Fungizone 50mg powder for concentrate for solution for infusion vials

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Amphotericin B

Tersedia dari:

Neon Healthcare Ltd

Kode ATC:

J02AA01

INN (Nama Internasional):

Amphotericin B

Dosis:

50mg

Bentuk farmasi:

Powder for solution for infusion

Rute administrasi :

Intravenous

Kelas:

No Controlled Drug Status

Jenis Resep:

Caution - AMP level prescribing advised

Ringkasan produk:

BNF: 05020300; GTIN: 5012712000358

Selebaran informasi

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, d

Karakteristik produk

OBJECT 1
FUNGIZONE 50MG POWDER FOR STERILE CONCENTRATE
Summary of Product Characteristics Updated 28-Nov-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
Fungizone 50 mg Powder for Sterile Concentrate
2. Qualitative and quantitative composition
Each vial contains amphotericin B 50,000 units (50 mg).
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 fine yellow to orange 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, 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
Fungizone should be administered by intravenous infusion over a period
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 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. Sinc