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Summary
f XENETIX: a new chemical concept f XENETIX: physicochemical features f XENETIX and clinical experience f XENETIX and handling optimization f XENETIX at a glance
Introduction (1)
f The ideal contrast agent should display:
{ an optimal diagnostic efficiency { an optimal safety osmolality viscosity { the highest biological inertia iodine content intrinsic features of the compound
f Benzene ring
I R1 R2
I R3
{ { { {
common structure to all nonionic monomers differenciation: R1, R2, R3 lateral side chains benzene ring: a very lipophilic and toxic structure hydrophobic interactions with biological media may occur (adverse effects)
Introduction (2)
f How ?
X 3 KEY STEPS:
4-O 5-O
Lipophilic zone
6-O
Hydroxyl radical
H radicals
Lipophilic zone
Hydrophilic zone
Decreased accessibility of the tri iodinated benzene ring through optimal spatial distribution of the hydroxyl radicals
Tertiary amides through binding of methyl groups preventing rotation = M RE RIGID M LECULE
XENETIX
Less molecular deformation
iodixanol 270 iohexol 240 XENETIX 250 iopamidol 250 iopromide 240
69 0 69 5 61 6 61 0
iodixanol 270 iohexol 240 XENETIX 250 iopamidol 250 iopromide 240
5. 7 6. 0 4. 5 4. 6
31
21 patients (clcreat < 0ml/mn) requiring an angiography 2 groups (one requiring contrast agent, the other not requiring contrast agent) Xenetix 3 0: 1.9 ml/kg Creatinine clearance follow up, 2 days after the injection of Xenetix
(ml/mn)
30
29
29
enet c ntr l
100 patients requiring a CT or an IVU examination Presenting either a normal renal function (group A, clcreat > 0ml/mn) or an impaired one (group B, clcreat < ml/mn) Xenetix 3 0: 1.3 ml/kg Creatinine clearance follow up, 3 days after the injection of Xenetix
36.6
38.1
38.9
Group A Group B
before inj.
at 48h
at 72h
(Louvel J.P., Eur. Radiol., 2000) XENETIX confirms its high safety profile by iv use in patients at risk
50 patients enrolled for a CT examen in a double blind randomised clinical trial (25 p/Xenetix 300 25 p/Visipaque 320) Presenting with a pre existing renal failure (clcreat < 5ml/mn) Volume administered: 113 ml/Xenetix group 112 ml/Visipaque group Assessment criteria Renal safety (creatininemia follow up at 3 days) Image quality
safety
Number of patient with U Creat clear > 25 %
NS
n= 3 n=3
3 2.5 2
Visipaque 320 Xenetix 300
Visipaque 320
229
1.5 1 0.5
Xenetix 300
before inj.
D3
Good to excellent
Average
3% 4% 4%
No imaging
13 1 patients requiring a CT examination Xenetix 250, 300, 350: 98ml (12 250ml)
Adverse effects
in %
0.3 9 0.8
Image quality
in %
poo o f 6 X n t x 50 X n t x 300 X n t x 350 91 goo o x ll nt
v mt g t
0.5
cc
t t l
4.4
0.2
94 96
d c
297 children (age < 14) 1457 adults (age > 0: 30 505)
renal failure cardiac failure
in %
9
Patients at risk 1 risk (19 %) n = 17 797 (29 %) 2 risks (7 %) more than 2 risks (3%)
24 27 2 2
Indication
in %
7
in %
2.5 5 3 9.5
1.5
91.5
80
Xenetix 250
Xenetix 300
Xenetix 350
CT
phlebo
DSA
angio
IVU
90 %
99 %
goo to e ellent
fair
yes
no
Advantages
Batch number Expiry date Name/ concentration
Product indentification right up to administration Accurate information on the product administered always possible Main label remains on bottle
Advantages Safety for the technician (no need to open the bottle) Improved handling No contrast agent waste
Fitted with air inlet
Advantages Patient line of the kit fitted with non return double valve to ensure highest security for the patient Kit partially kept in place, saving time and money
f 3 concentrations available
{ XENETIX 250 { XENETIX 300 { XENETIX 350
I CT
ce trati 300 350 300 350 250 300 350 300 300 350 250
A era e
se ( l/k )
1.4 1 1.9 1.8 2 1.2 1 1. 1.7 2.1 3.1 2.2 2.8 1.8 3. 1.8 2.
IVU iv SA IA SA Angiography
rapid slo
Angiocardiography Phlebography
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