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AstraZeneca

Cosentyx
secukinumab

Package leaflet: Information for the user Cosentyx 75 mg solution for injection in pre-filled syringe

secukinumab


Read all of this leaflet carefully before you (or your child) start using this medicine because it contains important information.


What Cosentyx looks like and contents of the pack

Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow. Cosentyx 75 mg solution for injection in pre-filled syringe is available in unit packs containing

1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes.

Not all pack sizes may be marketed.


Marketing Authorisation Holder

Novartis Europharm Limited Vista Building

Elm Park, Merrion Road

Dublin 4 Ireland


Manufacturer Novartis Pharma GmbH Roonstraße 25

90429 Nuremberg Germany


Sandoz GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11

Lietuva

SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50


България

Novartis Bulgaria EOOD Тел: +359 2 489 98 28

Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11


Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00


Danmark

Novartis Healthcare A/S Tlf: +45 39 16 84 00

Malta

Novartis Pharma Services Inc. Tel: +356 2122 2872


Deutschland

Novartis Pharma GmbH Tel: +49 911 273 0

Nederland

Novartis Pharma B.V. Tel: +31 88 04 52 111


Eesti

SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810

Norge

Novartis Norge AS Tlf: +47 23 05 20 00


Ελλάδα

Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12

Österreich

Novartis Pharma GmbH Tel: +43 1 86 6570


España

Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00

Polska

Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888


France

Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600


Hrvatska

Novartis Hrvatska d.o.o. Tel. +385 1 6274 220

România

Novartis Pharma Services Romania SRL Tel: +40 21 31299 01


Ireland

Novartis Ireland Limited Tel: +353 1 260 12 55

Slovenija

Novartis Pharma Services Inc. Tel: +386 1 300 75 50


Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439


Italia

Novartis Farma S.p.A. Tel: +39 02 96 54 1

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Κύπρος

Novartis Pharma Services Inc. Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB Tel: +46 8 732 32 00


Latvija

SIA Novartis Baltics Tel: +371 67 887 070

United Kingdom (Northern Ireland)

Novartis Ireland Limited Tel: +44 1276 698370


This leaflet was last revised in


Instructions for use of Cosentyx 75 mg pre-filled syringe


Read ALL the way through these instructions before injecting. It is important not to try to inject yourself or a person in your care until you have been trained by your doctor, nurse or pharmacist. The box contains one Cosentyx 75 mg pre-filled syringe individually sealed in a plastic blister.


image

Your Cosentyx 75 mg pre-filled syringe


Syringe Guard


Finger grips Plunger



Needle cap Viewing window Label &

expiry date


Syringe guard wings

Plunger head


After the medicine has been injected the syringe guard will be activated to cover the needle. This is intended to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed medicines, and individuals who assist self-injecting patients from accidental needlestick injuries.


image

What you additionally need for your injection:


Important safety information

Caution: Keep the syringe out of the sight and reach of children.

  1. The needle cap of the syringe may contain dry rubber (latex), which should not be handled by persons sensitive to this substance.

  2. Do not open the sealed outer box until you are ready to use this medicine.

  3. Do not use this medicine if either the seal on the outer box or the seal of the blister is broken, as it may not be safe for you to use.

  4. Never leave the syringe lying around where others might tamper with it.

  5. Do not shake the syringe.

  6. Be careful not to touch the syringe guard wings before use. By touching them, the syringe guard may be activated too early.

  7. Do not remove the needle cap until just before you give the injection.

  8. The syringe cannot be re-used. Dispose of the used syringe immediately after use in a sharps container.


Storage of the Cosentyx 75 mg pre-filled syringe

  1. Store this medicine sealed in its outer box to protect it from light. Store in the refrigerator between 2°C and 8°C. DO NOT FREEZE.

  2. Remember to take the syringe out of the refrigerator and allow it to reach room temperature before preparing it for injection (15-30 minutes).

  3. Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”. If it has expired, return the entire pack to the pharmacy.

image

The injection site


The injection site is the place on the body where you are going to use the syringe.

If a caregiver is giving you the injection, the outer upper arms may also be used.


image

Preparing the Cosentyx 75 mg pre-filled syringe ready for use

  1. Take the box containing the syringe out of the refrigerator and leave it unopened for about 15-30 minutes so that it reaches room temperature.

  2. When you are ready to use the syringe, wash your hands thoroughly with soap and water.

  3. Clean the injection site with an alcohol swab.

  4. Remove the syringe from the outer box and take it out of the blister by holding the syringe guard body.

  5. Inspect the syringe. The liquid should be clear. Its colour may vary from colourless to slightly yellow. You may see a small air bubble, which is normal. DO NOT USE if the liquid contains

easily visible particles, is cloudy or is distinctly brown. DO NOT USE if the syringe is broken. In all these cases, return the entire product pack to the pharmacy.


How to use the Cosentyx 75 mg pre-filled syringe


image

Carefully remove the needle cap from the syringe by holding the syringe guard body. Discard the needle cap. You may see a drop of liquid at the end of the needle. This is normal.


Gently pinch the skin at the injection site and insert the needle as shown. Push the needle all the way in at an angle of approximately

45 degrees to ensure that the medicine can be fully administered.

image


image

Disposal instructions

Hold the syringe as shown. Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.

Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.


Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site.


Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.


There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.


Dispose of the used syringe in a sharps container (closable, puncture resistant container). For the safety and health of you and others, needles and used syringes must never be re-used.