FUNGIZONE 50MG POWDER FOR STERILE CONCENTRATE

Active substance: AMPHOTERICIN

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31 01390 05

Package leaflet: Information for the patient

Fungizone 50mg
Powder for Sterile Concentrate

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or if you are breastfeeding, 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.

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.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
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

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 lifethreatening 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 2-4 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.

If you have recently had a specific type of transfusion called a leukocyte
transfusion, please tell your doctor.

PLEASE DETACH BEFORE HANDING ABOVE SECTION TO THE PATIENT

INFORMATION FOR HEALTH PROFESSIONALS
Below is a summary of the dosage, administration, reconstitution and
storage details for Fungizone 50mg Powder for Sterile Concentrate.
Reference should be made to the Summary of Product Characteristics
for full prescribing information.
ADMINISTRATION
Adults and children: Fungizone should be administered by intravenous
infusion over a period of 2-4 hours. Reduction of the infusion rate may
reduce the incidence of side effects. In rare instances infusion times of
up to 6 hours may be necessary. Initial daily dose should be 0.25 mg/kg
of body weight gradually increasing to a level of 1.0 mg/kg of body
weight depending on individual response and tolerance. Within the range
of 0.25-1.0 mg/kg the daily dose should be maintained at the highest
level which is not accompanied by unacceptable toxicity.
In seriously ill patients the daily dose may be gradually increased up to
a total of 1.5 mg/kg. Since amphotericin B is excreted slowly, therapy
may be given on alternate days in patients on the higher dosage
schedule. Several months of therapy are usually necessary; a shorter
period of therapy may produce an inadequate response and lead to
relapse.
When commencing all new courses of treatment, it is advisable to
administer a test dose immediately preceding the first dose. A volume of
the infusion containing 1mg (i.e. 10mL) should be infused over 20-30
minutes and the patient carefully observed for at least a further 30
minutes. It should be noted that patient responses to the test dose may
not be predictive of subsequent severe side effects.
Whenever medication is interrupted for a period longer than seven days,
therapy should be resumed by starting with the lowest dosage level, i.e.
0.25 mg/kg of body weight and increased gradually.

Safety and effectiveness in paediatric patients have not been established
through adequate and well-controlled studies. Systemic fungal infections
have been treated in paediatric patients, with reports of side effects
similar to those seen in adults.
Under no circumstances should a total daily dose of 1.5 mg/kg be
exceeded. The recommended concentration for intravenous infusion is
10 mg/100 mL.
Elderly: No specific dosage recommendations or precautions.
RECONSTITUTION:
Reconstitute as follows: An initial concentrate of 5 mg amphotericin B per
ml is first prepared by rapidly expressing 10ml sterile water for injection,
without a bacteriostatic agent, directly into the lyophilized cake, using a
sterile needle (minimum diameter: 20 gauge) and syringe. Shake the vial
immediately until the colloidal solution is clear. The infusion solution,
providing 10mg/100mL is obtained by further dilution (1:50) with 5%
Glucose Injection of pH above 4.2. The pH of each container of Glucose
Injection should be ascertained before use. Commercial Glucose
Injection usually has a pH above 4.2; however, if it is below 4.2 then 1 or
2 ml of buffer should be added to the Glucose Injection before it is used
to dilute a concentrated solution of amphotericin. The recommended
buffer has the following composition:
Dibasic sodium phosphate (anhydrous) 1.59 g
Monobasic sodium phosphate (anhydrous) 0.96 g
Water for Injections BP q.s. to 100 mL
The buffer should be sterilised before it is added to the Glucose Injection,
either by filtration through a bacterial filter, or by autoclaving for 30 mins
at 15 lb pressure (121°C).

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Patients treated with Fungizone have reported the following side effects:
Very Common side effects (affects more than 1 user in 10):
• Feeling sick and being sick
• High temperature (sometimes with shaking chills)
• Decrease in potassium in the blood
• Increase in creatine 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
• High blood pressure
Common side effects (affects 1 to less than 10 users in 100):
• Anaemia-low level of red blood cells
• Abnormal liver function
• Decreased magnesium in the blood
• Rash

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.

Uncommon side effects (affects 1 to less than 10 users in 1,000):
• Flushing

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

Other side effects were frequencies are unknown include:
• A rare form of anaemia where there is a low level of red blood cells
• Abnormal blood clotting
• High counts of white blood cells in the blood
• Low counts of white blood cells in the blood
• Low counts of platelets in the blood
• Increased potassium in the blood
• Heart attack
• Irregular heartbeat, sometimes severe
• Hearing loss, ringing in the ears
• Blurred or double vision
• Short-lived spinning sensation (vertigo)
• Stomach cramps, indigestion
• Diarrhoea
• Pain at the injection site, with swollen veins
• Allergic reactions
• Loss of appetite, weight loss
• Pain in muscles and joints
• Convulsions
• Altered mental state
• Inflammation of the lungs; spasm of the lungs and fluid in the lungs
• Itching
• Abnormal kidney function
• Bleeding in intestines, resulting in black faeces
• Rash- characterized by a flat red area on the skin that is covered with
small bumps
• Skin conditions
• Low blood pressure
• Shock

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 2014

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.
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.

PLEASE DETACH BEFORE HANDING ABOVE SECTION TO THE PATIENT
CAUTION:
Aseptic technique must be strictly observed in all handling, since no
preservative or bacteriostatic agent is present. Do not reconstitute with
saline solutions.
The use of any diluent other than the ones recommended or the presence
of a bacteriostatic agent in the diluent may cause precipitation of the
amphotericin. Do not use the initial concentrate or the infusion solution
if there is any evidence of precipitation of foreign matter.
An in-line membrane filter may be used for intravenous infusion of
amphotericin; however the mean pore diameter of the filter should not be
less than 1.0 micron in order to assure passage of the amphotericin
dispersion.
Other preparations for injection should not be added to the infusion
solution or administered via the cannula being used to administer
Fungizone. The use of Fungizone by other routes has been documented
in the published literature:
Bladder irrigation/instillation (eg candiduria): Continuous irrigation
with 50mg Fungizone in 1 litre sterile water each day until urinary cultures
are negative. Intermittent use of volumes of 100-400mL (concentrations
of 37.5-200 mcg/mL) has also been reported. The urine should be
alkalinized (with potassium citrate) and antifungal ointment applied to
the perineal area.
Lung inhalation (eg pulmonary aspergillosis): 8-40 mg amphotericin
B (nebulized in sterile water or 5% Glucose) has been given daily in
divided doses. Concurrent eradication of oral and intestinal yeast
reservoirs is recommended.

amphotericin B therapy with or without continuation of azole treatment.
The intrathecal dosage of amphotericin B normally ranges between
0.1mg and 1.5mg per dose, administered at intervals ranging from daily
to weekly, beginning at a low dosage and increasing the dosage until the
appearance of patient intolerance. Amphotericin B is irritating when
injected into the CSF.
Other: Other uses of solutions prepared using Fungizone include local
instillations for the treatment of fungal infections of the ear, eye,
peritoneum, lung cavities and joint spaces.
SPECIAL PRECAUTIONS FOR STORAGE
Vials of powder for reconstitution should be stored in a refrigerator.
Reconstituted: After reconstitution with 10 mL sterile Water for Injections
the concentrate
(5 mg/ml) should be stored protected from light. Chemical and physical
in-use stability has been demonstrated for 8 hours at up to 25 °C and 24
hours at 2-8 °C.
From a microbiological point of view, due to the absence of any microbial
preservative, the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the
responsibility of the user. These would normally not be longer than 24
hours at 2-8 °C unless reconstitution has taken place in controlled and
validated aseptic conditions. It is not intended as a multidose vial. Any
unused material should be discarded. Solutions prepared for intravenous
infusion (i.e. 10 mg or less amphotericin per 100 mL) should be used
promptly after preparation.

Intrathecal (eg coccidiodal meningitis): Patients who do not respond
to fluconazole or itraconazole would be candidates for intrathecal
31 01390 05

BACK
Black

This Artwork is Property of

Product:

INS-FUNGIZONE 50MG

Bristol-Myers Squibb
Die cut

Anagni (FR)

Mesurement:

Font Size/Leading

Materials:

g/mq

Tickness:

250 x 420 mm

FILM TAMPERING UNLEAVED
Product Code:

31 01390 05
Draft N°:

02
Execution Date:
The proof colour could be different by
true Pantone® reference

Die Cut

03-06-2014

10 / 11

Country:

UK
Bar-Code:

186 IXXXIXX
Draft N°

01

Execution Date

Film
Quality
Control

Date

Date:

Signature

...............................................................................

Artworks Status:

28-05-2014

02

03-06-2014

03

PO Number:

XX-XX-XXXX

04

XX-XX-XXXX

05

XX-XX-XXXX

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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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