Reviews Crotalidae Polyvalent Immune Fab Ovine


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Crofab Drug Description
CROFAB®
[Crotalidae Polyvalent Immune Fab) (Ovine)]
DRUG DESCRIPTION
CroFab® [Crotalidae Polyvalent Immune Fab (Ovine)] is a sterile, nonpyrogenic,
purified, lyophilized preparation of ovine Fab (monovalent) immunoglobulin fragments
obtained from the blood of healthy sheep flocks immunized with one of the following
North American snake venoms: Crotalus atrox (Western Diamondback rattlesnake),
Crotalus adamanteus (Eastern Diamondback rattlesnake), Crotalus scutulatus
(Mojave rattlesnake), and Agkistrodon piscivorus (Cottonmouth or Water
Moccasin). To obtain the final antivenin product, the four different monospecific
antivenins are mixed. Each monospecific antivenin is prepared by fractionating
the immunoglobulin from the ovine serum, digesting it with papain, and isolating
the venom-specific Fab fragments on ion exchange and affinity chromatography
columns.
CroFab is standardized by its ability to neutralize the lethal action of each
of the four venom immunogens following intravenous injection in mice. The potency
of the product will vary from batch to batch; however, a minimum number of mouse
LD50 neutralizing units against each of the four venoms is included
in every vial of final product, as shown in Table 1. For comparison, the minimum
potency of each monospecific component in the batches demonstrated to be efficacious
in clinical trials is also included in Table 1.
Table 1. Minimum Mouse LD50 Neutralizing Units*
for Each Venom Component


Venom
Minimum Potency per Vial of CroFab
Minimum Potency per Vial of Clinical Trial Batches
[95% Reference Interval]


Crotalus atrox
1350
935
[760 - 1200]


Crotalus adamanteus
800
1805
[1320 - 2250]


Crotalus scutulatus
5210
11630
[8000 - 17860]


Agkistrodon piscivorus
460
755
[580 - 980]


* One neutralizing unit is determined as the amount of the
mixed monospecific Fab proteins necessary to neutralize one LD50
of each of the four venoms, where the LD50 is the amount of venom
that would be lethal in 50% of mice.



Each vial of CroFab contains up to 1 g of total protein and sodium phosphate buffer consisting of dibasic sodium phosphate USP and sodium chloride USP. Thimerosal is used as a preservative in the manufacturing process, and as such, mercury is carried over into the final product at an amount no greater than 104.5 mcg per vial, which amounts to no more than 1.9 mg of mercury per dose (based on the maximum dose of 18 vials used in clinical studies of CroFab). The product is intended for intravenous administration after reconstitution with 10 mL of Sterile Water for Injection USP.
Last reviewed on RxList: 9/11/2008




Crofab Drug Description
CROFAB®
[Crotalidae Polyvalent Immune Fab) (Ovine)]
DRUG DESCRIPTION
CroFab® [Crotalidae Polyvalent Immune Fab (Ovine)] is a sterile, nonpyrogenic,
purified, lyophilized preparation of ovine Fab (monovalent) immunoglobulin fragments
obtained from the blood of healthy sheep flocks immunized with one of the following
North American snake venoms: Crotalus atrox (Western Diamondback rattlesnake),
Crotalus adamanteus (Eastern Diamondback rattlesnake), Crotalus scutulatus
(Mojave rattlesnake), and Agkistrodon piscivorus (Cottonmouth or Water
Moccasin). To obtain the final antivenin product, the four different monospecific
antivenins are mixed. Each monospecific antivenin is prepared by fractionating
the immunoglobulin from the ovine serum, digesting it with papain, and isolating
the venom-specific Fab fragments on ion exchange and affinity chromatography
columns.
CroFab is standardized by its ability to neutralize the lethal action of each
of the four venom immunogens following intravenous injection in mice. The potency
of the product will vary from batch to batch; however, a minimum number of mouse
LD50 neutralizing units against each of the four venoms is included
in every vial of final product, as shown in Table 1. For comparison, the minimum
potency of each monospecific component in the batches demonstrated to be efficacious
in clinical trials is also included in Table 1.
Table 1. Minimum Mouse LD50 Neutralizing Units*
for Each Venom Component


Venom
Minimum Potency per Vial of CroFab
Minimum Potency per Vial of Clinical Trial Batches
[95% Reference Interval]


Crotalus atrox
1350
935
[760 - 1200]


Crotalus adamanteus
800
1805
[1320 - 2250]


Crotalus scutulatus
5210
11630
[8000 - 17860]


Agkistrodon piscivorus
460
755
[580 - 980]


* One neutralizing unit is determined as the amount of the
mixed monospecific Fab proteins necessary to neutralize one LD50
of each of the four venoms, where the LD50 is the amount of venom
that would be lethal in 50% of mice.



Each vial of CroFab contains up to 1 g of total protein and sodium phosphate buffer consisting of dibasic sodium phosphate USP and sodium chloride USP. Thimerosal is used as a preservative in the manufacturing process, and as such, mercury is carried over into the final product at an amount no greater than 104.5 mcg per vial, which amounts to no more than 1.9 mg of mercury per dose (based on the maximum dose of 18 vials used in clinical studies of CroFab). The product is intended for intravenous administration after reconstitution with 10 mL of Sterile Water for Injection USP.
Last reviewed on RxList: 9/11/2008




Crofab Drug Description
CROFAB®
[Crotalidae Polyvalent Immune Fab) (Ovine)]
DRUG DESCRIPTION
CroFab® [Crotalidae Polyvalent Immune Fab (Ovine)] is a sterile, nonpyrogenic,
purified, lyophilized preparation of ovine Fab (monovalent) immunoglobulin fragments
obtained from the blood of healthy sheep flocks immunized with one of the following
North American snake venoms: Crotalus atrox (Western Diamondback rattlesnake),
Crotalus adamanteus (Eastern Diamondback rattlesnake), Crotalus scutulatus
(Mojave rattlesnake), and Agkistrodon piscivorus (Cottonmouth or Water
Moccasin). To obtain the final antivenin product, the four different monospecific
antivenins are mixed. Each monospecific antivenin is prepared by fractionating
the immunoglobulin from the ovine serum, digesting it with papain, and isolating
the venom-specific Fab fragments on ion exchange and affinity chromatography
columns.
CroFab is standardized by its ability to neutralize the lethal action of each
of the four venom immunogens following intravenous injection in mice. The potency
of the product will vary from batch to batch; however, a minimum number of mouse
LD50 neutralizing units against each of the four venoms is included
in every vial of final product, as shown in Table 1. For comparison, the minimum
potency of each monospecific component in the batches demonstrated to be efficacious
in clinical trials is also included in Table 1.
Table 1. Minimum Mouse LD50 Neutralizing Units*
for Each Venom Component


Venom
Minimum Potency per Vial of CroFab
Minimum Potency per Vial of Clinical Trial Batches
[95% Reference Interval]


Crotalus atrox
1350
935
[760 - 1200]


Crotalus adamanteus
800
1805
[1320 - 2250]


Crotalus scutulatus
5210
11630
[8000 - 17860]


Agkistrodon piscivorus
460
755
[580 - 980]


* One neutralizing unit is determined as the amount of the
mixed monospecific Fab proteins necessary to neutralize one LD50
of each of the four venoms, where the LD50 is the amount of venom
that would be lethal in 50% of mice.



Each vial of CroFab contains up to 1 g of total protein and sodium phosphate buffer consisting of dibasic sodium phosphate USP and sodium chloride USP. Thimerosal is used as a preservative in the manufacturing process, and as such, mercury is carried over into the final product at an amount no greater than 104.5 mcg per vial, which amounts to no more than 1.9 mg of mercury per dose (based on the maximum dose of 18 vials used in clinical studies of CroFab). The product is intended for intravenous administration after reconstitution with 10 mL of Sterile Water for Injection USP.
Last reviewed on RxList: 9/11/2008




Crofab Drug Description
CROFAB®
[Crotalidae Polyvalent Immune Fab) (Ovine)]
DRUG DESCRIPTION
CroFab® [Crotalidae Polyvalent Immune Fab (Ovine)] is a sterile, nonpyrogenic,
purified, lyophilized preparation of ovine Fab (monovalent) immunoglobulin fragments
obtained from the blood of healthy sheep flocks immunized with one of the following
North American snake venoms: Crotalus atrox (Western Diamondback rattlesnake),
Crotalus adamanteus (Eastern Diamondback rattlesnake), Crotalus scutulatus
(Mojave rattlesnake), and Agkistrodon piscivorus (Cottonmouth or Water
Moccasin). To obtain the final antivenin product, the four different monospecific
antivenins are mixed. Each monospecific antivenin is prepared by fractionating
the immunoglobulin from the ovine serum, digesting it with papain, and isolating
the venom-specific Fab fragments on ion exchange and affinity chromatography
columns.
CroFab is standardized by its ability to neutralize the lethal action of each
of the four venom immunogens following intravenous injection in mice. The potency
of the product will vary from batch to batch; however, a minimum number of mouse
LD50 neutralizing units against each of the four venoms is included
in every vial of final product, as shown in Table 1. For comparison, the minimum
potency of each monospecific component in the batches demonstrated to be efficacious
in clinical trials is also included in Table 1.
Table 1. Minimum Mouse LD50 Neutralizing Units*
for Each Venom Component


Venom
Minimum Potency per Vial of CroFab
Minimum Potency per Vial of Clinical Trial Batches
[95% Reference Interval]


Crotalus atrox
1350
935
[760 - 1200]


Crotalus adamanteus
800
1805
[1320 - 2250]


Crotalus scutulatus
5210
11630
[8000 - 17860]


Agkistrodon piscivorus
460
755
[580 - 980]


* One neutralizing unit is determined as the amount of the
mixed monospecific Fab proteins necessary to neutralize one LD50
of each of the four venoms, where the LD50 is the amount of venom
that would be lethal in 50% of mice.



Each vial of CroFab contains up to 1 g of total protein and sodium phosphate buffer consisting of dibasic sodium phosphate USP and sodium chloride USP. Thimerosal is used as a preservative in the manufacturing process, and as such, mercury is carried over into the final product at an amount no greater than 104.5 mcg per vial, which amounts to no more than 1.9 mg of mercury per dose (based on the maximum dose of 18 vials used in clinical studies of CroFab). The product is intended for intravenous administration after reconstitution with 10 mL of Sterile Water for Injection USP.
Last reviewed on RxList: 9/11/2008




Crofab Drug Description
CROFAB®
[Crotalidae Polyvalent Immune Fab) (Ovine)]
DRUG DESCRIPTION
CroFab® [Crotalidae Polyvalent Immune Fab (Ovine)] is a sterile, nonpyrogenic,
purified, lyophilized preparation of ovine Fab (monovalent) immunoglobulin fragments
obtained from the blood of healthy sheep flocks immunized with one of the following
North American snake venoms: Crotalus atrox (Western Diamondback rattlesnake),
Crotalus adamanteus (Eastern Diamondback rattlesnake), Crotalus scutulatus
(Mojave rattlesnake), and Agkistrodon piscivorus (Cottonmouth or Water
Moccasin). To obtain the final antivenin product, the four different monospecific
antivenins are mixed. Each monospecific antivenin is prepared by fractionating
the immunoglobulin from the ovine serum, digesting it with papain, and isolating
the venom-specific Fab fragments on ion exchange and affinity chromatography
columns.
CroFab is standardized by its ability to neutralize the lethal action of each
of the four venom immunogens following intravenous injection in mice. The potency
of the product will vary from batch to batch; however, a minimum number of mouse
LD50 neutralizing units against each of the four venoms is included
in every vial of final product, as shown in Table 1. For comparison, the minimum
potency of each monospecific component in the batches demonstrated to be efficacious
in clinical trials is also included in Table 1.
Table 1. Minimum Mouse LD50 Neutralizing Units*
for Each Venom Component


Venom
Minimum Potency per Vial of CroFab
Minimum Potency per Vial of Clinical Trial Batches
[95% Reference Interval]


Crotalus atrox
1350
935
[760 - 1200]


Crotalus adamanteus
800
1805
[1320 - 2250]


Crotalus scutulatus
5210
11630
[8000 - 17860]


Agkistrodon piscivorus
460
755
[580 - 980]


* One neutralizing unit is determined as the amount of the
mixed monospecific Fab proteins necessary to neutralize one LD50
of each of the four venoms, where the LD50 is the amount of venom
that would be lethal in 50% of mice.



Each vial of CroFab contains up to 1 g of total protein and sodium phosphate buffer consisting of dibasic sodium phosphate USP and sodium chloride USP. Thimerosal is used as a preservative in the manufacturing process, and as such, mercury is carried over into the final product at an amount no greater than 104.5 mcg per vial, which amounts to no more than 1.9 mg of mercury per dose (based on the maximum dose of 18 vials used in clinical studies of CroFab). The product is intended for intravenous administration after reconstitution with 10 mL of Sterile Water for Injection USP.
Last reviewed on RxList: 9/11/2008





Other reviews about Crotalidae Polyvalent Immune Fab Ovine on wordpress

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Acute Allergic Reactions Associated With CroFab
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In the April 2008 issue of Annals of Emergency Medicine appears an article entitled "Acute Hypersensitivity Reactions Associated with Administration of Crotalidae Polyvalent Immune Fab Antivenom," by Robert […]



Other reviews about Crotalidae Polyvalent Immune Fab Ovine on web:

Crotalidae Polyvalent Immune Fab, Ovine Brand names: CroFabテδ「テつテつ「 Espaテδεつアol: Crotalidae Inmune Fab Polivalente Soluciテδεつウn para inyecciテδεつウn Crotalidae Crotalidae Polyvalent Immune Fab, Ovine: Information from Answers.com


Learn about the prescription medication Crofab (Crotalidae Polyvalent Immune Fab Ovine), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Crofab (Crotalidae Polyvalent Immune Fab Ovine) Drug Information ...


Snakebite poisoning treatment using Crofab ... Crotalidae Polyvalent Immune Fab (Ovine) Introduction. Wyeth-Ayerst's Antivenin Crotalidae Polyvalent (ACP) has been the gold standard of ... Crotalidae Polyvalent Immune Fab (Ovine) | The Children's Hospital ...


Crotalidae Polyvalent Immune Fab (ovine) (CroFabテδ「テつテつ「) is used to treat patients who have been bitten by a rattlesnake. Wha crotalidae polyvalent immune fab - Pharmacy ...


Resources for You. Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics -- Crotalidae Polyvalent Immune Fab (Ovine) (CroFab)


CROFAB テδづつョ CROTALIDAE POLYVALENT IMMUNE FAB (OVINE) DESCRIPTION CroFab テδづつョ [Crotalidae Polyvalent Immune Fab (Ovine)] is a sterile, nonpyrogenic, purified, lyophilized preparation of ovine Fab ... Crotalidae Polyvalent Immune Fab (Ovine)


CROFAB テδづつョ CROTALIDAE POLYVALENT IMMUNE FAB (OVINE) DESCRIPTION CroFab テδづつョ [Crotalidae Polyvalent Immune Fab (Ovine)] is a sterile, nonpyrogenic, purified, lyophilized preparation of ovine ... CROFABテδづつョ CROTALIDAE POLYVALENT IMMUNE FAB (OVINE)


Ask the Librarian! Our librarians will help you research a specific health topic: Conditions InDepth A reference guide to more than 100 health and medical conditions Your Health - Crotalidae Polyvalent Immune FAB (Ovine)


Risk-benefit should be considered when the following medical problems exist テδづつサ Envenomation, history of {01} (treatment with antivenin [Crotalidae] polyvalent immune Fab [ovine ... Antivenin Polyvalent Immune Fab (Ovine) (Systemic) Drug ...


< Back < Back CROTALIDAE POLYVALALENT IMMUNE FAB is an anti-venom. It is used to treat patients who have been bitten by a poisonous snake. This medicine may be used for other purposes ... Drug Finder - Crotalidae Polyvalent Immune Fab, Ovine





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