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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:206488Orig1s000 MICROBIOLOGY/VIROLOGY REVIEW(S)Product Quality Microbiology Review 12 January 2016NDA:206488/N000Drug Product Name Proprietary: Nonproprietary:EXODUS

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How to fill out spinraza nusinersen injection

01

Step 1: Wash your hands thoroughly with soap and water.

02

Step 2: Prepare the Spinraza injection by removing it from the refrigerator and allowing it to reach room temperature.

03

Step 3: Clean the injection site with an alcohol swab and let it dry.

04

Step 4: Remove the protective cap from the needle of the Spinraza syringe.

05

Step 5: Pinch the skin at the injection site and carefully insert the needle at a 90-degree angle.

06

Step 6: Slowly push the plunger down to inject the Spinraza into the skin.

07

Step 7: Remove the needle from the skin and apply pressure to the injection site with a cotton ball or sterile gauze.

08

Step 8: Dispose of the used syringe and needle properly in a sharps container.

09

Step 9: Wash your hands again after completing the injection.

Who needs spinraza nusinersen injection?

01

Spinraza nusinersen injection is typically prescribed for individuals with spinal muscular atrophy (SMA), a genetic disorder that affects the muscles and motor function.

02

It is specifically indicated for the treatment of both pediatric and adult patients with SMA.

03

Your healthcare provider will determine if Spinraza is appropriate for you or your loved one based on the severity and type of SMA.

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What is spinraza nusinersen injection?

Spinraza nusinersen injection is a medication used to treat spinal muscular atrophy.

Who is required to file spinraza nusinersen injection?

Patients with spinal muscular atrophy who are prescribed Spinraza are required to receive this injection.

How to fill out spinraza nusinersen injection?

Spinraza nusinersen injection is administered by a healthcare professional through a spinal injection.

What is the purpose of spinraza nusinersen injection?

The purpose of Spinraza nusinersen injection is to improve motor function and slow down the progression of spinal muscular atrophy.

What information must be reported on spinraza nusinersen injection?

Information such as the date of administration, dosage, and any side effects experienced must be reported on Spinraza nusinersen injection.

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