Technetium tc 99m sulfur colloid

FDA label, Sun Pharmaceutical Industries, Inc., effective 2024-09-13. Full label on DailyMed

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Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Dosing in liver impairment

MBq (0.2 to 0.5 mCi); Liver/spleen imaging in children: 0.56 to

MBq (0.015 to 0.075 mCi) per kg of body weight (BW) by intravenous injection; liver/spleen imaging in newborns: 7.4 to

Preparation and administration

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Your numbers for technetium tc 99m sulfur colloid. Take vial strength, diluent, and limits from the label below.

Basis

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MBq (0.15 to 0.30 mCi) by oral administration; pulmonary aspiration studies: 11.1 to

MBq (0.30 to 0.50 mCi) by oral administration. In pediatric patients: gastroesophageal and pulmonary aspiration studies: 3.7 to

MBq (0.10 to 0.30 mCi) by oral or nasogastric tube administration. For oral administration, combine the radiopharmaceutical with a milk feeding. For nasogastric tube administration, administer the radiopharmaceutical into the stomach then instill a normal volume of dextrose or milk feeding.

Drug Preparation and Administration The contents of the two Solution vials, the Solution A vial containing the appropriate acidic solution and the Solution B vial containing the appropriate buffer solution, are intended only for use in the preparation of the Technetium Tc 99m Sulfur Colloid Injection and are not to be directly administered to the patient.

Do not use Sodium Pertechnetate Tc 99m containing oxidants to reconstitute this kit. The contents of the kit are not radioactive. However, after the Sodium Pertechnetate Tc 99m is added, maintain adequate shielding of the final preparation. Wear waterproof gloves during the preparation procedure. Do not use Sodium Pertechnetate Tc 99m containing more than 10 micrograms per mL of aluminum ion because a flocculent precipitate may occur and such a precipitate may localize in the lung.

The contents of the kit are sterile and non-pyrogenic. This preparation contains no bacteriostatic preservative. Follow the directions carefully and adhere strictly to aseptic procedures during preparation. Prepare Technetium Tc 99m Sulfur Colloid Injection by the following aseptic procedure: Remove the dark brown plastic cap from the Sulfur Colloid multi-dose Reaction Vial and swab the top of the vial closure with alcohol to sterilize the surface.

Complete the radiation label and affix to the vial. Place the vial in an appropriate lead-capped radiation shield labeled and identified. With a sterile shielded syringe, aseptically obtain 1 to 3 mL of a suitable, oxidant-free sterile and non-pyrogenic Sodium Pertechnetate Tc 99m, each milliliter containing a maximum activity of 18,500 MBq (500 mCi).

Aseptically add the Sodium Pertechnetate Tc 99m to the vial. Place a lead cover on the vial shield and dissolve the reagent by gentle swirling. Just before use, remove the red cap from the Solution A vial and swab the top of the vial closure with alcohol to sterilize the surface. Using a sterile needle and syringe, aseptically withdraw 1.5 mL Solution A from the vial.

Aseptically Inject 1.5mL Solution A into the multi-dose Reaction Vial and swirl again. Transfer the multi-dose Reaction Vial from vial shield and place in a vigorously boiling water bath (water bath should be shielded with 1/8” to 1/4” lead) deep enough to cover the entire liquid contents of the vial. Keep the vial in the water bath for five minutes.

Remove the multi-dose Reaction Vial from the water bath and place in the lead shield and allow to cool for three minutes. Swab the vial closure again with an antiseptic. Just before use, remove the blue cap from the Solution B vial and swab the top of the vial closure with alcohol to sterilize the surface. Using a sterile needle and syringe, aseptically withdraw 1.5 mL Solution B from the vial.

Aseptically Inject 1.5 mL Solution B into the multi-dose Reaction Vial and swirl again. Record time and date of preparation. Allow the preparation to cool to body temperature before use. Maintain adequate shielding of the radioactive colloid preparation at all times. Where appropriate, dilute the preparation with sterile Sodium Chloride Injection to bring the dosage to within the recommended range.

Mix the multi-dose Reaction Vial and aseptically withdraw material with a sterile shielded syringe for use within 6 hours of preparation. For optimum results this time should be minimized. The vial contains no bacteriostatic preservative. Store the reconstituted vial at 20 to 25°C (68 to77°F). Discard vial 6 hours after reconstitution.

Carefully agitate the shielded syringe immediately prior to administration of sulfur colloid to avoid particles aggregation and non-uniform distribution of radioactivity. Measure the patient dose by a suitable radioactivity calibration system immediately before administration. Check radiochemical purity before patient administration.

Inspect Technetium Tc 99m Sulfur Colloid Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.

Drug interactions

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Label text (1 paragraph)

Specific drug-drug interactions have not been studied.

Contraindications

None None

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for technetium tc 99m sulfur colloid. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Limited available data with Technetium Tc 99m Sulfur Colloid Injection use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; technetium Tc 99m crosses the placenta (see Data) . Animal reproduction studies have not been conducted with Technetium Tc 99m Sulfur Colloid Injection. All radiopharmaceuticals, including Technetium Tc 99m Sulfur Colloid Injection, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose.

If considering Technetium Tc 99m Sulfur Colloid Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Data Human Data Among 14 infants born to pregnant patients exposed to Technetium Tc 99m Sulfur Colloid Injection for lymph node localization, no birth defects were reported following drug exposure.

Breastfeeding (LactMed)

Information in this record refers to the intravenous use of technetium Tc 99m sulfur colloid as a diagnostic agent. A US Nuclear Regulatory Commission subcommittee has recommended that nursing be discontinued for 24 hours after administration of all technetium Tc 99m diagnostic products to simplify guidance recommendations, although this time interval may be longer than necessary. The International Commission on Radiological Protection and others recommend that breastfeeding need not be interrupted after administration technetium Tc 99m sulfur colloid. In order to follow the principle of keeping exposure "as low as reasonably achievable", the International Atomic Energy Administration recommends withholding breastfeeding for 4 hours. The mother can nurse the infant just before administration of the radiopharmaceutical.

Source: LactMed: Technetium Tc 99m Sulfur Colloid (NICHD, public domain)Revised Nov 15, 2024

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