AMBISOME LIPOSOMAL AMPHOTERICIN B 50 Milligram Concentrate for Soln for Inf

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

AMPHOTERICIN B

Commercializzato da:

Gilead Sciences International

Codice ATC:

J02AA01

INN (Nome Internazionale):

AMPHOTERICIN B

Dosaggio:

50 Milligram

Forma farmaceutica:

Concentrate for Soln for Inf

Tipo di ricetta:

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

Area terapeutica:

Antibiotics

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

1995-12-13

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMBISOME
Liposomal Amphotericin B 50 mg
Powder for Concentrate for Dispersion for Infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-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. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What AmBisome is and what it is used for
2. Before you are given AmBisome
3. How AmBisome is used
4. Possible side effects
5. How to store AmBisome
6. Contents of the pack and other information
1. WHAT AMBISOME IS AND WHAT IT IS USED FOR
AMBISOME IS AN ANTIFUNGAL ANTIBIOTIC. The active ingredient in
AmBisome is amphotericin B.
AMBISOME IS GIVEN AS AN INFUSION into a vein (a drip) by a doctor or
nurse.
AmBisome has been studied in patients aged one month and above.
AmBisome is used to treat serious infections caused by fungi:

FUNGAL INFECTIONS OF ONE OR MORE ORGANS INSIDE THE BODY

SUSPECTED FUNGAL INFECTIONS in patients who have a RAISED TEMPERATURE
AND A LOW WHITE BLOOD
CELL COUNT CALLED _NEUTROPENIA_.
Before you are given AmBisome your doctor will check that your fever
is not due to bacteria or
viruses and will try and treat the infection with a course of
antibiotics.

VISCERAL LEISHMANIASIS, a disease caused by a parasite.
AmBisome is not used to treat common fungal infections that are not
serious, for example skin
infections
2. BEFORE YOU ARE GIVEN AMBISOME
BEFORE YOUR FIRST TREATMENT
Before your first treatment your doctor may give you a small amount of
AmBisome. They will then
wait for approximately 30 minutes to see whether you have an allergic
reaction, before continuing the
infusion of the full dose.
YOUR DOCTOR WILL NOT GIVE YOU AMBISOME:

IF YOU ARE ALLERGIC (hypersensitive) to amphotericin B or any other
ingredients of this medicine
(listed in section 6). However, if YOUR CONDI

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AmBisome Liposomal Amphotericin B 50mg Powder for Concentrate for
Dispersion for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains as active ingredient 50 mg of amphotericin B
(50,000 units) encapsulated in liposomes. After
reconstitution, the concentrate contains 4mg/mL amphotericin B.
Excipients with known effect:
Each vial contains 213 mg of hydrogenated soy phosphatidylcholine, 900
mg of sucrose and a small amount of sodium.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Powder for Concentrate for Dispersion for Infusion.
A sterile, yellow lyophilised cake or powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AmBisome is indicated in adults and children aged 1 month to 18 years
old:
for
the treatment
of
_systemic mycotic infections_ due to organisms susceptible to this
anti-infective,
such as
cryptococcosis,
North American blastomycosis,
disseminated candidiasis,
coccidioidomycosis,
aspergillosis,
histoplasmosis, mucormycosis and in the treatment of some cases of
American mucocutaneous leishmaniasis.
for the treatment of_ fever of unknown origin (FUO)_ in neutropenic
patients.
In this context,
FUO is defined as
persisting fever,
unresponsive to at least 96 hours of antibiotic treatment; it is
highly indicative for a systemic
fungal
infection in this patient
population.
Before initiating AmBisome treatment,
common viral,
parasitic or
mycobacterial infections should also be excluded as far as possible as
causes for the observed FUO.
as
the primary therapy of
_visceral_
_leishmaniasis_
in immunocompetent
patients
including both adults
and
children.
In immunocompromised patients (e.g.
HIV positive)
AmBisome is also indicated as the primary
therapy of visceral leishmaniasis.
This drug should not
be used to treat
the common clinically inapparent
forms of fungal
disease which show only
positive skin or serologic tests.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adult patients_
Dosage of amphoteri