ΠΕΡΙΛΗΨΗ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΠΡΟΪΟΝΤΟΣ
CZ/H/173/01-02/IA/011
1.1 ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ
 !"#$%&'(
) !"#$%&'
1.2 ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ
*+!" !"#$%&', #%!-,.!/!0&1-'"2"
' 34",.!/!0&1-'"5(
)*+!" !"#$%&', #%!-,.!/!0&1-'"2"
' 34",.!/!0&1-'"5
63!%,$-2&+#" &,"7
*+!" !"#$%&', #%!-889:)88;-+ 1!5(
)*+!" !"#$%&', #%!-)<9:=<;-+ 1!5
>+!-? '3+!$!+2-,34%2-.5 $ /!@5)5
1.3 ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ
A !"#$%&'5
A$#" &-24B31+ -!&4+!-!,CD<=#2"=3
!&2! 34+'+,+0*E3=FG5
1.4 ΚΛΙΝΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ
1.4.1 Θεραπευτικές ενδείξεις
T!,-,13-+&,,-?3,"$+'H, ,1+2-
34!H2-!I0,2-:.5 $ /!"<5<35);7
J-,!-1+'"3!-4+'+"
K,$#-,"!I0,"+!# +!"3+2-3I-! 12-
L,.!/!0&1-'H #,-% '&!!,1+&+" !-/, H,1&,"
!I0,"4-!4+-H,2 ,1+3+'''% ?&'-+.3+' 3I-
 $4-+2-!&-&+I-+&-?H2"$+'- %3?H, ,1+I-+2-
!I0,2-5
J,!-,/ 1+3,,$#-,"!I0,"+2-! !/4 2-!I-:.5
 $ /!<5<;
M 4-.3+' 3? !&++1+
K&-!?.3+' 3!*-H 37 !/*0',++'-#3H,&'3H, ,+3?
$2$?:.5 $ /!<5<;5
J #,-.-!-+4N'!,1&',"3+,H-+? ,"!'$1,"$+'-
3+''% ?&'+2--+.3+' 3I- $4-+2-5
1.4.2 Δοσολογία και τρόπος χορήγησης
CZ/H/173/01-02/IA/011
O!%! '$,1+, $?,-!/#.#$%&'1?
*!/! #"', '&12"5L!&!!$1,0 ++4+!-+*!3+'&!. 4+'+
+'"!120'"3+'-,&H'&1+!H-!!$!*,-!+!H!$4-!5L
H, ,1,,.!/!0&1-',++'- %3?% ?&'+! &3,&+!"
,-!/,.12"! ,1-!!3' 2H,1,+!3+'! &3,*&4+!
&+4&*/2-,+'-JMJ$+,3#-,,+4#-!&313
4+-3 1-,+&34!$+!-3H,&H,-?5A,!#-'"+'".!P&!-1"+'"
 ,-+, 3?"3+'"4+!&+4+!"! /?"! ,1-% '&!!'H,1'
1!&!!$15
A!&!!$1
>+',.!/!0&1-'! !*--!H!*-!34!H,"!&!!$3#"
&&+&,"7
A!&!!$1&,&H,-,1",/&!!$3?-,/ 3?,+! $1:3H &'
3 ,+-1-'"QRS;
Ένδειξ
η
Ημερήσιο
δοσολογικό σχήμα
:-!$,+'
&!. 4+'+;
Διάρκεια
θεραπείας
1
:-!$,+'
&!. 4+'+;
μ J-, !-1 +'" 3!-4+'+" mg1?*!
/! #"', '&12"
7 - 14 μ' # ,"
J,!-,/ 1+ 500 mg μ 1 /! 
μ' , '&12"
7 - 10 μ' # ,"
K,$#-,"!I0,"
+2-! !/4 2-!I-
500 mg μ 1 /! 
μ' , '&12"
7 - 14 μ' # ,"
M 4- .3+' 3?
 !&++1+
500 mg μ 1 /! 
μ' , '&12"
28 μ' # ,"
K,$#-,"!I0,"
+!# +!"3+2-
3I-! 12-
500 mg μ 1 /! 
μ' , '&12"
7 - 14 μ' # ,"
K&-!? .3+' 3!*
-H 3
500 mg μ 1 /! 
μ' , '&12"
8 ,.!,"
)
L 3,+'"H, ,1", .-,,-!/#.34+!&+4+!"
$2$?5T% 4-!",++0'"4+'-,-!/#.&+'-4+!&+4+!"$2$?
,0 ++4+'-3-3?3+&+&'3,1-&-?H2"#2"<'# ,"5
K3!1'H&!1
U,2#-'-,/ 3?,+! $1:3H &'3 ,+-1-'"VRS;
Δοσολογικό
σχήμα
250 mg / 24 h 500 mg / 24 h 500 mg / 12 h
Κάθαρση
κρεατινίνης
 I+'4&'7


 I+'4&'7


 I+'4&'7


BRS
,+7
)<
W
,+7
<
W
,+7
)
W
)XB)RS
,+7
)<E
W
,+7
)<
W
,+7
))
W
Y)RS
,+7
)<E
,+7
)<
,+7
)<
CZ/H/173/01-02/IA/011
:&, .-!
#-'"!*&'"
3Z[;
)
W W W
)
A,-,1- 1+'+,", 4&H,+,"4&,",+4!*&'?&-,%?
, +'+3?, +!-!*&':Z[;5
U,2#-''+3?,+! $1
A,-+,1+ !& !$?+'"4&'"3HI"',.!/!0&1-',
,+.!1\,+&+!? &,&'-+34.H43!.,+3 12"4+!"
-,/ !*"5
J'H&4"'32#-2-
A,-+,1+ !& !$?+'"4&'"&+!"'32#-!",3+4"4+?!
,.,+.-!-+"4N'+'-,/ 3?,+! $1:.5 $ /!<5<
]^,-!-+1+3 ?0'+#-!-+_3] +&'+!&+?+!"`^_;5
J+ 34"'H&4"
O!-+,-,13-+&,3
-+&&4,-!",/?.!":.5 $ /!<5=;5
O 4!"%! ?$'&'"
O!LEVOFLOXACINGENERICS !! 1\,+4-!$ $?,-!/#.#$%&'3
%! '$,1+?*!/! #"', '&12"5T% 4-!"#$%&'"$+!
LEVOFLOXACINGENERICS #,-,1-+!$4+, !=,+$+mg?
@,+$+mg:.5 $ /!<5<;5
>&.+4+'+,".5 $ /!@53$&.+4+'+,*+
#$%&'".5 $ /!@5@5
1.4.3 Αντενδείξεις
O!,- #,-% '&!!,1+7
&,&H,-,1",, ,&H'&1&+',.!/!0&1-'?&,!!?!+,'
3-!4-'3&,3!!4+#3!%!-/# !-+&+'- $ /!
@5)
&,&H,-,1",,'N1
&,&H,-,1",&+! 34+ %I-+2-+,-4-+2-!&%,+1\!-+,+'
%! ?$'&'/H! !3-!4-'"
&,?,/?.!"3++' 3,+'"-+0'"
3++' 3,+'"3*'&'"
&,H'\!&,"$-13,"5
1.4.4 Ειδικές προειδοποιήσεις και προφυλάξεις κατά τη χρήση
T-H,3+34"&+',H31-'S
5
Aureus:MRSA;,1-H-4-H#+,4
3!-!*-H,3+34+'+&+"/H! !3-!4-,"&, .-!#-'"+'"
,.!/!0&1-'"5K!#-2"',.!/!0&1-',-&&+?-,+$+'H, ,1
$-2&+I-?!I0,2-*!+2-$MRSA,3+4",-+, $&+' 3
!+,#&+,.,.I&!-+'-,&H'&1+!! $-&!*&+'
,.!/!0&1-':3!-+.3+' 3!1 $!-+,"!&-?H2"&&+?-!-+
$+'H, ,1+2-!I0,2-4MRSA3 1-!-+3+'!;5
CZ/H/173/01-02/IA/011
L-H,3+34+'++!E
5
ColiB+!!&%-4H!$4-!!,#3,+&+"
!I0,"+!! !!'+3!*B&+"/H! !3-!4-,"!31,&+'-K 2P3?
6-2&'5a&+?-,+&+!",$$,+1,"+'"$,1"!&-+$!$ /!*--
.-!-4N'+!"+'-+!3?&%-4+'+,/-&'"+'"-H,3+34+'+"
+!E
5
Coli&+"/H! !3-!4-,"5
K&-!?.3+' 3!*-H 37'% ?&'+!&+!"-H I!".&1\,+&+
&+!%,1,&H'&1"+!Bacillus
anthracisin
vitro3&,,!#-4,#+,"&,
\I\1,, ! &#-&+!%,1&,-H I!"5T$+ !1!
&-+$!$ /!*-H #,--+ #%!-&+,H-3#$$ /?3&+"
,H-,1"&/2-1,",3I-&%,+3,+'H, ,1+!.3+' 3!*-H 35
M 4-!"#$%&'"
J #,-+' ,1+!&-&+I,-!",%&+!"% 4-!"#$%&'"+2-=,+I-
$+?+2-@,+I-$++!5
K1-$-2&+4$+'-!/!0&1-'4+3++' 3,+'"#$%&'"! ,1-
-+%H,1+%3 13 !3?+I&'+'"1,&'"+!1+!"5a,
&-,", +I&,"! ,1-,/-&+,133!/! 3?-, 3,2"
&-#,,$'"+I&'"+'"1,&'"+!1+!"5L#$%&' #,-
34+,+#&2"- !&&+,13++' 3,+'"#$%&'"+'"
,.!/!0&1-'":lb&!, #"+'"!/!0&1-'";,/-?"+I&'+'"1,&'"+!
1+!"5
J, ,%4,-!-+ !
c+4+!/ 3,+34 !P4-, #%,88 mmol :)88 mg;-+ 1!- ml
4&'" 3 )< mmol :=< mg; -+ 1! - ) ml 4&'"5 d  #, -
.-,+4N'4&H,-,1"!3!!H!*-1+,,$%4,-'&,-+ !5
O,-!-+1+3 ?0'+#-!-+
a-! ,1-,/-&+,1+,-!-+1+5a+", &&4+, ,", +I&,"
,' ,\,+!c%1,!"+#-!-+"3! ,1-!'$?&,&, ?0'+#-!-+5
O,-!-+1+3 ?0'+#-!-+, 3#"/! #"/!+, 4, '! ,1-
,/-&+,1,-+4"<E2 I-4+'-#- 0'+'"H, ,1",,.!/!0&1-'3
#%,-/, H,1$ 3,+!*"?-,",++'3!?+'"$2$?"5T31--!"
,/-&'"+,-!-+1+"3 ?0'"+#-!-+,1-0'#-!"&,&H,-,1"'31"
,$*+, '"+2-@,+I-&,&H,-,1"!.-!-', ?&,"4&,"+2-
)3&,&H,-,1"!% '&!!!*-3! +3!&+, !,?5L', ?&
!&!!$1 #,- !& 4\,+&,'32#-!"&H,-,1",.&'+'-
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&+,-? 3!!*H'&'+I-+2-&H,-I-&,, 1+2&'!+!"#%,
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&.!,*!-++!$+ 4+!",-,/-1&!-&+I++,-!-+1+"5K-
H-!!$,1++,-!-+1+'H, ,1,,.!/!0&1-'H #,-
3!,1#&2"3- %1&,3+''$2$?:5%53-'+!!1'&';$+!-
+#-!-+! !&.?H'3,:.5 $ /!"<5=3<5E;5
g4&!"!&%,+1\,+,+!9FhiRjRkjRlRmRn
A !1+, ,-,1-&!. ?,#-!&3?! $3?3++'
 3,?,++'-$2$?,,.!/!0&1-':&, .-!#-2-, 3I-
,.!2-,++'-$2$?;! ,1-,1-&*+2-4&!!&%,+1\,+
,+!
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:CDAD;5L&!. 4+'++'"CDAD31-,+4?
#2",'+3?$+'\2?'&!. 4+, '! /?+'"!!1",1-'
N,!,. -I'"3!1+:.5 $ /!<5E;5K1-&-,I"&'-+34
-'/H,14N'+?'$-2&'&,&H,-,1"! !&\!-&!. ?
CZ/H/173/01-02/IA/011
 !3++' 3,?,++'-$2$?,,.!/!0&1-'5K- %,
!N1CDAD?,-,.,.2H,1 #,-34+,+#&2"'%! ?$'&'
,.!/!0&1-'"3-0,3-,'3+''H, ,1%2 1"3H&+# '&'5a,
+#"+"3-3#"3+&+&,"-+,-,13--++/ 3,+3 !P4-+
!-&+#!-+'-, &++34+'++!,-+# !5
c&H,-,1", !H,&'$&&!*"
T3-!4-,"! ,1-,I&!-+!-!4+2-,'+3I-&&I-3
! ,1- !3#&!-,'+3!*"&&!*"5O!
-+,-,13-+&,&H,-,1",&+! 34,'N1"
:.5 $ /!<5=;342",,"3-!4-," #,-% '&!!,1+
,,$' !&!%?&,&H,-,1", !H,&'$&&!*"?++4% !-'
H, ,1, &+3#"!&1,"!,++I-!-+!-!4+2-,$3,/3I-
&&I-42"'H,!/1-':.5 $ /!<5;5a,, 1+2&'3 1&,2-,
&&!*":.5 $ /!<5E;'$2$?,,.!/!0&1-' #,-
34+,+5
c&H,-,1",#,N'/ !$!-&'"+'"@B/2&/! 3?"$34\'":B@Z[;
c&H,-,1",-H-!&,"? %!&,"-21,"&+' &+34+'++'"
/ !$!-&'"+'"@B/2&/! 3?"$34\'"! ,1-,1-, ,,1"&,
!+3#"-+ &,"4+-H, ,*!-+,-+.3+' 3!*" $!-+,"
+*!3-!4-'"5K!#-2",-',.!/!0&1-' #,-%! '$'H,1&,
+!*"+!"&H,-,1"H-4&.-4&'" #,-,#$%,+5
c&H,-,1",-,/ 3?&,+! $1
oHI"',.!/!0&1-',33 1-,+3 12"4+!"-,/ !*"'4&'+!
 #,- !& 4\,+&,&H,-,1",-,/ 3?
&,+! $1:.5 $ /!<5;5
c-+ &,", ,&H'&1"
L,.!/!0&1-'! ,1- !3#&,&!. #"-'+3H-+'/4 ,"
-+ &,", ,&H'&1":5%5$$,!!1'#2"3-/3+34FW9mG;
, 3#"/! #",++'- %3?4&':.5 $ /!<5E;5T&H,-,1"H #,
-34N!-#&2"+'-$2$?3-,3!-2-?&!-,+!$+ 4+!"?,
#-$+ 4&+,,1$!-+!!!1!"H %1&,+'-,/ !$?3+'2-
,,$4-+2-#+ 2-5
a!. #"!/!$I,"-+ &,"
J, &++3&!. I-!/!$2I-, +3I--+ &,2-42"&*- !!
hnpnSFBq9WSF9S?+!03?,, 3?-,3 4&'#%!--/, H,1,+'
,.!/!0&1-':.5 $ /!<5E;5T&H,-,1" #,-,-', I-!-+-
,3!-2-?&!-,&2",+!$+ 4+!" -+'&-#%&'+'"H, ,1",-
 !&&+!*--+ &,"&+!# 3?&+!".,--!$4-!"5
A&$31
f2",4,"+"3-!4-,"#%!--/, H,1+ %#"&+'$34\'1+!"
&, .-!#-'"+'"!$31"3+'", $31"&-?H2"&,
.'+3!*"&H,-,1"!.--&$%! '$!*,-'H, ,1,#--4+!
&+4+!"!$334 $!-+:5%5$.,-31';?-&!1-'5
J, &++3!$33!*3I+!"#%!--/, H,15a+!".'+3!*"
&H,-,1"&&+?-,+ !&,3+3? 3!!*H'&'+'"$34\'"1+!":.5
 $ /!<5E;5
J 4'N'/2+!,&H'&1"
CZ/H/173/01-02/IA/011
6%, -/, H,1 /2+!,&H'&1 , +' ,.!/!0&1-' :.5  $ /! <5E;5
a&+?-,+!&H,-,1"-'-,3+1H,-+%2 1"4$!&,#-+!-!'34/2"?
&,+,%-'+#", I,"3+1-,":5%5'3?"3+-!.!1"&! !;
3++' 3,+'"$2$?"3$<EI ,",++'3!?+'"H, ,1"
$+'- 4'N'/2+!,&H'&1"5
c&H,-,1"&+!"!!1!"%! '$!*-+-+$2-&+#"+'".+1-'"o
K0+1"H-?"*0'&'"+2-+I-+2- #+ 2-+'"?0'":Z^;
3?+'"! $1"&,&H,-,1"4$2$?,,.!/!0&1-'&,
&-&4,-+$2-&+?.+1-'"o:5%5. / 1-'; #,-
 3!!H!*-+! ,+ !+'"?0'"4+-++/ 3
%! '$!*-+++4% !-:.5 $ /!<5;5
r%2&3#"-+ &,"
6%!--/, H,1N%2&3#"-+ &,"&,&H,-,1"!.-!-
3-!4-,"&, .-!#-'"+'",.!/!0&1-'"5a,!*&-,"
, +I&,"+#",0,1%H'3-&,+!3+!-3#"&3#N,"3
+!3+&+ !/3?&, /! , 3#"/! #",+414-!4&'
,.!/!0&1-'":.5 $ /!<5E;5a,, 1+2&'!!&H,-?",/-1&,
+#"+"-+ &,"',.!/!0&1-' #,-3!,13-'/H!*-+
3+'#+ 5a-1&++ !&!%?,-',.!/!0&1-' 43,+-
% '&!!'H,1&,N%2&3!*"&H,-,1"?&H,-,1",&+! 34N%3?"-4&!5
J +&'+!&+?+!"`^
J #,-1,+ !&!%?3++'% ?&'/H! !3-!4-2-
&, .-!#-'",.!/!0&1-'"&,&H,-,1",$-2&+!*" $!-+,"
3-*-!$ +&'+!&+?+!"`^42"$ ,$&,7
B &$$,-#"&*- !! +,+#-!`^
B ++4% !-'% ?&'/ 32-!,1-$-2&+44+ +,1-!-+!
&+'`^:5%5-+ H33+'$! 1"sc3sss+ 333
-+3+H+33 !1,"-+N%2&3;
B '! H2#-'+ %?&! !1"+2-',3+ !+I-:5%5
!31!$-'&1;
B 3 3?-4&!:5%53 3?-, 3,#/ $+!
!3 1!. 3 1;5
T'32#-!&H,-,1"3!$-13,"! ,1-,1-, &&4+, !
,1&H'+!&,/ 3! +,1-!-+!`^m5K!#-2"% ,\,+ !&!%?
'% ?&'/H! !3-!!-I-&, .-!#-'"+'",.!/!0&1-'"&,
+!*"+!"'H&!*":.5 $ /!"<5
L32#-!
<5<5E3<5X;5
J, /, 3?-, !H,
c&H'+3??&H'+3!3-'+3?, /, 3?-, !H,#%,-/, H,1&,
&H,-,1"!.-!-/H! !3-!4-,"&, .-!#-'"+'"
,.!/!0&1-'"'!!1! ,1-#%,+%,1#- 0':.5 $ /!<5E;5L
,.!/!0&1-' #,-34+,+,-!&H,-?",/-1&,&+I+
-, !H,"#+&I&+,- !'/H,1''! $11"'-&+ #N'"
3+&+&'"5
A+ %#"+!?+!"3+2-%!'/4 2-
J, +I&,"'+3?"-#3 2&'"#2"3H-+'/4 !'+3?-, 3,
#%!--/, H,1,+',.!/!0&1-'3 12"&,&H,-,1",&!. #"
!3,1,-,"-4&!"5%5&?N':.5 $ /!<5E;5J #,-&&+?-,+
&+!"&H,-,1"-34N!-+'H, ,13-,3!-2-?&!-,+!$+ 4
+!",-,/-&+!*-&',13&+I+'+3?"-4&!42"-! ,01
13+, !"&3! 4% 2!* 3-'&4"?,&H'&1&+'-3!5
CZ/H/173/01-02/IA/011
J 40-&'&H#-,"itpRF
T/H! !3-!4-,"&, .-!#-'"+'",.!/!0&1-'"! !*--
 !3#&!--, !34!3,&43! ,1-,,-I&!-+'3?
-1&,&H,-,1",&H#-,itpRF5a!. #"-,H*'+,"-+ &,"
,++'-33!/! 1&, .-!#-2-H-+2-3+'"-$3'"$
--,&+3?!&+? 0'#%!-&&%,+&H,1,+'% ?&'/H! !3-!!-I-&,
&H,-,1",&H#-,itpRF5L,.!/!0&1-',-&&+?-,+&,&H,-,1"
,$-2&+4&+! 34&H#-,"itpRF5
A+ %#"4 &'"
K-'4 &',' ,&+,1? !&\!-+3!,", &,"&+!"
!/H!*"H #,-\'+,1+'$-I',-4"!/H1+ !#&2":.5
 $ /!"<583<5E;5
u, !120'
L% ?&',.!/!0&1-'",3,-,1- +,+#-'! ,1-!'$?&,
&,# ,+ '-+0''B,1&H'+2-3 !! $-&I-5K-3++' 3,
+'"H, ,1",/-&H,1, !120' #,-'/H!*-+3+'
#+ 5
J ,.!?&,, $&+' 3?,0#+&'
a,&H,-,1"!.-!-H, ,1,,.!/!0&1-'! !&! &4"
!!*%2-&+!* ! ,1-I&,N,I"BH,+3!+,#&+5U! ,1-
,1- 1+'+'',.,.12&'+2-H,+3I-!+,,&+2-&,,#$%!"
-1%-,&'"!!*%2-#&21", &&4+, !,3?",H4!5
L ,.!/!0&1-' ! ,1 - -&+,1, +'- -+0' +! Mycobacterium
tuberculosis
3,!#-2"! ,1-I&,N,I"B -'+3!+,#&+&+'
.3+' !!$3?$-2&'+'"/+12&'"5
1.4.5 Αλληλεπιδράσεις με άλλα φαρμακευτικά προϊόντα και άλλες
μορφές αλληλεπίδρασης
K1 &'2-/ 3,+3I- !P4-+2- &+',.!/!0&1-'
d,!/1-'/,-!/#-'? 4!'&+, !,?-+/,$!-I'/ 3
a,13-3?,#+',. #H'3-/ 3!3-'+3#"', &,"+'"
,.!/!0&1-'",H,!/1-'5K-+!*+!"! ,1-,/-&+,1&'-+3?
,12&'+!!!*+2-,$3,/3I-&&I-4+-3-!4-,"&$%! '$!*-+
,H,!/1-''&+, !,?-+/,$!-I'/ 3?,!"
 $!-+,"!,I-!-+!-!4+2-&&I-5
T&$3,-+ I&,"+'",.!/!0&1-'"?+-, 1!)=vN'4+, ," !&1
/,-!/#-'"44+4+-%! '$?H'3,4-'5
J !.,-,&1'3&,+1-'
L !.,-,&1'3'&,+1-',1%-1&++&+3&'-+3?,1 &'&+'-
#33 &'+'",.!/!0&1-'"5L-,/ 3?3H &'+'",.!/!0&1-'"
,IH'3,4+'&,+1-':<v;3+'- !.,-,&1':=<v;5c+4&.1-,
$+13+*!/ 3! !*--,!1&!-+'-,/ 3?&2'- 3?
#33 &'+'",.!/!0&1-'"5e&+4&!&+"4&,"!!3&+'3-&+'
,#+'!&++&+3&'-+3#"/! #"&+'-3-'+3?,-,1-H-4-
#%!-3-3?&'&15
CZ/H/173/01-02/IA/011
a-&++ !&!%?4+-',.!/!0&1-'&$%! '$,1+,/ 3!
, !*-&+'-,/ 3?&2'- 3?#33 &'42"' !.,-,&1'3'
&,+1-'1+, &,&H,-,1",,++2#-'-,/ 3?,+! $15
w,"&%,+3#"' !/! 1,"
o-3#"/ 3!!$3#",#+,"#,0-4+'/ 3!3-'+3?+'"
,.!/!0&1-'",-,' ,&+'3,,+ 4!!-#%,3-3?&'&14+-
&$%! '$?H'3,,+"34!H,"!&1,"7-H 334&.#&+!$!01-'
$.,-31' -+1-'5
K1 &'+'",.!/!0&1-'"&,/ 3,+3 !P4-+
o3!&! 1-'
T% 4-!"'1&,"\2?"+'"33!&! 1-'"0?H'3,3+==v4+-
&$%! '$?H'3,,,.!/!0&1-'5
c-+$2-&+#"+'".+1-'"o
6%!--/, H,10'#-,"+#" #+ 2-?0'":Z^;3?
! $1!! ,1-,1-&!. ?&,&H,-,1"4$2$?,
,.!/!0&1-'&,&-&4,-+$2-&+?.+1-'"o:5%5. / 1-';5
a-,I"H #,- 3!!H!*-+! ,+ !+'"?0'"&,&H,-,1"
!.-!-$2$?,-+$2-&+#".+1-'"o:.5 $ /!<5<;5
x 3!,1-$-2&+44+ +,1-!-+!&+'`^
L,.!/!0&1-'42"!,"/H! !3-!4-," #,-% '&!!,1+
, !&!%?&,&H,-,1"!!!1!.-!-/ 3!,1-$-2&+42"
 +,1-!-+!&+'`^:5%5-+ H33+'$! 1"sc3sss
+ 333-+3+H+33 !1,"-+N%2&3;:.5 $ /!<5<
J +&'+!&+?+!"`^;
w,"&%,+3#"' !/! 1,"
a,1/ 3!3-'+3?,#+'',1 &'"',.!/!0&1-',-
,' #&,+'/ 3!3-'+3?+'"H,!/1-'":!,1--+ !&2,+34
4&+ 2+!CYP)A;!,3-*!-+"4+',.!/!0&1-',-,1-
-&+!#"+!CYP)A5
1.4.6 Γονιμότητα, κύηση και γαλουχία
Εγκυμοσύνη
u %,, ! &#-!" H4",!#-2-4+'% ?&'+'",.!/!0&1-'"
&,#$3,"$-13,"5U,#+,"&,, +4\2,-#,0-,&,"?#,&,"
,..,1" &,"4&!-/! +'-+!034+'+&+'-- $2$?:.5
 $ /!5=;5e&+4&!,.&'+'-!&1&+!%,12-&,-H I!"3
4$2+!3-*-!!/-'3,4+,!#-, +2-3+&+ !/?"
+!&\,3+3!*%4- !+!-+&&4,-!! $-&!*4+"
/H! !3-!4-,"',.!/!0&1-',- #,-% '&!!,1+&,#$3,"
$-13,":.5 $ /!"<5=35=;5
Θηλασμός
L,.!/!0&1-'-+,-,13-+&,H'\!&,"$-13,"5u %!-
-, 3,1"' !/! 1,"&%,+3,+'-#33 &'+'",.!/!0&1-'"&+!
-H I-!$5e&+4&!,"/H! !3-!4-,",33 1-!-+&+!'+ 34
$5y4$2+'"!&1"&+!%,12-&,-H I!"34$2+!3-*-!!
/-'3,4+,!#-, +2-3+&+ !/?"+!&\,3+3!*%4- !
CZ/H/173/01-02/IA/011
+!-+&&4,-!! $-&!*4+"/H! !3-!4-,"',.!/!0&1-'
,- #,-% '&!!,1+&,H'\!&,"'+# ,":.5 $ /!"<5=3
5=;5
Γονιμότητα
L,.!/!0&1-',-,' #&,+'$!-4+'+?+'-- $2$3?3-4+'+
&+!" ! 1!"5
1.4.7 Επιδράσεις στην ικανότητα οδήγησης και χειρισμού μηχανών
o!,"-,H*'+,",-# $,,":5%5\'1$$!"-'1!+3#"
+ %#";! ,1-,++I&!-+'-3-4+'++!&H,-!*"-
&$3,-+ I-,+3--+ 32",3+!*+!&-&+!*- $!-+
3-*-!&,3+&+&,"4!!3-4+'+,"+#"#%!-1+, '&'&1
:5%5'!?$'&',-4"+!3-?+!?!%, &4"'%-I-;5
1.4.8 Ανεπιθύμητες ενέργειες
T' !/! 1,"!3!!H!*-.&1\!-+&,&+!%,1!#%!--3*N,
#&43-3#",#+,"! $+!!?H'3-&,, &&4+, !"4E=
&H,-,1"34,3+,-?,, 1,+4+'-33!/! 1+!/ 3!5
T&%-4+'+,"&,+4-+!-1-3! 1\!-+.&,+'"34!H'"&*.&'"7
!*&%-#":z));&%-#":z))#2"Y));4%&%-#":z))#2"
Y));&-,":z))#2"Y));!*&-,":Y));'
$-2&+#":,-! !*--,3+'H!*-4+H#&,!#-;5
K-+4"3H,3+'$! 1"&%-!+?+2-!-,H*'+,",-# $,," !&\!-+
3+&, /H1-!&"&!. 4+'+"5
Κατηγορία
Οργάνου
μ Συστή ατος
Συχνές Όχι συχνές Σπάνιες
Μη γνωστές (δεν
μπορούν να
εκτιμηθούν με
βάση τα διαθέσιμα
δεδομένα)
μ y! I0," 3
 &+I&,"
U3'+1&'
&, .
-!#-'"+'"
!120'"4
Candida
c-+1&+&'
+2-
H!$4-2-
A+ %#"+!
!!'+3!*
3+!
,/3!*
&&+?+!"
y,3!,-1
L2&-!/1
μd ! .!,-1
T,+, !,-1
J-3++ !,-1
μc3!33!3++  1
μ μ c !+3? - 1
Δ + %#" +!
-!&!!'+3!*
μ &&+? +!"
μc$$,!!1'
u, ,&H'&1
( . 4.4).  $ /!
c-/3+3?
3+'01

c-/3+!,?"
3+'01
:.5
 $ /!<5<;
A+ %#"+!
,+.!&!*
3+'"H #N'"
c-! ,01
u!$31
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u, $31
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:.5 $ /!<5<;
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&H,-,1":.5
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r%+ 3#"
+ %#"
c{-1 w$%!"
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3+&+&'
g, 34+'+
r%2&3#"
-+ &,":5%5
,N,&H?&,"
 -!;
o+HN'
A#$, &'
c-I4-, 
K/+,"
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&, /! 
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μ &&+? +!"
o,/$1
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Δ &$,&1
μ ( . a& !1 .
4.3  $ /!"
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J, /, 3?
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J !&1
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"+'"-!&1"
A&3-'&1
K02 3?
+ %?
c$,&1
a$3!?
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μ T/H 3#"
+ %#"
T+3#"
+ %#"42"
4 &'H?:.5
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4 &'":.5
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2+4"3+!
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}$$!" μ K .!#" cI,3!?"
63+2&'+'"
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o 3#"
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O%3 1
μ μ c1&H'  I-
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!! ,1-
!'$?&,&,
3 3?-3!?
o!3? H1
33!3?
+%3 113'-
1!:#%,
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&&+?+!"+!
HI 33
+!
,&!H2 3!
Δ *&-! μ~ !$%4&& !"
c, $3?
μ -, !-1+
Δ + %#" +!
$&+ ,-+, 3!*
Δ !
μ6 ,+!"
g+1
o!34
$!"
Δ&,N1
μU,+,2 & 4"
Δ&3!4+'+
c! $3? !
'!!1&,!*
&-,", +I&,"
! ,1-,1-
,-,3+3?
,-+, !3!1+"
&, .-4,-'"
+'"
N,!,. -I!"
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A+ %#"+!
?+!"3+2-
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/2&/+&'
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μ c0' #-'
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μ 1 +!"
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H-+'/4 2-
, &++3I-,!0,1
'+3?-, 3,
3 12"&,&H,-,1",
&!. #"!3,1,-,"
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L+1+
A+ %#"+!
# +!"3
+!!4 !
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.
μK0-H'
μo-'& 4"
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a*- !!StevensB
Johnson
J!*! /!, *H'
c-+1 &'
/2+!,&H'&1"
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y,3!3++ !3&+
B 3? $$,1+
μ a+! +1+
A+ %#"+!
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+!&-,+3!*
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A+ %#"+2-
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3<5<;
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+#-!-+;
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<5<;
μ•?0' &-#& !
μ•?0' 4"
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CZ/H/173/01-02/IA/011
A+ %#"
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μ1 +!"
T0,1-,/ 3?
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!/,4,-'&,
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3+&+&,"
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H2 33!*$!"3
$!"3 2-;
a
U, 3#"/! #"! ,1-,/-&+!*--/3+3#"3-/3+!,,1"
-+ &,"343,+4+'-%! ?$'&'+'" I+'"4&'"5
.
U, 3#"/! #"! ,1-,/-&+!*-, +!.,--!$4-,"-+ &,"
343,+4+'-%! ?$'&'+'" I+'"4&'"5
w,"-,H*'+,",-# $,,"!#%!-&&%,+&H,1,%! ?$'&'
/H! !3-!4-'", .-!-7
,,&4! / 1"&,&H,-,1",! / 15
c-/! H-!!$!*,-2--,H*'+2-,-, $,I-
L-/! H-!!$!*,-2--,H*'+2-,-, $,I-,+4+'%! ?$'&'
,"33!/! 1"+!/ 3,+3!* !P4-+!",1-&'-+3?5K+ #,
+'&-,%? 3!!*H'&'+'"&%#&'"!/#!"B3-*-!+!/ 3,+3!*
 !P4-+!"5|'+,1+4+!",$$,+1,"+!+!#+'"$,!-!3?"
, 1HN'"--/# !-!!,&?!+,H-!!$!*,-,"-,H*'+,"
,-# $,,"&+!-KH-34T $-&4x 32-U,&!$,12-E<B)@
M! $4"cH?-O'7€=)=<=E==8x07€=)@<XE
s&+4+!!"7WhhC7•••5n9‚5i5
1.4.9 Υπερδοσολογία
a*/2-,+!03!!$3#",#+,"&,, +4\2?3-3#"
/ 3!!$3#",#+,"!!!1,",0?%H'&-,4&,",$*+, ,"+2-
H, ,+3I-+#!-&'-+3&',1!-#-,+-,3'2H!*-,+
4!0,1, !&!!$1,.!/!0&1-'",1-+&+I+4+!
3,-+ 34-, 34&*&+'42"&*$%&'\'+ %?+'"&-,1'&'"3
3 1&,",'N1",?3-&'+!&+?+!"`^5
K &,"4+!oga&, .-!#-2-+'"&$%+3?"3+&+&'"
+2-&&I-+2-N,&H?&,2-3+!+ 4!#%!- +' 'H,14+'-
,, 1,++'-33!/! 15
a,, 1+2&', !&!!$1" #,-,/ 4\,+&+2+3?H, ,15
y4$2+'"H-4+'+",?3-&'"+!&+?+!"`^ #,-$1-,+
',3+ !3 !$ /34"#,$%!"5L!*&'&, .-!#-'"+'"
, +!-!*&'"3+'"Z[,-,1-!+,,&+3?&+'-
!3 -&'+'",.!/!0&1-'"4+!-! $-&45A,- %,,34
-+1!+!5
1.5 ΦΑΡΜΑΚΟΛΟΓΙΚΕΣ ΙΔΙΟΤΗΤΕΣ
1.5.1 Φαρμακοδυναμικές ιδιότητες
CZ/H/173/01-02/IA/011
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!/!0&1-'"5
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,.!/!0&1-'#%, &',1+!&#$+!"[B[B$ &'"3,1
+'"+!!P&!, &'"5
a%#&'/ 3!3-'+3?"/ 3!-3?"
T.H4"+'".3+' !3+4-! &'"+'",.!/!0&1-'",0 ++4+!
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U'%-&4"-+0'"-+!%?"
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,+0,2-+2-, !%I-B&+4%2-+2-+!!P&!, &I-+*!ss+'"[
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ZFnkj99StFtnikRS9Ft;
3!
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!2--+.3+' 3I- $4-+2-5
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)B)B);7
Παθογόνο Ευαίσθητο Ανθεκτικό
K-+, !.3+?  V)l Ql
ZFnkj99StFFCC5
V)l Ql
mRSnh9†tmhniFCC5
V)l Ql
htCW‡9m9mmkFFCC5
V)l Ql
5CSnk9SRtn
)
Vl Ql
Streptococcus A, B, C, G V)l Ql
D5RSˆknS‰tn
,3
V)l Q)l
ƒ5mthtiiWtRF
=
V)l Q)l
o-34 -+!%?"'
&%,+\4,-,+!,1!"
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V)l Ql
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4&'"5
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CZ/H/173/01-02/IA/011
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,-.-!-+3,-+!!+#,&,.,.2H,1+4+,+!
!!-2#-!&+#,%!" #,-!&+#,+&,#-, $&+? !-/! "5
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+ ,%4-+2-! 12--+1&+&'"+!1H-/# !-+-H,3+3!15
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Είδη συνήθως ευαίσθητα
, 4.itBH,+3.3+? 
Bacillus
anthracis
htCW‡9m9mmkFtkinkF
,1&H'+!"&+',H31-'
htCW‡9m9mmkFFtCi9CW‡hRmkF
a+ ,+43!33!!"3
Streptococcus
agalactiae
Streptococcus
pneumoniae
Streptococcus
pyogenes
c, 4.itB -'+3.3+? 
Eikenella
corrodens
Haemophilus
influenzae
Haemophilus
para
B
influenzae
Šn†FRnt9„‡h9mt
Moraxella catarrhalis
Pasteurella multocida
Proteus vulgaris
Providencia rettgeri
A -, 4. .3+? 
Peptostreptococcus
w
Chlamydophila pneumoniae
Chlamydophila psittaci
Chlamydia trachomatis
Legionella pneumophila
Mycoplasma pneumoniae
CZ/H/173/01-02/IA/011
Mycoplasma hominis
Ureaplasma urealyticum
Είδη για τα οποία η επίκτητη αντίσταση μπορεί να αποτελεί
πρόβλημα
, 4.itBH,+3.3+? 
Shni9m9mmkF‚tnmtRF
htCW‡9m9mmkFtkinkF
-H,3+34"&+',H31-'
htCW‡9m9mmkFFCC
 -'+3!1&+'-3!$3!&'
, 4.itB -'+3.3+? 
Acinetobacter baumannii
Citrobacter freundii
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Klebsiella pneumoniae
Morganella morganii
Proteus mirabilis
Providencia stuartii
Pseudomonas aeruginosa
Serratia marcescens
A -, 4. .3+?  :
Bacteroides fragilis
Ενδογενώς Ανθεκτικά Στελέχη
c, 4. Gram BH,+3.3+? 
Enterococcus
faecium
‹
T-H,3+34"&+',H31-'S
5
Aureus
,1-!*H-4-H#+,4
3!-!*-H,3+34+'+&+"/H! !3-!4-,"&, .-!#-'"+'"
,.!/!0&1-'"5
5.2 Φαρμακοκινητικές ιδιότητες
! 4/'&'
U,++'-4+!&+4+!"%! ?$'&''! 4/'&'+'",.!/!0&1-'",1-
+%,13&%,4-? '",+'#$&+'&$3#-+ 2&'&+!&-
,+$%-,+#&&,)BI ,"5L4+'.!H,&4+'+,1-XXb)
v5
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L&+H, ?3+&+&',+$%-,+,-+4"<E2 I-,#-!&!!$34&%?
mg1?*!/! #"', '&12"5
o+-!?
J, 1+!=b<v+'",.!/!0&1-'",&,*,+,+" 2+,Œ-,"+!! !*5T
#&!"4$3!"3+-!?"+'",.!/!0&1-'",1-, 1!)l,+4
,/0?,+4,-.-4,-,"4&,"+2-mg!'I-!-+"
, ,13+-!?&+!"&+!*"+!&I+!"5
CZ/H/173/01-02/IA/011
A,1&&'&+!"&+!*"3&+$ +!&I+!"7
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$ 4,#-&'"+!.,--!$4-!+2-. 4$%2-&+3N,33 !/$
+!--,!-34&+4&+!# :$ 4/&12-;&+!- !&++34&+43
&+!* 5e&+4&!',.!/!0&1-' !&\,3 ?,1&&'&+!
,$3,/!-2+1!$ 45
~!,+&%'+&4"
L,.!/!0&1-',+.!1\,+&,!*3 4!&!&+4,-I!,+.!1+,"
,1-'!#H!B,.!/!0&1-'3+!B!0,1!+'",.!/!0&1-'"5c+!1
!,+.!1+,"-+&+!%!*-&,Yv+'"4&'"3!.!-+&+!* 5L
,.!/!0&1-',1-&+, ,!%'3&+H, ?3,-/1&++!3?
,++ !?5
c!.!?
U,++'-4+!&+4+!"3+'-,-!/#.%! ?$'&'',.!/!0&1-'
!.,+4+!&:h•7@BEI ,";,&%,+3. * H45L
#33 &',1-3 12"#&2+2--,/ I-:QEv+'"4&'"!%! '$?H'3,;5
L#&'/-4,-'!3?&2+3?#33 &'+'",.!/!0&1-'",+41
,/04&'+2-mg?+-)8ŽXmLmin5
A,- %!-&'-+3#"/! #"&,4+/! +'/ 3!3-'+3?+'"
,.!/!0&1-'",+4,-!/#.34+!&+4+!"%! ?$'&'$,$!-4"
+!!!1!!'I-,2"',-!/#.3'4+!&+4+!"!4"%! ?$'&'"
! !*--,-%H!*-5
> 34+'+
L,.!/!0&1-'43,+&,$ 3?/ 3!3-'+3?&,#-,* !"#2"
)mg5
K3!1'H&!1
w+!,-,/ 3?-, 3,
L  / 3!3-'+3?  +'"  ,.!/!0&1-'"  ,' ,\,+  4  -,/ 3?
&,+! $15 f+- ,I-,+ ' -,/ 3? ,+! $1 ,I-!-+ ,1&'" '
#33 &'4+!"-,/ !*"3'3H &'4+!"-,/ !*",-I!% 4-!"
'1&," \2?" +'" !.!?" 0-, 42" /1-,+ &+!- 1-3 !
3!!H,17
x 3!3-'+3? ,1 -,/ 3?" -, 3," ,+ 4 1 ,/0 4 +!
&+4+!"4&'+2-mg

mi
RS( Y B<X BE

RS( )= @ 8
h
)
I ,"( = 8 X
L32#-+!
A,- %!-&'-+3#"/! #"&,4+/! +'-/ 3!3-'+3?+'"
,.!/!0&1-'"-,&&,-, 3&,'32#-+!,3+4"4,3,1-,"
!&%,+1\!-+,+"/! #"!/! !*-&+'-3H &'+'"3 ,+-1-'"5
A/! #"-!$,+!/*!
•,%2 &+#"-*&,"!!!1," $+!!?H'3-&, &,-33H'3
+! #,0- 3 ? #2" ! 3? /!  -!$ , +! /*! &+'
/ 3!3-'+3? +'" ,.!/!0&1-'"5 A,-  %!- ,-,10," ! -
!'I-!-2"'/! +?,+0*+2-/*2-#%,3-3?&'&15
CZ/H/173/01-02/IA/011
5.3 Προκλινικά δεδομένα για την ασφάλεια
U'3-3,!#-,-!3N-3!!,3431--!$+!"
-H I!",.&,&.+3#",#+,"+!034+'+""4&'"+!034+'+"
,-.-4,-'"4&'"-3!*3 3-!$#-,&'"3+!034+'+"&+'-
- $2$?3+'--+0'5
L,.!/!0&1-',-,' #&,+'$!-4+'+?+'-- $2$3?,1!&'
+2-,*2-,-I'4-',1 &?+'"&+#. ?+-'3H&+, '#-'
2 1-&'2"!+#,&+!034+'+"&+''+# 5
L,.!/!0&1-',- !3,&,$!-3#",+0,"&,3*++ 
.3+' 12-?H'&+3I-
RSpRhi9
 !3,&, ?0'+2-% 2!&2+2-
&+3*++ +2--,4-2-+2-3-#\32-%&+, 5c+#"! &,"! !*-
-!!H!*-&+'--&+!?+'"+!!P&!, &'"ss5T
RSpRp9
!3&1,"!
 $+!!?H'3-:3 ! ?-"-+$?,/I-% 2+12-'
 !$ +&#-'&*-H,&'[!3&1,"H-+'/4 !,3 +!*"
$!-1!;,-3+#,0-$!-!+!034-345
U,#+,"!!!1," $+!!?H'3-&,!-+13#,0-2"'
,.!/!0&1-'#%,/2+!+!03? &'4-!&,!*N'#"4&,"5L
,.!/!0&1-',-#,0,$!-!+!03? &'4+-% '&!!?H'3,'
/2+!,+0!$4-!"#H!!"3,12&,+'--+0'+2-4$32-&,1
,#+'-3!*/2+!3 3-!$#-,&'"5
f2" &%*, 3 , +" 4!," /H! !3-!4-," ' ,.!/!0&1-' #%,
 &' ,1 +2- %4- 2- :/&1," 3 3!4+'+,"; 4+- %! '$,1+ &,
 ! 1!"3&,&3*!"5O, ?++,1-!,/-?&+-, 
\I5
6. ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ
6.1 Κατάλογος εκδόχων
Sodium chloride
Hydrochloric acid (E507) for pH adjustment
Sodium hydroxide (E524) for pH adjustment
Water for injection
6.2 Ασυμβατότητες
c+4+!/ 3,+34 !P4-,- #,--$-*,+,' 1-'?,
33*+:5%540-!-H 33!*-+ 1!;5
O! 4-/ 3,+34 !P4-,- #,--$-*,+,
/ 3,+3 !P4-+# -,3,1-2-!-/# !-+&+'- $ /!@5@5
6.3 Διάρκεια ζωής
=% 4-
A 3,\2?",++! I+!-!$7
L%'3?3'/&3?&+H, 4+'+3++'% ?&'#%!-3+,%H,1$<
I ,"&+!"
9
,#3H,&'&+!/2"5
CZ/H/173/01-02/IA/011
c43 !.!!$3?"!N'"+! !"#$%&'H #,-
% '&!!,1+#&2"5K-,% '&!!'H,1#&2"!% 4-!/*0'"
3++'% ?&'3!&-H?3,"/*0'"!+,!*-,H*-'+!% ?&+'5
6.4 Ιδιαίτερες προφυλάξεις κατά την φύλαξη του προϊόντος
x&&,+,+!&3!&+!-/-?/3,4+!$- !&++,*,+4+!
/2"5
K#$0+,!+3 -4+'% ?&'5J #,-% '&!!!*-+4-!+$?
*+%2 1"&2+15
6.5 Φύση και συστατικά του περιέκτη
a3!"!!,/1-'"+2-!/# ,&',1!#-,&'"3&',1!#$%&'"!
!!1!",1- !&++,#-!",, +*$! !,-1!3/-#"
, +*$5 oH, &3!" , #%,  ml *+!"  !" #$%&'5 U,$#H'
&&3,&1"+2-)))=3&32-5(
a3!"!!,/1-'"+2-)!/# ,&',1!#-,&'"3&',1!#$%&'"!
!!1!",1- !&++,#-!",, +*$! !,-1!3/-#"
, +*$5 oH, &3!" , #%, ) ml *+!"  !" #$%&'5 U,$#H'
&&3,&1"+2-)))=3&32-5
U! ,1-'-33!/! !*-4,"!&&3,&1,"5
6.6 Ιδιαίτερες προφυλάξεις απόρριψης
T! #,-% '&!!,1+#&2",++!
 I+!-!$ !"!/$?.3+' 3?",4-&'"5o++' 3,+'"
#$%&'",-,1- 1+'+!- !&++,*,+4+!/2"5
c+4+!/ 3,+34 !P4-,1-$14-!% ?&'5
O!H #,-,#$%,+!+3 -4+'% ?&'5U! ,1-
% '&!!,1+4-!,/4&!-+!,1-$#" &-24B31+ -!
 3+3,,*H, !&2+12-5
f2"3$4+/ 33H,% '&!!1'+!/ 3,+34 !P4-
 #,-! 1+,+3+'3&*/2-,+"3++4!"&%*!&,"
, .!-+3#"+0,"5
Ανάμειξη με άλλα διαλύματα προς έγχυση:
O!,1-&.+4,+34!H*+ !"
#$%&'7
B %2 !*%!-+ 1!Xv5
B ,-#&'$34\'v5
B RSni•stmhthn:$3+34RSni•s;
>+"&.+4+'+,".5 $ /!@55
7. ΚΑΤΟΧΟΣ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ
Κάτοχος Άδειας Κυκλοφορίας για την Ελλάδα:
Generics Pharma Hellas ΕΠΕ, y. ~!$#-'"88
c
)@<B)c $ !*!'
+'7)BXX=@<)
CZ/H/173/01-02/IA/011
8. ΑΡΙΘΜΟΣ(ΟΙ) ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ
LEVOFLOXACINGENERICSmgml7))@)=B8B))
LEVOFLOXACINGENERICSmg)ml7))@))=B8B))
9. ΗΜΕΡΟΜΗΝΙΑ ΠΡΩΤΗΣ ΕΓΚΡΙΣΗΣ / ΑΝΑΝΕΩΣΗΣ ΤΗΣ ΑΔΕΙΑΣ
L, !'-1 I+'"#$3 &'"7)=B8B))
L, !'-1+,,+1"--#2&'"7
10. ΗΜΕΡΟΜΗΝΙΑ ΑΝΑΘΕΩΡΗΣΗΣ ΤΟΥ ΚΕΙΜΕΝΟΥ
CZ/H/173/01-02/IA/011