Xeomin

DRUG DESCRIPTION

The active ingredient of XEOMIN is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A. The botulinum toxin complex is purified from the culture supernatant and then the active ingredient is separated from the proteins (hemagglutinins and non-hemagglutinins) through a series of steps yielding the active neurotoxin with molecular weight of 150 kDa, without accessory proteins. XEOMIN is a sterile white to off-white lyophilized powder intended for intramuscular injection after reconstitution with preservative-free 0.9% Saline for Injection. One vial of XEOMIN contains 50 or 100 Units of incobotulinumtoxinA, 1 mg of human albumin, and 4.7 mg sucrose. One Unit corresponds to the mouse median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions. The method for conducting the assay is specific to XEOMIN, Units of biological activity of XEOMIN cannot be converted into Units of any other botulinum toxin assessed with other specific assays.

What are the precautions when taking incobotulinumtoxin a for injection (Xeomin)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, signs of infection near the injection site, muscle/nerve disorders such as Lou Gehrig's disease (ALS) or myasthenia gravis, seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia).

This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do...

Read All Potential Precautions of Xeomin


Xeomin Consumer (continued)

SIDE EFFECTS: Because this medication is given at the site of your condition, most of the side effects occur close to where the medication is injected. Redness, bruising, infection, and pain at the injection site may occur.

Dizziness, mild difficulty swallowing, respiratory infections such as cold or flu, pain, nausea, headache, and muscle weakness may occur when this medication is used to relax muscles. Double vision, drooping or swollen eyelid, eye irritation, dry eyes, tearing, reduced blinking, and increased sensitivity to light may also occur.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly. You may require protective eye drops/ointments, an eye patch, or other treatment.

When this medication is used to prevent migraines, side effects such as headache, neck pain, and drooping eyelid may occur.

When this medication is used for excessive sweating, side effects such as non-underarm sweating, respiratory infections such as cold or flu, headache, fever, neck or back pain, and anxiety may occur.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, signs of infection near the injection site, muscle/nerve disorders such as Lou Gehrig's disease (ALS) or myasthenia gravis, seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia).

This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Caution is advised if using this drug in children for muscle spasms, because they may be more sensitive to its possible side effects (such as difficulty breathing or swallowing). See Warning section. Discuss the risks and benefits with the doctor.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Use for the cosmetic treatment of wrinkles is not recommended during pregnancy.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding



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