ABELCET amphotericin B (amphotericin) 100mg/20mL injection vial

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

amphotericin B (amphotericin)

Sẵn có từ:

Teva Pharma Australia Pty Ltd

INN (Tên quốc tế):

amphotericin B (amphotericin)

Tình trạng ủy quyền:

Registered

Tờ rơi thông tin

_ _
ABELCET – Consumer Medicine Information
Page 1 of 3
ABELCET
®
_AMPHOTERICIN LIPID COMPLEX _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
ABELCET (amphotericin lipid
complex). It does not
contain all the available
information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
taking ABELCET against the
benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY
BEFORE ABELCET IS GIVEN
TO YOU AND KEEP IT. You may
need to read it again.
WHAT IT IS USED FOR
ABELCET
contains
amphotericin, 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. It is not used to
treat bacterial or viral
infections.
ABELCET
is only available
with a doctor’s prescription.
It is not addictive.
IF YOU HAVE ANY QUESTIONS
ABOUT USING ABELCET
ASK
YOUR DOCTOR.
BEFORE YOU ARE
GIVEN IT
_YOU MUST TELL YOUR DOCTOR IF: _
1. YOU HAVE EVER HAD AN
ALLERGIC REACTION TO
AMPHOTERICIN, THE ACTIVE
INGREDIENT IN ABELCET
OR AN ALLERGIC REACTION
TO ANY OF THE OTHER
INGREDIENTS OF
ABELCET
LISTED AT THE
END OF THIS LEAFLET.
You should not be given
ABELCET if you are allergic
to amphotericin or any of the
other ingredients in this
medicine, unless your doctor
believes it is important for
you to take it.
Symptoms of an allergic
reaction may include:
•
hives or an itchy skin
rash
•
swelling of the face, lips
or tongue, which may
cause difficulty in
swallowing or breathing
•
wheezing or troubled
breathing
•
faintness.
2. YOU HAVE KIDNEY OR LIVER
PROBLEMS OR ANY OTHER
SERIOUS ILLNESS.
Your doctor may need to
consider whether you should
receive ABELCET or change
the way it is given to you.
3. YOU ARE PREGNANT OR
INTEND TO BECOME
PREGNANT.
Like most medicines,
ABELCET
is not
re

Đặc tính sản phẩm

Teva Pharma Australia Pty Limited Version 2.0 1
Based on Teva CCSI: 766/03/05/18
AUSTRALIAN PI – ABELCET
® (AMPHOTERICIN LIPID COMPLEX)
INJECTION
1
NAME OF THE MEDICINE
Amphotericin B (amphotericin).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ABELCET is supplied as a 20 mL suspension in a vial. Each vial
contains the equivalent of 100 mg of
amphotericin B.
For the full list of excipients, see Section 6.1 “LIST OF
EXCIPIENTS.”
3
PHARMACEUTICAL FORM
ABELCET is a sterile, pyrogen-free suspension in isotonic saline. It
consists of amphotericin, of which
amphotericin B is the major component, in a complex with
phospholipids. Amphotericin is a
macrocyclic, polyene, broad-spectrum antifungal antibiotic produced by
_Streptomyces nodosus_. The
lipophilic moiety of amphotericin B allows molecules of the drug to be
complexed in a ribbon-like
structure with the phospholipids.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ABELCET is indicated for the treatment of invasive fungal disease
caused by organisms susceptible to
amphotericin B (see Section 5.1, PHARMACODYNAMIC PROPERTIES, CLINICAL
TRIALS).
4.2
D
OSE AND METHOD OF ADMINISTRATION
ABELCET is a sterile, pyrogen-free suspension to be diluted for
intravenous infusion only.
Vials are for single use in one patient on one occasion only. Aseptic
technique must be strictly
observed throughout handling of ABELCET since no bacteriostatic agent
or preservative is present.
DOSAGE
The recommended daily dose is 5.0 mg/kg given as a single infusion.
Use of other doses has not
been supported by adequate information.
An initial test dose of 1.0 mg should be infused intravenously over 15
minutes. Facilities for
resuscitation should be readily at hand.
ABELCET should be administered by intravenous infusion at a rate of
2.5 mg/kg/h. Before infusion,
the suspension must be filtered using the filter needle provided (to
remove any large particles
present) and then diluted with 5.0% glucose injection, according to
the Section below titled,
“Preparation of the Suspension for Infu