Label: information for the user

Viaflo Hartmann (Ringer lactate) solution for perfusion

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

Read this label carefully before starting to use this medicine, because

it contains important information for you.

• Keep this label, as you may need to read 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 medicine is called “Solution for Viaflo Hartmann (Ringer lactate) solution for perfusion”, but it will be referred to as “Viaflo Hartmann (Ringer lactate)” for the rest of this label

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

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

The sodium, potassium, calcium, chlorides, and lactate are chemical substances (electrolytes) that are found in the blood

Viaflo Hartmann (Ringer lactate) is used for:

• Treating a loss of body water and chemical substances (for example, excessive sweating, renal disturbances)
• Treating 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 given Viaflo Hartmann (Ringer lactate) if you have any of the following clinical situations

• 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 (Ringer lactate) (including in section 6)
• 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 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 Medicines and Viaflo Hartmann (Ringer lactate))

Warnings and precautions

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

• if you are receiving ceftriaxone (an antibiotic) (see also Other Medicines and Viaflo Hartmann (Ringer lactate))
• 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 in the ankles)
• pulmonary edema (accumulation of fluid in the lungs)
• 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 steroid treatment (see also Other Medicines and Viaflo Hartmann (Ringer lactate))
• 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 adrenal gland disease 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)

You will require intense control of your potassium levels in the blood

• 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
• 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 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 below Other Medicines and Viaflo Hartmann (Ringer lactate)

This may increase the risk of having low sodium levels in the blood and may 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 you 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 given this solution, your doctor will be able to take blood and urine samples to control:

• the amount of fluid in your body
• the amount of 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 (Ringer lactate) 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 lactate) should not be injected into muscle (intramuscular injection). Your doctor will also take this into account to avoid the solution penetrating the tissues around the veins.

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

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

Viaflo Hartmann (Ringer lactate) should be administered with special caution to babies under 6 months.

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 lactate), you will need extra nutrition.

Other medicines and Viaflo Hartmann (Ringer lactate)

Inform your doctor or nurse if you are taking or have taken recently or may have to take any other medicine.

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

• ceftriaxone (an antibiotic), which should not be administered through the same infusion route, unless it is well washed.
• cardiac glycosides (cardiotonics) such as digitals or digoxin, used to treat heart failure, as they should not be used together with Viaflo Hartmann (Ringer lactate) (See section “You should not be given Viaflo Hartmann (Ringer lactate) if you have any of the following clinical situations”). The effects of those medicines may be increased by calcium, which could cause dangerous heart rhythm disturbances.
• corticosteroids (anti-inflammatory medicines)

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

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

The following medicines can increase the concentration of potassium in the blood. This effect may be life-threatening. You are more likely to suffer from increased potassium levels in the blood if you have kidney disease.

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

(Note that these drugs may be included in some combinations of 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)
• ciclosporins (used to prevent transplant rejection)

Some medicines 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 relief
• medicines for pain and/or inflammation (also known as NSAIDs)

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

Other medicines that may affect or be affected by Viaflo Hartmann (Ringer lactate) 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 medicines, for example:
• salicylates used to treat inflammation (aspirin)
• barbiturates (sleeping tablets)
• 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., dexamphetamine, fenfluramine)

Use of Viaflo Hartmann (Ringer lactate) with food and drinks

Ask your doctor 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 medicine.

Viaflo Hartmann (Ringer lactate) 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 leaflet of the medicine that will be added

Driving and operating machinery

Ask your doctor or pharmacist before driving or operating machinery.

Viaflo Hartmann (Ringer lactate) will be administered by a doctor or a nurse. Your doctor will decide how much you need and when to administer 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 (Ringer lactate)if there are particles floating in the solution or if the container is damaged in any way.

Viaflo Hartmann (Ringer lactate) will usually be 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 unused remainder of the solution must be discarded. DO NOT receive Viaflo Hartmann (Ringer lactate) from a bag that has been partially used.

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

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

• fluid overload or sodium overload and accumulation of fluid in tissues (edema) causing swelling
• hyperkalemia (elevated blood potassium levels) 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 (the heart stops beating and life is at risk)
• confusion
• hypercalcemia (elevated blood calcium levels) causing symptoms such as:
• decreased 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 (flushing)
• dilation of peripheral blood vessels (vasodilation)
• hypokalemia (low blood potassium levels) 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

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 (Ringer lactate) before the excessive administration, that medication may also cause symptoms. You should read the list of possible symptoms in the medication's package insert.

Discontinuation of Viaflo Hartmann (Ringer lactate) infusion

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 medicines, this medicine 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 or even life-threatening allergic reaction called anaphylactic shock:

High levels of potassium in the blood (hyperkalemia).

Low levels of sodium in the blood that may develop 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").

Reactions related to the administration method 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 may cause redness, pain, or itching and swelling along the vein in which the solution is administered.
• Skin rash or itching (pruritus) at the infusion site

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

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

If a medication has been added to the perfusion 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.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or nurse, 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 of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication 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.

Do not administer Viaflo Hartmann (Ringer lactate) after the expiration date CAD that appears on the bag. The expiration date is the last day of the month indicated.

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

Composition of Viaflo Hartmann (Ringer lactate)

The active principles are:

• Sodium chloride: 6.00 g per liter
• Potassium chloride: 0.40 g per liter
• Dihydrated calcium chloride: 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) is a transparent, particle-free solution. It is presented in polyolefin/polyamide plastic bags (Viaflo). Each bag is packaged in a sealed plastic protective overbag.

The sizes of the bags 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 sizes of packaging 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) Spain

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: November 2018

The detailed and updated information on this medicine is available on 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 to detect particles and discoloration before administration, when the solution and packaging permit. Do not administer unless the solution is transparent and the packaging 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 bags in series. This type of use may cause gas embolism due to residual air carried from the primary container before the secondary container is fully administered. Pressurizing intravenous solutions in flexible plastic containers to increase flow rates may cause 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 may cause gas embolism. Such intravenous administration sets with ventilation filters in the open position should not be used with flexible plastic containers.

The solution is to be administered by intravenous route with a sterile administration set using an aseptic technique. The set must be primed with the solution to prevent air entry into the system.

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

When medicaments are added, the isotonicity must be checked before parenteral administration. It is essential that the mixing of products be done in extreme aseptic conditions. Solutions containing added medicaments must 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 case of an adverse reaction, the infusion must be interrupted immediately.

Dispose of after single use.

Dispose of 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 pressing 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.

• Hold one hand on the small loop of the neck of the outlet tube.
• Hold the other hand on the large loop of the closure cap and turn it.
• The cap will come off.
• 1. Use an 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 injection of added medicaments

Warning: Added medicaments may be incompatible. Check the compatibility of the added medicament with the solution and the container before use. When medicaments are added, the isotonicity must be checked before parenteral administration (see below the section 5 “Incompatibilities of added medicaments”)

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

Caution: Do not store bags with added medicaments.

For adding medicaments during administration

• Close the clamp of the administration set
• Disinfect the injection port
• Using a syringe with a 19 (1.10 mm) to 22 (0.70 mm) gauge needle, pierce the 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 the administration.

1. Expiry in use (added medicaments)

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

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)

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

After adding a medicament, the incompatibility of the added medicament with Viaflo Hartmann (Ringer lactate) should be visible by a change in color and/or precipitation, insoluble complexes, or appearance of crystals. The product leaflet 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) (pH 5.0 – 7.0).

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

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

• Incompatible medicaments with Viaflo Hartmann (Ringer lactate):

• Aminocaproic acid
• Anfotericin B
• Metaraminol tartrate
• Cefamandol
• Ceftriaxone
• Cortisone acetate
• Dietilestilbestrol
• Etamivan
• Ethyl alcohol
• Phosphate and carbonate solutions
• Oxitetraciclina
• Tiopental sodium
• Versenato de disodio

• Medicaments partially incompatible with Viaflo Hartmann (Ringer lactate)

• Tetracycline stable for 12 hours
• Ampicilina sódica

Concentration of 2%-3% stable for 4 hours

Concentration >3% should be administered within 1 hour

• Minociclina stable for 12 hours
• Doxiciclina stable for 6 hours

Should not be used those medicaments that are known to be incompatible.