CROFAB- ovine crotalidae venoms immune fab injection, powder, lyophilized, for solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE) (UNII: RBR61YAJ4V) (CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE) - UNII:RBR61YAJ4V), AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE) (UNII: IA6O0K772M) (AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE) - UNII:IA6O0K772M), CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE) (UNII: 7WZ1744G86) (CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE) - UNII:7WZ1744G86), CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE) (UNII: A4229A7019) (CROTALUS ADAMANTEUS IMMUNE FA

Dostopno od:

BTG International Inc.

INN (mednarodno ime):

CROTALUS ATROX IMMUNE FAB ANTIVENIN - UNII:RBR61YAJ4V)

Sestava:

CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE) 1 g

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

CROFAB is indicated for the management of adult and pediatric patients with North American crotalid envenomation. The term crotalid is used to describe the Crotalinae subfamily (formerly known as Crotalidae) of venomous snakes which includes rattlesnakes, copperheads and cottonmouths/water moccasins. Do not administer CROFAB to patients with a known history of hypersensitivity to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available. Risk Summary Animal reproduction studies have not been conducted with CROFAB. It is also not known whether CROFAB can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CROFAB should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary It is not known whether CROFAB is excret

Povzetek izdelek:

How Supplied CROFAB is supplied as a carton that contains 2 vials of product (diluent not included) [NDC 50633-110-12]. Each vial of CROFAB contains up to 1 gram of lyophilized total protein and not less than the indicated number of mouse LD50 neutralizing units: Storage and Handling

Status dovoljenje:

Biologic Licensing Application

Lastnosti izdelka

CROFAB- OVINE CROTALIDAE VENOMS IMMUNE FAB INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
BTG INTERNATIONAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CROFAB SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CROFAB.
CROFAB CROTALIDAE POLYVALENT IMMUNE FAB (OVINE)
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Dosage and Administration, Preparation and Administration (2.2)
01/2018
Dosage Forms and Strengths (3)
01/2018
Warning and Precautions, Mercury Toxicity (5.3) - REMOVED
01/2018
Use in Specific Population (8)
01/2018
Description (11)
01/2018
INDICATIONS AND USAGE
CROFAB is a sheep-derived antivenin indicated for the management of
adult and pediatric patients with
North American crotalid envenomation. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY
Initiate administration as soon as possible after snake bite in
patients who develop signs of
envenomation (e.g. local injury, coagulation abnormality or systemic
signs of envenomation)
Dose: (2.1)
Recommended initial dose is between 4 and 6 vials
Observe patient for up to one hour after the initial dose and give an
additional 4-6 vial dose as
needed to gain initial control of envenomation
After initial control is established, administer additional 2-vial
doses every 6 hours for 18 hours (total
of 3 doses)
Preparation and Administration: (2.2)
Reconstitute each vial of CROFAB with 18 mL of 0.9% Sodium Chloride
and mix by continuous
manual inversion at the rate of one to two inversions per second until
no solid material is visible in
the vial (contents will remain opalescent)
Do not shake as this can cause foaming
Further dilute the entire dose with 0.9% Sodium Chloride to a total
volume of 250 mL
Infuse each dose intravenously over at least 1 hour
DOSAGE FORMS AND STRENGTHS
CROFAB is available as lyophilized powder. Each vial contains up to 1
gram of total protein and not less
than the indicated number of mouse LD n