AmBisome Liposomal 50mg powder for dispersion for infusion vials

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Amphotericin B liposomal

から入手可能:

Gilead Sciences Ltd

ATCコード:

J02AA01

INN（国際名）:

Amphotericin B liposomal

投薬量:

50mg

医薬品形態:

Powder for dispersion for infusion

投与経路:

Intravenous

クラス:

No Controlled Drug Status

処方タイプ:

Caution - AMP level prescribing advised

製品概要:

BNF: 05020300; GTIN: 5391507144447

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMBISOME 50 MG POWDER FOR SOLUTION FOR INFUSION
LIPOSOMAL AMPHOTERICIN B
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
What you need to know before you are given AmBisome
3.
How to use AmBisome
4.
Possible side effects
5.
How to store AmBisome
6.
Content 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) in hospital by a
doctor or nurse.
AmBisome is used to treat serious infections caused by fungi:

FUNGAL INFECTIONS OF ONE OR MORE DEEP ORGANS OF THE BODY.

SUSPECTED FUNGAL INFECTIONS in patients with a RAISED TEMPERATURE AND
NEUTROPENIA.
Neutropenia is a reduced number of white blood cells called
neutrophils. These are
important in fighting infections. Neutropenia can be a side effect of
cancer treatments.
Before you are given AmBisome your doctor will check that your fever
is not due to
bacteria or viruses. You will probably have had one or more
antibiotics already. A fever
which continues despite treatment may be due to a fungal infection.
It’s difficult to
confirm this with current tests, however.

VISCERAL LEISHMANIASIS, a disease caused by a parasite.
2.
WHAT YOU NEED TO KNOW 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 ALL

製品の特徴

OBJECT 1
AMBISOME
Summary of Product Characteristics Updated 04-Apr-2017 | Gilead
Sciences Ltd
1. Name of the medicinal product
AmBisome 50 mg Powder for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 50 mg of amphotericin (50,000 units) encapsulated
in liposomes. After reconstitution,
the concentrate contains 4 mg/mL amphotericin B.
Excipient with known effect:
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Sterile, powder for solution for infusion.
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 severe systemic and/or deep mycoses
• the treatment of visceral leishmaniasis in immunocompetent
patients including both adults and children
• the empirical treatment of presumed fungal infections in febrile
neutropenic patients, where the fever
has failed to respond to broad spectrum antibiotics and appropriate
investigations have failed to define a
bacterial or viral cause.
Infections successfully treated with AmBisome include: disseminated
candidiasis, aspergillosis,
mucormycosis, chronic mycetoma, cryptococcal meningitis and visceral
leishmaniasis.
AmBisome 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
Posology
Treatment of mycoses
Therapy is usually instituted at a daily dose of 1.0 mg/kg of body
weight, and increased stepwise to 3.0
mg/kg, as required. Data are presently insufficient to define total
dosage requirements and duration of
treatment necessary for resolution of mycoses. However, a cumulative
dose of 1.0 - 3.0 g of amphotericin
B as AmBisome over 3 - 4 weeks has been typical. Dosage of
amphotericin B as AmBisome must be
adjusted to the specific requirements of each patient.
Mucormycosis
The recommended starting dose is 5 mg/kg/day. The duration of therapy
should be determine