Get the free label. Emflaza (deflazacort) oral tablets
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208684 NDA 208685 NDA APPROVAL Marathon Pharmaceuticals, LLC Attention: Matthew A. Lee, Pharma Director,
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How to fill out label emflaza deflazacort oral
How to fill out label emflaza deflazacort oral
01
Read the instructions on the label carefully.
02
Take out the required dose of Emflaza deflazacort oral.
03
You can take it with or without food, as directed by your doctor.
04
Swallow the tablet whole with a glass of water.
05
If you are using the liquid form, measure the dose using a special measuring device or spoon.
06
Do not crush, chew, or break the tablet unless instructed by your doctor.
07
Take Emflaza deflazacort oral at the same time(s) every day for the best results.
08
If you forget a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule.
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Do not stop taking Emflaza deflazacort oral abruptly without consulting your doctor.
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It is important to follow the instructions provided by your doctor or pharmacist regarding the dosage and duration of treatment.
Who needs label emflaza deflazacort oral?
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Emflaza deflazacort oral is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
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It should be used under the supervision of a healthcare professional experienced in the management of DMD.
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Individuals with DMD who can benefit from improved muscle strength and function may need Emflaza deflazacort oral.
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What is label emflaza deflazacort oral?
Label emflaza deflazacort oral is a required document that provides information about the medication Emflaza, which contains the active ingredient deflazacort and is administered orally.
Who is required to file label emflaza deflazacort oral?
The manufacturer or distributor of Emflaza is required to fill out and file the label emflaza deflazacort oral.
How to fill out label emflaza deflazacort oral?
To fill out the label emflaza deflazacort oral, the manufacturer or distributor must include information about dosage, administration instructions, side effects, warnings, and any other relevant details.
What is the purpose of label emflaza deflazacort oral?
The purpose of label emflaza deflazacort oral is to provide essential information to healthcare providers and patients about the safe and effective use of the medication Emflaza.
What information must be reported on label emflaza deflazacort oral?
The label emflaza deflazacort oral must include information about the active ingredient, dosage strength, administration instructions, side effects, contraindications, and warnings.
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