DYSPORT - botulinum toxin type a injection, powder, lyophilized, for solution
Galderma Laboratories, L.P.
What is the most important information I should know about DYSPORT?
DYSPORT may cause serious side effects that can be life threatening including:
• Problems breathing or swallowing
• Spread of toxin effects
These problems can happen within hours, or days to weeks after an injection of DYSPORT. Call your doctor or get medical help right away if you have any of these problems after treatment with DYSPORT:
1. Problems swallowing, speaking, or breathing. These problems can happen within hours, or days to weeks after an injection of DYSPORT usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with DYSPORT.
• People with certain breathing problems may need to use muscles in their neck to help them breathe. These patients may be at greater risk for serious breathing problems with DYSPORT.
• Swallowing problems may last for several weeks. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving DYSPORT have the highest risk of getting these problems.
2. Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include:
• loss of strength and muscle weakness all over the body
• blurred vision and drooping eyelids
• trouble saying words clearly (dysarthria)
• trouble breathing
• double vision
• hoarseness or change or loss of voice (dysphonia)
• loss of bladder control
• trouble swallowing
These symptoms can happen within hours, or days to weeks after you receive an injection of DYSPORT. These problems could make it unsafe for you to drive a car or do other dangerous activities. See "What should I avoid while receiving DYSPORT?"
What is DYSPORT?
DYSPORT is a prescription medicine that is injected into muscles and used:
It is not known whether DYSPORT is safe or effective in people younger than:
Who should not take DYSPORT?
Do not take DYSPORT if you:
What should I tell my doctor before taking DYSPORT?
Tell your doctor about all your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal products. Using DYSPORT with certain other medicines may cause serious side effects.
Do not start any new medicines until you have told your doctor that you have received DYSPORT in the past.
Especially tell your doctor if you:
Ask your doctor if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How will I receive DYSPORT?
What should I avoid while receiving DYSPORT?
DYSPORT may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking DYSPORT. If this happens, do not drive a car, operate machinery, or do other dangerous activities. See "What is the most important information I should know about DYSPORT?"
What are the possible side effects of DYSPORT?
DYSPORT can cause serious side effects. See "What is the most important information I should know about DYSPORT?"
The most common side effects of DYSPORT in people with cervical dystonia include:
The most common side effects of DYSPORT in people with glabellar lines include:
The most common side effects of DYSPORT in adults with upper limb spasticity include:
• muscle weakness
The most common side effects of DYSPORT in adults with lower limb spasticity include:
The most common side effects of DYSPORT in children (2 to 17 years of age) with upper limb spasticity include:
The most common side effects of DYSPORT in children (2 to 17 years of age) with lower limb spasticity include:
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects DYSPORT. For more information, ask your doctor or pharmacist.
Tell your doctor if you have dry eye or changes in vision following use of DYSPORT.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about DYSPORT:
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about DYSPORT. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DYSPORT that is written for healthcare professionals.
What are the ingredients in DYSPORT?
Active ingredient: (botulinum toxin Type A)
Inactive ingredients: human albumin and lactose. DYSPORT may contain cow's milk protein.
Distributed by: Ipsen Biopharmaceuticals, Inc. Cambridge, MA 02142 and Galderma Laboratories, L.P. Fort Worth, TX 76177;
Manufactured by: Ipsen Biopharma Ltd., Wrexham, LL13 9UF, UK U.S. License No. 1787
For more information about DYSPORT, call 855-463-5127 or go to www.dysport.com or www.DysportUSA.com.
This Medication Guide has been approved by the U.S. Food and Drug Administration
DYSPORT is a registered trademark of Ipsen Biopharm Limited. Botox, Xeomin and Myobloc are registered trademarks of their respective owners.
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