Canada SPECT products | Cardiology

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection

Deze informatie is uitsluitend bestemd voor Canadese medische professionals.

PRODUCTINFORMATIE

Curium Tc 99m Sestamibi—a choice for nuclear medicine professionals that provides imaging quality and economic value in a single product offering.

Equivalence
Tc 99m Sestamibi is fully substitutable for the brand name product.

Trust
Curium is an experienced manufacturer of generic pharmaceuticals with a strong history in the radiopharmaceutical industry.

Confidence
Tc 99m Sestamibi delivers a high degree of diagnostic accuracy.1

Value
Curium seeks to provide value to nuclear medicine professionals.

Aanwijzingen en gebruik

Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease.2

Warnings and precautions

  • The contents of the vial are intended only for use in the preparation of Technetium Tc 99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.
  • Radioactive drugs must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel and patients.
  • Contents of the kit before preparation are not radioactive. However, after the Sodium Pertechnetate Tc 99m Injection is added, adequate shielding of the final preparation must be maintained.
  • It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation.
  • Technetium Tc 99m labeling reactions depend on maintaining the stannous ion in the reduced state. Hence, Sodium Pertechnetate Tc 99m Injection containing oxidants should not be used.
  • Technetium Tc 99m Sestamibi should not be used more than six hours after preparation.
  • Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
  • Stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus.

Adverse reactions

  • The following adverse reactions have been reported in ≤ 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis; angioedema, arrhythmia, and severe hypersensitivity characterized by dyspnea.

Use in specific populations

  • Safety and effectiveness in the pediatric population have not been established.

Frequently asked questions

The reconstituted vial should be used within six (6) hours of preparation.

150 mCi (volume 1 to 3 mL), see Prescribing Information for additional details.

Technetium Tc 99m Sestamibi can be ordered through Canada Customer Service at 866.885.5988.  Orders are accepted Monday-Friday, 8:00 am through 5:00 pm. EST.

All order changes or cancellations are handled through the Canada Customer Service team at 866.885.5988. Please call a Customer Service Representative for specific information regarding ordering and cancellation of orders.  Order cut off times and cancellation times vary by product.

Call Curium Pharmacovigilance / Product Monitoring Department at 866.789.2211

How is this product supplied

Distribution

Direct

Expiration

Kit: 24 months post manufacture
Reconstituted vial: 6 hours from time of preparation

Storage conditions

Kit: Controlled room temperature 15° to 25°C (59° to 77°F); protect from light
Reconstituted vial: Controlled room temperature 15° to 25°C (59° to 77°F)

Order information

Description Qty Unit Size Order # NDC
Tc 99m Sestamibi kit, 5 vial 1 Kit 5 vial 092BCA 69945-092-20

References

Klocke FJ, Baird MG, Bateman TM, et al. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2003:10-11. 2Kit for the Preparation of Technetium Tc 99m Sestamibi Injection package insert. Curium Canada Inc. Laval, QC, H7T-2R3 CANADA; 2019.

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