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AstraZeneca

Victoza
liraglutide

Package leaflet: Information for the user


Victoza 6 mg/ml solution for injection in pre-filled pen

liraglutide


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


What Victoza looks like and contents of the pack

Victoza is supplied as a clear, and colourless or almost colourless, solution for injection in a pre-filled pen. Each pen contains 3 ml of solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.


Victoza is available in packs containing 1, 2, 3, 5 or 10 pens. Not all pack sizes may be marketed. Needles are not included.


Marketing Authorisation Holder and Manufacturer


Novo Nordisk A/S Novo Allé

DK-2880 Bagsværd Denmark


This leaflet was last revised in

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INSTRUCTIONS FOR USING THE VICTOZA PEN

Please read these instructions carefully before using your pen.

Your pen comes with 18 mg of liraglutide. You can select doses of 0.6 mg, 1.2 mg and 1.8 mg.

The pen is designed to be used with NovoFine or NovoTwist disposable injection needles up to a length of 8 mm and as thin as 32G (0.25/0.23 mm).


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Prepare your pen


Check the name and coloured label of your pen to make sure that it contains liraglutide. Using the wrong medicine could cause severe harm.


Pull off the pen cap.


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Pull off the paper tab from a new disposable needle. Screw the needle straight and tightly onto your pen.


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Pull off the outer needle cap and keep it for later.


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Pull off the inner needle cap and dispose of it.


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Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.

Be careful not to bend or damage the needle.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.


Caring for your pen

  • Do not try to repair your pen or pull it apart.

  • Keep your pen away from dust, dirt and all kinds of liquids.

  • Clean the pen with a cloth moistened with a mild detergent.

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  • Do not try to wash, soak or lubricate it – this can harm the pen.


Important information

  • Do not share your pen or needles with anyone else.

  • Keep your pen out of the reach of others, especially children.


With each new pen, check the flow


Check the flow before your first injection with each new pen. If your pen is already in use, go to ‘Select your dose’, step H.


Turn the dose selector until the flow check symbol lines up with the pointer.


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Hold the pen with the needle pointing up. Tap the cartridge gently with your finger a few times. This will make any air bubbles collect at the top of the cartridge.


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Keep the needle pointing up and press the dose button until 0 mg lines up with the pointer.


A drop of liraglutide should appear at the needle tip. If no drop appears, repeat steps E to G up to four times.


If there is still no drop of liraglutide, change the needle and repeat steps E to G once more.


Do not use the pen if a drop of liraglutide still does not appear. This indicates the pen is defective and you must use a new one.


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If you have dropped your pen against a hard surface or suspect that something is wrong with it, always put on a new disposable needle and check the flow before you inject.

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Select your dose


Always check that the pointer lines up with 0 mg.


Turn the dose selector until your needed dose lines up with the pointer (0.6 mg, 1.2 mg or 1.8 mg).


If you selected a wrong dose by mistake, simply change it by turning the dose selector backwards or forwards until the right dose lines up with the pointer.


Be careful not to press the dose button when turning the dose selector backwards, as liraglutide may come out.


If the dose selector stops before your needed dose lines up with the pointer, there is not enough liraglutide left for a full dose. Then you can either:


Split your dose into two injections:

Turn the dose selector in either direction until 0.6 mg or

1.2 mg lines up with the pointer. Inject the dose. Then prepare a new pen for injection and inject the remaining number of mg to complete your dose.


You may only split your dose between your current pen and a new pen if trained or advised by your healthcare professional. Use a calculator to plan the doses. If you split the dose wrong, you may inject too much or too little liraglutide.


Inject the full dose with a new pen:

If the dose selector stops before 0.6 mg lines up with the pointer, prepare a new pen and inject the full dose with the new pen.


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Do not try to select other doses than 0.6 mg, 1.2 mg or 1.8 mg. The numbers in the display must line up precisely with the pointer to ensure that you get the correct dose.

The dose selector clicks when you turn it. Do not use these clicks to select your dose.

Do not use the cartridge scale to measure how much liraglutide to inject – it is not accurate enough.


Inject your dose


Insert the needle into your skin using the injection technique shown by your doctor or nurse. Then follow the instructions below:


Press the dose button to inject until 0 mg lines up with the pointer. Be careful not to touch the display with your other fingers or press the dose selector sideways when you inject. This is because it may block the injection. Keep the dose button pressed down and leave the needle under the skin for at least 6 seconds. This is to make sure that you get your full dose.


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Pull out the needle.

After that, you may see a drop liraglutide at the needle tip.

This is normal and does not affect your dose.


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Guide the needle tip into the outer needle cap without touching the needle or the outer needle cap.


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When the needle is covered, carefully push the outer needle cap completely on. Then unscrew the needle. Dispose of it carefully and put the pen cap back on.


When the pen is empty, carefully dispose of it without a needle attached. Please dispose of the pen and needle in accordance with local requirements.


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Always remove the needle after each injection, and store your pen without a needle attached. This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.

Caregivers must be very careful when handling used needles – to prevent needle injury and cross-infection.


Annex IV


Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Scientific conclusions


Taking into account the PRAC Assessment Report on the PSUR(s) for liraglutide, the scientific conclusions of CHMP are as follows:


In view of available data on hypoglycaemia with liraglutide overdose, from clinical trial(s), literature and spontaneous reports, the PRAC considers a causal relationship between liraglutide overdose and hypoglycaemia a reasonable possibility. The existing wording in section 4.9 of the SmPC and corresponding sections in the Package Leaflet of liraglutide in T2DM and WM should be amended to inform HCP’s that hypoglycaemia has occurred in cases of liraglutide overdose.


The CHMP agrees with the scientific conclusions made by the PRAC.


Grounds for the variation to the terms of the marketing authorisation(s)


On the basis of the scientific conclusions for liraglutide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing liraglutide is unchanged subject to the proposed changes to the product information.


The CHMP recommends that the terms of the marketing authorisation(s) should be varied.