I-131 MIBG 20 MBq/ml injection for diagnostic use

Product code: I-RAO-1
Pharmaceutical form and description: 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).

Activity per vial: 20 MBq, 40 MBq, or 80 MBq at activity reference date and time
Specific activity ≥ 26.7 GBq/g MIBG at activity reference date and time
Radioactive concentration 20 MBq/ml at activity reference date and time
Radionuclid impurities ≤ 0.1%
Radiochemical purity: ≥ 95%
pH: 5–7
Expiry date: 5 days from manufacturing date
Indications and posology: Indication field: radioisotope diagnostics
Localisation and imaging of neuroendocrine tumours, especially:phaeochromocytomaneuroblastoma
Recommended dose: 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.

Storage: Store in refrigerator at 2–8°C. Comply with the regulations for radiation safety.
Packaging: 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: I-RAO-2
Pharmaceutical form and description: 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)

Activity per vial: 3300-4100 MBq at activity reference date and time
Specific activity: ≥ 555 GBq/g at activity reference date and time
Radioactive concentration: 333-410 MBq/ml at activity reference date and time
Radionuclid impurities: ≤ 0.1%
Radiochemical purity: ≥ 90%
pH: 5-5.5
Expiry date: 5 days from manufacturing date
Indications and posology: RADIOISOTOPE THERAPY

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

phaeochromocytoma

neuroblastoma

paraganglioma

medullar thyroid carcinoma

carcinoid

Recommended dose: 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.

Storage: 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.
Packaging: 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