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NUCLEO CMP FORTE Injectable

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About the medicine

How to use NUCLEO CMP FORTE Injectable

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Nucala 40mginjectable solution in pre-filled syringe

mepolizumab

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 the child in your care, and you should not give it to others, even if their symptoms are the same, as it may harm them.
  • If the child experiences side effects, consult a doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What Nucala is and what it is used for
  2. What you need to know before you use Nucala
  3. How to use Nucala
  4. Possible side effects
  5. Storage of Nucala
  6. Contents of the pack and further information
  7. Step-by-step instructions for use

1. What Nucala is and what it is used for

Nucala contains the active substance mepolizumab,a monoclonal antibody, a type of protein designed to recognize a specific target substance in the body. It is used to treat severe asthmain adults, adolescents, and children from 6 years of age.

Some people with severe asthma have too many eosinophils(a type of white blood cell) in their blood and lungs. This condition is called eosinophilic asthma– the type of asthma that Nucala can treat.

If the child is already using medicines such as high-dose inhalers, but their asthma is not well-controlled by these medicines, Nucala may reduce the number of asthma attacks. If the child is taking medicines called oral corticosteroids, Nucala may also help reduce the daily dose they need to control their asthma.

Mepolizumab, the active substance of Nucala, blocks a protein called interleukin-5. By blocking the action of this protein, it limits the production of eosinophils by the bone marrow and decreases the number of eosinophils in the blood and lungs.

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 Nucala

Do not use Nucala:

  • if the child in your care is allergicto mepolizumab or any of the other ingredients of this medicine (listed in section 6).
  • Consult your doctorif you think this applies to the child.

Warnings and precautions

Consult your doctor before starting treatment with Nucala.

Asthma worsening

Some people may experience side effects related to asthma, or their asthma may worsen during treatment with Nucala.

  • Consult your doctor or nurseif the child's asthma remains uncontrolled or worsens after starting treatment with Nucala.

Allergic reactions and injection site reactions

Medicines of this type (monoclonal antibodies) can cause severe allergic reactions when injected into the body (see section 4, “Possible side effects”).

If the child has ever had a similar reaction to any injection or medicine:

  • Consult your doctorbefore administering Nucala.

Parasitic infections

Nucala may weaken the child's resistance to parasitic infections. If they already have a parasitic infection, it should be treated before starting treatment with Nucala. If they live in an area where these infections are common or if they are traveling to such an area:

  • Consult your doctorif you think any of these circumstances apply to the child.

Children and adolescents

This medicine is not intended for use in children under 6 years of age.

Other medicines and Nucala

Tell your doctorif the child is taking, has recently taken, or might take any other medicines.

Other asthma medicines

  • Once you have started treatment with Nucala, do not suddenly stop givingthe child the medicines they were taking to prevent their asthma. These medicines (especially those called oral corticosteroids) should be stopped gradually, under the direct supervision of their doctor and depending on their response to Nucala.

Pregnancy and breastfeeding

Patients who are pregnant, think they may be pregnant, or plan to become pregnant should consult their doctorbefore using this medicine.

It is not known whether the components of Nucala can pass into breast milk. Patients who are breastfeeding should consult their doctorbefore using Nucala.

Driving and using machines

It is unlikely that the possible side effects of Nucala will affect the child's ability to drive or use machines.

Nucala contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 40 mg; i.e., it is essentially “sodium-free”.

3. How to use Nucala

Nucala is given by injection just under the skin (subcutaneous injection).

Your doctor or nurse will decide if you can inject Nucala to the child in your care. If they consider it appropriate, you will receive training to use Nucala correctly.

The recommended dosefor children from 6 to 11 years is 40 mg. It will be given as 1 injection every 4 weeks.

On the other side of the leaflet, you can find the Instructions for use of the pre-filled syringe.

If you use more Nucala than you should

Consult your doctorif you think too much Nucala has been administered.

If you miss a dose of Nucala

You should inject the next dose of Nucala as soon as you remember. If you do not realize you have missed a dose until it is time for the next dose, just inject the next dose as planned. If you are not sure what to do, ask your doctor, pharmacist, or nurse.

If you stop treatment with Nucala

Do not stop giving Nucala injections unless your doctor tells you to. Stopping or interrupting treatment with Nucala may cause the child's asthma symptoms and attacks to return.

If the child's asthma symptoms worsen while they are receiving Nucala injections:

  • Tell your doctor.

If you have any further questions on 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. The side effects caused by Nucala are generally mild to moderate, although they can occasionally be severe.

Allergic reactions

Some people may have allergic reactions or reactions of an allergic type. These reactions can be common (may affect up to 1 in 10 people). They usually occur within minutes to hours after the injection, but sometimes the symptoms may start even several days later.

The symptoms may include:

  • chest tightness, cough, difficulty breathing
  • fainting, dizziness, feeling dizzy (due to a drop in blood pressure)
  • swelling of the eyelids, face, lips, tongue, or mouth.
  • hives
  • rash
  • If you think the child is having an allergic reaction, seek medical attention immediately.

If the child has ever had a similar reaction to any injection or medicine:

  • Consult your doctorbefore administering Nucala to the child.

Other side effects include:

Very common:may affect more than 1 in 10 people

  • headache

Common:may affect up to 1 in 10 people

  • chest infection, whose symptoms may include cough and fever (high temperature)
  • urinary tract infection (blood in the urine, painful and frequent urination, fever, pain in the lower back)
  • upper abdominal pain (stomach pain or discomfort in the upper abdomen)
  • fever (high temperature)
  • eczema (red itchy patches on the skin)
  • injection site reactions (pain, redness, swelling, itching, and burning at the injection site)
  • back pain
  • arthralgia (joint pain)
  • pharyngitis (sore throat)
  • nasal congestion (stuffy nose)

Uncommon:may affect up to 1 in 100 people

  • herpes zoster (shingles)

Rare:may affect up to 1 in 1,000 people

  • severe allergic reactions (anaphylaxis)
  • If the child has any of these symptoms, consult a doctor or nurse immediately.

Reporting of side effects

If you experience any side effects, consult a doctor or nurse, even if they are 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 Nucala

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 or 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 packaging to protect it from light.

The Nucala pre-filled syringe can be removed from the refrigerator and stored in the outer packaging without opening for up to 7 days at room temperature (below 30°C) and protected from light. Discard if left out of the refrigerator for more than 7 days.

6. Container Contents and Additional Information

Nucala Composition

The active ingredient is mepolizumab.

Each 0.4 ml of the pre-filled syringe contains 40 mg of mepolizumab.

The other components are: sucrose, disodium phosphate heptahydrate, citric acid monohydrate, polysorbate 80, disodium edetate, water for injectable preparations.

Product Appearance and Container Contents

Nucala is presented in a single-use pre-filled syringe as 0.4 ml of a clear to opalescent, colorless to pale brown-yellow solution.

Nucala is available in a pack containing 1 pre-filled syringe, or in a multipack containing 3 x 1 pre-filled syringes.

Marketing Authorization Holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Manufacturer

GlaxoSmithKline Manufacturing S.P.A

Strada Provinciale Asolana, No 90

43056 San Polo di Torrile, Parma

Italy

You can request more information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tel: + 32 (0) 10 85 52 00

Lietuva

UAB “BERLIN-CHEMIE MENARINI BALTIC”

Tel: + 370 52 691 947

[email protected]

Text in Bulgarian language with contact information of “Berlin-Chemie/A Menarini Bulgaria” including phone and email

Luxembourg/Luxemburg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Belgique/Belgien

Tel: + 32 (0) 10 85 52 00

Ceská republika

GlaxoSmithKline, s.r.o.

Tel: + 420 222 001 111

[email protected]

Magyarország

Berlin-Chemie/A. Menarini Kft.

Tel.: + 36 23501301

[email protected]

Danmark

GlaxoSmithKline Pharma A/S

Tlf.: + 45 36 35 91 00

[email protected]

Malta

GlaxoSmithKline Trading Services Ltd.

Tel: +356 80065004

Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel.: + 49 (0)89 36044 8701

[email protected]

Nederland

GlaxoSmithKline BV

Tel: + 31 (0)33 2081100

Eesti

OÜ Berlin-Chemie Menarini Eesti

Tel: + 372 667 5001

[email protected]

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

Ελλάδα

GlaxoSmithKline Μονοπρόσωπη A.E.B.E.

Τηλ: + 30 210 68 82 100

Österreich

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

[email protected]

España

GlaxoSmithKline, S.A.

Tel: + 34 900 202 700

[email protected]

Polska

GSK Services Sp. z o.o.

Tel.: + 48 (0)22 576 9000

France

Laboratoire GlaxoSmithKline

Tél: + 33 (0)1 39 17 84 44

[email protected]

Portugal

GlaxoSmithKline – Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

[email protected]

Hrvatska

Berlin-Chemie Menarini Hrvatska d.o.o.

Tel: +385 1 4821 361

[email protected]

România

GlaxoSmithKline Trading Services Ltd.

Tel: +40 800672524

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Slovenija

Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.

Tel: + 386 (0)1 300 2160

[email protected]

Ísland

Vistor hf.

Sími: + 354 535 7000

Slovenská republika

Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.

Tel: + 421 2 544 30 730

[email protected]

Italia

GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 7741111

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30

Κύπρος

GlaxoSmithKline Trading Services Ltd.

Τηλ: +357 80070017

Sverige

GlaxoSmithKline AB

Tel: + 46 (0)8 638 93 00

[email protected]

Latvija

SIA Berlin-Chemie/Menarini Baltic

Tel: + 371 67103210

[email protected]

United Kingdom (Northern Ireland)

GlaxoSmithKline Trading Services Ltd.

Tel: + 44 (0)800 221441

[email protected]

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu

  1. Step-by-Step Instructions for Using Nucala 40 mg Pre-filled Syringe

Administration once every 4 weeks.

Follow these instructions on how to use the pre-filled syringe. Failure to follow these instructions may affect the proper functioning of the pre-filled syringe. You should also receive training on how to use the pre-filled syringe. Nucala pre-filled syringe is for subcutaneous use only.

How to Store Nucala

  • Keep refrigerated before use.
  • Do not freeze.
  • Keep the pre-filled syringe in the original packaging to protect it from light.
  • Keep out of sight and reach of children.
  • If necessary, the pre-filled syringe can be kept at room temperature, below 30 °C, for no more than 7 days, if kept in the original packaging. Carefully discard the syringe if it is left out of the refrigerator for more than 7 days.
  • Store below 30 °C.

Before Using Nucala

The pre-filled syringe should be used only once and then discarded.

  • Do notshare your pre-filled syringe with another person.
  • Do notshake the syringe.
  • Do notuse the syringe if it falls on a hard surface.
  • Do notuse the syringe if it appears to be damaged.
  • Do notremove the needle cap until just before injection.

Pre-filled syringe with white plunger and automatic needle guard before and after use showing needle retraction

Preparation

  1. Prepare what you need

Find a comfortable, well-lit, and clean surface. Make sure you have within reach:

  • Nucala pre-filled syringe
  • Alcohol swab (not included)
  • Gauze or cotton ball (not included)
  1. Remove your pre-filled syringe

Tray with pre-filled syringe and arrows indicating removal of plastic cover and extraction of syringe from tray

  • Take the case out of the refrigerator. Check that the security seals are not broken.
  • Remove the tray from the case.
  • Remove the plastic cover from the tray.
  • Holding the syringe by the middle, carefully pull it out of the tray.
  • Place the syringe on a clean, flat surface, at room temperature, away from direct sunlight and out of the reach of children.

Do notuse the syringe if the security seal of the box is broken.

Do notremove the needle cap at this time.

  1. Inspect and wait 30 minutes before use

Auto-injector with expiration date marked and clock indicating 30-minute wait for correct use

  • Check the expiration date on the syringe label.
  • Look through the inspection window to see if the liquid is clear (free of particles and turbidity) and colorless to pale brown-yellow.
  • It is normal to see one or more air bubbles.
  • Wait 30 minutes (and no more than 8 hours) before using.

Do notuse if the expiration date has passed.

Do notheat the syringe in the microwave, with hot water, or direct sunlight.

Do notinject the solution if it appears cloudy or discolored, or has particles.

Do notuse the syringe if it is left out of the packaging for more than 8 hours.

Do notremove the needle cap at this time.

  1. Choose the injection site

Human arm with shaded area indicating injection site on the upper armHuman silhouette with shaded areas in orange indicating possible injection sites on arms, abdomen, and thighs

  • You can inject Nucala into the upper arm, abdomen, or thighs of the child in your care.

Do notinject where the skin is bruised, tender, red, or hard.

Do notinject within 5 cm of the navel.

  1. Clean the injection site

Hands washing with soap and water on the left and cleaning the skin with a white swab on an orange background on the right

  • Wash your hands with soap and water.
  • Clean the injection site with an alcohol swab and let the skin dry.

Do nottouch the injection site again until you have finished.

Inject

  1. Remove the needle cap

Hands holding syringe with needle and removing orange protector, orange arrow indicates direction of removal

  • Remove the needle cap from the syringe by pulling it firmly, extending your hand from the end of the needle (as shown). You may need to pull the needle cap firmly to remove it.
  • Do notworry if you see a drop of liquid at the end of the needle. It is normal.
  • Inject immediately after removing the needle cap, and alwayswithin the next 5 minutes.

Do notlet the needle touch any surface.

Do nottouch the needle.

Do nottouch the plunger at this stage, as you may accidentally expel the liquid and not receive the full dose.

Do notexpel any air bubbles from the syringe.

Do notreplace the needle cap on the syringe. This could cause a needle injury.

  1. Start the injection

Pre-filled syringe with needle inserted into the skin at a 45-degree angle and arrow indicating slow plunger push

  • Use your free hand to pinch the skin around the injection site. Keep the skin pinched throughout the injection.
  • Insert the entire needle into the pinched skin at a 45° angle, as shown.
  • Move your thumb towards the plunger and place your fingers on the white handle, as shown.
  • Slowly press the plunger to inject your full dose.
  1. Complete your injection

Auto-injector in hand, white plunger down, lift thumb slowly, orange arrow indicates upward movement

  • Make sure to press the plunger all the way down, until the stopper reaches the bottom of the syringe and the entire solution is injected.
  • Slowly lift your thumb upwards. This will allow the plunger to rise and the needle to retract (go up) into the body of the syringe.
  • Once completed, release the pinched skin.
  • You may notice a small drop of blood at the injection site. This is normal. If necessary, press the area with a cotton ball or gauze for a few moments.
  • Do notreplace the needle cap on the syringe.
  • Do notrub the injection site.

Dispose of

  1. Dispose of the used syringe
  • Dispose of the used syringe and needle cap according to local regulations. If necessary, consult your doctor or pharmacist.
  • Keep used syringes and needle caps out of sight and reach of children.

Online doctors for NUCLEO CMP FORTE Injectable

Discuss questions about NUCLEO CMP FORTE Injectable, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (2)
Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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5.0 (77)
Doctor

Sergey Ilyasov

Psychiatry 7 years exp.

Dr Sergey Ilyasov is an experienced neurologist and qualified psychiatrist who provides online consultations for adults and adolescents. Combining deep neurological expertise with a modern psychiatric approach, he ensures comprehensive diagnostics and effective treatment for a wide range of conditions affecting both physical and mental health.

Dr. Ilyasov helps patients in the following cases:

  • Chronic headaches (migraine, tension-type headache), back pain, neuropathic pain, dizziness, numbness in limbs, coordination disorders.
  • Anxiety disorders (panic attacks, generalized anxiety disorder), depression (including atypical and treatment-resistant forms), sleep disturbances (insomnia, hypersomnia, nightmares), stress, burnout.
  • Chronic pain syndromes and psychosomatic symptoms (e.g., irritable bowel syndrome related to stress, vegetative-vascular dystonia).
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  • Memory impairments, phobias, obsessive-compulsive disorder (OCD), emotional swings, and support for post-traumatic stress disorder (PTSD).

Thanks to his dual specialization in neurology and psychiatry, Dr Sergey Ilyasov offers integrated and evidence-based care for complex conditions requiring a multidisciplinary approach. His consultations focus on accurate diagnosis, development of an individualized treatment plan (including pharmacotherapy and psychotherapeutic methods), and long-term support adapted to each patient's unique needs.

Book an online consultation with Dr. Sergey Ilyasov to receive qualified assistance and improve your well-being today.

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€89
5.0 (137)
Doctor

Taisiia Proida

Psychiatry 7 years exp.

Dr. Taisiia Proida is a psychiatrist and cognitive behavioural therapist (CBT), and a member of the European Psychiatric Association. She offers online consultations for adults aged 18 and over, combining evidence-based medicine with an individualised approach to mental health care.

She specialises in consultations and ongoing support for a wide range of mental health concerns, including:

  • Mood disorders: depression, bipolar disorder, postpartum depression.
  • Anxiety disorders: generalised anxiety, OCD, panic attacks, phobias.
  • Post-traumatic stress disorder (PTSD) and complex PTSD.
  • Attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). Assessment is provided only after an initial psychiatric evaluation and during a follow-up appointment.
  • Personality disorders and emotional instability.
  • Cyclothymia and mood fluctuations.
  • Schizophrenia spectrum and related conditions.

Dr. Proida combines clinical expertise with an empathetic approach, offering structured support based on evidence-based practices. Her work integrates CBT techniques with medical management, with a focus on anxiety and depressive disorders.

She works with clients from different countries and cultural backgrounds, adapting her communication style and recommendations to individual needs. With experience in international clinical trials (Pfizer, Merck), she values clarity, trust, and collaborative partnership in patient care.

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5.0 (2)
Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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€55

Frequently Asked Questions

Is a prescription required for NUCLEO CMP FORTE Injectable?
NUCLEO CMP FORTE Injectable requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
Who manufactures NUCLEO CMP FORTE Injectable?
NUCLEO CMP FORTE Injectable is manufactured by Ferrer Internacional S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of NUCLEO CMP FORTE Injectable online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether NUCLEO CMP FORTE Injectable is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to NUCLEO CMP FORTE Injectable?
Other medicines with the same active substance () include DUVYZAT 8.86 mg/mL ORAL SUSPENSION, EVRYSDI 0.75 mg/ml ORAL SOLUTION POWDER, EVRYSDI 5 mg FILM-COATED TABLETS. 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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