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AstraZeneca

Firazyr
icatibant

Package Leaflet: Information for the user


Firazyr 30 mg solution for injection pre-filled syringe

icatibant


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



The instructions include the following main steps:


1) General Information

2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less 2b) Preparing the syringe and needle for injection (all patients)

  1. Preparing the injection site

  2. Injecting the solution

  3. Disposal of the injection material

Step-by-Step Instructions for Injection


1) General Information

  • Clean the work area (surface) to be used before beginning the process.

  • Wash your hands with soap and water.

  • Open the tray by peeling back the seal.

  • Remove the pre-filled syringe from the tray.

  • Remove the cap from the end of the pre-filled syringe by unscrewing the cap.

  • Put down the pre-filled syringe after unscrewing the cap.






2a) Preparing the syringe for children and adolescents (2-17 years)

weighing 65 kg or less:


Important information for healthcare professionals and caregivers:


Where the dose is less than 30 mg (3 ml), the following equipment is required to extract the appropriate dose (see below):


  1. Firazyr pre-filled syringe (containing icatibant solution)

  2. Connector (adapter)

  3. 3 ml graduated syringe




image


The required injection volume in ml should be drawn up in an empty 3 ml graduated syringe (see table below).

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Table 1: Dosage regimen for children and adolescents


Body Weight

Injection Volume

12 kg to 25 kg

1.0 ml

26 kg to 40 kg

1.5 ml

41 kg to 50 kg

2.0 ml

51 kg to 65 kg

2.5 ml


Patients weighing more than 65 kg will use the full contents of the pre-filled syringe (3 ml).



nurse

If you are not sure which volume of solution to extract, ask your doctor, pharmacist or


  1. Remove the caps on each end of the connector.


    Avoid touching the ends of the connector and syringe tips, to prevent contamination


  2. Screw the connector onto the pre-filled syringe.


  3. Attach the graduated syringe to the other end of the connector ensuring that both connections fit securely.


Transferring the icatibant solution to the graduated syringe:


  1. To start transfer of icatibant solution, push the pre-filled syringe plunger (on far left of below image).

    image

  2. If the icatibant solution does not begin to transfer to the graduated syringe, pull slightly on the graduated syringe plunger until the icatibant solution starts to flow into the graduated syringe (see below image).


  3. Continue to push on the pre-filled syringe plunger until the required injection volume (dose) is transferred to the graduated syringe. Refer to table 1 for dosage information.


If there is air in the graduated syringe:




  1. Remove the pre-filled syringe and connector from the graduated syringe.

  2. Discard the pre-filled syringe and connector into the sharps container.


2b) Preparing the syringe and needle for injection:

All patients (adults, adolescents and children)


image


  • Remove the needle cap from the blister.

  • Remove the seal from the needle cap (the needle should be still in the needle cap).


image


  • Grip the syringe firmly. Carefully attach the needle to the syringe containing the colourless solution.

  • Screw the syringe on the needle still fixed in the needle cap.

  • Remove the needle from the needle cap by pulling the syringe. Do not pull up on the plunger.

  • The syringe is now ready for injection.




image


3) Preparing the injection site


  • Choose the injection site. The injection site should be a skin fold on your abdomen approximately 5-10 cm (2-4 inches) below your navel on either side. This area should be at least 5 cm (2 inches) away from any scars. Do not choose an area that is bruised, swollen, or painful.

  • Clean the injection site with a rubbing alcohol pad and allow it to dry.


4) Injecting the solution


image


  • Hold the syringe in one hand between two fingers with your thumb at the bottom of the plunger.

  • Make sure that there is no air bubble in the syringe by pressing the plunger until the first drop appears on the tip of the needle.


image

image



  • Hold syringe between 45-90 degrees angle to skin with needle facing the skin.

  • Keeping the syringe in one hand, use your other hand to gently hold a fold of skin between your thumb and fingers at the previously disinfected injection site.

  • Hold the fold of skin, bring the syringe to the skin and quickly insert the needle into the skin fold.

  • Slowly push the plunger of the syringe with a steady hand until all the fluid is injected into the skin and no liquid remains in the syringe.

  • Press slowly so that this takes approximately 30 seconds.

  • Release the skin fold and gently pull the needle out.






5) Disposal of the injection material


  • Discard the syringe, needle and needle cap into the sharp container for throwing away waste that might hurt others if not handled properly.

  1. Possible side effects


    Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients receiving Firazyr will experience a reaction at the site of the injection (such as skin irritation, swelling, pain, itchiness, redness of the skin and burning sensation). These effects are usually mild and clear up without the need for any additional treatment.


    Very common (may affect more than 1 in 10 people):

    Additional injection site reactions (pressure sensation, bruising, reduced sensation and/or numbness, raised itchy skin rash and warmth).


    Common (may affect up to 1 in 10 people): Feeling sick

    Headache Dizziness

    Fever Itching Rash

    Skin redness

    Abnormal liver function test


    Not known (frequency cannot be estimated from the available data): Hives (urticaria)


    Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received Firazyr.


    If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet.


    Reporting of side effects


    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


  2. How to store Firazyr


    Keep this medicine out of the sight and reach of children.


    Do not use this medicine after the expiry date stated on the label after ‘EXP’. The expiry date refers to the last day of that month.


    Do not store above 25C. Do not freeze.


    Do not use this medicine if you notice that the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed.


    Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  3. Contents of the pack and other information What Firazyr contains

The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for injection.


What Firazyr looks like and contents of the pack


Firazyr is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml. Hypodermic needle is included in the pack.


Firazyr is available as a single pack containing one pre-filled syringe with one needle or as a multipack containing three pre-filled syringes with three needles.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Takeda Pharmaceuticals International AG Ireland Branch

Block 3 Miesian Plaza

50 – 58 Baggot Street Lower

Dublin 2

D02 Y754, Ireland Tel: +800 66838470

E-mail: medinfoemea@takeda.com


Manufacturer

Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza

50 – 58 Baggot Street Lower

Dublin 2

D02 Y754, Ireland


Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza

50 – 58 Baggot Street Lower

Dublin 2

D02 Y754, Ireland


This leaflet was last revised in .



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