Patient Medication Information: uses, side effects, how to take - Bat
Serious Warnings and Precautions
- Prepare for monitoring and management of hypersensitivity reactions, infusion reactions or delayed allergic reactions (serum sickness)
- BAT is prepared using pools of equine plasma, therefore may carry the risk of transmitting infectious agents (see Transmission of Infectious Agents section)
What BAT is used for:
- BAT is a botulism antitoxin made from the plasma of horses which may make the illness from botulism less severe.
- Botulism is a muscle-paralyzing disease caused by the toxin made by a bacterium called Clostridium botulinum which can cause the following conditions: double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, muscle weakness that spreads through the body and difficulty breathing. BAT can also cause paralysis and death.
- Treatment with BAT will not reverse the paralysis but may decrease the duration and extent of paralysis.
How BAT works:
BAT contains antibody fragments which can neutralize botulism toxins. 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
“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR DOCUMENTED OR SUSPECTED EXPOSURE TO BOTULINUM NEUROTOXIN SEROTYPES A, B, C, D, E, F AND G BASED ON LIMITED CLINICAL TESTING IN HUMANS”
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.
The ingredients in BAT are:
Medicinal ingredient(s): antitoxins to serotypes A to G.
Non-medicinal ingredient(s): maltose, polysorbate 80
BAT comes in the following dosage form(s):
BAT is a sterile solution for intravenous injection provided in a single use 50 mL glass vial. Each vial contains a minimum potency of >4500 U serotype A antitoxin, >3300 U serotype B antitoxin, >3000 U serotype C antitoxin, >600 U serotype D antitoxin, >5100 U serotype E antitoxin, and >3000 U serotype F antitoxin, and >600 U serotype G antitoxin as listed in 6 Dosage Forms, Strengths, Composition, and Packaging.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BAT. Talk about any health conditions or problems you may have, including if you:
- You have experienced allergic reactions to horses, horse blood products, asthma or hay fever in the past.
Are pregnant or nursing.
Other warnings you should know about:
- BAT is made from horse plasma and therefore may contain infectious agents such as viruses that can cause disease. This risk has been reduced by screening the horses for certain viruses and by inactivating or removing viruses during the manufacturing process.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with BAT:
- Drugs that may interact with BAT have not been established.
- BAT contains maltose that can interfere with certain types of blood glucose monitoring systems (tests that check the level of sugar in your body).
How to take BAT:
BAT will be administered by a healthcare professional by an injection into your vein.
Usual dose:
Your doctor will determine the dose of BAT. The treatment may take several hours to administer.
Possible side effects from using BAT:
The most common side effects of BAT are headaches, fever, rash, hives, chills, nausea and swelling. 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.
Tell your healthcare professional 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 healthcare professional 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 “serum sickness” and can last for a few weeks.
These are not all the possible side effects you may have when taking BAT. If you experience any side effects not listed here, tell your healthcare professional.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
UNCOMMON Hemodynamic Instability | √ | √ | |
| Serum Sickness | √ | √ | |
| Anaphylaxis | √ | √ | |
| Allergic Reaction (trouble breathing, swollen tongue or lips, fast heart rate) | √ | √ | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or;
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store frozen at or below -15°C until used. Do not refreeze.
Keep out of reach and sight of children.
If you want more information about BAT:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website (www.emergentbiosolutions.com); via email at medicalinformation@ebsi.com, or by calling 1-800-768-2304
Date of Authorization: 2025-10-31
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.