Adenosine (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Adenosine Injection, USP is supplied as 20 mL and 30 mL single-dose vials of sterile, nonpyrogenic solution in normal saline as follows:

NDC

Adenosine Injection, USP (3 mg per mL)

Package Factor

67457-856-20

60 mg per 20 mL Single-Dose Vial

1 vial per carton

67457-857-30

90 mg per 30 mL Single-Dose Vial

1 vial per carton

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]

Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use.

Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free.

The container closure is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Advise patients that they may be at increased risk of fatal and nonfatal heart attacks, abnormal heart rhythms, cardiac arrest, heart block, significant increase or decrease in blood pressure, bronchoconstriction, hypersensitivity reactions, seizures, or cerebrovascular accidents with the use of adenosine [see Warnings and Precautions (5.1-5.9)].
Advise patients with COPD or asthma to discuss their respiratory history with their clinician before scheduling a myocardial perfusion imaging study with adenosine [see Warnings and Precautions (5.3)].
Methylxanthines have the potential to impact the effects of adenosine. Instruct patients to avoid consumption of any products containing methylxanthines, including caffeinated coffee, tea or other caffeinated beverages, caffeine-containing drug products, aminophylline, and theophylline prior to the myocardial perfusion imaging study. Question patients about a history of seizures [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Overdosage (10)].
Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.
Manufactured by:
Mylan Laboratories Limited
Bangalore, India
JULY 2022

Package/Label Display Panel

NDC 67457-856-20

Adenosine Injection, USP

60 mg per 20 mL

(3 mg per mL)

For Intravenous Infusion Only

Mylan

Rx only

Single-Dose Vial

Carton Label 20 mL
(click image for full-size original)

Package/Label Display Panel

NDC 67457-857-30

Adenosine Injection, USP

90 mg per 30 mL

(3 mg per mL)

For Intravenous Infusion Only

Mylan

Rx only

Singe-Dose Vial

Carton Label 30 mL
(click image for full-size original)
ADENOSINE adenosine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-856
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
adenosine (adenosine) adenosine 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-856-20 1 VIAL in 1 CARTON contains a VIAL
1 20 mL in 1 VIAL This package is contained within the CARTON (67457-856-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090212 03/28/2014
ADENOSINE adenosine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-857
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
adenosine (adenosine) adenosine 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-857-30 1 VIAL in 1 CARTON contains a VIAL
1 30 mL in 1 VIAL This package is contained within the CARTON (67457-857-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090212 03/28/2014
Labeler — Mylan Institutional LLC (790384502)
Registrant — Mylan Laboratories Limited (650548014)
Establishment
Name Address ID/FEI Operations
Mylan Laboratories Limited 650658052 ANALYSIS (67457-856), ANALYSIS (67457-857), MANUFACTURE (67457-856), MANUFACTURE (67457-857), STERILIZE (67457-856), STERILIZE (67457-857), LABEL (67457-856), LABEL (67457-857), PACK (67457-856), PACK (67457-857)

Revised: 07/2022 Mylan Institutional LLC

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