mg / ml Infusion solution
fluconazole

1. What Fluconazole B. Braun is and what it is used for

Fluconazole B. Braun belongs to a group of medicines used to treat fungal infections. The active substance is fluconazole.

Fluconazole B. Braun is used to treat the infection caused by fungi and may also be used to prevent that you get a yeast 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 cryptococci – a fungal infection of the brain
  • coccidioidomycosis – a lung disease
  • infection is caused by Candida and is found in the bloodstream, internal organs (eg heart, lungs), or urinary tract
  • oral cod – 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 B. Braun to:

  • prevent a recurrence of meningitis caused by cryptococci.
  • prevent the recurrence of a fungal infection in the mouth or throat.
  • prevent you from getting an 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 for the treatment of the following types of fungal infections:

  • oral cod 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 cryptococci – a fungal infection of the brain.

You can also get Fluconazole B. Braun to:

  • prevent you from getting an infection caused by Candida (if you have a weakened immune system)
  • prevent a recurrence of meningitis caused by cryptococci.

2. What you need to know before you are given Fluconazole B. Braun

Do not use Fluconazole B. Braun if you

  • is allergic to fluconazole, other medicines you have taken to treat a fungal infection, or any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing
  • if you are taking astemizole or terfenadine ( antihistamines 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)
  • if you are taking erythromycin ( antibiotic to treat infections ).

Warnings and cautions

Talk to your doctor before giving Fluconazole B. Braun

  • 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 ( chronic or prolonged fatigue, muscle weakness, decreased appetite, weight loss, abdominal pain). Adrenal cortex insufficiency means that the adrenal glands do not produce enough of certain steroid hormones such as cortisol.

Other drugs and Fluconazole B. Braun

Tell your doctor 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 B. Braun (see section “Do not use Fluconazole B. Braun”).

Some medications can be affected by or affect Fluconazole B. Braun.
Tell your doctor if you are taking any of the following medicines:

  • rifampicin, rifabutin, or azithromycin ( antibiotics for infections )
  • alfentanil, fentanyl (used as anesthetic)
  • amiodarone (used to treat heart rhythm disorders)
  • amitriptyline, nortriptyline (used to treat depression)
  • amphotericin B, voriconazole (for fungal infections)
  • blood-thinning drugs to prevent blood cells (eg warfarin )
  • benzodiazepines (eg midazolam, triazolam) used for insomnia or anxiety
  • carbamazepine, phenytoin (for epilepsy )
  • nifedipine, isradipine, amlodipine, felodipine, verapamil, hydrochlorothiazide (diuretic) or losartan (for high blood pressure )
  • 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 )
  • A vitamin (nutritional supplements)
  • ivacaftor (used to treat cystic fibrosis ).

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 for advice before using this medicine.

You should not take fluconazole if you are pregnant unless your doctor tells you to.

You can continue breastfeeding after taking a single dose of fluconazole up to 200 mg.

You should not breast-feed if you are taking repeated doses of fluconazole.

Driving and using machines

When driving 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 increased 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 B. Braun contains sodium

Fluconazole B. Braun contains 3.54 mg sodium per ml.
This should be considered by patients on a low-salt diet.

3. How to take Fluconazole B. Braun

This medicine will be given to you by a doctor or nurse as a slow injection ( infusion ) into a vein. Fluconazole B. Braun 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.

Recommended dose

The table below shows the recommended doses for different infections  Ask your doctor or nurse if you are not sure why you are receiving Fluconazole B. Braun.

Adults

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 the 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
To treat fungal infections that affect the mucous membranes of the mouth and throat and can cause mouth soreness 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) – the dose 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 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 you from getting fungal infections 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

Adolescents between 12 and 17 years of age
Use a dose prescribed by your doctor (according to the recommendations for either adults or children).

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
Oral cod 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 (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
To prevent the child from getting a fungal infection caused by Candida (if the child has a weakened immune system) 3 mg to 12 mg per kg body weight

Children between 0 and 4 weeks

Children between 3 and 4 weeks: The
same dose as above but one dose is given every other day. The maximum dose is 12 mg per kg body weight every other day (48 hours apart).

Children younger than 2 weeks:
Same dose as above but dose one is given every three days. The maximum dose is 12 mg per kg body weight every three days (72 hours apart).

Elderly
The usual dose for adults can be used unless you have kidney problems.

Patients with kidney problems

Your doctor may change the dose depending on your kidney function.

If you take more Fluconazole B. Braun then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

The symptoms of a possible overdose may be that you begin to hear, see, feel and think things that are not real (hallucinations and paranoid behaviors).

If a dose of Fluconazole B. Braun is 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 (may affect up to 1 in 1,000 people). If you get any of the following symptoms, contact your doctor immediately.

  • sudden wheezing, difficulty breathing, or tight feeling in the chest
  • swelling of the eyelids, face, or lips
  • itching all over the body, reddening of the skin or itchy, red spots
  • rash
  • severe skin reactions, e.g. a rash with blistering (this can affect the mouth and tongue).

Fluconazole B. Braun may affect your liver. Signs of hepatic impairment include:

  • fatigue
  • decreased appetite
  • vomiting
  • yellowish skin or yellowish whites of the eyes (jaundice).

If any of these occur, stop taking Fluconazole B. Braun 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 are (may affect up to 1 in 10):

  • headache
  • feeling uncomfortable in the stomach, diarrhea, nausea, vomiting
  • elevated liver values
  • rash.

Less common side effects are (may affect up to 1 in 100 user e):

  • decreased amount of red blood cells which can lead to pale skin and cause weakness and shortness of breath
  • decreased appetite
  • difficulty sleeping, drowsiness
  • seizures, dizziness, tingling sensation, and crawling, tingling or numbness, taste changes
  • constipation, indigestion, gas tension, dry mouth
  • muscle pain
  • liver damage and yellowing of the skin and eyes (jaundice)
  • streaks in the skin, blistering ( hives ), itching, sweating
  • fatigue, general malaise, fever.

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

  • reduced number of white blood cells that help defend the body against infection and reduced number of blood cells that help stop bleeding
  • red or purple discoloration of the skin that can be caused by a reduced number of platelets, other changes in the blood are
  • changes in the chemical composition of the blood (elevated blood cholesterol and blood fat levels)
  • shaking
  • decreased level of potassium in the blood
  • abnormal electrocardiogram ( ECG ), changes in heart rate or heart rate
  • liver failure
  • allergic reactions (sometimes severe), including investigated rash with blistering and flaky skin, severe skin reactions, and swelling of the lips and face
  • hair loss.

5. How to store Fluconazole B. Braun

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 carton after EXP. dat. or EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Do not freeze.

This medicine must be used immediately after opening the package.

Only clear solutions without any visible particles should be used. Do not use it if the bottle is damaged.

The bottles are for single use only. Dispose of after single use. Discard any remaining solution.

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 and water for injections.

What the medicine looks like and the contents of the pack

Fluconazole B. Braun is a clear, colorless solution containing the above substances in water.

Polyethylene bottles containing 50 ml, 100 ml, or 200 ml
Pack sizes: 10, 20, or 50 bottles

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany

Postal address :
34209 Melsungen, Germany

Tel: + 49-5661-71-0
Fax: + 49-5661-71-45 67

Manufacturer:
B. Braun Medical SA
Carretera de Terrassa, 121
08191 Rubí (Barcelona)
Spain

Information provided by:

B. Braun Medical AB
Box 110
182 12 Danderyd

This medicinal product is authorized under the European Economic Area under the names:

Austria, Germany, Luxembourg Fluconazole B. Braun 2 mg / ml infusion solution
Belgium Fluconazole B. Braun 2 mg / ml solution for infusion
Czech Republic Fluconazole B. Braun 2 mg / ml
Denmark Fluconazole ”B. Braun ”
Finland Fluconazole B. Braun 2 mg / ml infusion test, liuos
Greece Fluconazole B. Braun 2 mg / ml Dysalphine
Hungary Fluconazole B. Braun 2 mg / ml oldatos infusion
Ireland, United Kingdom Fluconazole 2 mg / ml solution for infusion
Italy Fluconazolo B. Braun 2 mg / ml solution for infusion
Netherlands Fluconazole B. Braun 2 mg / ml solution for infusion
Norway Fluconazole B. Braun solution for infusion
Poland Fluconazole B. Braun 2 mg / ml, infusion drug
Portugal Fluconazole B. Braun solution for perfusion
Slovakia Fluconazole B. Braun 2 mg / ml solution for infusion
Slovenia Fluconazole B. Braun 2 mg / ml raztopina for infusion
Spain Fluconazole B. Braun 2 mg / ml EFG perfusion solution

Muhammad Nadeem

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