NANOSCAN Kit for radiopharmaceutical preparation Ref.[27559] Active ingredients: Technetium ⁹⁹ᵐTc nanocolloid

The medicinal product should only be administered by trained healthcare professionals with technical expertise in performing and interpreting sentinel lymph node mapping procedures.

Posology

Adults and elderly population

Recommended activities are as follows:

Intravenous administration:

• Bone marrow scanning: 185-500 MBq as a single intravenous injection.
• Inflammation scanning: 370-500 MBq as a single intravenous injection.

Subcutaneous administration:

• Lymphatic scanning: The recommended activity by single or multiple injections by subcutaneous (interstitial) is from 20 to 110 MBq per injection site.
• Sentinel node detection:
  • The dose depends on the time interval between injection and the image acquisition or the surgery.
  • Melanoma: 10 to 120 MBq in several doses by intradermal peritumoural injection.
  • Breast carcinoma: 5-200 MBq in several doses each from 5-20 MBq to be administered by intradermal or subdermal or periareolar injection (superficial tumours) and by intratumoural or peritumoral injection (deep tumours).
  • Penile carcinoma: 40-130 MBq in several doses each of 20 MBq to be administered intradermally around the tumour.
  • Squamous cell carcinoma of the oral cavity: 15-120 MBq to be administered by single or multiple peritumoural injections
  • Vulvar carcinoma: 60-120 MBq to be administered by peritumoural injection.

Renal impairment/Hepatic impairment

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

Paediatric population

The activities to be administered to children and adolescents is recommended to be calculated according the recommended range of adult activity adjusted to the body weight. The Paediatric Task Group of the European Association of Nuclear Medicine (EANM 1990) recommends calculating the administered activity according to the body weight as shown in the table below.

Fraction of adult activity:

For use in children, it is possible to dilute the product before administration, see section 12.

Method of administration

For multidose use.

Intravenous administration:

• Bone marrow scanning: single intravenous injection.
• Inflammation scanning: single intravenous injection.

Subcutaneous administration:

• Lymphoscintigraphy: The product is given by single or multiple subcutaneous injections, depending on the anatomical areas to be investigated and upon the time interval between injection and imaging. The injected volume should not exceed 0.2-0.3 mL. A volume more than 0.5 mL per injection site must not be applied. The subcutaneous injection should be given after checking by aspiration that a blood vessel has not been inadvertently punctured.
• Detection of sentinel lymph nodes:
  • Melanoma: the activity is administered in four doses surrounding the tumor/scar, by injecting volumes of 0.1-0.2 mL.
  • Breast carcinoma: a single injection in small volume (0.2 mL) is recommended. Multiple injections may be used in particular circumstances/conditions. When using superficial injections, large volumes of injectate may interfere with normal lymphatic flow; therefore, volumes of 0.05–0.5 mL are recommended. With peritumoral injections, larger volumes (e.g. 0.5–1.0 mL) may be used.
  • Penile carcinoma: the dose should be administered thirty minutes after local spray anaesthesia by intradermal injection into three or four depots of 0.1 mL around the tumour of 0.3–0.4 mL. For large tumours not restricted to the glans, the product can be administered in the prepuce.
  • Squamous cell carcinoma of the oral cavity: the activity is administered in two to four doses surrounding the tumor/scar in a total volume of 0.1-1.0 mL.
  • Vulvar carcinoma: the activity is administered in four peritumoural doses in a total volume of 0.2 mL.

Precautions to be taken before handling or administration of the medicinal product

This medicinal product should be reconstituted before administration to the patient. For instructions on extemporaneous preparation of the medicinal product before administration, see section 12.

For patient preparation, see section 4.4.

This product is not intended for regular or continuous administration.

Image acquisition

Bone marrow scanning:

Images may be acquired 45-60 minutes after administration.

Inflammation scanning:

Dynamic imaging is performed immediately. Static imaging comprises an early phase, 15 minutes post-injection and a washout phase, 30-60 minutes post-injection.

Lymphatic scanning:

When imaging the lower limbs, dynamic images are taken immediately following injection and static imaging 30-60 minutes later. In parasternal lymph scanning, repeated injections and additional images may be required.

Sentinel node detection:

• Melanoma: Lymphoscintigraphic images are acquired starting after injection and regularly thereafter until the sentinel lymph node is visualized.
• Breast carcinoma: Scintigraphic images of breast and axillary region can be acquired by early detections (15-30 minutes) and late detections (3-18 hours) after injection.
• Penile carcinoma: dynamic imaging can be performed immediately after injection and followed by static imaging at 30 minutes, 90 minutes, and 2 hours post-injection by using dual-head gamma camera.
• Squamous cell carcinoma of the oral cavity: dynamic acquisition for 20 to 30 minutes starting immediately after injection. Two or three simultaneous static images from one or both sides in the anterior and lateral projections are recommended. Static images can be repeated at 2 hours, 4–6 hours, or just before surgery. SPECT imaging may improve the identification of sentinel lymph nodes, especially close to the injection site. Repeat injection and imaging may be considered; however, proceeding to neck dissection is preferred in order to avoid a false-negative sentinel lymph node.
• Vulvar carcinoma: image acquisition is to be obtained starting after the injection and every 30 min thereafter until the sentinel node(s) is visualized. The injection and images can be carried out the day before surgery or on the day of surgery. Planar images acquisition for 3–5 minutes in anterior and lateral views, and subsequent SPECT/CT images, are recommended.

Dosimetry

Technetium (^99mTc) is produced by means of a (⁹⁹Mo/^99mTc) generator and decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6.02 hours to technetium (⁹⁹Tc) which, in view of its long half-life of 2.13 × 10⁵ years can be regarded as quasi stable.

The radiation doses absorbed by a patient weighing 70 kg, after intravenous injection of ^99mTc-human albumin colloidal particles, are reported hereafter.

Adult and Children Category

Estimated Absorbed Radiation Dose after administration of Technetium ^99mTc NanoScan injection Absorbed doses:

Dose calculations were made with the standard MIRD method (MIRD Pamphlet No.1, Society of Nuclear Medicine, 1976). The Effective Dose Equivalence (EDE) was determined as specified in ICRP 80 (Ann. ICRP 18 (1-4), 1988). This value varied as follows: 6.24x10^-3 mSv/MBq for adults and 7.64x10^-3 mSv/MBq, 1.47x10^-2 mSv/MBq, 2.05x10^-2 mSv/MBq, 3.41x10^-2mSv/MBq and 7.32x10^-2 mSv/MBq respectively, for children aged 15, 10, 5 and 1 years and for newborns.

Pregnancy Category

Estimated Absorbed Radiation Dose after administration of Technetium ^99mTc-NanoScan injection:

Dose calculations were made with the standard MIRD method (MIRD Pamphlet No.1, Society of Nuclear Medicine, 1976).The Effective Dose Equivalence (EDE) was determined as specified in ICRP 80 (Ann. ICRP 18 (1-4), 1988). This value varied as follows: 5.74x10^-2 mSv/MBq for women and 5.74x10^-2 mSv/MBq, 5.76x10^-2 mSv/MBq and 5.76x10^-2 mSv/MBq respectively, for pregnant women in 3, 6 or 9-months.

The radiation doses absorbed by a patient weighing 70 kg, after subcutaneous injection of 99mTchuman albumin colloidal particles, are reported hereafter. The data listed below is based on MIRD reference man and MIRD S values, and has been calculated from biological data of organ uptake and blood clearance.

The effective dose resulting from the subcutaneous administration of a maximal recommended activity of 110 MBq for an adult weighing 70 kg is about 0.44 mSV. For an administered activity of 110 MBq the typical radiation dose to the target organ (lymph nodes) is 65 mGy and the typical radiation dose to the critical organ (injection site) is 1320 mGy.

In the case of subcutaneous administration for sentinel node detection it is assumed that the dose to the injection site, which varies greatly with location, injected volume, number of injections and retention, can be ignored due to the relatively low radiosensitivity of skin and the small contribution this makes to the overall effective dose.

In the case of sentinel node detection of breast carcinoma the data listed below (ICRP 106) assumes no leakage occurs and the absorbed dose to the remaining breast is equal to the dose to the lungs.

The effective dose resulting from the subcutaneous administration of a maximal recommended activity of 200 MBq with the removal of the injection site 18 hours post-injection for an adult weighing 70 kg is about 0.4 mSv.

In the event of administration of a radiation overdose with nanocolloidal technetium (^99mTc) albumin no practical measure can be recommended to satisfactorily diminish tissue exposure as the label is poorly eliminated in urine and faeces.

18 months.

After radiolabelling: 8 hours.

Do not store above 25°C after radiolabelling.

Do not store above 25°C.

Keep the vials in the outer carton in order to protect from light.

For storage conditions after radiolabelling of the medicinal product, see section 6.3.

Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.

8 ml colourless, Type I, brosilicate glass multi-dose vials, closed with chlorobutyl rubber stopper and plastic-aluminium caps (polypropylene-aluminium caps) with turned up edge.

Packsizes:

1 pack contains 6 vials.
Sample package: 2 vials.
Bundle pack of 2 packs of 6 vials.
Bundle pack of 4 packs of 6 vials.

Not all pack sizes may be marketed.

General warnings

Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licensees of the competent official organization. Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.

Contents of the vial are intended only for use in the preparation of nanocolloidal technetium (^99mTc) albumin and are not to be administered directly to the patient without first undergoing the preparative procedure.

For instructions on reconstitution of the medicinal product before administration, see section 12.

If at any time in the preparation of this product the integrity of this vial is compromised it should not be used.

Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.

The content of the kit before extemporary preparation is not radioactive. However, after reconstitution with sodium pertechnetate (^99mTc) Injection, Ph. Eur. is added, adequate shielding of the final preparation must be maintained.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

Any unused product or waste material should be disposed of in accordance with local requirements.