Plasmalyte

Patient Information Leaflet

Plasmalyte, infusion solution
Active substances: sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, and sodium gluconate
Please read this leaflet carefully before using this medicine, because
it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Leaflet Contents

1. What Plasmalyte is and what it is used for
2. Important information before using Plasmalyte
3. How to use Plasmalyte
4. Possible side effects
5. How to store Plasmalyte
6. Contents of the pack and other information

1. What Plasmalyte is and what it is used for

Pharmacotherapeutic group: electrolytes; ATC code: B05BB01
Plasmalyte is an aqueous solution containing the following substances:

• sodium chloride;
• potassium chloride;
• magnesium chloride hexahydrate;
• sodium acetate trihydrate;
• sodium gluconate.

Sodium, potassium, magnesium, chloride, acetate, and gluconate are chemical substances naturally present in blood.
Plasmalyte infusion solution is used:

• to replace fluids, for example:
  • in burns;
  • in head injury;
  • in fractures;
  • in infection;
  • in peritonitis (inflammatory conditions within the abdominal cavity);
  • as a source of fluids during surgical procedures;
  • in the treatment of shock caused by blood loss and in other conditions requiring rapid replacement of blood and/or fluids;
• in non-life-threatening metabolic acidosis (when blood becomes too acidic);
• in lactic acidosis (a type of acidosis caused by accumulation of lactic acid in the body). Lactic acid is produced mainly in muscles and eliminated by the liver.

Plasmalyte infusion solution may be used:

• in adult patients, elderly patients, and adolescents;
• in infants and young children aged 28 days to 23 months, and in children aged 2 to 11 years.

2. Important information before using Plasmalyte

DO NOT use Plasmalyte if the patient has any of the following conditions:

• Elevated blood potassium levels (hyperkalemia);
• Renal failure;
• Heart block (very slow heart rate);
• Conditions in which blood becomes too alkaline (metabolic or respiratory alkalosis);
• Deficiency of acid in gastric juice (hypochlorhydria);
• Hypersensitivity to the active substance or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
Before starting treatment with Plasmalyte, discuss with a doctor or nurse if the patient has or has ever had any of the following conditions:

• Heart failure;
• Respiratory failure (lung disease);
• Renal failure; (in the above conditions, special monitoring may be required)
• High blood pressure (hypertension);
• Fluid accumulation under the skin, especially 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 increased levels of the hormone called aldosterone);
• Any other conditions associated with sodium retention in the body (when the body retains excessive amounts of sodium), such as steroid therapy (see also section "Plasmalyte with other medicines");
• A condition that may cause elevated levels of vasopressin, a hormone regulating fluid balance in the body. Excessively high vasopressin levels may result, for example, from:
• Acute and serious illness;
• Pain;
• Surgery;
• Infection, burns, or brain disease;
• Conditions related to the heart, liver, kidneys, or central nervous system;
• Use of certain medications (see also section "Plasmalyte with other medicines"). This may increase the risk of low sodium levels in the blood and cause headache, nausea, seizures, drowsiness, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. Patients at higher risk of brain swelling include:
• Children;
• Women (especially those of childbearing age);
• Patients with problems related to cerebrospinal fluid levels, for example due to meningitis, intracranial hemorrhage, or brain injury.
• Elevated blood chloride levels (hyperchloremia);
• Elevated blood sodium levels (hypernatremia);
• Low blood calcium levels (hypocalcemia);
• Conditions increasing the likelihood of elevated blood potassium levels (hyperkalemia), such as:
• Renal failure;
• Adrenal cortex insufficiency (a disease of the adrenal glands affecting hormones responsible for regulating chemical substance concentrations in the body);
• Acute dehydration (loss of body water, e.g., due to vomiting or diarrhea);
• Extensive tissue damage (as may occur in severe burns); (in such cases, close monitoring of blood potassium levels is required).
• Myasthenia gravis (a disease causing progressive muscle weakness);
• The postoperative recovery period.

During infusion, the doctor will take blood and urine samples to monitor:

• Fluid levels in the body;
• Levels of chemical substances such as sodium and potassium in blood and urine (plasma and urine electrolytes);
• Acid-base balance (acidity of blood and urine).

Although Plasmalyte contains potassium, the amount is not sufficient to treat significant potassium deficiencies (very low plasma concentrations).
Plasmalyte contains substances that may cause metabolic alkalosis (blood becoming too alkaline).
If repeated treatment is required, the doctor will additionally prescribe other types of infusion solutions to meet the need for other chemical and nutritional (nutritional) substances.
If the patient's blood is tested for the presence of the fungus Aspergillus, the test may detect Aspergillus even when it is not actually present.

Plasmalyte with other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
It is not recommended to take the following medicines during treatment with Plasmalyte:

• Potassium-sparing diuretics (tablets such as: amiloride, spironolactone, triamterene, potassium canrenoate);
• Angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure);
• Angiotensin II receptor blockers (used to treat high blood pressure);
• Tacrolimus (used to prevent transplant rejection and in the treatment of certain skin diseases);
• Cyclosporine (used to prevent transplant rejection).

These medicines may increase blood potassium levels, which can be life-threatening.
Increased blood potassium levels are more likely in patients with renal failure.
Some medicines may affect vasopressin hormone levels. These include:

• Antidiabetic medicines (chlorpropamide);
• Cholesterol-lowering medicines (clofibrate);
• Certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide);
• Selective serotonin reuptake inhibitors (used to treat depression);
• Antipsychotic medicines;
• Opioids used to relieve severe pain;
• Painkillers and/or anti-inflammatory medicines (also known as NSAIDs);
• Medicines mimicking or enhancing the action of vasopressin, such as desmopressin (used to treat excessive thirst and urine output), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor);
• Antiepileptic medicines (carbamazepine and oxcarbazepine);
• Diuretics (water pills).

Other medicines that may interact with Plasmalyte or be affected by it:

• Corticosteroids (anti-inflammatory medicines);
• Carbenoxolone (an anti-inflammatory medicine used to treat stomach ulcers);
• Neuromuscular blocking agents (such as tubocurarine, suxamethonium, and vecuronium). These are medicines used during surgical procedures under the supervision of an anesthesiologist;
• Acetylcholine;
• Aminoglycosides (a type of antibiotic);
• Nifedipine (used to treat high blood pressure and chest pain);
• Acidic medicines, such as:
• Salicylates, used to treat inflammatory conditions (aspirin);
• Sleeping pills (barbiturates);
• Lithium (used to treat psychiatric disorders).
• Alkaline (basic) medicines, including:
• Sympathomimetics (stimulant medicines such as ephedrine and pseudoephedrine, found in cough and cold remedies);
• Other stimulants (e.g., dexamfetamine, fenfluramine).

Using Plasmalyte with food and drink
Ask the doctor what the patient may eat and drink.
Pregnancy, breastfeeding, and fertility:
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Plasmalyte may be used during pregnancy and breastfeeding. The doctor will monitor blood electrolyte levels and fluid balance in the body.
However, before adding another medicine to the infusion solution used during pregnancy or breastfeeding, the following must be done:

• Consult the doctor;
• Read the Package Leaflet of the medicine to be added.

Driving and operating machinery
Consult a doctor or pharmacist before driving or operating machinery.

3. How to use Plasmalyte

Plasmalyte is administered by a doctor or nurse. The dose and duration of administration are determined by the doctor. This depends on the patient's age, body weight, condition, and reason for treatment. The dose may also be influenced by other medications being used.
DO NOT use Plasmalyte if it contains visible particles or if the packaging is in any way damaged.
Plasmalyte infusion solution is administered through a plastic tube connected to a needle placed in a vein. Usually, this solution is given through a vein in the arm. However, the doctor may instruct a different method of administration.
Before and during the infusion, the doctor will monitor:

• fluid levels in the body
• blood and urine acidity
• electrolyte concentrations in the body (especially sodium, in patients with high vasopressin hormone levels or those taking other medicines that enhance the effect of vasopressin).

All unused remnants of the solution must be discarded. Partially used bags of medication MUST NOT be reconnected.
Administration of a higher than recommended dose of Plasmalyte:

Intravenous administration of excessive amounts of solution (overdose) or administration too rapidly may cause:

• excess fluid and/or sodium (salt), with fluid accumulation in tissues (edema), leading to swelling;
• tingling sensation in the fingers and toes (paresthesia);
• muscle weakness;
• loss of movement (paralysis);
• irregular heartbeat (arrhythmia);
• heart block (very slow heartbeat);
• heart attack (cessation of heartbeat; life-threatening condition);
• confusion;
• diminished tendon reflexes;
• shallow breathing (respiratory depression);
• nausea;
• vomiting;
• skin redness;
• thirst;
• low blood pressure (hypotension);
• drowsiness;
• slow heart rate (bradycardia);
• coma (loss of consciousness);
• blood acidification (acidosis), causing fatigue, confusion, lethargy, and increased breathing rate;
• hypokalemia (lower than normal potassium levels in blood) and metabolic alkalosis (when blood is too alkaline), especially in patients with kidney failure;
• mood changes;
• fatigue;
• shortness of breath;
• muscle stiffness;
• muscle tremors;
• muscle cramps.

If any of the above symptoms worsen, inform the doctor immediately. In such a case, the infusion will be stopped and appropriate treatment will be initiated depending on the symptoms.
If another medicine has been added to the Plasmalyte infusion solution before the overdose occurred, that additional medicine may also be causing symptoms. Please read the Package Leaflet of the added medicine to become familiar with the list of possible symptoms.
Interrupting the use of Plasmalyte
The decision to interrupt the use of Plasmalyte will be made by the doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You must immediately inform the doctor or nurse if any of the following symptoms occur in the patient. These may be symptoms of a very severe or even fatal allergic reaction (hypersensitivity):

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

The treatment will depend on the symptoms.

Other adverse reactions:

• reactions related to the method of administration:
• fever (pyrexia),
• infection at the site of administration,
• burning sensation,
• local pain or reaction (redness or swelling) at the site of administration,
• irritation and inflammation of the vein into which the solution is administered (phlebitis). This may cause redness, pain, burning, and itching along the vein,
• blood clot formation (venous thrombosis) at the site of administration, causing pain, swelling or redness in the area of the clot,
• leakage of the solution into the surrounding tissue (extravasation). This may damage tissues and lead to scarring,
• increased fluid volume in the body (hypervolemia),
• seizures,
• urticaria,
• severe allergic reactions causing difficulty in breathing or dizziness (anaphylactic reactions),
• rapid heartbeat (tachycardia),
• palpitations,
• chest pain,
• feeling of discomfort in the chest,
• shallow breathing (dyspnoea),
• increased respiratory rate,
• flushing,
• hyperaemia,
• feeling of weakness (asthenia),
• malaise,
• piloerection,
• peripheral oedema,
• fever,
• low blood sodium levels, which may be associated with hospital treatment (hospital-acquired hyponatraemia) and related neurological disorders (acute hyponatraemic encephalopathy). Hyponatraemia may lead to irreversible brain damage and death due to brain swelling/oedema (see also section 2 "Warnings and precautions").

If another medicine is added to the intravenous infusion solution, it may also cause adverse reactions. These will depend on the medicine added.
Please read the package leaflet of the added medicine to become familiar with possible adverse reactions.

Other adverse reactions observed with similar medicines:

• other signs of hypersensitivity/reactions to administration: low blood pressure (hypotension), wheezing, cold sweats, chills;
• hyperkalaemia.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the doctor or nurse immediately. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Plasmalyte

Keep the medicine out of the sight and reach of children.
There are no special storage temperature requirements for this medicine.
Do not use this medicine after the expiry date stated on the bag. The expiry date refers to the last day of the specified month.
Do not use this medicine if it contains visible particles or if the packaging is in any way damaged.

6. Contents of the package and other information

What Plasmalyte 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

Other ingredients are:

• water for injections
• sodium hydroxide

What Plasmalyte looks like and contents of the pack
Plasmalyte is a clear solution free from visible particles. It is available in
polyolefin-polyamide plastic bags (Viaflo). Each bag is enclosed in a sealed, protective, outer plastic container.
Bag sizes:

• 500 ml
• 1000 ml

Bags are supplied in cardboard packaging. A cardboard box may contain:

• 1 bag of 500 ml
• 20 bags of 500 ml
• 1 bag of 1000 ml
• 10 bags of 1000 ml
• 12 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warszawa

Manufacturers:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain

This medicinal product is authorised for marketing in the European Economic Area
and in the United Kingdom (Northern Ireland) 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) διάλυμα για έγχυση
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) διάλυμα για έγχυση
Iceland Plasmalyte innrennslislyf, lausn
Ireland Plasma-Lyte 148 (pH 7.4) Solution for infusion
Italy CrystalSol Solution for infusion
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

Baxter and Viaflo are trademarks of Baxter International Inc.
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Information intended exclusively for medical professionals:

Handling and preparation
Visually inspect the solution for particulate matter and discoloration, as much as possible, prior to administration. Use only if the solution is clear and the container is undamaged. Do not remove the bag from its protective overwrap until ready for use.
The inner bag ensures product sterility.
Administer immediately after connecting the infusion set.
Plastic containers must not be connected in series. Such use could result in air embolism due to residual air being drawn from the first container before the infusion from the second container is completed.
Applying additional pressure to intravenous solutions contained in flexible plastic containers to increase the flow rate may cause air embolism if all residual air has not been completely removed from the container prior to administration.
Using infusion sets with an air vent, with the vent valve open, may cause air embolism. Infusion sets with an air vent in the open position must not be used with flexible plastic containers.
The intravenous solution must be administered using sterile equipment and aseptic technique. The infusion set should be pre-filled with the solution to prevent air from entering the system.
Additional medications may be added to the solution before or during infusion via the medication addition port with self-sealing membrane.
Adding other medications or improper administration techniques may lead to febrile reactions due to the potential introduction of pyrogenic substances. If an adverse reaction occurs, the infusion must be stopped immediately.
Discard after single use.
Discard any unused portion of the solution.
Do not reconnect partially used bags.

1. Opening

a. Remove the Viaflo bag from its protective overwrap immediately before use.
b. Squeeze the inner bag firmly to check for leakage. If leakage is detected, discard the bag, as the contents may no longer be sterile.
c. Check whether the solution is clear and free from insoluble particles. If the solution is not clear or contains insoluble particles, discard it.

2. Preparation for administration

Use sterile materials during preparation and administration.
a. Hang the bag on an infusion stand.
b. Remove the plastic cover from the administration port located at the bottom of the bag:

• Hold the smaller wing on the neck of the port with one hand,
• Hold the larger wing on the cap with the other hand and twist,
• the cap will pop off.
  c. Maintain aseptic technique when connecting the infusion set.
  d. Connect the administration set, following the manufacturer’s instructions for connection, priming the set, and administering the solution.

3. Methods of adding additional medications

Note: Added medications may be incompatible. Before administration, check the compatibility of additional medications with the solution and the container. When administering another medication, confirm isotonicity prior to parenteral administration. Thorough and careful mixing under aseptic conditions is required with each added medication. Solutions containing added medications should be used immediately and must not be stored. (See section 5 below, “Incompatibility of added medications”).
Adding medications before administration
a. Disinfect the medication addition port.
b. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle through the self-sealing medication addition port and inject the medication.
c. Mix the solution thoroughly. For viscous preparations, such as potassium chloride, gently tap the ports while holding the bag with ports upward, then mix.
Note: Do not store bags containing added medications.
Adding medications during administration
a. Close the clamp on the administration set.
b. Disinfect the medication addition port.
c. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle through the self-sealing medication addition port and inject the medication.
d. Remove the bag from the stand and/or invert it with ports facing upward.
e. Empty both ports by gently tapping while holding the bag with ports upward.
f. Mix the solution thoroughly.
g. Rehang the bag in its original position, reopen the clamp, and continue administration.

4. Stability after first opening: the product must be used immediately after opening. Stability during use after reconstitution with additives: Prior to use, the chemical and physical compatibility of each added medication in the pH of Plasmalyte in the Viaflo container must be established. From a microbiological standpoint, the diluted medication should be used immediately. If the solution is not used immediately, the user is responsible for the storage duration and conditions, and storage should not exceed 24 hours at a temperature of 2 to 8°C, unless reconstitution was performed under controlled and validated aseptic conditions.

5. Incompatibility of added medications

When adding additional medications to the Plasmalyte solution, aseptic technique must be used. Each added medication must be thoroughly mixed. Solutions containing added medications must not be stored.
Before adding any medication to the solution in the Viaflo container, potential incompatibilities must be assessed.
Refer to the package insert of the medication to be added.
Before adding any substance or medication, verify its solubility and/or stability in water and confirm that the pH range of the Plasmalyte solution is suitable (pH 6.5 – 8.0). After addition, check for possible color change and/or formation of precipitate, insoluble complexes, or crystals.
Do not use additives known to be incompatible.
Baxter and Viaflo are trademarks of Baxter International Inc.