Viaflo Hartmann (Ringer Lactate) solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Viaflo Hartmann (Ringer's lactate) 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.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

1. What Viaflo Hartmann (Ringer lactate) is and what it is used for

Viaflo Hartmann (Ringer lactate) is a solution containing the following substances in water:

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

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

Viaflo Hartmann (Ringer lactate) is used for:

• treating loss of body water and chemicals (e.g., due to excessive sweating, kidney disorders)
• treating you 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)

2. What you need to know before Viaflo Hartmann (Ringer Lactate) is administered to you

DO NOT be given Viaflo Hartmann (Ringer Lactate) if you have any of the following clinical conditions

• in a newborn (less than 28 days old) receiving ceftriaxone (an antibiotic)
• if you are allergic to sodium lactate or any of the components of Viaflo Hartmann (Ringer Lactate) (listed in section 6).
• when there is excessive fluid in the body's extracellular spaces (extracellular hyperhydration)
• when there is an abnormally high blood volume in the blood vessels (hypervolemia)
• severe renal failure (when your kidneys are not functioning properly and you require dialysis)
• if you have uncompensated heart failure. This refers to heart failure that is not receiving adequate treatment and causes symptoms such as:
  • difficulty breathing
  • swelling of the ankles.
• if your blood potassium concentration is higher than normal (hyperkalemia)
• if your blood calcium concentration is higher than normal (hypercalcemia)
• if you have a condition causing blood to become too alkaline (metabolic alkalosis)
• if you have liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis)
• your blood is too acidic with life-threatening risk (severe metabolic acidosis)
• in a specific type of metabolic acidosis (lactic acidosis)
• severe liver disease (when the liver is not functioning properly and requires intensive treatment)
• impaired lactate metabolism (this occurs in severe liver disease, as lactate is cleared 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 (Ringer Lactate))

Warnings and precautions

Talk to your doctor or nurse before starting to use Viaflo Hartmann (Ringer Lactate) if you have or have had any of the following clinical conditions:

• if you are receiving ceftriaxone (an antibiotic) (see also Other Medicines and Viaflo Hartmann (Ringer Lactate))
• heart failure
• respiratory failure (lung disease) (in the above cases, special monitoring may be required)
• renal failure
• if your blood chloride concentration is higher than normal (hyperchloremia)
• high blood pressure (hypertension)
• fluid accumulation under the skin affecting the whole body (generalized edema)
• fluid accumulation under the skin, particularly around the ankles (peripheral edema)
• fluid accumulation in the lungs (pulmonary edema)
• high blood pressure during pregnancy (pre-eclampsia)
• diseases causing high levels of the hormone aldosterone (aldosteronism)
• if your blood sodium concentration 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 (Ringer Lactate)) or any type of heart disease
• any condition that may increase your risk of having high blood potassium levels (hyperkalemia), such as:
  • kidney failure
  • adrenocortical insufficiency (this adrenal gland disease affects hormones that regulate chemical concentrations in the body)
  • acute dehydration (loss of body water, for example due to vomiting or diarrhea)
  • extensive tissue damage (as occurs in severe burns)

Intensive monitoring of potassium levels in your blood is required.

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

This may increase the risk of low sodium levels in the blood and may 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 include:

• children
• women (particularly those of childbearing age)
• individuals with conditions affecting brain fluid levels, for example, due to meningitis, intracranial bleeding, or brain injury.

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

• your body's fluid levels
• the levels of chemicals 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 (Ringer Lactate) contains potassium, it does not contain enough to treat very low plasma potassium levels (severe potassium deficiency).

Calcium chloride can be harmful if injected into tissues. Therefore, Viaflo Hartmann (Ringer Lactate) must not be administered by intramuscular injection (into muscle). Your doctor will also take care to prevent the solution from leaking into the tissues surrounding the veins.

Viaflo Hartmann (Ringer Lactate) must not be administered through the same needle used for blood transfusion. This could damage or cause clumping of red blood cells.

Because Viaflo Hartmann (Ringer Lactate) contains lactate (a substance naturally present in the body), it may make the blood too alkaline (metabolic alkalosis).

Viaflo Hartmann (Ringer Lactate) should be administered with special caution in infants under 6 months of age.

Your doctor should consider whether you are receiving parenteral nutrition (nutrition delivered by intravenous infusion). During prolonged treatment with Viaflo Hartmann (Ringer Lactate), you may require additional nutritional support.

Other medicines and Viaflo Hartmann (Ringer Lactate)

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

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

• ceftriaxone (an antibiotic), which must not be administered through the same infusion line unless it is thoroughly flushed.
• cardiac glycosides (cardiotonics) such as digitalis or digoxin, used to treat heart failure, which must not be used together with Viaflo Hartmann (Ringer Lactate) (see section “Do not be given Viaflo Hartmann (Ringer Lactate) if you have…”). The effects of these medicines may be increased by calcium, potentially causing life-threatening cardiac rhythm disturbances.
• corticosteroids (anti-inflammatory medicines)

These medicines may cause the 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 blood potassium concentration. This effect may be life-threatening. The risk of increased blood potassium is higher if you have kidney disease.

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

(Note that these drugs 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)
• cyclosporines (used to prevent transplant rejection)

Some medicines affect the hormone vasopressin. These may include:

• antidiabetic medication (chlorpropamide)

• cholesterol-lowering medication (clofibrate)

• some cancer treatments (vincristine, ifosfamide, cyclophosphamide)

• selective serotonin reuptake inhibitors (used to treat depression)

• antipsychotics

• opioids for severe pain relief

• pain and/or anti-inflammatory medicines (also known as NSAIDs)

• medicines that mimic or enhance the effects of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)

• antiepileptic medicines (carbamazepine and oxcarbazepine)

• diuretics

Other medicines that may interact with or be affected by Viaflo Hartmann (Ringer Lactate) include:

• 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 tablets)
  • lithium (used to treat psychiatric disorders)
• alkaline (basic) medicines, for example:
  • sympathomimetics (stimulants such as ephedrine and pseudoephedrine, used in cough and cold preparations)
  • other stimulants (e.g., dexamphetamine, fenfluramine)

Use of Viaflo Hartmann (Ringer Lactate) with food and drink

Ask your doctor about what you may eat or drink.

Pregnancy, breastfeeding, and fertility

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

Viaflo Hartmann (Ringer Lactate) can be used safely during pregnancy and breastfeeding.

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

Calcium may 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:

• consult your doctor
• read the package leaflet of the medicine being added

Driving and using machines

Ask your doctor or pharmacist before driving or operating machinery.

3. How Viaflo Hartmann (Ringer's Lactate) will be administered to you

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

Viaflo Hartmann (Ringer's lactate) is usually administered through a plastic tube connected to a needle inserted into a vein. A vein in the arm is typically used for the infusion. However, your doctor may administer the medicine 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 levels of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin, or those taking other medications that enhance the effect of vasopressin).

Any unused portion of the solution must be discarded. DO NOT receive Viaflo Hartmann (Ringer's lactate) from a bag that has been partially used.

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

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

• fluid or sodium (salt) overload and accumulation of fluid in the tissues (edema), causing swelling
• hyperkalemia (higher than normal blood potassium levels), especially in patients with renal insufficiency, leading to symptoms such as:
  • tingling in the arms and legs (paresthesia)
  • muscle weakness
  • inability to move (paralysis)
  • irregular heartbeat (cardiac arrhythmias)
  • heart block (very slow heartbeat)
  • cardiac arrest (heart stops beating, life-threatening)
• confusion
• hypercalcemia (higher than normal blood calcium levels), causing symptoms such as:
  • decreased appetite (anorexia)
  • discomfort (nausea)
  • vomiting
  • constipation
  • abdominal pain
  • mental disturbances, such as irritability or depression
  • excessive thirst (polydipsia)
  • increased urine production (polyuria)
  • kidney disease due to calcium buildup in the kidneys (nephrocalcinosis)
  • kidney stones
  • coma (loss of consciousness)
  • chalky taste
  • flushing (redness)
  • dilation of blood vessels in the skin (peripheral vasodilation)
• hypokalemia (lower than normal blood potassium levels) and metabolic alkalosis (blood becomes too alkaline), especially in patients with renal insufficiency, causing symptoms such as:
  • changes in mood
  • fatigue
  • difficulty breathing
  • muscle stiffness
  • muscle twitching
  • muscle contractions

If you notice any of these symptoms, inform your doctor immediately. The infusion will be stopped and you will receive appropriate treatment depending on your symptoms.

If any medication has been added to Viaflo Hartmann (Ringer's lactate) before the overdose occurred, that medication may also cause symptoms. You should read the list of possible side effects in the package leaflet of the added medicine.

Discontinuation of Viaflo Hartmann (Ringer's lactate) infusion

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 medicines, this medicine can cause adverse effects, although not everyone 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 very severe or even life-threatening allergic reaction known as anaphylactic shock:

• hives (urticaria), which may be localized in one part of the body or widespread
• skin rash
• skin redness (erythema)
• itching (pruritus)
• skin swelling (angioedema)
• cough
• narrowing of the airways making breathing difficult (bronchospasm)
• rapid heartbeat (tachycardia)
• slow heartbeat (bradycardia)
• decreased blood pressure
• Chest discomfort or pain
• anxiety
• tightness in the chest (making breathing difficult)
• shortness of breath (dyspnea)
• flushing
• throat irritation
• sensation of prickling (paresthesia)
• numbness of the mouth (oral hypoesthesia)
• altered taste (dysgeusia)
• fever (pyrexia)
• nausea
• headache

Higher than normal blood potassium levels (hyperkalemia).

Low sodium levels in the blood that may occur during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy). Hyponatremia can lead to irreversible brain damage and death due to brain 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 where the solution is administered (phlebitis). This may cause redness, pain, stinging, and swelling along the vein used for infusion.
• skin 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/reactions due to infusion: nasal obstruction (nasal congestion), sneezing, throat swelling making breathing difficult (laryngeal edema, also called Quincke's edema), skin swelling (angioedema)
• changes in blood levels of chemical substances (electrolyte disturbances)
• increased blood volume in blood vessels beyond normal (hypervolemia)
• panic attacks
• other reactions related to the administration technique: infection at the infusion site, leakage of the infusion solution into surrounding tissues (extravasation), which may damage tissues and lead to scarring and numbness at the infusion site.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Viaflo Hartmann (Ringer Lactate)

Keep this medicine out of sight and reach of children.

250 ml bag: Do not store above 30°C.

500 ml and 1000 ml bags: No special storage conditions required.

Viaflo Hartmann (Ringer Lactate) must not be administered after the expiry date (CAD) stated on the bag. The expiry date refers to the last day of the month indicated.

Do not use Viaflo Hartmann (Ringer Lactate) if particles are 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 substances are:

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

The only excipient is water for injections.

Appearance of the product and contents of the pack

Viaflo Hartmann (Ringer lactate) is a clear, particle-free solution. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is contained within a sealed protective overpouch made of plastic.

Available bag sizes:

• 250 ml
• 500 ml
• 1000 ml

The bags are packed 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 certain pack sizes may be commercially available.

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 most recent revision of this leaflet: November 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only

Handling and Preparation

Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless the solution is clear and the container is intact.

Do not remove the bag from its overpouch until ready for use. The inner bag maintains sterility of the product. Administer immediately after connecting the infusion set.

Do not connect plastic containers in series. This type of use may result in air embolism due to residual air being entrained from the primary container before completion of administration from the secondary container. Pressurizing intravenous solutions in flexible plastic containers to increase flow rates may lead to air embolism if residual air in the container is not completely evacuated prior to administration. Use of an intravenous administration set with an air-venting filter in the open position may cause air embolism. Such intravenous administration sets with air-venting filters in the open position must not be used with flexible plastic containers.

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

Medications may be added before or during infusion through the injection site.

When medications are added, isotonicity must be checked prior to parenteral administration. Mixing must be performed under strict aseptic conditions. Solutions containing added medications should be used immediately and must not be stored.

The addition of other medications or the use of an incorrect administration technique may lead to febrile reactions due to possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately.

Discard after single use.

Discard partially used bags.

Do not reconnect partially used bags.

1. Opening

2. Remove the Viaflo bag from the protective overpouch immediately before use.

3. Check for small leaks by squeezing the inner bag firmly. If leaks are detected, discard the solution, as it may no longer be sterile.

4. Check the clarity of the solution and absence of foreign particles. Discard the solution if it is not clear or contains foreign particles.

5. Preparation for Administration

Use sterile materials for preparation and administration.

1. Hang the container by the eyelet.

2. Remove the plastic protector from the outlet port at the bottom of the container.

   • Hold the small fin on the neck of the outlet tube with one hand.
   • Hold the large fin on the closure cap with the other hand and twist.
   • The cap will detach.
   1. Use an aseptic technique for preparing the infusion.
   2. Connect the administration set. Refer to the instructions accompanying the administration set for connection, priming, and administration of the solution.

3. Techniques for Adding Medication

Warning: Added medications may be incompatible. Check compatibility of the added medication with both the solution and the container before use. When adding medications, isotonicity must be verified prior to parenteral administration (see section 5 “Incompatibilities of added medications” below).

To add medication before administration

• Disinfect the injection site.
• Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable injection site and inject the medication.
• Mix the medication and solution thoroughly. For high-density medications such as potassium chloride, gently move the tubes while in vertical position and mix.

Caution: Do not store bags with added medication.

To add medication during administration

• Close the clamp on the administration set.
• Disinfect the injection site.
• Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable injection site and inject the medication.
• Remove the container from the IV stand and/or rotate it to place it in vertical position.
• Gently tap both tubes to empty them while the container is in vertical position.
• Mix the solution and medication thoroughly.
• Return the container to its administration position, reopen the clamp, and continue administration.

1. In-use expiry (with added medications)

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

From a microbiological standpoint, the diluted product should be used immediately unless the addition of medication was performed under controlled, validated aseptic conditions. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user.

1. Incompatibilities of added medications

Ceftriaxone must not be mixed with calcium-containing solutions, including Viaflo Hartmann (Ringer lactate).

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

After adding a medication, incompatibility with Viaflo Hartmann (Ringer lactate) may become evident through a change in color and/or precipitation, formation of insoluble complexes, or appearance of crystals. The package leaflet of the medication to be added or other relevant sources should be consulted.

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

When adding medications to Viaflo Hartmann (Ringer lactate), an aseptic technique must be used. Mix the solution thoroughly after adding medications. Do not store solutions with added medications.

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

• Medications incompatible with Viaflo Hartmann (Ringer lactate):

• Aminocaproic acid

• Amphotericin B

• Metaraminol tartrate

• Cefamandol

• Ceftriaxone

• Cortisone acetate

• Diethylstilbestrol

• Etamivan

• Ethyl alcohol

• Phosphate and carbonate solutions

• Oxytetracycline

• Sodium thiopental

• Disodium versenate

• Medications partially incompatible with Viaflo Hartmann (Ringer lactate):

• Tetracycline – stable for 12 hours

• Sodium ampicillin

  • 2%-3% concentration stable for 4 hours
  • Concentration >3% must be administered within 1 hour

• Minocycline – stable for 12 hours

• Doxycycline – stable for 6 hours

Medications known to be incompatible must not be used.