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Sodium Iodide I 131 (Hicon)

Trade Name : HICON

Jubilant DraxImage Inc.

SOLUTION

Strength 1 mCi/mL

SODIUM IODIDE I-131 Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sodium Iodide I 131 (Hicon) which is also known as HICON and Manufactured by Jubilant DraxImage Inc.. It is available in strength of 1 mCi/mL per ml. Read more

Sodium Iodide I 131 (Hicon) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • HICON is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma.
  • HICON is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
  • No data
  • The concentrated sodium iodide I 131 solution USP provided with HICONu00ae must be diluted. ()
  • See Full Prescribing Information for important administration instructions and dilution and preparation instructions for sodium iodide l 131 tablets or oral solution. (,)
  • The recommended dose is based on the thyroid gland uptake as well as the size of the gland:n n n
  • HICON is available in 1 mL size, clear vials containing a colorless, aqueous, concentrated Sodium Iodide I 131 Solution [9,250 MBq, 18,500 MBq, and 37,000 MBq at time of calibration] for the preparation of sodium iodide I 131 capsules, therapeutic or sodium iodide I 131 solution, therapeutic. Refer to Table 2 for the radioactivity and volume in each vial. Large gelatin capsules (empty) and small gelatin capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous as the absorbing buffer are supplied along with HICON for the preparation of sodium iodide I 131 capsules, therapeutic.
  • Vials: Sodium Iodide I 131 Solution (9,250 MBq, 18,500 MBq, and 37,000 MBq at time of calibration) for the preparation of sodium iodide I 131 capsules, therapeutic or sodium iodide I 131 solution, therapeutic.
  • HICON is contraindicated in:
  • Patients with vomiting and diarrhea. ()Pregnancy. ()Lactation. ()Patients receiving concurrent anti-thyroid therapy.
  • No data
  • Radiation-induced thyroiditis may cause or worsen hyperthyroidism. Consider pre-treatment with anti-thyroid medications. ()
  • Multiple non-thyroid radiation toxicities, including hematopoietic suppression: Individualize dose and monitor for toxicity. ()
  • Fetal toxicity: May cause severe and irreversible hypothyroidism in the neonate. Verify absence of pregnancy before administering the product. (, , )
  • Radiation exposure to breast tissue with lactation: Sodium iodide I 131 concentrates in the breast of lactating women. Discontinue lactation 6 weeks prior to therapy. (,)
  • The following serious adverse reactions are described below and elsewhere in labeling:
  • The following adverse reactions have been identified during post-approval use of sodium iodide I 131. Because these reactions are voluntarily reported by from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • * In patients with iodide-avid brain metastases** In patients with iodide-avid lung metastases
  • Common adverse reactions reported with therapeutic doses of sodium iodide I 131 include local swelling, radiation sickness, sialadenitis, salivary gland dysfunction, bone marrow depression, lacrimal gland dysfunction, hypothyroidism, hyperthyroidism, thyrotoxic crisis, acute leukemia, solid cancer.
  • Many drugs and iodine-containing foods interfere with the accumulation of radioiodide by the thyroid. Instruct patients to maintain a low-iodide diet (2 weeks) and discontinue anti-thyroid therapy (3 days) before administration. (, )
  • No data
  • Females and Males of Reproductive Potential: May impair fertility in females and males. (, )
  • Geriatric Use: Dose selection may be necessary for geriatric patients due to possible decreased renal function. ()
  • Renal Impairment: May increase radiation exposure. (, )
  • In case of exposure to a radioactive dose of sodium iodide I 131 exceeding the intended therapeutic dose, provide general supportive care, promote frequent voiding, monitor for bone marrow and thyroid suppression. Consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate) promptly within 4 to 6 hours after the exposure. Assess the benefit of administering a thyroid blocking agent against the risk of failure of sodium iodide I 131 therapy. Appropriate replacement therapy is recommended if hypothyroidism occurs.
  • HICON, a radioactive therapeutic agent, provides a concentrated solution of sodium iodide I 131 with a radioconcentration of 37,000 MBq/mL (1,000 mCi/mL). Each mL of the concentrated solution contains 37,000 MBq of no-carrier-added sodium iodide I 131, disodium edetate dihydrate USP as a stabilizer, sodium thiosulfate pentahydrate USP as a reducing agent, and dibasic sodium phosphate anhydrous USP. The pH of the concentrated solution is between 7.5 and 10.n The concentrated solution provided with HICON is used for the preparation of sodium iodide I 131 capsules or sodium iodide I 131 solution of varying strengths for oral administration for therapy.
  • Sodium iodide I 131 solution is designated chemically as Na 131I and has a molecular weight of 153.99. Hard gelatin capsules, provided for the preparation of the sodium iodide I 131 capsules final dosage form, contain approximately 300 mg of dibasic sodium phosphate anhydrous USP as the absorbing buffer.
  • No data
  • No data
  • Radiation Safety Precautionsn- [see ]
  • Fetal Toxicityn- [see , and n ].
  • Lactationn- [see , and ].
  • Effects on Fertilityn- [see and ].
  • Manufactured by:Jubilant DraxImage Inc., Kirkland, Quu00e9bec Canada, H9H 4J4
  • Art rev.: 1.0
  • No data

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