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CroFab

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Overview

What is CroFab?

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 LD neutralizing units against each of the four venoms is included in every vial of final product, as shown in

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 30 mcg per vial, which amounts to no more than 0.6 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 18 mL of 0.9% Saline.



What does CroFab look like?



What are the available doses of CroFab?

CROFAB is available as lyophilized powder. Each vial contains up to 1 gram of total protein, a maximum of 0.03 mg of mercury, and not less than the indicated number of mouse LD neutralizing units:

What should I talk to my health care provider before I take CroFab?

How should I use CroFab?

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.

For intravenous use only


What interacts with CroFab?

Sorry No Records found


What are the warnings of CroFab?

Sorry No Records found


What are the precautions of CroFab?

Sorry No Records found


What are the side effects of CroFab?

Sorry No records found


What should I look out for while using CroFab?

CROFAB should not be administered 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.


What might happen if I take too much CroFab?

Sorry No Records found


How should I store and handle CroFab?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged by: Thousand Oaks, CA 91320Revised: 04/16CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged by: Thousand Oaks, CA 91320Revised: 04/16CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged by: Thousand Oaks, CA 91320Revised: 04/16CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged by: Thousand Oaks, CA 91320Revised: 04/16CTI-12 Rev. C CROFAB is supplied as a carton that contains 2 vials of product (diluent not included). Each vial of CROFAB contains up to 1 gram of lyophilized total protein and not less than the indicated number of mouse LD neutralizing units: NDC 50633-110-12CROFAB is supplied as a carton that contains 2 vials of product (diluent not included). Each vial of CROFAB contains up to 1 gram of lyophilized total protein and not less than the indicated number of mouse LD neutralizing units: NDC 50633-110-12


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Clinical Information

Chemical Structure

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Clinical Pharmacology

CROFAB is a venom-specific Fab fragment of immunoglobulin G (IgG) that works by binding and neutralizing venom toxins, facilitating their redistribution away from target tissues and their elimination from the body.

Non-Clinical Toxicology
CROFAB should not be administered 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.

Coagulopathy is a complication noted in many victims of viper envenomation that arises due to the ability of the snake venom to interfere with the blood coagulation cascade [, , ], and is seen more frequently in severely envenomated patients. In clinical trials with CROFAB, recurrent coagulopathy (the return of a coagulation abnormality after it has been successfully treated with antivenin), characterized by decreased fibrinogen, decreased platelets, and elevated prothrombin time, occurred in approximately half of patients studied. The clinical significance of these recurrent abnormalities is not known. Recurrent coagulation abnormalities were observed only in patients who experienced coagulation abnormalities during their initial hospitalization, although coagulopathy can initially appear at any time before, during or after treatment. Optimal dosing to completely prevent recurrent coagulopathy has not been determined. Because CROFAB has a shorter persistence in the blood than crotalid venoms that can leak from depot sites over a prolonged period of time, repeat dosing to prevent or treat such recurrence may be necessary ().

Recurrent coagulopathy may persist for 1 to 2 weeks or more. Patients who experience coagulopathy due to snakebite during hospitalization for initial treatment should be monitored for signs and symptoms of recurrent coagulopathy for up to 1 week or longer at the physician’s discretion. During this period, the physician should carefully assess the need for re-treatment with CROFAB and use of any type of anticoagulant or anti-platelet drug.

Because snake envenomation can cause coagulation abnormalities, the following conditions, which are also associated with coagulation defects, should be considered: cancer, collagen disease, congestive heart failure, diarrhea, elevated temperature, hepatic disorders, hyperthyroidism, poor nutritional state, steatorrhea, vitamin K deficiency.

Adverse reactions that occurred in ≥5% of subjects were urticaria, rash, nausea, pruritus and back pain.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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