Informatii Medicale-Thalidomide Celegene-Reducere Doza

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CASA NATIONALA DE ASIGUR,{R] DE SANATATE

CalcaCillnjilorni2l3,Blo.Slg,Sebrl, Beuftii
Einril didor g.n ml@cdanrc03?2 309274t Fix03?2 109233

nA 2ct" /rr t7. 2u.-


Casa de Asigureri de Sdndlate

Doamnei/Domiulu Prc9edinie- olectorGene€l

in lale cu adresa M.S nr. 34gO4E/06.11.2015 Inegi6tEte ta


conform
c.NA.s. - DMS cu nr. 3929/10.11.2015 v! educem ra cuno nla mesurite
lnlreprinse de Agenta Europeana a Medi@m€nluLo (EMA), Aoe(ia Nalona a a
Med€mentulu tia D spozilivelor Mgdiel€ (ANrvloM) pBnlru inlomarea conutli
med€l refe tor /a hedicanohtut rha daaid. c.ls.ao si anuh6. Edu.eba
dazei de lalidonlda lo incepe@a tfttanertutut, la pactqntii cu va6t€ pest6 75 d6
anr, h cazut adninistarii in anciere tu netatan.
Ve rug,m s,lualimAsli de inlomae a lumizoilor d€ seruciimedi€te prin
ali$rea pe pagna electrcnic, a casei do as gurad d€ sdnalate, tn Loc vzbit. a
documenluLul ,Talidomida (Thatidomtde cetgon6): reducer€a dozeide tatidomida
a incepere, I€lsmentlui, la paci6ill d vaBta p$te 75 de ani n €zul
adm nistbri.u meLfalan. "
Anexrm in rolocopie documenll rGpecitv.

OIRECTORGENERAL
Noieldbrie 2015

TrridoFidi (Th iilobld. cclgchc): r.duc.r€. dozei de blidonidi It


llccpcr.2 tmtametrtulqi, h prcl.trfii cu vArst. p$t€ 75 d€ nnl, in clzul
.dbldslrnr ln.socicrecu E.lftlan
sdnare plofGionist di! domoiuL sanatitn,

Dc comu acord cu Agenlia EwlcdA a M.dicam€ntllxi ti Agent'a Nalionala a


Mediceeftuluj i
a Dispoziti!.lor Mcdicale, conloia Celgene, dorege sa va
adlct la cuostinF o Doue EcobddN inlonate Prividd reducels ddzei inliale
de lalidonidl la.dninjstrdea in Aocierc cu 6clfal& ti p!.dnlsoa (MFI), la
peistricu !d'(t!> ?5 dce .utrielM "uhiplu nedarai

' in prczert, lo po.ienlii cu va,nd > 75 de atl se rcconrndd o dozn lnllld4


ndusd da tal lonldAt rnpe.tlt 100 r8 pe zi.

' La p@ienli d. ani, nzb e utitizatd o dozn inilidtd rcdwn de


,ABb > 75
devalan tu cazul adnlnbdfi tn asociere .u talidbhidd.

. PnJin Eenqol dI rcacliitot a.lv.tt. topo ate la pdcienlti cu firsta >75


de ani ttdtall .! ltlidobirla 100hC, o dotd pc zi, d lott si,nntu .u pro|ilrl
rcdcliitot ddteB. obs.nat. ld pecientii cu v6tda ati ttut,li cu
talidonidn 200 ng, o dntd pe zi, Cu rodte Ia =75.L
paciehli cv vArttu > 75
^cesreq
d. Mi, aind posinititaks tucttui de opuilie cu tededA ndi nne a
r.a4ltlor tdvese gave
I'lfornrtii rdplinontar. rcr.rilo.r. h nou! recomxdue p.ivird doa ri h prcbl.nr d.
!c!I34!
Mcdkahchtul Ttalidonid. C.lgana t0 ng capltle .at .ltotizat in Una.ea Ewap!.nd p.rnL
uilE-c k docier. cr mr.hn i prtdnkan, e rat@ta,t da yidd lini, la pEiantii tu ntialan
nu iplu nztutd, .u \:6*ta z 65 dc Mi tur .aE tu :nt tlEibili p.flru .hini.tcrapiz tu dole

Noite Hcoddddn pbihd ojtaafta lb,i in luncti. dt rddtd te bazaln pe reluL.Ele uni
stdil d. Jerz 3 sponnnd tz toipdnia c.lstne Cc-tol |MMA2A ) ri turt tuibut. da un
autliu de'fiytot de klssraupe Fr4@phonc d! Mtdltue tsludiul IFM 01/a 1")
o hotEn a ntuthtsta. tu pnvc ststnp di cdtttut Stud,utd CCtOl t-Mttt-OlA dca&d
]a
Ii codat ntu omant dga4ci. o inlica .n J.e*no s\{otd d! apnle a
Egutoa a
r.kbbt o^?t rq6 tt c daqtlkrodwq d. End t.t qoi.d to pa..n1ti w wta
r,> ) dr an, ) .arpa ot r tu podrnt :i d e68ta : h d2 drt ts6 5o.
Jap do 46.. 5^ 4lpodte.
1 t

' u no tor. 4 ) t |j L L h4t o.at. 4 ab. gtuFtr at urtd t! - t dc a"t


ou abrla d:!F.at .|kh sdn'j.dtw !tu baakr nsa,trp,,tt rr c
I > t d. ah,/ ", t-
Eqitt t advce Ew Metfu. ,i a.., di/.anta aozb . pawrd eanel. p4;o4 dc a;a. i4
8.Nrai klkn d. ddnFrta4 t dodlot dt Mlr ojtsraE ih nncrtu dr v.a,u a Jan bh.
tokat, to gruta d. rthld > 75 d. mL

P. t td, pruflu| ruttild adyet. ruparat. tt puientii a e66te > 7t dr .ni !tutoti cu
iatidoktdd !00ne, o do6 pa zt, a c! pnltut aetiit|r adftr& abs{;a ra
lol ndila
P@icrli e et4a a75 dc ml 1tu@ti cu talldaktdd 2a0 ng, o datd t. n. a hde Aan.a,la
tdtirhlii cur6t:b > 7t de nt paole dieo tkcd unthw4a n.i ndn de opttL d,.o4 .f

TfthtL rc4iotu! ldpttl .a, h .0dto1 ltvdiutui cc-5013-M71.02a, do\ de tnitlan a


ntun.rtohi p1ta h.l.tm :4 titud iaE a,] tt o, ni,fu pe n h Ja !,. dr Fxla tJ.
nddon oaatd. ru o Adns .,ptidotdd d. 50% , du.i i, -E dp tr\-tcmtd nnatd
md.lztd (cLow/ dadi'tn.t: < 50 flt/Dinu, re tMtck.F r.tuk *,i kk;^r4-,1
qrdkirei: < 3a hl/^bd) cn tE rt. o n t" vd.z td notucntut psctentlar tu teo

Ap.I ta tuta4o.d tk [email protected]


Ei. ihe(mr $ tuDoturi one Frd: rdt.ts. surp.cbr.. !soc:i- ., Jdm'nshj.r
T.dr.sm.nolL' I"Blidon:dc Cdgcdc, .tt. Ascntir N! on&6 a MrdEmrnstu r s
Di,po/ velor Medirde tw.smrD). lI .onfotu.llc o enchut ndrona, dc Fpd,.
tpm'rA pi,n in'trld'i -Fi5eipeorui.podftrtponhdad'erciitorldvcFc !hcdn;qc.,
dspohd . pe prSh: q.b. &cnrrciNal$ml.: M.dicd.,[lu: !,r Dapozrt:,.torvldiole
(ww anm.ro). b rclutrr0 M.d @s'q dc uz undnnspoF.@ o.re!r. adv.s4 kmkt c6rc.
c.nrtuI N{ionlt dc r'mtovtgflcnta
sr. Avidor sinrtc$u nr 43, s&ior t.
0l1473 - Bucuqti, Roadniq

Tobdsd rc*ti . e\as idp.dd. r por 6dnr ricAN (FsholF ro.ru ro.fnirotur.
,ubnal'd d.pu.ercp.pirtt, li uhJo&dc drc dc.onb.r:
Gcr4ts Ph.rR.s,A, R.pr46t nt!Romini!
Cller 13 S.pt hblicm.90
cNdontkh d. unt d dL /.tr4.!tt nt t b.tl. d d.ttndto ttt d. .ttdi.di. de punq. D.

D&i dv4i blE$lri liu doriti initutii erliD4tas. v[ dStn 3n @nrdli Ep@nhli
loeE r coDlDlol C.lg.6 h rd@r

Ccrsh PL!n! &A- R.!!d.rt !F Rodirh

se' d![ j !d6;


@ drdnhi, 4ostr, q qGi.a e hcnlo. fti&i d
ddtud dq d. D ddql .! dud dr r!. r4dhb, h uH.qB ( Mq m! dnsd,n( d tr:h
'did.n.4

i. sdq !r FM 0r0r .cnrrir ledr d. md6lq a prdiso 0@r q! d! q


--&
CNAS
CASA NATIONALA DE ASIGURIRT DE S;.NATATE
c,L.trcdl.msilo.nL
b{riLi
2,13, Bl@ Sl9, S.uror
dirocroiscnqrL@!son.ro
l,
0172 3092?4;
Bu.u,rrri
Fd 0172 309233

4A)nf/ lt n , za/f
casa d6Asgldride sanllate....... ........

0oamnei/oomnului P€9edinte - Dn6dor Gen€6

in conromtate cu adesa M.s nr.5287E/0511.2015, inrcgist€i la


C.N.A.S - DMS cu nr. 3913/09112015 !e
adu@m a cunottinle m5sudle
inlreprinse de Alenla Europeana a Medi.aneniuru (EMA), Agenlra NalioiaE a
ftredi€menruLu 9ia ospozitiveror [ledicare (ANrvoM) penrru Inromarea coQru
medi@l r6fertor to inl:otnalli noi inpotunta Ef.nbEE ta p@venirea sarcini,
ad6Ete atat fEheilat Et 6i b{balilq t@tati @ cELLcEPf (ni6fen.tat de

Va rusrn s, luali m&ui deinfoma€ a flhizo lor de Betolcll nedicat6 p n

ati9aEa pe paQina eleclrcnicl a casel ds asigudf de s:n:tare l. loc vizbil, a


documenrului de dofetiL (cerlc€pt): risc srav d€ teErogenraie
"Micotenoat
nromatrr noi inporlanlo rel€ toaE la pevennBa E6rcini , adresato atal feme lor car

Anexdm in fotocopje documentul Bpecliv

DIRECTOR GEI{ERAL
Miadf.noht d. dolc.jl (Cc[CDpt): riir 8nv do t.rrtos.dt1t. - lDforbntii Mi inpoturl.
r.f. onr.I! pr.v.rin! sr.inii dNttc rrai f.bcilor, cAl !i birn.!flot

siinat Dtofcsiobi$ din do@Diul sl!fintii,

D. .oEu &oid cu AEdlid EEopedt. M.dicumfiitri ti Aslola Nttio.alt a MedicuohiD $


a Dilpozinvdor Midicale, eobpeia f,mceuric[ F. Itofnnu-La Roch. hd. (d.numitd in
sntiniuc Rmhd, pdn rclucnbF sa locah R@hc Romanir SR.l, do!.th sr vr !du'i l.
cu6ridr, rccom&drih codolidan Drivjnd prcvenile! lecilii D. duL udliztuii hicofcnohtului
& dofcnL brcc$o! al lcidului nicofinolid):

R4mdut inJonsttihr priud


'\pnzt'
Micotslanrl eR Etc!slo8$ 6u puthic, c{., in.ml dpeeni in tinpul leiEi, cren.
6cul d. apd$c a avotului spoots ti a bd{omaliilor co!E.N6l.

La Dunctul 4.1 ol rezmanlui odct idciLor produuhi sc! sdaugd umA$&.1. noi

. Micoa.ldlatul N sc va rdnitisbi! sdci!4 cu.xclplis ceuilor ir ce nu cn disponlbil m


dr htn sltoativ ad.ovat de pEvorc t €j.$lui dc tNtlut
. Micofedolaol nu s. va administa fcdeiloi,nab h pdioada fcnili ti cNe nu utilizrui n.rottc
dc cdnta.otic fDd. aliclce
. t.n@ a *olud.lNitiliEtd uriurii eoidc sl. h limpul sminii hrd.ntul cu hicoicnolat
nu t.bujc initiat la lemcile ilal. io p*iordr fdill .ec nu ftc do$dd uui k$ d. s&.ini cu

. M.dicii sc vo! sigur cd !oD.il. $i b&bdtii ce. udli*el dicofcloldr i4cts ns.ul d.
rfccrm d Onlui, nccesioid udizlrn sor bc&dc contlc.ptivc cfice. ti d.ccsiilra d. x
consul@ incdi4 E dcdie, i! cdL h qc dis6 posibilitdea aPdiliei wi su.ini
. Sc vor eu. h dn!o{i. mdirl. cdu4i.nrle Dens ! plah in detdi! &ost. !nc$.

R..ondnddti tuolinz"t'tn t tidd t ddla d. sNntd

Inil . dc inccpcn! tohcdhnli c! [email protected] d. bofiril, tfltu a cx.ludc lot$iliiotea de


.irundc iocide dn a embiioNlci la Eicofdolu! fcnoilc aiate in pdioada fdill @bui. sl
ci..Nca b tal de !dci!4 reco4sdiJldui. r.iliztd t dou[ rsrc dc sdcinl udlz0nd p!oh. d.
uinl sau $r, cu s@ibilnlG dc nirituu 25 Butml; d doil* ten tcbuic .fcobar la inePrl d. I
l0 zil. d. la Drimrl td ti imcdiar inoiDrc d. inc.F.s hrhdtului cu nicofcnol.t de ooredl
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Llohotii rtlrinutt. t\.ritoetr td pr.atu a.halizdta a notctorpiend sisttq/o

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chrnl Nltiorrl dc Fcmlcoyicitcntii


sd avidor slnar.su r. 48. scctor I
0l l4?8 - Bdod.sti. Ronirit
+ 4 0157 |7 159

To-odrl. ,!xti c r!o* ,6peur r p.. hpom $ cao. rDEz.nrhl- to().d r d-ltriron ,
autonzt'o d! psseFepial\ a habud. dak de conra(r.

ROCIIE ROM,INIA S,RL.

clrdn6 Ciry cara - Thql dc Sud


Dcpdecnirl Mcdicdl, e6j 6, Seror I
013?02 - Bucurcsii, Roftrlia
+40?1 206 47 01taU0J

rcmdi [email protected]

c'otdondd. l. unaj dte 4rtctutonlct loealc,b D.lindtotubi n. dutoti4i. te pb.n p.


P@m InL.UI ,i don4' --pLher@ Gf.ibM l- dili2je- D.di.notutur Cellc..r
st (onEcq: D.ptucntut Vedi.jl at Cobp4cj POCH!

ROCrE Rolvlql.flA S.RL

ChdnB city Car - Tutul d. Sud


DeFanMcntol M!di6t, cEj d, s.@r l
0l1702 - lrcNsti. Rdanja
+402t2064715
+4V2r 20617 \it@tot
+4437 2@129A
FEei&[email protected]@

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