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GLUCAGON- glucagon injection, powder, lyophilized, for solutionGLUCAGON kit


  1. Patient Information
  2. Each Kit Contains:
  3. Revised: 5/2019document 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)].

NOVAPLUS is a registered trademark of Vizient, Inc.


Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047


www.fresenius-kabi.us

451462A
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PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon 1 mg Vial Label

NP509613

Glucagon for Injection

1 mg per vial


For intramuscular or intravenous injection.

For diagnostic use only.

Reconstitute with Sterile Water for Injection, USPRx only

vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon 1 mg Vial Tray Label

63323-596-16

Glucagon for Injection

For intramuscular or intravenous injection only.

1 mg per vial

For diagnostic use only.

10 Single Dose VialsRx only

Tray

PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon Kit 1 mg Vial Label

NP509603

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

Sterile Waterfor 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
water


PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon Kit 1 mg Vial Carton Panel

Glucagon for Injection


For intramuscular or intravenous injection only.

1 mg per vial

FOR DIAGNOSTIC USE ONLY.

Reconstitute with Sterile Water for Injection, USP immediately

before use.


Each Kit Contains: 

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

Single Dose Vials

Rx only

Carton

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:63323-596-1610 in 1 TRAY05/08/2015
1NDC:63323-596-081 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
GLUCAGON
glucagon kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-594
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-594-031 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:63323-596-061 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
sterile water injection
Product Information
Item Code (Source)NDC:63323-185
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER(UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)WATER1 mg in 1 mL
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(63323-594, 63323-596)

Revised: 5/2019document Id: 

897c7bb7-5a0a-7576-e053-2a95a90a894eSet id: 8c8acad6-44cc-43aa-966b-027e053be8f5Version: 3Effective Time: 20190522Fresenius Kabi USA, LLC



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