BAT- botulism antitoxin heptavalent liquid

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2 (UNII: LE3J6I6DXP) (EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2 - UNII:LE3J6I6DXP), EQUINE BOTULINUM NEUROTOXIN B IMMUNE FAB2 (UNII: VSK09VP4HL) (EQUINE BOTULINUM NEUROTOXIN B IMMUNE FAB2 - UNII:VSK09VP4HL), EQUINE BOTULINUM NEUROTOXIN C IMMUNE FAB2 (UNII: X5I2P7E9TY) (EQUINE BOTULINUM NEUROTOXIN C IMMUNE FAB2 - UNII:X5I2P7E9TY), EQUINE BOTULINUM NEUROTOXIN D IMMUNE FAB2 (UNII: 30Y9N0SEBE) (EQUINE BOTULINUM NEUROTOXIN D IMMUNE FAB2 - UNII:30Y9N0SEBE), EQUINE BOTUL

Dostupné s:

Emergent BIoSolutions Canada Inc.

INN (Mezinárodní Name):

EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2

Složení:

EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2 4500 [iU] in 10 mL

Podání:

INTRAVENOUS

Terapeutické indikace:

BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] is a mixture of immune globulin fragments indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients. The effectiveness of BAT is based on efficacy studies conducted in animal models of botulism. None. Risk Summary There are no human or animal data to establish the presence or absence of BAT associated risk. Risk Summary There are no data to assess the presence or absence of BAT in human milk, the effects on the breastfed child or the effects on milk production/excretion. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for BAT and any potential adverse effects on the breastfed child from BAT or from the underlying maternal condition. The effectiveness of BAT has not been established in pediatric patients. Limited pediatric safety data are available. Fifteen pediat

Přehled produktů:

BAT is supplied in either 20 milliliter or 50 milliliter glass vials seated with a butyl rubber stopper and an aluminum seal with a plastic flip-top cap, with a fill volume ranging from 10 to 26 milliliters per vial. Each vial, regardless of size or fill volume contains a minimum potency of > 4,500 U serotype A antitoxin, > 3,300 U serotype B antitoxin, > 3000 U serotype C antitoxin, > 600 U serotype D antitoxin, > 5,100 U serotype E antitoxin, > 3,000 U serotype F antitoxin, and > 600 U serotype G antitoxin. BAT is not made with natural rubber latex.

Stav Autorizace:

Biologic Licensing Application

Charakteristika produktu

BAT- BOTULISM ANTITOXIN HEPTAVALENT LIQUID
EMERGENT BIOSOLUTIONS CANADA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BAT
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BAT .
BAT , [BOTULISM ANTITOXIN HEPTAVALENT (A, B, C, D, E, F, G) -
(EQUINE)]
STERILE SOLUTION FOR INJECTION
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) –
(Equine)] is a mixture of immune globulin
fragments indicated for the treatment of symptomatic botulism
following documented or suspected
exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in
adults and pediatric patients. (1)
The effectiveness of BAT is based solely on efficacy studies conducted
in animal models of botulism. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY. (2)
PATIENT
GROUP (2)
DOSE (2)
STARTING INFUSION
RATE (2)
(FIRST 30 MINUTES)
(2)
INCREMENTAL INFUSION
RATE IF TOLERATED (2)
(EVERY 30 MINUTES)
(2)
MAXIMUM
INFUSION RATE (2)
Adults (2)
(≥ 17 years)
(2)
One vial (2)
0.5 mL/min (2)
Double the rate (2)
2 mL/min (2)
Pediatric (2)
(1 year to <
17 years) (2)
20 – 100% of adult
dose (2)
0.01 mL/kg/min (2)
Do not exceed the
adult rate (2)
0.01 mL/kg/min (2)
0.03 mL/kg/min (2)
Do not exceed the
adult rate (2)
Infants (2)
(< 1 year) (2)
10% of adult dose
regardless of body
weight (2)
0.01 mL/kg/min (2)
0.01 mL/kg/min (2)
0.03 mL/kg/min (2)
DOSAGE FORMS AND STRENGTHS
Each single-use vial contains a minimum potency of: (3)
•
•
•
•
•
•
•
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
®
®
®
Administer BAT by slow intravenous infusion after dilution 1:10 in
normal saline at the dose
recommended in the following table.
4,500 Units (U) for serotype A antitoxin,
3,300 U for serotype B antitoxin,
3,000 U for serotype C antitoxin,
600 U for serotype D antitoxin,
5,100 U for serotype E antitoxin,
3,000 U for serotype F antitoxin, and
600 U for serotype G antitoxin.
Hypersensitiv