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GALLIAPHARM RADIONUCLIDE GENERATOR 0.74 – 1.85 GBQ [SIN16844P]

Active ingredients: GALLIAPHARM RADIONUCLIDE GENERATOR 0.74 – 1.85 GBQ

Last updated 26 October 2025

Product Info

GALLIAPHARM RADIONUCLIDE GENERATOR 0.74 – 1.85 GBQ

[SIN16844P]

Product information

Active Ingredient and Strength

GALLIUM (68GA) CHLORIDE - > 60% OF THE LOADED ACTIVITY
GERMANIUM (68GE) CHLORIDE - 0.74 - 1.85 GBQ

Dosage Form

INJECTION, SOLUTION (RADIOPHARMACEUTICAL)

Manufacturer and Country

ECKERT & ZIEGLER RADIOPHARMA GMBH - GERMANY

Registration Number

SIN16844P

Licence Holder

LABGISTICS ASIA PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

V09X

4.1. Therapeutic indications
This pharmaceutical product is not intended for direct use in patients.

The eluate from the radionuclide generator (gallium (68Ga) chloride solution) is indicated for in vitro labelling of specific carrier molecules developed and approved for radiolabelling with such solution to be used for positron emission tomography (PET) imaging.

4.2. Posology and method of administration
This pharmaceutical product is for use in designated nuclear medicine facilities only, and should only be handled by specialists experienced with in vitro radiolabelling.

Posology
The quantity of the eluate gallium (68Ga) chloride solution required for radiolabelling and the quantity of 68Ga-labelled pharmaceutical product that is subsequently administered will depend on the pharmaceutical product that is radiolabelled and its intended use. Refer to the package insert of the particular pharmaceutical product to be radiolabelled.

Paediatric population
Please refer to the package insert of the 68Ga-labelled pharmaceutical product for more information concerning its paediatric use.

Method of administration
The gallium (68Ga) chloride solution is not intended for direct use in patients but is used for in vitro radiolabelling of various carrier molecules. The route of administration of the final pharmaceutical product should be adhered to.

For instructions on extemporary preparation of the pharmaceutical product before administration, see section 10 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3. Contraindications
Do not administer gallium (68Ga) chloride solution directly to the patient.

The use of 68Ga-labelled pharmaceutical products is contraindicated in case of hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

For information on contraindications to particular 68Ga-labelled pharmaceutical products prepared by radiolabelling with gallium (68Ga) chloride solution, refer to the package insert of the particular pharmaceutical product to be radiolabelled.