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BABYBIG- human botulinum neurotoxin a/b immune globulin injection, powder, lyophilized, for solution


  1. Patient Information
  2. For Additional Information Concerning Babybig, Contact:
  3. Revised: 11/2015document Id:

Patient Information 

  • Discuss the risks and benefits of BabyBIG use with the patient's legal guardians, including the possibility of adverse reactions, e.g., hypersensitivity reactions such as anaphylaxis, as well as aseptic meningitis, TRALI, hemolysis, renal failure, and thrombosis [seeWARNINGS AND PRECAUTIONS (5)].
  • Inform patient's legal guardians that BabyBIG is made from human plasma and may contain infectious agents that can cause disease. While the risk of transmitting an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing, the patient's guardian should report any symptoms that concern them[seeWARNINGS AND PRECAUTIONS (5.3)].
  • Inform patient's legal guardians that BabyBIG may interfere with immune response to live viral vaccines (e.g., MMR) and instruct them to notify the healthcare provider of this potential interaction when the patient is to receive vaccinations [seeDRUG INTERACTIONS (7)].

For Additional Information Concerning Babybig, Contact: 

Infant Botulism Treatment and Prevention Program
California Department of Public Health
850 Marina Bay Parkway, Room E-361
Richmond, California 94804
Telephone: 510-231-7600
US Govt. License No. 1797

Manufactured by:
Baxter Healthcare Corporation
Westlake Village, CA 91362, USA
US Govt. License No. 140; and

Cangene Corporation
Winnipeg, Manitoba, R3T 5Y3, Canada
US Govt. License No. 1201

Distributed by:
FFF Enterprises
Temecula, California 92591, USA

Distributed for:
Infant Botulism Treatment and Prevention Program
California Department of Public Health
850 Marina Bay Parkway, Room E-361
Richmond, California 94804

Revised October 2011

PRINCIPAL DISPLAY PANEL - 2 mL Vial Label

Botulism Immune Globulin Intravenous
(Human) (BIG-IV)

BabyBIG

DO NOT SHAKE VIAL
AFTER RECONSTITUTION;
AVOID FOAMING.

See package insert for
reconstitution, dosage, and
administration. Rx only.
Single use container.

Manufactured for:
California Department of
Public Health
by: Baxter Healthcare
Corporation and
Cangene Corporation

LOT
EXP.

PRINCIPAL DISPLAY PANEL - 2 mL Vial Label

PRINCIPAL DISPLAY PANEL - 1 Single Use Vial Carton

NDC 68403-1100-6

Rx Only

100 mg IgG, 100 mg Sucrose
20 mg Albumin (Human)
Lyophilized
Solvent Detergent Treated

Botulism Immune Globulin
Intravenous (Human) (BIG-IV)

BabyBIG

Store between 2 C and 8 C (35.6 F and 46.4 F).

PRINCIPAL DISPLAY PANEL - 1 Single Use Vial Carton
BABYBIG
human botulinum neurotoxin a/b immune globulin injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68403-1100
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
human botulinum neurotoxin a/b immune globulin(UNII: X641Y30OA7) (human botulinum neurotoxin a/b immune globulin - UNII:X641Y30OA7)human botulinum neurotoxin a/b immune globulin50 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
sucrose(UNII: C151H8M554)50 mg in 1 mL
albumin human(UNII: ZIF514RVZR)10 mg in 1 mL
sodium phosphate, monobasic, anhydrous(UNII: KH7I04HPUU)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68403-1100-61 in 1 CARTON
12 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12503410/23/2003
Labeler -CALIFORNIA DEPARTMENT OF PUBLIC HEALTH (004519216)
Establishment
NameAddressID/FEIBusiness Operations
Baxalta Inc.085206634MANUFACTURE(68403-1100)
Establishment
NameAddressID/FEIBusiness Operations
Cangene BioPharma Inc.050783398MANUFACTURE(68403-1100)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Pharma Solutions962674474LABEL(68403-1100) , PACK(68403-1100)

Revised: 11/2015document Id: 

9137e6f2-aef9-407a-8e55-326b67e27b65Set id: 9ec59262-35c1-4d8e-8451-a7cfbacb0675Version: 9Effective Time: 20151102CALIFORNIA DEPARTMENT OF PUBLIC HEALTH



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