देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
EDOTREOTIDE GALLIUM GA-68 (UNII: Y68179SY2L) (EDOTREOTIDE GALLIUM GA-68 - UNII:Y68179SY2L)
UIHC – P E T Imaging Center
INTRAVENOUS
PRESCRIPTION DRUG
Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. None Risk Summary There are no available data on the use of Ga 68 DOTATOC Injection in pregnant women to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Ga 68 DOTATOC. However, all radiopharmaceuticals, including Ga 68 DOTATOC Injection have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Ga 68 DOTATOC Injection administration to a pregnant woman, inform the patient of the potential for adverse pregnancy outcomes based on the radiation dose from Ga 68 DOTATOC Injection and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregn
Ga 68 DOTATOC Injection is supplied in a multiple-dose, capped 30 mL glass vial containing 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68 DOTATOC at calibration time in approximately 14 mL of solution (NDC 24417-681-30). Store Ga 68 DOTATOC Injection upright in a lead shielded container at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Receipt, transfer, handling, possession or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate. Store and dispose of Ga 68 DOTATOC Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State.
New Drug Application
GA-68-DOTATOC- EDOTREOTIDE GALLIUM GA-68 INJECTION, SOLUTION UIHC – P E T IMAGING CENTER ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GA 68 DOTATOC INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GA 68 DOTATOC INJECTION. GA 68 DOTATOC INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2019 RECENT MAJOR CHANGES Warnings and Precautions (5.2) 12/2021 INDICATIONS AND USAGE Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. (1) DOSAGE AND ADMINISTRATION Recommended dose for adults is 148 MBq (4 mCi) as a bolus intravenous injection (2.2) Recommended dose for pediatric patients is 1.59 MBq/kg (0.043 mCi/kg) with a range of 11.1 MBq (0.3 mCi) to 111 MBq (3 mCi), as a bolus intravenous injection (2.2) Initiate imaging 55 to 90 minutes after drug administration (2.4) See full prescribing information for additional preparation, administration, imaging and radiation dosimetry information (2) DOSAGE FORMS AND STRENGTHS Injection: 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68 DOTATOC Injection in a multiple-dose glass vial (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Radiation Risk: Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure Advise patients to hydrate before and after administration and to void frequently after administration (2.1, 2.3, 5.1) Hypersensitivity Reactions: Most reported reactions were rash and pruritus and reversible either spontaneously or with routine symptomatic management. (5.2) Risk for Image Misinterpretation: Uptake of Ga 68 DOTATOC injection can be seen in a variety of tumor types that contain somatostatin receptors, and in other pathologic conditions, and as a normal physiologic variant (e.g. uncinate process of the pancre पूरा दस्तावेज़ पढ़ें