Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/926
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| rdf:type | |
| rdfs:label |
Indiclor (Solution)
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| dailymed-instance:dosage |
Please refer to the package insert for ProstaScint or Zevalin for
this information on the final drug product.
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| dailymed-instance:descripti... |
INDICLOR Indium In-111 Chloride is a diagnostic radiopharmaceutical intended for radiolabeling ProstaScint (capromab pendetide) used for in vivo diagnostic imaging procedures and for radiolabeling Zevalin (ibritumomab tiuxetan) in preparations used for radioimmunotherapy procedures. It is supplied asa sterile, pyrogen-free solution of Indium (In) Chloride in 0.04M HCl. Each milliliter is supplied at a radioactive concentration of 370 MBq, 10 mCi of Indium In-111 Chloride at time of calibration (no carrier added, with specific activity of>1.85 GBq/��g Indium,>50 mCi/��g Indium at time of calibration). The pH of the solution is about 1.4.<br/>RADIONUCLIDIC PURITY: A Cadmium Cd-112 enriched target is bombarded in a cyclotron
to produce Indium In-111 by the (p,2n) reaction. The bombardment conditions, the energy of the proton beam and the length of the bombardment are chosen to ensure an Indium In-111 yield of high radionuclidic purity. Radionuclidic purity is checked at release particularly for the presence of Indium
In-114. The relative proportion of this impurity increases, after release of the batch, as a result of its longer half-life. Because of its beta-emitting component and its potentially high organ dose contribution, Indium In-114m is particularly important if present above carefully controlled levels. Release specifications:<br/>RADIOCHEMICAL PURITY: Release specification: Not less than 95% Indium present as ionic
In.<br/>PHYSICAL CHARACTERISTICS: Indium In-111 decays by electron capture with a physical half-life
of 67.2 hours (2.8 days). The energies of the photons that are useful for detection and imaging studies are listed in Table 1.<br/>EXTERNAL RADIATION: The exposure rate constant for 37 MBq, 1 mCi Indium In-111 is
8.3��10C/kg/hr, 3.21 R/hr at 1 cm. The first half value thickness of lead (Pb) for Indium In-111 is 0.023 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.834 cm of lead will decrease the external radiation exposure by a factor of about 1,000. These estimates of attenuation do not take into consideration the presence of longer-lived contaminants with higher energy photons, namely Indium In-114m/114. To allow correction for physical decay of Indium In-111, the fractions that remain at selected intervals before and after the time of calibration are shown in Table 3.
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| dailymed-instance:clinicalP... |
Please refer to the package insert for ProstaScint or Zevalin for
this information on the final drug product.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Please refer to the package insert for ProstaScint or Zevalin for
this information on the final drug product.
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| dailymed-instance:supply |
INDICLOR Indium-111 Chloride is supplied in 1 mL vials containing 0.2 milliliters, 74 MBq, 2.0 mCi or 0.5 milliliters, 185 MBq, 5.0 mCi of Indium In-111 at calibration time. This packaging design has been carefully selected to minimize leaching of cationic and anionic impurities into the product during transport and storage.<br/>SPECIAL HANDLING AND STORAGE: Store at room temperature 15��-25��C (59��-77��F). This radiopharmaceutical is licensed by Illinois Department
of Nuclear Safety for distribution to persons licensed pursuant to 32 III. Adm. Code 330.260(a) and Part 335, Subpart E, 335.4010, or under equivalent licenses of an Agreement State or a Licensing State. It is recommended that the vial be kept inside its transportation shield whenever possible and that it be handled with forceps when doses are being removed. INS.1PA���Wednesday Calibration INS.1PAF���Saturday Calibration ProstaScintis a trademark of Cytogen Corporation. Zevalinis a trademark of IDEC Pharmaceutical Corporation.
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: Strict aseptic techniques should be used to maintain
sterility throughout the procedures for using this product. Do not use after the expiration time and date stated on the label. The contents of the vial are radioactive. Adequate shielding must
be maintained at all times.<br/>CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF
FERTILITY: Please refer to the package insert for ProstaScint or Zevalin for
this information on the final drug product.<br/>PREGNANCY CATEGORY: Please refer to the package insert for ProstaScint or Zevalin for
this information on the final drug product.<br/>NURSING MOTHERS: Please refer to the package insert for ProstaScint or Zevalin for
this information on the final drug product.<br/>PEDIATRIC USE: Please refer to the package insert for ProstaScint or Zevalin for
this information on the final drug product.<br/>GERIATRIC USE: Please refer to the package insert for ProstaScint or Zevalin for
this information on the final drug product.
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| dailymed-instance:genericMe... |
Indium Chloride In-111
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| dailymed-instance:fullName |
Indiclor (Solution)
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| dailymed-instance:adverseRe... |
Please refer to the package insert for ProstaScint or Zevalin for
this information on the final drug product.
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| dailymed-instance:warning |
The contents of the vial of INDICLOR Indium In-111 Chloride solution are intended only to be used as an ingredient for radiolabeling ProstaScint used for in vivo diagnostic imaging procedures and for radiolabeling Zevalin in preparations used for radioimmunotherapy procedures. Indiclor is not to be administered directly to humans.
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| dailymed-instance:indicatio... |
INDICLOR Indium In-111 Chloride is indicated for radiolabeling
of ProstaScint (capromab pendetide) in preparations used for in vivo diagnostic imaging procedures. Indiclor is also indicated for radiolabeling Zevalin (ibritumomab tiuxetan) in preparations used for radioimmunotherapy procedures. Please refer to the package insert for ProstaScint or Zevalin for information regarding the radiolabeled product.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Indiclor
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