Get the free ULTOMIRIS- ravulizumab solution, concentrate - DailyMed
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CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:761108Orig1s000
LABELINGHIGHLIGHTS OF PRESCRIBING INFORMATION
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ULTOMIRIS
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How to fill out ultomiris- ravulizumab solution concentrate
How to fill out ultomiris- ravulizumab solution concentrate
01
To fill out ultomiris- ravulizumab solution concentrate, follow these steps:
02
Wash your hands thoroughly with soap and water.
03
Gather all the necessary supplies: Ultomiris solution concentrate, a syringe, and alcohol swabs.
04
Remove the protective cap from the vial of Ultomiris solution concentrate.
05
Clean the rubber stopper on the vial with an alcohol swab.
06
Take the syringe and attach a sterile needle onto it.
07
Draw air into the syringe by pulling the plunger back to the desired dose volume.
08
Insert the needle into the rubber stopper of the vial and gently push the plunger to inject the air into the vial.
09
Hold the vial upside down and slowly withdraw the desired amount of Ultomiris solution concentrate into the syringe.
10
Check for any air bubbles in the syringe and gently tap the syringe to remove them.
11
Remove the needle from the vial and replace it with an injection needle if necessary.
12
Administer the solution concentrate as per the prescribed dosage.
13
Properly dispose of all used needles and vials in a sharps container.
14
Note: Always consult a healthcare professional or follow the specific instructions provided by your doctor or pharmacist.
Who needs ultomiris- ravulizumab solution concentrate?
01
Ultomiris- ravulizumab solution concentrate is used for the treatment of certain rare blood disorders.
02
Specifically, it is prescribed for patients with paroxysmal nocturnal hemoglobinuria (PNH) or atypical hemolytic uremic syndrome (aHUS).
03
These conditions are characterized by abnormal destruction of red blood cells, leading to symptoms such as anemia, fatigue, and organ damage.
04
Ultomiris solution concentrate helps to prevent this destruction by inhibiting the complement system, a part of the immune system involved in cell lysis.
05
It is important to note that Ultomiris should only be used under the supervision of a healthcare professional and as prescribed.
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What is ultomiris- ravulizumab solution concentrate?
Ultomiris (ravulizumab) is a monoclonal antibody used as a medication for the treatment of certain blood disorders, specifically its indications include treatment for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
Who is required to file ultomiris- ravulizumab solution concentrate?
Filing for ultomiris (ravulizumab) solution concentrate is typically required by healthcare providers or institutions that administer the medication for reimbursement purposes, as well as by manufacturers in regulatory submissions.
How to fill out ultomiris- ravulizumab solution concentrate?
Filling out ultomiris involves properly preparing the solution concentrate according to the manufacturer's instructions, including diluting the concentrate with an appropriate diluent and ensuring that the dosage aligns with the patient's treatment regimen.
What is the purpose of ultomiris- ravulizumab solution concentrate?
The purpose of ultomiris (ravulizumab) solution concentrate is to provide therapeutic treatment aimed at inhibiting complement-mediated hemolysis in patients with PNH and aHUS, thereby improving clinical outcomes.
What information must be reported on ultomiris- ravulizumab solution concentrate?
Information that must be reported includes the patient's dosage, administration details, lot number of the product, expiration date, and any adverse reactions experienced during the treatment.
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