natalizumab: package leaflet

observed and/or the liquid in the vial is not colourless, clear to slightly opalescent, the vial must not be used.

syringe needle into the vial through the centre of the rubber stopper and remove 15 mL concentrate for solution for infusion.

(0.9%) solution for injection. Gently invert the solution to mix completely. Do not shake.

administration. Do not use if it is discoloured or if foreign particles are seen.

If the diluted medicinal product is stored at 2 °C to 8 °C (do not freeze), allow the solution to warm to room temperature prior to infusion.

7.
The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 mL per minute.

8.
After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/mL (0.9%) solution for injection.

9.
Each vial is for single–use only.

10.
In order to improve traceability of biological medicinal products, the product name (Tysabri) and batch number of the administered product should be clearly recorded.

11.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

• Collect the supplies and place them on a clean, flat surface in a well-lit area.

Refrigerator and Wait
30 Minutes.
- Take the carton, containing
TWO syringes, out of the refrigerator and let them come to room temperature (up to 30 °C) for at least 30 minutes.

Do not use external heat sources, such as hot water, to warm the syringes.

• Wash your hands well with soap and water. Then dry your hands.

a. Check the expiration date on both syringes (callout a).
Do not use the syringe if the expiration date has passed.

b. Check the syringes to see if they are damaged or cracked
(callout b).

Do not use the syringe if it is damaged or cracked.
c. Check that the medicine in both syringes is colourless to slightly yellow, slightly opalescent to opalescent (pearly), and free of visible particles (callout c).
Do not use the syringe if the liquid has visible particles.
Do not use the syringe if it has been dropped prior to using it. Notify your healthcare professional if you have any of these issues with the syringes.
You may see bubbles in the medicine. This is normal.
Note: The appearance of the medicine may change after it is removed from the refrigerator.
This is normal.

a. Use one of the following injection sites:
- Abdomen (at least
6 centimetres away from the belly button)
- Front of the thigh
- Upper outer arm (this is for caregiver administration only) b. Do not inject into an area of the body where the skin is tender, red, infected, bruised or has scars.
c. Change (rotate) injection sites between injections.

a. Wipe the skin with an alcohol wipe.
b. Let the injection site air dry before injecting the dose.

Do not touch, fan or blow on the clean area.

Injecting Your 1st Syringe
Remove the Needle Cap.
a. Hold the syringe body with one hand with the needle pointing up.
b. With your other hand, firmly hold the needle cap and pull it straight off the needle.
c. Dispose of the needle cap right away after removing it.

Note: you may see a drop of liquid on the needle tip. This is normal.

Do not touch or re-cap the needle.
You could get a needle stick injury.
Do not pull on the plunger rod.
Insert the Needle into the 1st
Site.
a. Pinch the skin around the cleaned injection site.
b. With your other hand, hold the syringe like a pencil and use a quick, dart-like motion to insert the needle at an angle of 45 to 90 degrees until the needle is fully under the skin.

Give Your 1st Injection.
a. After the needle is in the skin, release the pinched skin.
b. Slowly push the plunger all the way down as far as it will go to inject all of the medicine.

Make sure you push the plunger rod all the way down to get all your medicine and engage the needle guard.

10 Remove the Needle from the
Injection Site.
- When the syringe is empty, begin releasing the plunger and remove the syringe from the injection straight out until the entire needle is covered by the needle guard.

If the needle guard does not activate to cover the needle, do not recap the syringe. Place it in the sharps disposal container and contact your healthcare professional for assistance.
11 Check and Care for Your
Injection Site.
- Apply a gauze pad or adhesive bandage to your injection site, if needed.

Injecting Your 2nd Syringe
12 Choose the 2nd Injection Site.
a. Choose another area to inject.
You may use one of the following injection sites:
- Abdomen (at least
6 centimetres away from the belly button)
- Front of the thigh
- Upper outer arm (this is for caregiver administration only) b. Do not inject into an area of the body where the skin is tender, red, infected, bruised or has scars.
c. Change (rotate) injection sites between injections.
d. If using the same area of the body, make sure your 2nd injection site is at least 3 centimetres from your first injection site.

13 Clean the 2nd Injection Site.
a. Wipe the skin with an alcohol wipe.
b. Let the injection site air dry before injecting the dose.

Do not touch, fan or blow on the clean area.
14 Give Your 2nd Injection.
a. Repeat steps 7-11 to inject the SECOND syringe to get your full dose.
Administer injections one after the other without significant delay.
The second injection should be administered no later than
30 minutes after the first injection.

Disposing Tysabri
15 Dispose of Both Syringes.
- Put both used syringes in a sharps disposal container right away after use.

Do not dispose of your used sharps disposal container or any used syringes in your household trash.
If you do not have a sharps disposal container, you can ask your healthcare professional for one or you may use a household container that is:
- made of heavy-duty plastic,
- can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labelled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. There may be state or local laws about how you should dispose of used syringes.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.