TECHNESCAN HDP Powder for solution (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Curium US LLC

Λέξεις κλειδιά

69945-091

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1. Description

Technescan HDP is supplied as a lyophilized powder, packaged under nitrogen in vials for intravenous administration after reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m. Each vial contains ...

2. Clinical Pharmacology

During the 24 hours following injection, Technetium Tc 99m-labeled Technescan HDP is rapidly cleared from blood and other non-osseous tissues and accumulates in the skeleton and urine in humans. Blood ...

3. Indications and Usage

Technescan HDP Tc 99m is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult and pediatric patients.

4. Contraindications

None known.

5. Warnings

Technetium Tc 99m Oxidronate may cause life-threatening hypersensitivity reactions. Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions. ...

6.1. General

The components of the kit are sterile and non-pyrogenic. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation. Sodium pertechnetate Tc ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether Technetium Tc 99m Oxidronate affects fertility in males and females.

6.7. Pregnancy

Category C. Animal reproduction studies have not been conducted with Technetium Tc 99m Oxidronate. It is also not known whether Technetium Tc 99m Oxidronate can cause fetal harm when administered to a ...

6.9. Nursing Mothers

Technetium Tc 99m is excreted in human milk during lactation, therefore formula feedings should be substituted for breast feedings.

7. Adverse Reactions

Hypersensitivity reactions, including life-threatening reactions, as well as nausea, vomiting and injection site reactions, have been infrequently reported with Technetium Tc 99m Oxidronate use.

9. Overdosage

In the event of the administration of an overdose with Technescan HDP, encourage patients to drink fluids and void frequently to reduce the radiation dose to the patient.

10. Dosage and Administration

General Instructions The recommended adult dose of Technetium Tc 99m-labeled Technescan HDP is 555 MBq (15 mCi) with a range of 370 to 740 MBq (10 to 20 mCi). The recommended pediatric dose is 7.4 MBq ...

11. How Supplied

Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl<sub>2</sub>•2H<sub>2</sub>O), 0.297 mg, ...