Prohance Multipack (Gadoteridol) - Summary

SUMMARY

ProHance® Multipack™
(Gadoteridol) Injection, 279.3 mg/mL
Pharmacy Bulk Package - Not for Direct Infusion

ProHance (Gadoteridol) Injection is a nonionic contrast medium for magnetic resonance imaging (MRI), available as a 0.5M sterile clear colorless to slightly yellow aqueous solution for intravenous injection. Each vial is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device.

Central Nervous System

ProHance (Gadoteridol) Injection is indicated for use in MRI in adults and children over 2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.

Extracranial/Extraspinal Tissues

ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.

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NEWS HIGHLIGHTS

Media Articles Related to Prohance Multipack (Gadoteridol)

The Diagnostic Clinic Introduces A Vaccination Alternative To The Flu Jab
Source: Flu / Cold / SARS News From Medical News Today [2009.11.12]
The Diagnostic Clinic in London's New Cavendish Street, the UK's premier centre for Integrated Medicine, offers a vaccination alternative for private and corporate patients not wishing to have the Flu or Swine Flu jab. Many people have concerns regarding vaccinations. Whether this is as simple as needle phobia or concerns over the safety of vaccinations, an alternative can be considered.

Phadia Introduces New Food Allergy Diagnostic Tools To Meet The Needs Of Allergists
Source: Allergy News From Medical News Today [2009.11.10]
Today at the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology, Phadia US introduced two new products designed specifically to meet the unique needs of the nation's 6,000 allergists. ImmunoCAP ISAC and ImmunoCAP HR are new offerings designed to augment traditional allergy testing methodologies and enable diagnosis of complex food allergies at the molecular level, available through its own PiRL testing facility.

New Diagnostic Method For Gout: Dual Energy Computed Tomography Instead Of Joint Aspiration
Source: Gout News From Medical News Today [2009.06.05]
The most reliable method of diagnosing gout is to aspirate the joint in order to obtain fluid to verify the presence of monosodiumurate crystals (uric acid). Up to now, computed tomography (CT) has played a limited role in the evaluation of gout, since conventional CT systems cannot reliably verify deposits of uric acid.

Utility Of Circulating DNA As Novel Diagnostics For Human Cancer, Mad Cow Disease And Other Conditions
Source: CJD / vCJD / Mad Cow Disease News From Medical News Today [2009.03.12]
Chronix Biomedical - developing and applying proprietary techniques to detect and analyze circulating nucleic acid sequences for the diagnosis and management of disease - reported that three recent studies published in peer-reviewed journals have further confirmed the potential diagnostic and prognostic utility of fragments of DNA and RNA that circulate in the blood, known as circulating nucleic acids (CNAs).

Diagnostic Approved to Detect
Source: MedicineNet Clostridium Difficile Colitis Specialty [2009.01.14]
Title: Diagnostic Approved to Detect
Category: Health News
Created: 1/14/2009 2:00:00 AM
Last Editorial Review: 1/14/2009

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Published Studies Related to Prohance Multipack (Gadoteridol)

Risk for nephrogenic systemic fibrosis with gadoteridol (ProHance) in patients who are on long-term hemodialysis. [2008.05]
BACKGROUND AND OBJECTIVES: Recent studies strongly link nephrogenic systemic fibrosis to gadolinium administration for magnetic resonance imaging. In a recent advisory, the Food and Drug Administration stated that all gadolinium-containing chelates are potentially associated with nephrogenic systemic fibrosis; however, most reported cases are linked to gadodiamide (Omniscan) and gadopentetate dimeglumine (Magnevist). Given the severe consequences of nephrogenic systemic fibrosis, it is critical to define the risks associated with each gadolinium-containing chelate. The purpose of this study was to examine nephrogenic systemic fibrosis risk in a hemodialysis population exposed to gadoteridol (ProHance)... CONCLUSIONS: It is concluded that the risk for nephrogenic systemic fibrosis with gadoteridol in patients who are on long-term hemodialysis may be lower than with gadodiamide and gadopentetate dimeglumine.

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Clinical Trials Related to Prohance Multipack (Gadoteridol)

SH L 562BB Phase II/III Dose Justification and Gadoteridol-Controlled Comparative Study [Recruiting]
This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.

Safety and Efficacy of Gadobutrol 1.0 Molar (Gadovist®) in Patients for Central Nervous System (CNS) Imaging [Recruiting]
This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadovist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.

Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease [Recruiting]
The objective of this long term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1- patients with moderate chronic kidney disease eGFR 30-59 and Cohort 2- patients with severe chronic kidney disease or kidney failure eGFR <30).

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