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BabyBIG

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Overview

What is BabyBIG?

BabyBIG, Botulism Immune Globulin Intravenous (Human) (BIG-IV), is a solvent-detergent-treated, sterile, lyophilized powder of immunoglobulin G (IgG), stabilized with 5% sucrose and 1% albumin (human). It contains no preservative. The purified immunoglobulin is derived from pooled adult plasma from persons who were immunized with pentavalent botulinum toxoid and selected for their high titers of neutralizing antibody against botulinum neurotoxins type A and B. All donors were tested and their sera found to be negative for antibodies against the human immunodeficiency virus and the hepatitis B and hepatitis C viruses.

The pooled plasma was fractionated by cold ethanol precipitation of the proteins according to the Cohn/Oncley method, modified to yield a product suitable for intravenous administration. Several steps in the manufacturing process have been validated for their ability to inactivate or remove viruses that may not have been detected in the Source Plasma.

These include Cohn/Oncley fractionation (Fraction I through Supernatant III Filtrate); nanofiltration through one 75-nm and two 35-nm filters; and solvent/detergent viral inactivation. These viral reduction steps have been validated in a series ofexperiments for their capacity to inactivate and/or remove Human Immunodeficiency Virus type 1 (HIV-1) and the following model viruses: bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; mouse encephalomyelitis virus (MEMV) as a model for hepatitis A virus; and pseudorabies virus (PRV), feline calicivirus (FCV), and Sindbis virus to cover a wide range of physicochemical properties in the model viruses studied. Total mean log reductions range from 4.63 to greater than 16 log as shown in the following table.

Additional testing performed with bovine parvovirus (as a model for parvovirus B19) showed a mean cumulative reduction factor of greater than 7.34 log for Cohn/Oncley fractionation and solvent/detergent treatment followed by hydrophobic chromatography. A mean cumulative reduction factor of 2.55 log was observed for removal of porcine parvovirus by nanofiltration.

When reconstituted with Sterile Water for Injection USP, each cubic centimeter (milliliter) contains approximately 50 ± 10 mg immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg sucrose; 10 mg albumin (human); and approximately 20 × 10 mEq sodium. The reconstituted solution should appear colorless and translucent [].



What does BabyBIG look like?



What are the available doses of BabyBIG?

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

How should I use BabyBIG?

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.

For Intravenous Use Only


What interacts with BabyBIG?

Sorry No Records found


What are the warnings of BabyBIG?

Sorry No Records found


What are the precautions of BabyBIG?

Sorry No Records found


What are the side effects of BabyBIG?

Sorry No records found


What should I look out for while using BabyBIG?

Prior history of severe reaction to other human immunoglobulin preparations ()

Selective immunoglobulin A deficiency with anti-IgA antibodies ()


What might happen if I take too much BabyBIG?

Although limited data are available, clinical experience with other immunoglobulin preparations suggests that the major manifestations would be those related to volume overload.


How should I store and handle BabyBIG?

Store the generator and the eluate, Sodium Pertechnetate Tc99m Injection, below 25°C (77°F). Do not freeze.Store the saline eluent vial below 25°C (77°F). Do not freeze.Storage should be in accordance with local regulations for radioactive materials.Store the generator and the eluate, Sodium Pertechnetate Tc99m Injection, below 25°C (77°F). Do not freeze.Store the saline eluent vial below 25°C (77°F). Do not freeze.Storage should be in accordance with local regulations for radioactive materials.Store the generator and the eluate, Sodium Pertechnetate Tc99m Injection, below 25°C (77°F). Do not freeze.Store the saline eluent vial below 25°C (77°F). Do not freeze.Storage should be in accordance with local regulations for radioactive materials.DiphenhydrAMINE Hydrochloride Injection, USP in parenteral form is supplied as:It is supplied as a sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution, and available in packages of 25.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from light.  Do not freeze. PremierProRx is a registered trademark of Premier, Inc., used under license.DiphenhydrAMINE Hydrochloride Injection, USP in parenteral form is supplied as:It is supplied as a sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution, and available in packages of 25.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from light.  Do not freeze. PremierProRx is a registered trademark of Premier, Inc., used under license.DiphenhydrAMINE Hydrochloride Injection, USP in parenteral form is supplied as:It is supplied as a sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution, and available in packages of 25.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from light.  Do not freeze. PremierProRx is a registered trademark of Premier, Inc., used under license.DiphenhydrAMINE Hydrochloride Injection, USP in parenteral form is supplied as:It is supplied as a sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution, and available in packages of 25.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from light.  Do not freeze. PremierProRx is a registered trademark of Premier, Inc., used under license.DiphenhydrAMINE Hydrochloride Injection, USP in parenteral form is supplied as:It is supplied as a sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution, and available in packages of 25.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from light.  Do not freeze. PremierProRx is a registered trademark of Premier, Inc., used under license.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

BabyBIG contains antibodies specific for botulinum neurotoxin types A and B that bind to and neutralize circulating toxin types A and B in the patient.

Non-Clinical Toxicology
Prior history of severe reaction to other human immunoglobulin preparations ()

Selective immunoglobulin A deficiency with anti-IgA antibodies ()

Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin and concurrent use of these drugs should be avoided.

Oxacillin blood levels may be increased and prolonged by concurrent administration of probenecid which blocks the renal tubular secretion of penicillins. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillins.

Oxacillin-probenecid therapy should be limited to those infections where very high serum levels of oxacillin are necessary.

Only administer BabyBIG as an intravenous infusion, since other routes of administration have not been evaluated. Do not use BabyBIG if the reconstituted solution is turbid [].

Serious adverse reactions were not observed in clinical trials using BabyBIG.

The most common adverse reaction observed with BabyBIG treatment during clinical trials (>5%) was skin rash.

Other reactions such as chills, muscle cramps, back pain, fever, nausea, vomiting, and wheezing were the most frequent adverse reactions observed during the clinical trials of similarly-prepared human IGIV products. The incidence of these reactions was less than 5% of all infusions in BabyBIG clinical trials, and these reactions were most often related to infusion rates.

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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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