Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
paclitaxel
Laboratorios IMA S.A.I.C.
L01CD01
paclitaxel
300mg/vial
concentrate for solution for infusion
(1) glass vial 50ml and (1) infusion set
Prescription
Registered
2016-02-26
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