CARBOPLATIN INJECTABLE, BP Solution

Țară: Canada

Limbă: franceză

Sursă: Health Canada

Ingredient activ:

Carboplatine

Disponibil de la:

STRIDES PHARMA CANADA INC

Codul ATC:

L01XA02

INN (nume internaţional):

CARBOPLATIN

Dozare:

10MG

Forma farmaceutică:

Solution

Compoziție:

Carboplatine 10MG

Calea de administrare:

Intraveineuse

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

Numéro de groupe d'ingrédients actifs (GIA) :0117892002; AHFS:

Statutul autorizaţiei:

APPROUVÉ

Data de autorizare:

2020-05-20

Caracteristicilor produsului

02125 3,( '352',
3U
523/
,1( ,1-(
/(
3
ROXLRQVpULOHFRQFHQUpHSRXULQMHF LRQ
DUERSODLQHj
PJ P/
17,1e23/6,48(
RQFHQWUp
GRLWrWUHGLOXpDYDQWXWLOLVDWLRQ
PDL
'DWpGHUpYLVLRQ
1
R
GH FRQWUOH GHODSUpVHQWDWLRQ
DQDGD-
;3
9DUHQQHV 4XHEHF
%RXO
/LRQHO %RXOHW
6WULGHV 3KDUPD
DQDGD,QF
3U
5 23/
,1(,1-(/(
3
PJ P/
pULOH
/
,),
,21
e5 3(,4 (
JHQWDQWLQpRSODVLTXH
9(5,
(0(1
9(5,
(0(1
/(
5 23/
,1( (
10e',
0(1
3 ,
1
4,
1( '2,
5(
,/,
e 4 (3 5 '(0e'( ,1 (3e5,0(1e
' 1 /
,0,2
e53,(
1 ,1e23/
,4 (
92,5
0,
(
(1
5'(
(
35e
,21
'(
1 0e5 ,21
/2
/ ,5(
,1 , 4 ( '(
(
'(
)21
,21
5e1 /( (
e3
,4 ( '2,9(1
5( ())(
e
5e
/,Ê5(0(1
(
(5
/
'0,1,
5 ,21
'
0e',
0(1
(1
35e (1( '( 'e35(
,21 0e' // ,5(
1250 /( 2
'
120 /,(
'( )21
,21
e3
,4 ( 2 5e1 /(
02'( '
,21 (3
502/2,(
/,1,4(
/H FDUERSODWLQH D GHV SURSULpWpV ELRFKLPLTXHV VLPLODLUHVj FHOOHGX
FLVSODWLQH SURGXLVDQWDLQVLGH
O
'1 HVVHQWLHOOHPHQW HQWUH EULQV
GHV UpWLFXODWLRQV
KH
OHV SDWLHQWV GRQW OD FODLUDQFH GH OD
FUpDWLQLQH HVWGH PO PLQRXSOXV DX TXHOVRQ DGPLQLVWUH GX
FDUERSODWLQHLQMHFWDEOH j GHV GRVHV
GH
j
PJP OHV FRQFHQWUDWLRQV SODVPDWLTXHV GH FDUERSODWLQH GLPLQXHQW
GH PDQLqUH
ELSKDVLTXH
DYHF GHV GHPL YLHV ErWD HW DOSKD PRHQQHV GH
K HW
K UHVSHFWLYHPHQW
/D
FODLUDQFH FRUSRUHOOH WRWDOH OH YROXPH DSSDUHQW GH GLVWULEXWLRQ HW OH
WHPSV PRHQ GH UpVLGHQFH
SRXU OH FDUERSODWLQH HVW GH
P/ PLQ GH
/ HW GH
K UHVSHFWLYHPHQW
/D
PD
HW O
6
DXJPHQWHQW
GH IDoRQ OLQpDLUH DYHF OD GRVH
3DU FRQVpTXHQW
VXU OD SODJH GH GRVHV pWXGLpHV
OH
FDUERSODWLQH SUpVHQWH XQH SKDUPDFRFLQpWLTXH OLQpDLUH FKH
OHV SDWLHQWV GRQW
OD FODLUDQFH GH OD
FUpDWLQLQH HVW ≥ 60ml/PLQ
/ DGPLQLVWUDWLRQ UpSpWpH SHQGDQW
TXDWUH MRXUV FRQVpFXWLIV Q D SDV SURGXLW XQH DFFXPXODWLRQ GH
SODWLQH GDQV OH SODVPD
SUqV ODGPLQLVWUDWLRQ GH FDUERSODWLQH OHV YDOHXUV VLJQDOpHV SRXU
OHV
GHPL YLHVG pOLPLQDWLRQ WHUPLQDOH GH SODWLQHOLEUHXOWUDILOWUDEOH HW GH
FDUERSODWLQH FKH
OKRPPH
VRQW GHQYLURQ
KHXUHV HW
KHXUH
UHVSHFWLYHPHQW
3HQGDQW OD SKDVH LQLWLDOH
OD SOXSDUW
GX
SODWLQH OLEUHXOWUDILOWUDEOH HVWSUpVHQW VRXV IRUPH GH FDUERSODWLQH /D
GHPL YLH WHUPLQDOHGXSODWLQH
SODVPDWLTXH WRWDO HVWGH
KHXUHV (QYLURQ
GX S