CRYSTALSOL 500 ML Infusion solution

Зміст інструкції

1. Crystalsol solution for infusion
   1. What you need to know before using Crystalsol infusion
   2. How to use Crystalsol infusion
   3. Possible side effects
   4. How to store Crystalsol infusion
   5. Contents of the pack and other information
   6. Opening
   7. Preparation for administration
   8. Techniques for the injection of medicinal supplementations
   9. Incompatibilities with medicinal additions

Crystalsol solution for infusion

Active ingredients: sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate and sodium
gluconate

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.

This medicine is called ‘Crystalsol solution for infusion’, but will be referred to as ‘Crystalsol infusion’ in the
remainder of this leaflet.

Contents of this leaflet:

• 1. What Crystalsol infusion is and what it is used for
• 2. What you need to know before using Crystalsol infusion
• 3. How to use Crystalsol infusion
• 4. Possible side effects
• 5. How to store Crystalsol infusion
• 6. Contents of the pack and other information

What Crystalsol infusion is and what it is used for
Pharmacotherapeutic category: “Electrolytes” - ATC code: “B05BB01”
Crystalsol infusion is a solution of 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 chemicals 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 (inflammation in the abdomen)
• as a source of fluids during surgery
• for the treatment of shock due to blood loss and for other conditions requiring rapid replacement of blood and/or fluids
• in metabolic acidosis (when the blood becomes too acidic) that is not potentially life-threatening
• lactic acidosis (a type of metabolic acidosis caused by the build-up of lactic acid in the body). Lactic acid is mainly produced by muscles and eliminated by the liver.

Crystalsol infusion can be used

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

2. What you need to know before using Crystalsol infusion

Do not use Crystalsol infusion if you suffer from any of the following conditions

• levels of potassium in the blood higher than normal (hyperkalemia)
• kidney failure
• heart block (very slow heartbeat)
• disorders in which the blood becomes too alkaline (metabolic or respiratory alkalosis)
• a deficiency in acid secretion in the stomach (hypochlorhydria)
• hypersensitivity to the active ingredients or to any of the excipients listed in section 6.

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

• heart failure
• respiratory failure (lung disease)
• kidney failure (for the above conditions, particular monitoring may be required).
• high blood pressure (hypertension)
• fluid build-up under the skin, especially around the ankles (peripheral edema)
• fluid build-up in the lungs (pulmonary edema)
• high blood pressure during pregnancy (pre-eclampsia or eclampsia)
• aldosteronism (a disease that causes an increase in the 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 (see also below, “Taking Crystalsol infusion with other medicines”).
• if you are in a condition that can cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have too much vasopressin in your body because, for example:
• you have a sudden and serious illness
• you are in pain
• you have undergone surgery
• you have infections, burns or brain diseases
• you have diseases related to your heart, liver, kidneys or central nervous system
• because you are taking certain medications (see also below “Taking Crystalsol infusion with other medicines”). This can increase the risk of low sodium levels in your blood and can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death. Cerebral edema increases the risk of death and brain damage. People who are at higher risk of cerebral edema are:
• children
• women (especially of childbearing age) people who have problems with their brain fluid levels, for example, due to meningitis, intracranial bleeding or brain damage
• levels of chlorine in the blood higher than normal (hyperchloremia)
• levels of sodium in the blood higher than normal (hypernatremia)
• levels of calcium in the blood lower than normal (hypocalcemia)
• any condition that involves a greater likelihood of high potassium levels in the blood (hyperkalemia), such as:
• kidney failure
• adrenal insufficiency (this disease of the adrenal gland affects hormones that control the concentration of chemicals in the body)
• acute dehydration (a loss of water from the body, e.g. due to vomiting or diarrhea)
• extensive tissue damage (as can occur with severe burns) (In such cases, careful monitoring of blood potassium levels is required)
• myasthenia gravis (a disease that causes progressive muscle weakness)
• recovery after surgery

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

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

Although Crystalsol infusion contains potassium, it does not contain enough to treat severe potassium deficiency (very low levels in plasma).
Crystalsol infusion contains substances that can cause metabolic alkalosis (the blood becomes too
alkaline).
If treatment needs to be repeated, the doctor will also give you other types of infusions that
meet the body's need for other chemicals and other nutrients (food).
If you are undergoing a blood test to determine the presence of a fungus called Aspergillus,
the test may detect the presence of Aspergillus even if the fungus is not present.

Taking Crystalsol infusion with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
The use of the following medicines is not recommendedwhile you are being given a 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 some skin diseases)
• cyclosporine (used to prevent transplant rejection)

These medicines can increase the concentration of potassium in the blood and this can be
potentially fatal. An increase in potassium levels in the blood is more likely to occur in
the presence of kidney disease.
Some drugs affect the hormone vasopressin. These may include:

• antidiabetic drugs (chlorpropamide)
• cholesterol drugs (clofibrate)
• some cancer 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 reproduce or enhance the effect of vasopressin such as certain drugs like desmopressin (used to treat increased thirst and urination), terlipressin (used to treat esophageal bleeding) and oxytocin (used to induce labor).
• Anti-epileptic drugs (carbamazepine and oxcarbazepine)
• Diuretics (to promote diuresis)

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

• corticosteroids (anti-inflammatory drugs)
• carbenoxolone (an anti-inflammatory drug used to treat stomach ulcers)
• neuromuscular blocking agents (e.g. tubocurarine, suxamethonium and vecuronium). These are medicines used in 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)
• sleeping pills (barbiturates)
• lithium (used to treat psychiatric illnesses)
• alkaline (basic) medicines including:
• sympathomimetics (stimulating medicines such as ephedrine and pseudoephedrine, used in cough and cold preparations)
• other stimulants (e.g. desamphetamine, fenfluramine)

Taking Crystalsol infusion 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 a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
Crystalsol infusion can be given to you while you are pregnant or breastfeeding. The doctor
will monitor the levels of chemicals in the blood and the amount of fluid in the body.
However, if another medicine needs to be added to the infusion solution during pregnancy or breastfeeding:

• consult your doctor

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

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 to administer it. This will depend on age, weight, condition and the
reason for treatment. The amount administered to you 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 damaged in any way.
Crystalsol infusion will generally be administered 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 administer the medicine to you.
Before and during the infusion, your doctor will monitor:

• the amount of fluids in your body
• the acidity of the blood and urine
• the amount of electrolytes in your body (in particular sodium, in patients with high levels of vasopressin, or who are taking drugs that increase the effect of vasopressin).

All unused solution must be discarded. Crystalsol infusion infusion MUST NOT be
administered from a partially used bag.

If you receive moreCrystalsol infusion than you should
If you are given too much Crystalsol infusion (overinfusion) or if it is administered too
quickly, the following symptoms may occur:

• fluid and/or sodium (salt) overload with fluid accumulation in the 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 situation)
• confusion
• loss of tendon reflexes
• reduced breathing (respiratory depression)
• nausea
• vomiting
• flushing (redness) of the skin
• thirst
• low blood pressure (hypotension)
• drowsiness
• slow heartbeat (bradycardia)
• coma (loss of consciousness)
• acidification of the blood (acidosis), which causes 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 insufficiency
• mood changes
• fatigue
• shortness of breath
• muscle stiffness
• muscle spasms
• muscle contractions

If you develop any of these symptoms, you should 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 overinfusion occurs, the
added for a list of possible symptoms.

If you stop treatment with Crystalsol infusion
The doctor will decide when to stop administering the infusion.
If you have any doubts about the use of 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.
If any of the following symptoms occur, inform your doctor or nurse immediately.
They 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) You will be given treatment according to your symptoms

Other side effects are:

• 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 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) at the infusion site, which causes pain, swelling or redness in the area of the clot
• leakage of the infusion solution into the tissues around the vein (extravasation). This can damage the tissues and cause scarring.
• excess fluid in the body (hypervolemia).
• convulsions
• 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 that may be worsened 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 the “Warnings and Precautions” section)

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 added medicine.
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 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
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 particular storage temperature.
Do not use this medicine after the expiry date which is reported 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. Contents of the pack and other information

What Crystalsol infusion contains
The active ingredients 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 Crystalsol solution for infusion and contents of the pack
Crystalsol solution for infusion is a clear solution, free from visible particles. It is supplied in plastic bags of
polyolefin/polyamide (Viaflo). Each bag is wrapped in an outer protective plastic wrapper,
sealed.
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 Member States of the European Economic Area with the following
denominations:
Austria: Plasmalyt-Infusionslösung
Belgium, Luxembourg: Plasmalyte A Viaflo, solution pour perfusion
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 perfusion
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
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The following information is intended exclusively for healthcare professionals:
Handling and preparation
Before administration, when the solution and container allow, the solution must be
checked for the presence of particles and discoloration. Do not administer if the
solution is not clear and if the seal is not intact. Do not remove the unit from the outer wrapper until
the time of use.
The inner bag maintains the sterility of the solution. Administer immediately after inserting the
infusion set.
Do not use containers connected in series. Such use may cause a gas embolism
due to residual air drawn from the primary container before completion of the liquid delivery from the secondary container. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if the residual air
in the container is not completely removed before administration. Use of an intravenous administration set equipped with a vent may 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 is intended for intravenous administration through a sterile administration set
using aseptic technique. The equipment must be primed with the solution to
prevent air from entering the system.
Additions may be made before or during the infusion through the resealable access 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. If an adverse reaction occurs, 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 packaging immediately before use.
• b. By firmly compressing the inner bag, check for any small leaks. If leaks are observed, discard the solution because sterility may be compromised.
• c. Check that the solution is clear and free of foreign material. If the solution is not clear or contains foreign material, discard it.

2. Preparation for administration

Use sterile material for preparation and administration.

• a. Suspend the container by the support hole.
• b. Remove the plastic cap from the outlet point at the bottom of the container:
• hold firmly with one hand the small flap on the neck of the outlet point,
• grasp with the other hand the large flap 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, set priming and solution administration, see the complete instructions provided with the set.

3. Techniques for the injection of medicinal supplementations

Warning: supplementations may be incompatibleBefore use, check the compatibility
of the supplementations with the solution and with the container. When using a supplementation, verify its
isotonicity before parenteral administration. Careful and accurate mixing with aseptic technique of any supplementation is necessary. Solutions containing supplementations must
be used immediately and must not be stored (see paragraph 5

“Incompatibilities of medicinal supplementations” below).

To add a medicine before administration

• a. Disinfect the entry point for the dressing.
• b. Using a syringe with a 19 (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable dressing port and inject.
• c. Mix the solution and the medicine thoroughly. In the case of high-density medications, such as potassium chloride, gently tap the access ports while in a vertical position and mix.

Caution: Do not store bags containing medicinal supplementations.

To add a medicine during administration

• a. Close the clamp on the set.
• b. Disinfect the entry point of the dressing.
• c. Using a syringe with a 19 (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable dressing port and inject.
• d. Remove the container from the pole and/or rotate it to a vertical position.
• e. Empty both access ports by gently tapping while the container is in a vertical position.
• f. Mix the solution and the added medicine thoroughly.
• g. Return the container to the use position, reopen the clamp and continue administration.
• 4.Shelf life after first opening:The product must be used immediately after opening. Shelf life in useafter reconstitution with supplementations The chemical and physical stability of any medicine added to the pH of the Crystalsol solution in the Viaflo container must be evaluated before use. From a microbiological point of view, the diluted product must be used immediately. If not used immediately, the storage times and conditions during 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 with medicinal additions

When introducing medicinal products into Crystalsol, it is necessary to use an aseptic technique. Carefully mix the solution when additions have been made. Do not store solutions containing additions.
The incompatibility of a medicinal addition with the solution in the Viaflo container must be evaluated 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 Crystalsol is appropriate (pH 6.5-8.0). After addition, verify that the color has not changed and/or that precipitates, insoluble complexes, or crystals have not appeared.
Additions known to be incompatible must not be used.