6 Adverse Reactions
Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available.
Fludeoxyglucose Injection
FDA Label NDC 76451-118
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 3d Imaging Drug Design And Development Llc for the product Fludeoxyglucose (NDC 76451-118). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 6 adverse reactions, other, 3 dosage forms and strengths, 16 how supplied, package labels, inner and outer, outer label 30 ml vial, outer label 10 ml vial, outer label 5 ml syringe, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Other
Manufactured by: 3D Imaging Drug Design and Development LLC, 9015 Carti Way, Little Rock AR 72205
Distributed by: 3D Imaging Drug Design and Development LLC, 9015 Carti Way, Little Rock AR 72205
3 Dosage Forms And Strengths
Multiple-dose glass vial or single dose plastic syringe containing 0.74 - 11.1GBq (20 - 300 mCi) /mL of Fludeoxyglucose F 18 Injection and 4.5 mg of sodium chloride in citrate buffer (approximately 16 - 17 mL volume) for intravenous administration. The product may be diluted with sterile saline for injection (USP).
16 How Supplied
Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 10 or 30 mL glass vial or 5 or 10 mL plastic syringe containing between 0.740 – 11.1GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 16 - 17 mL. The contents of each vial are sterile, pyrogen-free, and preservative-free.
Package Labels, Inner And Outer
Outer labels are exterior to the radiation shielding for the product vial and contain the direct labeling information. There is an inner label that can be printed and applied in advance to avoid radiation dose to the operators and is small enough to affix to the vial. The inner label contains the product name and a batch number that positively connects it to the correct outer label. The outer label contains complete package label information and all dose information that is determined at the time of filling.
Outer Label 30 Ml Vial
30 mL Vial, Outer label
Outer Label 30 mL Vial (Vial30fdgouter)
Outer Label 10 Ml Vial
Outer label 10 mL Vial
Outer Label 10 mL Vial (Vial10fdgouter)
Outer Label 5 Ml Syringe
Outer label 5 mL Syringe
Outer Label 5 mL Syringe (Syringe5fdgouter)
Outer Label 10 Ml Syringe
Outer label 10 mL Syringe
Outer Label 10 mL Syringe (Syringe10fdgouter)
Inner Label, All Vials And Syringes
Inner Label, ALL vials and syringes
Inner Label, All Vials And Syringes (Innerall)
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