Optilyte

Package leaflet: Information for the user

Optilyte, infusion solution
compound preparation
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

1. What Optilyte is and what it is used for

Optilyte is an aqueous solution of mineral salts (sodium, potassium, calcium, magnesium) used to
maintain intravascular volume and restore water-electrolyte balance in the body. The composition
of the medicine is very similar to the electrolyte composition of plasma. The medicine is administered intravenously.
Indications:

• parenteral correction of water-electrolyte imbalances due to excessive loss of fluids and electrolytes caused, for example, by vomiting and diarrhoea, or intestinal or biliary fistulas, in cases of insufficient oral fluid intake;
• hydration during the perioperative period.

2. Important information before using Optilyte

When not to use Optilyte
Do not use this medicine if the patient has:

• hypersensitivity to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• acute renal failure;
• hypervolemia (excessive blood volume in the blood vessels);
• elevated blood levels of sodium, potassium, calcium, or magnesium;
• pulmonary edema.

Warnings and precautions
While administering Optilyte, the doctor will monitor the patient's condition and order blood tests
(to check for disturbances in fluid balance, electrolyte levels, and acid-base balance) as well as monitor urine output.
Optilyte contains calcium ions; therefore, it must not be administered simultaneously with blood transfusion through the same set.
The doctor will monitor calcium excretion in urine if the patient has:

• hypercalciuria (excessive excretion of calcium in urine);
• kidney stones.
  Optilyte contains sodium and should therefore be administered with caution if:
• the patient has circulatory failure;
• the patient has chronic renal failure;
• the patient has edema caused by sodium retention in the body.
  Too rapid administration of the medicine may cause pulmonary edema and circulatory failure, particularly in elderly patients (over 65 years of age) and in patients with impaired cardiovascular function.

Optilyte with other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used by the patient. Exercise particular caution when using the following medicines concomitantly with Optilyte:

• corticosteroids (also known as steroids, used, among others, in the treatment of rheumatic diseases) due to the risk of sodium retention in the body;
• diuretics (medicines that increase urine production), as they may cause disturbances in water and electrolyte balance;
• calcium channel blockers (used in the treatment of hypertension and heart failure), as calcium ions present in the solution may alter their effect;
• cardiac glycosides (medicines used in the treatment of heart failure), as potassium ions present in the solution may alter their effect.

Due to its calcium content, Optilyte must not be mixed with solutions containing carbonates, phosphates, amino acids, or fat emulsions.
Because of its high content of mineral components, Optilyte must not be used to dilute medicines administered by intravenous infusion.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Optilyte may be administered to women during pregnancy and breastfeeding only if the doctor considers it necessary.

Driving and operating machinery
Optilyte has no influence on the ability to drive vehicles or operate machinery.

3. How to use Optilyte

This medicine is administered exclusively by medical personnel.
Self-administration of this medicine is not allowed.
In case of any doubts, consult a doctor.
The dosage is determined individually by the doctor for each patient, depending on the clinical condition,
fluid and electrolyte requirements, age, body weight, and laboratory test results.
Use of a higher than recommended dose of Optilyte
If the patient feels that they have received too high a dose of the medicine, they should immediately
inform the doctor or nurse.
Overdose may lead to hypervolemia (excessively high blood volume in the blood vessels),
particularly in patients with renal insufficiency.
In case of any further doubts regarding the use of this medicine, consult a doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience them.
Frequency unknown (cannot be estimated from available data):

• phlebitis at the injection site;
• extravasation (leakage of the drug outside the vein);
• increased body temperature;
• venous thrombosis (formation of blood clots accompanied by inflammation, manifested by a palpable hardening of the vein, redness around it, pain and tenderness).

The medicine is usually well tolerated. If fever or other complications occur during treatment, the physician will decide whether to discontinue administration of the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, 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 authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Optilyte

Keep the medicine out of sight and reach of children.
Do not freeze.
Use only a clear, transparent solution.
Do not use this medicine if you notice any particulate contamination or discoloration, or if the packaging
is damaged.
Any unused portion of the medicine must not be used later.
Follow aseptic handling procedures.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Optilyte contains
The active substances in the medicine are: sodium chloride, sodium acetate trihydrate, sodium citrate dihydrate, calcium chloride dihydrate, potassium chloride, magnesium chloride hexahydrate.
1000 ml of solution contains:
Sodium chloride (Natrii chloridum) 5.75 g
Sodium acetate trihydrate (Natrii acetas trihydricus) 4.62 g
Sodium citrate dihydrate (Natrii citras dihydricus) 0.90 g
Calcium chloride dihydrate (Calcii chloridum dihydricum) 0.26 g
Potassium chloride (Kalii chloridum) 0.38 g
Magnesium chloride hexahydrate (Magnesii chloridum heksahydricum) 0.20 g

Ions:
Na⁺ 141 mmol
CH₃COO⁻ 34 mmol
C₆H₅O₇³⁻ 3 mmol
Ca²⁺ 2 mmol
K⁺ 5 mmol
Mg²⁺ 1 mmol
Cl⁻ 109 mmol

The osmolarity of the solution is 295 mOsmol/l, pH: 5.5 – 7.5.
Other components (excipients) are: water for injections, hydrochloric acid (for pH adjustment).

What Optilyte looks like and contents of the pack
The medicine is a clear, colourless solution.
Packaging:

• Polyethylene container KabiPac with closure - 100 ml, 250 ml, 500 ml, 1000 ml;
• Polyethylene container KabiPac with closure - 40 x 100 ml, 20 x 250 ml, 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml, in a cardboard box;
• Polypropylene container KabiClear with closure - 100 ml, 250 ml, 500 ml, 1000 ml;
• Polypropylene container KabiClear with closure - 40 x 100 ml, 20 x 250 ml, 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer
Fresenius Kabi Polska Sp. z o.o.
ul. Sienkiewicza 25
99-300 Kutno

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Tel.: +48 22 345 67 89

Information intended exclusively for medical professionals:

Dosage and method of administration
Intravenous administration.
Dosage is determined according to the patient's clinical condition, fluid and electrolyte requirements, age, body weight, and laboratory test results.

Adults, elderly patients, and adolescents:
The infusion rate depends on the patient's clinical condition. It is recommended to administer at a rate of 3 ml/kg body weight/hour (210 ml/hour for a patient weighing 70 kg).
The maximum daily dose depends on the patient's fluid and electrolyte requirements.
The maximum daily dose is 40 ml/kg body weight.

Children:
Dosage is based on body weight (according to the total fluid requirement regimen):

• Up to 10 kg: 100 ml/kg body weight/24 hours
• 10 to 20 kg: 1000 ml + (50 ml/kg body weight for each kg above 10 kg)/24 hours

• 20 kg: 1500 ml + (20 ml/kg body weight for each kg above 20 kg)/24 hours

When calculating the volume of Optilyte solution, other fluids administered to the patient (parenterally and enterally) must be taken into account. In certain clinical situations, limitation of the total volume of isotonic infusions may be necessary, and—if hypoglycemia risk exists—glucose 1–2.5% requirements should be considered. The infusion rate depends on body weight:

• Up to 10 kg: 6 to 8 ml/kg body weight/hour
• 10 to 20 kg: 4 to 6 ml/kg body weight/hour

• 20 kg: 2 to 4 ml/kg body weight/hour

The final decision on dosage will be made by the physician based on current medical knowledge and the patient's clinical condition.

Overdose
In case of overdose, hypervolemia may occur, particularly in patients with renal insufficiency.

Interactions with other medicinal products and other forms of interactions
Particular caution is required when administering Optilyte parenterally to patients receiving glucocorticoids or mineralocorticoids due to the potential for sodium ion retention. Concomitant use of diuretics may lead to disturbances in water-electrolyte balance. Calcium ions present in the product may alter the effects of calcium channel blockers. Potassium ions may alter the effects of cardiac glycosides. Due to the presence of multiple mineral components, Optilyte should not be used to dilute drugs administered in intravenous infusions. Because of calcium content, Optilyte must not be mixed with solutions containing carbonates, phosphates, amino acids, or fat emulsions.

Preparation of the medicinal product for administration
Use only a clear solution.

Do not use this medicinal product if contamination or discoloration is observed, or if the packaging is damaged.
Any unused portion of the medicinal product is not suitable for further use.
Follow aseptic procedures.

Instructions for use of KabiPac and KabiClear container types:

1. Before use, inspect the container and solution visually—the solution should be clear and free from particulate matter (do not use damaged or previously used containers).
2. Preparing the infusion:
   a) Place the KabiPac/KabiClear container on a stable, flat surface.
   b) Remove the plastic cover/cap from the larger port (infusion port), with the arrow pointing outward from the packaging.
   c) Insert the infusion set spike vertically into the infusion port, gently rotating the set with one hand while holding the container neck with the other.
3. Adding medicinal product to the container:
   a) Place the KabiPac/KabiClear container on a stable, flat surface.
   b) Remove the plastic cover/cap from the smaller port (injection port), with the arrow pointing inward toward the packaging, then insert the needle into the center of the injection port and add the medicinal product to the KabiPac/KabiClear container.

Note: Ports are sterile and do not require disinfection before first use.
Medical devices intended for infusion and drug addition must be used according to their instructions for use. The solution formed after adding the medicinal product should be thoroughly mixed, and it must be ensured that no precipitate has formed.

Pharmaceutical incompatibilities
Do not mix with blood due to the risk of coagulation.
Do not mix Optilyte with other intravenously administered drugs that may precipitate upon mixing.

Disposal of unused medicinal product or waste
Any unused residues of the medicinal product or waste materials must be disposed of in accordance with local regulations.