GNAK 50 mg /Ml Roztwór Do Infuzji

Treść ulotki

1. GNAK 50 mg/mL solution for infusion
   1. What is GNAK and what is it used for
   2. Possible side effects
   3. How to store GNAK
   4. Contents of the pack and other information

GNAK 50 mg/mL solution for infusion

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

Read this leaflet carefully before using this medicine as 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 any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

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 is GNAK and what is it used for

GNAK 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 sources of energy. This infusion solution provides 200
kilocalories per liter. Sodium, potassium, magnesium, chloride and acetate are chemicals present in the
blood.
GNAK is used to provide a source of fluids and chemicals and to administer carbohydrates (sugar) if you are unable to eat or drink normally.

• 2. What you need to know before you are given GNAKGNAK must not be given to you if you suffer from any of the following conditions
• levels of potassium in the blood higher than normal (hyperkalemia)
• serious kidney problems (renal failure) with reduced (oliguria) or absent (anuria) urine production
• heart or lung failure (decompensated cardiac or pulmonary insufficiency)
• diabetes that is not adequately treated, so that blood sugar levels rise more than normal (uncontrolled diabetes)
• states of glucose intolerance
• unconsciousness (hyperosmolar coma). This is a type of coma that can occur if you have diabetes and are not taking enough medication.
• levels of sugar in the blood higher than normal (hyperglycemia)
• levels of lactate in the blood higher than normal (hyperlactatemia)
• if you are allergic 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, as GNAK contains sugar derived from cereals, see section "Possible side effects"
• heart failure, severe heart rate disorder or other heart disease
• lung disease (respiratory failure)
• kidney failure or reduced kidney function
• large amount of 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 that causes an increase in the levels of a hormone called aldosterone (aldosteronism)
• any other condition associated with the retention of too much sodium by the body, such as treatment with steroids (see also below, “Other medicines and GNAK”).
• any condition that involves a greater likelihood of high potassium levels in the blood such as:
• Renal failure
• adrenal gland insufficiency (adrenocortical insufficiency)
• rapid loss of water from the body, for example due to vomiting or diarrhea
• severe burns or other causes of extensive tissue damage
• low levels of calcium in the blood
• a disease that causes progressive muscle weakness (myasthenia gravis)
• recent surgery involving the use of medicines that block nerves and muscles (neuromuscular block) under the control of the anesthesiologist
• disorders of blood pH
• head trauma in the last 24 hours; GNAK should not be used.
• high pressure in the skull
• stroke caused by a blood clot in the brain (ischemic stroke)
• malnutrition, if you have been hungry or have eaten very poorly for a while
• diabetes or altered glucose tolerance
• if you have problems with fluid levels in the brain (for example, due to meningitis, intracranial bleeding or brain damage)
• if you are in a condition that can cause high levels of vasopressin, a hormone that regulates fluids in your body, such as
• a sudden and serious illness or injury
• you have undergone surgery
• brain disease
• are taking certain medications. This may increase the risk of low sodium levels in your blood and may lead to migraine, nausea, seizures, lethargy, coma and cerebral edema.

When you are given this infusion, the doctor will take blood and
urine samples to monitor:

• the water balance and the amount of chemicals, such as sodium, potassium and magnesium in the blood and urine (electrolytes in plasma and urine)
• the acidity of the blood and urine (acid-base balance).

GNAK contains sugar (glucose), so it may cause a high level of sugar in the blood
(hyperglycemia). This is particularly important if you have diabetes. In this case, the doctor may:

• adjust the rate of infusion
• give you insulin to reduce the amount of sugar in the blood. If long-term treatment with GNAK is necessary, the doctor will also give you other types of infusions that will meet the body's needs for other chemicals and nutrients.

Children
In children, GNAK must be administered with particular caution and careful
monitoring is necessary.
Among newborns, especially premature babies and those with low birth weight, are more at risk of
developing too low or too high a blood sugar level due to the infusion of
glucose solutions. In newborns, a low sugar level can cause prolonged seizures,
coma and brain damage. A high sugar level has been associated with bleeding in the
brain, late-onset fungal and bacterial infections, intestinal tract infections, affecting the
eyes, causing lung problems, prolonged hospital stay and death.
Pediatric patients should be carefully monitored. In cases where increased secretion
of antidiuretic hormone (ADH) disrupts the normal regulation of blood water content, infusion of fluids with a low concentration of sodium chloride can lead to a low
level of sodium in the blood (hyponatremia). This can lead to headache, nausea, seizures,
lethargy, coma, brain swelling and death; these symptoms are therefore considered
a medical emergency.

Other medicines and GNAK
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The use of the following medicines is not recommendedwhile you are being given an infusion of
GNAK:

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

Other medicines that may have effects on GNAK or be affected by it:

• anti-inflammatory drugs (corticosteroids)
• an anti-inflammatory medicine used to treat stomach ulcers (carbenoxolone)
• some 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 some skin diseases)
• cyclosporine (used to prevent transplant rejection)
• acidic medicines including:
• salicylates (used to treat inflammation) (aspirin)
• barbiturates (sleeping pills)
• lithium (used to treat mental illness)
• alkaline medicines including:
• sympathomimetics (such as ephedrine and pseudoephedrine, used for example in cough preparations)
• stimulants (such as quinidine, desamphetamine sulfate (used to treat ADHD)), phenfluramine hydrochloride (used to treat overweight)).

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

• water tablets (diuretics)
• medicines for pain and/or inflammation (also called NSAIDs)
• antipsychotics
• medicines used to treat depression (selective serotonin reuptake inhibitors)
• medicines that produce a morphine-like effect (opioids)
• certain medicines used to treat epilepsy (antiepileptics)
• a hormone called oxytocin (which causes the uterus to contract)
• certain medicines used to treat cancer (chemotherapy).

GNAK with food and drink
Ask your doctor what you can eat or drink.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine. The doctor will decide whether
it will be possible to give you GNAK during pregnancy or breastfeeding.

Driving and using machines
This medicine does not affect your ability to drive vehicles or use machines.

• 3. How GNAK will be given to youGNAK will be given to you by a doctor or nurse. The doctor will decide how much is needed and when to give it. This will depend on your age, weight, medical condition and concomitant treatment. The doctor may check the levels of salts (electrolytes) and sugar (glucose) in your blood.

GNAK must not be given to you if there are particles in the solutionor if the
package is damaged in any way.
GNAK will generally be given to you through a plastic tube connected to a needle inserted
into a vein. Normally a vein in the arm is used for administering the infusion.
However, the doctor may use another method to give you the medicine.
GNAK must not be given under the skin (subcutaneously).
Any unused solution must be discarded. The GNAK infusion must not be
given from a partially used bag.

Because of the presence of glucose, this solution must not be given through
the same infusion equipment as whole blood (blood transfusion). This may damage the
red blood cells or cause them to clump together.

If you are given too much GNAK
If you are given too much GNAK (overinfusion) or if it is given too
quickly, the following symptoms may occur:

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

If you develop any of these symptoms, you should tell your doctor immediately. The infusion
will be stopped and you will be given treatment depending on the symptoms.
If a medicine has been added to GNAK and an overinfusion occurs, the symptoms may
list of possible symptoms.

If you stopthe administration of GNAK
The doctor will decide when to stop the infusion.
If you have any doubts about using this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The frequency of side effects is not known (frequency cannot be estimated

based on available data).
If you experience any of the following symptoms, inform your doctor or nurse immediately.
These may be signs of a very serious or even life-threatening allergic (hypersensitivity) reaction:

• 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, are a possible manifestation in patients allergic to corn.

You will be given treatment according to your symptoms.

Other side effects are:

• 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 can cause redness, pain or burning and swelling along the path of the vein into which the solution is infused.
• formation of a blood clot (venous thrombosis) sometimes accompanied by inflammation, causing pain, swelling or redness.
• leakage of the infusion solution into the tissues around the vein (extravasation).
• high levels of potassium in the blood that can cause abnormal heart rhythm (hyperkalemia)
• a high level of sugar in the blood (hyperglycemia)
• accumulation of excess 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 can cause brain damage (hypotonic 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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through 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 which is reported on the bag after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
GNAK must not be administered to you if there are particles in the solution or if the unit is
damaged in any way.

6. Contents of the pack and other information

What GNAK contains
The active ingredients 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 ingredients are:

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

Description of GNAK and contents of the pack
GNAK Solution for Infusion is a clear solution, free from visible particles. It is supplied in bags
of poliolefin/polyamide plastic (Viaflo). Each bag is wrapped in an outer protective
plastic wrapper, sealed.
The bag size is 1,000 mL.
The bags are supplied in cartons. Each carton 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 Member States of the European Economic Area 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 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
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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 not
damaged. Administer immediately after inserting the infusion set.
Do not remove the unit from the outer wrapper until the time of use.
The inner bag maintains the sterility of the product.
Do not use plastic containers connected in series. Such use could cause a gas embolism due to residual air drawn from the primary container before completion of the
administration of the liquid from the secondary container.
Pressurising intravenous solutions contained in flexible plastic containers to increase flow rates may cause a gas embolism if the residual air in the container is not
completely removed before administration.
The use of an intravenous administration set equipped with a vent can cause a gas embolism
when the vent is in the open position. Intravenous administration sets equipped with a vent should not
be used with flexible plastic containers when the vent is in the open position.
The solution must be administered with sterile equipment using aseptic technique.
The equipment must be primed with the solution to prevent air from entering
the system.
Additives can be introduced before or during the infusion through the resealable medication port.
The addition of other drugs or the use of incorrect administration technique may cause the
appearance of febrile reactions due to the possible introduction of pyrogens. In case of an adverse
reaction, immediately stop the infusion.
Discard after single use.
Discard any unused solution.
Do not reconnect partially used bags.

• 1. Opening
• a. Remove the Viaflo container from the outer wrapper immediately before use.

• b. Firmly compress the inner bag to check for small leaks. If leaks are observed, discard the solution because sterility may have been compromised.
• c. Check that the solution is clear and free from foreign matter. If the solution is not clear or contains foreign matter, discard it.
• 2. Preparation for administration Use sterile material for preparation and administration.
• a. Suspend the container by the hanging hole.
• b. Remove the plastic cap from the outlet port at the bottom of the container:
• hold firmly with one hand the small tab on the neck of the outlet port,
• grasp with the other hand the large tab on the cap and rotate,
• 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, see the complete instructions provided with the set.
• 3. Techniques for injecting medication additives The solution MUST not be administered subcutaneously.

Additives may be incompatible
When using an additive, verify its isotonicity before parenteral administration. Thorough mixing with aseptic technique of any additive is required. Solutions containing additives must be used immediately and must not be
stored.

To add a medication before administration

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

To add a medication during administration

• a. Close the clamp on the set.
• b. Disinfect the medication port.
• c. Using a syringe with a 19 (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable medication port and inject.
• d. Remove the container from the pole and/or rotate it to the vertical position.
• e. Empty both access points by gently tapping while the container is in the vertical position.
• f. Thoroughly mix the solution and the medication.
• g. Return the container to the use position, reopen the clamp and continue administration.
• 4. Period of validity in use: Additives The chemical and physical stability of any medication added to the pH of GNAK in the Viaflo container must be established before use.

From a microbiological point of view, the diluted product must be used immediately. If not
used immediately, the storage times during use and the conditions prior to use
are the responsibility of the user and normally do not exceed 24 hours at 2°C – 8°C unless the
reconstitution has taken place under controlled and 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 should not be mixed with other medications.
Consult the instructions for use of the medication to be added.
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 should not be used .