AMBISOME amphotericin B (amphotericin) B 50mg powder for injection

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

amphotericin B, Quantity: 50 mg

Beschikbaar vanaf:

Gilead Sciences Pty Ltd

INN (Algemene Internationale Benaming):

amphotericin B (amphotericin)

farmaceutische vorm:

Injection, powder for

Samenstelling:

Excipient Ingredients: hydrogenated soy phosphatidylcholine; sucrose; dl-alpha-tocopherol; distearoylphosphatidylglycerol; sodium succinate; cholesterol

Toedieningsweg:

Intravenous

Eenheden in pakket:

10 x 50mg + 10 x 5 micrometre filters, single vial and a single 5um filter

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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 Clinical Trials). Ambisome is indicated for the treatment of visceral leishmaniasis. Clinical studies of efficacy in visceral leishmaniasis are limited to Leishmania infantum. INDICATED AS AT 8 SEPTEMBER 2003 :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 Clinical Trials). 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 samenvatting:

Visual Identification: A yellow lyophilised cake or powder.; Container Type: Vial; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

1996-01-30

Bijsluiter

AmBisome CMI v2.0 (30 March 2017)
Page 1 of 2
AMBISOME

POWDER FOR INJECTION VIAL
_Liposomal amphotericin B (amphotericin) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AmBisome.
The medicine your doctor has prescribed
for you is called AmBisome for
Injection. This is the brand name of a
drug called liposomal amphotericin B
(amphotericin).
All medicines have risks and benefits.
Your doctor has weighed the risks of
you having AmBisome against the
benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS AMBISOME USED
FOR
AmBisome contains amphotericin B
(amphotericin) which 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 B (amphotericin) is also
used to treat a disease which is rare in
Australia called leishmaniasis.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY AMBISOME HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
AmBisome for another reason.
AmBisome is not addictive.
This medicine is available only with a
doctor’s prescription.
BEFORE YOU ARE GIVEN
AMBISOME
_WHEN YOU MUST NOT HAVE IT_
:
DO NOT HAVE AMBISOME IF YOU ARE
ALLERGIC TO:
•
amphotericin B (amphotericin) or
•
any of the other ingredients in
AmBisome listed at the end of this
leaflet.
_BEFORE YOU ARE GIVEN IT _
Tell your doctor if you have allergies to
any other medicines, foods,
preservatives or dyes. Tell your doctor if
you have, or have had, any of the
following medical conditions:
•
kidney disease
•
liver disease
•
diabetes
TELL YOUR DOCTOR IF YOU ARE PREGNANT,
OR LIKELY TO BECOME PREGNANT DURING
YOUR COURSE OF MEDICATION.
Your doctor can discuss with you the
benefits and risks of having AmBisome.
TELL YOUR DOCTOR IF YOU ARE
BREASTFEEDING, OR LIKELY TO BREASTFEED
DURING YOUR COURSE O

Productkenmerken

1
AUSTRALIAN PRODUCT INFORMATION – AMBISOME
®
(LIPOSOMAL AMPHOTERICIN) INJECTION
1
NAME OF THE MEDICINE
AmBisome (liposomal amphotericin).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AmBisome is available in vials as powder for injection. Each vial
contains amphotericin B.P.
equivalent to 50 mg of amphotericin B encapsulated in the bilayer of
liposomes consisting of
approximately 213 mg hydrogenated soy phosphatidylcholine, 52 mg
cholesterol, 84 mg
distearoylphosphatidylglycerol (as the sodium salt), 0.64 mg
alpha-tocopherol together with
900 mg sucrose, and 27 mg sodium succinate hexahydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
AmBisome is a sterile, lyophilised product for intravenous infusion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 5.1 Pharmacodynamic Properties, Clinical Trials).
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
D
OSE AND METHOD OF ADMINISTRATION
AmBisome should be administered by intravenous infusion over 30 to 60
minutes. 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.
a)
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.
2
Data are presently insufficient to define total dosage requirements
and duration of treatment
necessa