INDIUM (IN111) CHLORIDE INJECTION 370 MBQ/ML [SIN10571P]

Product Info

INDIUM (IN111) CHLORIDE INJECTION 370 MBQ/ML

[SIN10571P]

4.1 Therapeutic indications
This product is for diagnostic use only.

Indium (In111) chloride is used as an ingredient for the radiolabelling of certain suitably derivatised proteins which are subsequently administered intravenously for a variety of investigative purposes using appropriate imaging procedures.

Indium (In111) chloride is used extensively for the radiolabelling of monoclonal antibodies. The nature of the disease state to be investigated will be determined by the particular monoclonal antibody to be labelled.

Indium (In111) chloride has also been used as the radiolabelling ingredient in injectable preparations such as Indium (¹¹¹In)-labelled proteins.

4.2 Posology and method of administration
The vial contains a sterile aqueous solution for the in-vitro radiolabelling of suitable conjugated proteins such as monoclonal antibodies, which are subsequently administered intravenously.

The quantity of Indium (¹¹¹In) chloride required for radiolabelling and the quantity of Indium (¹¹¹In)-labelled pharmaceutical that is subsequently administered will depend on the pharmaceutical being labelled and its intended use. Information on recommended dosage and administration will be provided by the manufacturer of the pharmaceutical to be radiolabelled.

The activity to be administered to children may be calculated approximately by correcting on a weight, body surface area or age basis the activity to adults. For the newborn and children under about one year of age, the target organ size in relation to the whole body must also be taken into consideration.

4.3 Contraindications
Information on contra-indications to particular Indium (¹¹¹In)-labelled pharmaceuticals prepared by radiolabelling with Indium (¹¹¹In) chloride will be supplied by the manufacturer of the pharmaceutical to be radiolabelled.