QT INSTRUMENTS (S) PTE LTD

**4.1 Therapeutic indications** This medicinal product is for diagnostic use only. 1. Red blood cell labelling for blood pool scintigraphy. Major indications are: - Angiocardioscintigraphy for: \*evaluation of ventricular ejection fraction \*evaluation of global and regional cardiac wall motion \*myocardial phase imaging - Organ perfusion and vascular abnormalities imaging for the detection of hemangioma. - Diagnosis and localization of occult gastro-intestinal bleeding 2. Determination of blood volume 3. Spleen scintigraphy

<p><strong>4.1 Therapeutic Indications</strong><br> This medicinal product is for diagnostic use only.</p> <p>The eluate from the generator (Sodium Pertechnetate (^99mTc) Injection Ph. Eur.) may be used as a reagent for labelling of various carrier compounds supplied as kits or administered directly in-vivo.</p> <ol type="A"> <li><p>When administered intravenously, the sterile sodium pertechnetate (^99mTc) solution is used as a diagnostic aid in the following:</p> <ul class="bullet"> <li><p><strong>Thyroid scintigraphy:</strong> direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in thyroid disease.</p></li> <li><p><strong>Salivary gland scintigraphy:</strong> to assess salivary gland function and duct patency.</p></li> <li><p><strong>Location of ectopic gastric mucosa:</strong> Meckel's diverticulum.</p></li> <li><p><strong>Cerebral scintigraphy:</strong> to identify breaches in the blood-brain barrier caused by tumour, infarction, haemorrhage and oedema, when no other methods are available.</p></li> </ul> </li> <li><p>When used in conjunction with pre-treatment with a reducing agent to effect technetium (^99mTc)-labelling of red blood cells:</p> <ul class="bullet"> <li><p><strong>Cardiac and vascular scintigraphy</strong></p> <ul class="dash"> <li>angiocardioscintigraphy for:<br> * evaluation of ventricular ejection fraction<br> * evaluation of global and regional cardiac wall motion<br> * myocardial phase imaging<br><br></li> <li>organ perfusion or vascular abnormalities imaging</li> </ul></li> <li><p><strong>Diagnosis and localisation of occult gastrointestinal bleeding.</strong></p></li> </ul></li> <li><p>Following instillation of sterile sodium pertechnetate (^99mTc) solution into the eye:</p> <ul class="bullet"> <li><p><strong>Lacrimal duct scintigraphy:</strong> to assess patency of tear ducts</p></li> </ul></li> </ol>

<p><strong>Therapeutic indications</strong><br> After reconstitution with Sodium Pertechnetate (^99mTc) Injection (Fission or Non-Fission) the agent may be used for bone scintigraphy, where it delineates areas of altered osteogenesis.</p>

<p><strong>4.1 Therapeutic indications</strong><br> This product is for diagnostic use only.</p> <p>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.</p> <p>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.</p> <p>Indium (In111) chloride has also been used as the radiolabelling ingredient in injectable preparations such as Indium (¹¹¹In)-labelled proteins.</p>

**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.