Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vyepti

Document Subject

Generated Narrative: MedicinalProductDefinition mpfbb3ae3b0ec47d0ddb6ffbdc6984439f

identifier: http://ema.europa.eu/identifier/EU/1/21/1599/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: VYEPTI 100 mg concentrate for solution for infusion.

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-fbb3ae3b0ec47d0ddb6ffbdc6984439f

identifier: http://ema.europa.eu/identifier/EU/1/21/1599/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - vyepti

Attesters

What is in this leaflet

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

VYEPTI contains the active substance eptinezumab, which blocks the activity of calcitonin gene- related peptide (CGRP), a naturally occurring substance in the body. People with migraine may have increased levels of this substance.

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

VYEPTI can reduce the number of days with migraine and improve your quality of life. You may feel the preventive effect starting the day after receiving this medicine.

Do not use VYEPTI

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

Warnings and precautions
Talk to your doctor or nurse before being given VYEPTI if you have disease affecting the heart and blood circulation.

VYEPTI can cause serious allergic reactions. These reactions can develop quickly even while the medicine is being given. Tell your doctor immediately if you get any symptoms of an allergic reaction, such as:

• breathing difficulty
• a fast or weak pulse or a sudden drop in blood pressure which makes you feel dizzy or lightheaded
• swelling of the lips or tongue
• severe itching of the skin or rash while you receive VYEPTI, or afterwards

Children and adolescents VYEPTI is not recommended for children or adolescents under 18 years because it has not been studied in this age group.

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

Pregnancy, breast-feeding and fertility 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 being given this medicine.

It is preferable to avoid the use of VYEPTI during pregnancy as the effects of this medicine in pregnant women are not known.

It is not known if VYEPTI passes into breast milk. Your doctor will help you decide if you should stop breast-feeding or stop VYEPTI treatment. If you are breast-feeding or are planning to breast-feed, talk to your doctor before being treated with VYEPTI. You and your doctor should decide if you should breast-feed and be treated with VYEPTI.

Driving and using machines VYEPTI has no or negligible effect on the ability to drive or use machines.

VYEPTI contains sorbitol Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects. You must tell your doctor before receiving this medicine if you have HFI.

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

VYEPTI is given as a drip (infusion) into a vein. The infusion lasts about 30 minutes. VYEPTI will be given to you by a healthcare professional, who prepares the infusion before giving it to you. During and after the infusion the healthcare professional will observe you in accordance with normal clinical practice for signs of an allergic reaction.

The recommended dose is 100 mg given every 12 weeks. Some patients may benefit from a dose of 300 mg given every 12 weeks. Your doctor will decide the right dose for you and how long you should continue to be treated.

If you use more VYEPTI than you should Because the medicine will be given to you by a healthcare professional, it is unlikely you will receive too much VYEPTI. Inform your doctor if you think this has happened.

If you forget to use VYEPTI If a dose is missed, your doctor will decide when the next dose should be given.

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

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

Contact your doctor or nurse immediately if you notice any of the following side effects you may need urgent medical treatment:

Common: may affect up to 1 in 10 people:

• allergic reactions and other reactions due to the infusion Reactions can develop quickly during infusion. Symptoms of allergic reactions are:

• breathing difficulties
• fast or weak pulse
• sudden drop in blood pressure making you feel dizzy or lightheaded
• swelling of the lips or tongue
• severe skin itching, rash Serious allergic reactions are uncommon (may affect up to 1 in 100 people).

Other symptoms that may occur due to the infusion include respiratory symptoms (such as blocked or runny nose, throat irritation, cough, sneezing, shortness of breath) and feeling tired. These symptoms are usually non-serious and of short duration.

Other side effects can occur with following frequency:

Common: may affect up to 1 in 10 people:

• stuffy nose
• sore throat
• fatigue

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

Store in a refrigerater (2 C - 8 C). Do not freeze or shake. Keep the vial in the outer carton in order to protect from light.

If removed from the refrigerator, VYEPTI must be kept at room temperature (below 25 C) in the original carton and used within 2 days, or else discarded. Do not put VYEPTI back in the
refrigerator once it has been removed. After dilution, the solution may be stored at room temperature (below 25 C) or in a refrigerater at 2 C - 8 C. The diluted solution for infusion must be given within 8 hours.

Do not use this medicine if you notice that the solution contains visible particles or is cloudy or discolored.

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

What VYEPTI contains

• The active substance is eptinezumab.
• Each vial of 100 mg concentrate contains 100 mg of eptinezumab per mL.
• Each vial of 300 mg concentrate contains 300 mg of eptinezumab per 3 mL.
• The other ingredients are sorbitol (E420), L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80 and water for injections.

What VYEPTI looks like and contents of the pack VYEPTI concentrate for solution for infusion is clear to slightly milky, colourless to brownish-yellow. Each vial contains concentrate in a clear glass vial with a rubber stopper, aluminium seal and plastic flip-off cap.

VYEPTI 100 mg concentrate is available in pack sizes of 1 and 3 vial(s) for single-use. VYEPTI 300 mg concentrate is available in pack size of 1 vial for single-use.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark

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

Belgi /Belgique/Belgien Lundbeck S.A./N.V. T l/Tel: +32 2 535 7Lietuva H. Lundbeck A/S Tel: +45 36301311(Danija)
lietuva@lundbeck.com

Lundbeck Export A/S Representative Office Tel: +359 2 962 4Luxembourg/Luxemburg Lundbeck S.A. T l: +32 2 535 7 esk republika Lundbeck esk republika s.r.o. Tel: +420 225 275 Magyarorsz g Lundbeck Hungaria Kft. Tel: +36 1 4369Danmark Lundbeck Pharma A/S Tlf: +45 4371 4Malta H. Lundbeck A/S Tel: + 45 36301Deutschland Lundbeck GmbH Tel: +49 40 23649 0 Nederland Lundbeck B.V. Tel: +31 20 697 1Eesti Lundbeck Eesti AS Tel: + 372 605 9Norge H. Lundbeck AS
Tlf: +47 91 300
Lundbeck Hellas S.A. : +30 210 610 5 sterreich Lundbeck Austria GmbH Tel: +43 1 253 621 6Espa a Lundbeck Espa a S.A. Tel: +34 93 494 9Polska Lundbeck Poland Sp. z o. o.
Tel.: + 48 22 626 93 France Lundbeck SAS T l: + 33 1 79 41 29 Portugal Lundbeck Portugal Lda Tel: +351 21 00 45 Hrvatska Lundbeck Croatia d.o.o. Tel.: + 385 1 6448Ireland Lundbeck (Ireland) Limited Tel: +353 1 468 9Rom nia Lundbeck Romania SRL
Tel: +40 21319 88 Slovenija Lundbeck Pharma d.o.o. Tel.: +386 2 229 4 sland Vistor hf.
Tel: +354 535 7Slovensk republika Lundbeck Slovensko s.r.o. Tel: +421 2 5341 42 Italia Lundbeck Italia S.p.A. Tel: +39 02 677 4Suomi/Finland Oy H. Lundbeck Ab Puh/Tel: +358 2 276 5
Lundbeck Hellas A.E .: +357 22490Sverige H. Lundbeck AB Tel: +46 40 699 8Latvija H. Lundbeck A/S Tel: +45 36301311(D nija) latvia@lundbeck.com

United Kingdom (Northern Ireland) Lundbeck Ireland Limited Tel: +353 1 468 9This leaflet was last revised in

Other sources of information

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