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 MIBG 20 MBq/ml injection for diagnostic use

  • Product code

    Pharmaceutical form and description

    Activity per vial

    Specific activity

    Radioactive concentration

    Radionuclid impurities

    Radiochemical purity

    pH

    Expiry date

    Indications and posology

    Recommended dose

    Storage

    Packaging

  • I-RAO-1

    Radioactive sterile injection solution.
    The active ingredient of the radioactive solution for
    injection for intravenous use is I-131 radioisotope labelled meta-iodobenzyl-guanidine (MIBG).

    20 MBq, 40 MBq, or 80 MBq at activity reference date and time

    ≥ 26.7 GBq/g MIBG at activity reference date and time

    20 MBq/ml at activity reference date and time

    ≤ 0.1%

    ≥ 95%

    5–7

    5 days from manufacturing date

    Indication field: radioisotope diagnostics
    Localisation and imaging of neuroendocrine tumours, especially:phaeochromocytomaneuroblastoma

    The recommended individual patient dose is 20–40 MBq I-131-MIBG

    To prevent the uptake of the free radioiodine evolving in vivo, thyroid blockade is recommended
    before the examination. The injection should be administered slowly; time of administration is 2-4
    minutes.

    Rapid administration of MIBG can result in blood pressure increase, allergic symptoms, flush or
    asthmatic spasms.

    Store in refrigerator at 2–8°C. Comply with the regulations for radiation safety.

    In type I injection vial (6R) closed with brombutyl stopper and green aluminium cap in lead container
    with paper insert.

    Transported in a Type A package

I-131 MIBG 370 MBq/ml injection for therapy

  • Product code

    Pharmaceutical form and description

    Activity per vial

    Specific activity

    Radioactive concentration

    Radionuclid impurities

    Radiochemical purity

    pH

    Expiry date

    Indications and posology

    Recommended dose

    Storage

    Packaging

  • I-RAO-2

    Radioactive sterile solution for injection.

    For intravenous use. The active ingredient of the radioactive solution for injection for intravenous
    use is I-131 radioisotope labelled meta-iodobenzylguanidine (MIBG)

    3300-4100 MBq at activity reference date and time

    ≥ 555 GBq/g at activity reference date and time

    333-410 MBq/ml at activity reference date and time

    ≤ 0.1%

    ≥ 90%

    5-5.5

    5 days from manufacturing date

    RADIOISOTOPE THERAPY

    Local, lesion-specific treatment of neuro-endocrine tumours, especially:

    • phaeochromocytoma
    • neuroblastoma
    • paraganglioma
    • medullar thyroid carcinoma
    • carcinoid

    The recommended individual dose is 3.3–4.1 GBq.

    To prevent the uptake of the free radioiodine evolving in vivo, thyroid blockade is recommended
    before the examination.

    Do not administer the injection directly. 10 ml of the MIBG solution for injection must be mixed with
    90 ml of 5% glucose injection. The obtained solution which has a total volume of 100 ml should be
    administered to the patient slowly. Time of administration is 2 – 4 hours.

    Rapid administration of MIBG can result in blood pressure increase, allergic symptoms, flush or
    asthmatic spasms.

    Store in a freezer, below -18°C. Storage of radiopharmaceuticals should be in accordance with
    national regulation on radioactive material. To ensure the low temperature during shipping dry-ice
    is used to cool the container.

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

    Transported in a Type A package

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