FLUCONAZOLO 2 mg /Ml Roztwór Do Infuzji

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1. Fluconazole B. Braun 2 mg/ml solution for infusion
   1. WHAT IS FLUCONAZOLO B. BRAUN AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING FLUCONAZOLE B. BRAUN 2 MG/ML
   3. HOW TO TAKE FLUCONAZOLO B. BRAUN 2 mg/ml
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FLUCONAZOLO B. BRAUN 2 mg/ml
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Fluconazole B. Braun 2 mg/ml solution for infusion

Fluconazole

Generic medicine

Read this leaflet carefully before you start to use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, see your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS FLUCONAZOLO B. BRAUN AND WHAT IS IT USED FOR

Fluconazolo B. Braun belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
Fluconazolo is used for the treatment of fungal infections and can be used to prevent infections caused by
Candida. The most common cause of fungal infections is a yeast called Candida.

Adults
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain.
• Coccidioidomycosis - a disease of the bronchopulmonary system.
• Infections caused by Candida and found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract.
• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures.

Fluconazolo B. Braun may be prescribed for:

• preventing the recurrence of cryptococcal meningitis,
• preventing the recurrence of candidiasis of the mucous membranes,
• preventing Candida infections (if your immune system is weak or not functioning properly).

Children and adolescents(from 0 to 17 years)
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection.
• Infections caused by Candida and found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract.
• Cryptococcal meningitis - a fungal infection of the brain.

Fluconazolo B. Braun may be prescribed for:

• Preventing Candida infections (if your immune system is weak or not functioning properly).
• Preventing the recurrence of cryptococcal meningitis.

2. WHAT YOU NEED TO KNOW BEFORE USING FLUCONAZOLE B. BRAUN 2 MG/ML

Do not take Fluconazole B. Braun if you:

• are allergic to fluconazole, to other medicines that you have used for the treatment of fungal infections or to any of the excipients of Fluconazole (listed in section 6). Symptoms may include itching, redness of the skin or difficulty in breathing
• are taking astemizole, terfenadine (antihistamines used for allergies)
• are taking cisapride (used for the treatment of stomach disorders)
• are taking pimozide (used for the treatment of mental disorders)
• are taking quinidine (used for the treatment of heart arrhythmias)
• are taking erythromycin (antibiotic used for the treatment of infections).

Warnings and precautions
Tell your doctor before using Fluconazole B. Braun 2 mg/ml if:

• you have liver or kidney problems,
• you suffer from heart diseases, including problems with the heartbeat,
• you have abnormal levels of potassium, calcium or magnesium in the blood,
• severe skin reactions occur (itching, redness of the skin or difficulty in breathing)
• signs of “adrenal insufficiency” appear, that is, the adrenal glands do not produce enough of certain steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).

Other medicines and Fluconazole B. Braun 2 mg/ml
Tell your doctor if you are taking, have recently taken or might take any other medicine.
Immediately inform your doctor if you are taking astemizole, terfenadine (antihistamine used for the
treatment of allergies) or cisapride (used for the treatment of stomach disorders) or pimozide (used
for the treatment of mental disorders) or quinidine (used for the treatment of heart arrhythmias) or erythromycin
(antibiotic used for the treatment of bacterial infections), as these must not be taken with
Fluconazole B. Braun 2 mg/ml (see paragraph: ”Do not take Fluconazole B. Braun 2 mg/ml if you”).
There are some medicines that can interact with Fluconazole B. Braun 2 mg/ml. Tell your doctor if you are
taking any of the following medicines:

• rifampicin, rifabutin or azithromycin (antibiotics for infections),
• alfentanil, fentanyl (used as anesthetics),
• amiodarone (used for the treatment of irregular heartbeats or “arrhythmias”),
• amitriptyline, nortriptyline (used as antidepressants),
• amphotericin B, voriconazole (antifungals),
• medicines that thin the blood 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 for the treatment of seizures),
• nifedipine, isradipine, amlodipine, felodipine, verapamil, hydrochlorothiazide (a diuretic) and losartan (used for hypertension - high blood pressure),
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for the treatment of cancer,
• halofantrine (used for the treatment of malaria),
• statins (atorvastatin, simvastatin, fluvastatin or similar medicines) used to reduce high cholesterol levels,
• methadone (used for the treatment of 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 patients with HIV),
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide,
• theophylline (used for asthma control),
• vitamin A (food supplement),
• ivacaftor (used for the treatment of cystic fibrosis)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
The doctor will decide if you should take Fluconazole B. Braun 2 mg/ml.
You can continue breastfeeding after the administration of a single dose of fluconazole equal to or less than
200 mg.
You should not breastfeed if you are taking repeated doses of fluconazole.

Driving and using machines
You should be aware that dizziness or convulsions may occur while driving or using machines.

Fluconazole B. Braun 2 mg/ml contains sodium
Fluconazole B. Braun contains 3.54 mg of sodium per ml. This should be taken into consideration for patients on a
controlled sodium diet.

3. HOW TO TAKE FLUCONAZOLO B. BRAUN 2 mg/ml

This medicine will be given to you by a doctor or nurse as a slow injection
(infusion) into a vein. Fluconazolo B. Braun 2 mg/ml is available in solution. It will not be further diluted. The

Recommended dose
The recommended doses of this medicine to be taken depending on the infection are listed below. If
you have any doubts about why you have been prescribed Fluconazolo B. Braun 2 mg/ml, consult your doctor or nurse.

Adults

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (or the adult or children's dosage).

Children up to 11 years
The maximum dose in children is 400 mg per day.
The dose will be based on the child's weight in kilograms.

Use in infants aged 0 to 4 weeks
Use in infants aged 3 to 4 weeks of life:
The same dosage as described above, but administered once every 2 days. The maximum dose is 12 mg per kg
of body weight every 48 hours.

Use in infants under 2 weeks of age
The same dosage as described above, but administered once every 3 days. The maximum dose is 12 mg per kg
of body weight every 72 hours.

Use in the Elderly
The same dose as intended for adults should be used, unless you have kidney problems.

Patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

If you receive more Fluconazolo B. BRAUN 2 mg/ml than you should
If you are concerned that you may have been given a dose of Fluconazolo B. BRAUN higher than you should,
inform your doctor or nurse immediately. Symptoms of a possible overdose may include
experiencing, seeing, and thinking things that are not real (hallucinations and paranoid behavior).

If a dose of Fluconazolo B. BRAUN 2 mg/ml is forgotten
Since this medicine will be administered under close medical supervision, it is unlikely that a dose,
may be forgotten. However, inform your doctor or pharmacist if you think a dose has been forgotten.
If you have any doubts about using this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, fluconazole can cause side effects, although not everybody gets them.
Some people experience allergic reactions, although serious allergic reactions are rare (may
occur in up to 1 in 1000 people).
If you experience any of the following symptoms, tell your doctor immediately:

• sudden shortness of breath, difficulty breathing or feeling of tightness in the chest,
• swelling of the eyelids, face or lips,
• itching all over the body, redness of the skin or itchy red spots,
• skin rashes,
• severe skin reactions, for example, rashes that cause blisters (these can affect the mouth and tongue). Fluconazole B. Braun can have effects on the liver. Symptoms of liver problems include:
• fatigue,
• loss of appetite,
• vomiting,
• yellowing of the skin and the whites of the eyes (jaundice). If you experience any of these symptoms, stop taking Fluconazole B. Braun and tell your doctor immediately. Other side effects:If any of these side effects gets worse or if you notice any side effects not listed here, do not

Common side effects (may affect up to 1 in 10 people) are:

• headache,
• stomach discomfort, diarrhoea, nausea, vomiting,
• increases in liver function values in blood tests,
• skin rashes. Uncommon side effects (may affect up to 1 in 100 people) are:
• reduction in red blood cells which can cause paleness, weakness or shortness of breath,
• loss of appetite,
• insomnia, drowsiness,
• convulsions, dizziness, spinning sensation, tingling, prickling or numbness, changes in taste,
• constipation, difficulty digesting, flatulence, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• swellings, blisters (urticaria), itching, increased sweating,
• fatigue, feeling unwell, fever. Rare side effects (may affect up to 1 in 1000 people) are:
• lower than normal levels of white blood cells, which help defend against infections, and platelets, which help the blood to clot,
• red or purple discoloration of the skin which may be caused by a reduction in platelets, other changes in blood cells,
• changes in the chemical composition of the blood (high levels of cholesterol, fats),
• tremor,
• low levels of potassium in the blood,
• altered electrocardiogram (ECG), changes in heart rate and rhythm,
• liver failure,
• allergic reactions (sometimes severe), including rash with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face,
• hair loss.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. Side effects can also be reported directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili”.
Reporting side effects helps to provide more information on the safety of this
medicine.

5. HOW TO STORE FLUCONAZOLO B. BRAUN 2 mg/ml

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 label and the carton after SCAD. The
expiry date refers to the last day of the month.
Do not freeze.
Do not store at a temperature above 25°C. The medicine must be used immediately after
the vial has been opened for the first time.
Use the solution only if it is clear and free from visible particles. Do not use if the vial is damaged.
The vials are for single use only. After use, the vials and any remaining contents must be disposed of.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fluconazole B. Braun 2 mg/ml, solution for infusion contains
The active ingredient is fluconazole.
Each ml contains 2 mg of fluconazole.
The excipients are:
Sodium Chloride, water for injections.

Description of the appearance of Fluconazole B. Braun and contents of the pack
Fluconazole B. Braun is a clear, colourless solution, free from visible particles.
It is available in polyethylene bottles of 50 ml, 100 ml or 200 ml.
Packs of: 10, 20 or 50 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

• B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen. Postal address: 34209 Melsungen, Tel.: +49-5661-71-0, Fax: +49-5661-71-45 67. Manufacturer:
• B. Braun Medical S.A. Carretera de Terrassa, 121, 08191 Rubí (Barcelona), Spain This medicinal product is authorised in the Member States of the European Economic Area with the following denominations:

The following information is intended exclusively for healthcare professionals:
The infusion rate should not exceed 10 ml/min. Fluconazole B. Braun is formulated in a solution of
sodium chloride 9 mg/ml (0.9%); each 200 mg (100 ml bottle) contains 15 mmol of Na and Cl. Since
Fluconazole B. Braun is available diluted in sodium chloride solution, the percentage of
fluid administered should be carefully considered for patients requiring sodium or fluid restriction.
Fluconazole B. Braun 2 mg/ml, solution for infusion is compatible with the administration of the following
fluids:
a) glucose 200 mg/ml solution for infusion (if available);
b) Ringer's solution for infusion;
c) Hartmann's solution, Ringer's lactate solution (if available);
d) Potassium Chloride 20 mEq/l in glucose 50 mg/ml (if available);
e) Sodium Bicarbonate 84 mg/ml (8.4%) solution for infusion (if available);
g) Sodium Chloride 9 mg/ml (0.9%) solution for infusion;
h) Sterofundin ISO solution for infusion (if available).
Fluconazole can be administered using an existing intravenous access with one of the
solutions listed above. Although no specific incompatibilities are known, mixing other
medicinal products before infusion is not recommended.
The solution for infusion is for single use only.

Shelf life after first opening:
The medicinal product must be used immediately after the first opening of the container.

Shelf life after dilution in accordance with the instructions:
For mixtures with the solutions listed above, physicochemical stability has been demonstrated at 25°C for 72 hours.
From a microbiological point of view, dilutions must be used immediately. If not used
immediately, the storage times and conditions prior to use are the responsibility of the user and
should generally not exceed 24 hours at temperatures between 2°C and 8°C, unless the dilution has
been carried out under controlled and validated aseptic conditions.
Dilution must be carried out under aseptic conditions. The solution must be visually inspected for the
presence of particles or discoloration before administration. The solution must only be used if
it appears clear and free from particles.
Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with
local regulations. For complete information on this medicinal product, consult the summary of product characteristics.