SODIUM FLUORIDE F 18 Solution for injection (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
Shertech Laboratories, LLC
Λέξεις κλειδιά
16129-002
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1. Indications and Usage
Sodium Fluoride F18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity.
2. Dosage and Administration
2.1 Radiation Safety Drug Handling Wear waterproof gloves and effective shielding when handling Sodium Fluoride F18 Injection. Use appropriate safety measures, including shielding, consistent with proper ...
3. Dosage Forms and Strengths
Multiple-dose vial containing 374 MBq/mL – 7,400 MBq/mL (10 mCi/mL – 200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride ...
4. Contraindications
None.
5. Warnings and Precautions
5.1 Allergic Reactions As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available. 5.2 Radiation ...
6. Adverse Reactions
No adverse reactions have been reported for Sodium Fluoride F18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. ...
7. Drug Interactions
The possibility of interactions of Sodium Fluoride F18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.
8.1. Pregnancy
Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F18 Injection has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the ...
8.3. Nursing Mothers
It is not known whether Sodium Fluoride F18 Injection is excreted into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, ...
8.4. Pediatric Use
In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq–148 MBq (0.5 mCi 4 mCi) were used. Sodium Fluoride F18 was shown to localize to areas ...
11. Description
11.1 Chemical Characteristics Sodium Fluoride F18 Injection, USP is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F18 that is used for diagnostic purposes in ...
12.1. Mechanism of Action
Fluoride F18 ion normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition ...
12.2. Pharmacodynamics
Increased fluoride F18 ion deposition in bone can occur in areas of increased osteogenic activity during growth, infection, malignancy (primary or metastatic) following trauma, or inflammation of bone. ...
12.3. Pharmacokinetics
After intravenous administration, fluoride F18 ion is rapidly cleared from the plasma in a biexponential manner. The first phase has a half-life of 0.4 h, and the second phase has a half-life of 2.6 h. ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies to assess reproductive toxicity, mutagenesis and carcinogenesis potential of Sodium Fluoride F18 Injection have not been performed.
14. Clinical Studies
14.1 Metastatic Bone Desease The doses used in reported studies ranged from 2.7 mCi to 20 mCi (100 MBq to 740 MBq), with an average median dose of 10 mCi (370 MBq) and an average mean dose of 9.2 mCi (340 ...
15. References
Stablin, M.G., Stubbs, J.B. and Toohey R.E., <em>Radiation Dose Estimates for Radiopharmaceuticals</em>, U.S. Nuclear Regulatory Commission report NUREG/CR-6345, page 10, 1996. <em>Radiation Dose to Patients ...
16.1. How Supplied
Sodium Fluoride F18 Injection, USP is supplied in a multiple-dose Type I glass vial with (elastomeric) stopper and aluminum crimp seal containing between 374 MBq/mL 7,400 MBq/mL (10 mCi/mL 200 mCi/mL) ...
16.2. Storage and Handling
Storage Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C–30°C (59°F–86°F). Use the solution within 12 hours of the EOS reference time. Handling Receipt, transfer, handling, possession, or use ...
17. Patient Counseling Information
17.1 Pre-study Hydration Encourage patients to drink at least 500 mL of water prior to drug administration. 17.2 Post-study Voiding To help protect themselves and others in their environment, patients ...