Leaflet: information for the user

Maintelyte solution for infusion

Active ingredients: glucose monohydrate, sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or nurse.

- If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Throughout this text, we will refer to Maintelyte solution for infusion as Maintelyte.

1. What Maintelyte is and what it is used for

2. What you need to know before Maintelyte is given to you

3. How Maintelyte will be given to you

4. Possible side effects

5. Storage of Maintelyte

6. Contents of the pack and additional information

Maintelyte is a solution of the following substances in water:

• sugar (glucose)
• sodium chloride
• sodium acetate trihydrate
• potassium chloride
• magnesium chloride hexahydrate

Glucose is one of the body's energy sources. This perfusion solution provides 200kilocalories per liter. Sodium, potassium, magnesium, chloride, and acetate are chemical substances present in the blood.

Maintelyte is used to provide a source of liquids and chemical substances and to provide carbohydrates (sugar) when you cannot eat or drink normally.

You should not be administered Maintelyte if you have any of the following clinical situations:

• if your blood contains high levels of potassium above normal (hyperkalemia);
• if you have severe kidney problems (renal insufficiency), with a reduction in the amount of urine produced (oliguria) or complete absence of urine (anuria);
• if your heart or lungs do not function normally (uncompensated heart or lung failure);
• if you have diabetes and have not been properly treated, resulting in blood sugar levels above normal (uncontrolled diabetes);
• if you have glucose intolerance;
• if you have loss of consciousness (hyperosmolar coma). This is a type of coma that can occur if you have diabetes and do not receive enough medication.
• if your blood contains high levels of sugar above normal (hyperglycemia);
• if your blood contains high levels of lactate above normal (hyperlactatemia);
• if you are allergic to potassium chloride, sodium acetate trihydrate, sodium chloride, magnesium chloride hexahydrate, and glucose, or to any of the other components of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor if you have or have had any of the following clinical situations:

• allergy to corn, as Maintelyte contains corn-derived sugar; see the "Possible side effects" section;
• heart failure, severe heart rhythm disorder, or other heart disease;
• respiratory disease (respiratory insufficiency);
• renal insufficiency or reduced renal function;
• excessive fluid in the body or accumulation of fluid in the lungs or under the skin, particularly in the ankles;
• high blood pressure;
• high blood pressure during pregnancy (pre-eclampsia or eclampsia);
• a disease that causes an increase in a hormone called aldosterone (aldosteronism);
• any condition associated with sodium retention (when the body retains too much sodium), such as steroid treatment (see also "Other medications and Maintelyte" below);
• any situation that indicates you are prone to having high blood potassium levels, such as:

renal insufficiency

adrenal gland disease (corticosuprarenal insufficiency);

rapid loss of body water, e.g., due to vomiting or diarrhea;

severe burns or other significant tissue damage;

• if your blood contains low levels of calcium;
• myasthenia gravis, a disease that causes progressive muscle weakness;
• recent surgery in which you were given medications to block nerves and muscles (neuromuscular blockade) under the control of an anesthesiologist;
• alterations in blood pH;
• head injury within the last 24 hours (Maintelyte should not be used);
• high intracranial pressure;
• stroke due to a blood clot in the brain (ischemic stroke);
• malnutrition (if you have stopped eating or have been poorly nourished for some time);
• diabetes or impaired glucose tolerance;
• if you have problems with fluid levels in your brain (e.g., due to meningitis, intracranial bleeding, or brain injury);
• if you have a condition that could cause high levels of vasopresin, a hormone that regulates fluids in your body, such as:

recent or severe disease or injury

surgery

brain disease

certain medications you are taking

This may increase the risk of low sodium levels in the blood and can cause headache, nausea, convulsions, lethargy, coma, and cerebral inflammation.

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

• the balance of fluids and the amount of chemicals, such as sodium, chloride, and magnesium, present in the blood and urine (your plasma and urine electrolytes);

• the acidity of the blood and urine (your acid-base balance).

As Maintelyte contains sugar (glucose), it may cause high blood sugar levels (hyperglycemia). This is especially important if you have diabetes. In these cases, your doctor may:

• adjust the infusion rate;
• administer insulin to reduce blood sugar levels.

If prolonged treatment with Maintelyte is necessary, your doctor will also administer other types of infusions to cover the needs of other chemicals and nutrients in your body.

Children

Maintelyte should be administered with special care to children and under strict supervision.

Newborn babies, especially premature babies and those with low birth weight, have a higher risk of developing low or high blood sugar levels due to the infusion of solutions containing glucose. Low blood sugar in newborn babies can cause prolonged convulsions, coma, and brain damage. High blood sugar has been associated with intracranial hemorrhage, late-onset bacterial and fungal infections, intestinal infections, eye problems, respiratory problems, prolonged hospitalization, and death.

Rigorous monitoring of pediatric patients is required. In cases where the normal regulation of blood water content is altered due to increased secretion of antidiuretic hormone (ADH), infusion of fluids with low sodium chloride concentration may result in low sodium levels in the blood (hyponatremia). This can cause headache, nausea, convulsions, lethargy, coma, cerebral inflammation, and death. Therefore, these symptoms are considered a medical emergency.

Other medications and Maintelyte

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

Do not use the following medications while receiving Maintelyte:

• neuromuscular blocking agents (e.g., tubocurarine, suxamethonium, and vecuronium), which are medications used in surgical procedures under the control of an anesthesiologist;

Other medications that may affect Maintelyte or be affected by it:

• corticosteroids (anti-inflammatory medications);
• carbenoxolone, an anti-inflammatory used to treat stomach ulcers;

• diuretics that save potassium (e.g., amiloride, spironolactone, and triamterene);

• 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 certain skin diseases;

• ciclosporin, used to prevent transplant rejection;
• acidic medications, such as:
• • salicylates (used to treat inflammation) (aspirin),
  • barbiturates (sleeping pills),
  • litium (used to treat psychiatric disorders);
• alkaline medications, such as:
• • sympathomimetics (stimulants, such as ephedrine and pseudoephedrine, used in cough preparations),
  • stimulants (such as quinidine, dexanfetamine sulfate [used to treat ADHD, attention deficit hyperactivity disorder]), phenfluramine hydrochloride (used to treat obesity).

Some medications may increase the risk of adverse effects due to low sodium levels in the blood. These medications may include:

• diuretics;
• medications for pain and/or inflammation (also known as NSAIDs);
• antipsychotics;
• medications used to treat depression (selective serotonin reuptake inhibitors);
• medications that produce effects similar to those of morphine (opioids);
• some medications used to treat epilepsy (antiepileptics);
• oxytocin, a hormone used to induce uterine contractions;
• chemotherapy medications.

Use of Maintelyte with food and drinks

Ask your doctor about what you can 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 before using this medication. Your doctor will decide if you can use Maintelyte during pregnancy or breastfeeding.

Driving and operating machinery

This medication does not affect your ability to drive and operate machinery.

Maintelytewill 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, clinical condition, and concomitant treatment. Your doctor may check your blood levels of salts (electrolytes) and sugar (glucose).

DO NOT receiveMaintelyteif there are particles floating in the solutionor if the container is damaged in any way.

Maintelyteis usually administered through a plastic tube connected to a vein in your arm using a needle. However, your doctor may use another method to administer the medication.

DO NOT receiveMaintelyte through the skin (subcutaneous route).

Any unused solution should be discarded. You should NOT receive a perfusion ofMaintelytefrom a bagthat has been used partially.

Due to the presence of glucose, DO NOT receive this solution through the same infusion equipment used for blood transfusions. This can cause damage to red blood cells or cause them to clump.

If you receive more Maintelyte than you should

If you receive an excessive amount of Maintelyte (overinfusion) 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;
• high blood sugar (hyperglycemia);
• tingling in your arms and legs (paresthesia);
• muscle weakness;
• inability to move (paralysis);
• irregular heartbeats (cardiac arrhythmias);
• cardiac block (slow heart rate);
• cardiac arrest (heart stops beating and life is in danger);
• confusion;
• loss of tendon reflexes;
• reduced breathing (respiratory depression);
• nausea;
• vomiting;
• skin redness;
• thirst;
• low blood pressure (hypotension);
• drowsiness;
• slow heart rate (bradycardia);
• coma (loss of consciousness);
• blood acidification (acidosis), which causes fatigue, confusion, lethargy, and increased respiratory rate;
• mood changes;
• fatigue;
• difficult breathing;
• muscle stiffness;
• muscle spasms;
• muscle cramps (tetany);
• elevated magnesium levels in the blood.

If you experience any of these symptoms, you should inform your doctor immediately. Your infusion will be stopped and you will be treated based on your symptoms.

If another medication has been added to your Maintelyte and an overdose occurs, the symptoms may be caused by that medication as well. You should read the prospectus of the added medication to see the list of possible symptoms.

If you interrupt the treatment withMaintelyte

Your doctor will decide when to stop the infusion.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The frequency of side effects isunknown (cannot be estimated from the available data).

Inform your doctor or nurse immediately if you experience any of the following symptoms, as they may be signs of a severe or even life-threatening allergic reaction:

• Swelling of the skin on the face, lips, and throat;
• Difficulty breathing;
• Skin rash;
• Redness of the skin (erythema);
• Allergic reactions, including a severe allergic reaction called anaphylaxis, which are possible manifestations in patients allergic to corn.

You will be given the necessary treatment based on your symptoms.

Other side effects are:

• Reactions due to administration technique:
• Fever;
• Infection at the infusion site;
• Local pain or reaction (redness or swelling) at the infusion site;
• Irritation or inflammation of the vein in which the solution is infused (phlebitis). This may cause redness, pain, or burning and swelling along the vein in which the solution has been infused.
• Formation of blood clots (thrombosis), sometimes accompanied by inflammation that causes pain, swelling, or redness;
• Escape of the infusion solution into the surrounding tissues of the vein (extravasation);
• High levels of potassium in the blood that may cause an abnormal heart rhythm (hyperkalemia);
• High levels of sugar in the blood (hyperglycemia);
• Excessive accumulation of fluid in the body (hypervolemia);
• Alterations in the concentration of salts in the blood (electrolyte imbalance);
• Seizures;
• Low levels of sodium in the blood (hyponatremia);
• Swelling of the brain that may cause brain damage (hypontatremic encephalopathy).

If another medicine has been added to the infusion solution, it may happen that that medicine also causes side effects. These will depend on the added medicine. You should read the prospectus of the added medicine to see the list of these possible symptoms.

Reporting 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:http://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.

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 store at a temperature above 25°C.

Do not use this medication if there are particles floating in the solution or if the container is damaged in any way.

Composition of Maintelyte

The active principles are:

• glucose (as monohydrate): 50g per liter
• sodium chloride: 1g per liter
• sodium acetatetrihydrate: 3.13g per liter
• potassium chloride: 1.50g per liter

• magnesium chloridehexahydrate: 0.30g per liter

The other components are:

• concentrated hydrochloric acid (for pH adjustment)
• water for injection preparations

Appearance of the product and contents of the package

Maintelyteinfusion solutionis a transparent, particle-free solution. It is supplied in plastic polyolefin/polyamide (Viaflo) bags. Each bag is introduced into a sealed plastic protective overbag.

The bag size is 1000ml.

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

• 10 bags of 1000 ml
• 12 bags of 1000 ml

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

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 Sabiñánigo (Huesca)

Spain

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names

Bulgaria:GNAK 50 mg/ml solution for infusion

Croatia:GNAK 50 mg/ml otopina za infuziju

Czech Republic:GNAK 50 mg/ml infuzni roztok

Cyprus:Maintelyte 50 mg/ml δι?λυμα για ?γχυση

Denmark:Glucose – Na – K Baxter 50 mg/ml, infusionsvæske, opløsning

Spain:Maintelyte Solución para perfusión

Finland:Glucose – Na – K Baxter 50 mg/ml, infuusioneste, liuos

France:MAINTELYTE solution pour perfusión

Greece:Maintelyte 50 mg/ml δι?λυμα για ?γχυση

Germany:Maintelyte 50 mg/ml Infusionslösung

Ireland:Maintelyte Solution for infusion

Italy:GNAK 50 mg/ml Soluzione per infusione

Malta:Maintelyte, solution for Infusion

Netherlands:Maintelyte, oplossing voor infusie

Poland:GNAK 50

Portugal:Maintelyte 50 mg/ml Solução para perfusão

Romania:GNAK 50 mg/ml Solutie perfuzabila

Slovenia:GNAK raztopina za infundiranje

Slovakia:GNAK 50 mg/ml Infúzny roztok

Sweden:Glucose-Na-K Baxter 50 mg/ml infusionsvätska, lösning

United Kingdom:Maintelyte solution for infusion

(Northern Ireland)

Date of the last review of this leaflet:February 2020

The detailed and updated information on this medicinal product 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

Use the solution only if it is transparent, particle-free, and the package is not damaged. Administer immediately after connecting the infusion equipment.

Do not remove the bag from its protective overbag until it is ready for use.

The inner bag maintains the sterility of the product.

Do not connect plastic containers in series. This type of use may cause gas embolism due to residual air carried from the primary container before the administration of the liquid contained in the secondary container is complete.

The pressurization of intravenous solutions in flexible plastic containers to increase flow rates may cause 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. This type of intravenous administration set with the ventilation filter in the open position should not be used with flexible plastic containers.

The solution must be administered with a sterile equipment using an aseptic technique. The equipment must be primed with the solution to prevent air from entering the system.

Medicaments may be added before or during infusion through the resellable medication addition port.

The addition of other medicaments or the use of an incorrect administration technique may cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, the infusion must be interrupted immediately.

Dispose of after a single use.

Dispose of partially used containers.

Do not reconnect partially used bags.

1.To open

a.Remove the Viaflo bag from the protective overbag immediately before use.

b.Check for small leaks by compressing the inner bag firmly. If leaks are detected, discard the solution, as it may not be sterile.

c.Check the transparency of the solution and the absence of foreign particles. Discard the solution if it is not transparent or contains foreign particles.

2.Preparation for administration

Use sterile material for preparation and administration.

a.Hang the container by the hanger.

b.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 closure cap and turn.

-The cap will come off.

c.Use an aseptic technique to prepare the infusion.

d.Connect the administration equipment. Consult the instructions accompanying the equipment for its connection, priming, and administration of the solution.

3.Techniques for injection of added medicaments

The solution MUST NOT be administered subcutaneously.

Some added medicaments may be incompatible.

When adding medicaments, verify isotonicity before parenteral administration. A complete and careful aseptic mixing of any added medicament is necessary. Solutions containing added medicaments must be used immediately and not stored.

To add medicaments before administration

a.Disinfect the medication addition port.

b.Using a syringe with a 19G (1.10mm) to 22G (0.70mm) needle, pierce the resellable medication addition port and inject.

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

Warning: do not store bags with added medicaments.

To add medicaments during administration

a.Close the clamp of the equipment.

b.Disinfect the medication addition port.

c.Using a syringe with a 19G (1.10mm) to 22G (0.70mm) needle, pierce the resellable medication addition port and inject.

d.Remove the container from the intravenous support and/or turn it to the vertical position.

e.Empty both tubes by gently tapping them while the container is in the vertical position.

f.Mix the solution and medicament carefully.

g.Put the container back in the use position, reopen the clamp, and continue the administration.

4.Validity period after the first opening: (Added medicaments)

Before use, the physical and chemical stability of any additional medicament to the pH of Maintelyte in the Viaflo container must be established.

From a microbiological point of view, the diluted product must be used immediately. If not used immediately, the time and conditions of conservation once opened are the responsibility of the user and normally should not be greater than 24hours between 2 and 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

5.Incompatibilities of added medicaments

The incompatibility of added medicaments to the solution in the Viaflo bag must be verified before addition.

In the absence of compatibility studies, this solution should not be mixed with other medicaments.

The prospectus of the medicament to be added should be consulted.

Before adding a medicament, verify that it is soluble and stable in water at the pH of Maintelyte (pH 4.5-6.5).

Maintelyte solutions are not compatible with blood or red blood cells, as cases of coagulation have been reported.

Medicaments that are known to be incompatible should not be added.