About RUBY-FILL®
INDICATION (US): RUBY-FILL is a closed system used to produce rubidium (Rb82) chloride injection for intravenous use. Rubidium (Rb82) 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.

IMPORTANT SAFETY INFORMATION:
Warning: High Level Radiation Exposure with use of incorrect eluent and failure to follow quality control testing Procedure
Please see full prescribing information for complete boxed warning

High Level Radiation Exposure with Use of Incorrect Eluent
Using the incorrect eluent can cause high Strontium (Sr 82) and (Sr 85) breakthrough levels (5.1)

Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator (2.5)
Immediately stop the patient infusion and discontinue the use of the affected RUBY-Full® generator if the incorrect solution is used to elute the generator (4)
Evaluate the patient's radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow (2.9)
Excess Radiation Exposure with Failure to Follow the 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 specific limits (5.2)

Strictly adhere to the generator quality control testing procedure (2.6)
Stop using the generator if it reaches any of its Expiration Limit (2.7)


About Jubilant Pharma Limited
Jubilant Pharma Limited (JPL), a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Solid Dosage Formulations through five manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of around 3,500 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.


About Jubilant DraxImage Inc., dba Jubilant Radiopharma
Jubilant DraxImage Inc., dba Jubilant Radiopharma, a subsidiary of Jubilant Pharma Ltd., is an industry leader in the field of radiopharmaceuticals that is involved in the development, manufacturing and commercialization of radiopharmaceutical products through its Radiopharmaceuticals Division, as well as in the distribution of radiopharmaceuticals through its Radiopharmacies Division. Jubilant Radiopharma’s manufactured products are used in the diagnosis, treatment and monitoring of various diseases with specialization in lung, thyroid, bone and cardiac imaging products as well as in thyroid disease therapy. The Radiopharmacies Division is the second largest radiopharmacy network in the US with 46 pharmacies distributing nuclear medicine products to the largest national Group Purchasing Organisations (GPOs), regional health systems, stand-alone imaging centres, cardiologists and hospitals. This business has over 30 years of experience in serving the US nuclear medicine community and its current geographical reach enables it to serve over four million patients yearly. The Radiopharmacies Division complements the company’s niche radiopharmaceuticals business and provides it with direct access to hospital networks. Jubilant Radiopharma is focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of “Improving Lives Through Nuclear Medicine” on a global scale.

Back to HCB News

Cardiology Homepage