Gnak

Package leaflet: Information for the user

GNAK, infusion solution
Active substances: glucose, sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse immediately. See section 4.

Throughout this leaflet, GNAK, infusion solution will be referred to as GNAK.
Contents of the leaflet

1. What GNAK is and what it is used for
2. Important information before administration of GNAK
3. How to administer GNAK
4. Possible side effects
5. How to store GNAK
6. Contents of the pack and other information

1. What GNAK is and what it is used for

GNAK is an aqueous solution containing the following substances:

• 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 litre. Sodium, potassium, magnesium, chloride and acetate are chemical substances present in the blood. GNAK is used as a source of fluids and electrolytes, and as a source of carbohydrates (sugar), when the patient is unable to eat or drink normally.

2. Important information before administering GNAK

DO NOT use GNAK if the patient has any of the following conditions:

• elevated potassium levels in the blood (hyperkalemia);
• severe kidney dysfunction (renal failure) resulting in significantly reduced urine production (oliguria) or absence of urine production (anuria);
• heart or lung failure (decompensated heart or respiratory failure);
• inadequately treated diabetes with blood glucose levels above normal (uncontrolled diabetes);
• glucose intolerance states;
• loss of consciousness (hyperosmolar coma). This is a type of coma that may occur in diabetic patients not receiving adequate treatment;
• elevated blood glucose levels (hyperglycemia);
• elevated blood lactate levels (hyperlactatemia);
• hypersensitivity to potassium chloride, sodium acetate trihydrate, sodium chloride, magnesium chloride hexahydrate, glucose, or any of the other components of this medicine (listed in section 6).

Warnings and precautions
Inform the doctor if the patient has or has had any of the following conditions:

• allergy to corn, as GNAK contains corn-derived sugar; see section "Possible side effects";
• heart failure, severe heart rhythm disorders, or other heart diseases;
• lung disease (respiratory failure);
• kidney failure or impaired kidney function;
• excessive fluid in the body or fluid accumulation in the lungs or under the skin, especially around the ankles;
• high blood pressure;
• high blood pressure during pregnancy (pre-eclampsia or eclampsia);
• a condition causing increased activity of the hormone aldosterone (aldosteronism);
• any other conditions associated with excessive sodium retention in the body, such as steroid therapy (see also section "GNAK with other medicines");
• conditions increasing the risk of high blood potassium levels, such as:
  • kidney failure,
  • adrenal gland disease (adrenal insufficiency),
  • acute fluid loss due to vomiting or diarrhea,
  • severe burns or other causes of extensive tissue damage;
• low blood calcium levels;
• a disease causing progressive muscle weakness (myasthenia gravis);
• recent surgery involving neuromuscular blocking agents (neuromuscular blockade), used during surgical procedures and administered under anesthesiologist supervision;
• blood pH disturbances;
• head trauma within the last 24 hours – GNAK should not be used;
• increased intracranial pressure;
• stroke caused by a blood clot in a brain vessel (ischemic stroke);
• malnutrition due to starvation or poor nutrition;
• diabetes or glucose intolerance disorders;
• if the patient has abnormal cerebrospinal fluid volume (e.g., due to meningitis, intracranial hemorrhage, or brain injury);
• conditions that may increase vasopressin activity – a hormone regulating fluid balance in the body, such as:
  • acute and severe illness or trauma,
  • recent surgery,
  • brain disease,
  • use of certain medications. These conditions may increase the risk of low blood sodium levels, which can lead to headache, nausea, lethargy, coma, or brain edema.

During infusion of this solution, the doctor will take blood and urine samples to monitor:

• fluid balance and levels of chemical substances such as sodium, potassium, and magnesium in blood and urine (plasma and urine electrolytes);
• blood and urine acidity (acid-base balance).

GNAK contains sugar (glucose) and therefore may cause increased blood glucose levels (hyperglycemia). This is particularly important in diabetic patients. In such cases, the doctor may:

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

If prolonged treatment with GNAK is required, the doctor will also administer other types of infusions to meet the body's needs for additional chemical and nutritional components.

Children
Special caution and close monitoring are required when administering GNAK to children.
Newborns, especially those born prematurely and with low birth weight, are more susceptible to abnormally low or high blood glucose levels due to glucose infusion. Low blood glucose in newborns may lead to prolonged seizures, coma, and brain damage. High blood glucose is associated with intracranial hemorrhage, increased risk of bacterial and fungal infections, gastrointestinal infections, visual disturbances, lung complications, prolonged hospital stay, and death.
Children and adolescents must be closely monitored. In cases where normal regulation of blood water content is impaired due to increased secretion of antidiuretic hormone (ADH), infusion of low-sodium chloride solutions may lead to low blood sodium levels (hyponatremia). This may result in headache, nausea, seizures, lethargy, coma, brain edema, and death; therefore, these symptoms are considered medical emergencies requiring immediate intervention.

GNAK with other medicines
Inform the doctor or nurse about all medicines the patient is currently taking, has recently taken, or plans to take.
It is not recommended to use the following medicines during GNAK administration:

• neuromuscular blocking agents (e.g., tubocurarine, suxamethonium, vecuronium), used during surgical procedures under anesthesiologist supervision.

Other medicines that may interact with GNAK or be affected by it:

• anti-inflammatory drugs (corticosteroids);
• an anti-inflammatory used in treating gastric ulcers (carbenoxolone);
• certain potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene);
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure);
• angiotensin II receptor blockers (used to treat high blood pressure);
• tacrolimus (used to prevent transplant rejection and treat certain skin diseases);
• cyclosporine (used to prevent transplant rejection);
• acidic drugs, such as:
  • salicylates (used to treat inflammatory conditions) (aspirin);
  • barbiturates (sleeping pills);
  • lithium (used in treating psychiatric disorders);
• alkaline drugs, including:
  • sympathomimetics (such as ephedrine and pseudoephedrine, used e.g., in cough preparations);
  • stimulants (such as quinidine, dexamfetamine sulfate (used in ADHD treatment), fenfluramine hydrochloride (used in treating overweight)).

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

• diuretic tablets (diuretics);
• painkillers and/or anti-inflammatory drugs (also known as NSAIDs);
• antipsychotic drugs;
• antidepressants (selective serotonin reuptake inhibitors);
• drugs with morphine-like effects (opioids);
• certain antiepileptic drugs;
• the hormone oxytocin (causes uterine contractions);
• certain cancer treatments (chemotherapy).

GNAK with food and drink
Ask the doctor what the patient may eat or drink.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine. The doctor will decide whether GNAK can be administered during pregnancy or breastfeeding.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

3. How to administer GNAK

GNAK is administered by a doctor or nurse. The doctor determines the dose and duration of administration.
This depends on the patient's age, body weight, clinical condition, and concomitant treatment. The doctor may check the levels of salts (electrolytes) and sugar (glucose) in the blood.
DO NOT use GNAK if it contains visible particles or if the packaging is in any way damaged.
GNAK is usually administered through a plastic tube connected to a needle placed in a vein.
Typically, this solution is infused into a vein in the arm. However, the doctor may instruct a different method of administration.
GNAK must NOT be administered subcutaneously (through the skin).
Any unused solution remaining after administration must be discarded. DO NOT administer GNAK from a partially used bag.
Due to its glucose content, this solution should NOT be administered through the same infusion set as whole blood (blood transfusion). This may cause damage or clumping of red blood cells.

Administration of a higher than recommended dose of GNAK
If too much GNAK is administered (overdose) or administered too rapidly, the following symptoms may occur:

• Water and/or sodium (salt) overload, with fluid accumulation (edema) in tissues, causing swelling;
• High blood sugar (hyperglycemia);
• Tingling sensation in the arms and legs (paresthesia);
• Muscle weakness;
• Loss of motor function (paralysis);
• Irregular heartbeat (cardiac arrhythmia);
• Heart block (very slow heartbeat);
• Cardiac arrest (heart stops beating; life-threatening condition);
• Confusion;
• Diminished tendon reflexes;
• Reduced depth and rate of breathing (respiratory depression);
• Nausea;
• Vomiting;
• Skin redness;
• Thirst;
• Low blood pressure (hypotension);
• Drowsiness;
• Slow heartbeat (bradycardia);
• Coma (loss of consciousness);
• Blood acidification (acidosis), leading to fatigue, confusion, lethargy, and increased breathing rate;
• Mood changes;
• Fatigue;
• Shortness of breath;
• Muscle stiffness;
• Muscle tremors;
• Muscle cramps (tetany);
• Elevated magnesium levels in the blood.

If any of these symptoms occur in the patient, inform the doctor immediately. The infusion will be stopped, and the doctor will initiate appropriate treatment depending on the symptoms.
If another medicine has been added to GNAK and an overdose occurs, this additional medicine may also cause symptoms. Please read the Patient Information Leaflet included with the added medicine to become familiar with the list of possible symptoms.

Interrupting administration of GNAK
The decision to interrupt infusion is made by the doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The frequency of occurrence of side effects is unknown (frequency cannot be estimated from
the available data).
Immediately inform a doctor or nurse if the patient experiences any of the following symptoms.
These may be signs of a very severe or even life-threatening allergic reaction (hypersensitivity):

• swelling of the skin of the face, lips and throat swelling;
• difficulty breathing;
• skin rash;
• redness of the skin (erythema);
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis, potential symptoms in patients with corn allergy.

The treatment approach will depend on the symptoms.
Other side effects:

• reactions related to the administration technique:
• fever;
• infection at the infusion site;
• local pain or reaction (redness or swelling) at the injection site;
• irritation or inflammation of the vein into which the solution is administered. This may cause redness, pain or burning sensation, and swelling along the vein;
• blood clot formation (venous thrombosis), sometimes accompanied by inflammation. This causes pain, swelling or redness;
• leakage of the solution into the surrounding tissues (extravasation);
• high potassium levels in the blood, which may cause abnormal heart rhythm (hyperkalemia);
• high blood sugar levels (hyperglycemia);
• accumulation of excess fluid in the body (hypervolemia);
• disturbances in blood salt levels (electrolyte imbalances);
• seizures;
• low sodium levels in the blood (hyponatremia);
• brain swelling, which may lead to brain damage (hyponatremic encephalopathy).

If another medicine is added to the infusion solution, it may also cause side effects. These will depend on the medicine added. Please read the Package Leaflet supplied with the added medicine to become familiar with possible symptoms.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform a doctor or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting of side effects enables collection of further information on the safety of the medicine's use.

5. How to store GNAK medicine

Keep this medicine out of the sight and reach of children.
DO NOT use GNAK medicine after the expiry date stated on the pouch following “Expiry date”. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Do not use GNAK medicine if it contains visible particles or if the medicine’s packaging is damaged in any way.

6. Contents of the pack and other information

What GNAK contains
The active substances in GNAK are:

• glucose (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:

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

What GNAK looks like and contents of the pack
GNAK, solution for infusion, is a clear, particle-free solution. It is available in polyolefin-poliamide plastic bags (Viaflo). Each bag is contained within a sealed, protective, outer plastic packaging.
Bag volume: 1000 ml.
The bags are supplied in cardboard boxes. Each cardboard box contains one of the following quantities of bags:

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Manufacturer:
Bieffe Medital Sabiñànigo
Ctra de Biescas-Senegüe
22666 Sabiñanigo (Huesca)
Spain

This medicinal product is authorised for sale in the European Economic Area and 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
Portugal: GNAK 50 mg/ml Solução para perfusão
Romania: GNAK 50 mg/ml Soluţie perfuzabilă
Slovenia: GNAK raztopina za infundiranje
Slovakia: GNAK 50 mg/ml Infúzny roztok
Sweden: Glucose-Na-K Baxter 50 mg/ml infusionsvätska, lösning
United Kingdom (NI): Maintelyte solution for infusion

Baxter and Viaflo are trademarks of Baxter International Inc.

Information intended exclusively for medical professionals:

Administration and Preparation
Use only if the solution is clear and free of visible particles, and the container is undamaged.
Administer immediately after connecting the infusion set.
Do not remove the bag from its protective overwrap until ready for use.
The inner bag ensures sterility of the product.
Plastic containers must not be connected in series. Such use could result in air embolism due to residual air being drawn from the first container before infusion from the second container is completed.
Applying additional pressure to intravenous solutions contained in flexible plastic containers to increase flow rate may cause air embolism if residual air has not been completely removed from the container prior to administration.
Using infusion sets with an air vent, with the vent valve in the open position, may cause air embolism. Infusion sets with an air vent in the open position must not be used with flexible plastic containers.
The solution must be administered using sterile equipment and aseptic techniques. The infusion set should be pre-filled with the solution to prevent air from entering the system.
Additional medications may be added to the solution before or during infusion via the medication-addition self-sealing port.
Adding other drugs or improper administration techniques may lead to febrile reactions due to the potential introduction of pyrogens. If an adverse reaction occurs, infusion must be stopped immediately.
Discard after single use.
Discard any unused solution remaining after use.
Do not reconnect partially used bags.

1. Opening
   a. Remove the Viaflo bag from its protective overwrap immediately before use.
   b. Squeeze the inner bag firmly to check for leakage. If leakage is detected, discard the solution, as it may not be sterile.
   c. Check that the solution is clear and free of insoluble particles. If the solution is not clear or contains insoluble particles, discard it.

2. Preparation for Administration
   Use sterile materials during preparation and administration.
   a. Hang the bag by the hanger loop.
   b. Remove the plastic cover from the administration port located at the bottom of the bag:

   • Hold the smaller wing on the neck of the port with one hand,
   • Hold the larger wing on the cap with the other hand and twist,
   • the cap will pop off.
     c. Maintain aseptic technique when connecting the infusion set.
     d. Connect the administration set. Refer to all instructions provided with the set regarding connection, priming, and administration of the solution.

3. Methods of Adding Additional Medications
   The solution must not be administered subcutaneously.

Some added medications may be incompatible.
When adding a medication, isotonicity for parenteral administration must be confirmed prior to use.
Thorough and careful mixing under aseptic conditions is required with each added medication. Solutions containing added medications must be used immediately and must not be stored.

Adding medications before administration:
a. Disinfect the medication-addition port.
b. Using a syringe with a needle size from 19G (1.10 mm) to 22G (0.70 mm), insert the needle into the self-sealing medication-addition port and inject the medication.
c. Mix the solution thoroughly with the medication. For dense preparations such as potassium chloride, gently tap the ports while the bag is held with ports upward, then mix.
Note: Do not store bags containing added medications.

Adding medications during administration:
a. Close the clamp on the administration set.
b. Disinfect the medication-addition port.
c. Using a syringe with a needle size from 19G (1.10 mm) to 22G (0.70 mm), insert the needle into the self-sealing medication-addition port and inject the medication.
d. Remove the container from the IV pole and/or invert it with ports facing upward.
e. Clear both ports by gently tapping while holding the bag with ports upward.
f. Mix the solution thoroughly with the medication.
g. Return the container to its original position, reopen the clamp, and continue administration.

4. In-use stability period: Added medications
   Prior to use, the chemical and physical stability of each added medication at the pH of the GNAK solution in the Viaflo container must be established.

From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions prior to use, which must not exceed 24 hours at a temperature of 2°C to 8°C, unless the reconstitution was performed under controlled and validated aseptic conditions.

5. Incompatibility of added medications
   Prior to adding any medication to the solution in the Viaflo container, potential incompatibilities must be evaluated.

This solution must not be mixed with other medications without compatibility studies.
Refer to the package insert of the medication to be added.
Before adding a medication, verify that it is soluble and stable in water at a pH corresponding to the GNAK solution (pH 4.5–6.5).
GNAK solutions are incompatible with blood or red blood cells; cases of clot formation have been reported.
Do not use medications known to be incompatible.
Baxter and Viaflo are trademarks of Baxter International Inc.