Coherus BioSciences UDENYCA Instructions For Use Manual
Instructions for Use
UDENYCA™ (yoo-den-i-kah)
Single-Dose Prefilled Syringe
Guide to Parts
Before use
After use
Important
UDENYCA before using these Instructions for Use.
Storing the UDENYCA prefilled syringe
• Store UDENYCA prefilled syringes in the
Needle Safety Guard
Activated
Label
Needle Cap
Inspection Window
Needle
Plunger
Plunger Head
Finger Grips
Syringe
Body
Needle Safety Guard
Unactivated
(pegfilgrastim-cbqv)
Injection
Figure 1
Important: The needle is covered by a needle cap before use
Read the Patient Information for important information you need to know about
refrigerator between 36°F to 46° F (2°C to 8°C).
• Keep the UDENYCA prefilled syringe in the
original carton to protect from light.
• Do not freeze UDENYCA.
• Throw away (dispose of) any UDENYCA prefilled
syringes that have been left out at room
temperature for more than 48 hours.
• Keep the UDENYCA prefilled syringe out of the
reach of children.
o If UDENYCA is accidentally frozen, allow
the prefilled syringe to thaw in the
refrigerator before injecting.
o Throw away (dispose of) any UDENYCA
prefilled syringes that have been frozen
more than 1 time.
Figure 2
Using the prefilled syringe
It is important that you do not try to give the
questions.
•
injection unless you or your caregiver has
received training from your healthcare
provider.
• Make sure that the name UDENYCA appears
on the carton and prefilled syringe label.
• Check the carton and prefilled syringe label to
make sure the dose strength is 6 mg/0.6 mL.
• You should not inject a dose of UDENYCA to
children weighing less than 45 kg from a
UDENYCA prefilled syringe. A dose less than
0.6 mL (6 mg) cannot be accurately measured
using the UDENYCA prefilled syringe.
• Do not use a prefilled syringe after the
expiration date on the label.
• Do not shake the prefilled syringe
• Do not remove the needle cap from the
prefilled syringe until you are ready to inject.
• Do not use the prefilled syringe if the carton is
open or damaged.
• Do not use a prefilled syringe if it has been
dropped on a hard surface. The prefilled
syringe may be broken even if you cannot see
the break. Use a new prefilled syringe.
• Do not attempt to activate the needle safety
guard prior to injection
Call your healthcare provider if you have any
Prepare the injection
1 - Remove carton from refrigerator and check expiration date
1A: Remove the carton from the refrigerator and
check the expiration date printed on the carton.
Figure 3
1B: Open the carton and remove the sealed
Figure 4
2 - Allow UDENYCA to reach room temperature and gather supplies
2A: Place the sealed syringe tray on a flat, clean
Figure 5
2B: Gather the following supplies:
Figure 6
(See Figure 3)
Do not use if the expiration date has passed.
syringe tray. (See Figure 4)
work surface and allow it to sit at room
temperature for at least 30 minutes.
(See Figure 5)
Do not attempt to warm up the syringe in any
other way, such as a microwave, hot water, or
direct sunlight.
(See Figure 6)
• alcohol wipe
• cotton ball or gauze
• 1 adhesive bandage
• sharps disposal container
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