I-131 MIBG 20 MBq/ml injection for diagnostic use
Product codePharmaceutical form and descriptionActivity per vialSpecific activityRadioactive concentrationRadionuclid impuritiesRadiochemical puritypHExpiry dateIndications and posologyRecommended doseStoragePackaging
I-RAO-1Radioactive 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 time20 MBq/ml at activity reference date and time≤ 0.1%≥ 95%5–75 days from manufacturing dateIndication field: radioisotope diagnostics Localisation and imaging of neuroendocrine tumours, especially:phaeochromocytomaneuroblastomaThe recommended individual patient dose is 20–40 MBq I-131-MIBGTo 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
Pharmaceutical form and description
Activity per vial
Indications and posology
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
5 days from manufacturing date
Local, lesion-specific treatment of neuro-endocrine tumours, especially:
- medullar thyroid carcinoma
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
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