Creating and Validating Self-Efficacy Scales for ...

RADIOLOGIC ®

Journal of the American Society of Radiologic Technologists

Vol. 83, No. 1

September/October 2011

Creating and Validating Self-Efficacy Scales for Students Medical Imaging and Osteoarthritis of the Knee Digital Pelvic Radiography: Increasing Distance to Reduce Dose Contrast Media-Induced Compartment Syndrome Retrospective Analysis of CR Exposure Reporting

American Society of Radiologic Technologists

©2011 ASRT. All rights reserved.

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Win aSonography Trip to One of ASRT’s 2012 Events Radiology Quality Management Radiation Therapy Magnetic Resonance Computed Tomography Affiliates Military Advocacy Imaging Infomatics Education Dosimetry 2012 ASRT Educational SymposiumStudents • AnnualMammography Governance andMedical House of Delegates Meeting gas e V s LAS VEGAS • June 28-JulySonography 1, 2012 La Cardiovascular-interventional Management Registered Radiologist Assistant Nuclear Medicine Medical Dosimetry Cardiovascular-interventional Management Sonography Registered Radiologist Assistant Nuclear Medicine

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Computed Tomography

Gadavist

TM

(gadobutrol) injection

Strong signal. Strong bond.

Now approved in the United States

34-year-old female Diagnosis: Secondary progressive multiple sclerosis

9-year-old male Diagnosis: Chiasmatic glioma (WHO grade I)

High relaxivity*

Macrocyclic bond

BAYER and the Bayer Cross are registered trademarks of Bayer. Gadavist is a trademark of Bayer. © 2011, Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. All rights reserved. Printed in USA August 2011 325-10-0007-11

Indications and Usage GADAVIST is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Important Safety Information WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. • The risk for NSF appears highest among patients with: – Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or – Acute kidney injury. • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. • For patients at highest risk for NSF, do not exceed the recommended Gadavist dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions]. QThe possibility of serious or life-threatening hypersensitivity, anaphylactic or anaphylactoid reactions associated with cardiovascular, respiratory, or cutaneous manifestations, including death, should always be considered. QThe most frequent adverse reactions associated with Gadavist in clinical studies were headache, nausea, injection site reaction, dysgeusia and feeling hot. Please see brief summary on adjacent page.

For more information on GADAVIST, visit bayerimaging.com/GADAVIST today *Relaxivity of GADAVIST is 5.2 L·mmol-1 · s-1 at 1.5 Tesla (r1 in plasma at 37ºC)1 Reference: 1. GADAVIST [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; 2011.

Gadavist (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011 BRIEF SUMMARY oF pREScRIBInG InFoRMAtIon conSULt pAcKAGE InSERt FoR FULL pREScRIBInG InFoRMAtIon WARnInG: nEpHRoGEnIc SYStEMIc FIBRoSIS (nSF) Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. • The risk for NSF appears highest among patients with: • Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or • Acute kidney injury. • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. • For patients at highest risk for NSF, do not exceed the recommended Gadavist dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.1)]. 1 InDIcAtIonS AnD USAGE Gadavist is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system. 4 None

contRAInDIcAtIonS

5 WARnInGS AnD pREcAUtIonS 5.1 nephrogenic Systemic Fibrosis Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing. Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended Gadavist dose and allow a sufficient period of time for elimination of the drug prior to re-administration. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent’s elimination. The usefulness of hemodialysis in the prevention of NSF is unknown [see Clinical Pharmacology (12) and Dosage and Administration (2)]. 5.2 Hypersensitivity Reactions Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist administration [see Adverse Reactions (6)]. • Before Gadavist administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Gadavist. • Administer Gadavist only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation. Most hypersensitivity reactions to Gadavist have occurred within half an hour after administration. Delayed reactions can occur up to several days after administration. Observe patients for signs and symptoms of hypersensitivity reactions during and following Gadavist administration. 5.3 Extravasation and Injection Site Reactions Ensure catheter and venous patency before the injection of Gadavist. Extravasation into tissues during Gadavist administration may result in moderate irritation. Avoid intramuscular administration of Gadavist [see Nonclinical Toxicology (13.2)]. 6 ADVERSE REActIonS The most serious reactions to Gadavist are nephrogenic systemic fibrosis and hypersensitivity reactions [see Warnings and Precautions (5.1 and 5.2)]. 6.1 clinical trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect Gadavist exposure in 4549 subjects (4411 adults and 138 children aged 2–17) who received a dose that ranged from