Desirudin how supplied storage and handling

Desirudin
IPRIVASK® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Labels and Packages
Clinical Trials
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

How Supplied Storage and Handling

Iprivask (desirudin for injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection].

Each Iprivask Vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP.

Each carton of Iprivask (desirudin for injection) contains 10 individual doses of Iprivask, each in a separate tray.

Each tray of Iprivask (desirudin for injection) contains:

• One (1) x 15.75 mg Single Dose Vial
• One (1) x 0.6 mL Prefilled syringe of Diluent
• One (1) Eclipse™ needle
• One (1) Vial Adapter

Each prefilled syringe of diluent contains 0.6 mL Mannitol USP (3% w/v) in Water for Injection provided for reconstitution of the desirudin lyophilized powder.

Storage:

Protect from light.

Unopened vials or prefilled syringes: Store at 25°C (77°F); excursions permitted to 15–30°C (59-86°F). [See USP Controlled Room Temperature.]

Once Iprivask is reconstituted it may be used for up to 24 hours, when stored as indicated above. After 24 hours discard the solution.

Keep this and all medicines out of the reach of children.