www.ESTI2011.org

ESTI 2011June 23-25, 2011Heidelberg, Germany

EUROPEAN SOCIETY OF THORACIC IMAGING

THE FLEISCHNER SOCIETY

Innovation and

Education in

Chest Radiology

Joint Meeting of ESTI andThe Fleischner Society

Preliminary Programme and Call for abstracts

2

ESTI 2011 · June 23-25, 2011

Content

Welcome. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Congress Organisation . . . . . . . . . . . . . . . . . . . . . . 4

Preliminary Programme . . . . . . . . . . . . . . . . . . . . . 5

Programme Overview . . . . . . . . . . . . . . . . . . . . . . 6

Speaker ESTI - Faculty (accepted) . . . . . . . . . . . . . . .10

Abstract Information . . . . . . . . . . . . . . . . . . . . . . .11

General Information . . . . . . . . . . . . . . . . . . . . . . .12

Social Event . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Acknowledgements to Sponsors and Exhibitors . . . . . . . .17

Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

3

Heidelberg, GermanyHeidelberg, Germany

Dear Colleagues, Friends and Sponsors,

In 2011, the European Society of Thoracic Imaging (ESTI) and the Fleischner Society will hold a joint Educational and Scientifi c Meeting in Heidelberg, Germany, from Thursday, June 23, to Saturday, June 25.

The University of Heidelberg has been distinguished as a German elite University with an aca-demic tradition of 625 years and is one of the leading universities worldwide. Numerous major national and international research institutions are based in Heidelberg and underline the impor-tance of the “location” Heidelberg.

This joint ESTI / Fleischner meeting will offer the well-proven combination of basic systematic lectures on chest imaging and current scientifi c innovation both presented by world-renowned speakers. Beyond this traditional track, we strive to achieve the following new goals by a multi-disciplinary international faculty:

• Multidisciplinarity to also attract participants from respiratory medicine and oncology• Parallel clinical and radiological sessions with experts from ESTI and the Fleischner Society

as well as a dedicated session: ESTI meets the European Respiratory Society (ERS). • Dedicated training Course in Chest radiology in German (“Fit für den Facharzt”) supported by

the German Radiological Society (DRG)• Reinvigoration of ties between chest radiologists within Europe: ESTI meets the Italian

“Sezione Radiologia toracica - Società Italiana Radiologia Medica (SIRM)”• How-to-do Courses• Read-with-the-expert• “Population-based imaging”: Update on CT within large epidemiological studies on lung

cancer and COPD

It is our great pleasure to invite you to join us for this exciting meeting in Heidelberg.

We are looking forward to welcoming you in Heidelberg.

Hans-Ulrich Kauczor Massimo Pistolesi

Congress Organisation

4

ESTI 2011 · June 23-25, 2011

ESTI and Meeting President:

• Hans-Ulrich Kauczor

Fleischner Society President:

• Massimo Pistolesi

Local Organising Committee

• Hans-Ulrich Kauczor • Felix Herth • Stefan Diederich • Michael Thomas • Claus Peter Heußel • Roland Buhl • Sebastian Ley • Claus Vogelmeier

Organising Committee

• Hans-Ulrich Kauczor (ESTI) (Chair) • Massimo Pistolesi (Fleischner) (Co-Chair) • Katharina Marten (ESTI) • Martine Remy-Jardin (ESTI) • Johny Verschakelen (ESTI) • Takeshi Johkoh (Fleischner)

5

Heidelberg, GermanyHeidelberg, Germany

Preliminary Programme

Sessions

The joint ESTI/Fleischner meeting has a strong interdisciplinary scope which is refl ected by the set-up of the programme. Beyond plenary sessions of the major lung diseases, the ESTI/Fleischner meeting is offering two parallel tracks

1) current methodological and technological aspects of chest imaging (radiology track),

2) clinical role of imaging decision making and some basic knowledge for non-radiologists (clinical track).

Plenaries

Major lung diseases benefi t substantially from the appropriate use of high-quality imaging.

They include:

• Interstitial Lung Disease with experts from pathology, radiology, and respiratory medicine

• Lung Cancer with experts from radiology and nuclear medicine presenting the New TNM System current role of PET/CT role of imaging for radiotherapy planning Therapy response imaging (RECIST 1.1)• Airway disease: COPD with experts from pathology, radiology,

and respiratory medicine. This session will include the ESTI Honorary lecture given by Philippe Grenier (Paris/FR) on Imaging of the Airways:visualization of infl ammation

6

ESTI 2011 · June 23-25, 2011

Radiology Track

• Cardiopulmonary Interaction: Structure and FunctionRequirements for comprehensive imaging in pulmonary hypertension

• New Horizons in Chest Imaging: diffusion-weighted MRI PET/CT for molecular imaging optical imaging multi-energy CT • Computer-Assisted Diagnosis and Detection pulmonary nodules parenchyma: emphysema, airways pulmonary embolism • Pulmonary Infections community acquired pneumonia pneumonia in the immunocompromised host tuberculosis – an update • Image-guided Interventions chemoembolisation in the chest radiofrequency ablation in the chest pleural intervention interventional bronchoscopy in COPD

Clinical Track

• Acute Lung Injury genetic and infectious risk factors ventilator-induced lung injury pandemic infl uenza• Chest Radiograph: the Basics remaining role of CXR in the era of new technologies side-by-side comparison of CXR and MDCT innovations in CXR• Asthma and CF perspective of a pediatric radiologist novel aspects of CF is there a role of imaging in asthma? update on diagnosis and treatment of asthma• Comprehensive Cardiopulmonary Imaging acute chest pain novel CT techniques is there a role of MRT?• Chest radiology in Italy the role of MRI in diffuse lung disease COPD phenotyping pulmonary nodules

7

Heidelberg, GermanyHeidelberg, Germany

Hands-on Workshops

Read with the Experts

Reporting projection radiography, CT and MRI of the chest is a challenge for residents, fellows and non-radiologists. Clear depiction of pathology, recognition of typical patterns and use of adequate terminology are the major components for starting a good report. To improve your knowledge and confi dence we will offer four different interactive “read-with-the-experts” sessi-ons with highly experienced international chest radiologists.

They will be available in English and German and focused on • Pneumonia• Interstitial lung disease• Airway disease• Advanced differential diagnosis

How to do it

Expert will demonstrate how they perform radiology exams and of the chest, interventions and use software assistance while reporting. Some of these workshops will be supported by the industry, with their application specialists on-site.

Topics will include• Multidetector-CT, Spectral-CT with virtual scanning• MRI of the Lung: scanning volunteers• Operation of different software tools for diagnosis and therapy monitoring of pulmonary

nodules, lung cancer, emphysema, Airway disease and pulmonary embolism• Operation of software tools for navigation of bronchoscopic procedures• Percutaneous biopsy• Ultrasound of the chest• Imaging for Radiotherapy planning in the chest

Interactive Guided Tours

We are happy to offer guided tours as well as question and answer rounds forHigh-end imaging and treatment equipment is available at the Heidelberg campus. We are happy to offer guided tours and question and answer rounds for

• human high fi eld MRI (7T)• heavy ion radiotherapy of lung Cancer (Heidelberg Ion Therapy)• small animal imaging for lung research

Please note: The number of participants will be limited and preregistration is recommended. All these courses are included in the general registration fee.

8

ESTI 2011 · June 23-25, 2011

PROGRAMME OVERVIEW ESTI 2011*

Thursday, June -23 Friday, June -24 Saturday, June -25

CME course (FFF)in German

ESTI Radiology Track Pulmonary Track Radiology Track Pulmonary Track

8:00

Cardiopulmonary Interaction: Structure and Function

Acute Lung InjuryComputer-Assisted Detection

and Diagnosis (CAD)ESTI/Fleischner meet ERS:

Asthma and CF

´15´30´45

9:00

CME Course „Fit für den Facharzt“

Population-based imaging

´15´30

New Horizons in Chest Imaging

Chest Radiography: the Basics

Pulmonary Infections Comprehensive

Cardiopulmonary Imaging

´4510:00

´15´30´45

Coffee Break / Visit of the Exhibition Area / Poster Visit Coffee Break / Visit of the Exhibition Area / Poster Visit11:00´15´30

Opening Diffuse Lung Disease

Lung Cancer StagingAirway Disease: COPD

Honorary Lecture ´45

12:00´15´30 Visit of the Exhibition Area / Poster Visit Visit of the Exhibition Area / Poster Visit´45

13:00

LUNCH SYMPOSIUM LUNCH SYMPOSIUM LUNCH SYMPOSIUM LUNCH SYMPOSIUM LUNCH SYMPOSIUM LUNCH SYMPOSIUM´15´30´45

14:00 Break Break ´15

CME Course „Fit für den Facharzt“

Scientifi c Session Hands-on Workshops Image-Guided Interventions Hands-on Workshops Scientifi c Session ´30´45

15:00´1530´45

Coffee Break / Visit of the Exhibition Area / Poster Visit16:00´15´30

CME Course „Fit für den Facharzt“

Scientifi c Session Hands-on WorkshopsESTI/Fleischner meet SIRM: Sezione Radiologica Toracica

Film Panel Adjourn

´4517:00

´15´30´45

18:00

Welcome Reception´15´30´45

Dinner Ship Cruise19:00

Subject to be changed

9

Heidelberg, GermanyHeidelberg, Germany

PROGRAMME OVERVIEW ESTI 2011*

Thursday, June -23 Friday, June -24 Saturday, June -25

CME course (FFF)in German

ESTI Radiology Track Pulmonary Track Radiology Track Pulmonary Track

8:00

Cardiopulmonary Interaction: Structure and Function

Acute Lung InjuryComputer-Assisted Detection

and Diagnosis (CAD)ESTI/Fleischner meet ERS:

Asthma and CF

´15´30´45

9:00

CME Course „Fit für den Facharzt“

Population-based imaging

´15´30

New Horizons in Chest Imaging

Chest Radiography: the Basics

Pulmonary Infections Comprehensive

Cardiopulmonary Imaging

´4510:00

´15´30´45

Coffee Break / Visit of the Exhibition Area / Poster Visit Coffee Break / Visit of the Exhibition Area / Poster Visit11:00´15´30

Opening Diffuse Lung Disease

Lung Cancer StagingAirway Disease: COPD

Honorary Lecture ´45

12:00´15´30 Visit of the Exhibition Area / Poster Visit Visit of the Exhibition Area / Poster Visit´45

13:00

LUNCH SYMPOSIUM LUNCH SYMPOSIUM LUNCH SYMPOSIUM LUNCH SYMPOSIUM LUNCH SYMPOSIUM LUNCH SYMPOSIUM´15´30´45

14:00 Break Break ´15

CME Course „Fit für den Facharzt“

Scientifi c Session Hands-on Workshops Image-Guided Interventions Hands-on Workshops Scientifi c Session ´30´45

15:00´1530´45

Coffee Break / Visit of the Exhibition Area / Poster Visit16:00´15´30

CME Course „Fit für den Facharzt“

Scientifi c Session Hands-on WorkshopsESTI/Fleischner meet SIRM: Sezione Radiologica Toracica

Film Panel Adjourn

´4517:00

´15´30´45

18:00

Welcome Reception´15´30´45

Dinner Ship Cruise19:00

10

ESTI 2011 · June 23-25, 2011

Speaker ESTI - Faculty (accepted)

Speaker City / CountryP. Barnes London / UKA. Bankier Boston / USJ. Biederer Kiel / DEL. Bonomo Rome / ITP. Brillet Paris / FR A. Brody Cincinnati / USD. Christiani Boston / USE. Coche Brussels/ BET. Colby Scottsdale / USJ. Crapo Denver/ USC. Engelke Goettingen / DET. Franquet Barcelona / ESJ. Galvin Washington / USF. Gleeson Oxford / UKP. Grenier Paris / FRD. Hansell London /UKC. Haslett Edinburgh / UKC. Heussel Heidelberg / DEJ. Im Seoul / KRK.-F. Kreitner Mainz / DEA. Larici Rome / ITF. Laurent Bordeaux / FRK. Lee Seoul / KRS. Ley Heidelberg / DE J. Ley-Zaporozhan Heidelberg / DEH. MacMahon Chicago / USK. Malagari Athens / GRT. McLoud Boston / USA. Mehta Abu Dhabi/ UAEF. Molinari Rome / ITD. Naidich New York / USS. Padley London / UKE. Patz Durham / USM. Pistolesi Florence / ITM. Remy-Jardin Lille / FRG. Rubin Durham / USC. Schaefer-Prokop Amersfoot/ NLA. Slutsky Toronto / CAN. Sverzellati Parma / ITH. Tiddens Rotterdam / NLJ. Verschakelen Leuven/ BE D. Wever Leuven/ BEJ. Wildberger Maastricht / NL

11

Heidelberg, GermanyHeidelberg, Germany

Abstract Information

Abstract Submission

DEADLINE FOR SUBMISSION: February 21, 2011

You are kindly invited to submit scientifi c contributions to be presented during the meeting. Abstracts may only be submitted in English using the electronic abstract submission system on the website at: www.esti2011.org

Abstracts will be published in the online edition of a well accepted professional journal.

Abstracts should meet the following criteria

• The abstract cannot exceed 250 words• Abstracts must be written in English, explained abbreviations may be used• Graphs and Tables are not allowed

Structure of the Abstract

PurposeMaterials and MethodsResultsConclusions

General information on the Abstract Submission

Please kindly note that the submission of an abstract does not replace the registration to the congress. After the reviewing process all accepted abstracts will be presented via E-poster sessions under a special link which will be provided by the congress organiser. The E-poster may only have 10 MB. For uploading an E-poster please use a pdf, doc or ppt-fi le. Please do not in-clude a video. All submitters will be informed about their acceptance by Email. After that the submitters are invited to register for the congress.

Please note that publication of the selected abstract(s) and inclusion in the scientifi c program-me is subject to the congress registration of the presenting author.

The submitter confi rms that his research / study has not been supported by the tobacco industry or any associated bodies.

12

ESTI 2011 · June 23-25, 2011

Congress Venue

Kopfklinik Heidelberg Medizinische Klinik HeidelbergIm Neuenheimer Feld 400 Im Neuenheimer Feld 41069120 Heidelberg – Germany 69120 Heidelberg – Germany

Heidelberg is centrally located in Germany and Europe and easy to reach by plane, train, car or bus. Especially the proximity to Frankfurt airport, less than 60 minutes, is a great advantage.

ArrivalBy plane

Frankfurt Airport (about 80 km, 50 minutes)Transfers: Lufthansa Airport Bus: Departures directly from Terminal 1 in front of arrivals hall B, arrival at Crowne Plaze Hotel in the center of Heidel-berg. Pre-booking is recommended, check www.lufthansa-airportbus.de. Price approxi-mately 22 €.

Shuttle Bus service: departures from meeting points in Terminal 1 or 2. Takes you directly to your hotel or congress venue. Pre-booking required, check www.tls-heidelberg.de. Price approximately 35 €.

Train (German Railway): departure from the Fernbahnhof (long-distance train station) op-posite Terminal 1 to Mannheim, change trains in Mannheim and go to Heidelberg Haupt-bahnhof (main station). Check www.bahn.de. Price approximately 24.50 €. Stuttgart Airport (about 120 km, 90 minutes)Transfer: Train (German Railway): With the S-Bahn di-rectly to Stuttgart Hauptbahnhof, which is part of the ICE, EC and IC network and connects to Heidelberg.

By train

Heidelberg is connected directly to the ICE- and IC/EC-Network of German Railways (DB). Arrival is at Heidelberg Hauptbahnhof (main station). For connections see www.bahn.de

From Heidelberg Hauptbahnhof it is approxi-mately 10 minutes by car to the Congress ve-nue on the Heidelberg University Campus. You can take a taxi or bus to the „Kopfklinik“:Bus no. 32 towards “Neuenheimer Feld/Kopf-klinik” get off at the stop „Kopfklinik”.

By car

The A5/A6 autobahns, with their interconnec-ted exits and feeder highways, serve much of the greater Rhine-Neckar region. The A5/A656 autobahns have exits leading directly to Hei-delberg.

13

Heidelberg, GermanyHeidelberg, Germany

Registration

How to register?Registration can be made online via the congress website: www.esti2011.org

EARLY before May 9, 2011**

LATEafter May 9, 2011**

€ €

JUNIOR (younger 35 years)

Member ESTI or DRG 150 200

non-member 250 300

SENIOR

Member ESTI or Fleischner 250 300

non-member 400 450

STUDENTS, TECHNICIANS 100 150

ONE-DAY REGISTRATION 250 300

ACCOMPANYING PERSON 100 150

ONLY PRE CONGRESS COURSE 150 €

SOCIAL EVENT*

Boat Trip 60 €

Delegates’ registration fee includes

• Access to the scientifi c sessions and the company sponsored Satellite Symposia• Access to Exhibition Area• Certifi cate of Attendance• Opening and Welcome Reception• Link to E-Poster viewing

Accompanying persons’ fee includes:

• Welcome Reception • Access to Exhibition Centre

Group registration

For a group registration of more than 10 people, please contact directly esti2011@interplan.de

* Mentioned price includes German VAT** Mentioned prices are tax free according § 4, Nr. 22a German UStG

in the name of the European society of Thoracic Imaging, Vienna

14

ESTI 2011 · June 23-25, 2011

Payment

Payments are required to be made in EURO (€) by bank transfer or credit card (VISA, Eurocard or AMEX).

Payment by bank transfer must be made to the following account:

Account holder: INTERPLAN AGBank name: Hypovereinsbank MünchenAccount number: 654 028 4588Bank code: 700 202 70IBAN: DE87 7002 0270 6540 2845 88SWIFT (BIC): HYVEDEMMXXX

Please indicate the following reference: “ESTI 2011” and your name.Banking fees must be paid by the registrant. Please kindly note that payment by bank transfer can only be accepted until June 8, 2011. After this date only direct payment by credit card or payment on-site will be accepted.Payments by credit card will be charged directly with your online registration.

Please note that for payment by credit card a Pincode will be required. This code will be provi-ded by your bank.

Hotel Reservation

INTERPLAN has made reservations for the industry and participants with special rates and con-ditions in several hotels. All hotels are located near the congress venue or in the city centre and are well connected with the congress venue. To benefi t from these rates we kindly ask you to contact the following hotels. Please mention the key word “ESTI 2011”.

Hotel Tel.no. Fax.no. Address Price*

Heidelberg Marrriott Hotel

0049 (0) 6221-908650

0049 (0) 6221-908698

Vangerowstraße 16, 69115 Heidelberg

SR 140 EURDR 160 EUR

Crowne Plaza Heidelberg

0049 (0) 6221-917190

0049 (0) 6221 21007

Kurfürstenanlage 1, 69115 Heidelberg

SR 129 EURDR 149 EUR

Please use the keyword "ESTI 2011"

*Prices are mentioned in € and incl. breakfast and German VAT.

Further small hotels and guesthouses are published on our website at: www.esti2011.org

15

Heidelberg, GermanyHeidelberg, Germany

Cancellation Policy

In case of cancellation until May 23, 2011 the registration fee less EUR 50,- will be retained.

There will be no refunds after the May 23, 2011 deadline.Namechanges are possible.

Cancellation and changes in registrations must be sent to INTERPLAN in writing – esti2011@interplan.de.

Registration fee will be payable even in the case of nonattandance.

Important Dates:

May 9, 2011 Deadline for early registration fee

May 23, 2011 In case of cancellation until May 23, 2011 the registration fee less EUR 50,- will be retained. There will be no refunds after the May 23, 2011 deadline.Cancellation and changes in registrations must be sent to INTERPLAN in writing – esti2011@interplan.de

June 8, 2011 Payments by bank transfer must be received by INTERPLAN by that date. Payments received after that date can no longer be transacted. Please note that payments after June 8, 2011 are only possible by credit card or in cash at the venue.

16

ESTI 2011 · June 23-25, 2011

Social Event

Dinner ship cruise

Friday, June 24, 2011Departure: 19:00Arrival: 22:00Pier: “Stadthalle“

The Neckar River is 367 km long, mainly fl owing through the south-western state of Baden-Württemberg. Rising in the Black Forest at a height of 706 m above sea level, it passes Heidelberg, before discharging into the Rhine at Mannheim (at 95 m above sea level). The Neckar is the 4th largest tributary of the Rhine and the 10th largest river in Germany. Enjoy the city from the waterside and enter the MS “Alt Heidelberg” for a three hours trip including a local buffet dinner. You will experience the beautiful city of Heidelberg and the town’s landmark – the Heidelberg Castle – from a new point of view.

17

Heidelberg, GermanyHeidelberg, Germany

Acknowledgements to Sponsors, Exhibitors and Societies

We thank all Sponsors and Exhibitors and Societies for their support

Sponsors: GE Healthcare

Exhibitors: Covidien Deutschland GmbH b·e·imaging·gmbh Guerbet GmbH Bracco GE Healthcare

Societies: Deutsche Röntgengesellschaft e.V. (DRG)

For information about Sponsorship and Exhibition opportunities please contact:

esti2011@interplan.de

The list refl ects the Sponsors/Exhibitors that confi rmed before August 30, 2010.

18

ESTI 2011 · June 23-25, 2011

Contact

Scientifi c Secretary

Geoff Rubin, grubin@duke.eduMaria Gaetana Tarallo, maria.tarallo@med.uni-heidelberg.de

Organisation, Registration and HotelbookingIndustrial Exhibition and Sponsoring

INTERPLAN Congress, Meeting & Event Management AGEva Burk, Katharina HeinkeLandsberger Straße 155D-80687 MunichTel.: +49(89) 54 82 34-73Fax: +49(89) 54 82 34-42Email: esti2011@interplan.deWeb: www.esti2011.de

*

Ga

do

vis

t®

1.0

is

in

dic

ate

d i

n a

du

lts

, a

do

le

sc

en

ts

, a

nd

ch

ild

re

n a

ge

d 7

ye

ars

an

d o

ld

er f

or C

NS

, liv

er a

nd

kid

ne

ys

an

d f

or M

R a

ng

iog

ra

ph

y.

1 H

irs

ch

W,

Jir

ak

ov

a-T

rn

ko

va

Z,

Sc

hu

ltz

e-M

os

ga

u M

et a

l.

ES

PR

, Is

ta

nb

ul,T

urk

ey

, M

ay

31

–Ju

ne

9,

20

09

.2

Fo

rs

tin

g M

, E

ss

en

DE

. E

CR

SS

20

08

;18

06

a:B

-7

91

.3

Ba

lz

er J

O,

Lo

ew

e C

, D

av

is K

et a

l.

Eu

r R

ad

iol 2

00

3;1

3:2

06

7–

74

.4

To

mb

ac

h B

, H

ein

de

l W

. E

ur R

ad

iol 2

00

2;1

2:1

55

0–

6.

5T

om

ba

ch

B,

Bre

me

r C

, R

eim

er P

et a

l.

Ra

dio

l 2

00

1;2

18

:65

1–

7.

6

Fre

nz

el T

, L

en

gs

fe

ld

P,

Sc

hir

me

r H

et a

l.

In

ve

st R

ad

iol 2

00

8;4

3:8

17

–8

28

.7

Ba

ye

r S

ch

erin

g P

ha

rm

a.

Ga

do

vis

t s

um

ma

ry

of p

ro

du

ct c

ha

ra

cte

ris

tic

s 2

00

8.

Ga

do

vis

t®

  1.0

 mm

ol/m

L s

olu

tio

n f

or

in

jec

tio

n. C

om

po

sit

ion

: 1

 mL

so

lu

tio

n f

or i

nje

ctio

n c

on

ta

ins

60

4.7

2 m

g g

ad

ob

utro

l (

eq

uiv

. 1

.0 m

mo

l)

as

ac

tiv

e i

ng

re

die

nt.

Ex

cip

ien

ts

: c

alc

ob

utro

l s

od

ium

, tro

me

th

am

ol,

hy

dro

ch

lo

ric

ac

id,

wa

te

r f

or i

nje

ctio

ns

. In

dic

at

ion

s:

Th

is m

ed

icin

al p

ro

du

ct i

s

fo

r d

iag

no

stic

us

e o

nly

. G

ad

ov

ist®

 1.0

is

in

dic

ate

d i

n a

du

lts

, a

do

le

sc

en

ts

, a

nd

ch

ild

re

n a

ge

d 7

ye

ars

an

d o

ld

er f

or:

Co

ntra

st e

nh

an

ce

me

nt i

n c

ra

nia

l a

nd

sp

ina

l m

ag

ne

tic

re

so

na

nc

e i

ma

gin

g (

MR

I),

co

ntra

st e

nh

an

ce

d M

RI

of l

ive

r o

r k

idn

ey

s i

n p

atie

nts

wit

h h

igh

su

sp

icio

n o

r e

vid

en

ce

of h

av

ing

fo

ca

l l

es

ion

s t

o c

la

ss

ify

th

es

e l

es

ion

s a

s b

en

ign

or m

alig

na

nt,

co

ntra

st e

nh

an

ce

me

nt i

n m

ag

ne

tic

re

so

na

nc

e a

ng

iog

ra

ph

y (

CE

-M

RA

).

Co

nt

ra

ind

ica

tio

ns

: H

yp

ers

en

sit

ivit

y t

o t

he

ac

tiv

e s

ub

sta

nc

e o

r a

ny

of t

he

ex

cip

ien

ts

. S

pe

cia

l w

ar

nin

gs

an

d p

re

ca

ut

ion

s f

or

us

e:

Ga

do

vis

t®

 1.0

sh

ou

ld

no

t

be

us

ed

in

pa

tie

nts

wit

h u

nc

orre

cte

d h

yp

ok

ale

mia

. In

pa

tie

nts

wit

h s

ev

ere

ca

rd

iov

as

cu

la

r d

ise

as

e G

ad

ov

ist®

 1.0

sh

ou

ld

on

ly

be

ad

min

iste

re

d a

fte

r c

are

fu

l r

isk

be

ne

fi t a

ss

es

sm

en

t b

ec

au

se

on

ly l

imit

ed

da

ta

are

av

ail

ab

le s

o f

ar.

Ga

do

vis

t®

 1.0

sh

ou

ld b

e u

se

d w

ith

sp

ec

ial

ca

re

in

pa

tie

nts

wit

h

kn

ow

n c

on

ge

nit

al

lo

ng

QT

sy

nd

ro

me

or a

fa

mil

y h

isto

ry

of c

on

ge

nit

al l

on

g Q

T s

yn

dro

me

; w

ith

kn

ow

n p

re

vio

us

arrh

yth

mia

s a

fte

r t

ak

ing

me

dic

ina

l p

ro

du

cts

th

at p

ro

lon

g c

ard

iac

re

po

laris

atio

n;

wh

o a

re

cu

rre

ntly

ta

kin

g a

me

dic

ina

l p

ro

du

ct t

ha

t i

s k

no

wn

to

pro

lon

g c

ard

iac

re

po

laris

atio

n e

.g.

a C

lass I

II a

ntia

rrh

yth

mic

(e

.g. a

mio

da

ro

ne

, so

ta

lol)

. T

he

po

ssib

ilit

y t

ha

t G

ad

ov

ist®

 1.0

ma

y c

au

se

to

rs

ad

e d

e p

oin

te

s a

rrh

yth

mia

s i

n a

n i

nd

ivid

ua

l p

atie

nt c

an

no

t b

e e

xc

lu

de

d (

se

e S

PC

).

Sin

ce

co

ntra

st m

ed

ium

elim

ina

tio

n i

s d

ela

ye

d i

n p

atie

nts

wit

h s

ev

ere

ly

im

pa

ire

d r

en

al f

un

ctio

n,

th

e b

en

efi ts

mu

st b

e w

eig

he

d v

ery

ca

re

fu

lly

ag

ain

st t

he

ris

ks

in

su

ch

ca

se

s.

In p

artic

ula

rly

se

ve

re

ca

se

s,

it i

s a

dv

isa

ble

to

re

mo

ve

Ga

do

vis

t®

 1.0

fro

m t

he

bo

dy

by

ex

tra

co

rp

ore

al h

ae

mo

dia

ly

sis

: F

or r

em

ov

al o

f t

he

ag

en

t f

ro

m t

he

bo

dy

, a

t l

ea

st 3

dia

ly

sis

se

ss

ion

s w

ith

in 5

da

ys

of t

he

in

jec

tio

n s

ho

uld

be

pe

rfo

rm

ed

. N

o i

mp

air

me

nt o

f r

en

al f

un

ctio

ns

ha

s b

ee

n o

bs

erv

ed

du

rin

g c

lin

ica

l t

ria

ls

pe

rfo

rm

ed

on

a l

imit

ed

nu

mb

er o

f p

atie

nts

. D

ata

are

to

o l

imit

ed

to

ex

clu

de

th

e p

os

sib

ilit

y o

f r

en

al t

ox

icit

y o

r a

gg

ra

va

tio

n o

f r

en

al i

mp

air

me

nt.

Th

ere

ha

ve

be

en

re

po

rts

of n

ep

hro

ge

nic

sy

ste

mic

fi b

ro

sis

(N

SF

) a

ss

oc

iate

d w

ith

us

e o

f s

om

e g

ad

olin

ium

-c

on

ta

inin

g c

on

tra

st a

ge

nts

in

pa

tie

nts

wit

h s

ev

ere

re

na

l i

mp

air

me

nt (

GF

R <

30

ml/m

in/1

.73

m2).

As

th

ere

is

a p

os

sib

ilit

y t

ha

t N

SF

ma

y o

cc

ur w

ith

Ga

do

vis

t®

 1.0

, it

sh

ou

ld

on

ly

be

us

ed

in

th

es

e p

atie

nts

afte

r c

are

fu

l c

on

sid

era

tio

n.

Ha

em

od

ialy

sis

sh

ortly

afte

r G

ad

ov

ist®

 1.0

ad

min

istra

tio

n i

n p

atie

nts

cu

rre

ntly

re

ce

ivin

g h

ae

mo

dia

ly

sis

ma

y b

e u

se

fu

l a

t r

em

ov

ing

Ga

do

vis

t®

 1.0

fro

m t

he

bo

dy

, b

ut i

ts

po

te

ntia

l t

o p

re

ve

nt N

SF

is

un

kn

ow

n a

nd

sh

ou

ld

no

t b

e u

se

d a

s a

pre

ve

nta

tiv

e m

ea

su

re

in

oth

er p

atie

nt g

ro

up

s.

Hy

pe

rs

en

sit

ivit

y

re

ac

tio

ns

, a

s h

av

e b

ee

n r

ep

orte

d f

or o

th

er c

on

tra

st m

ed

ia c

on

ta

inin

g g

ad

olin

ium

, h

av

e a

ls

o b

ee

n o

bs

erv

ed

afte

r a

dm

inis

tra

tio

n o

f G

ad

ov

ist®

 1.0

. In

pa

tie

nts

wit

h a

n a

lle

rg

ic d

isp

os

itio

n t

he

de

cis

ion

to

us

e G

ad

ov

ist®

 1.0

mu

st b

e m

ad

e a

fte

r p

artic

ula

rly

ca

re

fu

l e

va

lu

atio

n o

f t

he

ris

k-b

en

efi t

ra

tio

. In

ra

re

ca

se

s d

ela

ye

d a

na

ph

yla

cto

id r

ea

ctio

ns

(a

fte

r h

ou

rs

to

da

ys

) h

av

e b

ee

n o

bs

erv

ed

. L

ike

wit

h o

th

er g

ad

olin

ium

co

nta

inin

g c

on

tra

st a

ge

nts

sp

ec

ial p

re

ca

utio

n i

s n

ec

es

sa

ry

in

pa

tie

nts

wit

h a

lo

w t

hre

sh

old

fo

r s

eiz

ure

s.

Un

de

sir

ab

le

effe

ct

s:

Fo

llo

win

g a

dv

ers

e r

ea

ctio

ns

ha

ve

be

en

ob

se

rv

ed

in

clin

ica

l t

ria

ls

. U

nc

om

mo

n (

≥ 1

/1

,00

0 t

o <

1/1

00

):

He

ad

ac

he

, D

izz

ine

ss

, P

are

sth

es

ia,

Dy

sg

eu

sia

, N

au

se

a,

Va

so

dil

ata

tio

n,

Inje

ctio

n s

ite

pa

in,

Inje

ctio

n s

ite

re

ac

tio

n.

Ra

re

(≥

1/1

0,0

00

to

< 1

/1

,00

0):

Pa

ro

sm

ia,

Dy

sp

no

ea

, V

om

itin

g,

Urtic

aria

, R

as

h,

Hy

po

te

ns

ion

, A

na

ph

yla

cto

id r

ea

ctio

n.

Fo

llo

win

g a

dd

itio

na

l a

dv

ers

e re

ac

tio

ns

h

av

e b

ee

n re

po

rte

d fro

m p

os

tm

ark

etin

g s

po

nta

ne

ou

s re

po

rtin

g:

Ra

re

(≥

1/1

0,0

00

to

<

1/1

,00

0):

Ca

rd

iac

a

rre

st,

Ta

ch

yc

ard

ia,

Lo

ss

o

f c

on

sc

iou

sn

es

s,

Co

nv

uls

ion

, C

on

jun

ctiv

itis

, E

ye

lid

o

ed

em

a,

Re

sp

ira

to

ry

a

rre

st,

Bro

nc

ho

sp

as

m,

Cy

an

os

is,

Oro

ph

ary

ng

ea

l s

we

llin

g,

Co

ug

h,

Sn

ee

zin

g,

Fa

ce

ed

em

a,

Hy

pe

rh

idro

sis

, P

ru

rit

us

, E

ry

th

em

a,

Cir

cu

la

to

ry

co

lla

ps

e,

Flu

sh

ing

, F

ee

lin

g h

ot,

Ma

la

ise

, A

na

ph

yla

cto

id s

ho

ck

. A

dd

itio

na

l s

afe

ty

in

fo

rm

at

ion

: S

ho

rt-la

stin

g m

ild

to

mo

de

ra

te

fe

elin

gs

of c

old

ne

ss

, w

arm

th

or p

ain

at t

he

in

jec

tio

n s

ite

ha

ve

be

en

un

co

mm

on

ly

ob

se

rv

ed

in

as

so

cia

tio

n w

ith

th

e v

en

ou

s p

un

ctu

re

or c

on

tra

st m

ed

ium

in

jec

tio

n.

On

pa

ra

va

sc

ula

r i

nje

ctio

n G

ad

ov

ist®

 1.0

ma

y c

au

se

tis

su

e p

ain

la

stin

g u

p t

o s

ev

era

l m

inu

te

s.

Hy

pe

rs

en

sit

ivit

y r

ea

ctio

ns

(e

.g.

urtic

aria

, ra

sh

, v

as

od

ila

ta

tio

n)

ha

ve

be

en

un

co

mm

on

ly

re

po

rte

d

an

d w

ere

mo

stly

of m

ild

to

mo

de

ra

te

in

te

ns

ity. In

ra

re

ca

se

s a

na

ph

yla

cto

id r

ea

ctio

ns

ra

ng

ing

to

sh

oc

k m

ay

oc

cu

r.

De

la

ye

d a

na

ph

yla

cto

id r

ea

ctio

ns

(a

fte

r h

ou

rs

to

da

ys

) h

av

e b

ee

n o

bs

erv

ed

ra

re

ly

. P

atie

nts

wit

h a

n a

lle

rg

ic d

isp

os

itio

n s

uffe

r m

ore

fre

qu

en

tly

th

an

oth

ers

fro

m h

yp

ers

en

sit

ivit

y

re

ac

tio

ns

. D

at

e o

f r

ev

isio

n o

f t

ex

t:

Se

pte

mb

er 2

00

9 P

le

as

e n

ot

e:

fo

r c

urre

nt p

re

sc

rib

ing

in

fo

rm

atio

n r

efe

r t

o t

he

pa

ck

ag

e i

ns

ert a

nd

/o

r c

on

ta

ct y

ou

r l

oc

al B

ay

er S

ch

erin

g P

ha

rm

a o

rg

an

isa

tio

n.

Ba

ye

r S

ch

erin

g P

ha

rm

a A

G,

13

34

2 B

erlin

, G

erm

an

y.

Ad

ve

rs

e r

ea

ctio

ns

ca

n b

e r

ep

orte

d t

o

GP

V.C

as

eP

ro

ce

ss

ing

@b

ay

erh

ea

lth

ca

re

.co

m

Now Available

for Children*

Q Proven tolerability and effi cacy

in children* and adults 1 – 5

Q Macrocyclic compound –

class with highest stability 6

Q Applicable in a broad range of

pediatric and adult pathologies 1, 7

When Safety Matters Most

OMNISCAN™

Discovery MR750 3.0TSigna HDxt 1.5T/3.0T

Medcyclopaedia™

GE Healthcare

MR Re-imaginedGESUNDHEIT beginnt mit GE.

Optima MR360 1.5T

Discovery MR450 1.5T

MRgFUS

Optima MR450w 1.5T

+PLUSPAK™

Signa HDe 1.5T

GE_ANZ_NEUE HORIZONTE RADIOL_A5_1 1 25.06.2010 11:01:49 Uhr