TEKCIS RADIONUCLIDE GENERATOR 2-50 GBQ [SIN15741P]

Product Info

TEKCIS RADIONUCLIDE GENERATOR 2-50 GBQ

[SIN15741P]

4.1 Therapeutic indications

This medicinal product is for diagnostic use only.

The eluate from the radionuclide generator (sodium pertechnetate (^99mTc) injection) is indicated for

• Labelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such solution.

• Thyroid scintigraphy: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in case of thyroid disease.

• Salivary gland scintigraphy: diagnosis of chronic sialadenitis (e.g. Sjögren's Syndrom) as well as assessment of salivary gland function and duct patency in salivary glands disorders and monitoring of the response to therapeutic interventions (in particular radio iodine therapy).

• Location of ectopic gastric mucosa (Meckel’s diverticulum).

• Lacrimal duct scintigraphy: to assess functional disorders of lacrimation and monitoring of the response to therapeutic interventions.

4.2 Posology and method of administration

Posology

If sodium pertechnetate (^99mTc) is administered intravenously, activities may vary widely according to the clinical information required and the equipment employed. The injection of activities greater than local DRLs (Diagnostic Reference Levels) should be justified.

Recommended activities are as follows:

Adults (70 kg) and elderly population:

• Thyroid scintigraphy: 20–80 MBq

• Salivary gland scintigraphy: 30 to 150 MBq for static images up to 370 MBq for dynamic images.

• Meckel’s diverticulum scintigraphy: 300–400 MBq

• Lacrimal duct scintigraphy: 2–4 MBq per eye.

Renal impairment
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.

Paediatric population
The use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in the patient group.

The activity to be administered to children and adolescents must be adapted and may be calculated according to the recommendations of the European Association of Nuclear Medicine (EANM) paediatric dosage card; the activity administered to children and to adolescents may be calculated by multiplying a baseline activity (for calculation purposes) by the weight-dependent correction factor given in the table below (see Table 1).

A[MBq]_Administered = Baseline Activity x Multiple

Thyroid scintigraphy:
Activity administered [MBq] = 5.6 MBq x correction factor (Table 1). A minimal activity of 10 MBq is necessary for obtaining images of sufficient quality.

Identification /location of ectopic gastric mucosa:
Activity administered [MBq] = 10.5 MBq x correction factor (Table 1). A minimal activity of 20 MBq is necessary in order to obtain images of sufficient quality.

Salivary gland scintigraphy:
The Paediatric Task Group of EANM (1990) recommends that the activity to be administered to a child should be calculated from the body weight according to the table below (see Table 2) with a minimum dose of 10 MBq in order to obtain images of sufficient quality.

Lacrimal duct scintigraphy:
Recommended activities apply as well for adults as for children.

Method of administration

For intravenous or ocular use.
For multidose use.
For instructions on extemporaneous preparation of the medicinal product before administration, see section 12 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
For patient preparation, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

In thyroid scintigraphy, salivary gland scintigraphy and identification/location of ectopic gastric mucosa, the sodium pertechnetate (^99mTc) solution is administered by intravenous injection.

In lacrimal duct scintigraphy, drops are instilled in each eye (ocular use).

Image acquisition

Thyroid scintigraphy: 20 minutes after intravenous injection.

Salivary gland scintigraphy: immediately after intravenous injection and at regular intervals for 15 minutes.
Identification/location of ectopic gastric mucosa (Meckel Diverticulum): immediately after intravenous injection and at regular intervals for 30 minutes.

Lacrimal duct scintigraphy: dynamic acquisition within 2 minutes after instillation, followed by static images acquired at regular intervals within 20 minutes.

4.3 Contraindications

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.