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Rubidium Chloride Rb-82 (Cardiogen-82)

Trade Name : CardioGen-82

Bracco Diagnostics Inc

INJECTION, SOLUTION

Strength 150 mCi/1

RUBIDIUM CHLORIDE RB-82 Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Rubidium Chloride Rb-82 (Cardiogen-82) which is also known as CardioGen-82 and Manufactured by Bracco Diagnostics Inc. It is available in strength of 150 mCi/1 per ml. Read more

Rubidium Chloride Rb-82 (Cardiogen-82) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • WARNING: HIGH LEVEL RADIATION EXPOSUREnWITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW THE ELUATE TESTINGnPROTOCOLn n- Please see full prescribing informationnfor complete boxed warning
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  • CardioGen-82 is a closed system used to producenrubidium Rb 82 chloride injection for intravenous administration.nRubidium Rb 82 chloride injection is indicated for Positron EmissionnTomography (PET) imaging of the myocardium under rest or pharmacologicnstress conditions to evaluate regional myocardial perfusion in adultnpatients with suspected or existing coronary artery disease.
  • CardioGen-82 is a closed system used to producenrubidium Rb 82 chloride injection for intravenous use. Rubidium Rbn82 chloride injection is a radioactive diagnostic agent indicatednfor Positron Emission Tomography (PET) imaging of the myocardium undernrest or pharmacologic stress conditions to evaluate regional myocardialnperfusion in adult patients with suspected or existing coronary arteryndisease. n
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  • Use only additive free 0.9% Sodium Chloride Injection USPnto elute the generator n
  • Use CardioGen-82 with a specific infusion system. n
  • The recommended adult (70 kg) dose of rubidium Rb 82 chlorideninjection is 1480 MBq (40 mCi), with a range of 1110-2220 MBq (30-60nmCi) infused intravenously at a rate of 50 mL/minute, not to exceedna total volume of 100 mL. Do not exceed a single dose of 2220 MBqn(60 mCi). n
  • Start imaging acquisition 60-90 seconds after completionnof the infusion; if a longer circulation time is anticipated, waitnfor 120 seconds. Image acquisition is typically 5 minutes long. n
  • To obtain rest and stress images, wait 10 minutes afterncompletion of the rest image acquisition then administer the pharmacologicnstress agent in accordance with its prescribing information. Threenminutes after administration of the pharmacologic stress agent, infusenthe second dose of rubidium Rb 82 chloride and complete the stressnimage acquisition. n
  • CardioGen-82 is a closed system used to producenrubidium Rb 82 chloride injection for intravenous use. CardioGen-82nconsists of strontium Sr 82 adsorbed on a hydrous stannic oxide columnnwith an activity of 90-150 millicuries Sr 82 at calibration time.
  • CardioGen-82 consists of strontium Sr 82 adsorbednon a hydrous stannic oxide column with an activity of 90-150 millicuriesnSr 82 at calibration time. n
  • CardioGen-82 is contraindicatednif a solution other than additive free 0.9% Sodium Chloride InjectionnUSP has been used to elute the generator at any time. Immediatelynstop the patient infusion and permanently discontinue the use of thenaffected CardioGen-82 generator whenever the incorrect eluent is used n
  • CardioGen-82 is contraindicated if a solutionnother than additive free 0.9% Sodium Chloride Injection USP has beennused to elute the generator at any time. n
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  • Pharmacologic induction of cardiovascular stress: May causenserious adverse reactions such as myocardial infarction, arrhythmia,nhypotension, broncho-constriction, and cerebrovascular events. Performntesting only in setting where cardiac resuscitation equipment andntrained staff are readily available. n
  • Volume overload: Observe patients with congestive heartnfailure during infusion and for several hours following injection. n
  • The following serious adverse reactions havenbeen identified during postapproval use of CardioGen-82. Because thesenreactions are reported voluntarily from a population of uncertainnsize, it is not always possible to reliably estimate their frequencynor establish a causal relationship to drug exposure.
  • Radiation Exposure
  • [see Boxed Warning and Warnings and Precautions ]
  • Excess radiation exposure has occurred innsome patients who received rubidium Rb 82 chloride injections at clinicalnsites where generator eluate testing appeared insufficient .
  • p28
  • To report SUSPECTED ADVERSE REACTIONS, contactnBracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088nor n
  • (6)
  • Specific drug-drug interactions have not beennstudied.
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  • Lactation: Do not resume breastfeeding until one hour afternthe last infusion. n
  • Pediatric Use: Safety and effectiveness in pediatric patientsnhave not been established. n
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  • No long-term studies have been performed to evaluate carcinogenicnpotential, mutagenicity potential, or to determine whether rubidiumnRb 82 chloride injection may affect fertility in males or females.
  • In andescriptive, prospective, blinded image interpretation study of adult patients with known or suspected coronarynartery disease, myocardial perfusion deficits in stress and rest PETnimages obtained with ammonia N 13 (n = 111) or rubidium Rb 82 chloriden(n = 82) were compared to changes in stenosis flow reserve (SFR) asndetermined by coronary angiography. PET perfusion defects at restnand stress for seven cardiac regions (anterior, apical, anteroseptal,nposteroseptal, anterolateral, posterolateral, and inferior walls)nwere graded on a scale of 0 (normal) to 5 (severe). Values for stenosisnflow reserve, defined as flow at maximum coronary vasodilatation relativento rest flow, ranged from 0 (total occlusion) to 5 (normal). Withnincreasing impairment of flow reserve, the subjective PET defect severitynincreased. A PET defect score of 2 or higher was positively correlatednwith flow reserve impairment (SFR<3).
  • A systematic review of published literature was conducted using pre-definedninclusion/exclusion criteria which resulted in identification of 10nstudies evaluating the use of Rb 82 PET myocardial perfusion imagingn(MPI) for the identification of coronary artery disease as definednby catheter-based angiography. In these studies, the patient was thenunit of analysis and 50% stenosis was the threshold for clinicallynsignificant coronary artery disease (CAD). Of these 10 studies, 9nstudies were included in a meta-analysis for sensitivity (excludingnone study with 100% sensitivity) and 7 studies were included in anmeta-analysis of specificity (excluding 3 studies with 100% specificity).nA random effects model yielded overall estimates of sensitivity andnspecificity of 92% (95% CI: 89% to 95%) and 81% (95% CI: 76% to 86%),nrespectively. The use of meta-analysis in establishing performancencharacteristics is limited, particularly by the possibility of publicationnbias (positive results being more likely to be published than negativenresults) which is difficult to detect especially when based on a limitednnumber of small studies.
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  • Manufacturednfor Bracco Diagnostics Inc.Monroe Twp., NJ 08831By GE HealthcareMedi-Physics, Inc.,SouthnPlainfield, NJ 07080
  • US Patent 7,504,646
  • 43-8200G
  • CardioGen-82NDC: 0270u20130091u201301Rubidium Rb 82 Generator
  • CardioGen-82NDC: 0270u20130091u201301Rubidium Rb 82 Generator

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