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FUNGIZONE 50MG POWDER FOR STERILE CONCENTRATE

Active substance(s): AMPHOTERICIN

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31 01390 06

Package leaflet: Information for the patient

Fungizone 50mg
Powder for Sterile Concentrate
Amphotericin B
Please read all of this leaflet carefully before you start taking your
medicine because it contains important information for you.
- Please keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
What is in this leaflet;
1. What Fungizone 50mg Powder for Sterile Concentrate is and what it
is used for
2. What you need to know before being given your medicine
3. How you will be given your medicine
4. Possible Side Effects
5. How to store your medicine
6. Contents of the pack and other information
1. What Fungizone 50mg Powder for Sterile Concentrate is and
what it is used for
The name of your medicine is Fungizone 50mg Powder for Sterile
Concentrate. It contains the active ingredient amphotericin B, which
belongs to a group of medicines called anti-fungal antibiotics.
Fungizone 50mg Powder for Sterile Concentrate is used to treat serious
infections caused by yeasts and certain fungi.
2. What you need to know before being given your medicine
You should not be given this medicine if you:
– are allergic (hypersensitive) to amphotericin or any of the other
ingredients in this medicine.
Take special care with Fungizone 50mg Powder for Sterile
Concentrate if you:
– have any kidney or liver problems
If this applies to you, talk to your doctor before being given Fungizone
50mg Powder for Sterile Concentrate.
Taking other medicines
Always tell your doctor or pharmacist about other medicines you may
be taking or have recently taken including those obtained without a
prescription.
This is especially important if you are taking:
– any anti-cancer medicines (e.g. methotrexate, cyclophosphamide,
cisplatin)
– any medicines which affect your kidney function (e.g. gentamicin,
vancomycin)
– any muscle relaxants (e.g. baclofen, dantrolene, diazepam)
– any corticosteroids (e.g. beclamethasone) or corticotrophins
– any medicines to treat heart failure (e.g. digoxin)
– a medicine called flucytosine used to treat fungal infections
If you have recently had a specific type of transfusion called a leukocyte
transfusion, please tell your doctor.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or if you are breast-feeding,

speak to your doctor before being given Fungizone 50mg Powder for
Sterile Concentrate.
Driving and using machinery
Fungizone 50mg Powder for Sterile Concentrate should not affect your
ability to drive.
Fungizone contains amphotericin B:
This medicinal product also contains less than 1mmol sodium (23mg)
per dose, i.e. essentially ‘sodium- free’.
3. How you will be given your medicine
Fungizone 50mg Powder for Sterile Concentrate will be given to you in
hospital by a doctor or nurse.
The daily dose is 0.25-1.0 mg per kg of your body weight. In some
cases your doctor may consider it necessary to increase this dose
to 1.5 mg/kg. If you are given too much of this medicine, you may
experience life-threatening heart or lung problems. If you have any
concerns about the amount of medicine you have been given, please
speak to the person who has given you the infusion for further advice.
It will be given to you slowly through a drip into a vein (an infusion). This
will usually take between 2-6 hours.
A test dose may be given before you start treatment with this medicine.
Several months of treatment is usually necessary to get rid of the
infection completely.
In some patients, the doctor may give other medicines to help reduce
other unwanted effects.
These include:
- medicines to help stop you feeling sick or being sick,
- aspirin,
- an anti-allergy medicine (antihistamine),
- a corticosteroid,
- a medicine to stop your blood from clotting (anticoagulant).
4. Possible side effects
Like all medicines, Fungizone 50mg Powder for Sterile Concentrate can
cause side effects, although not everybody gets them.
Treatment with Fungizone 50mg Powder for Sterile Concentrate may
affect your blood cells, kidneys, liver or heart. For this reason, your
doctor will want to monitor all these things before, during and after
giving you this medicine.
If you notice any of the following, contact your doctor immediately:
– swelling of the face, lips, or tongue
– skin reactions including severe rash and itching
– difficulty breathing
As these may be signs of an allergic reaction.
There have been reports of blood disorders which may be characterised
by fever or chills, sore throat, ulcers in the mouth or throat, unusual
tiredness or weakness, unusual bleeding or unexplained bruises.
Tell your doctor immediately if you notice any of these symptoms.
Fungizone 50mg Powder for Sterile Concentrate can cause kidney
problems. If you notice that you are more thirsty, need to go to the
toilet more frequently, or the volume of urine increases, tell your doctor
immediately.
Patients treated with Fungizone have reported the following side effects:
Very Common side effects (may affect more than 1 in 10 people):
• Feeling sick and being sick

PLEASE DETACH BEFORE HANDING ABOVE SECTION TO THE PATIENT
Doses may gradually be increased by 5 to 10 mg per day to a final daily
INFORMATION FOR HEALTH PROFESSIONALS
dosage of 0.5 to 1 mg/kg
Below is a summary of the dosage, administration, reconstitution and
Whenever medication is interrupted for a period longer than seven days,
storage details for Fungizone 50mg Powder for Sterile Concentrate.
therapy should be resumed by starting with the lowest dosage level, i.e.
Reference should be made to the Summary of Product Characteristics
0.25 mg/kg of body weight and increased gradually.
for full prescribing information.
CAUTION:
ADMINISTRATION
Under no circumstances should a total daily dose of 1.5 mg/kg be
Posology
exceeded. The recommended concentration for intravenous infusion is
Fungizone should be administered by intravenous infusion over a period
10 mg/100 mL.
of 2-6 hours. Reduction of the infusion rate may reduce the incidence
of side effects. Initial daily dose should be 0.25 mg/kg of body weight
Paediatric population
gradually increasing to a level of 1.0 mg/kg of body weight depending on
Safety and effectiveness in paediatric patients have not been established
individual response and tolerance. Within the range of 0.25-1.0 mg/kg
through adequate and well-controlled studies. Systemic fungal infections
the daily dose should be maintained at the highest level which is not
have been treated in paediatric patients, with reports of side effects
accompanied by unacceptable toxicity.
similar to those seen in adults.
In seriously ill patients the daily dose may be gradually increased up to a
Older people
total of 1.5 mg/kg. Since amphotericin B is excreted slowly, therapy may
No specific dosage recommendations or precautions.
be given on alternate days in patients on the higher dosage schedule.
RECONSTITUTION:
Several months of therapy are usually necessary; a shorter period of
Reconstitute as follows: An initial concentrate of 5 mg amphotericin B per
therapy may produce an inadequate response and lead to relapse.
ml is first prepared by rapidly expressing 10ml sterile water for injection,
When commencing all new courses of treatment, it is advisable to
without a bacteriostatic agent, directly into the lyophilized cake, using
administer a test dose immediately preceding the first dose. A volume
a sterile needle (minimum diameter: 20 gauge) and syringe. Shake the
of the infusion containing 1mg (i.e. 10mL) should be infused over
vial immediately until the colloidal solution is clear. The infusion solution,
20-30 minutes and the patient carefully observed for at least a further
providing 10mg/100mL is obtained by further dilution (1:50) with 5%
30 minutes. It should be noted that patient responses to the test dose
Glucose Injection of pH above 4.2. The pH of each container of Glucose
may not be predictive of subsequent severe side effects.
Injection should be ascertained before use. Commercial Glucose
Patients with a severe and rapidly progressing fungal infection, with
Injection usually has a pH above 4.2; however, if it is below 4.2 then 1 or
good cardiopulmonary function and who tolerates the test dose
2 ml of buffer should be added to the Glucose Injection before it is used
without a severe reaction, may then receive 0.3 mg/kg amphotericin
to dilute a concentrated solution of amphotericin. The recommended
B intravenously over a period of 2 to 6 hours. For patients with
buffer has the following composition:
cardiopulmonary impairment or severe reaction to the test dose, a lower
dose (i.e. 5 to 10 mg) is recommended.
Dibasic sodium phosphate (anhydrous) 1.59 g

High temperature (sometimes with shaking chills)
Decrease in potassium in the blood
Increase in creatinine in the blood
Kidney problems which may lead to abnormal urine production, kidney
stones and imbalances of substances in the blood (e.g. potassium)
• Difficulty in breathing
• Low blood pressure





Common side effects (may affect up to 1 in 10 people):
• Anaemia-low level of red blood cells
• Abnormal liver function shown by abnormal liver function tests
• Decreased magnesium in the blood
• Headache
• Diarrhoea
• Rash
• Decreased appetite
• Sudden loss of kidney function
• Pain at the injection site with or without swollen veins or a blood clot
Uncommon side effects (may affect up to 1 in 100 people):
• A rare form of anaemia where there is a low level of white blood cells
• Low counts of white blood cells in the blood
• Low counts of platelets in the blood
• Irregular heartbeat, sometime severe
• Impaired sensation or movement
• Spasm of the lungs
• Pain in the stomach
• Yellowing of the skin and eyes
• Pain in muscles
• Impaired or abnormal kidney function
• Flushing
Rare side effects (may affect up to 1 in 1000 people):
• Abnormal blood clotting
• High counts of white blood cells in the blood
• Allergic reaction
• Increased potassium in the blood
• Altered mental state
• Convulsion
• Vision blurred or double vision
• Hearing loss, ringing in the ears
• Short-lived spinning sensation (vertigo)
• Heart attack or heart not working properly
• High blood pressure
• Shock
• Inflammation of the lungs and fluid in the lungs
• Stomach cramps, indigestion
• Bleeding in intestines, resulting in black faeces
• Loss of liver function
• Rash- characterized by a flat red area on the skin that is covered with
small bumps
• Itching
• Flu like symptoms followed by a painful red or purple spreading rash
• Skin conditions including skin coming off in layers
• Pain in joints
• Abnormal kidney function including increased or decreased amounts
of urine produced
• Pain and tiredness
• Decreased weight

By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store your medicine
Keep this medicine out of the sight and reach of children.
Unopened product will be stored in a refrigerator (2-8°C) in the pharmacy
and should not be used after the expiry date shown on the carton/label.
This medicine will be prepared in a special area before the doctor or
nurse gives it to you. After being mixed together the medicine will be
kept for no more than 8 hours at room temperature (25°C) or 24 hours in
a refrigerator (2-8°C). It should be stored protected from light.
6. Contents of the pack and other information
What Fungizone 50mg Powder for Sterile Concentrate contains
The active substance is amphotericin B. Each vial contains 50mg (50,000
units) Amphotericin B. The other ingredients are desoxycholic acid,
concentrated phosphoric acid, sodium hydroxide, disodium phosphate
dodecahydrate, monosodium phosphate dehydrate, water.
What Fungizone 50mg Powder for Sterile Concentrate looks like
and contents of the pack
Fungizone 50mg Powder for Sterile Concentrate is a fine yellow to
orange, fluffy powder and is supplied in glass vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
E.R. Squibb & Sons Limited,
Uxbridge Business Park,
Sanderson Road,
Uxbridge,
Middlesex UB8 1DH,
England.
Tel: 0800 7311736
Manufacturer
Famar L’Aigle
Usine de Saint-Remy
Rue de I’Isle
28380 Saint-Remy-Sur-Avre
France
This leaflet was last revised in: May 2016

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

PLEASE DETACH BEFORE HANDING ABOVE SECTION TO THE PATIENT
Monobasic sodium phosphate (anhydrous) 0.96 g
divided doses. Concurrent eradication of oral and intestinal yeast
reservoirs is recommended.
Water for Injections BP q.s. to 100 mL
The buffer should be sterilised before it is added to the Glucose Injection,
Intrathecal (eg coccidiodal meningitis): Patients who do not respond to
either by filtration through a bacterial filter, or by autoclaving for 30 mins
fluconazole or itraconazole would be candidates for intrathecal amphotericin
at 15 lb pressure (121°C).
B therapy with or without continuation of azole treatment. The intrathecal
dosage of amphotericin B normally ranges between 0.1mg and 1.5mg per
CAUTION:
dose, administered at intervals ranging from daily to weekly, beginning at
Aseptic technique must be strictly observed in all handling, since no
a low dosage and increasing the dosage until the appearance of patient
preservative or bacteriostatic agent is present.
intolerance. Amphotericin B is irritating when injected into the CSF.
Do not use the initial concentrate or the infusion solution if there is any
Reports of neurological events such as arachnoiditis, myelopathy,
evidence of precipitation of foreign matter.
paresis and paralysis have been associated with the intrathecal route
An in-line membrane filter may be used for intravenous infusion of
of administration.
amphotericin B; however the mean pore diameter of the filter should not
Other: Other uses of solutions prepared using Fungizone include
be less than 1.0 micron in order to assure passage of the amphotericin
local instillations for the treatment of fungal infections of the ear, eye,
dispersion.
peritoneum, lung cavities and joint spaces.
Other preparations for injection should not be added to the infusion solution
or administered via the cannula being used to administer Fungizone.
SPECIAL PRECAUTIONS FOR STORAGE
Aseptic technique must be strictly observed during the preparation of
Vials of powder for reconstitution should be stored in a refrigerator
the concentrate, the buffer and the infusion.
Reconstituted: After reconstitution with 10 mL sterile Water for Injections
the concentrate (5 mg/ml) should be stored protected from light.
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
The absence of any antimicrobial preservative and the risk of contamination
during reconstitution mean that the product should be stored for no more
The use of Fungizone by other routes has been documented in the
than 8 hours at room temperature (25°C) or 24 hours in a refrigerator
published literature:
(2-8°C). Should the need arise and a validated aseptic reconstitution
Bladder irrigation/instillation (eg candiduria): Continuous irrigation with
technique is applied, the product is chemically stable when stored for 24
50mg Fungizone in 1 litre sterile water each day until urinary cultures are
hours at room temperature or one week in a refrigerator. It is not intended
negative. Intermittent use of volumes of 100-400mL (concentrations of
as a multidose vial. Any unused material should be discarded. Solutions
37.5-200 mcg/mL) has also been reported. The urine should be alkalinized
prepared for intravenous infusion (i.e. 10 mg or less amphotericin B per
(with potassium citrate) and antifungal ointment applied to the perineal area.
100 mL) should be used promptly after preparation.
Lung inhalation (eg pulmonary aspergillosis): 8-40 mg amphotericin
B (nebulized in sterile water or 5% Glucose) has been given daily in

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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