OCTREOSCAN: Package Insert and Label Information (Page 3 of 3)

Assay

1. Assay the activity of Fraction 1 in a suitably calibrated ionization chamber. This fraction contains the hydrophilic impurities (e.g., unbound indium In-111).
2. Assay the activity of Fraction 2. This fraction contains the indium In 111 pentetreotide.
3. Assay the activity of the Sep-Pak cartridge. This component contains the remaining non-elutable impurities.
4. Dispose of all of the materials used in the preparation, the sample analysis, and the assay in a safe and approved manner.

Calculations

1. Percent Indium In 111 Pentetreotide =

   (Fraction 2 Activity / Total Activity) x 100%

   Where Total Activity = Fraction 1 + Fraction 2 + activity remaining in Sep-Pak

   Note: If this value is less than 90%, do not use the preparation. Discard it in a safe and approved manner.

2. Percent hydrophilic impurities =

   (Fraction 1 Activity / Total Activity) x 100%

3. Percent non-elutable impurities =

   (Activity remaining in Sep-Pak cartridge / Total Activity) x 100%

This radiopharmaceutical is licensed by the Illinois Department of Nuclear Safety for distribution to persons licensed pursuant to 330.260(a) for the radioactive material specified in 32 IL. Adm. Code 335.4010 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

Curium^TM and the Curium logo are trademarks of a Curium company.
©2022 Curium US LLC. All Rights Reserved.

Sep-Pak^TM is a trademark of Waters Technologies Corporation.

Manufactured by:
Curium US LLC
Maryland Heights, MO 63043

Made in USA

A050I0

Revised 2/2022 CURIUM™

PRINCIPAL DISPLAY PANEL — A050V0

Octreoscan^™ (Kit for the Preparation of Indium In 111 Pentetreotide Injection)

Reaction Vial
Sterile, non-pyrogenic. For intravenous administration after drug preparation. See package insert for directions for use.
Vial Contains:
10 mcg Pentetreotide
2 mg Gentisic Acid
4.9 mg Sodium Citrate, Anhydrous
0.37 mg Citric Acid, Anhydrous
10 mg Inositol
Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 3.8 and 4.3. Contents are sealed under nitrogen.

Store refrigerated at 2° to 8°C (36° to 46°F). Protect from light.

Use only with Indium In 111 Chloride Solution.

Rx only

Manufactured by:
Curium US LLC
Maryland Heights, MO 63043

Made in USA
CURIUM™
A050V0

R02/2022

LOT XXXXXXXX

EXP DDMMMYYYY

PRINCIPAL DISPLAY PANEL — A117C0

Indium In 111 Chloride Solution
Sterile, non-pyrogenic solution, contains no bacteriostatic preservative.
NOT FOR DIRECT ADMINISTRATION
For intravenous use after drug preparation. See package insert for directions for use.
Vial contains 1.1 mL of 111 MBq/mL (3 mCi/mL) aqueous indium In-111 chloride and 3.5 mcg/mL ferric chloride (1.2 mcg/mL ferric ion) in 0.02N hydrochloric acid.
Store at or below 25°C (77°F).
Rx only
WARNING: Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within heavier shield.
Manufactured by:
Curium US LLC
Maryland Heights, MO 63043

Made in USA
CURIUM™
CAUTION RADIOACTIVE MATERIAL
A117C0

R02/2022

Total Act. MBq

( mCi)

As of 1800 CT

Volume mL

EXP 1800 CT DD MMM YYYY

LOT XXXXXXXX

OCTREOSCAN indium in -111 pentetreotide kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69945-050

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69945-050-40 1 KIT in 1 BOX None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, GLASS 1 mL Part 2 1 VIAL, GLASS 1 mL

Part 1 of 2 OCTREOSCAN REACTION VIAL pentetreotide injection, powder, lyophilized, for solution

Product Information Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDIUM IN-111 PENTETREOTIDE (INDIUM IN-111 PENTETREOTIDE) PENTETREOTIDE 10 ug in 1 mL

Inactive Ingredients Ingredient Name Strength GENTISIC ACID ANHYDROUS TRISODIUM CITRATE ANHYDROUS CITRIC ACID INOSITOL SODIUM HYDROXIDE HYDROCHLORIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 1 mL in 1 VIAL, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020314 05/01/2007

Part 2 of 2 INDIUM IN-111 CHLORIDE indium in-111 chloride injection, solution

Product Information Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDIUM CHLORIDE IN-111 (INDIUM CATION IN-111) INDIUM CATION IN-111 3 mCi in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID FERRIC CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 1 mL in 1 VIAL, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020314 05/01/2007

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020314 10/14/2015

Labeler — Curium US LLC (079875617)

Revised: 02/2022 Curium US LLC