Tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate

FDA label, SHINE SPECT USA, LLC, intravenous, effective 2026-09-10. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

Kidneys 2.0 20.0 2.0

Kidneys 1.7 16.7 1.7

Dosing in liver impairment

Liver 0.6 5.8 0.6

Liver 0.4 4.2 0.4

Preparation and administration

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Your numbers for tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate. Take vial strength, diluent, and limits from the label below.

Basis

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Instructions For Preparation Preparation of the Technetium Tc99m Sestamibi from the Kit for the Preparation of Technetium Tc99m Sestamibi is done by the following aseptic procedure: General Procedure: a.Prior to adding the Sodium Pertechnetate Tc99m Injection to the vial, inspect the vial carefully for the presence of damage, particularly cracks, and do not use the vial if found.

Tear off a radiation symbol and attach it to the neck of the vial. b.Waterproof gloves should be worn during the preparation procedure. Remove the plastic disc from the vial and swab the top of the vial closure with alcohol to sanitize the surface. Boiling Water Bath Procedure: c.Place the vial in a suitable radiation shield with a fitted radiation cap. d.With a sterile shielded syringe, aseptically obtain additive-free, sterile, non-pyrogenic Sodium Pertechnetate Tc99m Injection [925 - 5550 MBq, (25 - 150 mCi)] in approximately 1 to 3 mL. e.Aseptically add the Sodium Pertechnetate Tc99m Injection to the vial in the lead shield.

Without withdrawing the needle, remove an equal volume of headspace to maintain atmospheric pressure within the vial. f.Shake vigorously, about 5 to 10 quick upward-downward motions. g.Remove the vial from the lead shield and place upright in an appropriately shielded and contained boiling water bath, such that the vial is suspended above the bottom of the bath, and boil for 10 minutes.

Timing for 10 minutes is begun as soon as the water begins to boil again. Do not allow the boiling water to come in contact with the aluminum crimp. h.Remove the vial from the water bath, place in the lead shield and allow to cool for fifteen minutes. Recon-o-Stat (thermal cycler) Procedure: c.Place the vial in the thermal cycler radiation shield. d.With a sterile shielded syringe, aseptically obtain additive-free, sterile, non-pyrogenic Sodium Pertechnetate Tc99m Injection [925 - 5550 MBq, (25 - 150 mCi)] in approximately 1 to 3 mL. e.Aseptically add the Sodium Pertechnetate Tc99m Injection to the vial in the lead shield.

Without withdrawing the needle, remove an equal volume of headspace to maintain atmospheric pressure within the vial . f.Shake vigorously, about 5 to 10 quick upward-downward motions. g.Place shield on sample block. While slightly pressing downward, give the shield a quarter turn to make certain there is a firm fit between the shield and the sample block. h.Press the proceed button to initiate the program (the thermal cycler automatically heats & cools the vial and contents).

Please see the Recon-o-Stat Instruction Manual for further details. General Procedure (cont.): i.Using proper shielding, the vial contents should be visually inspected. Use only if the solution is clear and free of particulate matter and discoloration. j.Assay the reaction vial using a suitable radioactivity calibration system.

Record the Technetium Tc99m concentration, total volume, assay time and date, expiration time and lot number on the vial shield label and affix the label to the shield. k.Store the reaction vial containing the Technetium Tc99m Sestamibi at 15° to 25°C (59-77°F) until use; at such time the product should be aseptically withdrawn.

Technetium Tc99m Sestamibi should be used within six hours of preparation. The vial contains no preservative. [See table below.]

Note:Adherence to the above product reconstitution instructions is recommended.
The potential for cracking and significant contamination exists whenever vials containing radioactive material are heated.
Product should be used within 6 hours after preparation.
Final product with radiochemical purity of at least 90% was used in the clinical trials that established safety and effectiveness. The radiochemical purity was determined by the following method.

Drug interactions

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Label text (1 paragraph)

7. DRUG INTERACTIONS Specific drug-drug interactions have not been studied. Specific drug-drug interactions have not been studied.

Contraindications

4. CONTRAINDICATIONS None known. None known.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Limited available data with Technetium Tc99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc99m Sestamibi. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

If considering Technetium Tc99m Sestamibi administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc99m Sestamibi and the gestational timing of exposure. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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