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HSA Approval

GALLIUM CITRATE (Ga 67) INJECTION 37 MBq/ml

SIN09913P

GALLIUM CITRATE (Ga 67) INJECTION 37 MBq/ml

GALLIUM CITRATE (Ga 67) INJECTION 37 MBq/ml

July 28, 1998

QT INSTRUMENTS (S) PTE LTD

QT INSTRUMENTS (S) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantQT INSTRUMENTS (S) PTE LTD
Licence HolderQT INSTRUMENTS (S) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

GALLIUM CITRATE EQV Ga67

37 MBq/ml at ART

Gallium citrate

Documents

Package Inserts

05 CON 3103 Singapore PI 12082022.docx

Approved: January 18, 2023

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