Pronunciation:

BOT-ue-lizm EE-kwyne hep-ta-VAY-lent an-ti-TOX-in ABCDEFG

Brand Names:

• Botulism Antitoxin Heptavalent ABCDEFG Equine

Uses of This Medicine:

Botulism antitoxin is used to treat symptoms of botulism in patients who are exposed to botulinum toxin.

Botulism is a serious disease that causes paralysis of the muscles. It is caused by a toxin made by a bacteria called Clostridium botulinum. Symptoms of botulism include: double or blurred vision, drooping eyelids, slurred speech, difficulty with breathing or swallowing, dry mouth, or muscle weakness that spreads throughout the body.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of botulism antitoxin in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of botulism antitoxin in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to horses or horse blood products, history of or
• Asthma or
• Hay fever or seasonal allergies—May increase risk of an allergic reaction to occur again.

• Diabetes—This medicine contains maltose, which can interfere with some types of blood glucose monitoring systems. This can result in falsely elevated blood glucose readings which may lead to inappropriate insulin administration or unrecognized hypoglycemia

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

This medicine comes with patient information leaflet. It is very important that you read and understand this information. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, fast or uneven heartbeat, lightheadedness or fainting, tightness in the chest, or any swelling of your hands, face, or mouth after you receive the injection.

Check with your doctor right away if you have back or joint pain, a fever, swollen lymph glands, or a rash within 1 to 3 weeks after receiving this medicine. These can be signs and symptoms of a delayed allergic reaction called serum sickness.

This medicine may cause headaches, chills, nausea, vomiting, or unusual tiredness or weakness, while you are receiving the injection or within 24 hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.

This medicine is made from horse plasma. Some horse blood products have transmitted viruses to people who have received them, although the risk is low. Talk to your doctor if you have any symptoms that concern you.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Headache

hives or welts

itching skin

nausea

rash

redness of the skin

Less common

Chills

fever

throat discomfort

Rare

Chest pain or discomfort

cough

difficulty with breathing

fast, pounding, or irregular heartbeat or pulse

feeling of discomfort

increased sweating

inflammation of the joints

lightheadedness, dizziness, or fainting

muscle aches

no blood pressure or pulse

noisy breathing

slow or irregular heartbeat

stopping of heart

swollen lymph glands

tightness in the chest

unconsciousness

unusual tiredness

Incidence not known

Blurred vision

confusion

difficulty with moving

difficulty with swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

hoarseness

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

muscle cramping

muscle pains or stiffness

noisy breathing

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

sweating

swollen joints

swollen, painful, or tender lymph glands in the neck, armpit, or groin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Anxiety

decrease in the frequency of urination

decrease in urine volume

difficulty in passing urine (dribbling)

dry mouth

hyperventilation

irritability

painful urination

restlessness

shaking

trouble sleeping

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.