What LITAK contains
- The active substance is cladribine. Each ml solution contains 2 mg cladribine. Each vial contains 10 mg cladribine in 5 ml solution.
- The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.
What LITAK looks like and contents of the pack
LITAK is available in glass vials containing 5 ml of clear, colourless solution for injection. Pack size of 1 or 5 vials. Not all pack-sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Hegenheimer Strasse 2
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last approved in
INSTRUCTIONS FOR INJECTION
This section contains information on how to give an injection of LITAK. It is important that you do not try to give yourself the injection unless you have been instructed by your doctor or nurse. Your doctor will tell you how much LITAK you need and how often and when you have to inject yourself. LITAK should be injected into the tissue just under the skin (subcutaneous injection). If you have any question with regard to giving the injection, please ask your doctor or nurse for help.
LITAK is a cytotoxic and should therefore be handled with caution. When LITAK is not self-administered by the patient, the use of disposable gloves and protective garments is recommended when handling and administering LITAK. If LITAK contacts the skin or eyes, rinse the involved surface immediately with copious amounts of water. Pregnant women must avoid contact with LITAK.
What do I need for the injection?
To give yourself a subcutaneous injection, you will need:
- one vial of LITAK (or two vials if you need to inject more than 5 ml). Do not use vials which are damaged, or if the solution is not clear or if it contains any particles.
- one sterile syringe (e.g. 10 ml LUER syringe),
- one sterile injection needle (e.g. 0.5 x 19 mm, 25 G x ¾??),
- alcohol wipes,
- a puncture-proof container for safe disposal of the used syringe.
What should I do before I give myself a subcutaneous injection of LITAK?
1. Before injection, allow LITAK to warm up to room temperature.
2. Wash your hands thoroughly.
3. Find a comfortable, well-lit place and put everything you need where you can reach it.
How do I prepare the injection?
Before you inject LITAK, you must do the following:
1. Remove the red protective cap from the LITAK vial. Do not remove the rubber stopper of the 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.
2. Push the needle through the rubber stopper of the vial and turn the vial and the syringe upside down. Be sure that the tip of the needle is in the solution.
3. Draw the correct volume of LITAK into the syringe by pulling back the plunger (your doctor will inform you how many ml of LITAK you need to inject).
4. Pull the needle out of the vial.
5. Make sure there is no air left in the syringe: point the needle upwards and push the air out.
6. Check you have the right volume.
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
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.
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.