I-131 MIBG for diagnosis and therapy

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