Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**Dosage and administration** Usual dose 74–111 MBq (2–3mCi) by intravenous injection.
INTRAVENOUS
Medical Information
**Indications** Scintigraphy with gallium-67 is indicated in: - the clinical evaluation of patients suspected of neoplastic diseases, notably Hodgkin’s disease, other malignant lymphomas, soft tissue sarcomas and most bronchogenic carcinomas. - the localisation of metastases of malignant melanomas. - the differentiation of hepatoma and liver metastases, and pleural and peritoneal mesotheliomas. - determining the extent of involvement of malignancy. - the follow-up of tumour therapy and screening for recurrent tumour. - the localisation of focal inflammatory lesions and the evaluation of fever of unknown origin.
**Contraindications** Gallium Citrate (Ga-67) Injection is contraindicated in lactating mothers unless the child is formula-fed for a period of at least three weeks after the injection. No other contraindications are known.
V09HX01
gallium (67Ga) citrate
Manufacturer Information
QT INSTRUMENTS (S) PTE LTD
Curium Netherlands B.V.
Active Ingredients
Documents
Package Inserts
05 CON 3103 Singapore PI 12082022.docx
Approved: January 18, 2023