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AMYVID- florbetapir f 18 injection, solution


  1. Patient Information
  2. Revised: 12/2018document Id:

Patient Information 

  • Instruct patients to inform their physician or healthcare provider if they are pregnant or breastfeeding.
  • Inform patients who are breastfeeding to use alternate infant nutrition sources (e.g., stored breast milk or infant formula) for 24 hours (>10 half-lives of radioactive decay for the F 18 isotope) after administration of the drug or avoid use of the drug.

Marketed by Lilly USA, LLC, Indianapolis, IN 46285, USA

Copyright 2012, 2013, Eli Lilly and Company. All rights reserved.

PV 9201 AMP

PACKAGE LABEL Amyvid 30 mL PETNET Label

NDC Code 0002-1200-30 Sterile

AmyvidTMRx Only

CAUTION: RADIOACTIVE MATERIAL

Florbetapir F 18 Injection

____MBq (____mCi) in ____mL at ____:____ on ____

Batch No. ________________

For Intravenous Use.

Contains 0.1 to 19 micrograms of florbetapir, 4.5 mg sodium ascorbate USP and 0.1 mL dehydrated alcohol USP in 0.9% sodium chloride injection USP per milliliter of solution. Store at USP controlled room temperature 25 C (77 F); excursions permitted to 15 C to 30 C (59 F to 86 F).

Expires at ____:____ on ______________

Manufactured by PETNET Solutions, Inc. Knoxville, TN 37932 for Avid Radiopharmaceuticals, a wholly-owned subsidiary of Eli Lilly and Company, Philadelphia, PA 19104

Amyvid 30mL Container Label
AMYVID
florbetapir f 18 injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0002-1200
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLORBETAPIR F-18(UNII: 6W15Z5R0RU) (FLORBETAPIR F-18 - UNII:6W15Z5R0RU)FLORBETAPIR F-1851 mCi in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Ascorbate(UNII: S033EH8359)4.5 mg in 1 mL
Alcohol(UNII: 3K9958V90M)78.9 mg in 1 mL
Sodium Chloride(UNII: 451W47IQ8X)8.1 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0002-1200-301 in 1 CAN06/01/2012
130 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:0002-1200-501 in 1 CAN06/01/2012
250 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20200806/01/2012
Labeler -Eli Lilly and Company (006421325)
Registrant -Eli Lilly and Company (006421325)

Revised: 12/2018document Id: 

957ee1b5-dfa7-4e3f-96e1-6bed1ffc0abeSet id: bb5a5043-0f51-11df-8a39-0800200c9a66Version: 13Effective Time: 20181206Eli Lilly and Company



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