INDIUM IN 111 CHLORIDE solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

INDIUM CHLORIDE IN-111 (UNII: 58TD96H03I) (INDIUM CATION IN-111 - UNII:WJZ06C0H8L)

Beszerezhető a:

Curium US LLC

INN (nemzetközi neve):

INDIUM CHLORIDE IN-111

Összetétel:

INDIUM CATION IN-111 10 mCi in 1 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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.

Termék összefoglaló:

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

Engedélyezési státusz:

New Drug Application

Termékjellemzők

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_) . Photon