to life (severe metabolic acidosis)
• In 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 “Other medicines and Viaflo Hartmann (Lactated Ringer's) in 5% Glucose”)
• Untreated diabetes, allowing your blood sugar levels to be higher than normal (uncontrolled diabetes)
• States of glucose intolerance, such as:

• Metabolic stress (when the body's metabolism does not work correctly, e.g., due to severe 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.
• A higher than normal amount of sugar in the blood (hyperglycemia)
• A higher than normal amount of lactate in the blood (hyperlactatemia)

Warnings and precautions

Viaflo Hartmann (Lactated Ringer's) in 5% Glucose is a hypertonic solution (concentrated). Your doctor will take this into account when calculating how much solution to administer to you.

Consult your doctor or nurse before starting to use Viaflo Hartmann (Lactated Ringer's) in 5% Glucose 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) in 5% Glucose”)
• Heart failure
• Respiratory failure (lung disease) (in these 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) in 5% Glucose”)
• Diabetes (your blood sugar level will be carefully monitored and may need to be adjusted with insulin)
• Any type of heart disease
• Any situation that may increase your risk of having high potassium levels in the blood (hyperkalemia), such as:

• Kidney failure
• Adrenocortical insufficiency (a disease of the adrenal glands that affects the hormones that control the concentration of substances in the body)
• Acute dehydration (a loss of body water, e.g., due to 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 pressure inside the skull (intracranial hypertension)
• Stroke due to a blood clot in a blood vessel (cerebral stroke)
• If you have had a head injury in the last day

• If you have a condition that could cause high levels of vasopressin, a hormone that regulates your body's fluid. 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 injury
• You have diseases related to your heart, liver, kidneys, or central nervous system,
• You are taking certain medications (see “Other medicines and Viaflo Hartmann (Lactated Ringer's) in 5% Glucose”).

This can increase the risk of low sodium levels in the blood and may cause headache, nausea, seizures, 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 you are of childbearing age)
• People with problems with their cerebral fluid levels, e.g., due to meningitis, bleeding in the skull, or head injury.

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

• 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 (Lactated Ringer's) 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 (Lactated Ringer's) in 5% Glucose must 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 (Lactated Ringer's) in 5% Glucose must not be administered with the same needle used for a blood transfusion. Red blood cells may be damaged or clumped.

Since Viaflo Hartmann (Lactated Ringer's) in 5% Glucose contains lactate (a substance present in the body), it may make the blood too alkaline (metabolic alkalosis).

Viaflo Hartmann (Lactated Ringer's) in 5% Glucose contains sugar (glucose) and may 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 particularly 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 infants, are at higher risk of developing high or low blood sugar levels (hypoglycemia or hyperglycemia), which can lead to complications.

Your doctor should consider whether you are receiving parenteral nutrition (nutrition received through infusion into a vein). During prolonged treatment with Viaflo Hartmann (Lactated Ringer's) in 5% Glucose, you will need extra nutrition.

Other medicines and Viaflo Hartmann (Lactated Ringer's) in 5% Glucose

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

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

• Ceftriaxone (an antibiotic), which must 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 must not be used with Viaflo Hartmann (Lactated Ringer's) in 5% Glucose (see section “Viaflo Hartmann (Lactated Ringer's) in 5% Glucose must 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 life-threatening heart rhythm disorders.
• Corticosteroids (anti-inflammatory medicines)

These medicines may cause your body to retain sodium and water, leading to:

• Tissue swelling due to fluid accumulation under the skin (edema)
• High blood pressure (hypertension)

The following medicines may increase the potassium level in your blood. This effect can be life-threatening. It is more likely that you will experience an increase in 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 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 act on the hormone vasopressin. These may include:

• Antidiabetic medication (chlorpropamide)
• Cholesterol medication (clofibrate)
• Some cancer 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) in 5% Glucose 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) 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 are planning to have a baby, ask your doctor or nurse for advice before using this medicine.

Viaflo Hartmann (Lactated Ringer's) in 5% Glucose can be used safely during pregnancy and breastfeeding. Your doctor will monitor your blood electrolyte levels and fluid levels.

Calcium can pass to 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 or nurse
• Read the package leaflet of the medicine to be added

Driving and using machines

Ask your doctor or pharmacist before driving or using machinery.

3. How to Administer Viaflo Hartmann (Lactated Ringer's) in 5% Glucose

Viaflo Hartmann (Lactated Ringer's) in 5% Glucose will be administered to you by a doctor or nurse.

Your doctor will decide how much you need and when you should 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 Viaflo Hartmann (Lactated Ringer's) in 5% Glucose if there are particles floating in the solution or if the container is damaged in any way.

Viaflo Hartmann (Lactated Ringer's) in 5% Glucose is usually 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 medication 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 levels of vasopressin, or those taking other medications that increase the effect of vasopressin).

Any unused remainder of the solution must be discarded. DO NOT receive Viaflo Hartmann (Lactated Ringer's) in 5% Glucose from a bag that has been partially used.

If you receive more Viaflo Hartmann (Lactated Ringer's) in 5% Glucose than you should

If you receive too much Viaflo Hartmann (Lactated Ringer's) in 5% Glucose solution or if you receive it too quickly, you may experience the following symptoms:

• water or sodium overload and fluid accumulation in the tissues (edema) causing swelling
• high blood potassium levels (hyperkalemia) especially in patients with renal 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 in danger)
• confusion
• high blood calcium levels (hypercalcemia) causing symptoms such as:
• decreased appetite (anorexia)
• discomfort (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)
• chalky taste
• flushing (hot flashes)
• dilation of blood vessels in the skin (peripheral vasodilation)
• low blood potassium levels (hypokalemia) and metabolic alkalosis (the blood becomes too alkaline), especially in patients with renal failure, causing symptoms such as:
• mood changes
• fatigue
• difficulty breathing
• muscle stiffness
• muscle spasms
• muscle contractions
• excessive blood concentration (hyperosmolarity)
• water loss from the body (dehydration)
• high blood sugar levels (hyperglycemia)
• glucose in the urine (glucosuria)
• increased urine production (osmotic diuresis)

If you notice 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 Viaflo Hartmann (Lactated Ringer's) in 5% Glucose before excessive administration, the medication may also cause symptoms. You should read the list of possible symptoms in the medication's package insert.

If you interrupt the infusion of Viaflo Hartmann (Lactated Ringer's) in 5% Glucose

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

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

4. Possible Adverse Effects

Like all medications, Viaflo Hartmann (Lactated Ringer's) with 5% Glucose may cause adverse effects, although not all people will experience 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 life-threatening hypersensitivity reaction (allergy) called anaphylactic shock:

• hives (urticaria), which can be localized to one part of the body or widespread
• skin rash
• skin redness (erythema)
• itching (pruritus)
• skin swelling (angioedema)
• constriction of the airways that makes breathing difficult (bronchospasm)
• discomfort or chest pain
• shortness of breath (dyspnea)
• fever (pyrexia)
• nausea
• cough

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 cerebral edema/inflammation (see also section 2 "Warnings and Precautions").

Some reactions may be due to the administration technique:

• skin rash or itching (pruritus) at the infusion site
• pain or local reaction (redness or swelling at the infusion site)
• numbness at the infusion site

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

• other manifestations of hypersensitivity/infusion reactions: laryngeal edema (Quincke's edema), slow heartbeats (bradycardia), fast heartbeats (tachycardia), decreased blood pressure, difficulty breathing, flushing, throat irritation, skin inflammation, tingling and pinching (paresthesias), decreased sensitivity in the mouth (oral hypoesthesia), altered taste (dysgeusia), anxiety, headache, nasal congestion, sneezing
• alterations in blood concentrations of chemical substances (electrolyte disorders)
• high potassium levels in the blood (hyperkalemia)
• a higher than normal volume of blood in the blood vessels (hypervolemia)
• panic attacks
• other reactions due to the 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 adverse effects. These adverse effects will depend on the added medication. You should read the list of possible symptoms in the package insert of the added medication.

If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this package insert.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. 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 medication.

5. Storage of Viaflo Hartmann (Lactated Ringer's) in 5% Glucose

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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

DO NOT receive Viaflo Hartmann (Lactated Ringer's) in 5% Glucose 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 (Lactated Ringer's) in 5% Glucose

The active ingredients 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 injectable preparations

Appearance of the Product and Package Contents

Viaflo Hartmann (Lactated Ringer's) in 5% Glucose 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
• 20 bags of 500 ml
• 10 bags of 1000 ml
• 12 bags of 1000 ml

Not all packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Baxter S.L.

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

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 Package Insert: April 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/

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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 permit. 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 being dragged 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 using a sterile administration set and 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 the infusion through the injection point.

It is essential that the mixing of products is done under extreme aseptic 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 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 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 hanger
2. Remove the plastic protector from the outlet tube 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 aseptic technique to prepare the infusion
  2. Connect the administration set. Consult the instructions accompanying 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 (see below the section 5 "Incompatibilities of Added Medications")

To add medication before administration

• Disinfect the injection point

• Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) 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.

Precaution: do not store bags with added medication.

To add medication during administration

• Close the set clamp
• Disinfect the injection point
• Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) 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 use position, reopen the clamp, and continue administration.

1. Expiry Date for Use (Added Medications)

Before use, the physical and chemical stability of any added medication must be established in the pH of the Viaflo Hartmann (Lactated Ringer's) in 5% Glucose solution in the Viaflo container.

From a microbiological point of view, the diluted product must 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 containing calcium, including Viaflo Hartmann (Lactated Ringer's) in 5% Glucose

As with all parenteral solutions, added medications may be incompatible; therefore, the compatibility of added medications with Viaflo Hartmann (Lactated Ringer's) in 5% Glucose must be verified before addition.

After adding a medication, the incompatibility of the added medication with Viaflo Hartmann (Lactated Ringer's) in 5% Glucose should be visible by a change in color and/or precipitate, insoluble complexes, or the appearance of crystals. The package insert 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 (Lactated Ringer's) in 5% Glucose (pH 4.0 - 6.5) is appropriate.

When adding medications to Viaflo Hartmann (Lactated Ringer's) in 5% Glucose, aseptic technique must 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 (Lactated Ringer's) in 5% Glucose serves as a guide (non-exhaustive list):

• Medications incompatible with Viaflo Hartmann (Lactated Ringer's) in 5% Glucose:

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

• Medications partially incompatible with Viaflo Hartmann (Lactated Ringer's) in 5% Glucose

• 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 known to be incompatible should not be used.