DRUG STUDY ON CEREBROLYSIN

PATIENTS NAME: Saturnino Colegio AGE: 51 years old WEIGHT: approx.. 60 kg

DIAGNOSIS: TBI, moderate SEX: Male HEIGHT: approx. 5.7 !t
PHYSICIANS NAME: "r. C#arles Tan DATE OF ADMISSION: $e%ruary &, '01( BODY BUILD: st#eni)
Drug Data Class!"at#$
M%"&a$s' #(
A"t#$
I$)"at#$ C#$tra$)"at#$s A)*%rs% R%a"t#$ Nurs$g R%s+#$s,lt%s
G%$%r"
Na'%
Cere%rolysin
Tra)%
Na'%
$B* 1070

Pat%$ts
D#s%
10 )) I+TT e,ery
- #ours
M$'u'
D#s%
10 m.

Ma-'u'
D#s%
50m.

C#$t%$ts
/europeptide

A*ala,lt.
a$) "#l#r
R#ut%s #(
a)'$strat
#$
I+TT
T&%ra+%ut":
0erip#eral
,asodilators
P&ar'a"#l#g
"
/ootropi)s and
/eurotoni)s1/e
urotrop#i)s

Pr%g$a$".
Cat%g#r.

unkno2n
T#e peptide !ra)tion
stimulates )ell
di3erentiation,
%olsters ner,e )ell
!un)tion and indu)es
me)#anisms o!
prote)tion and repair.
In animal
experiments,
Cere%rolysin dire)tly
in4uen)es neuronal
and synapti)
plasti)ity, t#us
impro,ing learning.
T#is #as %een s#o2n
in young, adult and
aged animals 2it#
redu)ed )ogniti,e
a%ilities. In models o!
)ere%ral is)#emia,
Cere%rolysin redu)ed
in!ar)t ,olume,
in#i%ited edema
!ormation, sta%ili5ed
mi)ro)ir)ulation,
dou%led t#e sur,i,al
rate, and normali5ed
lesion6related
neurologi)al !ailure
and learning de7)its.
0ositi,e results 2ere
also o%tained using
models o!
8l5#eimer9s disease.
In addition to its
dire)t e3e)ts on
neurons,
Cere%rolysin appears
to signi7)antly
in)rease t#e num%er
o! glu)ose transport
mole)ules in t#e
%lood6%rain %arrier,
t#ere%y %alan)ing
out t#e )riti)al
energy de7)it
G%$%ral
I$)"at#$s
/eurotrop#i) agent
!or t#e treatment
o! a)ute is)#emi)
stroke, dementia :
traumati) %rain
in;ury< =rgani),
meta%oli) and
neurodegenerati,e
disorders o! t#e
%rain espe)ially
senile dementia o!
8l5#eimer9s type<
postapople)ti)
)ompli)ations<
)ranio)ere%ral
trauma<
postoperati,e
trauma, )ere%ral
)ontusion or
)on)ussion.
Pat%$ts
A"tual
I$)"at#$
Traumati) %rain
in;ury





>ypersensiti,ity to
one o! t#e
)omponents o!
Cere%rolysin.
*pilepsy. Se,ere
renal impairment.
8lt#oug# t#ere are
no data indi)ating
t#at Cere%rolysin
)auses renal stress,
Cere%rolysin s#ould
not %e administered
in t#e presen)e o!
existing se,ere renal
!ailure.
Pr%"aut#$
8llergi) diat#esis.
Cere%rolysin
treatment may result
in an in)rease in t#e
!re?uen)y o!
sei5ures< epilepti)
)onditions and grand
mal )on,ulsions.
Us% $ +r%g$a$".
/ la"tat#$: 8nimal
studies did not s#o2
any indi)ation o!
reprodu)ti,e toxi)ity.
>o2e,er, no data are
a,aila%le !or
#umans. T#ere!ore,
during pregnan)y
and la)tation,
Cere%rolysin s#ould
only %e used a!ter
)are!ul risk1%ene7t
)onsiderations.
Us% $ t&%
%l)%rl.: 8s
Cere%rolysin is used
in t#e elderly, and
t#e undesira%le
e3e)ts as !ollo2s,
are typi)al o! t#is
In rare )ases, t#e
desired a)ti,ating
e3e)ts #a,e also %een
asso)iated 2it#
agitation @aggression,
)on!usion, insomniaA.
In 1 study, rare )ases
o! #yper,entilation,
#ypertension,
#ypotension, tiredness,
tremor, depression,
apat#y, di55iness and
symptoms o! in4uen5a
@eg, )old, )oug#,
respiratory tra)t
in!e)tionsA 2ere
reported.
Single )ases o! grand
mal atta)ks and
)on,ulsions #a,e %een
reported a!ter
administration o!
Cere%rolysin.
In rare )ases,
gastrointestinal
distur%an)es eg, loss
o! appetite, dyspepsia,
diarr#ea, )onstipation,
,omiting and nausea,
#a,e %een o%ser,ed.
I! in;e)ted too ?ui)kly,
!eelings o! #eat or
s2eating, di55iness,
and in isolated
instan)es, palpitations
or arr#yt#mias may
result.
In;e)tion site rea)tions
eg, eryt#ema, pruritus
and %urning #a,e %een
reported.
In ,ery rare )ases,
#ypersensiti,ity or
allergi) rea)tions eg,
skin and lo)al
in4ammatory
B%(#r%
1.8ssess patients
)ondition
'.8ssess i! patient #as any
allergies to t#e )ontents
o! t#e medi)ation
&.8ssess i! patient #as any
renal impairments.
(.8ssess i! patient #as any
ot#er neurologi)
disorders t#at may %e
)ontraindi)ated !or t#is
drug.
5.C#e)k order !rom
do)tors orders in
patients )#art.
Dur$g
1. Identi!y patient.
'. 8dminister
medi)ation at t#e rig#t
time.
&. 8dminister
medi)ation at t#e rig#t
route.
(. "o not in!use
medi)ation to !ast.
5. *xplain to patient
or S= t#e purpose o!
medi)ation.
A(t%r
1. *xplain to t#e
patient or S= t#e
possi%le side e3e)ts o!
medi)ation.
'. Instru)t S= or
patient to report
immediately to t#e
#ealt# )are pro!essional
i! any ad,erse e3e)ts
o))ur.
&. Monitor patient
)losely !or at least 15
minutes.
asso)iated 2it# t#is
disease.
Buantitati,e
ele)troen)ep#alogra
p#y @**CA studies o!
#ealt#y ,olunteers
and patients
su3ering !rom
,as)ular dementia
#a,e s#o2n dose6
dependent a)ute
e3e)ts o! ele,ated
neuronal a)ti,ity
@in)rease in D and E
!re?uen)iesA a!ter (
2eeks o! treatment.
Fegardless o! t#e
)ause o! t#e disease,
%e it
neurodegenerati,e
dementia o!
8l5#eimer9s type or
,as)ular dementia,
Cere%rolysin t#erapy
results in
impro,ements in t#e
o%;e)ti,e )ogniti,e
a%ilities and in t#e
a)ti,ities o! daily
li,ing. 8!ter only '
2eeks, t#ere are
impro,ements in t#e
)lini)al glo%al
impression, 2#i)#
in)rease 2it#
)ontinuation o! t#e
t#erapy. 8lso
independent o! t#e
type o! dementia,
approximately 606
70G o! patients
respond positi,ely to
Cere%rolysin t#erapy.
In t#e )ase o! senile
dementia o!
8l5#eimer9s type, t#e
impro,ed )lini)al
state o! t#e patient is
maintained a!ter t#e
end o! a)ti,e
treatment. In
parti)ular, t#e
a)ti,ities o! daily
patient population,
t#ey may also %e
o%ser,ed 2it#out
drug use.
Drug $t%ra"t#$
0)rug t# )rug
=n t#e %asis o!
Cere%rolysin9s
p#arma)ologi)al
pro7le, spe)ial
attention s#ould %e
gi,en to possi%le
additi,e e3e)ts 2#en
used in )on;un)tion
2it# antidepressants
or M8= in#i%itors. In
su)# )ases, it is
re)ommended t#at
t#e dose o! t#e
antidepressant is
lo2ered.
In)ompati%ilitiesH
Cere%rolysin s#ould
not %e mixed 2it#
%alan)ed amino a)id
solutions in an
in!usion.
Cere%rolysin is
in)ompati%le 2it#
solutions 2#i)#
)#ange t#e p> @56-A
and 2it# lipid6
)ontaining solutions.
T#e )ompati%ility
o,er '( #rs at room
temperature in t#e
presen)e o! lig#t #as
%een tested 2it# t#e
!ollo2ing standard
in!usion solutionsH
0.IG sodium
)#loride solution
@/aCl I mg1m.A,
Finger9s solution
@/a
J
15&.I- mmol1.,
Ca
J'
'.7( mmol1.,
K
J
(.0' mmol1.,
Cl
6
16&.(- mmol1.A,
glu)ose 5G.
rea)tions, #eada)#e,
ne)k and lim% pain,
!e,er, lo2 %a)k pain,
dyspnea, )#ills and
s#o)k6like state #a,e
%een o%ser,ed.
(. Continue to
monitor +1S and
)ondition o! patient
t#roug#out t#erapy.
5. =%ser,e proper
do)umentation o!
medi)ation gi,en.
li,ing are impro,ed
and sta%ili5ed o,er
t#e long6term, 2#i)#
in general leads to a
redu)ed need !or
patient )are and
super,ision. =n t#e
%asis o! its
neurotrop#i) @ner,e
gro2t# !a)tor6likeA
a)ti,ity, Cere%rolysin
)an a)#ie,e a
signi7)ant redu)tion,
or in some )ases
e,en t#e )essation o!
progression, o!
neurodegenerati,e
pro)esses.L
P&ar'a"#1$%t"s
A: unkno2n
D: Can )ross t#e
%lood %rain %arrier.
M/E: unkno2n
O$s%t
unkno2n
P%a1
unkno2n
Durat#$
'( #ours

Drug Hal( L(%
unkno2n
+itamins and
)ardio,as)ular drugs
may %e gi,en
)on)omitantly 2it#
Cere%rolysin %ut t#e
drugs s#ould not %e
mixed 2it#
Cere%rolysin in t#e
syringe.
SOURCE: MIMS@'01&A MIMS0#ilippinesH Cere%rolysin. Fetrie,ed !rom &tt+s:223334''s4"#'2P&l++$%s2)rug2$(#2C%r%,r#l.s$25
t.+%6(ull7I$)"at#$s on $e%ruary 7, '01(.