123I-Solution 74 MBq/ml
Clinical Summary
Quick overview from the medicine insert
Indication
Used for diagnostic imaging in nuclear medicine, particularly for thyroid imaging and evaluation.
Dosage (summary)
Administered as a single intravenous injection, typically 74 MBq/ml depending on the specific imaging requirements.
Onset of Action / Duration
Immediate imaging results can be obtained, but biological clearance may take several hours to days depending on the individual's metabolism.
Special Populations
- Elderly patients
- Patients with renal impairment
- Patients with thyroid disorders
Pregnancy & Breastfeeding
Use during pregnancy and lactation should be avoided unless absolutely necessary, as iodine can cross the placenta and be excreted in breast milk.
Key Drug Interactions
- Antithyroid medications may interfere with iodine uptake.
- Certain contrast agents may affect imaging results.
Contraindications
- Hypersensitivity to iodine or iodinated compounds
- Severe renal impairment
- Thyroid storm
Common side effects
- Allergic reactions (rash, itching)
- Nausea
- Vomiting
- Thyroid dysfunction (hyperthyroidism or hypothyroidism)
Counselling Points
- Inform patients about the purpose of the imaging procedure.
- Advise patients to report any history of iodine allergy.
- Encourage hydration post-administration to facilitate clearance.
Important Disclaimer
The 123I-Solution 74 MBq/ml professional information leaflet below is the property of Ithemba Labs and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
Iodine-123 is suitable for diagnostic examinations of the thyroid and the diagnosis of thyroid cancer.
4.2 Posology and method of administration
The 123 I-Solution can be administered orally or intravenously. The dosage varies from 5 to 370 MBq according to the amount prescribed for a specific diagnostic examination.
4.3 Contraindications
Sensitivity to iodine.
4.4 Special warnings and precautions for use
123 I-Solution is radioactive and should only be handled and administered by legally authorised personnel. The 123 I-Solution is not recommended for pregnant patients. Since iodine-123 is excreted in human milk, formula feeding should be substituted for breastfeeding if 123 I-Solution must be administered to the mother during lactation.
4.5 Interaction with other medicines and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
The safety of this preparation in pregnancy has not been established. Since iodine-123 is excreted in human milk, formula feeding should be substituted for breastfeeding if 123 I-Solution must be administered to the mother during lactation (see section 4.4. Special warnings and precautions for use).
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
No side-effects are known. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d found online under SA HPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.
4.9 Overdose
No symptoms of overdosage are known.
