Fluconazole Kabi

Leaflet accompanying the packaging: information for the user

Fluconazole Kabi, 2 mg/mL, solution for infusion

Fluconazole

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Fluconazole Kabi and what is it used for

Fluconazole Kabi belongs to a group of antifungal medicines. The active substance is fluconazole.
Fluconazole Kabi is used to treat fungal infections and to prevent fungal infections. The most common cause of fungal infections is Candida yeast.

Adult patients

The doctor may recommend using this medicine to treat the following fungal infections:

• –cryptococcal meningitis – a fungal infection of the brain;
• –coccidioidomycosis – a disease of the respiratory system;
• –infections caused by Candida fungi, detected in the bloodstream, organs (e.g., heart, lungs), or urinary system;
• –mucosal thrush – an infection of the mucous membrane of the mouth, throat, and mouth ulcers associated with wearing dentures.

Fluconazole Kabi can also be used to:

• –prevent relapses of cryptococcal meningitis;
• –prevent relapses of oral thrush;
• –prevent fungal infections caused by Candida fungi (if the patient's immune system is weak and not functioning properly).

Children and adolescents (from 0 to 17 years old)

The doctor may recommend using this medicine to treat the following fungal infections:

• –oral thrush – an infection of the mucous membrane of the mouth or throat;
• –infections caused by Candida fungi, detected in the bloodstream, organs (e.g., heart, lungs), or urinary system;
• –cryptococcal meningitis – a fungal infection of the brain.

Fluconazole Kabi can also be used to:

• –prevent fungal infections caused by Candida fungi (if the patient's immune system is weak and not functioning properly);
• –prevent relapses of cryptococcal meningitis.

2. Important information before using Fluconazole Kabi

When not to use Fluconazole Kabi

If the patient is allergic to fluconazole or any of the other ingredients of this medicine (listed in section 6).
If the patient is allergic to other antifungal medicines. Symptoms may include itching, redness of the skin, or difficulty breathing.
If the patient is taking astemizole, terfenadine (antihistamines used to treat allergies).
If the patient is taking cisapride (used to treat stomach disorders).
If the patient is taking pimozide (used to treat mental disorders).
If the patient is taking quinidine (used to treat heart rhythm disorders).
If the patient is taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions

Before starting to use Fluconazole Kabi, the patient should discuss it with their doctor, pharmacist, or nurse:In patients treated with fluconazole, there have been cases of severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient experiences any of the symptoms of severe skin reactions described in section 4, they should stop using Fluconazole Kabi and seek medical help immediately.

Fluconazole Kabi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should immediatelytell their doctor if they are taking astemizole, terfenadine (antihistamines used to treat allergies), or cisapride (used to treat stomach disorders), or pimozide (used to treat mental disorders), or quinidine (used to treat heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as they should not be taken with Fluconazole Kabi (see "When not to use Fluconazole Kabi").
There are also other medicines that may interact with Fluconazole Kabi. The patient should make sure their doctor knows about the use of any of the following medicines, as it may be necessary to adjust the dose or monitor to check if the medicines are still effective:

• rifampicin or rifabutin (antibiotics used to treat infections);
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungal medicines);
• blood thinners, medicines that prevent blood clots (warfarin or similar medicines);
• benzodiazepines (midazolam, triazolam, or similar medicines), sleeping pills or sedatives;
• carbamazepine, phenytoin (medicines used to treat epilepsy);
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (medicines used to treat high blood pressure);
• olaparib (a medicine used to treat ovarian cancer);
• cyclosporine, everolimus, sirolimus, or tacrolimus (medicines that prevent transplant rejection);
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used to treat cancer;
• halofantrine (a medicine used to treat malaria);
• statins (atorvastatin, simvastatin, and fluvastatin or similar medicines) used to lower high cholesterol;
• methadone (a pain reliever);
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs));
• oral contraceptives;
• prednisolone (a steroid medicine);
• zidovudine, also known as AZT; saquinavir (a medicine used in patients with HIV);
• medicines for diabetics, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide;
• theophylline (used to treat asthma);
• tofacitinib (a medicine used to treat rheumatoid arthritis);
• tolvaptan used to treat hyponatremia (low sodium levels in the blood) or to slow the worsening of kidney function;
• vitamin A (dietary supplement);
• ivacaftor (used alone or in combination with other medicines to treat cystic fibrosis);
• amiodarone (a medicine used to treat heart rhythm disorders);
• hydrochlorothiazide (a diuretic);
• ibrutinib (a medicine used to treat blood cancer);
• lurasydon (used to treat schizophrenia).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
If the patient plans to become pregnant, it is recommended that they wait for one week after taking a single dose of fluconazole before becoming pregnant.
In case of longer treatment cycles with fluconazole, the patient should discuss with their doctor the need for adequate contraception during treatment and for one week after the last dose.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should not use Fluconazole Kabi unless their doctor has recommended it. If the patient becomes pregnant while using this medicine or within one week of the last dose, they should contact their doctor.
Fluconazole used in the first or second trimester of pregnancy may increase the risk of miscarriage.
Fluconazole used in the first trimester of pregnancy may increase the risk of congenital heart, bone, and/or muscle defects in the newborn.
There have been cases of children with congenital skull, ear, and femur defects born to mothers treated with high doses of fluconazole (400-800 mg/day) for at least 3 months for coccidioidomycosis. The relationship between fluconazole use and these cases is uncertain.
After taking a single dose of 150 mg of Fluconazole Kabi, breastfeeding can be continued.
Breastfeeding should not be done if the patient is taking multiple doses of Fluconazole Kabi.

Driving and using machines

When driving or using machines, the patient should take into account the occasional occurrence of dizziness or seizures.

Fluconazole Kabi contains sodium (salt)

This medicine contains 88.5 mg of sodium (the main component of common salt) in 25 mL. This corresponds to 4.4% of the maximum recommended daily intake of sodium in the diet for adults.
If the patient needs to use Fluconazole Kabi for a long time, especially if they have been prescribed a low-salt diet, they should discuss this with their doctor or pharmacist.

3. How to use Fluconazole Kabi

This medicine should always be used exactly as recommended by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
This medicine is administered by a doctor or nurse through slow intravenous infusion.
Fluconazole Kabi is supplied as a solution. The medicine will not be further diluted.
Detailed information for healthcare professionals is provided at the end of the leaflet.
The recommended dosage of Fluconazole Kabi, depending on the type of infection, is presented below.
The patient should ask their doctor or nurse if they have any doubts about using Fluconazole Kabi.

Adult patients

Adolescents from 12 to 17 years old

The patient should follow the doctor's recommendations (dosage for adults or children).

Children up to 11 years old

The maximum dose in children is 400 mg per day.
The dose should be determined based on the child's body weight (kg).

Infants from 0 to 4 weeks old

Infants from 15 to 27 days old
The same dose as above, but given every 2 days. The maximum dose is 12 mg/kg body weight every 48 hours.
Infants from 0 to 14 days old
The same dose as above, but given every 3 days. The maximum dose is 12 mg/kg body weight every 72 hours.
Sometimes the doctor may recommend a different dosage. The medicine should always be used as recommended by the doctor. In case of doubts, the patient should contact their doctor or pharmacist.

Elderly patients

The usual dose for adults is given, unless the patient has kidney problems.

Patients with kidney problems

In patients with kidney problems, the doctor may recommend changing the dosage.

Using more than the recommended dose of Fluconazole Kabi

If the patient is convinced that they have received too much Fluconazole Kabi, they should immediately inform their doctor or nurse. Symptoms of potential overdose may include hearing, vision, or feeling disturbances, and thinking about unreal things (hallucinations and paranoid behavior).

Missing a dose of Fluconazole Kabi

Since this medicine is used under strict medical supervision, it is unlikely that a dose will be missed. However, if the patient suspects that a dose has been missed, they should inform their doctor or pharmacist.
In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In some patients, allergic reactionsmay occur, but severe allergic reactions are rare. If the patient experiences any of the following symptoms, they should immediatelytell their doctor:

• Frequent side effects (may affect up to 1 in 10 people):
• rash on the skin. Less common side effects (may affect up to 1 in 100 people):
• itching all over the body, redness of the skin, or red, itchy spots. Rare side effects (may affect up to 1 in 1000 people):
• –sudden shortness of breath, difficulty breathing, or chest tightness;
• –swelling of the eyelids, face, or lips;
• –severe skin reactions, such as a rash with blisters (may also affect the mouth and tongue).

If the patient experiences any of the above symptoms, they should stop using Fluconazole Kabi and immediatelycontact their doctor.
Fluconazole Kabi may affect the liver. Liver-related symptoms include:

• Frequent side effects (may affect up to 1 in 10 people):
• nausea and vomiting. Less common side effects (may affect up to 1 in 100 people):
• –feeling tired;
• –loss of appetite;
• –yellowing of the skin or whites of the eyes (jaundice).

Fluconazole Kabi may also affect other body systems, which may manifest as follows:

• Less common side effects (may affect up to 1 in 100 people):
• –seizures.

Rare side effects (may affect up to 1 in 1000 people):

• –decreased number of white blood cells in the blood responsible for fighting infections and blood cells responsible for stopping bleeding, causing unexpected bruising and bleeding, sudden fever, sore throat, and mouth ulcers.

If the patient experiences any of the above symptoms, they should stop using Fluconazole Kabi and immediatelycontact their doctor.

Other side effects

If any of the side effects worsen or if the patient experiences any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
Frequent side effects (may affect up to 1 in 10 people):

• –headache;
• –abdominal pain, diarrhea, nausea;
• –increased liver enzyme values;
• –rash.

Less common side effects (may affect up to 1 in 100 people):

• –decreased number of red blood cells causing paleness, weakness, and shortness of breath;
• –insomnia, drowsiness;
• –dizziness, feeling of spinning, disturbances in feeling, usually in the form of tingling, numbness, or prickling, changes in taste;
• –constipation, indigestion, bloating, dry mouth;
• –muscle pain;
• –liver damage;
• –bubbles, hives, itching, increased sweating;
• –malaise, fever.

Rare side effects (may affect up to 1 in 1000 people):

• –red or purple discoloration of the skin, which may be caused by a decrease in the number of platelets or changes in other blood cells;
• –changes in blood biochemical parameters (high cholesterol, lipid levels in the blood);
• –tremors;
• –decreased potassium levels in the blood;
• –ECG changes, heart rhythm disorders;
• –liver failure;
• –hair loss.

Frequency not known, but may also occur (frequency cannot be estimated from the available data):

• hypersensitivity reaction with skin rash, fever, swelling of lymph nodes, increased number of white blood cells (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) (drug reaction with eosinophilia and systemic symptoms, DRESS).

If the patient experiences any of the above symptoms, they should stop using Fluconazole Kabi and immediatelyseek medical help:

• –widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Department of Medicinal Product Registration, Medical Devices, and Biocides)
Al. Jerozolimskie 181C
02-222 Warsaw
phone: +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.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Fluconazole Kabi

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and label. The expiry date refers to the last day of the month.
Bags (freeflex)
Do not store above 25°C. Do not freeze.
Bottles (KabiPac )
Do not freeze.
The medicine should be used immediately after opening the container.
Do not use this medicine if the solution is not clear or contains visible particles. Do not use if the bottle or bag is damaged.
The medicine is for single use only. Used bottles, bags, and any unused medicine should be disposed of.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fluconazole Kabi contains

• –The active substance of the medicine is fluconazole.
• –Each mL contains 2 mg of fluconazole.
• –The other ingredients are sodium chloride, water for injections, and sodium hydroxide and hydrochloric acid (to adjust pH).

What Fluconazole Kabi looks like and contents of the packaging

• –Clear, colorless solution without visible particles.
• –Packaging sizes:
• –1, 10, 20, 25, 30, 40, 50, or 60 bottles or bags of 50 mL, containing 100 mg of fluconazole.
• –1, 10, 20, 25, 30, 40, 50, or 60 bottles or bags of 100 mL, containing 200 mg of fluconazole.
• –1, 10, 20, 25, 30, or 40 bottles or bags of 200 mL, containing 400 mg of fluconazole.

Not all packaging sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Bottles (KabiPac )
Fresenius Kabi Polska Sp. z o.o.
ul. Sienkiewicza 25
99-300 Kutno
and
Bags (freeflex)
Fresenius Kabi France
6, Rue de Rempart
F-27400 Louviers
France
To obtain more detailed information, the patient should contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
phone: +48 22 345 67 89

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium
Fluconazole Fresenius Kabi 2 mg/ml solution for infusion
Czech Republic
Fluconazol Kabi
Denmark
Fluconazol Fresenius Kabi
Finland
Fluconazol Fresenius Kabi
France
Fluconazole Kabi 2 mg/ml
Greece
Fluconazole/Kabi 2 mg/ml διάλυμα για έγχυση
Spain
Fluconazol Kabi 2 mg/ml solución para perfusión
Netherlands
Fluconazole Fresenius Kabi 2 mg/ml oplossing voor infusie
Luxembourg
Fluconazol Kabi 2 mg/ml Infusionslösung
United Kingdom (Northern Ireland)
Fluconazole 2 mg/ml solution for infusion
Date of last revision of the leaflet:15.03.2024
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Information intended for healthcare professionals only:
Intravenous infusion should be administered at a rate not exceeding 10 mL/minute. Fluconazole Kabi contains 9 mg/mL (0.9%) sodium chloride injection solution. Each 200 mg (100 mL infusion solution) contains 15 mmol of sodium and chloride ions. Fluconazole Kabi is available as a solution diluted with sodium chloride solution, so patients controlling sodium and fluid intake should pay attention to the rate of solution administration.
Fluconazole infusion solution is compatible with the following infusion solutions:

• 20% dextrose solution;
• Ringer's solution;
• Ringer's solution with lactate;
• Potassium chloride solution in 5% dextrose solution;
• 4.2% sodium bicarbonate solution;
• 9 mg/mL (0.9%) sodium chloride solution.

Fluconazole can be administered through an existing intravenous access with one of the above solutions. Although there are no specific incompatibilities, it is not recommended to mix fluconazole with other medicines before administration.
The infusion solution is for single use only.
Chemical and physical stability of the diluted medicine has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration before use. The storage time should not exceed 24 hours at a temperature between 2°C and 8°C, unless the dilution has taken place in controlled and validated aseptic conditions.
Dilutions should be performed under aseptic conditions. The solution should be inspected before administration for changes in color and precipitation. The solution should only be used if it is clear and free from visible particles.
Any unused medicine or waste should be disposed of in accordance with local regulations.