Panataxel concentrate for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

paclitaxel

Available from:

Laboratorios IMA S.A.I.C.

ATC code:

L01CD01

INN (International Name):

paclitaxel

Dosage:

300mg/vial

Pharmaceutical form:

concentrate for solution for infusion

Units in package:

(1) glass vial 50ml and (1) infusion set

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-02-26

Patient Information leaflet

                                2
1
%
o
f
a
ll
p
atien
ts
(1
7
%
o
f th
o
se
w
itho
ut
b
a
s
e
lin
e
e
d
e
m
a
);
o
n
ly
1
%
h
a
d
se
v
ere
ed
em
a
a
nd
no
n
e
o
f
th
e
se
p
ati
ents
re
q
uir
e
d
treatm
e
nt
d
i
s
co
n
tin
u
a
tio
n
. Ed
em
a
wa
s
m
o
st c
o
m
m
on
ly fo
c
a
l a
n
d
d
is
ea
se
-r
e
la
te
d
.
E
d
e
m
a
w
a
s o
b
serv
e
d
in
5
%
o
f a
ll c
o
u
rse
s fo
r p
a
tie
n
ts with
n
orma
l b
a
se
lin
e
a
n
d
d
id
n
o
t
in
c
re
as
e
w
ith
tim
e
o
n
s
tu
d
y.
S
kin
a
b
no
rm
a
litie
s
re
la
te
d
t
o
r
a
d
ia
tio
n
re
c
all
a
s
w
e
ll
a
s
r
ep
o
rts
o
f
m
a
c
u
l
op
a
p
ula
r
r
a
s
h
,
p
r
u
ritus,
Ste
v
e
n
-
Jo
h
n
so
n
sy
ndr
o
m
e
a
n
d
to
xi
c
e
p
id
e
rm
a
l n
e
c
ro
l
ys
is
h
a
v
e
b
e
e
n
re
p
o
rted. R
e
po
rts
o
f a
st
h
e
n
ia
a
n
d mala
ise
h
av
e
b
e
e
n
re
ce
iv
e
d
a
s p
a
rt of the
c
o
n
tin
u
in
g
s
u
rv
e
illa
n
c
e
o
f pac
lita
x
e
l
sa
fe
ty. I
n
th
e
P
h
a
s
e 3 trial
of
p
ac
litaxe
l
1
3
5
m
g
/m
2
o
ve
r
2
4
h
o
u
rs
in
c
o
m
b
in
a
tio
n w
ith
c
is
p
la
tin
a
s
firs
t
-lin
e
th
e
ra
p
y o
f
o
va
ria
n
c
a
nc
e
r, a
s
th
e
n
ia
w
a
s rep
or
te
d
in
1
7
%
o
f
th
e
p
a
tie
nt
s
, sig
n
i
fic
a
n
tly
gre
a
te
r
th
a
n
th
e
1
0
%
in
cid
e
n
c
e
o
b
se
r
ve
d
in
t
h
e
c
o
nt
ro
l arm
o
f cyc
lo
p
ho
sp
h
a
m
id
e
/
cis
p
la
tin.
C
o
nj
u
nc
tiv
iti
s,
i
n
cre
as
e
d
la
cr
im
a
tio
n
,
an
o
re
xia
,
co
nfu
s
io
n
a
l
sta
t
e,
p
h
o
to
p
s
ia
,
visu
a
l floate
rs, ve
rti
g
o
a
n
d
in
c
r
e
as
e
in b
lo
o
d
c
re
a
tin
i
n
e h
av
e
be
e
n
rep
o
r
te
d
.
AC
C
ID
E
N
TA
L
E
XP
O
S
U
RE
U
po
n
in
h
a
la
tio
n
, d
y
sp
n
e
a,
ch
e
st pain
,
b
u
rn
in
g e
y
e
s,
s
or
e thro
at
, a
n
d
n
a
u
s
e
a
ha
v
e
b
e
e
n
re
p
orted
. Fo
llow
in
g to
p
ic
a
l e
x
p
o
s
ure
, e
v
e
n
t
s
h
a
ve
in
c
l
u
d
ed
ting
lin
g
, burn
i
n
g
, an
d
re
d
n
e
ss
.
O
VE
RD
O
SA
G
E
T
h
e
re
is
n
o
kn
o
wn
a
n
t
id
ot
e
fo
r
p
a
c
lit
a
xe
l
o
v
e
rd
o
s
a
g
e
.
T
h
e
p
rima
ry
a
n
tic
ip
a
t
e
d
c
o
m
p
lic
a
tio
n
s o
f o
v
e
rd
o
sa
g
e
w
o
u
ld
c
o
n
sist o
f
b
o
n
e ma
rro
w
s
up
p
re
s
sio
n,
p
erip
h
er
al
n
e
u
r
o
to
x
ic
it
y,
a
n
d
m
u
c
osit
is.

                                
                                Read the complete document
                                
                            

Search alerts related to this product