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

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

human botulinum neurotoxin a/b immune globulin (UNII: X641Y30OA7) (human botulinum neurotoxin a/b immune globulin - UNII:X641Y30OA7)

Tersedia dari:

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

INN (Nama Internasional):

human botulinum neurotoxin a/b immune globulin

Komposisi:

human botulinum neurotoxin a/b immune globulin 50 mg in 1 mL

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

BabyBIG® , Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age. - As with other immunoglobulin preparations, BabyBIG should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations.[1-4] - Individuals with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin A. BabyBIG has been studied for safety and efficacy only in patients below one year of age [see ADVERSE REACTIONS (6) and CLINICAL STUDIES (14) ]. It has not been tested in other populations. NDC 68403-1100-7 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).

Status otorisasi:

Biologic Licensing Application

Karakteristik produk

BABYBIG- HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
CALIFORNIA DEPARTMENT OF PUBLIC HEALTH
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BABYBIG, [BOTULISM
IMMUNE GLOBULIN INTRAVENOUS (HUMAN)], SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR BABYBIG.
BABYBIG [BOTULISM IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (BIG-IV)]
LYOPHILIZED POWDER FOR RECONSTITUTION AND INJECTION
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Drug Interactions (7)
06/2021
INDICATIONS AND USAGE
BabyBIG is an immune globulin intravenous (human) indicated for:
Treatment of infant botulism caused by toxin types A or B in patients
below one year of age (1).
DOSAGE AND ADMINISTRATION
INTRAVENOUS USE ONLY (2)
Recommended dose is 1.0 mL/kg (50 mg/kg) given as a single intravenous
infusion (2).
Reconstitute in 2 mL Sterile Water for Injection USP and initiate
infusion within 2 hours of reconstitution
(2.1).
Administer BabyBIG through a separate intravenous line (2.3).
Begin infusion slowly (0.5 mL/kg/h); if no untoward reaction in 15
minutes, increase rate to 1.0 mL/kg/h
(2.2, 2.3).
DO NOT EXCEED THE RECOMMENDED DOSE, CONCENTRATION, AND RATE OF
INFUSION (2.3).
DOSAGE FORMS AND STRENGTHS
Single-use vial of 100 mg ± 20 mg lyophilized immunoglobulin (3)
Reconstitution as directed results in a BabyBIG solution concentration
of 50 mg/mL (2.1)
CONTRAINDICATIONS
Prior history of severe reaction to other human immunoglobulin
preparations (4)
Selective immunoglobulin A deficiency with anti-IgA antibodies (4)
WARNINGS AND PRECAUTIONS
Assess renal function prior to and following administration (5.1,
5.2).
Anaphylaxis and hypersensitivity reactions may occur (5.4). This risk
should be considered when an IgA-
deficient patient is to receive subsequent administration of blood
products containing IgA after previous
treatment with BabyBIG (4).
Hyperproteinemia, increased serum viscosity and hyponatremia may occur
in patients receiving
imm