Cancidas Injection 70mgvial

Country: Malaysia

Language: English

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

Active ingredient:

CASPOFUNGIN ACETATE

Available from:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (International Name):

CASPOFUNGIN ACETATE

Units in package:

10ml mL

Manufactured by:

FAREVA Mirabel

Patient Information leaflet

EUPPI-CAN-IV-012007
EN EMEA/H/C/379/N031
1
dec 2006
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANCIDAS 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
CASPOFUNGIN (AS ACETATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What CANCIDAS is and what it is used for
2. Before you take CANCIDAS
3. How to take CANCIDAS
4. Possible side effects
5. How to store CANCIDAS
6. Further information
1. WHAT CANCIDAS IS AND WHAT IT IS USED FOR
CANCIDAS is an antifungal medicine that interferes with the production
of a component (glucan
polysaccharide) of the fungal cell wall that is necessary if the
fungus is to continue living and growing.
Fungal cells exposed to CANCIDAS have incomplete or defective cell
walls, making them fragile and
unable to grow.
CANCIDAS may have been prescribed to treat a serious fungal infection
called invasive candidiasis.
The infection is caused by fungal (yeast) cells called
_Candida_
. These yeast cells are normally found in
the digestive tract, and do not cause an infection unless they enter
the bloodstream (in which case the
infection is referred to as candidaemia) or other tissues or organs,
such as the lining of the abdomen
(peritonitis), the heart, the kidneys, the liver, bones, muscles,
joints, spleen, or eyes. Persons at high
risk for invasive candidiasis include surgical patients and those
whose immune systems are deficient.
Fever and chills that do not respond to antibacterial therapy are the
most common symptoms of this
type of infection.
Alternatively, your doctor may have prescribed CANCIDAS to treat a
fungal infection in y

Summary of Product characteristics

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