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Botulism Antitoxin Heptavalent (Bat)

Trade Name : BAT

Emergent BIoSolutions Canada Inc.

LIQUID, PLASMA DERIVATIVE

Strength 45003300300060051003000600 [iU]/10mL[iU]/10mL[iU]/10mL[iU]/10mL[iU]/10mL[iU]/10mL[iU]/10mL

EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN B IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN C IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN D IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN E IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN F IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN G IMMUNE FAB2

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Botulism Antitoxin Heptavalent (Bat) which is also known as BAT and Manufactured by Emergent BIoSolutions Canada Inc.. It is available in strength of 4500; 3300; 3000; 600; 5100; 3000; 600 [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL per ml. Read more

Botulism Antitoxin Heptavalent (Bat) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Dosage and Administration, Preparation (2.2) [09/2016]
  • BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) u2013 (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.
  • BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) u2013 (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 solely on efficacy studies conducted in animal models of botulism.
  • BAT is for intravenous use only.
  • For intravenous use only.
  • u00a0
  • BAT is a sterile solution of purified F(ab') plus F(ab')-related immune globulin fragments derived from equine plasma, containing antitoxin activity to botulinum neurotoxins A, B, C, D, E, F, and G.
  • Each single-use vial, regardless of size or fill volume, contains a minimum antitoxin potency of:
  • Each single-use vial contains a minimum potency of:
  • None.
  • None.
  • No data
  • The most common adverse reactions observed in u2265 5 % of healthy volunteers in clinical trials were headache, nausea, pruritus, and urticaria.
  • The most common adverse reactions reported in u2265 1% of patients in a clinical study were pyrexia, rash, chills, nausea and edema.
  • The following serious adverse reactions are discussed in detail in other sections of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioSolutions Canada Inc. at 1-800-768-2304 or FDA at 1-800-FDA-1088 or n
  • BAT contains maltose which can interfere with certain types of blood glucose monitoring systemsn ) Only test systems that are glucose-specific should be used in patients receiving BAT. This interference can result in falsely elevated glucose readings that can lead to untreated hypoglycemia or to inappropriate insulin administration, resulting in life-threatening hypoglycemia.
  • The product information of the blood glucose testing system, including that of the test strips, should be carefully reviewed to determine if the system is appropriate for use with maltose-containing parenteral systems. If any uncertainty exists, contact the manufacturer of the testing system to determine if the system is appropriate for use with maltose-containing parenteral products.
  • No data
  • u2022
  • 8.4 Pediatric Use
  • BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) u2013 (Equine)] is a sterile solution of F(abu2019) and F(ab')-related antibody fragments prepared from plasma obtained from horses that have been immunized with a specific serotype of botulinum toxoid and toxin. To obtain the final heptavalent product, the seven antitoxin serotypes are blended. BAT is supplied in either a 20 or 50 milliliter vial size, with a fill volume ranging from 10 to 22 milliliters per vial. BAT is administered intravenously.
  • The manufacturing process for each antitoxin type includes cation-exchange chromatography to purify the immune globulin fraction, digestion with pepsin to produce F(ab') plus F(ab')-related immune globulin fragments, anion exchange chromatography to remove the pepsin as well as other impurities and filtration. In addition, the manufacturing process includes two viral inactivation/removal steps; solvent/detergent (S/D) treatment and virus filtration [].
  • The S/D treatment step is effective at inactivating known lipid-enveloped viruses such as equine encephalitis, equine arteritis, West Nile virus, equine infectious anemia, equine herpes virus, rabies, and equine influenza. The BAT manufacturing process also includes a robust filtration step that is effective in reducing the levels of some lipid-enveloped viruses (listed above) as well as non-enveloped viruses including equine rhinovirus, equine adenoviruses and adeno-associated viruses, and equine parvovirus.
  • The product potency is expressed in units based on the mouse neutralization assay (MNA). Each unit of BAT is designed to neutralize 10,000 mouse intraperitoneal lethal dose 50% units (MIPLD) of botulinum neurotoxin for serotype A, B, C, D, F, and G and 1,000 MIPLD of serotype E.
  • No data
  • Toxicological studies were not conducted for BAT or its components.
  • The evaluation of new treatment options for botulism using controlled human trials is unethical and infeasible. Therefore the effectiveness of BAT for treatment of botulism is based on well controlled efficacy studies conducted in guinea pigs and rhesus macaques.
  • Guinea Pig
  • In a controlled therapeutic efficacy study, guinea pigs were intoxicated with various BoNT serotypes (A, B, C, D, E, F or G) at a dose of 1.5x guinea pig intramuscular lethal dose 50% units (GPIMLD) via intramuscular injection into the right hind limb. The animals were then treated with either placebo control or 1x scaled human dose of BAT (weight/weight based on an average human body weight of 70 kilograms), after the onset of moderate clinical signs of botulism (right hind limb weakness, salivation, lacrimation, weak limbs and noticeable changes in breathing rate or pattern). Treatment with BAT resulted in a statistically significant improvement in the survival rate of animals across all of the serotypes tested [].
  • Nonhuman Primate
  • In a controlled therapeutic efficacy study, rhesus macaques were intoxicated with BoNT serotype A delivered intravenously at a dose of 1.7x nonhuman primate intravenous lethal dose 50% (NHPLD) units per kilogram of body weight. The animals were then treated with either placebo control or 1x scaled human dose of BAT (weight/weight based on an average human body weight of 70 kilograms), after the onset of clinical signs of botulism (ptosis, muscular weakness, or respiratory distress). Treatment with BAT resulted in a statistically significant improvement in the survival rate [].
  • The effectiveness of BAT is based on efficacy studies demonstrating a survival benefit in animal models of botulism . The safety has been tested in healthy adults and patients with suspected botulism who were treated with BAT under an expanded access clinical study.
  • The pharmacokinetic, pharmacodynamic, and safety profiles of BAT have been evaluated in two clinical studies. In these clinical studies, BAT was shown to have an acceptable safety profile when one or two vials of BAT were administered intravenously to healthy subjects.
  • In a randomized, single-center, double-blind trial the pharmacokinetics and safety of BAT was evaluated in 40 healthy subjects receiving either one (n = 20) or two (n = 20) vials of BAT by IV infusion. Serum BAT levels were measured in the subjects using the Mouse Neutralization Assay (MNA) .
  • In a randomized single center, double-blind trial the pharmacodynamics and safety of BAT was evaluated in 26 healthy subjects receiving either a single vial of BAT (n=16) or placebo (n=10) by IV infusion. The effects of BAT in preventing paralysis of the EDB foot muscle following administration of botulinum neurotoxin serotype A or B was determined .
  • To provide additional support for the efficacy demonstrated in the animal models, a preliminary analysis of data from a Centers for Disease Control and Prevention (CDC) open-label, observational expanded access clinical study for the treatment of subjects with suspected or confirmed botulism with BAT was conducted. Across the 148 subjects treated with BAT in the period analyzed, 109 subjects had a final discharge diagnosis of suspected or confirmed botulism and were included in the analysis population. The median time from the onset of botulism symptoms to treatment with BAT was 3.6 days (range: 0.25 u2013 38 days). Early treatment (u2264 2 days after onset of symptoms) with BAT was associated with a shorter length of hospitalization, duration in intensive care unit (ICU) and duration of mechanical ventilation compared to later treatment [] and is consistent with the mechanism of action ).
  • No data
  • No data
  • See FDA-approved patient labeling (Patient Information).
  • BAT and any and all Emergent BioSolutions Inc. brand, product, service and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All rights reserved.
  • Manufactured By:
  • Emergent BioSolutions Canada Inc.155 Innovation DriveWinnipeg, ManitobaCanada, R3T 5Y3
  • U.S. License No. 2084
  • PATIENT INFORMATION
  • BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) u2013 (Equine)]
  • What is botulism?
  • Botulism is a muscle-paralyzing disease caused by a toxin made by a bacterium called .
  • Botulism can cause the following conditions:
  • Botulism can also cause paralysis and death. After a person is exposed to the toxin, problems can start as early as three hours or as late as a few days. It can take weeks or months to get better. During that time, many people need special care in the hospital.
  • The effectiveness of BAT has been studied in animals with botulism.
  • What is BAT?
  • BAT is a botulism antitoxin made from the plasma of horses. It contains antibody fragments which can neutralize botulism toxins. BAT may make the illness from botulism less severe. Treatment with BAT will not reverse the paralysis, but may decrease the duration and extent of paralysis.
  • Who should use BAT?
  • Your doctor may give you BAT if they suspect that you have been exposed to botulism toxin. You should get the treatment as quickly as possible to stop the progression of the illness.
  • Unless the benefits outweigh the risks, you should not receive BAT if you have a known history of allergies to horses or horse blood products, asthma or hay fever (seasonal allergies).
  • How will you receive BAT?
  • BAT is given as an injection into your vein. Your doctor will determine the dose of BAT. The treatment may take several hours to administer. Your doctor will decide if you need more than one injection.
  • What are the possible or reasonably likely side effects of BAT?
  • The most common side effects of BAT are:
  • Some people have a chilly feeling, difficulty breathing, and have a quick rise in body temperature within the first 20 to 60 minutes after getting BAT. This can be managed by your doctor.
  • BAT can cause allergic reactions. Tell your doctor or go to the emergency department right away if you have trouble breathing, swelling of your tongue or lips, or a very fast heart rate because this can be signs of a serious allergic reaction.
  • Tell your doctor if you get pains in your joints and back, fever, and a rash within one to three weeks after getting BAT. These can be signs of u201cserum sicknessu201d and can last for a few weeks. Your doctor can give you medicine to help with serum sickness.
  • Talk to your doctor about any side effects that concern you. You can ask your doctor for additional prescribing information that is available to healthcare professionals.
  • What other information do you need to know about BAT?
  • BAT is made from horse plasma. The horses are carefully screened and the plasma is carefully cleaned, but there is a small risk that it may give you a virus. Talk to your doctor if you have any symptoms that concern you.
  • You may report side effects directly to Emergent BioSolutions Canada Inc. at 1-800-768-2304 or to the FDAu2019s MedWatch reporting system at 1-800-FDA-1088.
  • BAT and any and all Emergent BioSolutions Inc. brand, product, service and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All rights reserved.
  • Manufactured By:
  • Emergent BioSolutions Canada Inc.155 Innovation DriveWinnipeg, ManitobaCanada, R3T 5Y3
  • US License No. 2084
  • No data
  • No data
  • No data

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