SPC - Περίληψη χαρακτηριστικών SEVELAMER/DEMO F.C.TAB 800MG/TAB BOTTLEx180 (χωρίς εξωτερικό κουτί)

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SPC : SEVELAMER/DEMO F.C.TAB 800MG/TAB BOTTLEx180 (χωρίς εξωτερικό κουτί)

ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ

1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ

mg

2. ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ

   !" 800 mg sevelamer carbonate.

#"$%&!'( 

!")*+),mg-'.!&/

0&!'$%"%+1/!$!2*/3/

3. ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ

4/

O1+!56)

mmx7mm8"%!5$!& !9'5/:"%;SVL<'

!/

4. ΚΛΙΝΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ

4.1 Θεραπευτικές ενδείξεις

:SEVELAMERDEMO$$"'5!2%25

&5 51 !'&!=&

 !'/

:      '5  $    $"  '5

!2%25    &5   5    "!  2!&    '

15 !'2>2!!9?3+7@@ABB/

: !"!'5

5  &5  !&5  !$$'5+  '      !9  

!1&!%1+3+),C!D1'E&

$'5+$$"'5DD'5'52!&5&5

/

4.2 Δοσολογία και τρόπος χορήγησης

F$

F'!D'5

G>''!D'5HIJIBK@ILMKLNAOKPI)+QR&Q+R

''!1'55$52%2!

!9/  :    !    1  !5  2!5  '

'!$9/

42%2!!9

 >

S&'!&'sevelamer

carbonate!'2 E

$9''!

1+78 - 2+42 mmol/l (5.5 - 7.5 mg/dl) 2+4 g*

> 2+42 mmol/l (> 7.5 mg/dl) 4+8 g*

TS '''92%5'$5

0   5    &  !'$%5    $%$&      

2%2!Usevelamer hydrochloride6!"%!&1!'8&1'

1V+         !        1'

$!!!5$!!!9 ''%%2%2!

!9$'2'1%'!&%%/

:''&!''

:2%2!!9!! 9''

sevelamer carbonate       !D&5    +  R  !5

2!5''!6)+QR'!8 )CQ15%5'D'5

92%2!!9+&!9 ''2D&5/

W 51 !'!9

5$$!29555/

S'&!&+' ! 1-">5'$'

$"  %  %    2%2!    !9    '  '!&  '

55!5!*g''!/

X!5' 5

G2''"

'!% '5%%3>/

:!5"!&$''5

Y5"!&'/

:  ! '! !

 1+9&"-!'"!&$''/

4.3Αντενδείξεις

 Z! ''!&&"

2!'!$!2*/3/

 Z2%2

 4!&2!D'

4.4 Ειδικές προειδοποιήσεις και προφυλάξεις κατά τη χρήση

G  2    '  '      

"  11%     &5   5    "!  2!&    '

15 !'2>2!!9[3+7mmoll/0$

+!5$"!&'

5 5/

G  2    '  '      

"11%  55 5!"5(

 2$

 !"5'5

 1!5  !"5  $!!&5  ''5  %5  '

!   &  1!&  $!!'+  !''  $!9

!">'&'!&%'

 !$2$>'!&

 -$"!''$!!9%&

0    $  +    !"&    "!'

955 5/

4!&2!D'5&55

S  9  5  !>5+  !&  2!D'    5&5

5"!'!'  5' !HIJIBK@IL

\]^LAM\BAL_^I6`8+!"!$&

HIJIBK@IL  MKLNAOKPI/  G  '  "      

!!  9%/  W   5    '    !  

! 9  !  %      !  

/  G  $%$&        !  

D$ 591!&'&

1!$!!>/

a515

Y 5    "!  2!&    6bcc8  "    9D

"'%>1>++d+$

''&!'`''1!''55/F!

          !    9

5  15    !"    !'2   !2&/  S

 51'!%515!

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!D$/S'!>

1>!'/

S   5    bcc  '  15     !'    

'!>1'56!Qef2&51'5

   '!8    !      !5  5  19

!5  !5  &`'    '    '  '

5/S 51!=&

 !'! '!9 ''>1>

29D5+%1>++d

!& '&'>% >/

Y!29

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 '5  !5  29    '  !"!  $%$&  

/

Z1!1

W   5    bcc  !    9D  1  &

!1/  :      !"   

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! 9      &      !    

">51%5&!%/

g1&D%'

W   5   "!  2!&   "  ! '  $ D'

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X!

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Z !5

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BIJAP\]LAi_OI61/!$!2Q/,8/

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Z!! !5

:        $    $"  

!! !9/  S   5    ! &

!! !        !  

"!'5&5 !&5!$$'5

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n$>5F!"50!!9&5

#"2! '11$!2!>51!>2$%>

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>/

FD'-'

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!12!/

4.5 Αλληλεπιδράσεις με άλλα φαρμακευτικά προϊόντα και

άλλες μορφές αλληλεπίδρασης

 !'

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1 !'/

q_pLArAiKM_O

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+%'1 'M_pLArAiKM_O

!,s'$"!&$''HIJIBK@IL \]^LAM\BAL_^I

'  2D  '5/    +        

!1"!M_pLArAiKM_O/

q_MBAHpAL_O+ @]MAp\IOABKPI @AtIP_B PKMLAB_@uH " 2!  

" 5 5

g%    M_MBAHpAL_O+  @]MAp\IOABKPI  @AtIP_B    PKMLAB_@uH

" 2!   " 5  5 $"!'$& '

  HIJIBK@IL  \]^LAM\BAL_^I  "%!5    &    6'/

!!`'"958/G '5'!'5!

        !    $  &  !9 ''  %

$!>%      %  M_MBAHpAL_O+  @]MAp\IOABKPI  @AtIP_B  

PKMLAB_@uH    '  !  '5  "!&'5  9      '

&/

IJAP\]LAi_OI

X9  5  !>5   !9  "  2!   

 555$"!'$& 'HIJIBK@IL\]^LAM\BAL_^I+

!"      !$  &  %5    HIJIBK@IL  MKLNAOKPI+  

BIJAP\]LAi_OI/  S  %5  !'  !9 ''  %

% !! !'5  6lm8  5 1

HIJIBK@ILMKLNAOKPIBIJAP\]LAi_OI/

Y!! '2!!=

W 51!! 2!!=$

$"!! >' 2!!=$

  $"  '>  !">  '    5  5

5/  Y  !"&    '  $$!2''

     5    1  '5    

2!!=/

_RAi_O+vKLtKL_O+IOKBKpL_B&@IPApLABAB

S  5  '!%    $5   5+    HIJIBK@IL

\]^LAM\BAL_^I+    !"      !$  &     sIJIBK@IL

MKLNAOKPI+"!''1 '%^_RAi_O+vKLtKL_O+

IOKBKpL_B&@IPApLABAB/

Y5'55!%%

Y'!'2!+9"2! 

!>5  D'%  %  2%2!>     5  

1  5  '5  5  !%%  $"!'$95  

HIJIBK@ILMKLNAOKPI/

w '

:!!2"'!'

1 '%2!>!=%/'"!&$''

&  2!9  !=5    '  %'  '5

1 '5    !9    "    '&  !'

'2&''+2!!= 

! "!'$">!! &!5 >!5

+  &    $!5    !    1  `'  '

!9 ''%%/

4.6 Γονιμότητα, κύηση και γαλουχία

4$9'

F &!!"'

"!&''51!'5$5$5/g5->D

D''!$%$&''1!'

"!'$& '    5    `'5  5  61/  !$!2  ,/E8/  G

1!'  "  '5  2    >  '  !!2''  2!%

1> !1  29 D5 61/!$!25

Q/Q,/E8/W"55$ !%$%5/

: !$5$5

    2>5  !'    29  $  !&  '

9%2>$''!$1!/

x'5

F   $%    '  1!'  15 ! 

 !>$/G'!!2>'29''51!'59

'!''51!'5'!$ '/g

2'  $        "    '5  &    

"' ! !

'2 15`'25 '9$

25'5 !5$'$/

0'

F  !"    $  '  !'  '5  1!'5  '

$'% !>%/g5->D'1!'

'!'$'!95& '955

 '5     !>'  9'  '    '5  $'5  '5

&5&5%3ER'!+19$!'5"&525

>5/

4.7 Επιδράσεις στην ικανότητα οδήγησης και χειρισμού

μηχανών

G  1!'    "     &  "  '  !'  '

'&$''5"!9'">/

4.8 Ανεπιθύμητες ενέργειες

Περίληψη του προφίλ ασφαλείας

W  "!  2-5  6?  ,s  %   >8   9'5

!5&5!"5$!!9&5/W

!!5    5  5   9'5  !$5  &  &5  %5

!5'5/

$5% 9'%!%!2&

G  2  '5  1!'5  6  %5   !  5    %5

!"%!  58 "  !'     ! 5  5  5

  2!9    y*y   5     !'    !

$%$&5Q%5,1567)Q 51& ' !

  HIJIBK@IL  \]^LAM\BAL_^I    )Q,  1& '    !  

HIJIBK@ILMKLNAOKPI8+y7 5!=& !'!

$%$&5  3)  15  61& '      !    HIJIBK@IL

\]^LAM\BAL_^I83) 5bcc'15 !'

!$%$&5%53)1567y 51& '

 !HIJIBK@IL\]^LAM\BAL_^IQy1& ' !

HIJIBK@ILMKLNAOKPI8/

Y 9'5  !5    !'    '  !

>>&2! ' !''!'

2!$!2!"'5!%/

G "' 2!5 D  %5 9"5 6?338+ "5

6?33  %5  [338+  "  "5  6?33/  %5  [338+  5

6?33/%5[33/8+956[33/8+"$%56

!9$9 8/

'$!

W!$9

&5

MedDRA

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F!"5

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&5

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$5+

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!''

F!"5

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D '

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

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$$5      '5  $&5 ! `'5    2!

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 9  &5  2!5    $!2     4 

W!$n!%+g$%)Q+{C3,,*)b!$5+Y &+:'(

|E)3  E)QEEE7+  nD(  |E  )3  *,Qy,,+  }5(

\PPp(vvv/IAt/RL

4.9 Υπερδοσολογία

:  HIJIBK@IL \]^LAM\BAL_^I+   !"   !$  &   

HIJIBK@IL  MKLNAOKPI+   '    2$95  $5   5  

5  %5  3Q  $!!  '  '!  $  ">  '!5  "%!5  

 9'' !$/ S  5   bcc+ ' $' ' '!&

'& '&3Q+Q$!!HIJIBK@ILMKLNAOKPI

2D'!&'/

5. ΦΑΡΜΑΚΟΛΟΓΙΚΕΣ ΙΔΙΟΤΗΤΕΣ

5.1 Φαρμακοδυναμικές ιδιότητες

n! !&  '$!(  Y$%$&  !2%25/  %5

lq(E)/

:    !"  1!'+    '  !!2>

2%2!  !5  !>+  "%!5    

1/G1!'!"55"%!-

       !          !95+    5

!%>"/Y5!%%559

!'2!%5'52>2!5!/

g''%2%2!> $!!%&'

%'  '5  !!2''5+  '  1!'  >  '  $!%'  

2%2!!/G&!9 ''%%2%2!

!9!'''"!&$''>2%2!/

S  9  "'5+  !95  5  5+  

HIJIBK@ILMKLNAOKPI+%59%%59

%5+ "!'$9!5 2!5 ' '!  " "  

!  9      HIJIBK@IL  \]^LAM\BAL_^I    %5

$"2%2!!9 5

bcc1 !'/

G!>''DHIJIBK@ILMKLNAOKPI$

"&  !5  2!5  '  '!  &  9      HIJIBK@IL

\]^LAM\BAL_^I    $  "&  !5  2!5  '  '!    7y

 !5   5    1& '    $%$&  $  9

"'5  !5  $%$&5    1%  6  5  "!

 552%2!!9&3+,~+E@@ABB$2!

sevelamercarbonatesevelamerhydrochloride8/G9!''D

'5HIJIBK@ILMKLNAOKPI$"&!52!5'

'!&9'HIJIBK@IL\]^LAM\BAL_^I$

"&!52!5''!E3!2%2956!-%5

"5    2%2!  !9  ?  3+7  @@ABB8   !5

 5    9  "'5  !5  $%$&5  Q  1%  6

5"! 552%2!!9&3+*~+,@@ABB

$    HIJIBK@IL carbonate   3+7  ~  +Q mmoll $   sevelamer

hydrochloride8/

S5  5  5     !5   5+  '  1!'

''5"&'&!'' '

! !&!'6_klm8!9/S'3)1%

2!9 51!=& !'+%+

!'!& '5>5'5_klm9$!' 5

1  D  1/  S   5    ! &

!! !        !  

"!'5&5 !&5!$$'5

 !9!1 1%5'!>+3+),C

!D  1' E  &      $  '5 $  '  %'  %

%'5 '5! !95!'56_klm8/

G1!'""9"D

_OJ_PLA



J_JA

!-%/G'%">D%

5  !'5        '!%'   5

%'5  '5  "'!'5    5/  S  5  5

1!'5+    '  '  &  "'!'      '  C

"'!'  > '    3,CEys/  G  %'  '5  "'!'5

!'!& '      )  15  $%$&5    '!  

!! '  !/  :    !$!%+  mC

"'!'5    %'5    D      !  

1!'/

4&'1!'9"D+!'!

'!!2''%>1>%5++

d/

G  1!'    !"  1    >  '  %'

!1>  %    9$!'    5   5  

"!'92%2!1'1/W

!5'51!'52>2!1"'

'!& ' ''!5'5!9 ''

5  5/  Y&  '  '!2!  &2 '    5  5  5

"!'& 'HIJIBK@IL\]^LAM\BAL_^I/

5.2 Φαρμακοκινητικές ιδιότητες

F  "  D"   2!'5  5      HIJIBK@IL

MKLNAOKPI/  :  HIJIBK@IL  \]^LAM\BAL_^I+    !"      !$

&      HIJIBK@IL  MKLNAOKPI+    !!2    

$!!  %&+  %5  11> '      '

!!2''5$5 5/

5.3 Προκλινικά δεδομένα για την ασφάλεια

:''1!'9!

  $     !%    1'  5  15  5

2!$&5  25+  D'5  1%  %

$D'5/

g5  !$  !'5        5  HIJIBK@IL

\]^LAM\BAL_^I  D&" '   65 %5  y  R•R'!8 

56+E+3+&ER•R'!8/Z&!DD''%' '>5

  1>  !%  '5  !"  9'5    !!5  5

'    `'&5  '5  6 !>'  9'  '    '5

$'5  '5  &5  &5  %  3Q+Q  R8/  F  !'!& '

D''  %'  $%      6 !>'  9'  '

E'5$'5'5&5&58/

S   

_O  J_PLA

 !$&  D'  '>    1&

!$''+    HIJIBK@IL  \]^LAM\BAL_^I  !  

'&9D''! %>"!%%>%>/

:  HIJIBK@IL  \]^LAM\BAL_^I  & D$  '  1'!&

&D'5@IH/

S  5    95+  '  1!'  %  '  !!2''  %

>  1>  +      d  6'  !$58    

29D5/

X!'!& '    '  &  ''    !5

51! '>%55 '1!'

5    `'5  5  6 !>'  9'  '  !!'

  '  $'  '  &5  &5  %  3Q+Q  R8/  W  !5

"!$5$%%'5'51'5/

S2!9 '55

HIJIBK@IL\]^LAM\BAL_^I'5'!$$'+9D''

%  !>%  !!2&%  !`  '    `'&5  '5

6 !>'  9'  '    '5  $'5  '5  &5

&58/

:  HIJIBK@IL \]^LAM\BAL_^I   '! ' $' !>  &

'>%'"!&$''5'!2&'

'1$%$&3Q'!5!-$!%

''9''!1$%$&$)'!5

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R•R'!  6 !>'  9'  '  )  '5  $'5  '5

&5&5%3ER'!+19$!'5"&525

>58/

6. ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ

6.1 Κατάλογος εκδόχων

X!&5(

g.!&-'

€!5D!

S5`!$!5

4`'(

Z!-'64Q*Q8

F%$!

6.2 Ασυμβατότητες

F2!-/

6.3 Διάρκεια ζωής

)"!

6.4 Ιδιαίτερες προφυλάξεις κατά τη φύλαξη του προϊόντος

02!9!5 &529D'5/

6.5 Φύση και συστατικά του περιέκτη

n'mk!   !"3 6

"%!5D%!8/

W25HDPE!"D'!/

6.6 Ιδιαίτερες προφυλάξεις απόρριψης

&"!%'$!!`'/

7. ΚΑΤΟΧΟΣ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ

•+w'"n!%



"4 &5W9Y '>a5

3Q,*!!Y&5

:'()33*3)

‚Ki()33*3,7

@K_B(_OtAƒ^I@A/RL

8. ΑΡΙΘΜΟΣ(ΟΙ) ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ

3E)*Q3Q3*C3C)3,

9. ΗΜΕΡΟΜΗΝΙΑ ΠΡΩΤΗΣ ΕΓΚΡΙΣΗΣ/ΑΝΑΝΕΩΣΗΣ ΤΗΣ

ΑΔΕΙΑΣ

7C3C)3Q

10. ΗΜΕΡΟΜΗΝΙΑ ΑΝΑΘΕΩΡΗΣΗΣ ΤΟΥ ΚΕΙΜΕΝΟΥ