CERETEC Powder for solution for injection (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Medi-Physics Inc. dba GE Healthcare.

Λέξεις κλειδιά

17156-022

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1. Description

The Ceretec kit is supplied as a pack of 5 vials for use in the preparation of a technetium Tc99m exametazime intravenous injection as a diagnostic radiopharmaceutical for use as an adjunct in the detection ...

2. Clinical Pharmacology

General When technetium Tc99m pertechnetate is added to exametazime in the presence of stannous reductant, a lipophilic technetium Tc99m complex is formed. This lipophilic complex is the active moiety. ...

3. Indications and Usage

Technetium Tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime is indicated for leukocyte labeled scintigraphy ...

4. Contraindications

None known.

6. Precautions

As with any injected product, acute hypersensitivity or allergic reactions are possible. Limited reports have been received of hypersensitivity reactions following administration of Tc99m labeled leukocytes ...

6.1. General

The contents of the Ceretec vial are sterile and pyrogen free. The vial contains no bacteriostatic preservative. It is essential that the user follow the directions carefully and adhere to strict aseptic ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term animal studies have not been performed to evaluate carcinogenic potential or whether exametazime affects fertility in males or females. When evaluated in the Ames test, exametazime increased ...

6.7. Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Tc99m exametazime. It is also not known whether Tc99m exametazime can cause fetal harm when administered to a pregnant woman ...

6.9. Nursing Mothers

Technetium Tc99m is excreted in human milk during lactation. It is not known whether exametazime is excreted in human milk. Therefore, formula feedings should be substituted for breast feeding for 60 hours. ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

Clinical studies of Ceretec did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not ...

7. Adverse Reactions

Rash with generalized erythema, facial edema and fever has been reported in less than 1% of patients. A transient increase in blood pressure was seen in 8% of patients.

10. Dosage and Administration

<b>Tc99m labeled leukocytes for adjunctive localization of intra-abdominal infection or inflammation.</b> The normal adult (70 kg) dose is 0.259-0.925 GBq (7-25 mCi) as Tc99m labeled leukocytes by intravenous ...

11. How Supplied

The kit comprises 5 individual vials of sterile, non-pyrogenic, freeze-dried mixture of exametazime, stannous chloride dihydrate and sodium chloride, 5 radiation labels, 5 radiochemical purity worksheets, ...

12. Storage and Handling

Store the kit at 15°-25°C (59°-77°F). Store the formulated drug for up to 30 minutes at 20°-25°C (68°-77°F) using appropriate radiation shielding.

13. Clinical Studies

Two clinical trials were performed in a total of 88 patients who had suspected intra-abdominal infection or inflammation. Subjects received both Tc99m labeled leukocytes and In-111 labeled leukocytes. ...