NutropinAQNuSpin NuSpin 5 Somatropin Injection For Subcutaneous Use Instruction Manual

August 23, 2024
NutropinAQNuSpin

NutropinAQNuSpin NuSpin 5 Somatropin Injection For Subcutaneous Use Instruction Manual

COMPONENTS

INSTRUCTIONS FOR USE

Description: The Nutropin AQ NuSpin 5 is a multi-dose, dial-a-dose injection device prefilled with Nutropin AQ (somatropin) injection, for subcutaneous use. It features automatic injection of the drug and is disposable. The Nutropin AQ NuSpin 5 (Clear Color, 5 mg/2 mL) delivers doses from 0.05 to 1.75 mg in increments of 0.05 mg.

Intended Use: The Nutropin AQ NuSpin 5 is intended to be used by a healthcare professional or patient to deliver Nutropin AQ (somatropin) injection, for subcutaneous use, from an injection device. The device can be used in any setting, including the home, and is disposable.

IMPORTANT NOTES

  • Always follow the directions of your healthcare professional and the instructions provided on the back. Contact your healthcare professional if you have any questions.

  • Check the label on the NuSpin 5 to make sure the medicine matches your prescription and it has not expired.

  • Inspect the cartridge before use to ensure that the medicine in it is clear. If it is cloudy or hazy, do not inject. Return the NuSpin 5 to your healthcare professional.

  • Store your NuSpin 5 inside the refrigerator at 2–8°C (36–46°F). Protect from light.

  • The product can be used for 28 days after it has been primed and kept under proper storage conditions.

  • For the first use of each NuSpin 5, always follow the New NuSpin 5 Set Up Instructions to ensure that air is expelled from the cartridge.

  • Do not store with the needle attached.
    The needle should be removed and safely disposed of immediately after use.

  • Keep NuSpin and all medicines out of the reach of young children.

FREQUENTLY ASKED QUESTIONS

  1. What type of needles should be used?
    Your Healthcare Professional will recommend a needle that is appropriate for you. The following needles will fit and work on the Nutropin AQ NuSpin:

    • BD Ultra-Fine™ 29 g x 1/2 inch (12.7 mm)
    • BD Ultra-Fine™ III short pen needle 31 g x 5/16 inch (8 mm)
    • NovoFine® Autocover® 30 G 8 mm Pen needles from other countries may not fit on your NuSpin device. If you travel outside the United States, make sure you take enough needles for the duration of your stay.
  2. Do I need to change the needle every time I use my Nutropin AQ NuSpin?
    Yes. A new needle must be used for every injection.
    The needle is sterile only for one single injection.

  3. Do I need to prime the Nutropin AQ NuSpin each time?
    No. The NuSpin 5 only needs to be primed once, at first use. After the first use of each NuSpin 5, follow the instructions and skip Step 2.

  4. When and how do I dispose of my Nutropin AQ NuSpin?
    Your NuSpin 5 is prefilled and the cartridge cannot be replaced. When your NuSpin 5 is empty, dispose of the entire NuSpin 5 as instructed by your healthcare professional. If the empty NuSpin 5 is disposed of with the needle attached, discard the entire device using the same procedure as for needle disposal.

  5. Where should I store my Nutropin AQ NuSpin?
    When not in use, your NuSpin 5 should be stored inside a refrigerator at 2–8°C (36–46°F) to maintain the potency of Nutropin AQ (somatropin) injection, for subcutaneous use. During use, we recommend that you have your NuSpin 5 outside of the refrigerator for no longer than one hour per day. When traveling, place your NuSpin 5 in a water-resistant container before placing in a cooler.
    DO NOT FREEZE. KEEP DRY.

  6. What should I do if my Nutropin AQ NuSpin is dropped or damaged?
    If you drop the NuSpin 5, check to see if it is damaged.
    You should also check to see that the black dose knob and the Activator are moving properly. If you notice the NuSpin 5 is damaged, contact your healthcare professional or call 1-866-NUTROPIN for advice.

  7. What should I do if my Nutropin AQ NuSpin needs cleaning?
    Use a damp cloth to wipe away dirt.
    Do not place underwater. Do not use alcohol.

NEW NuSpin 5 SET UP: STEP-BY-STEP INSTRUCTIONS FOR THE FIRST USE OF EACH NEW NUTROPIN AQ NuSpin 5

STEP 1:
Attach the needle

Before you begin, wash your hands.
Twist gently and pull to remove the NuSpin 5 cap. Inspect the cartridge before use to ensure that the medicine in it is clear. If it is cloudy or hazy, do not inject.
Open a new needle by peeling off the paper tab from the needle package.

Attach the needle by carefully screwing the needle onto the needle holder.
Do not overtighten.
Remove both protective covers from the needle and save the outer cover.

STEP 2:
Prime the Nutropin AQ NuSpin

Turn the dose knob to the P position in the dose window.
It may take multiple clicks to get to P .
Hold the NuSpin 5 with the needle pointing upwards.
Gently tap the cartridge holder to move any air bubbles to the NuSpin 5 tip.

Slide the Activator toward the needle.
If you do not see fluid at the needle tip, redial to P and slide the Activator forward again.
Repeat until you see fluid.

ROUTINE USE: DOSING AND ADMINISTRATION

STEP 3:
Set the dose

Make sure the dose window reads 0.0 .
Turn the dose knob until the dose prescribed by your healthcare professional appears in the dose window.

If your dose is “between” two numbers in the dose window, the – between those two numbers indicates your dose. Turn the dose knob to – . The P position indicates a 0.35 mg dose on your NuSpin 5.
If you turn the dose knob too far, simply turn it back to the correct dose.
(Example above shows a dose of 0.05 mg, represented by – ).

STEP 4:
Give the injection

Select and prepare your injection site as instructed by your healthcare professional.
Position your hand so you can easily slide the Activator.
Push the needle into the skin.

Slide the Activator toward the needle.
Hold the Activator down until the dose knob returns to 0.0 and continue to hold in place for 5 seconds.
Withdraw the Nutropin AQ NuSpin 5 until the needle is removed from the skin.
If the dose knob returns to 0.0 , you have received your full dose.

Check dose given

If the dose knob stops before it returns to 0.0 , your Nutropin AQ NuSpin 5 is empty and you have not received your full dose.
The number shown in the dose window is the amount needed to obtain a full dose.
Your healthcare professional will advise you on the procedure for using the last dose in the NuSpin 5.

REMOVAL AND DISPOSAL OF THE NEEDLE
Carefully place the outer cover of the needle package over the needle, unscrew, and dispose of it as instructed by your healthcare professional.

STORAGE AND NEXT USE
Replace the cap and store your NuSpin 5 inside the refrigerator at 2–8°C (36–46°F). Protect from light.
For the next use, it is already primed. Follow the instructions and skip Step 2.

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