Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
INDIUM CHLORIDE IN-111 (UNII: 58TD96H03I) (INDIUM CATION IN-111 - UNII:WJZ06C0H8L)
Curium US LLC
INDIUM CHLORIDE IN-111
INDIUM CATION IN-111 10 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.
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
New Drug Application
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 Soma hati kamili