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Fda.gov/AboutFDA/CentersOffices/CDER/ucm090142. htm. REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA 21 CFR 314. In addition under 21 CFR 314. 81 b 2 vii and 314. 81 b 2 viii you should include a status summary of each commitment in your annual report to this NDA. Collect analyze and submit data from the HCV infected subjects with decompensated Child-Pugh Turcotte CPT C cirrhosis treated with sofosbuvir/velpatasvir regimen to obtain...
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How to fill out epclusa tablet 400 mg100
How to fill out epclusa tablet 400 mg100
01
Wash your hands thoroughly before handling the Epclusa tablet.
02
Take one tablet of Epclusa orally with food.
03
Do not crush, break, or chew the tablet. Swallow it whole.
04
If you have difficulty swallowing the tablet, you can crush it and mix it with a small amount of soft food such as applesauce or yogurt before swallowing.
05
It is important to take Epclusa at the same time every day to maintain a consistent level of the medication in your body.
06
Continue taking Epclusa for the prescribed duration, even if you start feeling better.
07
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Who needs epclusa tablet 400 mg100?
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Epclusa tablet 400 mg100 is typically prescribed for individuals with chronic hepatitis C infection.
02
It is used for the treatment of adults with genotypes 1, 2, 3, 4, 5, or 6 chronic hepatitis C virus (HCV) infection.
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Epclusa is approved for use in patients with or without cirrhosis.
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It may also be prescribed for individuals who have failed previous hepatitis C treatment or are coinfected with human immunodeficiency virus (HIV).
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However, the use of Epclusa should be determined by a healthcare professional based on individual patient factors and medical history.
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What is epclusa tablet 400 mg100?
Epclusa tablet 400 mg100 is a medication used to treat Hepatitis C.
Who is required to file epclusa tablet 400 mg100?
Healthcare professionals are required to file epclusa tablet 400 mg100 for their patients.
How to fill out epclusa tablet 400 mg100?
Epclusa tablet 400 mg100 should be filled out with the patient's information, dosage details, and any other relevant medical information.
What is the purpose of epclusa tablet 400 mg100?
The purpose of epclusa tablet 400 mg100 is to treat Hepatitis C and improve the patient's liver function.
What information must be reported on epclusa tablet 400 mg100?
Information such as patient name, dosage instructions, prescription date, and any relevant medical history must be reported on epclusa tablet 400 mg100.
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