CASPOCAN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 70 MGVIAL

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

Caspofungin Acetate 77.69mg equivalent to Caspofungin

Tillgänglig från:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC-kod:

J02AX04

Läkemedelsform:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Sammansättning:

Caspofungin Acetate 77.69mg equivalent to Caspofungin 70.00 mg/vial

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

Prescription Only

Tillverkad av:

MEFAR İLAÇ SANAYİİ A.Ş.

Bemyndigande status:

ACTIVE

Tillstånd datum:

2019-05-24

Bipacksedel

01
29.04.2020
InA
11.05.2020
InA
160 x620 mm
Pharmathen (Elpen)
5.5 pt
319109.01-SG
29.04.2020
11.05.2020
1. Profile
2.
3.
1. black
2.
3.
4.
5.
6.
AAAM0196 - Caspofungin All strengths, PIL, Singapore
I. THERAPEUTIC CLASS
CASPOCAN is a sterile, lyophilized product for intravenous infusion
that contains
a semi-synthetic lipopeptide (echinocandin) compound synthesized from
a
fermentation product of Glarea lozoyensis. CASPOCAN 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.
II. CLINICAL PHARMACOLOGY
IIa. Mechanism of Action
Caspofungin acetate, the active ingredient of CASPOCAN, 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.
IIb. Pharmacokinetics
IIb-1. Absorption
Absorption is not relevant since caspofungin acetate is administered
intravenously.
IIb-2. Distribution
Plasma concentrations of caspofungin decline in a polyphasic manner
following
single 1-hour intravenous infusions. A short α -phase occurs
immediately post-
infusion, followed by a β -phase with a half-life of 9 to 11 hours
that characterizes
much of the profile and exhibits clear log-linear behavior from 6 to
48 hours
postdose, during which the plasma concentration decreases by 10-fold.
An
additional γ-phase also occurs with half-life 40-50 hours.
Distribution, rather than
excretion or biotransformation, is the dominant mechanism influencing
plasma
clearance. Caspofungin is extensively bound to albumin (approximately
97%),
and distribution into red blood cells is minimal. Mass balance results
showed
that approximately 92% of the administered radioactivity was
distributed to
tissues by 36 to 48 hours after a single 70-mg dose of [
3
H] caspofungin acetate.
There is little excretion or biotransformation of caspofungin during
the first 30
hours after administration.
IIb-3. Metabolism
Caspofungin is slowly metabolized

Produktens egenskaper

5
05/07/2021
v.b.m
25/05/2022
v.b.m
160 x620 mm
Pharmathen (Elpen)
6.5
05/07/2021
NO
1. Profile
2.
3.
1. black
2.
3.
4.
5.
6.
AAAN5562 - Caspofungin All strengths, PIL, Singapore
I. THERAPEUTIC CLASS
CASPOCAN is a sterile, lyophilized product for intravenous infusion
that
contains a semi-synthetic lipopeptide (echinocandin) compound
synthesized
from a fermentation product of Glarea lozoyensis. CASPOCAN 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.
II. CLINICAL PHARMACOLOGY
IIA. MECHANISM OF ACTION
Caspofungin acetate, the active ingredient of CASPOCAN, 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.
IIB. PHARMACOKINETICS
IIB-1. ABSORPTION
Absorption is not relevant since caspofungin acetate is administered
intravenously.
IIB-2. DISTRIBUTION
Plasma concentrations of caspofungin decline in a polyphasic manner
following single 1-hour intravenous infusions. A short α -phase
occurs
immediately post-infusion, followed by a β -phase with a half-life of
9 to
11 hours that characterizes much of the profile and exhibits clear
log-linear
behavior from 6 to 48 hours postdose, during which the plasma
concentration
decreases by 10-fold. An additional γ-phase also occurs with
half-life
40-50 hours. Distribution, rather than excretion or biotransformation,
is
the dominant mechanism influencing plasma clearance. Caspofungin is
extensively bound to albumin (approximately 97%), and distribution
into red
blood cells is minimal. Mass balance results showed that approximately
92%
of the administered radioactivity was distributed to tissues by 36 to
48 hours
after a single 70-mg dose of [
3
H] caspofungin acetate. There is little
excretion or biotransformation of caspofungin during the first 30
hours after
administration.
IIB-3. METABOLISM
Caspofungin is slowly metabolized by hydrolysis and N-a