FLUCONAZOLE KABI 2 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Fluconazol Kabi 2mg/ml solution for infusion EFG

Fluconazole

Read all of this leaflet carefully before you start 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 pack and other information:

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

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

Fluconazol Kabi is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Fluconazol Kabi is used to treat infections caused by fungi and can also be used to prevent fungal infections from occurring. The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine to treat the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection in the brain
• Coccidioidomycosis – a disease of the bronchopulmonary system
• Infections caused by Candidalocated in the bloodstream, in body organs (e.g. heart, lungs) or in the urinary tract
• Mucosal candidiasis – an infection that affects the mucous membranes of the mouth, throat or associated with dental prostheses

They may also prescribe Fluconazol Kabi for:

• preventing the recurrence of cryptococcal meningitis
• preventing the recurrence of mucosal infections
• preventing the spread of Candidainfections (if your immune system is weak and not working properly)

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medicine to treat the following types of fungal infections:

• Mucosal candidiasis – an infection that affects the lining of the mouth or throat.
• Infections caused by Candidalocated in the bloodstream, in body organs (e.g. heart, lungs) or in the urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

They may also give you Fluconazol Kabi for:

• preventing the spread of Candidainfections (if your immune system is weak and not working properly). preventing the recurrence of cryptococcal meningitis.

2. What you need to know before you use Fluconazol Kabi

Do not use Fluconazol Kabi

• if you are allergic to fluconazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other medicines used to treat fungal infections. Symptoms may include itching, skin rash or difficulty breathing
• if you are taking cisapride (used to treat stomach upset)
• if you are taking astemizole, terfenadine (antihistamine medicines used to treat allergies)
• if you are taking pimozide (used to treat mental illness)
• if you are taking quinidine (used to treat irregular heartbeats “arrhythmias”)
• if you are taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions

Tell your doctor, pharmacist or nurse before you start taking Fluconazol Kabi

• if you have liver or kidney problems
• if you have a heart condition, including problems with your heart rhythm
• if you have abnormal levels of potassium, calcium or magnesium in your blood
• if you experience severe skin reactions (itching, skin rash or difficulty breathing)
• if you have signs of adrenal insufficiency where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic fatigue or weakness, muscle weakness, loss of appetite, weight loss, abdominal pain).
• if the fungal infection does not improve, as alternative antifungal treatment may be necessary
• if you have ever developed a severe skin rash or skin peeling and/or sores in the mouth after using Fluconazol Kabi.

Severe skin reactions, including a drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with fluconazole treatment. Stop using Fluconazol Kabi and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Using Fluconazol Kabi with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor immediatelyif you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used for stomach upset), pimozide (used for treating mental illness), quinidine (used for treating irregular heartbeats) or erythromycin (an antibiotic for treating infections), as these medicines must not be taken with Fluconazol Kabi (see section: “Do not use Fluconazol Kabi”).

There are some medicines that may interact with Fluconazol Kabi. Make sure your doctor knows if you are taking any of the following medicines, as it may be necessary to adjust the dose or monitor to check that the medicines are still working as intended:

• rifampicin or rifabutin (antibiotics for infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (used as anesthetics)
• amitriptyline, nortriptyline (used as antidepressants)
• amphotericin B, voriconazole (antifungals)
• medicines that make the blood less viscous, to prevent the formation of clots (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
• carbamazepine, phenytoin (used to treat seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (for high blood pressure)
• olaparib (used to treat ovarian cancer)
• cyclosporine, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used to treat cancer
• halofantrine (used to treat malaria)
• statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used to reduce high cholesterol levels
• methadone (used for pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs))
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
• medicines for diabetes, such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used to treat rheumatoid arthritis)
• tolvaptan (used to treat hyponatremia (low sodium levels in the blood) or to slow the deterioration of kidney function)
• vitamin A (nutritional supplement)
• ivacaftor (alone or in combination with other medicines used to treat cystic fibrosis)
• amiodarone (used to treat irregular heartbeats “arrhythmias”)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• lurasidone (used to treat schizophrenia)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are planning to become pregnant, it is recommended that you wait one week after a single dose of fluconazole before becoming pregnant.

For longer treatment cycles with fluconazole, consult your doctor about the need to use adequate contraceptive methods during treatment, which should be continued for one week after the last dose.

Do not take Fluconazol Kabi if you are pregnant, think you may be pregnant, are trying to become pregnant or are breastfeeding, unless your doctor has told you to.

If you become pregnant while taking this medicine or within 1 week of the last dose, tell your doctor.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester may increase the risk of the baby being born with birth defects affecting the heart, bones and/or muscles.

There have been reports of babies born with congenital anomalies affecting the skull, ears and bones of the thigh and elbow in women treated for three months or more with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis. The relationship between fluconazole and these cases is unclear.

You can continue breastfeeding after taking a single dose of up to 150 mg of Fluconazol Kabi.

Do not continue breastfeeding if you are taking repeated doses of Fluconazol Kabi.

Driving and using machines

When driving vehicles or operating machines, keep in mind that dizziness or seizures may occasionally occur.

Fluconazol Kabi contains sodium

This medicine contains 88.5 mg of sodium (main component of table/cooking salt) per 25 ml. This is equivalent to 4.4% of the maximum recommended daily intake of sodium for an adult.

Ask your doctor or pharmacist if you need Fluconazol Kabi daily for a prolonged period, especially if you have been advised to follow a low-salt diet.

3. How to use Fluconazol Kabi

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor or nurse will give you this medicine by slow injection (infusion) directly into your vein. Fluconazol Kabi is supplied as a solution. It does not need to be diluted. Further information is provided at the end of this leaflet for healthcare professionals.

The following are the recommended doses of this medicine for the different types of infections. Check with your doctor or nurse if you are unsure whether you should receive treatment with Fluconazol Kabi.

Adults

Adolescents 12 to 17 years of age

Follow the dose prescribed by your doctor (adult or child posology).

Children up to 11 years

The maximum daily dose for children is 400 mg per day.

The dose will be based on the child's weight in kilograms.

Use in infants 0 to 4 weeks of age

Infants between 15 and 27 days of age:

? The same dose as described in the table, but given every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.

Infants between 0 and 14 days of age:

? The same dose as described in the table, but given every 3 days. The maximum daily dose is 12 mg per kg of body weight every 72 hours.

Sometimes, doctors may prescribe different doses than those described. Follow your doctor's instructions exactly. Ask your doctor or pharmacist if you have any doubts.

Elderly patients

The usual adult dose, unless you have kidney problems.

Patients with kidney problems

Your doctor may change your dose, depending on how well your kidneys are working.

If you receive more Fluconazol Kabi than you should

If you are worried that you may have been given too much Fluconazol Kabi, tell your doctor or nurse immediately. Symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucinations and paranoid behavior).

If you miss a dose of Fluconazol Kabi

Since this medicine will be given under close medical supervision, it is unlikely that a dose will be missed. However, if you think that a dose may have been missed, talk to your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some people develop allergic reactions, although severe allergic reactions are rare.If some of the following symptoms appear, tell your doctor immediately.

Common Adverse Effects(may affect up to 1 in 10 people):

• skin rash

Uncommon Adverse Effects(may affect up to 1 in 100 people):

• itching all over the body, skin redness or red spots with itching

Rare Adverse Effects(may affect up to 1 in 1,000 people):

• sudden wheezing when breathing, difficulty breathing or chest tightness
• swelling of the eyelids, face or lips
• severe skin reactions, such as a rash that causes blisters (this can affect the mouth and tongue).

If you experience any of these symptoms, stop using Fluconazol Kabi and tell your doctor immediately.

Fluconazol Kabi may affect your liver. Signs that indicate liver problems include:

Common Adverse Effects(may affect up to 1 in 10 people):

• vomiting

Uncommon Adverse Effects(may affect up to 1 in 100 people):

• fatigue
• loss of appetite
• yellowing of the skin or the whites of the eyes (jaundice)

Fluconazol Kabi may also affect other organs, which can lead to the following symptoms:

Uncommon Adverse Effects(may affect up to 1 in 100 people):

• seizures

Rare Adverse Effects(may affect up to 1 in 1,000 people):

• white blood cells in the blood that help defend against infections and blood cells that help stop bleeding, lower than normal, leading to bruising or unexplained bleeding, sudden fever, sore throat, ulcers in the mouth.

If you experience any of these symptoms, stop using Fluconazol Kabi and tell your doctor immediately.

Other Adverse Effects:

Additionally, if you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Common Adverse Effects (may affect up to 1 in 10 people):

• headache
• stomach upset, diarrhea, discomfort
• high blood test results indicating liver function
• rash

Uncommon Adverse Effects (may affect up to 1 in 100 people):

• reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
• insomnia, feeling of numbness
• dizziness, feeling of spinning, tingling, pinching or numbness, changes in taste sensation
• constipation, heavy digestion, gas, dry mouth
• muscle pain
• liver damage
• hives, blisters (hives), itching, increased sweating
• general feeling of discomfort, fever

Rare Adverse Effects (may affect up to 1 in 1,000 people):

• red or purple skin discoloration, which may be due to a low platelet count, other changes in blood cells
• changes in blood tests (high cholesterol, fat levels)
• agitation
• low potassium levels in the blood
• abnormal electrocardiogram (ECG), changes in heart rate or rhythm
• liver failure
• hair loss.

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

• hypersensitivity reaction with skin rash, fever, swollen glands, increased eosinophils and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))

Stop using Fluconazol Kabi and seek medical attention immediately if you notice any of the following symptoms:

• Widespread skin rash, elevated body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fluconazol Kabi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Bags (freeflex®): Do not store above 25°C. Do not freeze.

Vials (KabiPac®): Do not freeze.

The medicine should be used immediately after opening the packaging.

Do not use this medicine if you notice that the solution is not transparent or if you notice visible particles. Do not use if the packaging shows visible signs of deterioration.

This medicine is for single use. After use, discard the vial or bag and any remaining contents.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fluconazol Kabi

The active ingredient is fluconazole.

Each ml of solution contains 2 mg of fluconazole.

The other components are: sodium chloride, water for injectable preparations and sodium hydroxide (to adjust the pH).

Appearance of the Product and Package Contents

• Fluconazol Kabi is a clear, colorless solution without visible particles.
• Formats:

1, 10, 20, 25, 30, 40, 50, 60 vials/bags of 50 ml containing 100 mg of fluconazole

1, 10, 20, 25, 30, 40, 50, 60 vials/bags of 100 ml containing 200 mg of fluconazole

1, 10, 20, 25, 30, 40 vials/bags of 200 ml containing 400 mg of fluconazole.

Not all formats may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

c/ Marina 16-18,

08005 Barcelona

Spain

Manufacturer

Vials (KabiPac®):

Fresenius Kabi Polska Sp. Zo.o

Ul. Sienkiewicza 25, 99-300 Kutno

Poland

Bags (Freeflex®):

Fresenius Kabi France

6, Rue de Rempart

F-27400 Louviers

France

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

BelgiumFluconazole Fresenius Kabi 2mg/ml oplossing voor infusie

Czech RepublicFluconazol Kabi

DenmarkFluconazol Fresenius Kabi

FinlandFluconazol Fresenius Kabi

FranceFluconazole Kabi 2mg/ml

GermanyFluconazol Kabi 2mg/ml Infusionslösung

GreeceFluconazole/Kabi 2mg/ml δι?λυμα για ?γχυση

HungaryFluconazol Kabi

ItalyFluconazolo Kabi

LuxembourgFluconazol Kabi 2mg/ml Infusionslösung

MaltaFluconazole Kabi 2mg/ml solution for infusion

NetherlandsFluconazole Fresenius Kabi 2mg/ml oplossing voor infusie

PolandFluconazol Kabi

PortugalFluconazol Kabi

RomaniaFluconazol Kabi 2mg/ml solutie perfuzabila

SlovakiaFluconazol Kabi 2mg/ml, infúzny roztok

SpainFluconazol Kabi 2 mg/ml solución para perfusión

SwedenFluconazol Fresenius Kabi

United Kingdom

(Northern Ireland)Fluconazole 2mg/ml solution for infusion

Date of the last revision of this leaflet:February 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

The following information is intended only for healthcare professionals:

Intravenous infusion should be administered at a rate not exceeding 10 ml/min.

Fluconazol Kabi is formulated with a 9 mg/ml (0.9%) sodium chloride solution for infusion. Each 200 mg (100 ml vial) contains 15 mmol of Na+ and also Cl-. Since Fluconazol Kabi is available in a diluted sodium chloride solution, in patients with sodium or fluid restriction, the fluid administration rate should be taken into account.

Fluconazol is compatible with the following solutions:

• 20% glucose solution

• Ringer's solution

• Lactated Ringer's solution

• Potassium chloride solution in 5% glucose solution

• 4.2% sodium bicarbonate solution

• 9 mg/ml (0.9%) sodium chloride solution

Fluconazol can be infused through an existing line along with any of the fluids listed above. Although no specific incompatibilities have been described, it is not recommended to mix Fluconazol Kabi with other medicines before infusion.

The infusion solution is for single use.

The physical-chemical stability of the diluted product has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, dilutions should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless the dilution has been made in validated aseptic conditions.

Dilution should be performed in aseptic conditions. Before administration, the solution should be inspected to check for visible particles or discoloration. The solution should only be used if it is transparent and free of particles.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.