DRAX EXAMETAZIME Kit, Powder for solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Λέξεις κλειδιά
65174-200
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
1. Indications and Usage
Drax Exametazime is indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.
2. Dosage and Administration
2.1 Radiation Safety Drug Handling Technetium Tc 99m exametazime is a radioactive solution and should be handled with appropriate safety measures to minimize radiation exposure. During handling use waterproof ...
3. Dosage Forms and Strengths
Drax Exametazime is a kit containing five (5) single-dose vials. Each 10 mL, clear glass vial contains a non-radioactive lyophilized mixture of: 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate ...
4. Contraindications
None.
5. Warnings and Precautions
5.1 Hypersensitivity Reactions Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Tc 99m labeled leukocytes prepared using Tc 99m exametazime have ...
6. Adverse Reactions
The following adverse reactions are described elsewhere in the labeling; Hypersensitivity reactions <em>[see Warnings and Precautions (5.1)]</em>. The following adverse reactions associated with the use ...
8.1. Pregnancy
Risk Summary Limited available data with technetium Tc 99m exametazime use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. Technetium Tc 99m ...
8.2. Lactation
Risk Summary There are limited data available in the scientific literature on the presence of technetium Tc 99m exametazime in human milk. There no data available on the effects of technetium Tc 99m exametazime ...
8.4. Pediatric Use
Safety and efficacy in pediatric patients have not been assessed.
8.5. Geriatric Use
Clinical studies of Tc 99m exametazime did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience ...
8.6. Renal Impairment
Technetium Tc 99m exametazime is substantially excreted by the kidneys, so excretion is decreased/delayed and therefore radiation exposure is greater in patients with impaired renal function. A reduction ...
10. Overdosage
In the event of the administration of a radiation overdose, hydration and frequent micturition should be encouraged in order to minimize the absorbed dose to patient.
11. Description
11.1 Chemical Characteristics Drax Exametazime (kit for the preparation of technetium Tc 99m exametazime for leukocyte labeling) prepares a radioactive diagnostic agent. Each single-dose vial contains ...
12.1. Mechanism of Action
When technetium Tc 99m pertechnetate is added to exametazime in the presence of stannous reductant, a lipophilic technetium Tc 99m complex is formed. This lipophilic complex is the active moiety. The lipophilic ...
12.2. Pharmacodynamics
The relationship between technetium Tc 99m exametazime labeled WBC concentrations and successful imaging was not explored in clinical trials. GI activity is typically not seen through the initial four ...
12.3. Pharmacokinetics
Distribution During the first hour following the injection, radioactivity is seen in the lungs, liver, gall bladder, spleen, blood pool, bone marrow, kidneys, and bladder. Over the first 1-6 hours, the ...
14. Clinical Studies
Two clinical trials of technetium Tc 99m exametazime were performed in a total of 88 patients who had suspected intra-abdominal infection or inflammation. Subjects received both Tc 99m labeled leukocytes ...
16.1. How Supplied
Drax Exametazime kit (NDC 65174-200-05) comprises: 5 Single-dose vials (0.5 mg/vial). Each vial contains a non-radioactive sterile, non-pyrogenic lyophilized mixture of: 0.5 mg of exametazime, 7.6 mcg ...
16.2. Storage and Handling
Store Drax Exametazime kit at 15°C-25°C (59°F-77°F). Drax Exametazime is for distribution to and use by persons licensed authorized by the U.S. Nuclear Regulatory Commission or the relevant regulatory ...
17. Patient Counseling Information
<u>Administration Instructions:</u> Advise patients to hydrate after administration of technetium Tc 99m exametazime labeled leukocytes and to void frequently to minimize radiation dose <em>[see Dosage ...