mg / ml Infusion solution
fluconazole
What Fluconazole Fresenius Kabi is and what it is used for
Fluconazole Fresenius Kabi belongs to a group of medicines used to treat fungal infections. The active substance is fluconazole.
Fluconazole Fresenius Kabi is used to treat infections caused by fungi, and can also be used to prevent a fungal infection. The most common cause of fungal infections is a yeast called Candida
Adults
You can get this medicine from a doctor to treat the following fungal infections:
- Meningitis caused by cryptococcus – a fungal infection of the brain
- Coccidioidomycosis is – a lung disease
- Infection is caused by Candida and is found in the bloodstream, internal organs (eg heart, lungs), or urinary tract.
- A fungal infection that affects the lining of the mouth, throat and can cause mouth soreness when using a denture
You can also get Fluconazole Fresenius Kabi to:
- prevent recurrence of meningitis caused by cryptococci.
- prevent the recurrence of fungal infections in the mouth
- prevent infection caused by Candida (if you have a weakened immune system)
Children and adolescents (0 to 17 years)
You can get this medicine from your doctor to treat these types of fungal infections:
- Fungal infection in the mouth – an infection that affects the lining of the mouth and throat
- Infection is caused by Candida and is found in the bloodstream, internal organs (eg heart, lungs), or urinary tract.
- Meningitis caused by cryptococcus – a fungal infection of the brain
You can also get Fluconazole Fresenius Kabi to:
- prevent infection caused by Candida (if you have a weakened immune system).
- prevent recurrence of meningitis caused by cryptococci.
Fluconazole contained in Fluconazole Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you get Fluconazole Fresenius Kabi
You should not be treated with Fluconazole Fresenius 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 that you have taken to treat fungal infections. Symptoms may include itching, redness of the skin, or difficulty breathing.
- if you are taking astemizole or terfenadine ( antihistamine for the treatment of allergies )
- if you are taking cisapride (for stomach upset)
- if you are taking pimozide (used to treat mental illness)
- if you are taking quinidine (used to treat irregular heartbeat, “arrhythmia”)
- if you are taking erythromycin ( antibiotic to treat infections ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Fluconazole Fresenius Kabi:
- if you have liver or kidney problems
- if you have any heart disease, e.g. irregular heartbeat
- if you have abnormal levels of potassium, calcium, or magnesium in your blood
- if you develop severe skin reactions ( itching, redness of the skin, or difficulty breathing).
- if you develop signs of adrenal insufficiency, where the adrenal glands do not produce enough of certain steroid hormones such as cortisol ( chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
Other medicines and Fluconazole Fresenius Kabi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for the treatment of allergies ) or cisapride (used to treat stomach upset) or pimozide (used to treat mental disorders) or quinidine (used to treat irregular heartbeat), or erythromycin (an antibiotic for the treatment of infections ) as these should not be taken with Fluconazole Fresenius Kabi (see section “You should not be treated with Fluconazole Fresenius Kabi”).
Some medications can be affected by or affect Fluconazole Fresenius Kabi.
Tell your doctor if you are taking any of the following medicines:
- rifampicin, rifabutin ( antibiotics for infections )
- Alfentanil, fentanyl (used as anesthetic)
- Amitriptyline, nortriptyline (used to treat depression)
- amphotericin B, voriconazole (for fungal infections)
- blood-thinning drugs (eg warfarin ) to prevent blood clots
- benzodiazepines (eg midazolam, triazolam) used for insomnia or anxiety
- carbamazepine, phenytoin (for epilepsy )
- nifedipine, isradipine, amlodipine, verapamil, felodipine or losartan (for high blood pressure )
- olaparib (used to treat ovarian cancer)
- ciclosporin, everolimus, sirolimus or tacrolimus (used after transplants)
- cyclophosphamide, vinca alkaloids (eg vincristine, vinblastine) used to treat cancer
- halofantrine (against malaria )
- statins (eg atorvastatin, simvastatin, and fluvastatin) used to lower blood cholesterol
- methadone (for pain)
- celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs, NSAIDs )
- birth control pills
- prednisone ( steroid )
- zidovudine (also known as AZT) or saquinavir (used to treat HIV )
- drugs against diabetes as chlorpropamide, glibenclamide, glipizide or tolbutamide
- theophylline (for asthma )
- tofacitinib (for rheumatoid arthritis )
- A vitamin (nutritional supplements)
- Ivacaftor (used to treat cystic fibrosis )
- amiodarone (used to treat irregular heartbeat, “arrhythmia”)
- hydrochlorothiazide (diuretic)
- ibrutinib (used to treat blood cancer)
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Fluconazole Fresenius Kabi when you are pregnant unless your doctor tells you to.
You can continue breastfeeding after taking a single dose of 150 mg Fluconazole Fresenius Kabi.
You should not breast-feed if you take repeated doses of Fluconazole Fresenius Kabi.
Driving and using machines
When driving a vehicle or using machines, keep in mind that you may experience dizziness or seizures during treatment.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Fluconazole Fresenius Kabi contains sodium
This medicinal product contains 177/354/708 mg sodium (the main ingredient in table salt/table salt) per 50/100/200 ml. This corresponds to 8.85 / 17.7 / 35.4% of the highest recommended daily intake of sodium for adults.
How Fluconazole Fresenius Kabi is given
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
This medicine will be given to you by a doctor or nurse as a slow injection ( infusion ) into a vein. Fluconazole Fresenius Kabi is provided as a solution and will not be further diluted. There is more information for healthcare professionals in the last section of the package leaflet.
The table below shows the recommended doses for different infections. Ask your doctor or nurse if you are not sure why you are getting Fluconazole Fresenius Kabi.
| Infection | Dose |
| To treat meningitis caused by cryptococci | 400 mg on the first day, then 200 mg to 400 mg once daily for 6 to 8 weeks or longer as needed. Sometimes the dose is increased by up to 800 mg |
| To prevent recurrence of meningitis caused by cryptococci | 200 mg once daily until your doctor tells you to stop |
| To treat coccidioidomycosis | 200 mg to 400 mg once daily from 11 months up to 24 months or longer if needed. Sometimes the dose is increased by up to 800 mg |
| To treat internal fungal infections caused by Candida | 800 mg on the first day, then 400 mg once daily until your doctor tells you to stop |
| Fungal infection of the mouth affects the lining of the mouth, throat and can cause inflammation of the oral mucosa when using a denture | 200 mg to 400 mg on the first day, then 100 mg to 200 mg until your doctor tells you to stop |
| To treat a fungal infection in the mouth (cod) – dose one depends on exactly where the infection is | 50 mg to 400 mg once daily for 7 to 30 days until your doctor tells you to stop |
| To prevent the recurrence of fungal infections that affect the mucous membranes of the mouth and throat | 100 mg to 200 mg once daily or 200 mg three times a week as long as you are at risk of getting an infection |
| To prevent infection caused by Candida (if you have a weakened immune system) | 200 mg to 400 mg once daily as long as you are at risk of getting an infection |
Use in adolescents between 12 and 17 years of age
Use dose one prescribed by your doctor (according to the recommendations for either adults or children).
Use in children up to 11 years
The maximum dose for children is 400 mg daily.
Dose one is based on the child’s weight in kg.
| Infection | Daily dose |
| Fungal infections of the mouth and throat infections caused by Candida – dose, and duration of treatment depends on how severe the infection is and where it is located | 3 mg per kg body weight once daily (6 mg per kg body weight can be given on the first day) |
| Meningitis caused by cryptococcus or internal fungal infections caused by Candida | 6 mg to 12 mg per kg body weight once daily |
| To prevent the recurrence of meningitis caused by cryptococci | 6 mg per kg body weight once daily |
| To prevent the child from getting an infection caused by Candida (if the child has a weakened immune system) | 3 mg to 12 mg per kg body weight once daily |
Use in infants between 0 and 4 weeks
Infants between 15 and 27 days:
- The same dose as above is given every other day. The maximum dose is 12 mg per kg body weight every other day (48 hours).
Infants 0-14 days:
- The same dose as above is given every three days. The maximum dose is 12 mg per kg body weight every three days (72 hours).
Your doctor may prescribe you other doses than those listed here. Always use Fluconazole Fresenius Kabi exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Older
The usual dose for adults can be used unless you have kidney problems.
Patients with renal failure
Your doctor may change the dose depending on your kidney function.
If you take more Fluconazole Fresenius Kabi then you should
If you are concerned that you have received too much Fluconazole Fresenius Kabi, or if, for example, a child has accidentally ingested the medicine, tell your doctor or nurse immediately, or contact the Poison Information Center to assess the risk and advice. The symptoms of a possible overdose may be that you start hearing, seeing, feeling, and thinking things that are not real (hallucinations and paranoid behaviors).
If a dose of Fluconazole Fresenius Kabi has been missed
As you will receive this medicine under close medical supervision, it is unlikely that a dose will be missed. Talk to your doctor or pharmacist if you think a dose has been missed.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some people develop allergic reactions, although severe allergic reactions are rare. If you get any of the following symptoms, contact your doctor immediately.
Common side effects (may affect up to 1 in 10 people) are:
- rash
Uncommon side effects (may affect up to 1 in 100 people) are:
- itching all over the body, reddening of the skin or itchy, red spots
Rare side effects (may affect up to 1 in 1,000 people) are:
- sudden wheezing, difficulty breathing, or a tight feeling in the chest
- swelling of the eyelids, face, or lips
- severe skin reactions, e.g. a rash with blistering (this can affect the mouth and tongue).
If any of these occur, stop using Fluconazole Fresenius Kabi and contact your doctor immediately.
Fluconazole Fresenius Kabi can affect your liver. Signs of hepatic impairment include:
Common side effects (may affect up to 1 in 10 people) are:
- vomiting
Uncommon side effects (may affect up to 1 in 100 people) are:
- fatigue
- decreased appetite
- yellowish skin or yellowish whites of the eyes (jaundice)
Fluconazole Fresenius Kabi can also affect other organ systems, which can cause the following symptoms:
Uncommon side effects (may affect up to 1 in 100 people) are:
- cramps
Rare side effects (may affect up to 1 in 1,000 people) are:
- decreased number of white blood cells that help defend the body against infection and decreased number of blood cells that help stop bleeding, leading to unexpected bruising or bleeding, sudden fever, sore throat, sore mouth
If any of these occur, stop using Fluconazole Fresenius Kabi and contact your doctor immediately.
Other side effects are
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people):
- headache
- feeling uncomfortable in the stomach, diarrhea, nausea
- elevated liver values
- rash
Uncommon side effects (may affect up to 1 in 100 people):
- decreased amount of red blood cells which can lead to pale skin and cause weakness and shortness of breath
- difficulty sleeping, drowsiness
- dizziness, tingling sensation, and crawling, tingling or numbness, taste changes
- constipation, indigestion, gas tension, dry mouth
- muscle pain
- liver damage
- streaks in the skin, blistering ( hives ), itching, sweating
- general malaise, fever
Rare side effects (may affect up to 1 in 1,000 people):
- red or purple discoloration of the skin that may be caused by decreased platelet count or other changes in the blood
- elevated blood cholesterol and blood fat levels
- shaking
- decreased level of potassium in the blood
- abnormal ECG, changes in heart rate or heart rate
- liver failure
- hair loss
No known frequency but may occur (cannot be calculated from the available data):
- hypersensitivity reaction with skin rash, fever, swollen glands, increased amount of a white blood cell type ( eosinophilia ), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) (so-called “drug reaction with eosinophilia and systemic symptoms”, (DRESS )).
5. How to store Fluconazole Fresenius Kabi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Bags (free flex ): Do not store above 25 ° C. Do not freeze.
Bottles (KabiPac): Do not freeze.
The medicine must be used immediately after opening the bottle or bag.
Do not use this medicine if you notice that the solution is not clear or if you see visible particles.
Do not use it if the bottle or bag is damaged.
The bottles or bags are for single use only. Once used, the bottles or bags and any remaining medicine should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is fluconazole. Each ml contains 2 mg of fluconazole
- The other ingredients are: sodium chloride, water for injections, and sodium hydroxide or hydrochloric acid (for pH adjustment)
What the medicine looks like and the contents of the pack
- Fluconazole Fresenius Kabi is a clear, colorless solution with no visible particles.
- Pack sizes:
1, 10, 20, 25, 30, 40, 50, 60 bottles / bags x 50 ml with 100 mg fluconazole
1, 10, 20, 25, 30, 40, 50, 60 bottles / bags x 100 ml with 200 mg fluconazole
1, 10, 20, 25, 30, 40 bottles / bags x 200 ml with 400 mg fluconazole
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi AB
751 74 Uppsala
Manufacturer
Bottles (KabiPac)
Fresenius Kabi Polska Sp. z oo
ul. Sienkiewicza 25, 99-300 Kutno
Poland
and
Bags (free flex ).
Fresenius Kabi France
6, Rue de Rempart
F-27400 Louviers
France