Winrevair Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned as follows.
Special precautions for disposal and other handling: Selecting the appropriate product kit: If a patient's weight requires the use of two 45 mg or two 60 mg vials, a 2-vial kit should be used instead of two 1-vial kit to eliminate the need for multiple injections.
Reconstitution and administration instructions: Winrevair powder and solvent for solution for injection should be reconstituted before use and administered as a single injection according to patient weight (see Dosage & Administration).
See the separate Instructions for Use under Cautions for Usage for detailed step by step instructions on how to prepare and administer the medicinal product. An overview of the reconstitution and administration instructions is provided as follows.
Reconstitution: Remove the kit from the refrigerator and wait 15 minutes to allow the prefilled syringe(s) and medicinal product to come to room temperature prior to preparation.
Check the vial to ensure the medicinal product is not expired. The powder should be white to off-white and may look like a whole or broken up cake.
Remove the lid from the vial containing the powder and swab the rubber stopper with an alcohol wipe.
Attach the vial adaptor to the vial.
Visually inspect the prefilled syringe for any damage or leaks and the sterile water inside to ensure there are no visible particles.
Break off the cap of the prefilled syringe and attach the syringe to the vial adaptor.
Inject all of the sterile water from the attached syringe into the vial containing the powder: The prefilled syringe provided with the vial 45 mg contains 1 mL of sterile water; The prefilled syringe provided with the vial 60 mg contains 1.3 mL of sterile water.
After reconstitution, the 45 mg vial can only provide up to a dose of 0.9 mL of medicinal product and the 60 mg vial can only provide up to a dose of 1.2 mL of medicinal product. The final concentration after reconstitution is 50 mg/mL.
Gently swirl the vial to reconstitute the medicinal product. Do not shake or vigorously agitate.
Allow the vial to stand for up to 3 minutes to allow bubbles to disappear.
Visually inspect the reconstituted solution. When properly mixed, the reconstituted solution should be clear to opalescent and colourless to slightly brownish-yellow, and should not have clumps or powder.
Unscrew the syringe from the vial adaptor and discard the emptied syringe into a sharps container.
If prescribed a 2-vial kit, repeat the steps within this section to prepare the second vial.
Use the reconstituted solution as soon as possible, but no later than 4 hours after reconstitution.
Dosing syringe preparation: Before preparing the dosing syringe, visually inspect the reconstituted solution. The reconstituted solution should be clear to opalescent and colourless to slightly brownish-yellow, and should not have clumps or powder.
Swab the vial adaptor with an alcohol wipe.
Remove the dosing syringe from its packaging and attach the syringe to the vial adaptor.
Turn the syringe and vial upside-down and withdraw the appropriate volume for injection, based on the patient's weight.
If the dose amount requires the use of two vials, withdraw the entire contents of the first vial and slowly transfer the entire contents into the second vial, to ensure dose accuracy.
Turn the syringe and vial upside-down and withdraw the required amount of medicinal product.
If necessary, push the plunger in to remove excess medicinal product or air from the syringe.
Remove the syringe from the vial adaptor and attach the needle.
Administration: Winrevair is to be administered as a single subcutaneous injection.
Select the injection site on the abdomen (at least 5 cm away from navel), upper thigh, or upper arm and swab with an alcohol wipe. Select a new site for each injection that is not scarred, tender, or bruised.
For administration by the patient or caregiver, train them to inject only in the abdomen or upper thigh (see Instructions for Use as follows).
Perform subcutaneous injection.
Discard the emptied syringe into a sharps container. Do not reuse the syringe.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
See Precautions for instructions on the traceability of biological medicinal products.
Instructions for Use: Any patient or caregiver who is to prepare and inject Winrevair must first be trained and deemed capable of independent administration of Winrevair by a healthcare professional.
1. Check Winrevair product and expiry date.
Remove the Winrevair kit from the refrigerator.
Check the expiry date and look for any signs of damage on the kit or in the supplies. If expired or damaged, do not use. Patients must be advised to talk to the doctor or pharmacist immediately to get a new kit.
Check that the medicine is what the doctor prescribed.
2. Let the kit come to room temperature, gather supplies, and wash hands.
Wait 15 minutes to allow the kit to warm to room temperature. Cold medicine is more painful to inject.
Along with the kit, gather these items and find a clean, flat surface where the dose will be prepared and injected: Sharps disposal container; Gauze, cotton ball or bandage.
Wash hands with soap and water.
Mix powdered medicine into liquid form: Start with the top tray (use items from the top tray).
3. Remove vial, prefilled syringe, and vial adaptor from the kit.
4a. Check the medicine and the vial.
Check the vial label to confirm the medicine is not expired.
Visually inspect the medicine powder. It should be white to off-white and may look like a whole or broken up cake. Do not use if expired, damaged, or if there are particles in it.
4b. Remove plastic cap and clean the vial.
Flip off the plastic cap and clean the rubber stopper on top of the vial with an alcohol wipe. Do not use if vial cap is missing. Do not touch the cleaned rubber stopper.
Set vial aside on a clean, flat surface.
5a. Align vial adaptor to vial.
Peel open the vial adaptor package and remove it from its package.
Hold the blue neck of the adaptor and align the vial adaptor on top of the vial. Do not touch the inside of the vial adaptor to keep it clean and avoid sharps.
To attach the vial adaptor: Hold the blue neck of vial adaptor. Do not hold bottom of the adaptor.
5b. Attach vial adaptor to vial.
Hold the vial with one hand. Push the vial adaptor down firmly so it snaps in place. (There may be a feeling of some resistance.)
5c. Clean vial adaptor.
Clean the top of the vial adaptor with an alcohol wipe.
6. Check prefilled syringe.
Confirm the product is not expired. Visually inspect that the sterile water inside the prefilled syringe is clear. Do not use if there are any clumps, particles, discolouration, or if product is expired.
7. Break off prefilled syringe white cap.
Break off the prefilled syringe cap along the perforation. Do not touch the tip of the prefilled syringe. Do not push the plunger; it may spill the sterile water.
8. Connect prefilled syringe to vial adaptor.
Now, pick up the medicine vial with the vial adaptor attached.
Align the prefilled syringe tip on the blue circle of the vial adaptor.
Push and twist the prefilled syringe onto the vial adaptor until it cannot be turned further. While twisting, be sure to hold onto the vial adaptor. Do not push the plunger; it may spill the sterile water.
9. Transfer sterile water from prefilled syringe to vial.
Slowly push the plunger all the way down to transfer all the sterile water into the vial. (The plunger will move up; this is normal.)
Make sure all sterile water is transferred to the vial.
10. Swirl to mix medicine.
Do not shake the vial. Hold the prefilled syringe and gently swirl the vial in a circular motion until the powder is fully dissolved. This may take up to 2 minutes. Do not shake or agitate vigorously.
When the medicine is mixed well, it should be clear. If not, repeat this step until it is clear.
Press the plunger down again to make sure all the liquid is in the vial since some liquid could have moved back into the syringe. (The plunger will move up; this is normal.)
11. Wait for the bubbles to go away.
Set the vial aside for bubbles to go away. This may take up to 3 minutes.
Before continuing, make sure the medicine in the vial: Is clear to opalescent; Is colourless to slightly brownish-yellow; Does not have clumps or powder; Does not have large bubbles.
It is okay to have slight foam (small bubbles) around the edges of the vial.
12. Prepare vial by removing extra air.
While the vial oriented upright, gently pull the plunger upwards to the top of the barrel but be careful not to pull the plunger out of the syringe.
Tip: This step only pulls extra air out of the vial to reduce the pressure in the vial and prevent medicine from spilling during the syringe removal.
13. Remove prefilled syringe from vial.
Hold the vial adaptor and unscrew the syringe from the vial.
Throw away the syringe in the sharps container.
A vial of medicine should be prepared and ready to be used in the next steps.
Withdraw the prescribed dose: For the next steps, the following will be needed: Mixed vial of medicine; Items from the bottom tray (use items from the bottom tray).
14. Clean top of vial adaptor.
With a new alcohol wipe from the bottom tray, clean the top of the vial adaptor.
15. Remove empty dosing syringe from its package.
Find the empty dosing syringe in the bottom tray and remove it from its package.
This dosing syringe will be used to measure out the medicine needed (based on the prescribed dose). Do not touch tip of the dosing syringe.
16. Pull air into the dosing syringe.
This must be done to make sure pressure in the vial is even and to get an accurate dose.
Hold the dosing syringe upright and pull down the plunger to draw air into the dosing syringe. Stop when the amount in 'mL' listed in the prescription is reached.
Top rim of plunger should be at the prescribed dose.
Tip: Each line on the dosing syringe is 0.1 mL.
17. Connect dosing syringe to the vial.
While holding the vial adaptor, screw the dosing syringe on until it stops.
Dosing syringe should contain amount of air matching the prescription.
18. Push air into vial, then flip upside down.
Push the plunger all the way down to transfer all the air into the vial.
Then hold the plunger in place with the thumb and flip the vial upside down.
19. Pull plunger back to withdraw the dose.
With the vial and dosing syringe upside down, slowly pull the plunger back.
Stop when the amount in 'mL' listed on the prescription is reached.
Top rim of the plunger should line up with the prescribed dose.
Tip: Each line on the dosing syringe is 0.1 mL.
20. Check for air bubbles and air pockets.
Check to see if there are large air bubbles or an air pocket in the syringe. Extra air will be removed in the next steps.
21. Remove air bubbles and air pockets.
If there are air bubbles or an air pocket, tap the side of the dosing syringe to move the air to the top. Slowly push the plunger up to remove extra air.
Large bubbles and air pockets must be removed to get an accurate dose (1 or 2 small bubbles are okay).
22. Compare amount to prescribed dose.
After removing all extra air, compare the amount to the prescribed dose.
If the prescribed amount in the syringe is not reached, slowly pull the plunger back again to withdraw more medicine.
Repeat Steps 19 to 21 until the prescribed dose is reached and no large bubbles are visible.
23. Confirm the prescribed dose.
Before continuing, check to make sure the prescribed dose is reached in the dosing syringe.
The top rim of the plunger should line up with the prescribed dose.
If the amount does not match the prescribed dose, repeat Steps 19 to 22.
24. Remove the dosing syringe from the vial and set the dosing syringe aside.
Hold the plunger in place with one hand. With the other hand, hold the vial adaptor and unscrew the filled dosing syringe from the vial.
Throw away the vial into the sharps container.
Place the filled dosing syringe on a clean, flat surface.
Do not touch the dosing syringe tip or let it touch any surfaces.
25. Attach the injection needle.
Do not touch the connection hub of the needle.
Find the needle in the bottom tray and open its package.
With the needle still in the package, grip the base of the needle and twist on the dosing syringe until it stops. Remove the needle package.
Move the safety shield away from the needle and toward the syringe. Place the dosing syringe on a clean, flat surface. Do not uncap the needle.
26. Choose and clean the injection site.
Select an injection site on the stomach (abdomen) or the upper thigh. If injecting on the stomach area, avoid a 5 cm area around the belly button.
Choose a different site for every injection. Do not inject into skin that is damaged, sore, bruised, or has red patches. Do not inject through clothes.
Clean the injection site with a new alcohol wipe. Do not touch the cleaned injection site again.
Now, the medicine is ready to be injected.
27. Inject the medicine.
Pull the cap straight off the needle.
Throw away the cap. Do not touch the plunger until ready to inject so no medicine will be lost.
Gently pinch and hold a fold of skin where it will be injected. Insert the needle with a dartlike motion at a 45° to 90° angle. This helps to inject directly under the skin (subcutaneous injection).
Push the plunger with slow, steady pressure all the way down until the dosing syringe is empty. Confirm all the medicine has been injected.
Let go of the skin fold now. Keep the fingers away from the needle at all times.
While keeping the plunger pushed in, remove the needle from the skin at the same angle it was inserted.
To reapply the safety shield, push the shield against a flat surface until a "click" can be heard and the needle is covered.
Throw away the dosing syringe and used items in a sharps disposal container. Do not remove the needle from the dosing syringe.
How to throw away Winrevair: Throw away any used vial (including any remaining Winrevair liquid), needle, vial and needle caps, and used syringes in a sharps disposal container.
Do not throw away the Winrevair vials, syringes, or needle in the household waste.
Do not reuse any of the supplies. This product is disposable and should only be used one time.
If there is no sharps disposal container, a household container may be used that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharp objects being able to come out, upright and stable during use, leak resistant, and properly labelled to warn of hazardous waste inside the container.
When the sharps disposal container is almost full, the local guidelines should be followed for the right way to throw away the sharps disposal container. Do not throw away any medicines, vials, loose needles, or syringes via household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Do not recycle used sharps container.