Iodopol/Sodium Iodide (I-131) – therapeutic capsules

About:

Sodium Iodide Na131I, Hard Capsule: 37 - 7.400 MBq

Marketing Authorization:

SmPC in: Denmark | Sweden | Norway | Finland

Specifications:

  • MI-4T

  • Radioiodide thyroid therapy is indicated in adults and children for:

    • Hyperthyroidism: treatment of Graves’ disease, toxic multinodular goitre or autonomous nodules

    • Treatment of large euthyroid (nontoxic) goitre

    • Reatment of papillary and follicular thyroid carcinoma, including metastatic disease.

    Sodium Iodide (131I) therapy is often combined with surgical intervention and with antithyroid medicinal products.

    • One capsule contains sodium iodide (Na131I)

    • 37 - 7.400 MBq at time of calibration.

  • 37 - 7.400 MBq on calibration day

    • Monday, Tuesday & Wednesday

    • 7 days after production

  • Hard capsule - Medium orange hard gelatin capsule, approximately 18 mm long, containing white powder.

  • Capsule contents:

    • Sodium carbonate

    • Sodium hydrogen carbonate

    • Sodium hydroxide

    • Disodium phosphate dihydrate

    • Sodium thiosulfate

     

    Gelatin capsule shell composition:

    • Quinoline yellow (E 104)

    • Erythrosine (E 127)

    • Titanium dioxide (E 171)

    • Gelatin

  • 21 days after production

  • ≥ 95%

  • ≥ 99,9%

    • The polypropylene vial placed in a shielding lead container, closed with a lead stopper which contains polypropylene insert with iodine absorber

    • The package contains a single capsule

    • Each package is accompanied by a separate polypropylene applicator for capsule administration

  • In the original package, below 25° C