INDIUM IN 111 CHLORIDE solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
INDIUM CHLORIDE IN-111 (UNII: 58TD96H03I) (INDIUM CATION IN-111 - UNII:WJZ06C0H8L)
Available from:
Curium US LLC
INN (International Name):
INDIUM CHLORIDE IN-111
Composition:
INDIUM CATION IN-111 10 mCi in 1 mL
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint preparations used for in vivo diagnostic imaging procedures. It is also indicated for radiolabeling Zevalin preparations used for Radioimmunotherapy procedures. Please refer to the package insert for ProstaScint or Zevalin for information on the final drug product. Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug product.
Product summary:
Indium In 111 Chloride Sterile Solution is supplied in 10 mL vials containing 0.5 mL of solution. It is a sterile non-pyrogenic solution in 0.05 molar hydrochloric acid. No carrier is added to the solution. Each 0.5 mL contains 185 megabequerels (5 millicuries) of Indium In 111 Chloride at time of calibration. The pH of the solution is 1.1 to 1.4. Special Storage and Handling The contents of the vial are radioactive and adequate shielding and handling precautions must be maintained. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Storage and disposal of Indium In 111 Chloride Sterile Solution should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of the radionuclide. The vial should be kept inside its transportation shield whenever possible and should be handled with forceps when contents are being removed. Pharmacovigilance:1-866-789-2211 ProstaScint is a trademark of EUSA Pharma (USA), Inc. Zevalin is a trademark of RIT Oncology, LLC. Curium and the Curium logo are trademarks of a Curium company. ©2018 Curium US LLC. All Rights Reserved. Manufactured by: Curium US LLC Maryland Heights, MO 63043 Made in USA A132I0 R12/2018 CURIUMTM
Authorization status:
New Drug Application
Authorization number:
69945-132-06

INDIUM IN 111 CHLORIDE- indium in 111 chloride solution

Curium US LLC

----------

Indium In 111

Chloride Sterile Solution

Rx only

Diagnostic - For use only in radiolabeling ProstaScint™ (Capromab Pendetide).

Radioimmunotherapy - For use only in radiolabeling Zevalin™ (Ibritumomab Tiuxetan).

FOR SINGLE USE ONLY

DESCRIPTION

Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint™ preparations used

for in vivo diagnostic imaging procedures. It is also indicated for radiolabeling Zevalin™ preparations

used for Radioimmunotherapy procedures. It is supplied as a sterile, non-pyrogenic solution of Indium

In 111 Chloride in 0.05 molar hydrochloric acid. No carrier has been added to the solution. Each 0.5

milliliter of the solution contains 185 megabequerels (5 millicuries) of Indium In 111 Chloride at time

of calibration (specific activity of >1.85 GBq/μg Indium; >50 mCi/μg Indium at this time of calibration).

The solution pH is 1.1 to 1.4.

Radionuclidic Purity

Indium In-111 is cyclotron produced by the proton irradiation ((p,2n) reaction) of cadmium Cd-112

enriched target. At time of calibration, it contains not less than 99.925% indium In-111 and, not more than

0.075% indium In-114m and zinc Zn-65 combined. At the time of expiration, it contains not less than

99.85% indium 111 and not more than 0.15% indium In-114m and zinc Zn-65 combined. No carrier has

been added.

Radiochemical Purity

At the time of calibration, the Indium In 111 Chloride Sterile Solution contains not less than 95% of the

Indium present as ionic In

Chemical Purity

Indium In 111 Chloride Sterile Solution is tested for the following metallic impurities: copper, iron,

cadmium, lead, zinc, nickel, and mercury, and contains extremely low levels of these metals. The sum of

the individual impurity ratios for the metals listed is not more than 0.60 ppm.

Physical Characteristics

Indium In-111 decays by electron capture to cadmium Cd-111 (stable) with a physical half-life of 67.32

hours (2.81 days) (see Table 2) . Photons useful for detection and imaging are listed in Table 1.

Table 1. Principal Radiation Emission Data

Radiation Mean Percent Per Disintegration Mean Energy (keV)

Gamma-2

90.2

171.3

Gamma-3

94.0

245.4

*

Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-

11026, 115 (1981).

External Radiation

The exposure rate constant for 37 MBq (1 mCi) of indium In-111 is 8.3 x 10

C/kg/hr (3.21 R/hr) at 1

cm. The specific gamma ray constant for indium In-111 is 3.21 R/hr-mCi @ 1 cm . The first half-value

thickness of lead (Pb) is 0.023 cm. A range of values for the relative attenuation of the radiation emitted

by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For

example, the use of 0.834 cm of Pb will decrease the external radiation exposure by a factor of about

1000.

Table 2. Indium In-111 Radiation Attenuation by Lead

Shielding

Shield Thickness (Pb) cm

Coefficient of Attenuation

0.023

0.203

0.513

0.834

1.12

These estimates of attenuation do not take into consideration the presence of longer-lived contaminants

with higher energy photons, namely indium In-114m.

To correct for physical decay of indium In-111, the fractions that remain at selected intervals before and

after calibration time are shown in Table 3.

Table 3. Indium In-111 Physical Decay Chart; Half-Life

67.32 hours (2.81 days)

* Calibration time

Hours Fraction Remaining Hours Fraction Remaining

2.10

1.00

1.85

0.94

1.64

0.88

1.45

0.78

1.28

0.69

1.13

0.61

1.06

0.48

CLINICAL PHARMACOLOGY

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug

product.

INDICATIONS AND USAGE

From Radiopharmaceutical Internal Dosimetry Information Center, Oak Ridge Associated Universities, Oak

Ridge, TN 37831-0117, February 1985.

Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint preparations used for

in vivo diagnostic imaging procedures. It is also indicated for radiolabeling Zevalin preparations used

for Radioimmunotherapy procedures. Please refer to the package insert for ProstaScint or Zevalin for

information on the final drug product.

CONTRAINDICATIONS

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug

product.

WARNINGS

CONTENTS OF THE VIAL OF INDIUM In 111 CHLORIDE SOLUTION ARE INTENDED ONLY

TO BE USED AS AN INGREDIENT FOR RADIOLABELING PROSTASCINT FOR USE IN IN

VIVO DIAGNOSTIC IMAGING PROCEDURES OR TO BE USED AS AN INGREDIENT FOR

RADIOLABELING ZEVALIN™ FOR USE IN RADIOIMMUNOTHERAPY PROCEDURES, AND

ARE NOT TO BE ADMINISTERED DIRECTLY TO HUMANS.

PRECAUTIONS

General

Caution must be used to maintain proper aseptic technique while withdrawing and transferring

contents of the Indium Chloride solution vial.

Do not use after expiration time and date indicated on vial label.

Contents of the vial are radioactive and adequate shielding and handling precautions must be

maintained at all times.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug

product.

Pregnancy Category

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug

product.

Nursing Mothers

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug

product.

Pediatric Use

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug

product.

ADVERSE REACTIONS

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug

product.

DOSAGE AND ADMINISTRATION

Radiation Dosimetry

Please refer to the package insert for ProstaScint or Zevalin for this information on the final drug

product.

HOW SUPPLIED

Indium In 111 Chloride Sterile Solution is supplied in 10 mL vials containing 0.5 mL of solution. It is a

sterile non-pyrogenic solution in 0.05 molar hydrochloric acid. No carrier is added to the solution.

Each 0.5 mL contains 185 megabequerels (5 millicuries) of Indium In 111 Chloride at time of

calibration. The pH of the solution is 1.1 to 1.4.

Special Storage and Handling

The contents of the vial are radioactive and adequate shielding and handling precautions must be

maintained. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Storage and disposal of Indium In 111 Chloride Sterile Solution should be controlled in a manner that is

in compliance with the appropriate regulations of the government agency authorized to license the use

of the radionuclide.

The vial should be kept inside its transportation shield whenever possible and should be handled with

forceps when contents are being removed.

Pharmacovigilance:1-866-789-2211

ProstaScint is a trademark of EUSA Pharma (USA), Inc.

Zevalin is a trademark of RIT Oncology, LLC.

Curium and the Curium logo are trademarks of a Curium company.

©2018 Curium US LLC. All Rights Reserved.

Manufactured by:

Curium US LLC

Maryland Heights, MO 63043

Made in USA

A132I0

R12/2018

CURIUM

PRINCIPAL DISPLAY PANEL

Indium In 111 Chloride Sterile Solution

Sterile, Non-Pyrogenic Solution

Contains no Bacteriostatic Preservative

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F)

SINGLE DOSE - NOT FOR DIRECT ADMINISTRATION

NO CARRIER ADDED

FOR USE ONLY IN RADIOLABELING

ProstaScint™ (Capromab Pendetide),

and Zevalin™ (Ibritumomab Tiuxetan)

SEE PACKAGE INSERT FOR INFORMATION

Rx only

TM

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

A132C0

R12/2018

A132C0-CN0000-us122018 SPL

INDIUM IN 111 CHLORIDE

indium in 111 chloride solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 9 9 45-132

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

INDIUM CHLO RIDE IN-111 (UNII: 58 TD9 6 H0 3I) (INDIUM CATION IN-111 -

UNII:WJZ0 6 C0 H8 L)

INDIUM CATION IN-

10 mCi

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

TM

Curium US LLC

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 9 45-132-

1 in 1 CAN

12/0 7/20 0 7

1

0 .5 mL in 1 VIAL, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 19 8 41

12/0 7/20 0 7

Labeler -

Curium US LLC (079875617)

Revised: 12/2019

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