Fungizone 50 mg Powder for sterile concentrate

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Amphotericin

Disponível em:

Bristol-Myers Squibb Pharmaceuticals uc

Código ATC:

J02AA; J02AA01

DCI (Denominação Comum Internacional):

Amphotericin

Dosagem:

50 milligram(s)

Forma farmacêutica:

Powder for solution for infusion

Tipo de prescrição:

Product subject to prescription which may not be renewed (A)

Área terapêutica:

Antibiotics; amphotericin B

Status de autorização:

Marketed

Data de autorização:

1977-04-01

Folheto informativo - Bula

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.
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 B 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

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fungizone 50 mg Powder for sterile concentrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg of amphotericin B.
Excipient with known effect:
Each vial contains approximately 2.68 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Concentrate for Solution for Infusion. (Powder for sterile
concentrate).
Fungizone powder is a yellow to orange, fine, fluffy powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fungizone should be administered primarily to patients with
progressive, potentially fatal infections. This potent drug
should not be used to treat the common forms of fungal disease which
show only positive skin or serological tests.
Fungizone is specifically intended to treat cryptococcosis
(torulosis); North American blastomycosis; the disseminated
forms of candidosis, coccidioidomycosis and histoplasmosis;
mucormycosis (phycomycosis) caused by species of the
genera_ Mucor_,_ Rhizopus_,_ Absidia_,_ Entomophthora, Conidiobolus_
and_ Basidiobolus_ sporotrichosis (_Sporotrichum_
_schenckii_), aspergillosis (_Aspergillus fumigatus_).
Amphotericin B may be helpful in the treatment of American
mucocutaneous leishmaniasis but is not the drug of
choice in primary therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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. 10 mL)
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.
Fungizone should be administered by intravenous infusion over a period
of 2-6 hours (in rare instances infusion times
of up to 6 hours may be necessary). Reduction of the infusion rate may
reduce the incidence of side-effects. Initial
daily dose should be 0.25 mg/kg