Crystalglu

Patient Information Leaflet: Information for the User

Crystalglu infusion solution

Active substances: glucose, sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate and sodium gluconate
Please read 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, including those not listed in this leaflet, talk to your doctor or nurse. See section 4.

This medicine is called "Crystalglu infusion solution", but for the remainder of this leaflet it will be referred to as "Crystalglu infusion".
Contents of this leaflet:

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

1. What Crystalglu infusion is and what it is used for

Pharmacotherapeutic category: "Electrolytes with carbohydrates" - ATC code: "B05BB02"
Crystalglu infusion is a solution containing the following substances in water:

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

Glucose is one of the body's sources of energy. This infusion solution provides 220 kcal per litre. Sodium, potassium, magnesium, chloride, acetate and gluconate are chemical substances found in the blood.

Crystalglu infusion is used:

• to provide a source of fluids and carbohydrates (sugar), for example, in the following conditions:
• burns
• head trauma
• fractures
• infection
• peritoneal irritation (inflammation in the abdomen)
• as a source of fluids during surgery
• in non-life-threatening metabolic acidosis (when the blood becomes too acidic)
• in lactic acidosis (a type of metabolic acidosis caused by accumulation of lactic acid in the body). Lactic acid is mainly produced by muscles and eliminated by the liver.

Crystalglu infusion can be used:

• in adults, elderly and adolescents
• in infants and young children (from 28 days to 23 months of age) and children (from 2 to 11 years of age).

2. What you must know before being given Crystalglu infusion

DO NOT receive Crystalglu infusion if you have any of the following conditions:

• elevated chloride levels in the blood (hyperchloremia)
• elevated sodium levels in the blood (hypernatremia)
• elevated potassium levels in the blood (hyperkalemia)
• renal failure
• cardiac block (very slow heart rate)
• conditions in which the blood becomes too alkaline (metabolic or respiratory alkalosis)
• low calcium levels in the blood (hypocalcemia)
• deficiency in gastric acid secretion (hypochlorhydria)
• if you are taking potassium-sparing diuretics (diuretics that cause potassium accumulation in the body), for example:
  • amiloride
  • potassium canrenoate
  • spironolactone
  • triamterene (these medicines may be included in combination medicines)
• inadequately treated diabetes, causing blood glucose levels to rise above normal (uncompensated diabetes)
• conditions involving glucose intolerance, such as:
  • metabolic stress (when the body’s metabolism is not functioning properly, e.g., due to a severe illness)
  • hyperosmolar coma (unconsciousness); this is a type of coma that may occur if you have diabetes and do not receive sufficient medication
  • elevated blood glucose levels (hyperglycemia)
  • elevated lactate levels in the blood (hyperlactatemia)
• hypersensitivity to the active substances or to any of the excipients listed in section 6.

Warnings and precautions
Crystalglu infusion is a hypertonic solution (concentrated). Your doctor will take this into account when calculating the amount of solution to administer to you.
Inform your doctor if you have or have had any of the following medical conditions:

• heart failure
• respiratory failure (lung disease)
• renal failure (in these conditions, special monitoring may be required)
• high blood pressure (hypertension)
• fluid accumulation under the skin, particularly around the ankles (peripheral edema)
• fluid accumulation in the lungs (pulmonary edema)
• high blood pressure during pregnancy (pre-eclampsia or eclampsia)
• aldosteronism (a condition causing high levels of a hormone called aldosterone)
• any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (also see “Other medicines” below)
• diabetes (blood glucose levels will be closely monitored and insulin therapy may need to be adjusted)
• any condition indicating you may be at increased risk of high potassium levels in the blood (hyperkalemia), such as:
  • renal failure
  • adrenal insufficiency (this disease of the adrenal gland affects hormones that regulate chemical concentrations in the body)
  • acute dehydration (loss of water from the body, e.g., due to vomiting or diarrhea)
  • extensive tissue damage (such as in severe burns) (in these cases, careful monitoring of blood potassium levels is necessary)
• myasthenia gravis (a disease causing progressive muscle weakness)
• recovery after surgery
• head trauma within the last 24 hours
• increased intracranial pressure (intracranial hypertension)
• stroke due to a blood clot in a brain vessel (ischemic stroke)
• if you have problems with fluid levels in the brain (e.g., due to meningitis, intracranial bleeding, or brain injury)
• if you have a condition that may cause high levels of vasopressin, a hormone that regulates fluids in the body, such as:
  • a sudden, severe illness or injury
  • surgery
  • a brain disease
  • taking certain medicines
    These conditions may increase the risk of low sodium levels in the blood, which can cause headache, nausea, seizures, lethargy, coma, and brain swelling.

During administration of this infusion, your doctor will take blood and urine samples to monitor:

• fluid levels in the body
• levels of chemicals such as sodium and potassium in blood and urine (electrolytes in plasma and urine)
• blood glucose levels
• acid-base balance (acidity of blood and urine)

Crystalglu infusion contains potassium, but not in sufficient quantity to treat severe potassium deficiency (very low plasma levels).
Crystalglu infusion must not be administered through the same needle as a blood transfusion, as it may damage red blood cells or cause red blood cell clumping.
Crystalglu infusion contains substances that may cause metabolic alkalosis (when the blood becomes too alkaline).
Crystalglu infusion contains sugar (glucose), and therefore may cause hyperglycemia (high blood sugar levels). In this case, your doctor may:

• adjust the infusion rate
• administer insulin to reduce blood sugar levels
  This is particularly important if you have diabetes.

If repeated treatment is required, your doctor will administer other types of infusions to meet the body’s needs for other chemicals and nutrients (food).
If your blood is tested for the presence of a fungus called Aspergillus, the test may detect Aspergillus even if it is not actually present.

Children
Crystalglu infusion must be administered to children with particular caution.
Newborns, especially premature infants and those born with low birth weight, are at higher risk of developing high or low blood sugar levels (hyperglycemia or hypoglycemia), which may lead to complications.

Other medicines and Crystalglu infusion
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
The following medicines must not be used when receiving a Crystalglu infusion:

• potassium-sparing diuretics (certain diuretics such as amiloride, spironolactone, triamterene, potassium canrenoate) (these medicines may be included in combination medicines. See also “DO NOT receive Crystalglu infusion if you have any of the following conditions” at the beginning of this section).

The use of the following medicines is not recommended when receiving a Crystalglu infusion:

• 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)
  These medicines may increase potassium levels in the blood. This can potentially be life-threatening. Increased blood potassium levels are more likely in patients with kidney disease.

Some medicines may increase the risk of side effects due to low sodium levels in the blood, for example:

• certain anticancer drugs
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• opioids
• pain and/or anti-inflammatory medicines (also known as NSAIDs)
• certain antiepileptic medicines
• oxytocin (a medicine used during treatment of pregnant women, during childbirth, and in postpartum care)
• diuretics

Other medicines that may affect or be affected by Crystalglu infusion:

• corticosteroids (anti-inflammatory medicines)
• carbenoxolone (an anti-inflammatory medicine used to treat stomach ulcers)
• neuromuscular blockers (e.g., tubocurarine, suxamethonium, vecuronium); these are medicines used during surgery and are controlled by the anesthesiologist
• acetylcholine
• aminoglycosides (a type of antibiotic)
• nifedipine (used to treat high blood pressure and chest pain)
• acidic medicines, including:
  • salicylates used to treat inflammation (aspirin)
  • hypnotics (barbiturates)
  • lithium (used to treat psychiatric disorders)
• alkaline (basic) medicines, including:
  • sympathomimetics (stimulant medicines such as ephedrine and pseudoephedrine, used in cough and cold preparations)
  • other stimulants (e.g., dexamfetamine, fenfluramine)

Crystalglu infusion with food and drink
Ask your doctor what you may eat or drink.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or nurse before taking this medicine.
You may receive Crystalglu infusion during pregnancy or while breastfeeding. Your doctor will monitor chemical levels in your blood and your body fluid levels.
However, if another medicine is added to the infusion solution during pregnancy or breastfeeding, you must:

• consult your doctor. Concomitant administration of a medicine called oxytocin during labor may cause reduced sodium levels in the blood (increased risk of hyponatremia)
• read the package leaflet of the medicine to be added.

Driving and using machines
Ask your doctor or pharmacist for advice before driving or using machines.

3. How Crystalglu infusion will be administered to you

Crystalglu infusion will be administered to you by a doctor or a nurse. The doctor will decide the dose you need and when it should be given. This will depend on your age, body weight, clinical condition, and the reason for treatment. The amount you receive may also depend on other treatments you are currently receiving.
Crystalglu infusion MUST NOT be administered to you if particles are present in the solution or if the packaging is damaged in any way.
Crystalglu infusion is generally administered through a small plastic tube connected to a needle inserted into a vein. However, the doctor may use another method to administer the medicine.
Any unused solution must be discarded. DO NOT be given an infusion of Crystalglu infusion from a partially used bag.

If you receive more Crystalglu infusion than you should
If you are given too much Crystalglu infusion (over-infusion) or if the product is administered too quickly, the following symptoms may occur:

• Overload of water and/or sodium (salt) with fluid accumulation in tissues (edema), causing swelling
• 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 condition)
• Confusion
• Loss of tendon reflexes
• Reduced breathing (respiratory depression)
• Feeling unwell (nausea)
• Vomiting
• Redness (flushing) of the skin
• Thirst
• Low blood pressure (hypotension)
• Drowsiness
• Slow heartbeat (bradycardia)
• Coma (loss of consciousness)
• Acidification of the blood (acidosis), causing fatigue, confusion, lethargy, and increased breathing rate
• Hypokalemia (lower than normal potassium levels in the blood) and metabolic alkalosis (when the blood becomes too alkaline), particularly in patients with renal failure
• Mood changes
• Fatigue
• Labored breathing
• Muscle stiffness
• Muscle spasms
• Muscle contractions
• Hyperosmolarity (excessive concentration of the blood)
• Loss of water from the body (dehydration)
• High blood sugar level (hyperglycemia)
• Sugar in the urine (glucosuria)
• Increased urine production (osmotic diuresis)

If any of these symptoms occur, inform your doctor immediately. The infusion will be stopped, and treatment will be provided according to your symptoms.
If a medicine has been added to Crystalglu infusion before the over-infusion, the symptoms may be caused by the added medicine. Please read the package leaflet of the added medicine for a list of possible side effects.

If you stop treatment with Crystalglu infusion
Your doctor will decide when to discontinue this infusion.
If you have any doubts about 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 gets them.
If you experience any of the following symptoms, you must inform your doctor or nurse immediately.
They could be signs of a very severe 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)

You will be given treatment according to your symptoms.

Other side effects include:

• reactions due to the administration technique:
• fever (febrile reaction)
• infection at the infusion site
• pain or local reaction (redness or swelling) at the infusion site
• irritation and inflammation of the vein into which the solution is infused (phlebitis), which may cause redness, pain or burning, and swelling along the vein
• formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling or redness in the area of the clot
• leakage of the infusion solution into the surrounding tissues (extravasation), which may damage tissues and cause scarring
• excess fluid in the body (hypervolemia)
• high levels of potassium in the blood, which may cause abnormal heart rhythm (hyperkalemia)
• hyperglycemia
• seizures (epileptic seizures)
• urticaria
• allergic reaction that may be life-threatening, causing difficulty breathing or dizziness (anaphylactoid reaction)
• low blood pressure (hypotension)
• chest discomfort
• shortness of breath (dyspnea)
• wheezing
• flushing
• hyperemia
• feeling of weakness (asthenia)
• cold sweating
• fever (pyrexia)
• chills
• low levels of sodium in the blood (hyponatremia)
• brain swelling, which may cause brain damage

If a medicine has been added to the infusion solution, the added medicine may also cause side effects. These side effects will depend on the medicine added. Please read the package leaflet of the added medicine for a list of possible symptoms.

Other side effects observed with similar products:

• Other manifestations of hypersensitivity reactions/infusion reactions: rapid heartbeat (tachycardia), palpitations, chest pain, increased respiratory rate, feeling of uneasiness, piloerection, peripheral edema

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or nurse.
You can also report side effects directly via the national reporting system at https://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 Crystalglu infusion

Keep this medicine out of the sight and reach of children.
Do not store above 30 °C.
This medicine must not be administered after the expiry date stated on the bag following "Exp". The expiry date refers to the last day of that month.
This medicine must not be administered to you if you notice particles in suspension in the solution or if the unit shows any damage of any kind.

6. Package contents and other information

What Crystalglu infusion contains
The active substances are:

• glucose (sugar): 55.00 g per litre
• sodium chloride: 5.26 g per litre
• potassium chloride: 0.37 g per litre
• magnesium chloride hexahydrate: 0.30 g per litre
• sodium acetate trihydrate: 3.68 g per litre
• sodium gluconate: 5.02 g per litre

The other components are:

• water for injections
• hydrochloric acid concentrated

Description of the appearance of Crystalglu infusion and package contents
Crystalglu infusion is a clear solution free from visible particles. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is enclosed in an outer protective plastic wrapper, sealed.
The following bag sizes are available:

• 250 mL
• 500 mL
• 1,000 mL

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

• 30 bags of 250 mL
• 20 bags of 500 mL
• 10 bags of 1,000 mL

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
BAXTER S.p.A.
Via del Serafico, 89
00142 ROMA
Italy

Responsible manufacturers for batch release:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Bieffe Medital Sabiñanigo
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Plasmalyte 148 + Glucose 5 % w/v Viaflo, solution for infusion
Croatia: Plasma-Lyte + Glucose 5%, otopina za infuziju
Cyprus: PLASMA-LYTE®+GLUCOSE 5%
Czech Republic: PLASMALYTE S GLUKÓZOU, 5%, Infuzní roztok
Denmark: Plasmalyte Glucos 50 mg/ml, infusionsvæske, opløsning
Finland: Plasmalyte Glucos 50 mg/ml infuusioneste, liuos
France: Plasmalyte + Glucose 5% solution for perfusion
Greece: PLASMA-LYTE®+GLUCOSE 5%
Iceland: Plasmalyte Glucos 50 mg/ml innrennslislyf, lausn
Ireland: Plasma-Lyte 148 & Glucose 5% w/v Solution for infusion
Italy: Crystalglu, Soluzione per infusione
Luxembourg: Plasmalyte 148 + Glucose 5 % w/v Viaflo, solution pour perfusion
Malta: Plasma-Lyte 148 & Glucose 5% w/v Solution for infusion
Netherlands: Plasma-Lyte 148 + Glucose 5%, oplossing voor infusie
Norway: Plasmalyte Glucose 50 mg/ml infusjonsvæske, oppløsning
Portugal: Plasma-Lyte 148 e Glucose 5% p/v Viaflo
Slovenia: Plasmalyte z glukozo 50 mg/ml raztopina za infundiranje
Slovakia: Plasmalyte + Glucose 5% infúzny roztok
Spain: Viaflo Plasmalyte 148 y Glucosa 5% solución para perfusion
Sweden: Plasmalyte Glucos 50 mg/ml infusionsvätska, lösning
United Kingdom: Plasma-Lyte® 148 & Glucose 5% w/v solution for infusion
To be completed with national data

The following information is intended exclusively for physicians or healthcare professionals:
Handling and preparation
The solution should be inspected visually prior to administration, whenever possible, to check for particulate matter or discoloration. Do not administer if the solution is not clear or if the seal is not intact. Do not remove the unit from the outer wrapper until ready for use.
The inner bag maintains the sterility of the product. Administer immediately after inserting the infusion set.
To avoid potentially fatal fluid over-infusion in neonates, particular care must be taken with the method of administration. When using a syringe pump to administer intravenous fluids or medications to neonates, a bag of fluid must not be left connected to the syringe. When using an infusion pump, all clamps on the intravenous administration set must be closed before removing the administration set from the pump or switching off the pump. This precaution is necessary regardless of whether the administration set is equipped with an anti-siphoning device. The intravenous infusion device and administration set must be monitored frequently.
Do not use plastic containers connected in series. This practice may cause gas embolism due to residual air being drawn from the primary container before the secondary container has finished delivering its fluid. Pressurized intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely removed 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 is for intravenous administration via a sterile administration set using aseptic technique. Priming of devices 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 the use of incorrect administration techniques may lead to pyrogenic reactions due to possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately.
Dispose of after single use.
Dispose of any unused residual solution.
Do not reconnect partially used bags.

1. Opening

• Remove the Viaflo container from the outer packaging immediately before use.
• Check for any small leaks by firmly pressing the inner bag. If any leaks are detected, discard the solution as sterility may be compromised.
• Check that the solution is clear and free from foreign particles. If the solution is not clear or contains foreign particles, discard it.

2. Preparation for Administration

The solution MUST NOT be administered through a peripheral vein.
Use sterile equipment for preparation and administration.

• Hang the container on the hanger support.
• Remove the plastic protector from the outlet port at the bottom of the container:
  • hold the small tab on the neck of the outlet port with one hand;
  • hold the large tab on the cap with the other hand and twist;
  • the cap will open.
• Using an aseptic technique, prepare the infusion.
• Connect the administration set. Refer to the complete instructions provided with the set for connection, priming the set, and administering the solution.

3. Techniques for Injection of Additive Drugs

Warning: Additives may be incompatible
Before use, check compatibility of additives with the solution and container. When using an additive, verify osmolarity prior to parenteral administration. Mix any additive thoroughly and using aseptic technique. After addition of additives, use the solution immediately and do not store. (See section 5 “Incompatibilities of additive drugs” below).
To add a drug before administration

• Disinfect the medication access site.
• Using a syringe with a needle gauge from 19 (1.10 mm) to 22 (0.70 mm), puncture the resealable medication access site and inject the drug.
• Mix the solution and drug thoroughly. For high-density drugs such as potassium chloride, gently tap the access ports while the container is in vertical position, then mix.

Caution: Do not store bags containing added drugs.
To add a drug during administration

• Close the clamp on the administration set.
• Disinfect the medication access site.
• Using a syringe with a needle gauge from 19 (1.10 mm) to 22 (0.70 mm), puncture the resealable medication access site and inject the drug.
• Remove the container from the infusion pole and/or place it in vertical position.
• Release air from both access ports by gently tapping them while the container is in vertical position.
• Mix the solution and drug thoroughly.
• Return the container to its administration position, reopen the clamp, and continue infusion.

4. Shelf life during use: Additives

The chemical and physical stability of any additive to the pH of Crystalglu infusion in the
Viaflo container must be established prior to use. From a microbiological standpoint, the diluted
product should be used immediately. Otherwise, the storage times for the product in use and the
conditions prior to use are the responsibility of the user and should normally not exceed 24 hours,
stored at temperatures between 2 °C and 8 °C, unless reconstitution has been carried out under
controlled and validated aseptic conditions.

5. Incompatibilities of additive drugs

When introducing additives into Crystalglu infusion, an aseptic technique must be used.
After adding the additives, mix the solution thoroughly. Do not store solutions containing additives.
Before addition, assess the incompatibilities of the medicinal product to be added to the solution in the Viaflo container.
Refer to the instructions for use of the medicinal product to be added.
Before adding any substance or drug, verify that it is soluble and/or stable in water and that the pH range of Crystalglu infusion is appropriate (pH 4.0–6.0). After addition, check for any possible change in colour and/or formation of precipitates, insoluble complexes, or crystals.
Solutions containing 5% glucose are incompatible with blood or erythrocytes, as haemolysis and agglutination have been observed.
Do not use additives with known incompatibilities.