I-131 capsule and solution for diagnosis and therapy

I-131 hard capsules for diagnosis and therapy

  • Product name
    Product code
    ATC code
    Marketing Auth. No.
    Pharmaceutical Form and Description
    Activity per capsule
    Radionuclidic purity
    Radiochemical purity
    Expiry time
    Indications and Phosology
    Storage
    Packaging
  • ThyroTop D 0.5-37 MBq hard capsule complies with the European Pharmacopoeia 0938 monograph
    I-RA-7/D
    V09F
    OGYI-T-9681/05
    Hard capsule, size “0”, colourless, transparent, CONI-SNAP type gelatine capsule, containing I-131 labelled sodium iodide, for oral administration.
    0.5-37 MBq
    131I ≥ 99.9 %
    ≥ 95 %
    21 days from the manufacturing date
    Thyroid diagnostics
    • 0.2-0.5 MBq capsule for radioiodine uptake of thyroid in case no accurate dosimetry is needed.
    • 2-4 MBq capsule can be used for calculation of personalised dose for the radionuclide therapy and thyroid scintigraphy for the establishment of the size of the hyperfunctioning tissue in thyroid nodules.
    • For whole body radioiodine scintigraphy in differentiated thyroid cancer 37-185 MBq (usually 74-111 MBq) I-131 is needed. 2-3 capsules should be administered per os.
    Do not store above 25 ºC. Store in the original packaging. Comply with the regulations for radiation safety.
    1-10 capsules in type I injection vial, closed with brombutyl stopper and green aluminium cap in lead container with paper insert.
  • I-131-sodium-iodide ThyroTop 38-7400 MBq hard capsules complies with the European Pharmacopoeia 2116 monograph
    I-RA-7/K
    V10XA01
    OGYI-T-9681/01
    Hard capsule, size “0”, colourless, transparent, CONI-SNAP type gelatine capsule, containing I-131 labelled sodium iodide, for oral administration.
    38-7400 MBq
    131I ≥ 99.9 %
    ≥ 95 %
    21 days from the manufacturing date
    Radionuclide therapy Treatment of hyperthyreosis
    • Graves disease.
    • Hyperfunctioning adenoma.
    • Non immunogenic diffuse goiter.
    Treatment of thyroid carcinoma
    • Ablation of residual thyroid tissues following thyroid cancer surgery and treatment of recidivations and metastases.
    • Required amount of activity is administered per os in one or max. 2 capsules
    Do not store above 25 ºC. Store in the original packaging. Comply with the regulations for radiation safety.
    1 capsule in a plastic insert with screwed cap placed into a lead container with wall thickness of 15-38 mm.

I-131 sodium iodide solutions, drug substances supported with Active Substance Master File

  • Product name

    Product code

    Description

    Volume

    Radioactive concentration

    Radionuclidic purity

    Radiochemical purity

    pH

    Expiry time

    Other information

    Storage

    Packaging

  • I-131 sodium iodide sterile solution, drug substance according to European Pharmacopoeia 0281
    monograph

    I-RA-7

    Clear, colourless and sterile solution of 131I sodium iodide containing iodine-131 in the form of
    sodium idoide in Na2CO3/NaHCO3/NaOH buffer and 0.5-2 mg/ml sodium thiosulphate solution, reducing
    agent diluted accoring to the cusomer specified active concentration. Bacterial endotoxins <100
    IU/ml.

    Non-carrier added

    0.2 – 10.0 ml

    0.1 – 55.5 GBq/ml

    131I ≥ 99.9 %

    ≥ 95 %

    7 – 10

    21 days from manufacturing date

    Active pharmaceutical ingredient for manufacture of radiopharmaceuticals by dilution with water or by
    for capsule preparation.

    For oral administration.

    Store at room temperature in its own container, in accordance with the regulations on radioactive
    materials.

    In type I injection vial (6R or 10 R), closed with brombutyl stopper and green aluminium cap in lead
    container with paper insert (Type A packaging).

    Pack size: ≤ 29.6 GBq (at the indicated calibration date)/vial

  • I-131 sodium iodide non-sterile solution, drug substance for radiolabelling according to European
    Pharmacopoeia 02121 monograph

    I-RA-5

    Clear, colourless and non-sterile solution of 131I sodium iodide containing iodine-131 in the form of
    sodium iodide in Na2CO3/NaHCO3/NaOH buffer diluted with 0.0001M NaOH according to the customer
    specified active concentration.

    Non-carrier added. No reducing agents added.

    0.2 – 10.0 ml

    ≥ 0.1-55.5 GBq/ml

    131I ≥ 99.9 %

    ≥ 95 %

    8 – 11

    21 days from manufacturing date

    Active ingredient for manufacture of radiopharmaceuticals by dilution – e.g. with water or buffer for
    labelling purposes or capsule preparation, for oral administration.

    Store at room temperature in its own container, in accordance with the regulations on radioactive
    materials.

    In type I injection vial (6R or 10 R), closed with brombutyl stopper and green aluminium cap in lead
    container with paper insert (Type A packaging).

    Pack size: ≤ 111 GBq (at the indicated calibration date)/vial

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