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
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
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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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