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AstraZeneca

Cetrotide
cetrorelix

Package leaflet: Information for the user


Cetrotide 0.25 mg powder and solvent for solution for injection

Cetrorelix


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


Marketing Authorisation Holder

Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands

Manufacturer

Merck Healthcare KGaA, Frankfurter Straße 250, D-64293 Darmstadt, Germany


This leaflet was last revised in {MM/YYYY}.


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HOW TO MIX AND INJECT CETROTIDE



Before you start


  1. This medicine must be at room temperature prior to injection. Remove from the refrigerator approximately 30 minutes before use.


  2. Wash your hands

    • It is important that your hands and the things you use are as clean as possible.


  3. Lay out everything you need on a clean surface:

    • one vial of powder

    • one pre-filled syringe with sterile water (solvent)

    • one needle with a yellow mark – for injecting the sterile water into the vial and drawing the made-up medicine out from the vial

    • one needle with a grey mark – for injecting the medicine into your belly

    • two alcohol swabs.


Mixing the powder and water to make up your medicine


  1. Remove the cap from the vial

    • There will be a rubber stopper underneath – keep this in the vial.

    • Wipe the rubber stopper and metal ring with your first alcohol swab.


  2. Adding the water from the pre-filled syringe to the powder in the vial

    • Unwrap the needle with the yellow mark on it.

    • Remove the cap from the pre-filled syringe and screw the yellow needle onto it. Remove the cap from the needle.

    • Push the yellow needle through the centre of the rubber stopper of the vial.

    • Slowly push in the plunger of the syringe to inject the water into the vial. Do not use any other sort of water.

    • Leave the syringe in the rubber stopper.

      image


  3. Mixing the powder and water in the vial

    • While carefully holding the syringe and vial, swirl gently to mix the powder and water together. When it is mixed, it will look clear and have no particles in it.

    • Do not shake or you will create bubbles in your medicine.


  4. Re-filling the syringe with the medicine from the vial

    • Turn the vial upside down. Then, gently pull back the plunger, in order to draw the medicine from the vial into the syringe. Take care not to pull out completely the plunger

      with the attached plunger stopper. In case you pulled out the plunger with the plunger stopper by mistake, make sure to discard the dose as sterility will be lost, and prepare a new dose (and restart from step 1).

    • If any medicine is left in the vial, pull out the yellow needle until the end of the needle is just inside the rubber stopper. If you look from the side through the gap in the rubber stopper, you can control the movement of the needle and the liquid.

    • Make sure that you collect all of your medicine from the vial.

      image

    • Put the cap back on the yellow needle. Unscrew the yellow needle from the syringe and lay down the syringe.


Preparing the injection site and injecting your medicine


  1. Removing air bubbles

    • Unwrap the needle with the grey mark on it. Screw the grey needle onto the syringe and remove the cap from the grey needle.

    • Hold the syringe with the grey needle pointing upwards and check for any air bubbles.

    • To remove air bubbles, gently flick the syringe until all the air collects at the top - then slowly push the plunger in until the air bubbles are gone.

    • Do not touch the grey needle and do not let the needle touch any surface.


      image


  2. Clean the injection site

    • Choose an injection site on your belly. It is best around the belly button (navel). To reduce skin irritation, select a different part of your belly each day.

    • Clean the skin at your chosen injection site with your second alcohol swab - use a circular motion.


  3. Piercing your skin

    • Hold the syringe in one hand – like you would hold a pencil.

    • Gently pinch up the skin around where you are going to inject and hold this firmly with your other hand.

    • Slowly push the grey needle completely into your skin at an angle of about 45 to 90 degrees – then let go of your skin.


      image

  4. Injecting your medicine

    • Gently pull back the plunger of the syringe. If blood appears, follow Step 5 below.

    • If no blood appears, slowly push the plunger in to inject your medicine.

    • When the syringe is empty, take out the grey needle slowly at the same angle.

    • Use your second alcohol swab to gently apply pressure where you have just injected.


  5. If blood appears:

    • take out the grey needle slowly at the same angle

    • use your second alcohol swab to gently apply pressure where you have just pierced your skin

    • empty your medicine into a sink and follow Step 6 below

    • wash your hands and start again with a new vial and pre-filled syringe.


  6. Disposal

    • Use each needle, vial and syringe only once.

    • Put the cap back on the needles so that they are safe to be thrown away.

    • Ask your pharmacist how to safely dispose of used needles, vial and syringe.