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Rubidium Rb 82 (Ruby-Fill)

Trade Name : RUBY-FILL

Jubilant DraxImage Inc.

INJECTION, SOLUTION

Strength 100 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 Rb 82 (Ruby-Fill) which is also known as RUBY-FILL and Manufactured by Jubilant DraxImage Inc.. It is available in strength of 100 mCi/1 per ml. Read more

Rubidium Rb 82 (Ruby-Fill) 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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  • No data
  • High Level Radiation Exposure with Use of Incorrect Eluent
  • Patients are exposed to high radiation levels when the generator is eluted with the incorrect eluent due to high Sr 82 and Sr 85 breakthrough levels n
  • Arrayn- Excess Radiation Exposure with Failure to Follow Quality Control Testing Procedure
  • Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed specified limits n
  • High Level Radiation Exposure with Use of Incorrect Eluent
  • Using the incorrect eluent can cause high Strontium (Sr 82) and (Sr 85) breakthrough levels ()
  • RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
  • RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use. Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.u00a0n
  • Use RUBY-FILL with a specific Elution System. (n
  • u2022 Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator. ()u2022 The recommended weight-based dose of rubidium Rb 82 is between 10 to 30 Megabecquerels (MBq)/kg [0.27 to 0.81 millicuries (mCi)/kg]. ()u2022 Do not exceed a single dose of 2220 MBq (60 mCi) per rest or stress component of a procedure. (2.2)u2022 Administer the single dose at a rate of 15 to 30 mL/minute through a catheter inserted into a large peripheral vein; do not exceed an infusion volume of 60 mL. ()u2022 Use the lowest dose necessary to obtain adequate cardiac visualization and individualize the dose depending on multiple factors, including, patient weight, imaging equipment and acquisition type used to perform the procedure. ()u2022 Start imaging acquisition 60 to 90 seconds after completion of the infusion; if a longer circulation time is anticipated, wait for 120 seconds. Acquisition may be started immediately post-injection if dynamic imaging is needed. Image acquisition is typically 3 to 7 minutes long. ()u2022 To obtain rest and stress images, wait 10 minutes after completion of the rest image acquisition then administer the pharmacologic stress agent in accordance with its prescribing information. After administration of the pharmacologic stress agent, infuse the second dose of Rb 82, at the time interval according to the prescribing information of the pharmacological stress agent and complete the stress image acquisition. ()
  • RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use. RUBY-FILL consists of Sr 82 adsorbed on a hydrous stannic oxide column with an activity of 3145 to 4255 MBq (85 to 115 mCi) Sr 82 at calibration time.
  • RUBY-FILL consists of Sr 82 adsorbed on a hydrous stannic oxide column with an activity of 3145 to 4255 MBq (85 to 115 mCi) Sr 82 at calibration time. ()
  • RUBY-FILL is contraindicated for use if a solution other than additive-free 0.9% Sodium Chloride Injection USP has been used to elute the generator at any time. Immediately stop the patient infusion and permanently discontinue the use of the affected RUBY-FILL generator whenever the incorrect eluent is used [].n
  • RUBY-FILL is contraindicated if a solution other than additive-free 0.9% Sodium Chloride Injection USP has been used to elute the generator at any time.u00a0()
  • u2022Pharmacologic induction of cardiovascular stress: May be associated with serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Perform testing only in setting where cardiac resuscitation equipment and trained staff are readily available. ()
  • The following serious adverse reaction associated with the use of rubidium Rb 82 chloride was identified in clinical trials or post marketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Radiation Exposure
  • [see Boxed Warning, Warnings and Precautions ()]
  • [see Boxed Warning, Warnings and Precautions (), Dosage and Administration ()]
  • To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc., dba Jubilant Radiopharma at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • u2022 Lactation: Do not resume breastfeeding until at least one hour after completion of RUBY-FILL infusion. ()
  • No data
  • No data
  • No long-term studies have been performed to evaluate carcinogenic potential, mutagenicity potential, or to determine whether rubidium Rb 82 chloride injection may affect fertility in males or females.
  • In a descriptive, prospective, blinded image interpretation study of adult patients with known or suspected coronary artery disease, myocardial perfusion deficits in stress and rest PET images obtained with ammonia N 13 (n = 111) or Rb 82 (n = 82) were compared to changes in stenosis flow reserve (SFR) as determined by coronary angiography. PET perfusion defects at rest and stress for seven cardiac regions (anterior, apical, anteroseptal, posteroseptal, anterolateral, posterolateral, and inferior walls) were graded on a scale of 0 (normal) to 5 (severe). Values for stenosis flow reserve, defined as flow at maximum coronary vasodilatation relative to rest flow, ranged from 0 (total occlusion) to 5 (normal). With increasing impairment of flow reserve, the subjective PET defect severity increased. A PET defect score of 2 or higher was positively correlated with flow reserve impairmentu00a0(SFR < 3).
  • A systematic review of published literature was conducted using pre-defined inclusion/exclusion criteria which resulted in identification of 10 studies evaluating the use of Rb 82 PET myocardial perfusion imaging (MPI) for the identification of coronary artery disease as defined by catheter-based angiography. In these studies, the patient was the unit of analysis and 50% stenosis was the threshold for clinically significant coronary artery disease (CAD). Of these 10 studies, 9 studies were included in a meta-analysis for sensitivity (excluding one study with 100% sensitivity) and 7 studies were included in a meta-analysis of specificity (excluding 3 studies with 100% specificity). A random effects model yielded overall estimates of sensitivity and specificity of 92% (95% CI: 89% to 95%) and 81% (95% CI: 76% to 86%), respectively. The use of meta-analysis in establishing performance characteristics is limited, particularly by the possibility of publication bias (positive results being more likely to be published than negative results) which is difficult to detect especially when based on a limited number of small studies.
  • No data
  • No data
  • No data

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