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OMNIPAQUE INJECTION 240MG I/ML SOLUTION FOR INJECTION

Active substance: IOHEXOL

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11810113 GBR

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1111 Dl3

11810113 GBR

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t eftwnttlcltand GOI'Ile

SCIENnFIC LEAFLET

.,.,,,...

..., rna 1/ml

30-15Dml/1n).

lOOmal/ml
lDDma 1/ml

do~o.woight

IIIIIIKiiw COranGI)'

GEHoalthca..

IOMNIPAQUE"' I 0
IOHEl
-~O!IJOPhil

Nam• ofth• mlldlclnal product

*

OMM"AQUE"'
rogllml, ~ 1/ml, 311Gmg llroL
UOma lim~ Saulllon rw ll1lodl'"'

Qualitative and quantitative composltlan

5!r!nA!h
1411 ma 1/mll
Z4D mglhnl

lmCJRiml/k9

Digital1ubtractian

-

:t,:'"Phil

4-amlnnJ.

or 350 mg Vml cmd

14Dmgl/ml

.I

4-!0mi/1111,

orZliOmgVml 1-lSmVi~.

~~~~ waghtand pathology
~7~u~"~'
Ccmmants

Conttnt pw, ml
302 rna oqulv. 1110 ma 1
511 mg ~lv. 2..0 mg I
6&7 mg "''!lv,lOO rng I

lOll mglhnl
3SD ma 1/ml
755 rna oqulv. 350 ma 1
of.clpJtntt, ... PhclrmcleautJcal pal'll'o.llart
tohud II a naHonic, monomlrlc. tJtloclnat:ecl. watlr-solubll
l(..rayc::ont:I'Cistmll!llann.
=d~!ft:::a:ntradan aflQO mg 1/mii•IIDt:anlc: wlth

n.o.rnolaltttard wt!QO!Ityvgl~.~e~ ofOmnlpgcp 1;1111 CJI follows:
Conamtradan
loiJD"'9IIml
z.omal/lnl
30Dmgllml

.:.~nr.o
3~
290
51D
~

l50 rna 1/ml
7.0
•in aqUIOUIIOkrtlons ollohiMOI

\llocoolt!flmP ZO"C
2.3

s.&

57-c
LS

11.15

z:u

To rrllnirl"'lz:tpoaalbltadweruNGCtlor. attrtaldCIIIIIof3 a ladln•
lhauldnat beexc:eeded.

Gw. .ll... fwilody....ttl•
lndloa11an

3.3

Ccmm•nts

>4Drna 1/ml

&.1

w

ERP/ERCP

Pharmaceutical fann

Homlagraphy

Solutlan far lr;.c:tkln.

_..._..aaa'"P'1..c, rna 1/ml

alnlcal partlcula,.
lndiartlans

~:;::=..~~~::~:'tb':d~~ktrtnt\Y
h)clro~C~Ipl

l.v. DSo\ cr. artarlography,
DSA.
.~m=se~.
and~Mintfie~trDCt.

l'lloolog)'ancl,_od ofadmlnlotratlan

~=-:~~t!:'.of~~~tl~nt,~:nd

voluiTII! • used asfarothe:rlodilated K-r:aYcaltrust media In

===~=~~M,:~befortand
~~ru;dOICIQeamay•I'Yicaagulde:

fa' lntnnte:naus,lntru-ar12rial and ~ea:d use. and Llll! In

Guidelines far lntr1Ninaul. ....
lndk:adon
CDnc~ntradan

ualum.

40-toml
~-!Dml

4ml/1ogb.w.

3 ml/kGb.w.
3 ml/1ogb.w.
• ml/loilb.w.
lD-lDDmi/10!1

-

CT...nhcmcllmlftt

Harrgl~
1DO·Iamml
or2ll0mgllml 1D0-2SOml
ar30Drngl/rnl 100-zmml

or lSO mp lim I 100-lSOml

3DDmgl/lnl
30D"'9llml
3SOma1/lnl
lDDmgl/lnl

l~~"i1nt'

3D-40ml/l~
5-lOmllf .
40-liDml/l

30-50ml/il"f.

doPII)dinllontypoof
Maminatian

5 ->ami

orJOOmg Vml 5 -15ml
or JSO mg 1/ml 5 - 10 ml
l~ rng 1/ml
20-50 ml

>40 rna 1/ml

so ml
15- so m1

or300mg Vml 1!5-ZS ml
l~ rng 1/ml
0.5- z ml

or 3DD ma 1/ml 0.5- 2 ml
GoMroiMHtlr~aiiWdiel

350 rng 1/ml

10 - ZD ml

--.

~

tie Healthc:att AS

NJcow!len 1-Z

P.o.eo. WO

Gf: Healtheart lttklr'ld,

or

IDA flu*iess Pari!

Nydolon

Contglohlll

-OSLO.-

Co.Cork.ll'lland

Te~+47ll1150 50

Tel: +1532118ll6&
Fax: +353 21 11 3325

fait +47 ZJ 11 iO 00

Marketing authoriiiCitlon numbers
Omnlpaquel.tOmg llml
Omnlpoque 2..0 M!l111ml
Omnlpaque 300 mg 1/ml

PLOD5371D0lll
"-f.IM37/QCJM
Pl. 00637/DDJS

OmnlpDqu• JSO mg llml

PL. ((1537/00l115

Lagal catagory

""' offlm authorltation/ren-1 ofthe
Date
authorisation
20"1"11191]

Date or rellillian ofthe-

Augu~~t.201A

~:~~~~~~~~=a~~~ttt;:';&neruiEiectric

Cornpgny,

1181083GI!R

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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