LEUKOSCAN Powder for solution for injection Ref.[27586] Active ingredients: Technetium ⁹⁹ᵐTc sulesomab

The radiolabelled solution should be administered as an intravenous injection. After injection, any remaining portion of the reconstituted solution should be discarded.

LeukoScan is not recommended for use in children.

Formal studies have not been performed in patients with renal or hepatic impairment. However, due to the low dose of protein administered and the short half-life of ^99mTc, dosage adjustment is probably not necessary in such patients.

Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.

This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organisations.

Immediately prior to use, contents of the vial are reconstituted in the unlabeled form to prepare LeukoScan [^99mTc]. The unreconstituted contents of the vial before radiolabelling are not to be directly administered to patients.

For instructions for preparation see section 6.6.

For readministration see section 4.4.

For this medicinal product, the effective dose equivalent resulting from an administered activity of 750 MBq is typically 7.7 mSv for a 70 kg individual.

Technetium [^99mTc] disintegrates with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium [99Tc] which can be regarded as quasi stable.

The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous administration of LeukoScan labeled with 750 MBq of technetium-99m are provided in Table 1. These dose estimates assume a urinary bladder voiding interval of two hours. These values were calculated according to Medical Internal Radiation Dosimetry.

Table 1:

^* Effective Dose Equivalent and Effective Dose are in units of µSv/MBq.

The maximum amount of LeukoScan [^99mTc] that can be administered safely has not been determined. In clinical trials, single doses of 1.0 mg of LeukoScan radiolabelled with 900 ± 200 MBq of 99mTc were administered to 11 patients with various types of infection and there were no adverse reactions at this dose.

In the unlikely event of a radiation overdose being administered with LeukoScan [^99mTc], the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the radiolabel.

Kit – 48 months.

Reconstituted and radiolabelled material – 4 hours.

Kit – Store in a refrigerator (2ºC-8ºC). Do not freeze.

Reconstituted and radiolabelled material – Do not store above 25ºC. Do not refrigerate or freeze.

One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.

The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.

Pack size: one vial per carton container.

Read complete directions thoroughly before starting the preparation procedure.

LeukoScan is a sterile, lyophilised formulation, containing 0.31 mg of sulesomab per vial and includes 0.22 mg stannous chloride dihydrate, 3.2 mg potassium sodium tartrate tetrahydrate, 7.4 mg sodium acetate trihydrate, 5.5 mg sodium chloride, glacial acetic acid (trace), hydrochloric acid (trace), 37.8 mg sucrose, nitrogen (vacuum). The imaging agent, technetium-99m LeukoScan [technetium-99m sulesomab] is formed by reconstitution of the contents of the LeukoScan vial with 0.5 mL sodium chloride for injection followed by the addition of 1100 MBq of sodium pertechnetate [^99mTc] in 1 mL of Sodium Chloride for Injection. The resulting solution has a pH of 4.5-5.5 and is intended for intravenous use only.

Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals.

Reconstituted radiopharmaceuticals should be handled using waterproof gloves, adequate shielding of radioactivity, and aseptic technique. Following reconstitution, unused radiopharmaceutical and vial should be handled as radioactive waste and disposed of in accordance with local requirements.

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

Method of preparation:

1. Obtain 900 ± 200 MBq of freshly eluted ^99mTc sodium pertechnetate eluate from any commercial source which has been eluted within the past 24 hours. Using saline injection, bring the final volume of eluate solution to 1.0 ml.
2. Clean the rubber closure of each vial such as with an alcohol wipe. For reconstitution of lyophilised powder, with a sterile disposable syringe add 0.50 ml of saline injection into the shielded LeukoScan 3-ml vial.
3. Swirl and shake the vial contents gently for 30 seconds to insure dissolution. Radiolabelling must take place immediately after reconstitution of product.
4. Add the prepared eluate into the shielded vial, shake and allow the labelling reaction to proceed for ten minutes. Total volume in vial equals 1.5 ml.
5. Based on the activity measured in the activity calibrator, withdraw a sufficient amount of the product to provide the desired activity (750-1100 MBq of ^99mTc, see Dosage and Administration). LeukoScan [^99mTc] can be used after ten minutes and should be used within four hours after preparation. LeukoScan [^99mTc] can be stored at room temperature after formulation. Do not refrigerate after formulation.
6. Prior to administration, the solution should be inspected visually for particulate matter and discoloration, and quality control should be performed (see section 12). If either are present, the product should be discarded.