MAINTELYTE SOLUTION FOR INFUSION

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

Maintelyte must not be given to you if you have any of the following conditions:

• if your blood contains high levels of potassium above normal (hyperkalemia);
• if you have severe kidney problems (renal failure), with a reduction in the amount of urine produced (oliguria) or absence of urine (anuria);
• if your heart or lungs are not working normally (uncompensated heart or lung failure);
• if you have diabetes and it has not been treated properly, resulting in high blood sugar levels (uncontrolled diabetes);
• if you are intolerant to glucose;
• if you have lost consciousness (hyperosmolar coma). This is a type of coma that can occur if you have diabetes and are not receiving 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 medicine (listed in section 6).

Warnings and precautions

Tell your doctor if you have or have had any of the following conditions:

• allergy to corn, as Maintelyte contains corn-derived sugar; see the section "Possible side effects";
• heart failure, severe heart rhythm disorder, or other heart disease;
• lung disease (respiratory failure);
• kidney failure or reduced kidney function;
• excess fluid in the body or fluid accumulation 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 the elevation of a hormone called aldosterone (aldosteronism);
• any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (see also "Other medicines and Maintelyte" below);
• any situation that indicates you are prone to having high blood potassium levels, such as:

• kidney failure
• adrenal gland disease (adrenal insufficiency);
• rapid loss of body water, e.g., due to vomiting or diarrhea;
• severe burns or other significant tissue injuries;
• if your blood contains low levels of calcium;
• a disease that causes progressive muscle weakness (myasthenia gravis);
• a recent surgical procedure 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 pressure in the skull;
• stroke due to a blood clot in the brain (ischemic stroke);
• malnutrition (if you have stopped eating or have been eating poorly for some time);
• diabetes or impaired glucose tolerance;
• if you have problems with fluid levels in your brain (e.g., due to meningitis, bleeding in the skull, or brain injury);
• if you have a condition that could cause high levels of vasopressin, a hormone that regulates fluids in your body, such as:

• a sudden and severe illness 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, seizures, lethargy, coma, and brain swelling.

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

• the balance of fluids and the amount of chemical substances, 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).

Since 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;
• give you insulin to reduce blood sugar levels.

In case prolonged treatment with Maintelyte is necessary, your doctor will also give you other types of infusions to cover the needs of other chemical substances and nutrients in your body.

Children

Maintelyte should be given to children with special care and under close supervision.

Newborn babies, especially premature and low-birth-weight babies, are at higher risk of developing low or high blood sugar levels due to infusion of glucose-containing solutions. Low blood sugar in newborns can cause prolonged seizures, coma, and brain damage. High blood sugar has been associated with brain bleeding, late-onset bacterial and fungal infections, intestinal infection, eye problems, lung problems, prolonged hospitalization, and death.

Close monitoring of pediatric patients is required. In cases where normal water regulation in the blood 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, seizures, lethargy, coma, brain swelling, and death. Therefore, these symptoms are considered a medical emergency.

Other medicines and Maintelyte

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

It is not recommendedto use the following medicines while receiving a Maintelyte infusion:

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

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

• corticosteroids (anti-inflammatory medicines);
• an anti-inflammatory medicine used to treat stomach ulcers (carbenoxolone);

• certain diuretic tablets (potassium-sparing diuretics, e.g., amiloride, spironolactone, 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 to treat certain skin diseases);

• cyclosporin (used to prevent transplant rejection);
• acidic medicines, for example:
• • salicylates (used to treat inflammation) (aspirin),
  • barbiturates (sleeping pills),
  • lithium (used to treat psychiatric diseases);
• alkaline medicines, for example:
• • sympathomimetics (stimulants, such as ephedrine and pseudoephedrine, used in cough preparations),
  • stimulants (such as quinidine, dexamphetamine sulfate [used to treat ADHD], and fenfluramine hydrochloride [used to treat obesity]).

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

• diuretic tablets;
• medicines for pain and/or inflammation (also known as NSAIDs);
• antipsychotics;
• medicines used to treat depression (selective serotonin reuptake inhibitors);

Using Maintelyte with food and drink

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 are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will decide whether you can use Maintelyte during pregnancy or breastfeeding.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

3. How Maintelyte will be given to you

Maintelyte will be given to you 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, medical condition, and any other treatment you are having. Your doctor may check the levels of salts (electrolytes) and sugar (glucose) in your blood.

DO NOT receive Maintelyte if there are particles floating in the solution or if the container is damaged in any way.

Maintelyte is usually given to you through a plastic tube connected to a needle in a vein, usually in your arm. However, your doctor may use another method to give you the medicine.

DO NOT receive Maintelyte through the skin (subcutaneously).

Any unused solution should be discarded. You should NOTreceive a Maintelyte infusion from a partially used bag.

Due to the presence of glucose, DO NOTreceive this solution through the same infusion equipment used for blood transfusions. This can cause damage to red blood cells or make them clump together.

If you receive more Maintelyte than you should

If you receive too much Maintelyte (overinfusion) or if it is given too quickly, you may experience the following symptoms:

• fluid overload or sodium (salt) overload and fluid accumulation in the tissues (edema) that causes swelling;
• high blood sugar levels (hyperglycemia);
• 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;
• loss of tendon reflexes;
• reduced breathing (respiratory depression);
• nausea;
• vomiting;
• redness of the skin;
• thirst;
• low blood pressure (hypotension);
• drowsiness;
• slow heartbeats (bradycardia);
• coma (loss of consciousness);
• acidification of the blood (acidosis), which causes fatigue, confusion, lethargy, and increased respiratory rate;
• mood changes;
• fatigue;
• difficult breathing;
• muscle stiffness;
• muscle spasms;
• muscle spasms (tetany);
• high magnesium levels in the blood.

If you experience any of these symptoms, you should tell your doctor immediately. Your infusion will be stopped and you will be treated according to your symptoms.

If another medicine has been added to your Maintelyte and an overdose occurs, it may be that the other medicine also causes symptoms. You should read the leaflet of the added medicine to see the list of possible symptoms.

If you stop treatment with Maintelyte

Your doctor will decide when to stop the infusion.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects is unknown (cannot be estimated from the available data).

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

• swelling of the skin on the face, lips, and throat;
• difficulty breathing;
• skin rash;
• redness of the skin (erythema);
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis, which are possible manifestations in patients allergic to corn.

You will be given the necessary treatment according to your symptoms.

Other side effects are:

• reactions due to the infusion technique:
• fever;
• infection at the infusion site;
• local pain or reaction (redness or swelling) at the infusion site;
• irritation or inflammation of the vein into which the solution is infused (phlebitis). This can cause redness, pain, or burning and swelling along the vein into which the solution is infused.
• formation of blood clots (thrombosis), sometimes accompanied by inflammation that causes pain, swelling, or redness;
• leakage of the infusion solution into the tissues surrounding the vein (extravasation);
• high levels of potassium in the blood that can cause an abnormal heart rhythm (hyperkalemia);
• high blood sugar levels (hyperglycemia);
• excess fluid in the body (hypervolemia);
• alterations in the concentration of salts in the blood (electrolyte imbalance);
• seizures;
• low sodium levels in the blood (hyponatremia);
• brain swelling that can cause brain damage (hyponatremic encephalopathy).

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

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Maintelyte

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

Do not use this medicine after the expiry date which is stated on the bag after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C.

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

6. Container Content and Additional Information

Maintelyte Composition

The active ingredients are:

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

• magnesium chloride hexahydrate: 0.30 g per liter

The other components are:

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

Product Appearance and Container Content

Maintelyte solution for infusion is a clear, particle-free solution. It is supplied in polyolefin/polyamide (Viaflo) plastic bags. Each bag is placed in a sealed protective overbag.

The bag size is 1000 ml.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Baxter S.L.

Pouet de Camilo, 2.

46394 Ribarroja del Turia (Valencia)

Spain

Manufacturer:

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) under 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 revision of this leaflet:February 2020

Detailed and updated information on this medicinal product 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

Use the solution only if it is clear, free of visible particles, and if the container is not damaged. Administer immediately after connecting the infusion equipment.

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

The inner bag maintains the product's sterility.

Do not connect plastic containers in series. This type of use can produce gas embolisms due to residual air dragged from the primary container before the administration of the liquid contained in the secondary container is completed.

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 the ventilation filter in the open position should not be used with flexible plastic containers.

The solution must be administered with a sterile set using an 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 infusion through the resealable medication addition port.

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 the event of an adverse reaction, the infusion must be interrupted immediately.

Discard after a single use.

Discard partially used containers.

Do not reconnect partially used bags.

1. To open
   • Remove the Viaflo bag from the protective overbag immediately before use.
   • Check for the absence of small leaks by squeezing the inner bag firmly. If leaks are detected, discard the solution, as it may not be sterile.
   • 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.

• Suspend the container by the hanger.

• Remove the plastic protector from the outlet port 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.

• Use an aseptic technique to prepare the infusion.

• Connect the administration set. Consult the instructions accompanying the set for connection, priming, and administration of the solution.

1. Techniques for injecting added medication

The solution MUST NOT be administered subcutaneously.

Some added medications may be incompatible.

When adding medications, verify isotonicity before parenteral administration. A complete and careful aseptic mixture of any added medication is necessary. Solutions containing added medications should be used immediately and not stored.

To add medication before administration

• Disinfect the medication addition port.

• Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, puncture the resealable medication addition port and inject.

• Mix the solution and medication carefully. For high-density medications, such as potassium chloride, gently move the tubes while they are in a vertical position and mix.

Caution: do not store bags with added medication.

To add medication during administration

• Close the set clamp.

• Disinfect the medication addition port.

• Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, puncture the resealable medication addition port and inject.

• Remove the container from the intravenous support and/or turn 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. Validity period after first opening: (Added medications)

Before use, the physical and chemical stability of any added medication at 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 storage conditions after opening are the responsibility of the user and should not normally exceed 24 hours between 2 and 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

1. Incompatibilities of added medications

The incompatibility of added medications 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 medications.

The summary of product characteristics of the medication to be added should be consulted.

Before adding a medication, 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.

Medications known to be incompatible should not be added.