Active substances: sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate and sodium gluconate
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 further questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

This medicine is called ‘Crystalsol infusion solution’, but will be referred to as ‘Crystalsol infusion’ throughout this leaflet.
Contents of this leaflet:

What Crystalsol infusion is and what it is used for
What you need to know before you are given Crystalsol infusion
How Crystalsol infusion is given
Possible side effects
How to store Crystalsol infusion
Contents of the pack and other information

What Crystalsol infusion is and what it is used for
Pharmacotherapeutic group: “Electrolytes” - ATC code: “B05BB01”
Crystalsol infusion is a solution containing the following substances in water:

sodium chloride
potassium chloride
magnesium chloride hexahydrate
sodium acetate trihydrate
sodium gluconate

Sodium, potassium, magnesium, chloride, acetate and gluconate are chemical substances normally present in the blood. Crystalsol infusion is used:

to provide a source of fluids, for example in cases of:
burns
head trauma
fractures
infection
peritoneal irritation (inflammations in the abdomen)
as a source of fluids during surgical procedures
for the treatment of shock due to blood loss and other conditions requiring rapid replacement of blood and/or fluids
in non-life-threatening metabolic acidosis (when the blood becomes too acidic)
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.

Crystalsol infusion may be used

in adult, elderly, and adolescent patients
in neonates and young children from 28 days to 23 months of age, and in children from 2 to 11 years of age.

2. What you should know before using Crystalsol infusion

Do NOT use Crystalsol infusion if you have any of the following conditions

elevated levels of potassium in the blood (hyperkalemia)
renal failure
heart block (very slow heartbeat)
conditions in which the blood becomes too alkaline (metabolic or respiratory alkalosis)
deficiency in acid secretion in the stomach (hypochlorhydria)
hypersensitivity to the active substances or to any of the excipients listed in section 6.

Warnings and precautions
Talk to your doctor or nurse before receiving Crystalsol infusion if you have or have previously had any of the following medical conditions:

heart failure
respiratory failure (lung disease)
renal failure (for 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 disorder causing increased 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 below, “Other medicines”)
if you are in a condition that may cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have excess vasopressin in your body, for example, if:
- you have a sudden and serious illness
- you have pain
- you have undergone surgery
- you have infections, burns, or brain disorders
- you have diseases affecting your heart, liver, kidneys, or central nervous system
- you are taking certain medications (also see below “Taking Crystalsol infusion with other medicines”)
  This may increase the risk of low sodium levels in your blood and may lead to headache, seizures, lethargy, coma, cerebral edema, and death. Cerebral edema increases the risk of death and brain damage. People at higher risk of cerebral edema include:
- children
- women (especially if of childbearing age)
- people who have problems with their brain fluid levels, for example due to meningitis, intracranial hemorrhage, or brain injury
elevated levels of chloride in the blood (hyperchloremia)
elevated levels of sodium in the blood (hypernatremia)
lower than normal levels of calcium in the blood (hypocalcemia)
any condition that increases the likelihood of elevated potassium levels in the blood (hyperkalemia), such as:
- renal failure
- adrenal insufficiency (this adrenal gland disorder affects hormones that regulate the concentration of chemicals in the body)
- acute dehydration (loss of water from the body, e.g. due to vomiting or diarrhea)
- extensive tissue damage (as may occur with severe burns)
  (In such cases, careful monitoring of blood potassium levels is required)
myasthenia gravis (a disorder causing progressive muscle weakness)
recovery after surgery

When this infusion is administered, your doctor will take blood and urine samples to monitor:

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

Although Crystalsol infusion contains potassium, it does not contain enough to treat severe potassium deficiency (very low plasma levels).
Crystalsol infusion contains substances that may cause metabolic alkalosis (blood becoming too alkaline).
If repeated treatment is necessary, your doctor will also administer other types of infusions to meet the body’s requirements for other chemicals and nutrients (food).
If you undergo a blood test to detect a fungus called Aspergillus, the test may indicate the presence of Aspergillus even if the fungus is not actually present.

Taking Crystalsol infusion with other medicines
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 Crystalsol infusion:

potassium-sparing diuretics (some diuretic tablets, e.g. amiloride, spironolactone, triamterene, potassium canrenoate)
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 disorders)
cyclosporine (used to prevent transplant rejection)

These medicines may increase potassium levels in the blood, which can be potentially fatal. Increased potassium levels are more likely to occur in the presence of kidney disease.
Some medicines affect the hormone vasopressin. These may include:

antidiabetic drugs (chlorpropamide)
cholesterol-lowering drugs (clofibrate)
some anticancer drugs (vincristine, ifosfamide, cyclophosphamide)
selective serotonin reuptake inhibitors (used to treat depression)
antipsychotics
opioids for treating severe pain
painkillers and/or anti-inflammatory drugs (also known as NSAIDs)
drugs that mimic or enhance the effect of vasopressin, such as certain medicines like desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
antiepileptic drugs (carbamazepine and oxcarbazepine)
diuretics (to promote diuresis)

Other medicines that may affect Crystalsol infusion or be affected by it:

corticosteroids (anti-inflammatory medicines)
carbenoxolone (an anti-inflammatory medicine used to treat stomach ulcers)
neuromuscular blocking agents (e.g. tubocurarine, suxamethonium, and vecuronium) – these are medicines used during surgery and are controlled by the anesthetist
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)
- sleeping tablets (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. dexamphetamine, fenfluramine)

Taking Crystalsol infusion 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 to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Crystalsol infusion may be administered during pregnancy or while breastfeeding. Your doctor will monitor the levels of chemicals in your blood and the amount of fluid in your body.
However, if during pregnancy or breastfeeding another medicine needs to be added to the infusion solution:

consult your doctor
read the package leaflet of the medicine to be added

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

3. How to use Crystalsol infusion

Crystalsol infusion will be administered to you by a doctor or nurse. The doctor will decide the amount needed and when it should be given. This will depend on your age, weight, condition, and the reason for treatment. The amount you receive may also depend on other treatments you are receiving.
Crystalsol infusion must NOT be administered if particles are present in the solution or if the packaging is in any way damaged.
Crystalsol infusion is usually administered through a plastic tube connected to a needle inserted into a vein. Normally, a vein in the arm is used for the infusion. However, your doctor may use another method to administer the medicine.
Before and during the infusion, your doctor will monitor:

the amount of fluid in your body
the acidity of your blood and urine
the level of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin, or who are taking medications that enhance the effect of vasopressin).

Any unused solution must be discarded. Crystalsol infusion must NOT be administered from a partially used bag.
If you receive more Crystalsol infusion than you should
If you are given too much Crystalsol infusion (excessive infusion) or if it is administered too rapidly, the following symptoms may occur:

overload of water and/or sodium (salt) with fluid accumulation in tissues (edema), causing swelling
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
reduced breathing (respiratory depression)
nausea
vomiting
skin flushing (redness)
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 (blood becoming too alkaline), particularly in patients with renal impairment
mood changes
fatigue
shortness of breath
muscle stiffness
muscle spasms
muscle contractions

If you develop any of these symptoms, you must inform 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 Crystalsol infusion before the excessive infusion occurred, the symptoms may also be caused by that added medicine. Please read the package leaflet of the added medicine for a list of possible symptoms.
If you stop treatment with Crystalsol infusion
Your doctor will decide when to stop the infusion administration.
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, inform your doctor or nurse immediately.
They could be signs of a very severe, potentially life-threatening allergic reaction (hypersensitivity):

swelling of the skin of the face, lips, and throat
difficulty breathing
skin rash
skin redness (erythema)

You will be given treatment depending on your symptoms.

Other side effects include:

reactions due to the administration technique:
fever (febrile response)
infection at the infusion site
burning sensation
local pain or reaction (redness or swelling) at the infusion site
irritation and inflammation of the vein into which the solution is infused (phlebitis). This may cause redness, pain, burning, and swelling along the course of 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). This may damage tissues and lead to scarring.
excess fluid in the body (hypervolemia)
seizures
urticaria
severe allergic reaction causing difficulty breathing or dizziness (anaphylactoid reaction)
rapid heartbeat (tachycardia)
palpitations
chest pain
chest discomfort
shortness of breath (dyspnea)
increased respiratory rate
flushing
hyperemia
feeling of weakness (asthenia)
abnormal sensation
piloerection (goosebumps)
peripheral edema
fever (pyrexia)
low levels of sodium in the blood, which may worsen during hospitalization (nosocomial hyponatremia) and related neurological disorders (acute hyponatremic encephalopathy). Hyponatremia can cause irreversible brain damage and death due to the development of cerebral edema/swelling (see also section “Warnings and Precautions”)

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.
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/infusion reactions: low blood pressure (hypotension), wheezing, cold sweat, chills
Hyperkalemia

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 the following website:
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 Crystalsol infusion

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the bag. The expiry date refers to the last day of the month.
Do not use this medicine if you notice particles in the solution or if the unit is damaged in any way.

6. Package contents and other information

What Crystalsol infusion contains
The active substances are:

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 ingredients are:

water for injections
sodium hydroxide

Description of the appearance of Crystalsol infusion solution and package contents
Crystalsol 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 plastic overwrap.
The bag sizes are:

500 ml
1,000 ml

The bags are supplied in cartons. Each carton contains one of the following quantities:

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.
Piazzale dell’Industria 20
00144 Rome
Italy

Manufacturers responsible for batch release:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain
Baxter Manufacturing Sp. z o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Plasmalyt-Infusionslösung
Belgium, Luxembourg: Plasmalyte A Viaflo, solution for infusion
Croatia: Plasma-Lyte 148 (pH 7.4) Viaflo, otopina za infuziju
Czech Republic: Plasmalyte roztok
Cyprus: Plasma-Lyte 148 (pH 7.4) Solution for Infusion
Spain: Viaflo Plasmalyte 148 (pH 7.4), solución para perfusión
Denmark: Plasmalyte, infusionsvæske, opløsning
Finland: Plasmalyte infuusioneste, liuos
France: Plasmalyte Viaflo, solution pour perfusion
Greece: Plasma-Lyte 148 (pH 7.4) Solution for infusion
Iceland: Plasmalyte innrennslislyf, lausn
Ireland: Plasma-Lyte 148 (pH 7.4) Solution for infusion
Italy: CrystalSol
Lithuania: Plasmalyte infuzinis tirpalas
Malta: Plasma-Lyte 148 (pH 7.4) Solution for infusion
Netherlands: Plasma-Lyte 148, oplossing voor infusie
Norway: Plasmalyte infusjonsvæske, oppløsning
Poland: Plasmalyte roztwór do infuzji
Portugal: Plasma-Lyte (pH 7.4) 148 Viaflo
Slovenia: Plaslyte raztopina za infundiranje
Slovakia: Plasmalyte infúzny roztok
Sweden: Plasmalyte infusionsvätska, lösning
United Kingdom: Plasma-Lyte 148 (pH 7.4) Solution for Infusion

This Patient Information Leaflet was last approved on ………..

The following information is intended for healthcare professionals only:

Handling and Preparation
Prior to administration, whenever solution and container permit, the solution should be visually inspected for particulate matter and 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 packaging until immediately before use.
The inner bag maintains the sterility of the solution. Administer immediately after insertion of the infusion set.
Do not use plastic containers connected in series. Such use may result in a gas embolism due to residual air being drawn from the primary container before completion of fluid administration from the secondary container. Pressurizing intravenous solutions in flexible plastic containers to increase flow rates may cause a 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 a 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 in the open position.
The solution is intended for intravenous administration through a sterile administration set using aseptic technique. Priming of the administration equipment with the solution is required to prevent air from entering the system.
Additions may be made prior to infusion or during infusion through the resealable access port.
The addition of other drugs or the use of incorrect administration techniques may lead to febrile reactions due to the possible introduction of pyrogens. In case of an adverse reaction, discontinue the infusion immediately.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

1. Opening

a. Remove the Viaflo container from the outer wrapper immediately before use.
b. By firmly compressing the inner bag, check for any small leaks. If leaks are observed, discard the solution, as sterility may be compromised.
c. Check that the solution is clear and free from foreign particles. If the solution is not clear or contains foreign matter, discard it.

2. Preparation for Administration

Use sterile equipment for preparation and administration.
a. Suspend the container by the support hole.
b. Remove the plastic cap from the outlet at the bottom of the container:

firmly hold with one hand the small tab on the neck of the outlet,
grasp with the other hand the large tab on the cap and rotate,
the cap will open.
c. Use an aseptic technique when setting up the infusion.
d. Connect the infusion set. For connection, priming the set, and administration of the solution, refer to the complete instructions provided with the set.

3. Techniques for injection of medicinal additives

Warning: Additives may be incompatible. Before use, check the compatibility of additives with the solution and container. When using an additive, verify its isotonicity prior to parenteral administration. Careful and thorough mixing using aseptic technique is required for any additive. Solutions containing additives must be used immediately and must not be stored (see section 5 "Incompatibilities of medicinal additives" below).
To add a medicinal product before administration
a. Disinfect the medication entry site.
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. Mix the solution and medicinal product thoroughly. For high-density medications, such as potassium chloride, gently tap the access ports while in upright position to ensure mixing.
Caution: Do not store bags containing medicinal additives.
To add a medicinal product during administration
a. Close the clamp on the administration set.
b. Disinfect the medication entry site.
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 into an upright position.
e. Empty both access ports by gently tapping while the container is in upright position.
f. Mix the solution and added medicinal product thoroughly.
g. Return the container to its administration position, reopen the clamp, and continue administration.

Duration of validity after first opening: The product must be used immediately after opening.
In-use shelf life after reconstitution with additives: The chemical and physical stability of any medicinal product added to the pH of Crystalsol solution in the Viaflo container must be evaluated before use. From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and normally should not exceed 24 hours at 2°C – 8°C, unless reconstitution has taken place under controlled and validated aseptic conditions.

5. Incompatibilities of medicinal additives

When introducing medicinal additives into Crystalsol, aseptic technique must be used. Mix the solution thoroughly after additives have been added. Do not store solutions containing additives.
The incompatibility of a medicinal additive with the solution in the Viaflo container must be assessed before addition.
The instructions for use of the medicinal product to be added must be consulted.
Before adding a substance or medicinal product, verify that it is soluble and/or stable in water and that the pH range of Crystals0l is appropriate (pH 6.5–8.0). After addition, check that there has been no change in colour and/or that no precipitates, insoluble complexes or crystals have appeared.
Additives known to be incompatible must not be used.