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 'Nephrogenic Systemic Fibrosis' 
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Result : Searchterm 'Nephrogenic Systemic Fibrosis' found in 1 term [] and 13 definitions []
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Searchterm 'Nephrogenic Systemic Fibrosis' was also found in the following services: 
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News  (8)  Forum  (1)  
 
Nephrogenic Systemic FibrosisForum -
related threads
 
(NSF) Nephrogenic systemic fibrosis is a rare and highly debilitating disorder that involves extensive thickening and hardening of the skin with fibrotic nodules and plaques.
MRI contrast media have very low side effects, but accumulating data indicate that gadolinium-based contrast agents increase the risk for the development of NSF among patients with severe renal insufficiency or renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period.
Due to this reason, gadolinium contrast agents are now considered contraindicated in patients with an estimated glomerular filtration rate fewer than 30 mL/min/1.73m2. In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI).

Recognized or possibly associated factors for NSF:
Severe renal failure;
high dose of gadolinium chelate;
high dose of erythropoietin;
high serum phosphate levels;
high serum calcium levels;
major surgery, infection, vascular event;
history of hypothyroidism;
metabolic acidosis.
When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the contrast medium from the body prior to any readminstration. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests.
See also Contrast Medium, Adverse Reaction, MRI Risks, MRI Safety, Ionic Intravenous Contrast Agents, Nonionic Intravenous Contrast Agents, and Contraindications.
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• For this and other aspects of MRI safety see our InfoSheet about MRI Safety.
• Patient-related information is collected in our MRI Patient Information.

 
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• View the NEWS results for 'Nephrogenic Systemic Fibrosis' (8).Open this link in a new window.
 
Further Reading:
  Basics:
Important Drug Warning for Gadolinium-Based Contrast Agents
Wednesday, 12 September 2007   by www.ismrm.org    
European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents
Friday, 20 November 2009   by www.ema.europa.eu    
Gadolinium-based MR Contrast Agents and Nephrogenic Systemic Fibrosis
Thursday, 1 March 2007   by radiology.rsna.org    
NSF-Active and NSF-Inert Species of Gadolinium: Mechanistic and Clinical Implications
Friday, 27 June 2008   by www.ajronline.org    
  News & More:
Questions and Answers on Gadolinium-Based Contrast Agents
Friday, 9 January 2009   by www.fda.gov    
MRI Safety Resources 
Pacemaker - Cochlear Implant - Shielding - Safety Products - Safety Training
 
ABLAVAR™InfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.
 
ABLAVAR™ (formerly named Vasovist™) is a blood pool agent for magnetic resonance angiography (MRA), which opens new medical imaging possibilities in the evaluation of aortoiliac occlusive disease (AIOD) in patients with suspected peripheral vascular disease.
ABLAVAR™ binds reversibly to blood albumin, providing imaging with high spatial resolution up to 1 hour after injection, due to its high relaxivity and to the long lasting increased signal intensity of blood.
As with other contrast media: the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered.
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
See also Cardiovascular Imaging, Adverse Reaction, Molecular Imaging, and MRI Safety.

Drug Information and Specification
NAME OF COMPOUND Diphenylcyclohexyl phosphodiester-Gd-DTPA, gadofosveset trisodium, MS-325
DEVELOPER EPIX Pharmaceuticals, Inc.
CENTRAL MOIETY Gd2+
CONTRAST EFFECT T1, predominantly positive enhancement
RELAXIVITY 20-45 mmol-1sec-1, Bo=0,47T
PHARMACOKINETIC Intravascular
OSMOLALITY 825 mOsmol/kg H2O
CONCENTRATION 244 mg/mL, 0.25mmol/mL
DOSAGE 0.12 mL/kg, 0.03 mmol/kg
PREPARATION ready to use
INDICATION Contrast enhanced magnetic resonance angiography
DEVELOPMENT STAGE FDA approved
DISTRIBUTOR See below
PRESENTATION 10 mL vials
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT

Distribution Information
TERRITORY TRADE NAME DEVELOPMENT
STAGE
DISTRIBUTOR
EU Vasovist™ Approved ?
USA, Canada, Australia ABLAVAR™ Approved Lantheus Medical Imaging, Inc.

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• View the DATABASE results for 'ABLAVAR™' (3).Open this link in a new window


• View the NEWS results for 'ABLAVAR™' (1).Open this link in a new window.
 
Further Reading:
  Basics:
Ablavar Prescribing Information
   by www.ablavar.com    
  News & More:
The first FDA-approved blood-pool MR agent offers additional time for imaging and possibly some new applications
Thursday, 1 July 2010   by www.radiologytoday.net    
MRI Resources 
Health - Hospitals - Contrast Agents - Spectroscopy pool - Breast MRI - MRI Technician and Technologist Schools
 
Dotarem®InfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
Dotarem® is a paramagnetic ionic MRI contrast agent. Extracellular contrast agents like Dotarem®, can be bolus injected because of the relatively low rate of side effects. This contrast medium is useable to enhance signal intensity in magnetic resonance imaging for intracranial and spinal lesions with an abnormal blood brain barrier or abnormal vascularity, and in whole body imaging.
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

Drug Information and Specification
NAME OF COMPOUND Gadoterate meglumine, Gd-DOTA
DEVELOPER Guerbet S.A.
CENTRAL MOIETY Gd2+
CONTRAST EFFECT T1, Predominantly positive enhancement
RELAXIVITY r1=3.4, r2=4.8, B0=1.0T
PHARMACOKINETIC Intravascular, extracellular, renal excretion
OSMOLALITY 1350 mosm/kgH2O
CONCENTRATION 0.5 mol/L
DOSAGE 0.1 mmol/kg / 0.2mL/kg
PREPARATION Finished product
INDICATION Neuro/whole body
DEVELOPMENT STAGE For sale
DISTRIBUTOR See below
PRESENTATION Vials of 5, 10, 15, 20mL
Pre-filled syringes of 15 and 20 mL
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT

Distribution Information
TERRITORY TRADE NAME DEVELOPMENT
STAGE
DISTRIBUTOR
EU Dotarem® for sale Guerbet S.A.
France, Switzerland Artirem® for sale Guerbet S.A.
Australia Dotarem® for sale

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• View the DATABASE results for 'Dotarem®' (7).Open this link in a new window

 
Further Reading:
  Basics:
Important Drug Warning for Gadolinium-Based Contrast Agents
Wednesday, 12 September 2007   by www.ismrm.org    
  News & More:
RSNA Statement on Gadolinium-Based MR Contrast Agents
Thursday, 1 February 2018   by www.rsna.org    
EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans
Friday, 21 July 2017   by www.ema.europa.eu    
Guerbet to Exhibit Recently U.S. Approved Imaging Agents at 100 Year Anniversary of RSNA
Thursday, 13 November 2014   by money.cnn.com    
Searchterm 'Nephrogenic Systemic Fibrosis' was also found in the following services: 
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News  (8)  Forum  (1)  
 
Gadovist®InfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
Gadovist® is an extracellular, neutral macrocyclic (gadolinium (Gd) complex) MRI contrast agents for central nervous system indications, particularly suited for studies in which high doses are required or advantageous. Gadovist® (also Gadograf) was available in two concentrations, currently only Gadovist® 1.0 is marketed.
The product was approved in Switzerland in 1999 and in Germany in 2000. Gadovist® 1.0 is in USA currently in the drug development and approval process, particularly for magnetic resonance angiography.
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
See also Paramagnetic Contrast Agents and Gadobutrol.

Drug Information and Specification
NAME OF COMPOUND Gadobutrol, Gd-BT-DO3A
DEVELOPER Bayer Schering Pharma AG
CENTRAL MOIETY Gd2+
CONTRAST EFFECT T1, Predominantly positive enhancement
RELAXIVITY r1=3.6, B0=1.0 T
PHARMACOKINETIC Intravascular, extracellular, renal excretion
OSMOLALITY 557 and 1603 mosm/kgH2O
CONCENTRATION 1 mol/L
DOSAGE 0.1mmol/kg
PREPARATION Finished product
INDICATION Central nervous system / whole body
DEVELOPMENT STAGE For sale / submit for approval
DISTRIBUTOR See below
PRESENTATION Vials of 15, 30 mL
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT

Distribution Information
TERRITORY TRADE NAME DEVELOPMENT
STAGE
DISTRIBUTOR
USA Gadovist® Submit for approval Bayer HealthCare Pharmaceuticals
Japan Gadovist® Phase III
EU Gadovist® for sale Bayer Schering Pharma AG
Australia Gadovist® for sale Bayer Schering Pharma AG

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• View the DATABASE results for 'Gadovist®' (5).Open this link in a new window

 
Further Reading:
  Basics:
Important Drug Warning for Gadolinium-Based Contrast Agents
Wednesday, 12 September 2007   by www.ismrm.org    
Gadograf, Gadovist
Friday, 13 April 2007   by www.ema.europa.eu    
  News & More:
EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans
Friday, 21 July 2017   by www.ema.europa.eu    
Bayer receives approval for Gadovist (gadobutrol) injection in Japan
Thursday, 26 March 2015   by press.healthcare.bayer.com    
FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
Tuesday, 19 December 2017   by www.fda.gov    
FDA approves Bayer's Gadavist® (gadobutrol) injection as the first magnetic resonance contrast agent for pediatric patients less than 2 years of age
Monday, 5 January 2015   by www.prnewswire.com    
New data presented at RSNA on use of Bayer's Gadavist® (gadobutrol) injection in children less than 2 years of age
Wednesday, 3 December 2014   by www.prnewswire.com    
MRI Resources 
MRI Physics - Jobs - RIS - MRI Training Courses - Stimulator pool - Liver Imaging
 
Magnevist®InfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
Magnevist® is a paramagnetic ionic contrast agent for use in magnetic resonance imaging. Contrast enhanced MRI with Magnevist® allows additional diagnostic information of tumors, inflammation and vascular lesions and the determination or differentiation of such lesions.
The contrast enhancing effect is produced by the di-N-methylglucamine salt of gadopentetate (Gd-DTPA), the gadolinium complex of diethylenetriamine pentaacetic acid. Magnevist® has the strongest effect on T1 weighted images, by increasing T1 signal intensity in tissues where Magnevist® has accumulated.
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
See also Ionic Intravenous Contrast Agents and Gadopentetate Dimeglumine.

Drug Information and Specification
NAME OF COMPOUND Gadopentetate dimeglumine, Gd-DTPA
DEVELOPER Bayer Schering Pharma AG, Germany
CENTRAL MOIETY Gd3+
CONTRAST EFFECT T1, Predominantly positive enhancement
RELAXIVITY r1=3.4, r2=3.8, B0=1.0T
PHARMACOKINETIC Intravascular, extracellular, renal excretion
OSMOLALITY 1960 mosm/kgH2O
CONCENTRATION 0.5 mol/L
DOSAGE 0.1-0.3 mmol/kg / 0.2-0.6 mL/kg
PREPARATION Finished product
INDICATION Neuro/whole body
DEVELOPMENT STAGE For sale
DISTRIBUTOR See below
PRESENTATION Vials of 5, 10, 15, 20 and 100 mL bulk package
Pre-filled syringes of 10, 15 and 20 mL
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT

Distribution Information
TERRITORY TRADE NAME DEVELOPMENT
STAGE
DISTRIBUTOR
USA, Canada Magnevist® for sale Bayer HealthCare Pharmaceuticals
Asia Magnevist® for sale Bayer Schering Pharma AG
EU Magnevist® for sale Bayer Schering Pharma AG
Turkey Magnevist®, Magnograf for sale Bayer Schering Pharma AG
Australia Magnevist® for sale Bayer Schering Pharma AG

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• View the DATABASE results for 'Magnevist®' (7).Open this link in a new window

 
Further Reading:
  Basics:
Magnevist Prescription Drug Discount Sources
   by www.institutedc.org    
Important Drug Warning for Gadolinium-Based Contrast Agents
Wednesday, 12 September 2007   by www.ismrm.org    
MAGNEVIST ® (brand of gadopentetate dimeglumine) Injection - WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
May 2009   by berlex.bayerhealthcare.com    
Magnevist Package Insert
2000
  News & More:
EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans
Friday, 21 July 2017   by www.ema.europa.eu    
Gadolinium-containing contrast agents: removal of Omniscan and iv Magnevist, restrictions to the use of other linear agents
Friday, 5 January 2018   by www.gov.uk    
FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
Tuesday, 19 December 2017   by www.fda.gov    
Spurious Hypocalcemia After Omniscan- or OptiMARK-Enhanced Magnetic Resonance Imaging: An Algorithm for Minimizing a False-Positive Laboratory Value
October 2004   by www.findarticles.com    
MRI Resources 
Implant and Prosthesis - Quality Advice - Spine MRI - Spectroscopy pool - Distributors - Non-English
 
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