· pdf filepatient leaflet dear patient, please read this leaflet carefully because it...

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3) = = != != = = != !"= != != = = !"K= I= !"= = = != = = = = != = = !"= = = = =K 4) !"#= = = = = = != = K ========= I=I=I=!" 1~10% ( I=ALP I = ! I !=! ) ! I= 1~10% · !I=I= 1~10% ! 1~10% I=I=! 1~10% 5) = != = != = = = = = != !"= = !"= = = = = = != = = = =K======!= = = = = != = !"= K= = = = = != = !"#= = = K=!======= =K 4. 1) ===!"#=!K 2) = !"= != = = != = = I= !"= = = != ==== L ==K 3) !"#= I= !I= = != = = != = = != = = = =!"K 4) = = E= !FI= !"#= = ==!"===!"=K 5) = != = = != !"= = = !"#$= = = = = = != K= = = = !"#= = = = = != = !K= != = !"#$= = = = = = = ====K=!=!== K= = = != !"= = = = !"= = K= Glucose dehydrogenase pyrroloquinoline-quinone (GDH PQQ) ==!= = = K= !"#$= = !"= = !"= != = != = != !"#= = = = = !K 6) (over hydration) = (under hydration) = ====!"=K=== = = = != = != != !====K 7) = !"#= !"= !"#$%= ! = !"= = I= != I= !" != != != = = = != !=K 8) = !"= = = = = != ===K=!==== = != = = !"= = != = != = !"#= = = K ! !" PQN !"= !====W 1000ml !"#$ EF 75.0 !"#$ 3.045mg/ml !" E!F 5.38 !"# 0.069mg/ml !"#E60.0%F E!F 7.5 !"#$% 0.006mg/ml E!"#$% 4.48 F !"# 3.415mg/ml ! E!F 0.257 !"# 3.577mg/ml !"# E!F 0.0508 == !"#= = = I= = !"#= = =====!=(Continuous Ambulatory Peritoneal Dialysis: CAPD) =!"#(APD) = != ! CAPD !"= !"= = N ==!==!"=!K !"#= = != !"#= !"#$= 7. 5% = != = !"#$K= !"#= !" !"= !K= = != != K= ==!"#=!=!K == !"#= = !" ! !K= ) !" (CAPD) !"# (APD) ! ! !K : ! (CAPD) !"# (APD) 24 ! !" ! : : 18 !" ! . ! !" !" K= 10 – 20 !" K= !" 2.0 !" K= !" 1.5 !K= !" CAPD 6 – 12 APD 14 – 16 K= ! K= ! . !=! 1. ! ! 1) !" 2) !"# 3) ! !" ( )I= I= I= !" 4) !"#$% 2. ! 1) 2) 3) 3. !"#=!=!"#==!"#= =!K 1) !"#" ! I= = = = = = = = =E= = F= W= I= !"= E I= = = FI= = I= I= !I= I=!I=I=I=I=I=I== I= !I= !I= I= I= !I= I= I= = = !"= = = != != 50 – 70% ==!"#= == !K !"=! 1 = ~ 3 ==!K= !==== 20 – 30% K 2) !"# !"#$= = !"#= K= = ! !I=I=I=!I=I=E!"I !"I=!"F=!"I=!I= I= L I=!I==I== L = I= I= !I= = = = != ==!K

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Page 1: · PDF filePATIENT LEAFLET Dear patient, Please read this leaflet carefully because it contains important information for you. ... (APD) regimen for the treatment of

3)��=�=�� !=�� !=�=��=�� !=�� !"=��� !=�� !=��=�� =�� !"K=���I=�� �� !"=�� =�=�� !=�� =�� =�� =����=�� !=��=�� =�� !"=�=��=�� =���� =��K

4)�� !"#=�=�=��=�� =�� =�� !=�� =��K

�===�===�===� ��

�� ��I=�� I=��I=�� !" 1~10%��� ��(�� ��I=ALP ���I=�� �� ! ��I�� !=�� ! ��)

�� ! �� I=�� 1~10%

�� ·�� �� !I=��I=�� 1~10%

�� �� ! 1~10%

�� ��I=�� I=�� ! 1~10%

5)�� =�� !=�� =�� !=�� =�=�=��=�� �=�� !=�� !"=�� =�� !"=��=�� =���=��� =�� =�� !=�� =�� =�� =���� =��K=�� =�� =��=��=�� =�� !=��� =�=��=�� =�� !=�� =�� !"=��K=��=��=�=��=�� !=�� =�� !"#=�� =�=��K=�� !=�� =�� =��=��� =�=��=�� �� =�� K

4. �� ��1)�=��=�� =�� !"#=�� !K2)�� =�� !"=�� !=��=�� =�� !=�� ��=�� =�� I=�� !"=��=��=�� !=�� �� =�� =�=��=� L�� =�� =�� K

3)�� !"#=�� I=�� !I=�� =�� !=��=���=�� !=�� =�� =�� !=�� =��=��=���=�� !"K

4)��=�� =��E��=�� !FI=�� !"#=�� =��� =�� =�� !"=�� =��=�� !"=��K

5)�� =�� !=�� =�� =�� !=�� !"=���=��=�� !"#$=��=�� =�� =�� =��=��� !=��K=�� =�� =��=�� !"#=�� =���=�� =�� =�� !=��=�� !K=�� !=����=�� !"#$=�=�� =��=��=��=�� =����=�� =�� =�=��K=�� !=�� !=�� =���K=��=�� =�� !=�� !"=�� =�� =���= �� !"= �� = ��K = Glucose dehydrogenasepyrroloquinoline-quinone (GDH PQQ) �=�� =�� !=��� =�� =��K=�� !"#$=��=�� !"=����=�� !"=�� !=�� =�� !=�� =�� �� !=�� !"#=��=�� =�� =��=�� !K

6)�� (over hydration) ��=�� (under hydration) �=����=�� =�� =�� =�� !"=��K=��=��=���=��=�� =�� !=�� =�� !=�� !=���� !=�� =�� =�=��K

7)��=�� !"#=�� !"=�� !"#$%=�� !�� =�� !"=��=��I=�� !=��I=�� !"�� !=�� !=�� !=�� =�� =�=�� !=��� !=��K

8)�� =�� !"=��=�� =��=��=�� !=�� ��=�� =�=��K=�� !=�� =��=�� =�� �� =�� !=�� =��=�� !"=��=�� !=��=�� !=�� =�� !"#=�� =�� =�� K

�� !�� !"

PQN

�� !"=���� !=�=�=��=W 1000ml ��� !"#$ E��F 75.0 �� �� !"#$ 3.045mg/ml�� !" E�� !F 5.38 �� �� !"# 0.069mg/ml�� !"#E60.0%F E�� !F 7.5 �� �� !"#$% 0.006mg/mlE�� !"#$% 4.48 ��F �� !"# 3.415mg/ml�� ! E�� !F 0.257 �� �� !"# 3.577mg/ml�� !"# E�� !F 0.0508 ��

���=�=���� !"#=��=�� =��I=��=�� !"#=��=�� �=�� =�� =�� =��=�� !=(Continuous AmbulatoryPeritoneal Dialysis: CAPD) ��=�� !"#(APD) �� =���� !=�� ! CAPD �� !"=�� !"=�� =�� N�=��=�� !=�� =�� !"=�� !K

����� !"#=�� =�� !=�� !"#=�� !"#$=7.5% �=�� !=��=�� !"#$K=�� !"#=�� !"�� !"=�� !K=�� =�� !=�� !=�� K=�� �� =�� =�� !"#=�� !=�� !K

���=�=���� !"#=��=� �� !" �� ! �� �� !K=�) ��� �� �� !" (CAPD) �� �� �� �� �� ��� !"# (APD) �� ! � � �� ! �� �� !K�� : �� �� �� ! (CAPD) �� �� !"# (APD)��� 24�� ! �� !" �� ! �� �� ���� : �� ���� : 18 � �� �� !" �� ! �� .�� ! �� �� !" �� !" ��K=�� �� �10 – 20 �� �� �� �� �� �� !" ��K=�� �� �� �� �� �� !" 2.0 �� �� !" ���K=� �� �� �� �� !" 1.5 �� �� !K=��� �� !" CAPD�� 6 – 12 �� ��� APD��� 14 – 16 �� ��� K=�� �� �� �� �� ��� �� ! ��K=�� �� � �� �� �� �� �� �� ! �� �� �� �� �� �� ��.

��� !=�� !

1. �� �� ! �� ! � �1)�� �� �� �� !" �� ��2)�� �� �� !"# �� ��3)�� ! �� �� !" �� �� (�� �� �� ��)I=��I=�� ��I=�� �� �� !" �� �� ��

4)�� !"#$% ��

2. �� �� ! �� �� �1)�� �� �� 2)��3)�� �� ��

3. �� �� !"#=�� !=�� !"#=��=�� !"#=��� =�� !K1)�� !"#" �� ! �� ��I=�� =��=�=���=�� =��� �=��� =��=E�� =��=�� F=�� W=��I=�� !"=��E��I=�� =��=��FI=�� =��I=�� I=�� !I=����I=�� !I=�� I=�� I=��I=��I=��I=��=��� I=�� !I=�� !I=��I=��I=�� !I=��I=��I=�� =�=�� !"=���=��=�� !=�� !=�50 – 70% �=��=�� !"#=��� =�� =�� !K�� !"=�� ! 1 �=� ~ 3 ��=��=�� !K=���� !=�� =��=��=�� 20 – 30% ��K

2)�� !"# �� �� �� !"#$=�� =�� !"#=��K=��=�� !�� !I=��I=��I=�� !I=��I=�� E�� !"I�� !"I=�� !"F�=�� !"I=�� !I=�� �I=� L�� I=�� !I=�� =�� I=�� =�� L���=�� I=��I=�� !I=�� =�=�� =�� !=���=�� =�� !K

Page 2: · PDF filePATIENT LEAFLET Dear patient, Please read this leaflet carefully because it contains important information for you. ... (APD) regimen for the treatment of

9) �� ALP ���=�� =�=��K=�� !=�� !=���=�� !=�� K

10) ���=�� !=�� =�� !"=��K

5. �� !1)�� =��=�� =��=�� =�� =��=�� =�� �=�� =�=��K

2)�� !" (cardiac glycosides) �=�� !=�� =��=���=�� !=�� !=�� !"=��K=�� !"=���=��=��=�� =�� =�� !=��K

3)��=�� =�� !"=�� !"=�� =�� =�� �� !"=�� =��K=Glucose dehydrogenase pyrroloquino-linequinone (GDH PQQ) �=�� =�� !=�� !=�� ��K=�� !"#$=��=�� !"=��=��=�� !�=�� !=�� =�� !=�� =�� !"#$=���� !=��=�� =�� =��=�� !K

6. ��=�=�� !=��=��1)�� =�� =��K=�� !"#$=�� !=�� K=���=�� !"=�=�� !=�� =�=�=�� =��=����=�� =�=�=�� !=�� =�� =��=��K

2)�=��=�� !"#=�� !=�� =�� =�� !=��=�=�� !=�� K=��=�� !=��=�� =�� �� !"=�� !=��=�� =�� !"#$ 7.5% ��� �!=��K=�� =�� =�� !"=��=�� =���=�� =��=��K

7. �� �� ��� �� 18 � �� �� ! �� ! �� .

8. �� !"#$ ���=��=�� =��=�� =��=��=�� =�� =��=��=�� !=��=��=�=�� !=�� !=��K=�� =��� =�� =��=�� =�� =��=��=�� =�� =��� K

9. �� !"# ��24 ��=��=�=�=1 �=�� =�� !=�� K=24 ��=��1 �=�� =�� !"=�� !=�� !=�� !=�� =��=�� =�� !K=�� =�� =��=��=���=�� �� =�� =�� !=��=�� !=�� !=�=��K=��� !=��=�� =�� !"#$%=�� !=��=���� !=�� !"=�� !"=��K

10. �� ! ��1)�� !=�� !=�=�� !=�� !"#=�� !=���=��=�� !K

2)�� !"=�� =�=�� =�� =�� =�=�� =����=��=�� !"=�� !"#=�� !=��=�� �=��=��=��=�� !K

3)�� =��=��=�� =�� =�� !=�� !=�� K4)�� =�� !"=�� =��K5)�� =�� !=�� !"=�� =�� !=�� =���=��=37°C �=�� K=�� !=�� !=�� =�� �� =�� =�� !"=�� !=��=�� �!K=���� =�� =��=�� I=��=�� =�� !=��=���K

6)��=�� =�� !=�=�� !"=�� !=�� pH ��=(salts) �=�� !"=��K=��=��=�=��=�� !"��K

7)��=�=��=�� =�� !=��K8) 1 �� !"=�� !K

11. ���� �� �� �� �� �� ! �� .

� �� !=�=�� !W=�� !I 30°C �� !=��I=���� ! 24 ��

EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin

�� !�� !"#$%& �� !"# 023687 �

�� !"#$%

�� !"#

�� !"#

�� !"#$%&'()*+,-./0123456�� !"#$%!&'()*+),

�� !EXTRANEAL (Icodextrin 7.5%) Peritoneal Dialysis Solution

���� !"#$%&

EXTRANEAL �� !"#$%&'()*+,

� 100 ml EXTRANEAL ��

Icodextrin�� !"#$ 7.5 g

Sodium Chloride�� !" 538 mg

Sodium Lactate�� !" 448 mg

Calcium Chloride�� !" 25.7 mg

Magnesium Chloride�� !" 5.08 mg

� 1000 ml�� !"#$

Sodium�� 132 mmol

Calcium�� 1.75 mmol

Magnesium�� 0.25 mmol

Chloride�� 96 mmol

Lactate�� ! 40 mmol

�� !"# 284�milliosmoles / ��

�� =W Baxter Healthcare SA, Singapore Branch * ��=�� =��I=��=��=�� =�� =��=�� !=�� =��=��=�� =�� =�� !K

�� =W (�)=�� =�� =��=�� 10 �� !"#$% 5 �=(Tel: 02-6262-7100)

�� !EXTRANEAL�� !"#$%EXTRANEAL �� !�� !

�� !"��#$EXTRANEAL �� !EXTRANEAL�� !"#$%&'()* 7.5% Icodextrin�� !"

EXTRANEAL �� !"#$%&'( !)*+,&

EXTRANEAL�� !"#$ PVC�� !"#$%&'�� !

�� �� ! �� !

�� ! �� !(mL) (mL)

FNB4974 2000 2000 AMBU-FLEX 6

FNB4982 1500 2000 �� 8

FNB4984 2000 2000 �� 6

��EXTRANEAL �� !Icodextrin�� !"#$%&'()*+,-./012�� !"(CAPD) �� !"#$ EXTRANEAL �� 12�� !"#$%&'()* (CAPD) �� !"#$%&�� !"#$"%&�� ' 4.25%�� !"#$�� EXTRANEAL�� !"#$%&'()*+,-.��

�� �� !"#$

Page 3: · PDF filePATIENT LEAFLET Dear patient, Please read this leaflet carefully because it contains important information for you. ... (APD) regimen for the treatment of

��

�� !"#$%& EXTRANEAL\

EXTRANEAL �� !"#$%&'()*+, Icodextrin�� !"#$%&

EXTRANEAL �� !"#$%&'()*+,-./0�� !"#$%& �(�� !")�� �!"#$�� !"#$%&'()*+,-.

�� !

�� !"#

EXTRANEAL �� !"#$

�� !"#$%&'()*+,-./0123%45�� !"#$%&'()*

�� !"#$%&'()*+,-./01(234"�� 37°C�� !"#$%&'()*+,-./"#�� �!"#$%&'()*

��� !"#$%#&'()*+,-./#0123�� !"#$%&'()*+,�-./0123�� !"#$%&'

��� !"#$%&'(

��� !"#$%&'()*+,-./012345�� !"#$%&'()*+,-./012

��� !"#$%&'E�� !"#$F�� !"#��� !"#

��� !"#$%�&'()*+,-./0123�� !"#$%&'()*!+,-./0$%1'�� EXTRANEAL�� !"#$%&'()*+%�� !"#$ glocose dehydrogenase pyroloquino-linequinone (GDH-PQQ) �� !"#$%&�'()*+�� !"#$%&'()* EXTRANEAL�� !"�� !"#$%&'()*+,-.� /01$%�� !"#$% EXTRANEAL�� !"#$%&'��

�� !"#$%&'()*+,-./01203

���� !"#$%&'()*+,-./0&'(123

�� !"#$%"&'()*+,-./012345�� !"#$%&

�� !"#$%&'(

�� !"#$%&'()*+!",-.&'/0()�� !"#$%&'()�*&+,'-./0123�� !"#$

�� !"#

�� !"#$ EXTRANEAL �

�� !"#

EXTRANEAL�� !"#$%&'()*+,-./�� !�"#$%&'()*+ EXTRANEAL�� !�� !"#

�� !"#$%&'(&)*%&+,-./0123�� !"#$%&'()*+,-./0120345�� !"#$%&'()*+,-.

�� !"#$%&'(� )*#$%&'EXTRANEAL�� !"#$%\

EXTRANEAL�� ! cardiac glycoside�� !"#$%&�� !"#$%&'(%&)*+,-./01.23�� !"#$

�� !"#$%&

�� !"#$%&'()*+,-

�� !EXTRANEAL �� !"#$%&'\

�� EXTRANEAL�� !"#$%&'()*

�� !" EXTRANEAL�� !"# vancomycin �cephazolin � ampicillin/flucloxacillin � ceftazidime �gentamicin � amphotericin�� !"#$%&'()

�� �!

�� �!"#$% EXTRANEAL��� !"#$ EXTRANEAL�� !"#

EXTRANEAL�� !"#$%&'()*+,-./0�� !(CAPD) �� !"#$%&'()*+(APD) ��� !"#$

�� ! 24�� !"#$%&'()

�� !"�#

�� !"#���� 18 ����

�� ! 10 � 20 �� !"#$%&'()*+, -�� !"#$%&'()*+,-� !./012 2�� !"#$%&'()*+,- 1.5 �� !"#$%�� !" (CAPD) �� !"#$%& 6� 12�� !"�� !"# (APD) �� !"#$% 14-16�� !"#�� !"#$%&'()*+,-./0)*-123�� �!"#$%&'()*+,-."/01234�� !"#

�� !

EXTRANEAL�� !"#$%&�� !"#$%&'()*+,-.) !/0123��

��� !"#$%&'()*+,-.,/01230�� !"#$%&�'()E�� !"#$F�� !�� !"#$%&'($)'($*+,-./01�� !"# 50% � 70%�� !"#$%&'()*� 1.5 �� 3�� !"#$%&'()*+,-./0�� 20% � 30%�� !"#$%&'(�

��� !"#$%&'(�)*+,"#$%&'-.�� !"#$%&'()*+,-.!/01234�� !"#$%&'!(&'$)*+,!-./0�� !"#$%& EXTRANEAL�� !"#$%&�� !"#$%&'()*+,-./

�� !"#$%&'()*

�� !"#$%&'()*+,-./0

�� !"#$%&'()*+,-./0�12345�� !"#$%&'()!*+,-+.

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�� !"# EXTRANEAL�� !"#$24�� !"#$%&'() 1 �� EXTRANEAL �� 24�� !"#$% 1�� !"#$%&�'()*+,�� ! Icodextrin �� !"#$%&'()*+,-.�� !"#$

�� !"#$

�� ! EXTRANEAL�

� EXTRANEAL�� 2�� !"#$%&'�� !"#�� !"#$�� !

��� ! 30�� !"#$%&'()*+,-./�� !"#

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�� !"Baxter Healthcare SA, Singapore Branch�� !" 2 Woodlands Industrial Park D,

Singapore 738750, Singapore

�� !"�� !"#$%&'()�� !"����� !"# 216 � 15��� !" (02)2378-5000

EXTRANEAL� =AMBU-FLEX=�ULTRABAG�� !" #$�� !"#$%

Page 4: · PDF filePATIENT LEAFLET Dear patient, Please read this leaflet carefully because it contains important information for you. ... (APD) regimen for the treatment of

EXTRANEAL Peritoneal Dialysis Solutionwith 7.5% IcodextrinFor intraperi toneal administrat ion only

BAR CODE LOCATION (FOR POSITION ONLY)REFER TO PARA. 5.2 FOR ACTUAL LOCATION

*PPD15064*

PATIENT LEAFLETDear pat ient ,Please read th is leaf le t carefu l ly because i t conta ins important in format ion for you. I f youhave fur ther quest ions, p lease ask your physic ian or pharmacist .

Product nameEXTRANEAL ( Icodextr in 7.5%).

Composit ionWhat are the act ive substances?EXTRANEAL is a s ter i le so lut ion for in t raper i toneal adminis t rat ion.Each 100 ml of EXTRANEAL conta ins: Electro ly te solut ion content per 1000 ml :Icodextr in 7.5 g Sodium 132 mmolSodium Chlor ide 538 mg Calc ium 1.75 mmolSodium Lactate 448 mg Magnesium 0.25 mmolCalc ium Chlor ide 25.7 mg Chlor ide 96 mmolMagnesium Chlor ide 5.08 mg Lactate 40 mmolTheoret ica l osmolar i ty 284 (mi l l iosmoles per l i t re) .

Composit ion in Ful lWhat else does EXTRANEAL contain?EXTRANEAL also conta ins:Water for in ject ions.

Pharmaceutical form and pharmaco-therapeutic groupWhat is EXTRANEAL?EXTRANEAL is a steri le peritoneal dialysis f luid containing Icodextrin as the active ingredientat a concentrat ion of 7.5%, in an e lect ro ly te solut ion.EXTRANEAL is a so lu t ion fo r in t raper i tonea l admin is t ra t ion on ly . I t shou ld not be usedfor in t ravenous admin is t rat ion.EXTRANEAL is presented in f lex ib le PVC conta iners and is avai lab le in the fo l lowing bags izes:

Code Fi l l Volume Conta iner Size Product Pack Size(mL) (mL) Conf igurat ion

FNB4974 2000 2000 AMBU-FLEX 6FNB4982 1500 2000 ULTRABAG 8FNB4984 2000 2000 ULTRABAG 6

Market ing Authorisat ion HolderWho is responsible for market ing EXTRANEAL?Baxter Healthcare (Asia) Pte Ltd10 Hoe Chiang Road, #11-01 Keppel Towers, Singapore 089315Baxter Healthcare Ltd.15F, 216 Tun-Hua S. Rd. , Sec. 2, Taipei 106, TaiwanBaxter Incorporated5th FL. , KNTO Bldg. , 10 Da-dong, Chung-gu, Seoul 100-180, KoreaBaxter Healthcare LtdRoom 2004-6 CRC Protect ive Tower, 38 Gloucester Road, Wanchai , Hong Kong

Name and address of the manufacturerWho is responsible for the manufacture of EXTRANEAL?Baxter Healthcare SA, Singapore Branch2 Woodlands Industr ia l Park D, Singapore 738750

Propert iesHow does EXTRANEAL work?I codex t r in i s a s ta rch -der i ved g lucose po lymer wh ich ac ts as an osmot i c agen t whenadmin is te red in t raper i tonea l l y fo r con t inuous ambu la to ry pe r i t onea l d ia l ys i s (CAPD) .EXTRANEAL produces sus ta ined u l t ra f i l t ra t ion over a per iod up to 12 hours in CAPD,wi th a reduct ion in ca lor ic load compared to 4 .25% Dext rose so lu t ions , but w i th s imi la rvo lume of u l t ra f i l t ra te.

Therapeutic Indicat ionsWhy use EXTRANEAL?EXTRANEAL is recommended as a once dai ly replacement for a s ingle Dextrose exchangeas par t o f a CAPD or automated per i tonea l d ia lys is (APD) reg imen for the t rea tment o fchron ic rena l fa i lu re , par t i cu la r ly fo r pa t ien ts who have los t u l t ra f i l t ra t ion on Dext rosesolut ions, because i t can extend t ime on CAPD therapy in such pat ients.

Contraindicat ionsWhen should you not use EXTRANEAL?EXTRANEAL should not be used i f you have a known a l lergy to s tarch based polymers oran Icodextr in in to lerance.EXTRANEAL shou ld a lso not be used i f you have a h is tory o f abdomina l surgery in themonth preceding commencement of therapy or i f you are suffer ing f rom abdominal f is tu lae(non-heal ing weeping wounds), tumours, open wounds, herniae or other condi t ions affect ingyour abdomen.

Precautions for useWhat precautions have to be taken?EXTRANEAL is for in t raper i toneal admin is t rat ion only. To change the d ia lys is bag, i t is o fv i ta l impor tance that you carefu l ly fo l low the s teps which have been shown to you dur ingt ra in ing, and that you make sure that a l l the connect ing par ts remain complete ly c lean toreduce the poss ib i l i t y o f in fec t ion . To reduce d iscomfor t on admin is t ra t ion , the so lu t ionshou ld be warmed in the oversea led bag to a tempera tu re o f 37°C p r io r to use . Th isshould be done us ing dry heat , idea l ly us ing a warming p la te spec ia l ly des igned for thepurpose. Hot water should not be used to warm the bag in order to avo id contaminat ionof connectors.– An accurate f lu id balance record must be kept and your body weight should be carefu l ly

moni tored to avo id over - and underhydra t ion , wh ich may have severe consequences,inc luding congest ive hear t fa i lure, vo lume deplet ion and shock.

– An asept ic technique should be observed throughout the bag change procedure.– Sign i f icant losses of prote in , amino ac ids and water -so lub le v i tamins may occur dur ing

per i tonea l d ia lys is . Rep lacement therapy shou ld be prescr ibed as necessary by yourphys ic ian.

– Se rum e lec t ro l y t e concen t ra t i ons (pa r t i cu l a r l y b i ca rbona te ) , b l ood chem is t r y andhaematologica l factors should be evaluated per iodica l ly by your physic ian.

– I f you have diabetes, b lood glucose levels should be moni tored and the dosage of insul inor o ther t reatment for hyperg lycaemia should be ad jus ted by your phys ic ian. I t shou ldbe no ted tha t EXTRANEAL may in te r fe re w i th the measurement o f b lood g lucose bycer ta in tes t ing k i ts . Glucose dehydrogenase pyro loqu ino l inequ inone (GDH-PQQ)-basedmethods should not be used. A fa lse ly h igh b lood g lucose leve l might be found. I f youneed to measure your b lood g lucose leve ls and you use EXTRANEAL, your phys ic ianwi l l advise you on which blood glucose test k i t to use, or contact the test k i t manufacturerto determine i f EXTRANEAL wi l l in ter fere wi th b lood g lucose test resul ts .

In case of doubt on the above precautions, you should not hesitate to consult your physicianor pharmacis t .

Special WarningsMinor fa l l in serum sodium and increase in osmolar i ty .Increase in p lasma leve l o f o l igosacchar ides and mal tose can occur. Long te rm e f fec tsnot repor ted.What do you have to consider during pregnancy and while breast feeding?EXTRANEAL is no t recommended dur ing pregnancy or wh i le b reas t feed ing . Women o fchi ldbearing potent ial should be treated with EXTRANEAL only when adequate contracept iveprecaut ions have been taken. Potent ia l e ffects on male and female fer t i l i ty are unknown.What needs to be taken into considerat ion for chi ldren?EXTRANEAL is not recommended in chi ldren.What else needs to be taken into considerat ion?There are o ther cond i t ions which may make the use o f EXTRANEAL unsu i tab le fo r you,fo r examp le cond i t i ons a f fec t ing your nu t r i t i on , b rea th ing o r i f you have a po tass iumdef ic iency. EXTRANEAL should not be used i f you have acute renal fa i lure.The dra ined f lu id should be inspected for the presence of f ibr in or c loudiness, which mayindicate the presence of infect ion or aseptic peri tonit is. I f this occurs, contact your physicianor d ia lys is nurse immediate ly .

Interactions with other Medicaments and other forms of InteractionWhat other products can EXTRANEAL effect?The e f fec t o f t rea tment w i th ca rd iac g lycos ides may be a ffec ted i f taken wh i l s t us ingEXTRANEAL. Plasma levels at potassium and calc ium must therefore be carefu l ly checkedby your physic ian. In the event of abnormal levels , appropr iate act ions should be taken.Other forms of interact ionSee the measurement of b lood g lucose by cer ta in test ing k i ts under precaut ions for use.

Incompatibi l i t iesIs EXTRANEAL incompatible with any other medicines?There are no known problems wi th compat ib i l i ty of EXTRANEAL and other medic ines.A range of ant ibiot ics including vancomycin, cephazol in, ampici l l in/ f lucloxaci l l in, ceftazidime,gen tamic in , amphote r i c in , and insu l in have shown no ev idence o f incompat ib i l i t y w i thEXTRANEAL.

Posology and Method of Administrat ionHow and when should you use EXTRANEAL?Your physic ian wi l l decide on the dosage of EXTRANEAL.EXTRANEAL is recommended for use dur ing the longest dwel l per iod, i .e . in CAPD usual lyovernight and in APD for the long dayt ime dwel l .Adu l ts : By in t raper i tonea l admin is t ra t ion l im i ted to a s ing le exchange in each 24 hour -per iod, as par t of a CAPD or APD regimen.Elder ly : As for Adul ts .Chi ldren: Not recommended for use in chi ldren ( less than 18 years) .The volume to be inst i l led should be given over a per iod of approximately 10 to 20 minutesat a ra te which the pat ient f inds comfor tab le . For adul t pat ients o f normal body s ize theinst i l led vo lume should not exceed 2.0 l i t res. I f th is causes abdominal tens ion a 1.5 l i t revo lume should be used. The recommended dwel l t ime is between 6 and 12 hours in CAPDand 14 – 16 hours in APD. Drainage of the f lu id is by gravi ty at a rate comfor table for thepat ien t . The dra ined f lu id shou ld be inspected fo r the presence o f f ib r in or c loud iness ,which may indicate the presence of in fect ion or asept ic per i ton i t is .

Undesirable EffectsWhat side-effects may EXTRANEAL cause?Undesirable effects of per i toneal d ia lys is inc lude procedure and solut ion re lated problems.– Those which are re lated to the procedure are abdominal pain, b leeding, c loudy eff luents

wi th or w i thout bac ter ia , asept ic per i ton i t i s (see Spec ia l Warn ings Sect ion) , in fec t ionaround the catheter , catheter b lockage, i leus and shoulder pain. Per i ton i t is is est imatedto occur in be tween 50% and 70% of a l l pa t ien ts dur ing the course o f t rea tment . Onaverage peri tonit is occurs once every 11/2 – 3 years. The corresponding f igure for infect ionaround the catheter is 20% – 30%. The f requency of the other ment ioned compl icat ionsis less.

– Those which are re la ted to per i tonea l d ia lys is so lu t ions are seen less f requent ly thanthose re la ted to the procedure and inc lude e lect ro ly te and f lu id imbalances, hypo- andhypervolaemia, hypo- and hyper tens ion, muscle cramping and dysequi l ibr ium syndrome.There have been rare reports of rashes, occasionally associated with exfol iat ion in patientsusing other medic ines in conjunct ion wi th EXTRANEAL.

What measures are to be taken i f side effects occur?Should any of the above l is ted s ide-effects occur, immediate ly in form your physic ian.I f you not ice any unwanted effects not ment ioned in th is leaf let or i f you are unsure aboutthe effect of th is product , p lease in form your physic ian or pharmacist .

OverdoseWhat to do i f you use too much EXTRANEAL?You should not use more than one bag of EXTRANEAL per 24 hours. I f you have repet i t ivelyused more than one bag per 24 hours , you shou ld consu l t a phys ic ian as i t may a ffec tleve ls o f Icodext r in metabol i tes in your b lood. The phys ic ian wi l l u l t imate ly dec ide i f anycorrect ive t reatment is necessary.

Special Precautions for StorageHow should EXTRANEAL be stored?EXTRANEAL has a she l f l i fe o f 2 years . Do not use the product a f ter exp i ry date shownon the car ton and product label .Store at temperature below 30°C. Do not use unless the solut ion is c lear and the containerundamaged.Keep out o f reach of ch i ldren. Any unused por t ion of d ia lys is so lut ion in a bag should bediscarded.

Date on which package leaf let was last revisedPPD-15-338 January 2004

EXTRANEAL, AMBU-FLEX and ULTRABAG are t rademarks of Baxter In ternat ional Inc.