Gnak

Package leaflet: Information for the user

GNAK 50 mg/mL solution for infusion

Active substances: glucose, sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride
hexahydrate
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4. Within this leaflet, this 50 mg/mL infusion solution is referred to as GNAK.

Contents of this leaflet

1. What GNAK is and what it is used for
2. What you need to know before GNAK is administered to you
3. How GNAK will be administered to you
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 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 chemical substances present in the blood.
GNAK is used to provide a source of fluids and chemicals, and to administer carbohydrates (sugar) when you are unable to eat or drink normally.

2. What you should know before being given GNAK
   GNAK must NOT be administered to you if you have any of the following conditions:

• elevated levels of potassium in the blood (hyperkalemia)

• severe kidney problems (renal failure) with reduced urine output (oliguria) or absence of urine production (anuria)

• heart or lung failure (decompensated cardiac or pulmonary insufficiency)

• inadequately treated diabetes, resulting in abnormally high blood sugar levels (uncontrolled diabetes)

• glucose intolerance states

• unconsciousness (hyperosmolar coma). This is a type of coma that may occur if you have diabetes and are not taking sufficient medication.

• elevated blood sugar levels (hyperglycemia)

• elevated blood lactate levels (hyperlactatemia)

• allergy to potassium chloride, sodium acetate trihydrate, sodium chloride, magnesium chloride hexahydrate, and glucose, or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor if you have or have had any of the following medical conditions.

• allergy to corn, since GNAK contains sugar derived from cereals; see section "Possible side effects"
• heart failure, severe heart rhythm disorders, or other heart diseases
• 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, especially around the ankles
• high blood pressure
• high blood pressure during pregnancy (pre-eclampsia or eclampsia)
• a disease causing increased levels of a hormone called aldosterone (aldosteronism)
• any condition associated with excessive sodium retention in the body, such as steroid treatment (also see below, "Other medicines and GNAK").
• any condition that increases the likelihood of elevated potassium levels in the blood, such as:
  • kidney failure
  • adrenal gland insufficiency (adrenal cortical insufficiency)
  • rapid fluid loss from the body, e.g., due to vomiting or diarrhea
  • severe burns or other causes of extensive tissue damage
  • low calcium levels in the blood
  • a disease causing progressive muscle weakness (myasthenia gravis)
  • recent surgery involving medications that block nerves and muscles (neuromuscular blockade) under anesthesiologist supervision
  • blood pH disturbances
  • head trauma within the last 24 hours; GNAK must not be used.
  • increased intracranial pressure
  • stroke caused by a blood clot in the brain (ischemic stroke)
  • malnutrition, if you have been starving or eating very poorly for some time
  • diabetes or impaired glucose tolerance
  • if you have problems with fluid levels in the brain (e.g., due to meningitis, intracranial hemorrhage, or brain injury)
  • if you are in a condition that may cause high levels of vasopressin, a hormone regulating body fluids, such as:
    • a sudden and severe illness or injury
    • recent surgery
    • brain disease
    • taking certain medications. This may increase the risk of low sodium levels in your blood and may lead to headache, nausea, seizures, lethargy, coma, and cerebral edema.

When this infusion is administered, your 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 urinary electrolytes)
• blood and urine acidity (acid-base balance).

GNAK contains sugar (glucose), which may cause elevated blood sugar levels (hyperglycemia). This is particularly important if you have diabetes. In such cases, your doctor may:

• adjust the infusion rate
• administer insulin to reduce blood sugar levels. If long-term treatment with GNAK is required, your doctor will also administer other types of infusions to meet the body's needs for additional chemicals and nutrients.

Children
GNAK must be administered to children with particular caution and requires careful monitoring.
Among neonates, especially premature infants and those with low birth weight, there is an increased risk of developing blood sugar levels that are too low or too high due to glucose solution infusions. In newborns, low blood sugar may cause prolonged seizures, coma, and brain damage. High blood sugar has been associated with brain hemorrhage, late-onset fungal and bacterial infections, intestinal tract infection affecting the eyes, lung problems, prolonged hospitalization, and death.
Pediatric patients must be closely monitored. In cases where increased secretion of antidiuretic hormone (ADH) disrupts normal regulation of blood water content, infusion of fluids with low sodium chloride concentration may result in low blood sodium levels (hyponatremia). This may lead to headache, nausea, seizures, lethargy, coma, brain swelling, and death; these symptoms are therefore considered a medical emergency.

Other medicines and GNAK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines are NOT recommended during administration of GNAK infusion:

• neuromuscular blocking agents (e.g., tubocurarine, suxamethonium, and vecuronium). These are medicines used during surgery and are controlled by the anesthesiologist.

Other medicines that may affect or be affected by GNAK:

• anti-inflammatory medicines (corticosteroids)
• an anti-inflammatory medicine used to treat stomach ulcers (carbenoxolone)
• certain potassium-sparing diuretic tablets (e.g., amiloride, spironolactone, triamterene)
• angiotensin-converting enzyme (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 including:
  • salicylates (used to treat inflammation) (aspirin)
  • barbiturates (sleeping tablets)
  • lithium (used to treat psychiatric disorders)
• alkaline medicines including:
  • sympathomimetics (such as ephedrine and pseudoephedrine, used, for example, in cough preparations)
  • stimulants (such as quinidine, dexamfetamine sulfate (used to treat ADHD)), hydrochloride phenfluramine (used to treat overweight)).

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

• water tablets (diuretics)
• pain and/or anti-inflammatory medicines (also known as NSAIDs)
• antipsychotics
• medicines used to treat depression (selective serotonin reuptake inhibitors)
• medicines that produce morphine-like effects (opioids)
• certain medicines used to treat epilepsy (antiepileptics)
• a hormone called oxytocin (which causes uterine contractions)
• certain medicines used to treat cancer (chemotherapeutics).

GNAK with food and drink
Ask your doctor what you may eat or drink.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine. Your doctor will decide whether GNAK can be administered during pregnancy or breastfeeding.
Driving and using machines
This medicine does not affect your ability to drive or operate machinery.

3. How GNAK will be administered to you
   GNAK will be administered by a doctor or nurse. Your doctor will determine the required dose and timing. This will depend on your age, weight, clinical condition, and concomitant treatments. Your doctor may monitor levels of salts (electrolytes) and sugar (glucose) in your blood.

GNAK must NOT be administered if particles are present in the solution or if the container is damaged in any way.
GNAK is usually administered through a plastic tube connected to a needle inserted into a vein. Typically, a vein in the arm is used for the infusion. However, your doctor may use another method to administer the medicine.
GNAK must NOT be administered into the skin (subcutaneously).
All unused solution must be discarded. GNAK infusion must NOT be administered from a partially used bag.
Due to the presence of glucose, this solution must NOT be administered through the same infusion set used for whole blood (blood transfusion). This may damage red blood cells or cause their agglutination.

If you are given more GNAK than you should
If you receive too much GNAK (excessive infusion) or if it is administered too rapidly, the following symptoms may occur:

• fluid and/or sodium (salt) overload with fluid accumulation in tissues (edema), causing swelling
• elevated blood sugar levels (hyperglycemia)
• tingling in arms and legs (paresthesia)
• muscle weakness
• inability to move (paralysis)
• irregular heartbeat (cardiac arrhythmias)
• heart block (very slow heartbeat)
• cardiac arrest (heart stops beating; a potentially life-threatening condition)
• confusion
• loss of tendon reflexes
• shortness of breath (respiratory depression)
• feeling unwell (nausea)
• vomiting
• skin redness
• thirst
• low blood pressure (hypotension)
• drowsiness
• slow heartbeat (bradycardia)
• coma (unconsciousness)
• blood acidification (acidosis), causing fatigue, confusion, lethargy, and increased breathing rate
• mood changes
• fatigue
• shortness of breath
• muscle stiffness
• muscle contractions
• muscle spasms (tetany)
• elevated magnesium levels in the blood.

If you develop any of these symptoms, inform your doctor immediately. The infusion will be stopped, and you will receive treatment according to your symptoms.
If another medicine has been added to GNAK and an excessive infusion occurs, symptoms may also be caused by that medicine. Refer to the package leaflet of the added medicine for a list of possible symptoms.

If GNAK administration is stopped
Your doctor will decide when to discontinue the infusion.
If you have any doubts about using this medicine, consult 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 (the frequency cannot be determined from the available data).
If you experience any of the following symptoms, inform your doctor or nurse immediately. They could be signs of a very severe, even life-threatening, allergic reaction (hypersensitivity):

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

You will be given treatment depending on your symptoms.
Other side 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, burning sensation, and swelling along the course of the vein.
• formation of a blood clot (venous thrombosis), sometimes accompanied by inflammation, causing pain, swelling or redness.
• leakage of the infused solution into the surrounding tissues (extravasation).
• high levels of potassium in the blood, which may cause heart rhythm abnormalities (hyperkalaemia)
• high blood sugar levels (hyperglycaemia)
• excessive accumulation of fluid in the body (hypervolaemia)
• disturbances in blood electrolyte concentrations (electrolyte imbalance)
• seizures
• low levels of sodium in the blood (hyponatraemia)
• brain swelling, which may lead to brain damage (hyponatraemic encephalopathy).

If a medicine has been added to the infusion solution, the side effects may also be caused by the added medicine. These side effects will depend on the medicine added. Read the package leaflet of the added medicine for a list of possible symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GNAK

Keep this medicine out of the sight and reach of children.
GNAK MUST NOT be administered after the expiry date stated on the bag after
Exp. The expiry date refers to the last day of that month.
Do not store above 25 °C.
GNAK must not be administered if particles are present in the solution or if the unit is damaged in any way.

6. Package contents and other information

What GNAK contains
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 (to adjust pH)
• Water for injections

Description of the appearance of GNAK and contents of the pack
GNAK Infusion Solution is a clear solution free from visible particles. It is supplied in plastic polyolefin/polyamide bags (Viaflo). Each bag is enclosed in a sealed protective outer plastic wrapper.
The bag size is 1,000 mL.
The bags are supplied in boxes. Each box contains 10 bags of 1,000 mL.

Marketing Authorisation Holder and Manufacturer
Baxter S.p.A.
Piazzale dell’Industria 20
00144 Rome (Italy)

Manufacturers:
Bieffe Medital Sabiñànigo
Ctra de Biescas-Senegüé-
22666 Sabiñànigo (Huesca)
Spain

This medicinal product is authorised in the European Economic Area Member States 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 (to be approved)
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 50 mg/ml Solution pour perfusion
Greece: Maintelyte 50 mg/ml διάλυμα για έγχυση
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

The following information is intended for healthcare professionals only:

Handling and Preparation
Use only if the solution is clear and free from visible particles, and if the container is undamaged. Administer immediately after attaching the infusion set.
Do not remove the unit from the outer wrapper until ready for use.
The inner bag maintains the sterility of the product.
Do not use plastic containers connected in series. Such use may result in gas embolism due to residual air being drawn from the primary container before completion of fluid delivery from the secondary container.
Pressurization of intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely expelled before administration.
Using an intravenous administration set with an air vent may cause gas embolism when the vent is open. Intravenous administration sets with air vents must not be used with flexible plastic containers when the vent is open.
The solution must be administered using sterile equipment and aseptic technique.
Priming of the administration equipment with the solution is required to prevent air from entering the system.
Additives may be introduced before or during infusion through the resealable medication port.
The addition of other drugs or incorrect administration techniques may lead to febrile reactions due to possible introduction of pyrogens. In case of an adverse reaction, discontinue infusion immediately.
Discard after single use.
Dispose of all unused solution.
Do not reconnect partially used bags.

1. Opening
   a. Remove the Viaflo container from the outer wrapper immediately before use.
   b. Check for small leaks by firmly squeezing the inner bag. If leaks are observed, discard the solution as sterility may be compromised.
   c. Inspect the solution to ensure it is clear and free from foreign matter. If the solution is not clear or contains foreign material, discard it.

2. Preparation for Administration
   Use sterile materials for preparation and administration.
   a. Suspend the container using the hanging hole.
   b. Remove the plastic cap from the outlet port at the bottom of the container:

   • firmly hold the small wing on the neck of the outlet port with one hand,
   • grasp the large wing on the cap with the other hand and twist,
   • the cap will open.
     c. Use an aseptic method to set up the infusion.
     d. Connect the infusion set. For connection, priming of the set, and administration of the solution, refer to the complete instructions provided with the set.

3. Techniques for Injection of Medication Additives
   The solution must not be administered subcutaneously.

Medication additives may be incompatible
When using an additive, verify its isotonicity prior to parenteral administration. Thorough mixing using aseptic technique is required for any additive. Solutions containing additives must be used immediately and must not be stored.

To add medication before administration
a. Disinfect the medication injection port.
b. Using a syringe with a 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable medication port and inject the medication.
c. Mix the solution and medication thoroughly. For high-density medications such as potassium chloride, gently tap the access ports while in vertical position and mix well.
Caution: Do not store bags containing medication additives.

To add medication during administration
a. Close the clamp on the administration set.
b. Disinfect the medication injection port.
c. Using a syringe with a 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable medication port and inject the medication.
d. Remove the container from the pole and/or rotate it to vertical position.
e. Empty both access ports by gently tapping them while the container is in vertical position.
f. Mix the solution and medication thoroughly.
g. Return the container to its administration position, reopen the clamp, and continue administration.

4. In-use shelf life: Additives
   The chemical and physical stability of any drug added to GNAK pH in the Viaflo container must be established prior to use.

From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the duration and storage conditions during use are the responsibility of the user and normally should not exceed 24 hours at 2°C – 8°C, unless reconstitution was performed under controlled, validated aseptic conditions.

5. Incompatibilities of Medication Additives
   The compatibility of a medication additive with the solution in the Viaflo container must be assessed before addition.

In the absence of compatibility studies, this solution must not be mixed with other medications.
The package insert of the medication to be added must be consulted.
Before adding a medication, verify that it is soluble and stable in water at the pH of GNAK (pH 4.5–6.5).
GNAK solutions are not compatible with blood or red blood cells, as coagulation has been reported.
Additives known to be incompatible must not be used.