MYOBLOC- rimabotulinumtoxinb injection, solution
Solstice Neurosciences, LLC
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MEDICATION GUIDE
MYOBLOC ® (My-o-block) (rimabotulinumtoxinB) injection, for intramuscular or intraglandular use |
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This Medication Guide has been approved by the U.S. Food and Drug Administration. | Rev: 3/2021 | ||
What is the most important information I should know about MYOBLOC? | |||
MYOBLOC may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems after treatment with MYOBLOC: | |||
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These symptoms can happen hours to weeks after you receive an injection of MYOBLOC. | |||
These problems could make it unsafe for you to drive a car or do other dangerous activities. See " What should I avoid while receiving MYOBLOC?" | |||
What is MYOBLOC? | |||
MYOBLOC is a prescription medicine used in adults that is injected into:
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It is not known whether MYOBLOC is safe or effective in children. | |||
Do not receive MYOBLOC if you:
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Before receiving MYOBLOC, tell your doctor about all your medical conditions, including if you have:
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Tell your doctor if you:
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Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicine after you receive MYOBLOC. | |||
Using MYOBLOC 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 MYOBLOC in the past. Especially tell your doctor if you:
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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 should I receive MYOBLOC?
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What should I avoid while receiving MYOBLOC? | |||
MYOBLOC may cause loss of strength or general muscle weakness or vision problems within hours to weeks of receiving MYOBLOC. 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 MYOBLOC?" | |||
What are the possible side effects of MYOBLOC? | |||
MYOBLOC can cause serious side effects including: | |||
See "
What is the most important information I should know about MYOBLOC?"
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The most common side effects of MYOBLOC in people with cervical dystonia include: | |||
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The most common side effects of MYOBLOC in people with sialorrhea include dry mouth and trouble swallowing (dysphagia). | |||
These are not all the possible side effects of MYOBLOC. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Solstice Neurosciences at 1-888-461-2255. | |||
General information about the safe and effective use of MYOBLOC. | |||
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. | |||
You can ask your doctor or pharmacist for information about MYOBLOC that is written for healthcare professionals. | |||
What are the ingredients in MYOBLOC? | |||
Active ingredient: botulinum toxin type B | |||
Inactive ingredients: albumin human, sodium chloride and sodium succinate. | |||
Manufactured by: Solstice Neurosciences, LLC, Rockville MD 20852
U.S. License No. 1718 SNI-MYO424A-0410 RA-MYO-MGV2 "MYOBLOC" and the "MYOBLOC Logo" are registered trademarks of Solstice Neurosciences, LLC All trademarks are the property of their respective owners. |
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For more information about MYOBLOC call 1-888-461-2255 or go to www.MYOBLOC.com. |