SODIUM IODIDE I-131 solution, concentrate

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

SODIUM IODIDE I-131 (UNII: 29VCO8ACHH) (IODIDE ION I-131 - UNII:4GC1FOQ22U)

Доступно од:

International Isotopes Inc

INN (Међународно име):

SODIUM IODIDE I-131

Састав:

IODIDE ION I-131 3500 mCi in 1 mL

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Sodium Iodide I-131 is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. Sodium Iodide I-131 is contraindicated in: - Patients with vomiting and diarrhea [see Warning and Precautions (5.7)] . - Pregnancy [see Warnings and Precautions (5.4), see Use in Specific Populations (8.1)] . - Lactation [see Warnings and Precautions (5.5)] . - Patients receiving concurrent anti-thyroid therapy [see Warning and Precautions (5.1) and Drug Interactions (7)] . Risk Summary Sodium Iodide I-131 is contraindicated in pregnancy because fetal exposure can lead to neonatal hypothyroidism, which in some cases is severe and irreversible. Data from the published literature describe thyroid abnormalities after fetal exposure; including agene

Резиме производа:

The Sodium Iodide I-131 Solution can be supplied in any of the following vials: 1, 2, 3 and 5 mL clear glass V-Vials and in 2 and 5 mL serum vials.The strength is specified by the customer from 18.5 to 129.5 GBq/mL (500 to 3500 mCi/mL) at time of calibration.   The Sodium Iodide I-131 should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of sodium iodide I 131 in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. Discard unused capsules after all sodium iodide I 131solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of Sodium Iodide I-131 Solution. This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Статус ауторизације:

unapproved drug other

Карактеристике производа

SODIUM IODIDE I-131- SODIUM IODIDE I-131 SOLUTION, CONCENTRATE
INTERNATIONAL ISOTOPES INC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM IODIDE I-131 SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR SODIUM IODIDE I-131.
SODIUM IODIDE I-131 (FOR THE PREPARATION OF SODIUM IODIDE I 131
CAPSULES AND SOLUTION), THERAPEUTIC, FOR ORAL
USE.
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Sodium Iodide I-131 is a radioactive therapeutic agent indicated for
the treatment of hyperthyroidism and selected cases
of carcinoma of the thyroid. (1)
DOSAGE AND ADMINISTRATION
The concentrated sodium iodide I 131 solution provided must be
diluted. ( 2.2)
See Full Prescribing Information for important administration
instructions and dilution and preparation instructions for
sodium iodide l 131 capsules or oral solution. ( 2.2, 2.4)
The recommended dose is based on the thyroid gland uptake as well as
the size of the gland:
Treatment of Hyperthyroidism: Recommended dosage is 148 to 370
megabecquerels (MBq) [4 to 10 millicuries (mCi).
( 2.3)
Treatment of Thyroid Carcinoma: Recommended dosage is 1,110 to 33,700
MBq (30 to 100 mCi). ( 2.3)
DOSAGE FORMS AND STRENGTHS
Vials: Sodium Iodide I-131 solution (with a radioconcentration ranging
between 18.5 - 129.5 GBq/mL (500 and 3500
mCi/mL) at the time of calibration) for the preparation of sodium
iodide I-131 capsules, therapeutic or sodium iodide I-131
solution, therapeutic. ( 3)
CONTRAINDICATIONS
Patients with vomiting and diarrhea. ( 4)
Pregnancy. ( 4)
Lactation. ( 4)
Patients receiving concurrent anti-thyroid therapy.
WARNINGS AND PRECAUTIONS
Radiation-induced thyroiditis may cause or worsen hyperthyroidism.
Consider pre-treatment with anti-thyroid
medications. ( 5.1)
Multiple non-thyroid radiation toxicities, including