facebook
Subscribe50$/product give away!


Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

ARGATROBAN injection


  1. Patient Information
  2. Specifically Inform Patients To Report:
  3. Revised: 10/2019document Id:

Patient Information 

Inform patients of the risks associated with Argatroban Injection as well as the plan for regular monitoring during administration of the drug[seeWarnings 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:
Cipla Ltd., India for
Sandoz Inc.
Princeton, NJ 08540

Principal Display Panel - Carton Label

NDC0781-3314-95

Argatroban Injection

50 mg per 50 mL
(1 mg per mL)

For Intravenous Infusion Only

Rx only 10 Single Use Vials

SANDOZ
a Novartis Company

Principal Display Panel - Carton Label

Principal Display Panel - Carton Label

NDC0781-3314-91

Argatroban
Injection

50 mg per 50 mL

(1 mg per mL)

Do not dilute prior to administration

For Intravenous Infusion Only

Discard Unused Portion

Rx only

Single Use Vial

SANDOZ
a Novartis Company

Principal Display Panel - Carton Label

Principal Display Panel - Vial Label

NDC0781-3314-91Rx Only

Argatroban Injection

50 mg per 50 mL

(1 mg per mL)

Principal Display Panel - Vial Label
ARGATROBAN
argatroban injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-3314
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Argatroban(UNII: IY90U61Z3S) (Argatroban Anhydrous - UNII:OCY3U280Y3)Argatroban Anhydrous1 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
Lactobionic acid(UNII: 65R938S4DV)2 mg in 1 mL
Methionine(UNII: AE28F7PNPL)2 mg in 1 mL
Sodium Chloride(UNII: 451W47IQ8X)8 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-3314-9510 in 1 CARTON02/03/2017
1NDC:0781-3314-911 in 1 CARTON
150 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02243409/06/2011
Labeler -Sandoz Inc (005387188)
Establishment
NameAddressID/FEIBusiness Operations
Cipla Limited650072015MANUFACTURE(0781-3314)

Revised: 10/2019document Id: 

cd107022-289f-4945-8b8f-5276068f941dSet id: 641c4c2b-87a3-44ca-a126-f83a4d58e988Version: 13Effective Time: 20191016Sandoz Inc



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: pharmacyhq.mail@gmail.com