CASPOFUNGIN MYX caspofungin (as acetate) 50 mg powder for injection vial

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

caspofungin

MAH:

Mayne Pharma International Pty Ltd

INN:

Caspofungin

authorization_status:

Registered

PIL

CASPOFUNGIN MYX™
_FOR INTRAVENOUS INFUSION _
_Caspofungin acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Caspofungin MYX.
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 using Caspofungin
MYX against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CASPOFUNGIN
MYX IS USED FOR
Caspofungin MYX is used to treat
the following fungal infections:
•
Invasive candidiasis, including
candidaemia
•
Oesophageal candidiasis
•
Invasive aspergillosis, when
other antifungal treatments
have not worked or when other
antifungal treatments have not
been tolerated.
Also, your doctor may suspect that
you have a fungal infection in the
following situation, and prescribe
Caspofungin MYX to treat it.
•
Chemotherapy or other
medical treatments or
conditions can lower the
body's resistance to disease by
lowering counts of certain
white blood cells. If you have
persistent fever following
chemotherapy or under other
conditions as noted above, and
your fever is not reduced by
treatment with an antibiotic,
you may have a fungal
infection.
Candidiasis is an infection caused
by a fungus (yeast) called candida.
Invasive candidiasis is a serious
type of candidiasis which occurs in
your bloodstream (referred to as
candidaemia), or in tissues or
organs such as the lining of the
abdomen (peritonitis), the heart,
kidneys, liver, bones, muscles,
joints, spleen, or eyes.
Candidiasis can also occur in your
food pipe, also known as the
oesophagus (oesophageal
candidiasis). It may cause difficulty
or pain when swallowing.
Invasive aspergillosis is an infection
caused by a fungus, called
aspergillus (as-pur-jilus). Most of
these infections begin in the
respiratory tract (in the nose,
sinuses, or

SPC

Product Information
CASPOFUNGIN MYX™
POWDER FOR INJECTION
NAME OF THE MEDICINE
Caspofungin acetate
Caspofungin acetate is 1-[(4
_R_
,5
_S_
)-5-[(2-aminoethyl)amino]-
_N_
2
-(10,12- dimethyl-1-
oxotetradecyl)-4-hydroxy-
_L-_
ornithine]-5-[(3
_R_
)-3-hydroxy-
_L_
- ornithine]pneumocandin B
0
diacetate (salt).
The
empirical formula is C
52
H
88
N
10
O
15
•2C
2
H
4
O
2
and the formula weight is 1213.42. The
CAS No is 179463-17-3. The structural formula is:
DESCRIPTION
Caspofungin MYX
is a sterile, lyophilised product for intravenous infusion that
contains a
semisynthetic lipopeptide (echinocandin) compound synthesised from a
fermentation
product of Pneumocandin B
0
_. _
Caspofungin acetate belongs to a class of antifungal drugs
(echinocandins) that inhibit the synthesis of
β
(1,3)-D-glucan, an integral component of the
fungal cell wall. Caspofungin acetate is a hygroscopic, white to
off-white powder. It is
freely soluble in water and methanol, and slightly soluble in ethanol.
The pH of a saturated
aqueous solution of caspofungin acetate is approximately 6.6.
In addition to the active ingredient caspofungin acetate, Caspofungin
MYX contains the
following inactive ingredients: sucrose, mannitol, glacial acetic
acid, and sodium hydroxide.
v 1.0
1
Product Information
PHARMACOLOGY
MECHANISM OF ACTION
Caspofungin acetate, the active ingredient of Caspofungin MYX,
inhibits the synthesis of
β
(1,3)-D-glucan, an essential component of the cell wall of many
filamentous fungi and
yeast.
β
(1,3)-D-glucan is not present in mammalian cells.
MICROBIOLOGY
ACTIVITY _IN VITRO_
Caspofungin has
_in vitro _
activity against:
_Aspergillus _
species (including
_Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger, _
_Aspergillus nidulans, Aspergillus terreus and Aspergillus candidus_
)
_Candida _
species (including
_Candida albicans, Candida dublinensis_
,
_Candida glabrata, _
_Candida guilliermondii, Candida kefyr, Candida krusei, Candida
lipolytica, Candida _
_lusitaniae, Candida parapsilosis_
,
_Candida rugosa, _
and
_Can