Ox Brochure Inside Pages.indd

Transcription

Are you seeing
the whole picture?
The whole picture
on osmolality
Lowest osmolality of all monomers
• The threshold of vascular pain was determined to be
approximately 700 to 750 mOsms3*
• Low osmolality improves patient comfort and
minimizes patient movement
– In a randomized, parallel, double-blind, controlled
study of 112 patients, OXILAN® was well tolerated
on patient measures of pain and warmth2
Compare the osmolality of OXILAN® 3001
Monomers
700
Dimers
672
616
600
607
651
600
(mOsm/kgH2O)
585
500
400
300
290
200
100
0
OXILAN®
300
Omnipaque™
300
Isovue®
300
Ultravist®
300
Optiray®
300
Hexabrix®
320
Visipaque™
320
Compare the osmolality of OXILAN® 3501
Monomers
Dimers
900
844
800
(mOsm/kgH2O)
700
796
774
792
695
600
600
500
400
300
290
200
100
0
OXILAN®
350
Omnipaque™
350
Isovue®
370
Ultravist®
370
Optiray®
350
Hexabrix®
320
Visipaque™
320
*The clinical significance of this data is not known.
OXILAN® gives you both patient comfort and
The whole picture
on viscosity
Lowest viscosity of all the monomers at 350-370 concentration
• Low viscosity allows for easy injection through small
diameter catheters4
• Low viscosity allows for high-speed injection6
• Low viscosity provides better flow through small blood
vessels and capillaries5
Compare the viscosity of OXILAN® 3001
Monomers
Dimers
Monomers
Dimers
12
30
11.8
8
20
15
cPs at 37° C
cPs at 20° C
10
26.6
25
15.7
10
11.8
9.4
8.8
9.2
Isovue®
300
Ultravist®
300
6.3
5.5
5.1
4
4.9
4.7
2
5
0
7.5
6
0
OXILAN® Omnipaque™
300
300
Hexabrix®
320
OXILAN® Omnipaque™ Isovue®
300
300
300
Visipaque™
320
Ultravist®
300
Optiray®
300
Hexabrix®
320
Visipaque™
320
Compare the viscosity of OXILAN® 3501
Monomers
Dimers
Monomers
Dimers
12
30
11.8
26.6
25
10
10.4
20
15
20.4
20.9
16.3
cPs at 37° C
cPs at 20° C
9.4
22
15.7
10
9
8.1
7.5
6
4
2
5
0
8
10
350
350
Isovue®
370
Ultravist®
370
Hexabrix®
320
Visipaque™
320
0
350
350
Isovue®
370
Ultravist®
370
Optiray®
350
Hexabrix®
320
Visipaque™
320
• 39% less viscosity than Visipaque and 20% less viscosity than Omnipaque at 20°C
the visibility you need
(ioxilan) Injection
Compare and Contrast
Ox Brochure Inside Pages.indd 4
2/25/2009 5:08:54 PM
The whole picture
on safety
Renal Safety
The OXILAN® balance of low viscosity and
low osmolality may help reduce the risk of
renal complications*
• Low osmolar contrast media (CM) are as safe as
iso-osmolar for contrast-induced nephropathy (CIN),
as ICON and CARE studies have shown7
• Hydration plays a major role in at least limiting the
incidence of CIN8
• Osmolality is not a factor in decreasing
renal blood flow or glomerular filtration9*
• High viscosity CM can be responsible for
hypoperfusion of the inner medulla and cortex in
animal studies10*
• High viscosity can significantly reduce renal blood
flow from baseline10*
• Low osmolar dimeric CM may have a greater
potential for cytotoxic effects on proximal renal
tubular cells than monomeric CM11* (in vitro study)
Arrhythmia
OXILAN® contains sodium (9 mmol/L Na)
with a citrate buffer
• The addition of sodium to CM solutions has
been shown to reduce the risk of ventricular
fibrillation (VF) in animal studies12*
– OXILAN® produced a much lower incidence of VF
compared to other nonionic monomers studied
(ioversol12, iomeprol12, iopromide12, iohexol13)
Hemodynamics
In these studies vs iohexol, OXILAN®:
• significantly decreased platelet aggregation
and activation14 (clinical study, N=37)
• had less effect on the endothelium15* (animal study,
electron micrograph of aortic rings)
• had minimal effect on mean blood pressure
and heart rate16* (animal study)
• had no negative inotropic effect16* (animal study)
*The clinical significance of this data is not known.
Please see full Prescribing Information for complete disclosure of safety risks and warnings.
2/25/2009 5:08:46 PM
The whole picture
on the unique molecular structure
The molecular structure of OXILAN® provides
both patient comfort and the visibility you need
Hydrophilic Group
• Increases solubility which can contribute to
rapid renal clearance3
• Reduces binding with other molecular structures,
which may promote endothelial tolerance3
Hydrophobic Region
• Promotes “transient molecular aggregation”
of the molecules, reducing osmolality3
• Achieves lower osmolality at diagnostically
useful concentrations3
(ioxilan) Injection
2/25/2009 5:08:52 PM
The whole picture
on the OXILAN® balance
balanced with
The low viscosity
characteristic of
a monomer
The low osmolality
provided by the
hydrophobic region
of the molecule
Viscosity is determined
by the size of the molecules
in solution
Osmolality is determined
by the number of particles
in solution
OXILAN® has been used in more than 4.5 million patients since 19961
Indications
OXILAN® is available in 2 concentrations for the following indications:
Intra-arterial
OXILAN® (ioxilan) Injection (300 mgI/mL)
is indicated for cerebral arteriography
OXILAN® (ioxilan) Injection (300 mgI/mL) and
OXILAN® (ioxilan) Injection (350 mgI/mL) are indicated
for excretory urography and contrast enhanced computed
tomographic (CECT) imaging of the head and body
OXILAN® (ioxilan) Injection (350 mgI/mL) is indicated for
coronary arteriography and left ventriculography, visceral
angiography, aortography and peripheral arteriography
Intravenous
2/25/2009 5:08:53 PM
d
References:
1. Data on file. Guerbet LLC.
2. McIntosh CL, Reed R. Ioxilan injection: an overview
and results of aortofemoral arteriography study. Invest
Radiol. 1994;29 Suppl 2:S40-S42.
3. Sovak M. The need for improved contrast media.
Ioxilan: updating design theory. Invest Radiol.
1988;23 Suppl 1:S79-S83.
4. Roth R, Akin M, Deligonul U, et al. Influence of
radiographic contrast media viscosity to flow through
coronary angiographic catheters. Cathet Cardiovasc
Diag. 1991;22:290-294.
5. Dawson P, Clauss W. Contrast media in practice:
questions and answers. Springer-Verlag Berlin
Heidelberg. 1999.
6. Eloy R, Corot C, Belleville J. Contrast media for angiography: physicochemical properties,
pharmacokinetics and biocompatibility. Clin Mater.
1991;7:89-197.
7. O’Riordan M. No difference in the incidence of
contrast-induced nephropathy with iso-osmolar or
low-osmolar contrast agent. HeartWire>News.
25 October 2006.
<http://www.theheart.org/article/749937.do>.
8. Bettmann MA. Contrast agents and contrast-induced
nephropathy: are there differences between specific
agents? The J of Invas Cardiol. 2006;18 Suppl
A:13A-15A.
9. Persson PB, Hansell P, Liss P. Pathophysiology of
contrast medium-induced nephropathy. Kidney Intl.
2005;68:14-22.
10. Lancelot E, Idée JM, Couturier V, et al. Influence of the
viscosity of iodixanol on medullary and cortical blood
flow in the rat kidney: a potential cause of nephrotoxicity. J Appl Toxicol. 1999;19:341-346.
11. Heinrich MC, Kuhlmann MK, Grgic A, et al. Cytotoxic
effects of ionic high-osmolar, nonionic monomeric,
and nonionic iso-osmolar dimeric iodinated contrast media on renal tubular cell in vitro. Radiology.
2005;235:843-849.
12. Misumi K, Tateno O, Fujiki M, et al. The risk of contrast media-induced ventricular fibrillation is low in
canine coronary arteriography with ioxilan.
J Vet Med Sci. 2000;62(4):421-426.
13. Sakamoto H, Tabuchi T, Kamimura T, et al. The
effects of ioxilan, a new non-ionic contrast medium,
on the cardiovascular system. J Jap Coll Angiol.
1992;32(12).
14. Ogawa T, Fujii S, Urasawa K, et al. Effects of nonionic
contrast media on platelet aggregation.
Jpn Heart J. 2001;42:115-124.
15. Schneider KM, Ham KN, Friedhuber A, et al.
Functional and morphologic effects of ioxilan, iohexol,
and diatrizoate on endothelial cells. Invest Radiol.
1988;23 Suppl 1:S147-S149.
16. Nakamura H, Kurata M, Haruta K, et al. Effects of
ionic and nonionic contrast media on
cardiohemodynamics and quality of radiographic
image during canine angiography. J Vet Med Sci.
1994;56:91-96.
(ioxilan) Injection
References:
1. Data on file. Guerbet LLC.
2. McIntosh CL, Reed R. Ioxilan injection: an overview
and results of aortofemoral arteriography study. Invest
Radiol. 1994;29 Suppl 2:S40-S42.
3. Sovak M. The need for improved contrast media.
Ioxilan: updating design theory. Invest Radiol.
1988;23 Suppl 1:S79-S83.
4. Roth R, Akin M, Deligonul U, et al. Influence of
radiographic contrast media viscosity to flow through
coronary angiographic catheters. Cathet Cardiovasc
Diag. 1991;22:290-294.
5. Dawson P, Clauss W. Contrast media in practice:
questions and answers. Springer-Verlag Berlin
Heidelberg. 1999.
6. Eloy R, Corot C, Belleville J. Contrast media for
angiography: physicochemical properties,
pharmacokinetics and biocompatibility. Clin Mater.
1991;7:89-197.
7. O’Riordan M. No difference in the incidence of
contrast-induced nephropathy with iso-osmolar or
low-osmolar contrast agent. HeartWire>News.
25 October 2006.
<http://www.theheart.org/article/749937.do>.
8. Bettmann MA. Contrast agents and contrast-induced
nephropathy: are there differences between specific
agents? The J of Invas Cardiol. 2006;18 Suppl
A:13A-15A.
9. Persson PB, Hansell P, Liss P. Pathophysiology of
contrast medium-induced nephropathy. Kidney Intl.
2005;68:14-22.
10. Lancelot E, Idée JM, Couturier V, et al. Influence of the
viscosity of iodixanol on medullary and cortical blood
flow in the rat kidney: a potential cause of nephrotoxicity. J Appl Toxicol. 1999;19:341-346.
11. Heinrich MC, Kuhlmann MK, Grgic A, et al. Cytotoxic
effects of ionic high-osmolar, nonionic monomeric,
and nonionic iso-osmolar dimeric iodinated contrast media on renal tubular cell in vitro. Radiology.
2005;235:843-849.
12. Misumi K, Tateno O, Fujiki M, et al. The risk of contrast media-induced ventricular fibrillation is low in
canine coronary arteriography with ioxilan.
J Vet Med Sci. 2000;62(4):421-426.
13. Sakamoto H, Tabuchi T, Kamimura T, et al. The
effects of ioxilan, a new non-ionic contrast medium,
on the cardiovascular system. J Jap Coll Angiol.
1992;32(12).
14. Ogawa T, Fujii S, Urasawa K, et al. Effects of nonionic
contrast media on platelet aggregation.
Jpn Heart J. 2001;42:115-124.
15. Schneider KM, Ham KN, Friedhuber A, et al.
Functional and morphologic effects of ioxilan, iohexol,
and diatrizoate on endothelial cells. Invest Radiol.
1988;23 Suppl 1:S147-S149.
16. Nakamura H, Kurata M, Haruta K, et al. Effects of
ionic and nonionic contrast media on
cardiohemodynamics and quality of radiographic
image during canine angiography. J Vet Med Sci.
1994;56:91-96.
(ioxilan) Injection
For more information, please call 877.729.6679
or visit our Web site at www.guerbet-us.com
© 2008 Guerbet LLC
Oxilan is a registered trademark of Guerbet LLC.
Other brand names are trademarks or registered trademarks of their respective owners.
Please see accompanying
full Prescribing Information
Available in 300 and 350 mgI/mL latex-free bottles
Single Dose: 50 mL, 100 mL, 150 mL and 200 mL
Pharmacy Bulk Package: 500 mL
• Excellent hemodynamic profile
• Contains sodium citrate to reduce the
risk of ventricular fibrillation
• Unique molecular structure contributes
to patient comfort and rapid renal
clearance
• Lowest osmolality of all monomers
contributes to patient comfort
Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been
reported during angiographic procedures with
both ionic and nonionic contrast media. Therefore,
meticulous intravascular administration technique is
necessary, particularly during angiographic procedures, to minimize thromboembolic events.
Nonionic iodinated contrast media inhibit blood
coagulation, in vitro, less than ionic contrast
media. The use of plastic syringes in place of glass
syringes has been reported to decrease but not
eliminate the likelihood of in vitro clotting.
Serious adverse reactions have been reported
due to the inadvertent intrathecal administration
of iodinated contrast media that are not indicated
for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal
failure, cardiac arrest, seizures, rhabdomyolysis,
hyperthermia, and brain edema. Special attention
must be given to insure that this drug product is not
administered intrathecally.
NOT FOR INTRATHECAL USE
• Low viscosity for easy administration
All OXILAN® bottles are manufactured latex-free.1
OXILAN® looks like
the right choice
When you see the whole picture,
Product Information
OXILAN® (ioxilan) Injection Nonionic Contrast Agent
is a water-soluble, triiodinated contrast medium
administered by intravascular injection
to enhance radiographic visualization
and diagnosis.

Ox Brochure Inside Pages.indd

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