药物信息为OctreoScan Kit for the Preparation of Indium In-111 Pentetreotide (Mallinckrodt Inc.): DESCRIPTION

OctreoScan^® is a kit for the preparation of Indium In-111 pentetreotide, a diagnostic radiopharmaceutical. It is a kit consisting of two components:

• A 10-mL OctreoScan^® Reaction Vial which contains a lyophilized mixture of:

  (i) 10 μg pentetreotide [N-(diethylenetriamine-N,N,N',N”-tetraacetic acid-N”-acetyl)-D-phenylalanyl-L-hemicystyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-L-hemicystyl-L-threoninol cyclic (2→7) disulfide], (also known as octreotide DTPA),(ii) 2.0 mg gentisic acid [2, 5-dihydroxybenzoic acid],(iii) 4.9 mg trisodium citrate, anhydrous,(iv) 0.37 mg citric acid, anhydrous, and(v) 10.0 mg inositol.

  Pentetreotide has the following structural formula:

  

  Prior to lyophilization, sodium hydroxide or hydrochloric acid may have been added for pH adjustment. The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present.

• A 10-mL vial of Indium In-111 Chloride Sterile Solution, which contains: 1.1 mL or 111 MBq/mL (3.0 mCi/mL) indium In-111 chloride in 0.02N HCl at time of calibration. The vial also contains ferric chloride at a concentration of 3.5 μg/mL (ferric ion, 1.2 μg/mL). The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present.

Indium In-111 pentetreotide is prepared by combining the two kit components (see INSTRUCTIONS FOR THE PREPARATION OF INDIUM In-111 PENTETREOTIDE). Indium In-111 reacts with the diethylenetriaminetetraacetic acid portion of the pentetreotide molecule to form indium In-111 pentetreotide. The pH of the resultant indium In-111 pentetreotide solution is between 3.8 and 4.3. No bacteriostatic preservative is present.

The indium In-111 pentetreotide solution is suitable for intravenous administration as is, or it may be diluted to a maximum volume of 3.0 mL with 0.9% Sodium Chloride Injection, U.S.P., immediately before intravenous administration. In either case, the labeling yield of indium In-111 pentetreotide should be determined before administration to the patient. A method recommended for determining the labeling yield is presented at the end of this package insert.