cladribine: package leaflet

vial. Clean the rubber top of the vial with an alcohol wipe. Remove the syringe from the wrapping without touching the tip of the syringe. Remove the injection needle from the wrapping and place it firmly on the tip of the syringe. Remove the needle guard without touching the needle.

down. Be sure that the tip of the needle is in the solution.

will inform you how many ml of LITAK you need to inject).

7.
Inject straight away.

Where should I give my injection?

The most suitable places to inject yourself are shown here: the top of your thighs and the abdomen, except for the area around the navel.
If someone else is injecting you, they can also use the outer surface of the upper arms or the buttocks.

How do I give my injection?

3.
Pull slightly on the plunger to check that no blood vessel has been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.

4.
Inject the liquid slowly and evenly for approximately one minute, always keeping the skin pinched.

5.
After injecting the liquid, remove the needle.

6.
Put the used syringe in the puncture-proof container. Use a new syringe and injection needle for each injection. The vials are for single use only. Return any portion of the contents remaining after use to your doctor or pharmacist for proper disposal.

Disposing of used syringes

Put used syringes into a puncture-proof container and keep it out of the reach and sight of children.

Dispose the puncture-proof container as instructed by your doctor, nurse or pharmacist.

Do not put used syringes into the normal household garbage bin.

1.
Disinfect your skin by using an alcohol wipe, wait for the area to dry and pinch the skin between your thumb and forefinger, without squeezing it.

2.
Put the needle fully into the skin at an angle of about 45°, as shown in the picture.

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
OF THE MARKETING AUTHORISATIONS

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSURs for cladribine (apart from products with multiple sclerosis indication), the scientific conclusions of PRAC are as follows:

In view of available data on excretion of cladribine in human breastmilk from the literature, the PRAC considers that excretion of cladribine in human milk is at least a reasonable possibility. The PRAC concluded that the product information of products containing cladribine (apart from products with multiple sclerosis indication) should be amended accordingly.

Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.

Grounds for the variation to the terms of the Marketing Authorisations

On the basis of the scientific conclusions for cladribine (apart from products with multiple sclerosis indication) the CHMP is of the opinion that the benefit-risk balance of the medicinal products containing cladribine (apart from products with multiple sclerosis indication) is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the Marketing Authorisations should be varied.

tablet(s).

(2) Push in the hooks on the sides of the carton simultaneously with your index finger and thumb, and keep hooks pushed.
(3) Pull the tray out until it stops. Caution: Do not remove the tray from the carton.

including this step-by-step guide and keep it in a safe place.

the blister pack and push 1 or 2 tablet(s) into your hand, according to your prescribed dose.

dissolve in your mouth. Contact with skin should be limited. Avoid touching your nose, eyes, and other parts of the body.

7.
Wash your hands thoroughly with soap and water.

8.
Push the tray back into the carton. Store in the original package in order to protect from moisture.

Keep your tablets in the blister until your next dose. Do not pop the tablets out of the blister. Do not store the tablets in a different container.