Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ajovy

Document Subject

Generated Narrative: MedicinalProductDefinition mp684d3ac7eb172f49f26955be7ae4a00d

identifier: http://ema.europa.eu/identifier/EU/1/19/1358/001 – 1 pre-filled syringe

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: AJOVY 225 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-684d3ac7eb172f49f26955be7ae4a00d

identifier: http://ema.europa.eu/identifier/EU/1/19/1358/001 – 1 pre-filled syringe

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - ajovy

Attesters

What is in this leaflet

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

What AJOVY is AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and attaches to a specific target in the body.

How AJOVY works A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine. Fremanezumab attaches to CGRP and prevents it from working. This reduction in CGRP's activity reduces migraine attacks.

What AJOVY is used for AJOVY is used to prevent migraine in adults who have at least 4 migraine days per month.

What are the benefits of using AJOVY AJOVY reduces the frequency of migraine attacks and days with headache. This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks.

Do not use AJOVY Do not use this medicine if you are allergic to fremanezumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse immediately if you get any signs of a serious allergic reaction, e.g. trouble breathing, swelling of the lips and tongue, or severe rash, after injecting AJOVY. These reactions can occur within 24 hours after using AJOVY but can sometimes be delayed.

Tell your doctor if you have or have had cardiovascular disease (problems affecting the heart and blood vessels) before using this medicine, because AJOVY has not been studied in patients with certain cardiovascular diseases.

Children and adolescents AJOVY is not recommended for children and adolescents below the age of 18 years because it has not been studied in this age group.

Other medicines and AJOVY 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, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is preferable to avoid the use of AJOVY during pregnancy as the effects of this medicine in pregnant women are not known.

If you are breast-feeding or are planning to breast-feed, talk to your doctor or pharmacist before using this medicine. You and your doctor should decide if you will use AJOVY while breast-feeding.

Driving and using machines This medicine is not expected to have any effect on your ability to drive or use machines.

AJOVY contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially sodium-free .

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

Read the Instructions for Use for the pre-filled syringe carefully before using AJOVY.

How much and when to inject Your doctor will discuss and decide with you the most appropriate dosing schedule. There are two alternative recommended dosing options:

• one injection (225 mg) once a month (monthly dosing) or
• three injections (675 mg) every 3 months (quarterly dosing)

If your dose is 675 mg, inject the three injections one after another, each in a different place.

AJOVY is given by injection under your skin (subcutaneous injection). Your doctor or nurse will explain to you or your caregiver how to give the injection. Do not inject AJOVY until you or your caregiver have been trained by your doctor or nurse.

Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you do not miss a dose or have a dose too soon after the last one.

If you use more AJOVY than you should If you have used more AJOVY than you should, tell your doctor.

If you forget or miss to use AJOVY If you have missed a dose of AJOVY, inject your missed dose as soon as you can. Do not take a double dose to make up for a forgotten dose. If you are not sure when to inject AJOVY, talk to your doctor, pharmacist or nurse.

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.

The following side effects can occur:

Very common (may affect more than 1 in 10 people) Pain, hardening or redness at the injection site

Common (may affect up to 1 in 10 people) Itching at the injection site

Uncommon (may affect up to 1 in 100 people) Rash at the injection site Allergic reactions such as rash, swelling or hives

Rare (may affect up to 1 in 1,000 people) Serious allergic reactions (signs may include trouble breathing, swelling of the lips, tongue or severe rash) (see section 2. Warnings and precautions ).

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 syringe label and on the outer carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Do not freeze. Keep the pre-filled syringe in the outer carton to protect the medicine from light.

This medicine may be removed from the refrigerator and stored at a temperature up to 30 C for a maximum period of up to 7 days. The medicine must be discarded if it has been out of the refrigerator for longer than 7 days. Once stored at room temperature, do not place back in the refrigerator.

Do not use this medicine if you notice that the outer carton has been tampered with, the syringe is damaged, or the medicine is cloudy, discoloured, or contains particles.

The syringe is for single use only.

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

What AJOVY contains

• The active substance is fremanezumab.
  Each pre-filled syringe contains 225 mg of fremanezumab.
• The other ingredients (excipients) are L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80 and water for injections.

What AJOVY looks like and contents of the pack AJOVY is a solution for injection (injection) in a pre-filled syringe with a fixed injection needle in a blister. AJOVY is a clear, colourless to slightly yellow solution. Each pre-filled syringe contains 1.5 mL solution.

AJOVY is available in packs containing 1 or 3 pre-filled syringes. Not all pack sizes may be available in your country.

Marketing Authorisation Holder
TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Manufacturer Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Teva Pharmaceuticals Europe B.V. Swensweg 5 2031 GA Haarlem The Netherlands

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

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

Te : +359 24899Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt.
Tel: +36 12886Danmark Teva Denmark A/S
Tlf: +45 44985Malta Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407Deutschland TEVA GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal
Tel: +372 6610Norge Teva Norway AS
Tlf: +47 66775
TEVA HELLAS . . : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970Espa a Teva Pharma, S.L.U.
Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda.
Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland
Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o.
Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267Italia Teva Italia S.r.l.
Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
TEVA HELLAS . .

: +30 2118805Sverige Teva Sweden AB
Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in {month YYYY}.

Other sources of information

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