Cardioite (Injection, Powder, Lyophilized, For Solution)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1109

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Cardioite (Injection, Powder, Lyophilized, For Solution)
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Each 5 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: Prior to lyophilization the pH is 5.3 to 5.9. The contents of the vial are lyophilized and stored under nitrogen. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The pH of the reconstituted product is 5.5 (5.0 - 6.0). No bacteriostatic preservative is present. The precise structure of the technetium complex is Tc99m[MIBI]where MIBI is 2-methoxy isobutyl isonitrile.
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CARDIOLITE, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of two (2) (NDC # 11994-001-52), five (5) (NDC # 11994-011-55), and twenty (20) (NDC # 11994-001-20), sterile and non-pyrogenic. Prior to lyophilization the pH is between 5.3-5.9. The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25��C before and after reconstitution. Technetium Tc99m Sestamibi contains no preservatives. Included in each two (2) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each twenty (20) vial kit is one (1) package insert, twenty four (24) vial shield labels and twenty four (24) radiation warning labels. This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.533 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.
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TETRAKIS(1-ISOCYANO-2-METHOXY-2-METHYL-PROPANE)-COPPER(I) TETRAFLUOROBORATE
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Cardioite (Injection, Powder, Lyophilized, For Solution)
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Cardioite