I-131 capsule and solution for diagnosis and therapy

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-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.

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

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