AmBisome

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Amphotericin B 50mg

Available from:

Gilead Sciences (NZ)

INN (International Name):

Amphotericin B 50 mg

Dosage:

50 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Amphotericin B 50mg Excipient: Cholesterol Hydrochloric acid alpha-tocopherol distearoylphosphatidylglycerol Phosphatidylcholines, soya, hydrogenated Phosphatidylglycerols as sodium salt Sodium hydroxide Sodium succinate Sucrose

Units in package:

Vial, glass, 1 vial, 20mL, 50 mg

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

North China Pharmaceutical Huasheng Co., Ltd

Therapeutic indications:

AmBisome is indicated for: · prophylaxis in liver transplant patients at risk of systemic Candida, Aspergillus and Cryptococcus infections, and for · the treatment of systemic fungal infections caused by organisms susceptible to Amphotericin B. AmBisome is indicated for empirical treatment of presumed fungal infections in febrile neutropaenic patients whose fever has failed to respond to broad spectrum antibiotic treatment. AmBisome is indicated for the treatment of visceral leishmaniasis. Clinical studies of efficacy in visceral leishmaniasis are limited to Leishmania infantum.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 50mg - 1 dose units - 48 months from date of manufacture stored at or below 25°C 72 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 50mg - 10 dose units - 48 months from date of manufacture stored at or below 25°C 72 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1995-06-23

Patient Information leaflet

AmBisome CMI (10 September 2014) Page 1 of 3
CONSUMER MEDICINE
INFORMATION
AMBISOME
® (LIPOSOMAL
AMPHOTERICIN) FOR INJECTION
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TO TAKE YOUR
MEDICINE,
EVEN
IF
YOU
HAVE
TAKEN THIS MEDICINE BEFORE.
The
medicine
your
doctor
has
prescribed
for
you
is
called
AmBisome
®
for Injection. This
is the brand name of a drug called
LIPOSOMAL AMPHOTERICIN.
This leaflet is only a summary of
information. Ask your doctor or
pharmacist
if
you
have
any
questions or are not sure about
your treatment with AmBisome.
They
will
have
more
detailed
information.
WHAT IS AMBISOME USED
FOR AND HOW DOES IT
WORK?
AmBisome contains
amphotericin
which
is
an
antibiotic that belongs to a group
of medicines called antifungals.
It
is
used
to
help
the
body
overcome
serious
fungal
infections
by
either
killing
the
fungus or stopping it spreading.
Amphotericin is also used to treat
a
disease
which
is
rare
in
Australia called leishmaniasis.
WHAT DO I NEED TO
KNOW BEFORE AND
WHILE TAKING THE
MEDICINE?
You
should
always
follow
the
advice
given
to
you
by
your
doctor or pharmacist. This leaflet
is not a substitute for things that
your doctor or pharmacist tell you
or should tell you, based on your
individual circumstances.
DO NOT TAKE AMBISOME
IF YOU:
•
have
ever
had
a
reaction
to
amphotericin
or
any
other
ingredient in the injection. For
information on ingredients, see
the section headed
“WHAT IS
IN AMBISOME?”
If you have not done so already,
it is important to tell your doctor
or pharmacist immediately about
the following things, which may
have particular relevance to your
treatment.
•
MEDICAL PROBLEMS.
Tell your
doctor
or
pharmacist
if
you
presently have, or have ever
had,
any
medical
problems
especially
any
of
the
following:
•
kidney disease
•
liver disease
•
diabetes
•
CURRENT MEDICINES.
Tell your
doctor or pharmacist about any
other
medicines
you
are
currently taking, whether they
are
prescription
or
non-
prescription medicines.
In particular, tell your doctor of
pharmacist if you are ta

Summary of Product characteristics

Draft AmBisome Data Sheet 21 December 2017 Page 1 of 20
DATA SHEET
1. AMBISOME
® (LIPOSOMAL AMPHOTERICIN B 50 MG) FOR INJECTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains the active substance amphotericin B.P. equivalent
to 50 mg of
amphotericin B encapsulated in the bilayer of liposomes.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
AmBisome is a sterile, lyophilised product for intravenous infusion.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AmBisome is indicated for:

Prophylaxis in liver transplant patients at risk of systemic Candida,
Aspergillus
and Cryptococcus infections, and for

The treatment of systemic fungal infections caused by organisms
susceptible to
Amphotericin B (see section 5.1 Clinical efficacy and safety).
AmBisome is indicated for empirical treatment of presumed fungal
infections in
febrile neutropaenic patients whose fever has failed to respond to
broad spectrum
antibiotic treatment.
AmBisome is indicated for the treatment of visceral leishmaniasis.
Clinical studies of
efficacy in visceral leishmaniasis are limited to _Leishmania
infantum_.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
The recommended concentration for intravenous infusion is 0.20 mg/mL
to 2.00
mg/mL amphotericin as AmBisome. Dosage of amphotericin as AmBisome
must be
adjusted to the specific requirements of each patient.
1. For systemic mycoses, therapy is usually instituted at a daily dose
of 1.0
mg/kg/day of body weight, and increased stepwise to 5.0 mg/kg/day, as
required.
A cumulative dose of 1.0 to 3.0 g of amphotericin B as AmBisome over
three
to four weeks is typical.
Mucormycosis: Initiate treatment with 5 mg/kg, administered daily. The
duration of therapy should be determined on an individual basis.
Courses of up
Draft AmBisome Data Sheet 21 December 2017 Page 2 of 20
to 56 days are commonly used in clinical practice; longer durations of
therapy
may be required for deep seated infections or in cases of prolonged
courses of
chemotherapy or neutropenia.
Dos