Fungizone 50 mg Powder for sterile concentrate

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Amphotericin

থেকে পাওয়া:

CHEPLAPHARM Arzneimittel GmbH

এটিসি কোড:

J02AA; J02AA01

INN (International Name):

Amphotericin

ডোজ:

50 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Powder for concentrate for solution for infusion

Therapeutic area:

Antibiotics; amphotericin B

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1977-04-01

তথ্য লিফলেট

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

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
17 April 2019
CRN008S29
Page 1 of 8
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