Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - aimovig

Document Subject

Generated Narrative: MedicinalProductDefinition mp27621dca9c70d4aa804aaf075667f6df

identifier: http://ema.europa.eu/identifier/EU/1/18/1293/001-006

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Aimovig 70 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-27621dca9c70d4aa804aaf075667f6df

identifier: http://ema.europa.eu/identifier/EU/1/18/1293/001-006

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - aimovig

Attesters

What is in this leaflet

1. What Aimovig is and what it is used for
2. What you need to know before you use Aimovig
3. How to use Aimovig
4. Possible side effects
5. How to store Aimovig
6. Contents of the pack and other information

Aimovig contains the active substance erenumab. It belongs to a group of medicines called monoclonal antibodies.

Aimovig works by blocking the activity of the CGRP molecule, which has been linked to migraine (CGRP stands for calcitonin gene-related peptide).

Aimovig is used to prevent migraine in adults who have at least 4 migraine days per month when starting treatment with Aimovig.

Do not use Aimovig

• if you are allergic to erenumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor before using Aimovig:

• if you have ever had an allergic reaction to rubber latex. The container of this medicinal product contains latex rubber within the cap.
• if you suffer from a cardiovascular disease. Aimovig has not been studied in patients with certain cardiovascular diseases.

Talk to your doctor or get emergency medical help immediately:

• if you get any symptoms of a serious allergic reaction, such as rash or swelling usually of the face, mouth, tongue, or throat; or difficulty breathing. Serious allergic reactions can happen within minutes, but some may happen more than one week after using Aimovig.
• Contact a doctor if you get constipation and seek medical help immediately if you develop constipation with severe or constant belly (abdominal) pain and vomiting, swelling of abdomen or bloating. Constipation can occur when treated with Aimovig. It is usually mild or moderate in intensity. However, some patients using Aimovig have had constipation with serious complications and have been hospitalised. Some cases have required surgery.

Children and adolescents Do not give this medicine to children or adolescents (under 18 years old) because the use of Aimovig has not been studied in this age group.

Other medicines and Aimovig Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy Your doctor will decide whether you should stop using Aimovig during pregnancy.

Breast-feeding Monoclonal antibodies like Aimovig are known to pass into breast milk during the first few days after birth, but after this first period Aimovig can be used. Talk to your doctor about using Aimovig while breast-feeding in order to help you decide whether you should stop breast-feeding or stop using Aimovig.

Driving and using machines Aimovig is unlikely to affect your ability to drive and use machines.

Aimovig contains sodium Aimovig contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

If your doctor prescribes the 70 mg dose you should have one injection once every 4 weeks. If your doctor prescribes the 140 mg dose you should have either one injection of Aimovig 140 mg or two injections of Aimovig 70 mg once every 4 weeks. If you are having two injections of Aimovig 70 mg, the second injection must be given immediately after the first one at a different injection site. Make sure that you inject the entire contents of both syringes.

Aimovig is given as an injection under your skin (known as a subcutaneous injection). You or your caregiver can give the injection into your abdomen or your thigh. The outer area of your upper arm can also be used as an injection site, but only if someone else is giving you the injection. If you need 2 injections, they should be given in different sites to avoid hardening of the skin and should not be given into areas where the skin is tender, bruised, red or hard.

Your doctor or nurse will give you or your caregiver training in the right way to prepare and inject Aimovig. Do not try to inject Aimovig until this training has been given.

If you have not noticed any treatment effect after 3 months, tell your doctor who will decide whether you should continue treatment.

Aimovig syringes are for single use only.

For detailed instructions on how to inject Aimovig, see Instructions for use of Aimovig pre-filled syringe at the end of this leaflet.

If you use more Aimovig than you should If you have received more Aimovig than you should or if the dose has been given earlier than it should have been, tell your doctor.

If you forget to use Aimovig

• If you forget an Aimovig dose, take it as soon as possible after you realise.
• Then contact your doctor, who will tell you when you should schedule your next dose. Follow the new schedule exactly as your doctor has told you.

If you stop using Aimovig Do not stop using Aimovig without talking to your doctor first. Your symptoms may return if you stop the treatment.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are listed below. Most of these side effects are mild to moderate.

Common: may affect up to 1 in 10 people

• allergic reactions such as rash, swelling, hives or difficulty breathing (see section 2)
• constipation
• itching
• muscle spasms
• injection site reactions, such as pain, redness and swelling where the injection is given.

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

• skin reactions such as rash, itching, hair loss or mouth/lip sores.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

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

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Keep the syringe(s) in the outer carton in order to protect from light. Store in a refrigerator (2 C
8 C). Do not freeze.

After Aimovig has been taken out of the refrigerator, it must be kept at room temperature (up to 25 C) in the outer carton and must be used within 7 days, or else discarded. Do not put Aimovig back in the refrigerator once it has been removed.

Do not use this medicine if you notice that the solution contains particles, is cloudy or is distinctly yellow.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. There may be local regulations for disposal. These measures will help protect the environment.

What Aimovig contains

• The active substance is erenumab.
• Aimovig 70 mg solution for injection in pre-filled syringe contains 70 mg erenumab.
• Aimovig 140 mg solution for injection in pre-filled syringe contains 140 mg erenumab.
• The other ingredients are sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections.

What Aimovig looks like and contents of the pack Aimovig solution for injection is clear to opalescent, colourless to light yellow, and practically free from particles.

Each pack contains one single-use pre-filled syringe.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Alcon-Couvreur Rijksweg B-2870 Puurs Belgium

Novartis Pharma GmbH Roonstrasse 90429 Nuremberg Germany

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD : +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: