This result is different from that in the PRISM-PLUS study, where the arm that included AGGRASTAT without heparin (n=345) was dropped at an interim analysis by the Data Safety Monitoring Committee for increased mortality at 7 days.
16 HOW SUPPLIED/STORAGE AND HANDLING
AGGRASTAT is supplied as a clear, non-preserved, colorless, isosmotic, sterile premixed solution with sodium chloride for tonicity adjustment.
Table 7 AGGRASTAT product details
Strength Total Amount Packaging NDC #
50 mcg/mL 5 mg/100 mL bag 25208-002-01
50 mcg/mL 12.5 mg/250 mL bag 25208-002-02
50 mcg/mL 5 mg/100 mL vial 25208-002-03
250 mcg/mL 3.75 mg/15 mL bolus vial 25208-001-04
FOR INTRAVENOUS USE ONLY
Store AGGRASTAT at controlled room temperature, 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) [see USP]. Do not freeze. Protect from light during storage.
17 PATIENT COUNSELING INFORMATION
Advise patients to watch closely for any signs of bleeding or bruising and to report these to their health care provider when they occur.
Advise patients to discuss with their health care provider their use of any other medications, including over-the-counter or herbal products prior to AGGRASTAT use.
Patent: www.medicure.com/aggrastat/patents
AGGRASTAT is manufactured for:
MEDICURE INTERNATIONAL, INC.
by:
BAXTER HEALTHCARE CORPORATION
Deerfield, Illinois 60015 USA
And
EMERGENT BIOSOLUTIONS
Baltimore, Maryland 21230 USA
Distributed by:
MEDICURE PHARMA, INC.
Somerset, NJ 08873 USA
1-800-509-0544
Printed in USA
PIM-05
* Registered trademark of Medicure International, Inc.
© 2016
Copyright used under license.
All rights reserved.
Intravia is a registered trademark of Baxter International Inc.
PRINCIPAL DISPLAY PANEL
Insert
Insert
PRINCIPAL DISPLAY PANEL
Container
Container
PRINCIPAL DISPLAY PANEL
Carton
Carton
PRINCIPAL DISPLAY PANEL
Insert
Insert
PRINCIPAL DISPLAY PANEL
Container
Container
PRINCIPAL DISPLAY PANEL
Carton
Carton
CARTON 3.75 MG/15 ML
small-carton
LABEL 3.75 MG/15 ML
15mL-label
CARTON 5 MG/100 ML
carton-100mL
LABEL 5 MG/100 ML
label-5mg
INGREDIENTS AND APPEARANCE
AGGRASTAT
tirofiban injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25208-002
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIROFIBAN HYDROCHLORIDE (UNII: 6H925F8O5J) (TIROFIBAN - UNII:GGX234SI5H) TIROFIBAN 5 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 3.2 mg in 100 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 54 mg in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 900 mg in 100 mL
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:25208-002-01 1 in 1 CARTON 05/14/1998
1 100 mL in 1 CONTAINER; Type 0: Not a Combination Product
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