CASPOFUNGIN PANPHARMA INJECTION caspofungin (as acetate) 70 mg powder for injection vial

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

caspofungin acetate

Verfügbar ab:

Panpharma Australia Pty Ltd

INN (Internationale Bezeichnung):

caspofungin acetate

Berechtigungsstatus:

Registered

Gebrauchsinformation

CASPOFUNGIN PANPHARMA INJECTION
_FOR INTRAVENOUS INFUSION_
_Caspofungin (as acetate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Caspofungin acetate.
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 acetate 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
ACETATE IS USED FOR
Caspofungin acetate 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 acetate 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 respir

Fachinformation

Product Information
Page 1
Caspofungin Panpharma Powder for Injection [Caspofungin (as acetate)
50 mg & 70 mg]
______________________________________________________________________________________________________________________________
PRODUCT INFORMATION
Caspofungin Panpharma Powder for Injection
[Caspofungin (as acetate) 50 mg, 70 mg]
NAME OF THE MEDICINE
Caspofungin Panpharma Powder for Injection [Caspofungin (as acetate)
50 mg and 70
mg]
The structural formula of caspofungin acetate is shown below:
Active ingredient:
caspofungin acetate
Chemical name:
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)
Molecular formula:
C
52
H
88
N
10
O
15
.2C
2
H
4
O
2
Molecular weight:
1213.42
CAS registry number:
CAS-179463-17-3
DESCRIPTION
Caspofungin Panpharma
Powder for Injection is a sterile, lyophilised product for
intravenous infusion that contains a semisynthetic lipopeptide
(echinocandin) compound
synthesised from a fermentation product of _Glarea lozoyensis_.
Caspofungin belongs to
the class of antifungal drugs (echinocandins) that inhibit the
synthesis of β (1,3)-D-
glucan, an integral component of the fungal cell wall.
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Version 1.0
Product Information
Page 2
Caspofungin Panpharma Powder for Injection [Caspofungin (as acetate)
50 mg & 70 mg]
______________________________________________________________________________________________________________________________
In
addition
to
the
active
ingredient
caspofungin
acetate,
Caspofungin
(acetate)
Panpharma contains the following inactive ingredients: sucrose,
mannitol, succinic acid
and sodium hydroxide. 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.
PHARMACOLOGY
MECHANISM OF ACTION
C