Fluconazole kabi

Package leaflet: Information for the user

Fluconazole Kabi, 2 mg/mL, solution for infusion
Fluconazole
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fluconazole Kabi is and what it is used for
2. What you need to know before you are given Fluconazole Kabi
3. How to use Fluconazole Kabi
4. Possible side effects
5. How to store Fluconazole Kabi
6. Contents of the pack and other information

1. What Fluconazole Kabi is and what it is 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 are Candida yeasts.

Adult patients
Your doctor may prescribe this medicine to treat the following fungal infections:

• cryptococcal meningitis – a fungal infection of the brain;
• coccidioidomycosis – a respiratory (lung and airway) disease;
• Candida infections detected in the bloodstream, organs (e.g. heart, lungs) or urinary tract;
• mucosal candidiasis – fungal infection of the mucous membranes of the mouth, throat, and oral thrush associated with wearing dentures.

Fluconazole Kabi may also be used:

• to prevent recurrence of cryptococcal meningitis;
• to prevent recurrence of mucosal candidiasis;
• to prevent Candida fungal infections (when the patient's immune system is weakened and does not function properly).

Children and adolescents (aged 0 to 17 years)
Your doctor may prescribe this medicine to treat the following fungal infections:

• mucosal candidiasis – infection of the mucous membranes of the mouth or throat;
• Candida infections detected in the bloodstream, organs (e.g. heart, lungs) or urinary tract;
• cryptococcal meningitis – a fungal infection of the brain.

Fluconazole Kabi may also be used:

• to prevent Candida fungal infections (when the patient's immune system is weakened and does not function properly);
• to prevent recurrence of cryptococcal meningitis.

2. Important information before using Fluconazole Kabi

When not to use Fluconazole Kabi
­ Do not use if the patient is allergic to fluconazole or any of the other ingredients of this medicine
(listed in section 6).
­ Do not use if the patient is allergic to other medicines used to treat fungal infections. Symptoms may
include itching, skin redness or difficulty breathing.
­ Do not use if the patient is taking astemizole or terfenadine (antihistamines used to treat
allergies).
­ Do not use if the patient is taking cisapride (used to treat stomach disorders).
­ Do not use if the patient is taking pimozide (used to treat mental disorders).
­ Do not use if the patient is taking quinidine (used to treat heart rhythm disorders).
­ Do not use if the patient is taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions
Before starting treatment with Fluconazole Kabi, discuss with your doctor, pharmacist or nurse:
­ if the patient has liver or kidney problems;
­ if the patient has heart disease, including heart rhythm disorders;
­ if the patient has abnormal levels of potassium, calcium or magnesium in the blood;
­ if the patient has had severe skin reactions (itching, skin redness, difficulty breathing);
­ if the patient shows symptoms of adrenal insufficiency, i.e. when the adrenal cortex produces
insufficient amounts of certain steroid hormones such as cortisol (persistent or prolonged fatigue,
muscle weakness, loss of appetite, weight loss, abdominal pain);
­ if the fungal infection does not improve, alternative antifungal treatment may be necessary;
­ if the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral ulcers
after taking Fluconazole Kabi.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS),
have been reported in patients treated with fluconazole. If the patient experiences any of the
symptoms of severe skin reactions described in section 4, treatment with Fluconazole Kabi must be
discontinued immediately and medical help should be sought without delay.

Fluconazole Kabi with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently
taken or might take in the future.

Inform your doctor immediately if the patient is taking astemizole or terfenadine (antihistamines
used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental
disorders), quinidine (used to treat heart rhythm disorders), or erythromycin (an antibiotic used to
treat infections), as these must not be used together with Fluconazole Kabi (see section “When not to
use Fluconazole Kabi”).

There are also other medicines that may interact with Fluconazole Kabi. Make sure your doctor is
aware if the patient is taking any of the following medicines, as dose adjustment or monitoring may
be necessary to ensure their continued effectiveness:

• rifampicin or rifabutin (antibiotics used to treat infections);
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema);
• alfentanil, fentanyl (anaesthetic medicines);
• 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 aids 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 used to prevent transplant rejection);
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines), used in the treatment of cancer;
• halofantrine (a medicine used to treat malaria);
• statins (atorvastatin, simvastatin and fluvastatin or similar medicines), used to lower high cholesterol levels;
• methadone (a painkiller);
• 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 (medicines used in HIV patients);
• diabetes medicines such as chlorpropamide, glyburide, glipizide or tolbutamide;
• theophylline (used in asthma);
• tofacitinib (a medicine used to treat rheumatoid arthritis);
• tolvaptan (used to treat hyponatremia (low blood sodium levels) 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);
• lurasidone (used to treat schizophrenia).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.

If the patient is planning to become pregnant, it is recommended to wait one week after taking a single
dose of fluconazole before attempting conception.

For longer treatment courses with fluconazole, discuss with the doctor the need for appropriate
contraception during treatment and for one week after the last dose.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should not use Fluconazole Kabi unless otherwise advised by a doctor. If the patient
becomes pregnant while taking this medicine or within 1 week after the last dose, she should contact
her doctor immediately.

Fluconazole used during the first or second trimester of pregnancy may increase the risk of
miscarriage.

Fluconazole used during the first trimester of pregnancy may increase the risk of congenital heart,
bone and/or muscle abnormalities in the newborn.

Cases of infants with congenital malformations of the skull, ears, femur and elbow bones have been
reported in mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily)
for at least 3 months. The causal relationship between fluconazole use and these cases remains
uncertain.

After a single 150 mg dose of Fluconazole Kabi, breastfeeding can be continued.
Breastfeeding should be avoided if the patient is receiving multiple doses of Fluconazole Kabi.

Driving and operating machinery
When driving or operating machinery, take into account the rare occurrence of dizziness or seizures.

Fluconazole Kabi contains sodium (salt)
This medicine contains 88.5 mg of sodium (the main component of table salt) in 25 mL. This corresponds to 4.4% of the maximum recommended daily sodium intake in the diet for adults.
If the patient needs to take Fluconazole Kabi daily for a prolonged period, especially if on a low-salt diet, this should be discussed with a doctor or pharmacist.

3. How to use Fluconazole Kabi

This medicine should always be used exactly as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
This medicine will be administered by a physician or nurse as a slow intravenous injection (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 this leaflet.
The recommended dosage of Fluconazole Kabi, depending on the type of infection, is given below.
If in doubt about the use of Fluconazole Kabi, consult the physician or nurse.
Adult patients

Adolescents aged 12 to 17 years
Follow the doctor's instructions (dosage for adult or pediatric patients).
Children up to 11 years of age
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 of age
Infants from 15 to 27 days of life
The same dose as above, but administered once every 2 days. The maximum dose is
12 mg/kg body weight every 48 hours.
Infants from 0 to 14 days of life
The same dose as above, but administered once every 3 days. The maximum dose is
12 mg/kg body weight every 72 hours.
Sometimes the doctor may recommend a different dosing regimen. The medicine should always be used as prescribed
by the doctor. If in doubt, contact the doctor or pharmacist.
Elderly patients
The dose usually used in adult patients should be given, unless the patient has renal function impairment.
Patients with renal function impairment
In patients with impaired renal function, the doctor may recommend adjustment of the dosage.
Administration of a higher than recommended dose of Fluconazole Kabi
If the patient believes they have received too high a dose of Fluconazole Kabi, they should immediately
inform the doctor or nurse. Symptoms of potential overdose may include disturbances in hearing, vision, sensation, and thinking about unreal things (hallucinations and paranoid behaviors).
Missed administration of Fluconazole Kabi
Since this medicine is administered 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 the doctor or pharmacist.
If there are any further doubts regarding the use of this medicine, consult the
doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Allergic reactions may occur in some patients, although severe allergic reactions are rare.
If any of the following symptoms occur, tell your doctor immediately:

Common adverse reactions (may affect up to 1 in 10 patients):

• Skin rash.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• Itching of the whole body, redness of the skin, or red, itchy patches.

Rare adverse reactions (may affect up to 1 in 1000 patients):

• Sudden wheezing, difficulty breathing, or tightness in the chest;
• Swelling of the eyelids, face, or lips;
• Severe skin reactions such as rash with blistering (may also affect the mouth and tongue).

If any of the above symptoms occur, treatment with Fluconazole Kabi must be discontinued and you must contact your doctor immediately.

Fluconazole Kabi may affect the liver. Liver-related symptoms include:

Common adverse reactions (may affect up to 1 in 10 patients):

• Vomiting.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• Feeling tired;
• Loss of appetite;
• Yellowing of the skin or whites of the eyes (jaundice).

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

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• Seizures.

Rare adverse reactions (may affect up to 1 in 1000 patients):

• Decrease below normal levels of white blood cells responsible for fighting infections and blood cells responsible for stopping bleeding, leading to unexpected bruising and bleeding, sudden fever, sore throat, and mouth ulcers.

If any of the above symptoms occur, treatment with Fluconazole Kabi must be discontinued and you must contact your doctor immediately.

Other adverse reactions

If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, tell your doctor or pharmacist.

Common adverse reactions (may affect up to 1 in 10 patients):

• Headache;
• Abdominal pain, diarrhoea, nausea;
• Increased liver function test values;
• Rash.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• Decrease in the number of red blood cells causing paleness, weakness, and breathlessness;
• Insomnia, drowsiness;
• Dizziness, sensation of spinning, sensory disturbances, most commonly as tingling, pricking, or numbness, taste alterations;
• Constipation, indigestion, bloating, dry mouth;
• Muscle pain;
• Liver damage;
• Blisters, urticaria, itching, increased sweating;
• Malaise, fever.

Rare adverse reactions (may affect up to 1 in 1000 patients):

• Red or purple skin discolouration, possibly due to a decrease in platelet count or changes in other blood cells;
• Changes in blood biochemical parameters (elevated cholesterol, blood lipids);
• Tremor;
• Decreased potassium levels in the blood;
• Abnormalities in ECG recording, heart rhythm disturbances;
• Liver failure;
• Hair loss.

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

• Hypersensitivity reaction with skin rash, fever, lymph node swelling, increased white blood cell count (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) (drug-induced eosinophilia and systemic symptoms, DRESS syndrome – drug reaction with eosinophilia and systemic symptoms).

If any of the following symptoms occur in a patient, treatment with Fluconazole Kabi must be discontinued and immediate medical help must be sought:

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

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell 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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Fluconazole Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and label. The expiry date refers to the last day of the stated month.
Bags (free flex)
Do not store above 25°C. Do not freeze.
Bottles (KabiPac)
Do not freeze.
The medicine should be used immediately after first opening the container.
Do not use this medicine if the solution is not clear or if visible solid particles are present. Do not use if the bottle or bag is damaged.
This medicine is for single use only. Used bottles, bags, and any unused remnants of the medicine should be discarded.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fluconazole Kabi contains

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

What Fluconazole Kabi looks like and contents of the pack

• A clear, colourless solution free from visible solid particles.

Pack sizes:

• 1, 10, 20, 25, 30, 40, 50 or 60 vials or bags of 50 mL, each containing 100 mg of fluconazole.
• 1, 10, 20, 25, 30, 40, 50 or 60 vials or bags of 100 mL, each containing 200 mg of fluconazole.
• 1, 10, 20, 25, 30 or 40 vials or bags of 200 mL, each containing 400 mg of fluconazole.

Not all pack sizes may be marketed.

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

Manufacturer
Vials (KabiPac)
Fresenius Kabi Polska Sp. z o.o.
ul. Sienkiewicza 25
99-300 Kutno
Poland

Bags (free flex)
Fresenius Kabi France
6, Rue de Rempart
F-27400 Louviers
France

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

This medicinal product is authorised for sale in 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 solution for infusion
Spain Fluconazol Kabi 2 mg/ml solution for infusion
Netherlands Fluconazole Fresenius Kabi 2 mg/ml solution for infusion
Luxembourg Fluconazol Kabi 2 mg/ml Infusionslösung
M Fluconazole Kabi 2 mg/ml solution for infusion
Germany Fluconazol Kabi 2 mg/ml Infusionslösung
Poland Fluconazole Kabi
Portugal Fluconazol Kabi
Romania Fluconazol Kabi 2 mg/ml solution for infusion
Slovakia Fluconazol Kabi 2 mg/ml, infusion solution
Sweden Fluconazol Fresenius Kabi
Hungary Fluconazol Kabi
Italy Fluconazolo Kabi
United Kingdom Fluconazole 2 mg/ml solution for infusion
(Northern Ireland)

Information intended exclusively for medical professionals:

The intravenous infusion should be administered at a rate not exceeding 10 mL per minute. Fluconazole Kabi contains 9 mg/mL (0.9%) sodium chloride solution for infusion. Each 200 mg (100 mL of infusion solution) contains 15 mmol of sodium and chloride ions. Fluconazole Kabi is formulated with sodium chloride solution; therefore, in patients requiring restriction of sodium and fluid intake, the infusion rate should be carefully considered.

Fluconazole infusion solution for intravenous use is compatible with the following infusion solutions:

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

Fluconazole may be administered through an existing intravenous line containing one of the above-mentioned solutions. Although no specific incompatibilities are known, mixing fluconazole with other medicinal products prior to administration is not recommended.

The infusion solution is intended for single use only.

Chemical and physical stability of the diluted product has been demonstrated for 24 hours at 25°C. From a microbiological standpoint, the diluted solution should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration prior to use. The storage period should not exceed 24 hours at a temperature of 2 to 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.

Dilutions must be performed under aseptic conditions. The solution should be inspected visually for discoloration and precipitation prior to administration. The solution should only be used if it is clear and free from visible particulate matter.

Any unused portions of the medicinal product or waste materials should be disposed of in accordance with local regulations.