MainTelyte solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Maintelyte infusion solution

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

Read the entire 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, ask your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Throughout this text, Maintelyte infusion solution will be referred to as Maintelyte.

Leaflet contents

1. What Maintelyte is and what it is used for
2. What you need to know before Maintelyte is administered to you
3. How Maintelyte will be administered to you
4. Possible side effects
5. How to store Maintelyte
6. Contents of the pack and other information

1. What Maintelyte is and what it is used for

Maintelyte is a solution containing the following substances in water:

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

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

Maintelyte is used to provide you with a source of fluids and electrolytes, and to supply carbohydrates (sugar) when you are unable to eat or drink normally.

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

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

• high levels of potassium in your blood above normal (hyperkalemia);
• severe kidney problems (renal failure), with reduced urine output (oliguria) or complete absence of urine (anuria);
• heart or lung dysfunction that is not properly controlled (uncompensated cardiac or pulmonary failure);
• diabetes that has not been adequately treated, leading to blood sugar levels above normal (uncontrolled diabetes);
• glucose intolerance;
• loss of consciousness (hyperosmolar coma). This is a type of coma that may occur if you have diabetes and have not received sufficient medication;
• high levels of sugar in your blood (hyperglycemia);
• high levels of lactate in your blood above normal (hyperlactatemia);
• allergy 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

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

• allergy to corn, as Maintelyte contains sugar derived from corn; see section “Possible side effects”;

• heart failure, severe heart rhythm disorders, 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 condition causing elevated levels 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 condition indicating you may be prone to high blood potassium levels, such as:

  • kidney failure
  • adrenal gland disease (adrenocortical insufficiency);
  • rapid loss of body water, e.g., due to vomiting or diarrhea;
  • severe burns or other causes of significant tissue injury;
  • low calcium levels in your blood;
  • a disease causing progressive muscle weakness (myasthenia gravis);
  • recent surgery during which you received medications to block nerves and muscles (neuromuscular blockade) under the supervision of an anesthetist;
  • disturbances in blood pH;
  • head injury within the last 24 hours (Maintelyte must not be used);
  • increased pressure inside the skull;
  • stroke caused by 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;
  • conditions affecting fluid levels in your brain (e.g., due to meningitis, bleeding in the skull, or brain injury);
  • any condition that could lead to elevated levels of vasopressin, a hormone that regulates fluids in your body, such as:
  • sudden and severe illness or injury
  • surgery
  • brain disease
  • certain medications you are taking

This may increase the risk of low sodium levels in your blood and may cause headache, nausea, seizures, lethargy, coma, and brain swelling.

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

• fluid balance and levels of chemical substances such as sodium, chloride, and magnesium in your blood and urine (your plasma and urinary electrolytes);

• the acidity of your 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 such cases, your doctor may:

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

If prolonged treatment with Maintelyte is required, your doctor will also administer other types of infusions to meet your body’s needs for other chemicals and nutrients.

Children

Maintelyte must be administered with special caution in children and under close supervision.

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

Close monitoring of pediatric patients is essential. In cases where normal regulation of blood water content is disrupted due to increased secretion of antidiuretic hormone (ADH), infusion of fluids with low sodium chloride concentration may result in low blood sodium levels (hyponatremia). This may cause headache, nausea, seizures, lethargy, coma, brain swelling, and death. Therefore, these symptoms should be considered a medical emergency.

Other medicines and Maintelyte

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

The following medicines are NOT recommended during infusion with Maintelyte:

• neuromuscular blocking agents (e.g., tubocurarine, suxamethonium, and vecuronium), which are medicines used during surgery under the supervision of an anesthetist;

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

• anti-inflammatory drugs (corticosteroids);

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

• certain tablets for urination known as 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);

• cyclosporine (used to prevent transplant rejection);

• acidic medicines, for example:

  • salicylates (used to treat inflammation) (aspirin),
  • barbiturates (sleeping tablets),
  • lithium (used to treat psychiatric conditions);

• alkaline medicines, for example:

  • sympathomimetics (stimulants such as ephedrine and pseudoephedrine, used in cough preparations),
  • stimulants (such as quinidine, dexamfetamine sulfate [used to treat ADHD, attention deficit hyperactivity disorder], fenfluramine hydrochloride [used to treat overweight]).

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

• tablets for urination (diuretics);

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

• antipsychotics;

• medicines used to treat depression (selective serotonin reuptake inhibitors);

• medicines with morphine-like effects (opioids);

• certain medicines used to treat epilepsy (antiepileptics);

• a hormone called oxytocin (used to contract the uterus);

• medicines used to treat cancer (chemotherapy).

Use of Maintelyte with food and drinks

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 are planning to become pregnant, consult your doctor 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 operate machinery.

3. How Maintelyte will be administered to you

Maintelyte will be administered 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, clinical condition, and concomitant treatment. Your doctor may check the levels of salts (electrolytes) and sugar (glucose) in your blood.

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

Usually, Maintelyte will be administered through a plastic tube connected via a needle to a vein, most often in your arm. However, your doctor may use another method to administer the medicine.

Maintelyte must NOT be administered through the skin (subcutaneous route).

Any unused portion of the solution must be discarded. You must NOT receive an infusion of Maintelyte from a bag that has already been partially used.

Due to the presence of glucose, this solution must NOT be administered through the same infusion set used for blood transfusions. This may cause damage to red blood cells or cause them to clump together.

If you receive more Maintelyte than you should

If you receive an excessive amount of Maintelyte (over-infusion) or if it is administered too quickly, you may experience the following symptoms:

• water or sodium (salt) overload and fluid accumulation in the tissues (edema), causing swelling;
• high blood sugar level (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 (heart stops beating, life-threatening);
• confusion;
• loss of tendon reflexes;
• reduced breathing (respiratory depression);
• nausea;
• vomiting;
• skin redness;
• thirst;
• drop in blood pressure (hypotension);
• drowsiness;
• slow heartbeats (bradycardia);
• coma (loss of consciousness);
• acidification of the blood (acidosis), causing fatigue, confusion, lethargy, and increased breathing rate;
• changes in mood;
• fatigue;
• difficulty breathing;
• muscle stiffness;
• muscle twitching;
• muscle spasms (tetany);
• elevated magnesium levels in the blood.

If you experience any of these symptoms, you must inform your doctor immediately. Your infusion will be stopped and you will be treated according to the symptoms present.

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

If you interrupt treatment with Maintelyte

Your doctor will decide when to stop the infusion.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The frequency of adverse effects is unknown (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 very serious or even life-threatening allergic reaction (hypersensitivity):

• swelling of the skin of 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 maize.

You will be given appropriate treatment depending on the symptoms.

Other adverse effects include:

• reactions due to the 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 into which the solution is infused (phlebitis). This may cause redness, pain or burning, and swelling along the vein where the solution was infused;
• formation of blood clots (venous thrombosis), sometimes accompanied by inflammation causing pain, swelling, or redness;
• leakage of the infusion solution into the surrounding tissues near the vein (extravasation);
• high levels of potassium in the blood which may cause an abnormal heart rhythm (hyperkalemia);
• high blood sugar level (hyperglycemia);
• excessive accumulation of fluid in the body (hypervolemia);
• disturbances in the concentration of salts in the blood (electrolyte imbalance);
• seizures;
• low levels of sodium in the blood (hyponatremia);
• brain swelling that may cause brain damage (hyponatremic encephalopathy).

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

Reporting of adverse effects

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

5. Storage of Maintelyte

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

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

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. Package contents and other information

Composition of Maintelyte

The active substances are:

• glucose (as monohydrate): 50 g per litre
• sodium chloride: 1 g per litre
• sodium acetate trihydrate: 3.13 g per litre
• potassium chloride: 1.50 g per litre
• magnesium chloride hexahydrate: 0.30 g per litre

The other components are:

• concentrated hydrochloric acid (for pH adjustment)
• water for injections

Appearance of the medicinal product and contents of the container

Maintelyte infusion solution is a clear, particle-free solution. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is enclosed in a sealed protective overpouch made of plastic.

The bag size is 1000 ml.

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised 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 διάλυμα για έγχυση
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 perfusion
Greece: Maintelyte 50 mg/ml διάλυμα για έγχυση
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 most recent revision of this leaflet: February 2020

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/

This information is intended for healthcare professionals only:

Handling and preparation

Use the solution only if it is clear and free from visible particles, and if the container is undamaged. Administer immediately after connecting the infusion set.

Do not remove the bag from its protective overpouch until ready for use.

The inner bag maintains the sterility of the product.

Do not connect plastic containers in series. This type of use may result in gas embolism due to residual air being entrained from the primary container before completion of infusion from the secondary container.

Pressurization of intravenous solutions in flexible plastic containers to increase flow rates may lead to gas embolism if residual air in the container is not completely evacuated before administration.

Using an intravenous administration set with a vented filter in the open position may cause gas embolism. Such intravenous administration sets with vented filters in the open position must not be used with flexible plastic containers.

The solution must be administered using sterile equipment and aseptic technique. The administration set should be primed with the solution to prevent air from entering the system.

Added medications may be introduced before or during infusion through the resealable medication addition port.

The addition of other medications or the use of incorrect administration techniques may cause 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 containers.

Do not reconnect partially used bags.

1. To open

   • Remove the Viaflo bag from the protective overpouch immediately before use.
   • Check for leaks by squeezing the inner bag firmly. If leaks are detected, discard the solution, as sterility may be compromised.
   • Check the clarity of the solution and absence of foreign particles. Discard the solution if it is not clear or contains foreign particles.

2. Preparation for administration

Use sterile materials for preparation and administration.

• Hang the container by the hanger loop.

• 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.

• Use aseptic technique for preparing the infusion.

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

1. Techniques for injection of added medication

The solution must not be administered by subcutaneous route.

Some added medications may be incompatible.

When adding medications, verify isotonicity before parenteral administration. Complete and careful aseptic mixing of any added medication is required. Solutions containing added medications should be used immediately and not stored.

To add medication before administration

• Disinfect the resealable medication addition port.

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

• Mix the solution and medication thoroughly. For high-density medications such as potassium chloride, gently move the bag while in vertical position to ensure mixing.

Caution: Do not store bags with added medication.

To add medication during administration

• Close the clamp on the administration set.

• Disinfect the resealable medication addition port.

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

• Remove the container from the intravenous stand and/or rotate it to place it in an upright position.

• Empty both tubes by gently tapping them while the container is in upright position.

• Mix the solution and medication carefully.

• Return the container to its administration position, reopen the clamp, and continue administration.

1. Period of validity after first opening: (Added medications)

Prior to 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 standpoint, the diluted product should be used immediately. If not used immediately, storage time and conditions are the responsibility of the user and should normally not exceed 24 hours between 2 and 8 °C, unless reconstitution has taken place under controlled and validated aseptic conditions.

1. Incompatibilities of added medications

Incompatibility of added medications with the solution in the Viaflo bag must be verified before addition.

In the absence of compatibility studies, this solution must not be mixed with other medicinal products.

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

Before adding a medicinal product, 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.

Medicinal products known to be incompatible must not be added.