I-131 hard capsules for diagnosis and therapy

Product name:
ThyroTop D 0.5-37 MBq hard capsule complies with the European Pharmacopoeia 0938 monograph
I-131-sodium-iodide ThyroTop 38-7400 MBq hard capsules complies with the European Pharmacopoeia 2116 monograph
Product code:
I-RA-7/D
I-RA-7/K
ATC code:
V09F
V10XA01
Marketing Auth. No.
OGYI-T-9681/05
OGYI-T-9681/01
Pharmaceutical Form and Description:

Hard capsule, size “0”, colourless, transparent, CONI-SNAP type gelatine capsule, containing I-131 labelled sodium iodide, for oral administration.

Activity per capsule: 0.5-37 MBq 38-7400 MBq
Radionuclidic purity: 131I ≥ 99.9 % 131I ≥ 99.9 %
Radiochemical purity: ≥ 95 % ≥ 95 %
Expiry time:

21 days from the manufacturing date

Indications and Phosology:

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.

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
Storage:

Do not store above 25 ºC. Store in the original packaging. Comply with the regulations for radiation safety.

Packaging: 1-10 capsules in type I injection vial, closed with brombutyl stopper and green aluminium cap in lead container with paper insert. 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:
I-131 sodium iodide sterile solution, drug substance according to European Pharmacopoeia 0281 monograph
I-131 sodium iodide non-sterile solution, drug substance for radiolabelling according to European Pharmacopoeia 02121 monograph
Product code:
I-RA-7
I-RA-5
Description: 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

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.

Volume: 0.2 – 10.0 ml 0.2 – 10.0 ml
Radioactive concentration: 0.1 – 55.5 GBq/ml ≥ 0.1-55.5 GBq/ml
Radionuclidic purity: 131I ≥ 99.9 % 131I ≥ 99.9 %
Radiochemical purity: ≥ 95 % ≥ 95 %
pH 7 – 10 8 – 11
Expiry time: 21 days from manufacturing date 21 days from manufacturing date
Other information: Active pharmaceutical ingredient for manufacture of radiopharmaceuticals by dilution with water or by for capsule preparation.

For oral administration.

Active ingredient for manufacture of radiopharmaceuticals by dilution – e.g. with water or buffer for labelling purposes or capsule preparation, for oral administration.
Storage: Store at room temperature in its own container, in accordance with the regulations on radioactive materials. Store at room temperature in its own container, in accordance with the regulations on radioactive materials.
Packaging: 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

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