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Emgality 120 mg solución inyectable

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About the medicine

How to use EMGALITY 120 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Contents of the leaflet

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

Introduction

Package Leaflet: Information for the Patient

Emgality 120mg solution for injection in pre-filled syringe

galcanezumab

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

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Emgality and what is it used for

Emgality contains galcanezumab, a medicine that blocks 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 adults who have at least 4 days of migraine per month.

Emgality may reduce the frequency of migraine and improve your quality of life. It starts to work in about one week.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use Emgality

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 severe cardiovascular disease. Emgality has not been studied in patients with severe cardiovascular diseases.

Monitor for signs of allergic reactions

Emgality may cause potentially serious allergic reactions. Serious allergic reactions usually occur within 1 day after using Emgality, but some reactions may be delayed (occurring more than 1 day and up to 4 weeks after using Emgality). Some allergic reactions can be long-lasting. You should monitor for signs of these reactions while using Emgality. Stop using Emgality and tell your doctor or seek medical attention immediately if you notice any signs of a serious allergic reaction. These signs are listed under “Serious side effects” in section 4.

Children and adolescents

This medicine must not be given to children and adolescents under 18 years 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 breastfeeding

If you are a woman who could become pregnant, you are advised to avoid becoming pregnant while using Emgality.

If you are pregnant or think you may be pregnant, talk to your doctor before using this medicine. It is preferable to avoid using Emgality during pregnancy, as the effects of this medicine in pregnant women are not known.

If you are breastfeeding or plan to breastfeed, talk to your doctor before using this medicine. You and your doctor must decide whether to breastfeed or use Emgality.

Driving and using machines

Galcanezumab may have a small effect on your ability to drive and use machines. Some patients have experienced dizziness while using Emgality.

Emgality contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 120 mg dose; it is essentially “sodium-free”.

3. How to use Emgality

Follow exactly the administration instructions for this medicine given by your doctor, pharmacist, or nurse. If you are unsure, talk to your doctor, pharmacist, or nurse again.

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

  • The first time you are given Emgality, your doctor or nurse will inject two syringes (240 mg in total).
  • After the first dose, you will use one syringe (120 mg) every month.

Your doctor will decide how long you should use Emgality.

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

It is important that you do not try to inject yourself until you have been trained on how to do it by your doctor or nurse. A caregiver can also give you your Emgality injection if they are properly trained.

The syringe must not be shaken.

Read the “Instructions for Use” of the syringe 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 the medicine twice in one month, or if someone else has used Emgality accidentally, talk to your doctor immediately.

If you forget to use Emgality

Do not inject a double dose to make up for a 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 one month from that date.

If you stop using Emgality

Do not stop using Emgality without talking to your doctor first.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

Serious side effects

Generally, allergic reactions with Emgality are mild to moderate (such as rash or itching). Serious allergic reactions can occur rarely (may affect up to 1 in 1000 people) and signs may include:

  • difficulty breathing or swallowing,
  • low blood pressure, which can cause dizziness or fainting,
  • swelling of the neck, face, mouth, lips, tongue, or throat that can develop rapidly,
  • intense itching of the skin with rash or hives.

Talk to your doctor or seek medical attention immediately if you notice any of these signs.

Other side effects reported

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

  • Pain at the injection site
  • Injection site reactions (e.g., red skin, itching, bruising, swelling)

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

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

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

  • Hives (itchy rash on the skin)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Emgality

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 is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Keep the pre-filled syringe in the original package to protect it from light.

Emgality can be left outside the refrigerator for a single period of up to 7 days at a temperature not above 30°C. The syringe should be discarded if stored at a higher temperature or for a longer period.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Emgality

  • The active substance is galcanezumab. Each pre-filled syringe contains 120 mg of galcanezumab in 1 ml of solution.
  • The other ingredients are: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, and water for injectable preparations.

Appearance and pack contents of the product

Emgality is an injectable solution in a single-dose, transparent glass syringe. Its color may vary from colorless to slightly yellow. Pack sizes of 1, 2, or 3 pre-filled syringes.

Only some pack sizes may be marketed.

Marketing authorisation holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Manufacturer

Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy.

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Lietuva

Tel. +370 (5) 2649600

Text in Bulgarian language with contact information of a pharmaceutical company and phone number

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Ceská republika

ELI LILLY CR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 60 00

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Nederland B. V.

Tel: +372 6 817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges.m.b.H.

Tel: + 43-(0) 1 711 780

España

Organon Salud, S.L.

Tel: +34 91 591 12 79

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Organon France

Tél: +33-(0) 1 57 77 32 00

Portugal

Lilly Portugal Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0)1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly (Suisse) S.A Parstavnieciba Latvija

Tel: +371 67364000

United Kingdom(Northern Ireland)

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

Instructions for use

Emgality 120mg solution for injection in pre-filled syringe

galcanezumab

For subcutaneous use

Pre-filled syringe transparent with plunger retracted and blue-green needle ready for use

Before using your pre-filled syringe:

Importantinformation

  • Your doctor or nurse should teach you how to prepare and inject Emgality using the syringe. Do not inject or inject someone else until you have been shown how to inject Emgality.
  • Keep these instructions and re-read them if you need to.
  • Each syringe is for SINGLE USE ONLY. Do not share or reuse your syringe. Otherwise, you may transmit or be infected.
  • Your doctor, pharmacist, or nurse can help you decide which area of your body to inject your dose. You can also read in these instructions the section “Choose your injection site” to help you choose which area may be best for you.
  • If you have vision problems, do not use the Emgality syringe without the help of a caregiver.

INSTRUCTIONS FOR USE

Before using the Emgality syringe, read and follow all the step-by-step instructions carefully.

Emgality syringe with blue plunger, green rod, medicine body, needle, and transparent protector labeled

Before you start

Take the syringe out of the refrigerator

Put the original package with the remaining unused syringes back in the refrigerator.

Leave the needle protector on the syringe until you are ready to inject.

Do notshake.

For a more comfortable injection, leave the syringe at room temperature for 30 minutes before injecting.

Do notput the syringe in the microwave, run hot water over it, or put it in direct sunlight.

Inspect the syringe and medicine

Make sure you have the correct medicine. The medicine inside should be clear. The color may vary from colorless to slightly yellow.

Do notuse the syringe and dispose of it as instructed by your doctor, pharmacist, or nurse if:

  • it appears damaged
  • the medicine is cloudy, discolored, or has small particles
  • the expiration date printed on the label has passed
  • the medicine is frozen

Pre-filled syringe transparent with blue plunger and black ring highlighted in red circle indicating expiration date

Prepare to inject

Wash your hands with water and soap before injecting Emgality. Make sure you have a sharps container nearby.

Choose your injection site

Your doctor, pharmacist, or nurse can help you choose the best injection site for you.

Back of the arm with overlaid text indicating injection areaHuman body diagram showing areas for medical patch application on abdomen, hip, and knees

  • You can inject the medicine into the area around your stomach (abdomen) or thigh. Do not inject into the area within 5 centimeters around your navel.
  • Someone else can inject you in the back of your arm or buttock.
  • Do not inject in the same spot as the previous time. For example, if your first injection was in your abdomen, your next injection could be in another area of your abdomen.
  • Clean and dry the injection site before injecting.

1

Remove the cap

Hand holding syringe with needle protector and other hand removing protective cap with red arrow indicating direction

  • Leave the needle protector on the syringe until you are ready to inject.
  • When you are ready to inject, remove the needle protector and throw it away.
  • Do not put the needle protector back on the syringe – this could damage the needle or cause accidental injury.
  • Do not touch the needle.

2

Insert

Hand injecting with syringe in thigh skin, 90-degree angle indicated with red lines, needle inserted and liquid visible

  • Gently pinch and hold a fold of skin at the injection site.
  • Insert the needle at a 45-degree angle.

3

Inject

Hand holding auto-injector with needle inserted in arm skin, red arrow indicating injection direction

  • Slowly push the plunger to push the plunger all the way down until all the medicine is injected.
  • The gray plunger of the syringe should move to the end of the syringe.
  • When the injection is complete, you should see the blue-green plunger rod through the syringe body.
  • Remove the needle from your skin and gently release the skin fold.
  • Do not put the needle protector back on the syringe.

White and turquoise auto-injector device held by a hand with arrows indicating parts of the mechanism

Blue-green plunger rod

Syringe gray plunger

After injecting your medicine

Dispose of the syringe

DO NOT put the needle protector back on the syringe. Dispose of the syringe in a sharps container or as instructed by your doctor, pharmacist, or nurse.

Hand holding syringe with needle over white biological waste container with hazard symbol

When disposing of the syringe and sharps container:

  • Do not recycle the filled sharps container.
  • Ask your doctor, pharmacist, or nurse how to dispose of unused medicines.

Frequently asked questions

Q.

What if I see air bubbles in my Emgality syringe?

A.

It is normal to have air bubbles in the syringe. Emgality is injected under the skin (subcutaneous injection).

Q.

What if there is a drop of liquid on the tip of the needle when I remove the needle protector?

A.

A drop of liquid on the tip of the needle is not unusual.

Q.

What do I do if I cannot push the plunger?

A.

If the plunger is stuck or damaged:

  • Do not continue using the syringe
  • Remove the needle from your skin
  • Dispose of the syringe and get a new one

Q.

What if there is a drop of liquid or blood on my skin after injection?

A.

This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Q.

How do I know when the injection is complete?

A.

Your injection is complete when:

  • The blue-green plunger rod should be visible through the syringe body.
  • The gray plunger of the syringe should have moved to the end of the syringe.

To learn more about your medicine, read the complete Emgality leaflet inside this package.

Revision date:

Online doctors for EMGALITY 120 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Discuss questions about EMGALITY 120 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, including use, safety considerations and whether a prescription is appropriate, subject to medical assessment and local regulations.

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Andrei Popov

General medicinePain medicine7 years of experience
Licence no. 464628925

Dr. Andrei Popov is a General Practitioner with specialized training in chronic pain. He provides online consultations for adult patients in Spain and other European countries.

Dr. Popov understands that seeking help with weight-related concerns or pain that has persisted for months can be difficult. Many patients come to him after trying different approaches without feeling truly heard. During the consultation, the doctor creates a comfortable and supportive, non-judgmental environment where the patient’s medical history can be discussed in detail, questions can be answered, and the next steps can be decided together.

Weight Management and Metabolic Health

Dr. Popov can help assess overweight, obesity, and related conditions such as hypertension, diabetes, or metabolic disorders. During the consultation, the patient’s medical history, test results, current medications, and previous treatments will be reviewed.

If you would like to learn about possible medication options or have already started treatment, the doctor can assess your situation, review the effectiveness and tolerability of the therapy, and clearly explain its benefits, potential risks, and alternatives.

Not every patient requires the same treatment. A consultation does not guarantee a prescription — it provides an objective medical assessment and a plan tailored to your individual situation.

Pain and General Medicine

You can also consult Dr. Popov regarding:

* chronic pain, migraines, neuralgia, and fibromyalgia;

* back, neck, lower back, or joint pain;

* hypertension, diabetes, and follow-up of chronic conditions;

* review of test results, medical reports, and current treatment;

* preventive medicine and a second medical opinion.

How the Consultation Works

The video consultation lasts up to 30 minutes. The doctor will listen carefully, review the information you provide, and explain the next steps in clear and understandable language.

If additional tests, an in-person consultation, or urgent medical care are required, the doctor will inform you directly.

Dr. Popov’s goal is to make sure the patient feels heard and leaves the consultation with a clear understanding of their condition and the next steps they can take.

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Yevgen Yakovenko

General medicine12 years of experience
Licence no. 35/35/09707

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
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  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Lina Travkina

General medicine13 years of experience

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.

  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.

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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.

  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.

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Additional care areas:

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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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5.0(21)

Nuno Tavares Lopes

General medicine18 years of experience

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies

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  • Skin and ENT issues: acne, eczema, allergies, rashes, sore throat, sinusitis

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  • Sick leave (Baixa médica) connected to Segurança Social in Portugal

  • IMT medical certificates for driving licence exchange

Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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€70

Frequently Asked Questions

EMGALITY 120 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in EMGALITY 120 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE is galcanezumab. This information helps identify medicines with the same composition but different brand names.

EMGALITY 120 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE is manufactured by Eli Lilly Nederland B.V.. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether EMGALITY 120 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

The prescription is issued by a doctor after assessing your health. In Spain, EMGALITY 120 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

Other medicines with the same active substance (galcanezumab) include EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN, AIMOVIG 140 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN, AIMOVIG 70 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.

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