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Intructions For Use Vol III

The document provides guidance on creating an Instructions for Use document for drug products. It outlines key sections that should be included such as purpose statement, visual of drug product, important information for patients, preparation instructions, and administration instructions. Examples are provided for each section to illustrate the types of content that could be covered.

Uploaded by

Eduardo Gonzalez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
42 views8 pages

Intructions For Use Vol III

The document provides guidance on creating an Instructions for Use document for drug products. It outlines key sections that should be included such as purpose statement, visual of drug product, important information for patients, preparation instructions, and administration instructions. Examples are provided for each section to illustrate the types of content that could be covered.

Uploaded by

Eduardo Gonzalez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Purpose Statement

• Appears below the product title


• Informs the patient about the IFU contents – why it was created

INSTRUCTIONS FOR USE


MYDRUG [mye-drug]
(drugoxide injection)
for intramuscular use

This “Instructions for Use” contains information on how to inject


MYDRUG.

21
Visual of Drug Product
• Examples:
– Photograph
– Simple illustration
– Line drawing

• Clearly identify and label each part of the drug product,


including device components, and the purpose or use of the
components, where applicable
• Include a visual of a drug product in an oral dosage form where
manipulation is necessary to prepare and administer a dose
22
Important Information for Patients
• Include specific, critical actions to prepare, administer, store, or dispose of the drug
product
• Generally intended to prevent or reduce potentially dangerous consequences that
might occur if a specific action is not followed

INSTRUCTIONS FOR USE


MYDRUG [mye-drug]
(drugoxide injection)
for intramuscular use

This “Instructions for Use” contains information on how to inject


MYDRUG.
VISUAL

Important Information You Need to Know Before Injecting MYDRUG


23
Important Information for Patients:
Content Examples
• Example 1:
– Where there is potential for confusion about route of administration
based on dosage form
– Include statement that explains how drug product should be
administered
• For oral use only (take by mouth)

• Example 2:
– Where timing of a dose is specified relative to a behavior or action
• Take [Insert Drug Name] 1 hour before eating.

24
Important Information for Patients:
Content Examples
• Example 3:
– Safety information or other important instructions specifically related to
administration
• Inject [Insert Drug Name] into the thigh. Do not inject [Insert Drug Name] into
any other area of the body.

• Example 4:
– Prevention or mitigation of risk of secondary exposure to drug
• To prevent the transfer of [Insert Drug Name] from your body to others, avoid
direct skin contact or cover the areas of your body where [Insert Drug Name] has
been applied.
25
Preparation Instructions
• Specific instructions patients need to prepare the drug product or drug-device
combination for administration

INSTRUCTIONS FOR USE


MYDRUG [mye-drug]
(drugoxide injection)
for intramuscular use
...
Preparing to Inject MYDRUG

26
Preparation Instruction Examples

• Supplies and materials for administering the dose


• Amount of time required to warm a refrigerated product to room temperature
• Maximum amount of time the product may remain unrefrigerated before use
• Check the expiration date on the product’s label
• Check the drug product for particles or discoloration
• How to insert a co-packaged bottle adaptor

27
Administration Instructions
• Appear as logically ordered, detailed, step-by-step instructions
• Provided so patients can safely and effectively take or administer drug product

INSTRUCTIONS FOR USE


MYDRUG [mye-drug]
(drugoxide injection)
for intramuscular use

...

Injecting MYDRUG

28

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