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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202278Orig1s000 MICROBIOLOGY REVIEW(S) Product Quality Microbiology Review 6 December 2012 NDA: 202278 Drug Product Name Proprietary: Nonproprietary:
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How to fill out sumatriptan iontophoretic transdermal system
How to fill out sumatriptan iontophoretic transdermal system:
01
Start by thoroughly washing your hands with soap and water.
02
Carefully remove the sumatriptan iontophoretic transdermal system from its packaging.
03
Peel off the protective liner from the adhesive side of the system.
04
Choose a clean, dry area of skin where you will apply the system. It is typically recommended to apply it to the upper arm or thigh.
05
Avoid applying the system to areas with broken or irritated skin, scars, tattoos, or where there is excessive hair growth.
06
Firmly press the adhesive side of the system onto the chosen area of skin and hold it in place for a few seconds to ensure proper adhesion.
07
Once the system is securely in place, avoid touching or rubbing it to prevent dislodging.
08
Make sure to record the date and time when you applied the sumatriptan iontophoretic transdermal system for future reference.
09
Follow the specific instructions provided by your healthcare provider or the product's packaging for the duration of use and proper disposal of the used system.
Who needs sumatriptan iontophoretic transdermal system:
01
Individuals who suffer from migraines with or without aura may benefit from using sumatriptan iontophoretic transdermal system.
02
It is suitable for adults who have been diagnosed with migraines and have been prescribed sumatriptan by their healthcare provider.
03
This system may be particularly helpful for those who experience difficulty swallowing oral medications during migraines or experience gastrointestinal side effects from oral sumatriptan.
04
It is important to consult with a healthcare professional to determine if sumatriptan iontophoretic transdermal system is appropriate for your specific condition and medical history.
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What is sumatriptan iontophoretic transdermal system?
Sumatriptan iontophoretic transdermal system is a method of delivering sumatriptan through the skin using a small electric current.
Who is required to file sumatriptan iontophoretic transdermal system?
The manufacturer or distributor of the sumatriptan iontophoretic transdermal system is required to file it with the appropriate regulatory authorities.
How to fill out sumatriptan iontophoretic transdermal system?
The sumatriptan iontophoretic transdermal system should be filled out according to the guidelines provided by the regulatory authorities, including all relevant information about the product.
What is the purpose of sumatriptan iontophoretic transdermal system?
The purpose of the sumatriptan iontophoretic transdermal system is to provide an alternative method of delivering sumatriptan for the treatment of migraine headaches.
What information must be reported on sumatriptan iontophoretic transdermal system?
The information that must be reported on the sumatriptan iontophoretic transdermal system includes the composition of the product, its manufacturing process, and any potential side effects.
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