particulate matter and discoloration prior to administration whenever solution and container permit. Should either be observed, the solution should be discarded and fresh solution prepared.
Administration:
RETROVIR IV Infusion is administered intravenously at a constant rate over 1 hour. Rapid infusion or bolus injection should be avoided. RETROVIR IV Infusion should not be given intramuscularly.
HOW SUPPLIED
RETROVIR IV Infusion, 10 mg zidovudine in each mL.
20-mL Single-Use Vial, Tray of 10 (NDC 49702-213-05).
Store vials at 15° to 25°C (59° to 77°F) and protect from light.
Manufactured for:
ViiV Healthcare
Research Triangle Park, NC 27709
by:
GlaxoSmithKline
Research Triangle Park, NC 27709
©2010, ViiV Healthcare. All rights reserved.
September 2010
RTV:1PI
Principal Display Panel
NDC 49702-213-01
RETROVIR®
(zidovudine)
IV INFUSION STERILE
Rx only
Each mL contains 10 mg zidovudine.
20-mL Single-Use Vial
FOR INTRAVENOUS INFUSION ONLY. MUST BE DILUTED FOR ADMINISTRATION.
Dilute with 5% Dextrose Injection to a concentration no greater than 4mg/mL. Contains no preservative. The vial stopper of this product contains dry natural rubber. The vehicle contains Water for Injection, qs. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH. See prescribing information for dosage information. Store at 15o to 25oC (59o to 77oF) and protect from light.
Distributed by: ViiV Healthcare, RTP, NC 27709
Made in UK
10000000088757 Rev.10/10
RETROVIR
zidovudine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49702-213
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIDOVUDINE (ZIDOVUDINE) ZIDOVUDINE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 49702-213-05 10 VIAL In 1 TRAY contains a VIAL, SINGLE-USE (49702-213-01)
1 49702-213-01 20 mL In 1 VIAL, SINGLE-USE This package is contained within the TRAY (49702-213-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019951 11/04/2010
Labeler - ViiV Healthcare Company (027295585)
Revised: 11/2010 ViiV Healthcare Company
