Cancidas Injection 50mgvial

Land: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

CASPOFUNGIN ACETATE

Fáanlegur frá:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Alþjóðlegt nafn):

CASPOFUNGIN ACETATE

Einingar í pakka:

10ml mL

Framleitt af:

FAREVA Mirabel

Vara einkenni

LPC-MK0991-IV-102016C-
MALAYSIA
LOCAL PRODUCT CIRCULAR
CANCIDAS
®
(CASPOFUNGIN ACETATE) FOR INJECTION
I. THERAPEUTIC CLASS
CANCIDAS
®
is a sterile,
lyophilized
product for
intravenous
infusion that contains a semi-
synthetic
lipopeptide
(echinocandin) compound
synthesized
from a
fermentation
product of
Glarea
lozoyensis.
CANCIDAS
is the first of a new class of
antifungal
drugs
(echinocandins)
that inhibit the synthesis of β
(1,3)-D-
glucan, an integral component of the fungal cell wall.
CANCIDAS
(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]pn
eumocandin
B
0
diacetate (salt). In addition to the active ingredient caspofungin
acetate, CANCIDAS contains
the following inactive
ingredients:
sucrose,
mannitol,
acetic 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. 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
structural formula is:
II. INDICATIONS
CANCIDAS is indicated
in
adults and pediatric patients (12
months and older)
for:

Empi
rical therapy for presumed fungal infections in febrile, neutropenic
patients
.

Treatment of
Invasive Candidiasis, including
candidemia
.

Treatment of
Esophageal Candidiasis
.

Treatment of Invasive
aspergillosis
in patients who are
refractory
to or
intolerant
of other
therapies (i.e.
amphotericin
B,
lipid formulations of
amphotericin
B, and/ or
itraconazole).
CANCIDAS has not bee
n studied as initial therapy for invasive aspergillosis.
III. CLINICAL PHARMACOLOGY
OH
N
N
H
H
N
OH
HN
O
NH
CH
3
OH
O
H
N
NH
HO
N
HO
O
HO
OH
O
O
O
O
H
3
C
CH
3
CH
3
H
2
N
HO
H
2
N
•
2CH
3
CO
2
H
IIIA. MECHANISM OF ACTION
Caspofungin
acetate,
the
active
ingredient
of
CANCIDAS,
inhibits
the
synthesis
of
β
(1,3)-D-glucan, an
e