Optilite

Package Leaflet: Information for the User

Optilyte, Solution for Infusion

Complex product

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Optilyte and what is it 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 is Optilyte and what is it used for

Optilyte is a water solution of mineral salts (sodium, potassium, calcium, magnesium) used to fill the vascular bed and restore the body's water-electrolyte balance. The composition of the medicine is very similar to the electrolyte composition of plasma. The medicine is administered intravenously.

Indications for use:

• Parenteral correction of water-electrolyte balance disorders, with excessive fluid and electrolyte loss due to, for example, vomiting and diarrhea or through intestinal or biliary fistulas, in case 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 you have:

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

Warnings and precautions

During the administration of Optilyte, the doctor will monitor the patient's condition and order blood tests (to check for fluid balance, electrolyte levels, and acid-base balance) and monitor urine output.
Optilyte contains calcium ions and will not be administered during blood transfusion through the same set.
The doctor will monitor calcium excretion in the urine if the patient has:

• hypercalciuria (excreting too much calcium in the urine);
• kidney stones.

Optilyte contains sodium and will 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, especially in elderly patients (over 65 years) and in patients with circulatory system disorders.

Optilyte and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Be especially careful when using the following medicines with Optilyte:

• corticosteroids (also known as steroids, used to treat, among other things, rheumatic disease) due to the risk of sodium ion retention in the body;
• diuretics (increasing urine production), as this may cause water-electrolyte balance disorders;
• calcium channel blockers (used to treat hypertension and heart failure), as the calcium ions in the solution may alter their effect;
• cardiac glycosides (used to treat heart failure), as the potassium ions in the solution may alter their effect.

Due to the calcium content, Optilyte should not be mixed with solutions containing carbonates, phosphates, amino acids, and fat emulsions.
Due to the presence of many mineral components, Optilyte should not be used to dilute medicines administered intravenously.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Optilyte may be administered to pregnant and breastfeeding women only if the doctor considers it necessary.

Driving and using machines

Optilyte has no effect on the ability to drive and use machines.

3. How to use Optilyte

This medicine is administered only by medical personnel. Do not use the medicine yourself.
In case of doubts, consult a doctor.
The dosage is determined by the doctor individually for each patient, depending on the clinical condition, need for fluids and electrolytes, age, weight, and laboratory test results.

Using a higher dose of Optilyte than recommended

If a higher dose of the medicine is used, tell your doctor or nurse immediately.
Overdose of the medicine may cause hyperolemia (excessive blood volume in the blood vessels), especially in patients with renal failure.
If you have any further doubts about using this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequency not known (cannot be estimated from the available data):

• vein inflammation at the injection site;
• extravasation (leakage of the medicine outside the vein);
• increased body temperature;
• vein thrombosis (formation of inflammation and small blood clots, manifesting as palpable hardening of the vein, redness around it, pain, and tenderness).

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Optilyte

Store the medicine out of sight and reach of children.
Do not freeze.
Use only a clear solution.
Do not use this medicine if you notice contamination or color changes, or if the packaging is damaged.
Unused medicine is not suitable for further use. Follow the principles of asepsis.
Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Optilyte contains

The active substances of the medicine are: sodium chloride, sodium acetate trihydrate, sodium citrate dihydrate, calcium chloride dihydrate, potassium chloride, magnesium chloride hexahydrate.
1000 ml of the 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
CH COO
34 mmol
3 mmol
C H O
Ca
2 mmol
5 mmol
K
Mg
1 mmol
Cl
109 mmol
The osmolality of the solution is 295 mOsmol/l, pH: 5.5 – 7.5.
The other ingredients (excipients) are: water for injections, hydrochloric acid (for pH adjustment).

What Optilyte looks like and contents of the pack

The medicine is a clear, colorless solution.
Packaging of the medicine:

• Polyethylene container KabiPac with cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• Polyethylene container KabiPac with cap - 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 cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• Polypropylene container KabiClear with cap - 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 authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Dosage and administration

Intravenous administration.
Dosage is determined based on the patient's clinical condition, need for fluids and electrolytes, age, weight, and laboratory test results.
Usually, the administered dose in intravenous infusion is: 1000 ml in 24 hours.
Maximum infusion rate:
The maximum 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 with a body weight of 70 kg).
Maximum daily dose:
The maximum daily dose depends on the patient's need for fluids and electrolytes.
Adult patients: the maximum daily dose is 40 ml/kg body weight.

Overdose

In case of overdose, hyperolemia may occur, especially in patients with renal failure.

Interactions with other medicines and other types of interactions

Be especially careful when using Optilyte in patients treated with corticosteroids or mineralocorticosteroids, due to the possibility of sodium ion retention in the body.
Concomitant use of diuretics may cause water-electrolyte disorders.
The calcium ions in the solution may alter the effect of calcium channel blockers.
The potassium ions in the solution may alter the effect of cardiac glycosides.
Due to the presence of many mineral components, Optilyte should not be used to dilute medicines administered intravenously.
Due to the presence of calcium, do not administer medicines containing phosphates and carbonates, amino acid solutions, and fat emulsions.

Preparation of the medicine for use

Use only a clear solution.
Do not use this medicine if you notice contamination or color changes, or if the packaging is damaged.
Unused medicine is not suitable for further use. Follow the principles of asepsis.
Instructions for use of KabiPac and KabiClear containers:

• 1. Before use, check the appearance of the container and the solution – the solution should be clear without contamination (do not use damaged and/or previously used containers).
• 2. Preparation of infusion: a) Place the KabiPac/KabiClear container on a stable and even surface. b) Remove the plastic cover/plug from the larger port (infusion port) with the arrow pointing outward. c) Insert the infusion set needle vertically into the infusion port, gently rotating the set with one hand, while holding the neck of the container with the other hand.
• 3. Adding medicine to the packaging: a) Place the KabiPac/KabiClear container on a stable and even surface. b) Remove the plastic cover/plug from the smaller port (injection port) with the arrow pointing inward, and then insert the needle into the center of the injection port and add the medicinal product to the KabiPac/KabiClear container.

Note: The ports are sterile, do not require disinfection before first use.

Medical devices intended for administration and addition of the medicine should be used in accordance with their instructions for use. The solution obtained after adding the medicine should be carefully mixed and checked to ensure that no precipitate has formed in the solution.

Incompatibilities

Do not mix with blood due to the possibility of coagulation.
Do not mix the medicine with other medicines administered intravenously that may precipitate when mixed.

Disposal of unused medicine

Any unused medicine or waste material should be disposed of in accordance with local regulations.