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GLUCAGON injection, powder, lyophilized, for solutionGLUCAGON kit


  1. Patient Information
  2. For Diagnostic Use Only.reconstitute With Sterile Water For Injection, Usp Immediately Before Use.each Kit Contains:
  3. Revised: 4/2016document Id:

Patient Information 

  • Inform patients that generalized allergic reactions have been reported with glucagon treatment including generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. Advise patients to monitor and report any signs or symptoms of a hypersensitivity reaction[seeWarnings and Precautions (5.5)].
  • Inform patients that hypoglycemia has occurred with treatment with glucagon. Inform patients of the symptoms of hypoglycemia and how to treat it. Advise patients to avoid driving or operating machinery until ingesting a meal. Advise patients to inform their health care provider if hypoglycemia occurs so that treatment may be given if necessary[seeAdverse Reactions (6)].
  • Inform patients with diabetes mellitus that treatment with Glucagon for Injection may increase their risk of hyperglycemia[see Warnings and Precautions (5.3)].
  • Inform patients with cardiac disease that treatment with Glucagon for Injection may increase their risk of a transient increase in blood pressure and heart rate[see Warnings and Precautions (5.4)].

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Lake Zurich, IL 60047

www.fresenius-kabi.us

451081C

PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon Kit 1 mg Vial Label
509603
Glucagon for Injection
1 mg per vial
For intramuscular or intravenous injection.
For diagnostic use only.
Reconstitute with Sterile Water for Injection, USP Rx only



vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon Kit 1 mL Diluent Vial Label
NDC 63323-185-03
95127
Sterile Water for Injection, USP
1 mL per vial
FOR DRUG DILUENT USE ONLY.
Contains no antimicrobial or other added substance. Do not
give intravenously unless rendered nearly Isotonic.
Discard unused portion.
1 mLSingle Dose Vial Rx only



vial




PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon Kit 1 mg Vial Carton Panel
Glucagon for Injection
1 mg per vial
For intramuscular or intravenous injection only.

For Diagnostic Use Only.reconstitute With Sterile Water For Injection, Usp Immediately Before Use.each Kit Contains: 

  • One single use vial with 1 mg of Glucagon for Injection
  • One single use vial with 1 mL of Sterile Water for Injection, USP

Single Use Vials
Rx only

carton

PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon 1 mg Vial Label
Glucagon for Injection
1 mg per vial
For intramuscular or intravenous injection.
For diagnostic use only.
Reconstitute with Sterile Water for Injection, USP Rx only



509613 vial


PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon 1 mg Vial Tray Label
Glucagon for Injection
1 mg per vial
For intramuscular or intravenous injection only.
For diagnostic use only.
10 VialsRx only



509613 tray
GLUCAGON
glucagon injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-596
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLUCAGON HYDROCHLORIDE(UNII: 1H87NVF4DB) (GLUCAGON - UNII:76LA80IG2G)GLUCAGON1 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-596-1310 in 1 TRAY05/08/2015
11 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20184905/08/2015
GLUCAGON
glucagon kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-593
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-593-031 in 1 CARTON; Type 1: Convenience Kit of Co-Package12/01/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL, SINGLE-USE1 mL
Part 21 VIAL, SINGLE-USE1 mL
Part 1 of 2
GLUCAGON
glucagon injection, powder, lyophilized, for solution
Product Information
Item Code (Source)NDC:63323-596
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLUCAGON HYDROCHLORIDE(UNII: 1H87NVF4DB) (GLUCAGON - UNII:76LA80IG2G)GLUCAGON1 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-596-031 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20184905/08/2015
Part 2 of 2
WATER
water liquid
Product Information
Item Code (Source)NDC:63323-185
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Inactive Ingredients
Ingredient NameStrength
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-185-031 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08840011/23/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20184912/01/2015
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Fresenius Kabi USA, LLC023648251MANUFACTURE(63323-593, 63323-596)

Revised: 4/2016document Id: 

cc829cfc-5792-4216-bb90-8bb1fd2e95ccSet id: e4be1c0e-0fe6-45a0-9229-5cde98434b84Version: 3Effective Time: 20160429Fresenius Kabi USA, LLC



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