4. Possible side effects Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion @ Tell your doctor or healthcare professional immediately if you notice any of the following side effects: piperacillin/tazobactam Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - !" 5 5 5 5 5 ( (' ( 3 6 (9( 4 A ( ( 6 What is in this leaflet Common side effects (may affect up to 1 in 10 people): # ) * " , - 5 5 $% &'( $(% &' +(% &' % +(% &' . Uncommon side effects (may affect up to 1 in 100 people): 1. What Piperacillin/Tazobactam is and what it is used for % (01 2 ' ( ' % &' ( 3 43 4 % &' ( (( 34 % &' )1#) 3 4 3 4% &' ( (( 34 % &'( 5 5 5 5 5 5 5 5 5 5 5 3 4( 3 4 34 ( 3 4 B3 ((4 ' 3 4 3 4 B 3 4 Rare side effects (may affect up to 1 in 1,000 people): Warnings and precautions 5 3 4 & 3 4 (343 4 34 394 3 48( 3 4 5 3 & 4 5 5 3 4 5 34 ?(3 4' 3 1 4 5 ( 39 4( 3 4 5 B 5 5 & % &'6 Very rare side effects (may affect up to 1 in 10,000 people): 2. What you need to know before you are given Piperacillin/Tazobactam Do not use Piperacillin/ Tazobactam: 5 '3 -4 5 ( 1 % &' 5 5 7(8 ( 5 ( ( 5 ( 5 3 49 3 0 4 9 5 5 (( 5 ( 3 4 ( 34 5 3 4 3.4 34 5 3 4 3 4 5 39 4( ( 3!1C!4 5 % (8 Reporting of side effects (.!6(((& (D 5. How to Store Piperacillin/Tazobactam Children below 2 years % &' ()8 Other medicines and Piperacillin/Tazobactam ! ( ' 6 5 34 ' 5 3(4 5 9 5 934% ' 9 5 3 4 5 : % &' Pregnancy, breast-feeding and fertility 1 ( % &' % '( 1( % &' Driving and using machines 7% &'9( 0:E%29 F 67),G. H 6. 1 #)(),G. "=()1=G.(( 7 6 > 1 #)),G."=()1=G.( A ( 1 ( #) ),G."=)1=G. A 7 >( ( 6. Contents of the pack and other information % &'9 Piperacillin/Tazobactam contains sodium What Piperacillin/Tazobactam contains % &')&;),( "-< 3#;=4 1 ' : ) 3 4;),'3 4 What Piperacillin/Tazobactam looks like and contents of the pack 3. How Piperacillin/Tazobactam is given ( 3*;4 (( > #) " &;, &' -1= ( 3 4 . )#) ( #;;&#),&( &' =3 4 ( (( =;&#;&( &'-3 4 ( ?( ( 9"&;,% & ' ( % &' 3,#"4 $((8 ( : %'6# I ' Marketing Authorisation Holder and manufacturer Marketing authorisation holder ! F"J. @ $+ $7#=<!! F 6;""#<)*),,,=; : 6K1 Distributed by %8'@HH !(.#*<ICF Manufacturer %( % &'( ( If you are given more Piperacillin/Tazobactam than you should >( % &' ( +(9 """ #;7'(! ;*1)*;$( % %6;;"=))-#";;=# This leaflet was last revised in 09/2013 H6F9%)#L; 1022680 If you miss a dose of Piperacillin/Tazobactam % &' The following information is intended for healthcare professionals only: Piperacillin/Tazobactam 2 g/ 0.25 g powder for solution for infusion % &')&;),( ( 3*;4 Intravenous use H ( ( ( !( 3 (4 Content of vial Volume of solvent* to be added to vial )&;),3) ;),'4 #; Co-administration of Piperacillin/Tazobactam with aminoglycosides 7in vitro 1 % &' % &' (( Special precautions for storage FM 67),G. H 6. 1 #)(),G. "=()1=G.(( 34 N. 6 5 ;<O3<& 4 B 5 ! (B3#4 5 P ,O 3#4 J9 (B,; (( $ ((( ' 3,; #,; 4( ( 6 5 ;<O3<& 4 B 5 P ,O 5 79-O;<O 7 6 > 1 #)),G."=()1=G.( 34 A ( 1 ( #) ),G."=)1=G. Disposal Incompatibilities 5 % &' (@H?3+?4 % &' be (@H?3+?4 5 % &'91( $% &' (3 4 91 ( in vitro 5 % &' 9( Dimension: 160x 520 mm 5 % &' 5 D % &' ( 5 % &' Front Side >( ( A 7 H6F9%)#L; Dimension: 160x 520 mm Back Side