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ARGATROBAN injection, solution


  1. Inform Patients Of The Risks Associated With Argatroban Injection As Well As The Plan For Regular Monitoring During Administration Of The Drug. Specifically, Inform Patients To Report:
  2. Patient Information
  3. Specifically, Inform Patients To Report:
  4. Revised: 12/2018document Id:

Inform Patients Of The Risks Associated With Argatroban Injection As Well As The Plan For Regular Monitoring During Administration Of The Drug. Specifically, Inform Patients To Report: 

the use of any other products known to affect bleeding.
any medical history that may increase the risk for bleeding, including a history of severe hypertension; recent lumbar puncture or spinal anesthesia; major surgery, especially involving the brain, spinal cord, or eye; hematologic conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders and gastrointestinal lesions such as ulcerations.
any bleeding signs or symptoms.
the occurrence of any signs or symptoms of allergic reactions (e.g., airway reactions, skin reactions and vasodilation reactions).

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

T2018-13

Patient Information 

Inform patients of the risks associated with Argatroban Injection as well as the plan for regular monitoring during administration of the drug[see Warnings and Precautions (5.1)].

Specifically, Inform Patients To Report: 

  • the use of any other products known to affect bleeding.
  • any medical history that may increase the risk for bleeding, including a history of severe hypertension; recent lumbar puncture or spinal anesthesia; major surgery, especially involving the brain, spinal cord, or eye; hematologic conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders and gastrointestinal lesions such as ulcerations.
  • any bleeding signs or symptoms.
  • the occurrence of any signs or symptoms of allergic reactions (e.g., airway reactions, skin reactions and vasodilation reactions).

Manufactured by:
logo
Lake Zurich, IL 60047

www.fresenius-kabi.com/us

451160H

PACKAGE LABEL-PRINCIPAL DISPLAY - Argatroban 2.5 mL Single Dose Vial Label
Argatroban Injection
250 mg per 2.5 mL
(100 mg per mL)
For intravenous use only.
Must be diluted prior to administration.
Preservative free.
Single Dose Vial Rx only
Discard unused portion.



vial


PACKAGE LABEL
-PRINCIPAL DISPLAY - Argatroban 2.5 mL Single Dose Vial Carton Panel
Argatroban Injection
250 mg per 2.5 mL
(100 mg per mL)
For intravenous use only.
Must be diluted prior to administration.
Preservative free.
Sterile, Nonpyrogenic.
Discard unused portion.
Packaged Individually.
Rx only
Single Dose Vial




box




ARGATROBAN
argatroban injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-526
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARGATROBAN(UNII: IY90U61Z3S) (ARGATROBAN ANHYDROUS - UNII:OCY3U280Y3)ARGATROBAN ANHYDROUS100 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)954 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-526-031 in 1 CARTON03/23/2015
12.5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20181103/23/2015
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Fresenius Kabi USA, LLC840771732MANUFACTURE(63323-526)

Revised: 12/2018document Id: 

4ac40e9f-707e-435f-bb8a-3378a013eba6Set id: e1cf0ad0-0b23-497e-9deb-3de3bf48be44Version: 7Effective Time: 20181203Fresenius Kabi USA, LLC



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