Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - emgality

Document Subject

Generated Narrative: MedicinalProductDefinition mpf45f6799ffdf756697ce11d9c2b8c128

identifier: http://ema.europa.eu/identifier/EU/1/18/1330/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Emgality 120 mg solution for injection in pre-filled pen

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-f45f6799ffdf756697ce11d9c2b8c128

identifier: http://ema.europa.eu/identifier/EU/1/18/1330/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - emgality

Attesters

What is in this leaflet

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

Emgality contains galcanezumab, a medicine that stops the activity of a naturally occurring substance in the body called calcitonin gene-related peptide (CGRP). People with migraine may have increased levels of CGRP.

Emgality is used to prevent migraine in adult patients who have at least 4 migraines days per month.

Emgality can reduce the frequency of migraine headache and improve your quality of life. It starts working in about a week.

Do not use Emgality:

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before or during treatment with Emgality if:

• you have a serious cardiovascular disease. Emgality has not been studied in patients with serious cardiovascular diseases.

Look out for allergic reactions Emgality can potentially cause serious allergic reactions. Serious allergic reactions happen mainly within 1 day after having taken Emgality, but some reactions can be delayed (happen more than 1 day to 4 weeks after having taken Emgality). Some allergic reactions can be prolonged in duration. You must look out for signs of these reactions while you are using Emgality. Stop using Emgality and tell your doctor or seek medical help immediately if you notice any signs of a serious allergic reaction. Such signs are listed under Serious side effects in section 4. Children and adolescents This medicine should not be given to children and adolescents under 18 years of age because it has not been studied in this age group.

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

Pregnancy and breast-feeding
If you are a woman able to have children, you are advised to avoid becoming pregnant while using Emgality.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is preferable to avoid the use of Emgality in 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 before using this medicine. You and your doctor should decide if you should breast feed and use Emgality .

Driving and using machines
Galcanezumab could have a minor effect on your ability to drive and use machines. Some patients have had vertigo whilst using Emgality.

Emgality contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say essentially sodium-free .

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

Emgality pre-filled pen is for single use only and contains one dose of Emgality (120 mg).

• The first time you receive Emgality your doctor or nurse will inject two pens (total 240 mg).
• After the first dose, you will use one pen (120 mg) every month.

Your doctor will decide for how long you should use Emgality.

Emgality is given by injection under your skin (subcutaneous injection). You and your doctor or nurse should decide if you can inject Emgality yourself.

It is important not to try to inject yourself until you have been trained by your doctor or nurse. A caregiver may also give you your Emgality injection after proper training.

The pen must not be shaken.

Read the Instructions for Use for the pen carefully before using Emgality.

If you use more Emgality than you should
If you have injected more Emgality than you should, e.g. if after the first dose of 240 mg, you have injected it twice in a single month, or if anyone else has accidentally used Emgality, contact your doctor immediately.

If you forget to use Emgality
Do not take a double dose to make up for forgotten injection

If you have forgotten to inject a dose of Emgality, inject the missed dose as soon as possible and then inject the next dose after a month from that date.

If you stop using Emgality
You should not stop using Emgality without speaking to your doctor first.

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.

Serious side effects

Allergic reactions with Emgality are usually mild to moderate (such as rash or itching). Serious allergic reactions may occur rarely (may affect up to 1 in 1 000 people) and the signs may include:
difficulty breathing or swallowing, low blood pressure, which can cause dizziness or light-headedness, swelling of the neck, face, mouth, lips, tongue or throat which may develop rapidly, severe itching of the skin, with a red rash or raised bumps.

Tell your doctor or get emergency medical help straight away if you notice any of those signs.

Other side effects that have been reported.

Very common side effects (may affect more than 1 in 10 people):

• Injection site pain
• Injection site reactions (e.g. red skin, itching, bruising, swelling)

Common side effects (may affect up to 1 in 10 people):

• Vertigo (a feeling of dizziness or spinning )
• Constipation
• Itching
• Rash

Uncommon side effects (may affect up to 1 in 100 people):

• Hives (raised itchy areas of skin)

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

Store in a refrigerator (2 C to 8 C). Do not freeze. Store in the original package in order to protect from light.

Emgality may be stored unrefrigerated for a single period up to 7 days when stored at temperatures up to 30 C. If the pen is stored at a higher temperature or for a longer period it must be discarded.

Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy or has particles in it.

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

What Emgality contains
The active substance is galcanezumab. Each pre-filled pen contains 120 mg of galcanezumab in 1 mL solution.

The other ingredients are: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride and water for injections.

What Emgality looks like and contents of the pack Emgality is a solution for injection in a clear glass syringe. Its colour may vary from colourless to slightly yellow.

The syringe is encased in a disposable, single-dose pen. Pack sizes of 1, 2 or 3 pre-filled pens.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B. V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer: Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy. Lilly, S.A., Avda. de la Industria, 30, 28108 Alcobendas, Madrid Spain.

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

Belgique/Belgi /Belgien Eli Lilly Benelux S.A./N.V. T l/Tel: + 32-(0)2 548 84 Lietuva Eli Lilly Lietuva Tel. +370 (5) 2649
" " . . -
. + 359 2 491 41 Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V. T l/Tel: + 32-(0)2 548 84 esk republika ELI LILLY R, s.r.o. Tel: + 420 234 664 Magyarorsz g Lilly Hung ria Kft. Tel: + 36 1 328 5Danmark Eli Lilly Danmark A/S
Tlf: +45 45 26 60 Malta Charles de Giorgio Ltd. Tel: + 356 25600 Deutschland Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2Nederland Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 Eesti Eli Lilly Nederland B. V. Tel: +372 6 817 Norge Eli Lilly Norge A.S.
Tlf: + 47 22 88 18

• . . . .
  : +30 210 629 4 sterreich Eli Lilly Ges.m.b.H.
  Tel: + 43-(0) 1 711 Espa a Lilly S.A. Tel: + 34-91 663 50 Polska Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 France Lilly France T l: +33-(0) 1 55 49 34 Portugal Lilly Portugal Produtos Farmac uticos, Lda Tel: + 351-21-4126Hrvatska Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 Rom nia Eli Lilly Rom nia S.R.L. Tel: + 40 21 4023Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4Slovenija Eli Lilly farmacevtska dru ba, d.o.o. Tel: +386 (0)1 580 00 sland Icepharma hf. S mi + 354 540 8Slovensk republika Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 Italia Eli Lilly Italia S.p.A. Tel: + 39- 055 42Suomi/Finland Oy Eli Lilly Finland Ab
  Puh/Tel: + 358-(0) 9 85 45
  Phadisco Ltd
  : +357 22 715Sverige Eli Lilly Sweden AB Tel: + 46-(0) 8 7378Latvija Eli Lilly (Suisse) S.A P rst vniec ba Latvij Tel: +371 67364United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4This leaflet was last revised in

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