Get the free Mepsevii (vestronidase alfa-vjbk) Injection - FDA

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:205489Orig1s000 OTHER REVIEW(S)INFORMATION PROVIDED VIA RELIANCE (LISTED DRUG OR LITERATURE) 2) List the information essential to the approval

How to fill out mepsevii vestronidase alfa-vjbk injection

How to fill out mepsevii vestronidase alfa-vjbk injection

1. Step 1: Gather all the necessary materials such as the injection vial, syringe, and alcohol swab.
2. Step 2: Wash your hands thoroughly with soap and water to maintain cleanliness.
3. Step 3: Take the vial out of the refrigerator and allow it to reach room temperature.
4. Step 4: Inspect the vial for any visible particles or discoloration. Do not use if the solution is cloudy or contains particles.
5. Step 5: Clean the rubber stopper of the vial using an alcohol swab.
6. Step 6: Draw up the appropriate dose of Mepsevii Vestronidase Alfa-VJBK into the syringe as instructed by your healthcare provider.
7. Step 7: Remove any air bubbles from the syringe by gently tapping it and then pushing the plunger to expel the air.
8. Step 8: Choose an injection site, such as the thigh or abdomen, and clean the area with an alcohol swab.
9. Step 9: Pinch the skin at the injection site and insert the needle at a 90-degree angle. Slowly inject the medication.
10. Step 10: Remove the needle from the skin and apply gentle pressure with a cotton ball or clean tissue to the injection site.
11. Step 11: Dispose of the used needle and syringe in an appropriate sharps container.
12. Step 12: Wash your hands again after the injection.
13. Step 13: Store any remaining medication as instructed by your healthcare provider.

Who needs mepsevii vestronidase alfa-vjbk injection?

1. Mepsevii Vestronidase Alfa-VJBK injection is typically prescribed for individuals with Mucopolysaccharidosis VII (MPS VII), also known as Sly syndrome. MPS VII is a rare genetic disorder that results in the deficiency of an enzyme called beta-glucuronidase.
2. This treatment is specifically indicated for pediatric and adult patients with MPS VII. It is important to consult with a healthcare provider to determine if this injection is appropriate for you or your child's condition.

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What is mepsevii vestronidase alfa-vjbk injection?

Mepsevii vestronidase alfa-vjbk injection is an enzyme replacement therapy used to treat patients with mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome.

Who is required to file mepsevii vestronidase alfa-vjbk injection?

Mepsevii vestronidase alfa-vjbk injection must be administered by healthcare professionals who are trained in the proper handling and administration of the medication.

How to fill out mepsevii vestronidase alfa-vjbk injection?

Mepsevii vestronidase alfa-vjbk injection is typically administered as an intravenous infusion over a period of several hours. The healthcare provider will follow specific instructions for preparing and administering the medication.

What is the purpose of mepsevii vestronidase alfa-vjbk injection?

The purpose of mepsevii vestronidase alfa-vjbk injection is to replace the deficient enzyme in patients with MPS VII, helping to improve symptoms and slow disease progression.

What information must be reported on mepsevii vestronidase alfa-vjbk injection?

When filing mepsevii vestronidase alfa-vjbk injection, healthcare providers must report the patient's medical history, current medications, any adverse reactions, and the date and time of administration.