ICATIBANTO FRESENIUS 30 mg Injectable Solution in Pre-filled Syringe

Ask a doctor about a prescription for ICATIBANTO FRESENIUS 30 mg Injectable Solution in Pre-filled Syringe

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Tarek Agami

General medicine10 years of experience

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
Evaluation of symptoms and guidance on further diagnostic testing
Preventive check-ups and regular health monitoring
Medical support during travel or after relocation
Treatment adjustments and lifestyle recommendations based on your personal history

Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) 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 Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

Book a video appointment

Abdullah Alhasan

General medicine10 years of experience

Dr. Abdullah Alhasan is a physician specialising in cardiology and general medicine, with international clinical experience and a commitment to evidence-based care. He offers online consultations for adults, focusing on both acute symptoms and long-term health management.

Main areas of consultation:

Chest pain, shortness of breath, heart palpitations, high blood pressure
Hypertension control and cardiovascular disease prevention
Interpretation of ECG, blood tests, and Holter monitor results
Management of heart failure and coronary artery disease
General medical issues: infections, fever, fatigue, gastrointestinal symptoms
Guidance on diagnostics, treatment plans, and medication adjustments

Dr. Alhasan’s approach is based on thorough assessment, clear communication, and personalised care – helping patients understand their health and make informed decisions about their treatment.

Book a video appointment

Tarek Agami

General medicine10 years of experience

Main areas of consultation:

Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
Evaluation of symptoms and guidance on further diagnostic testing
Preventive check-ups and regular health monitoring
Medical support during travel or after relocation
Treatment adjustments and lifestyle recommendations based on your personal history

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

Book a video appointment

Abdullah Alhasan

General medicine10 years of experience

Main areas of consultation:

Chest pain, shortness of breath, heart palpitations, high blood pressure
Hypertension control and cardiovascular disease prevention
Interpretation of ECG, blood tests, and Holter monitor results
Management of heart failure and coronary artery disease
General medical issues: infections, fever, fatigue, gastrointestinal symptoms
Guidance on diagnostics, treatment plans, and medication adjustments

Dr. Alhasan’s approach is based on thorough assessment, clear communication, and personalised care – helping patients understand their health and make informed decisions about their treatment.

Book a video appointment

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use ICATIBANTO FRESENIUS 30 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Icatibant Fresenius 30 mg solution for injection in pre-filled syringe EFG

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 or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you experience side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

What is Icatibant Fresenius and what is it used for
What you need to know before you use Icatibant Fresenius
How to use Icatibant Fresenius
Possible side effects

5 Storage of Icatibant Fresenius

Contents of the pack and other information

1. What is Icatibant Fresenius and what is it used for

This medicine contains the active substance icatibant.

Icatibant is used to treat the symptoms of hereditary angioedema (HAE) in adults, adolescents, and children over 2 years of age.

In HAE, the levels of a substance present in the blood called bradykinin increase, producing symptoms such as swelling, pain, nausea, and diarrhea.

Icatibant blocks the activity of bradykinin and thus slows down the progression of the symptoms of an HAE attack.

2. What you need to know before you use Icatibant Fresenius

Do not use Icatibant Fresenius

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

Warnings and precautions

Consult your doctor before starting treatment with Icatibant Fresenius:

if you have angina pectoris (reduced blood flow to the heart)
if you have recently had a stroke

The side effects related to Icatibant are similar to the symptoms of your own disease. Consult your doctor immediately if you notice that the symptoms of the attack worsen after Icatibant is administered.

In addition:

You or your caregiver must learn the technique of subcutaneous injection (under the skin) before self-administering or having Icatibant administered by your caregiver.
Immediately after self-administering Icatibant or having it administered by your caregiver while experiencing a laryngeal attack (upper airway obstruction), you should seek medical attention at a medical institution.
If your symptoms do not resolve after a self-administered injection of Icatibant or an injection administered by your caregiver, you should consult your doctor about the administration of additional injections of Icatibant. In adult patients, up to 2 additional injections can be administered within 24 hours.

Children and adolescents

Icatibant is not recommended for use in children under 2 years of age or weighing less than 12 kg, as it has not been studied in these patients.

Other medicines and Icatibant Fresenius

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

No interactions of Icatibant with other medicines are known. If you are taking any medicine that is an angiotensin-converting enzyme inhibitor (ACEI) (e.g., captopril, enalapril, ramipril, quinapril, lisinopril) to lower blood pressure or for any other reason, inform your doctor before using Icatibant.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are breastfeeding, you should not breastfeed your child during the 12 hours following the last administration of Icatibant.

C

Do not drive or use machines if you feel tired or dizzy as a result of the HAE attack or after using Icatibant Fresenius.

I

This medicine contains less than 23 milligrams (1 mmol) of sodium per dose, so it is essentially "sodium-free".

3. How to use Icatibant Fresenius

Follow the instructions for administration of this medicine exactly as indicated by your doctor.

In case of doubt, consult your doctor again.

If you have never been administered Icatibant before, the first dose should always be injected by medical or nursing staff. The doctor will discharge you when it is considered safe for you to go home. After analyzing it with your doctor or nurse and learning the technique for subcutaneous injections (under the skin), you or your caregiver can administer Icatibant if you have an HAE attack. It is essential to inject Icatibant subcutaneously (under the skin) as soon as you notice an angioedema attack. The healthcare staff will teach you and your caregiver how to safely inject Icatibant, following the instructions in the package leaflet.

When and how often should you use Icatibant Fresenius?

Your doctor has determined the exact dose of Icatibant and will tell you how often it should be used.

The recommended dose of Icatibant is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice the angioedema attack (e.g., with increased skin swelling, especially on the face and neck, or increased abdominal pain).

If you do not notice an improvement in symptoms after six hours, you should seek medical advice on the administration of additional injections of Icatibant. In adults, up to 2 additional injections can be administered within 24 hours.

You should not receive more than 3 injections in a 24-hour period, and if you need more than 8 injections in a month, you should seek medical advice.

Children and adolescents from 2 to 17 years

The recommended dose of Icatibant is an injection of 1 ml up to a maximum of 3 ml, depending on body weight, administered subcutaneously (under the skin) as soon as symptoms of an angioedema attack appear (e.g., increased skin swelling, especially on the face and neck, or increased abdominal pain).

Consult the section on instructions for use to see the dose you should inject.

If you are unsure about the dose to inject, consult your doctor, pharmacist, or nurse.

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Icatibant Fresenius is administered by subcutaneous injection (under the skin). Each syringe should only be used once.

Icatibant Fresenius is injected with a short needle into the fatty tissue under the skin of the abdomen (belly). If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

The following step-by-step instructions are intended for

self-administration (adults)
administration by a caregiver or healthcare professional for adults, adolescents, or children over 2 years of age (weighing at least 12 kg).

The instructions include the following main steps:

General information

2a) Preparation of the syringe for children and adolescents (2-17 years) weighing 65 kg or less

2b) Preparation of the syringe and needle for injection (all patients)

Preparation of the injection site
Injection of the solution
Disposal of injection materials

Step-by-step instructions for injection

General information

Clean the work surface (area) before starting the process.
Wash your hands with water and soap.
Open the tray by removing the seal.
Remove the pre-filled syringe from the tray.
Unscrew and remove the cap from the end of the pre-filled syringe.
Leave the pre-filled syringe with the cap unscrewed.

2a) Preparation of the syringe for children and adolescents (2-17 years) weighing 65 kg or less:

Important information for healthcare professionals and caregivers:

When the dose is less than 30 mg (3 ml), the following equipment is needed to extract the appropriate dose (see information below):

Pre-filled syringe of Icatibant Fresenius (with icatibant solution)
Connector (adapter)
Graduated syringe 3 ml

The required injection volume in ml should be prepared in an empty 3 ml graduated syringe (see table below).Table 1: Dosage guidelines for children and adolescents

	Body weight	Injection volume
	12 kg to 25 kg	1.0 ml
	26 kg to 40 kg	1.5 ml
	41 kg to 50 kg	2.0 ml
	51 kg to 65 kg	2.5 ml

Patient weighing more than 65 kgwill use the entire contents of the pre-filled syringe (3 ml).

Yellow triangle with black border and black exclamation mark in the center indicating warning

If you are unsure about the volume of solution to extract, consult your doctor, pharmacist, or nurse

Remove the caps from each end of the connector.

Warning triangle with black border and central black exclamation mark on white background

Avoid touching the ends of the connector and the tips of the syringes to prevent contamination

Screw the connector onto the pre-filled syringe.
Attach the graduated syringe to the other end of the connector, making sure both connections fit securely.

Disassembled syringe showing cylinder, plunger with rubber rings, and needle with transparent protector

Transfer the icatibant solution to the graduated syringe

To initiate the transfer of the icatibant solution, push the plunger of the pre-filled syringe (on the left end of the image below).
If the icatibant solution does not start to transfer to the graduated syringe, gently pull the plunger of the graduated syringe until the icatibant solution starts to flow into the graduated syringe (see image below).
Continue pushing the plunger of the pre-filled syringe until the required injection volume (dose) is transferred to the graduated syringe. Consult Table 1 for dosage information.

Pre-filled transparent syringe with black plunger and two white needle protectors, arrow indicating injection direction

If there is air in the graduated syringe:

Turn the connected syringes so that the pre-filled syringe is on top (see image below).

Pre-filled transparent syringe with retracted plunger and visible graduated scale, arrow indicating injection direction

Push the plunger of the graduated syringe to transfer the air back to the pre-filled syringe (this step may need to be repeated several times).
Extract the required volume of icatibant solution.

Remove the pre-filled syringe and connector from the graduated syringe.
Discard the pre-filled syringe and connector in the sharps container or other puncture-resistant container.

2b) Preparation of the syringe and needle for injection:

All patients (adults, adolescents, and children)

Hands holding and applying a grayish rectangular medicinal patch on the skin

Remove the safety needle from the blister.
Remove the seal from the needle (the needle should remain inside the cap).

Gloved hand holding an auto-injector with the needle inserted into the abdominal skin fold

Hold the syringe firmly. Carefully connect the needle to the pre-filled syringe with the colorless solution. Push the syringe firmly while turning it clockwise until it is securely attached to the needle.

Hand holding syringe with needle, showing pressure on the plunger with the thumb for injection, and arrow indicating direction

Pull the safety cap back towards the syringe and away from the needle.

Hands holding an injection device with a connected needle and a pressed button

Pull the syringe to remove the needle from the cap. Do not pull the plunger.

Hand holding syringe with needle, showing subcutaneous injection technique with skin pinch

The syringe is now ready to administer the injection.

Preparation of the injection site

Hand holding a syringe applying a subcutaneous injection in the abdomen with a lifted skin fold

Choose the injection site. The injection site should be a fold of the abdomen, approximately 5-10 cm (2-4 inches) below the navel, to one side or the other. The area should be at least 5 cm (2 inches) away from any scar. Do not choose an area with bruises, inflammation, or pain.
Clean the injection site by rubbing it with an alcohol swab and let it dry.

Injection of the solution

Hand holding syringe with needle inserted into the skin with metal protector and arrow indicating direction of insertion

Hold the syringe between two fingers, with your thumb on the end of the plunger.
Check that there is no air in the syringe by pressing the plunger until the first drop appears at the tip of the needle.

Hand holding syringe with needle inserting into the arm skin with an upward angle indicated by an arrow

Hold the syringe with the needle pointing towards the skin at an angle of 45 to 90 degrees.
Hold the syringe in one hand and with the other hand gently take a fold of skin between your thumb and fingers at the previously cleaned site.
Hold the skin fold, bring the syringe close, and quickly insert the needle into the skin fold.
Slowly press the plunger with a firm pulse until all the fluid has been injected into the skin and no liquid remains in the syringe.
Press slowly so that the process takes approximately 30 seconds.
Release the skin fold and gently remove the needle.

Disposal of injection materials

Hand holding an auto-injector with two positions shown, one with the button pressed and the other without pressing

Hand disposing of a needle in a biological waste container with visible hazard symbol

Push the safety cover over the needle forward until you hear and feel it click into place.
Discard the syringe, needle, and its cap in the sharps container or other puncture-resistant container for disposal of sharp objects.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients who receive Icatibant notice a reaction at the injection site (such as skin irritation, inflammation, pain, itching, redness of the skin, and burning). These effects are usually mild and improve without the need for any additional treatment.

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

Additional reactions at the injection site (feeling of pressure, bruising, decreased sensitivity and/or numbness, increased skin rash with itching and heat).

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

Nausea

Headache

Dizziness

Fever

Itching

Rash

Redness of the skin

Abnormal liver function tests

Frequency not known (cannot be estimated from the available data):

Hives (urticaria)

Tell your doctor immediately if you notice that the symptoms of the attack worsen after receiving Icatibant.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Icatibant Fresenius

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 carton and the pre-filled syringe after “EXP”. The expiry date refers to the last day of the month stated.

Do not store above 30°C. Do not freeze.

Use immediately after opening and only in undamaged containers. For single use only.

Do not use this medicine if you notice that the syringe or needle is damaged or if you notice visible signs of deterioration, such as the solution being turbid, containing floating particles, or a change in the color of the solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Icatibant Fresenius

The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). Each milliliter of solution contains 10 mg of icatibant. The other ingredients are sodium chloride, glacial acetic acid, sodium hydroxide, and water for injectable preparations.

Appearance and Package Contents of the Product

Icatibant Fresenius is presented as a clear and colorless injectable solution in a pre-filled syringe.

3 ml of solution in a 3 ml pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber coated with fluorocarbon polymer). The package includes a 25 G, 16 mm safety hypodermic needle.

Single unit package of one pre-filled syringe with one needle or multiple package of three pre-filled syringes with three safety needles.

Only certain package sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi España, S.A.U.

Torre Mapfre-Vila Olímpica

C/Marina 16-18

08005 Barcelona

Spain

Manufacturer

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

This medicine is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)under the following names:

Member State Name	Medicine Name
Austria	Icatibant Fresenius 30 mg Injektionslösung in einer Fertigspritze
Belgium	Icatibant Fresenius 30 mg oplossing voor injectie in een voorgevulde spuit, solution injectable en seringue pré-remplie, Injektionslösung in einer Fertigspritze
Croatia	Ikatibant Fresenius 30 mg otopina za injekciju u napunjenoj štrcaljki
Czech Republic	Icatibant Fresenius
Denmark	Icatibant Fresenius
Estonia	Icatibant Fresenius
Finland	Icatibant Fresenius 30 mg injektioneste, liuos, esitäytetty ruisku
France	ICATIBANT FRESENIUS 30 mg, solution injectable en seringue préremplie
Germany	Icatibant Fresenius 30 mg Injektionslösung in einer Fertigspritze
Hungary	Icatibant Fresenius 30 mg oldatos injekció eloretöltött fecskendoben
Ireland	Icatibant 30 mg solution for injection in pre-filled syringe
Italy	Icatibant Fresenius
Latvia	Icatibant Fresenius 30 mg šķidums injekcijām pilnšļirce
Lithuania	Icatibant Fresenius 30 mg injekcinis tirpalas užpildytame švirkšte
Netherlands	Icatibant Fresenius 30 mg, oplossing voor injectie in een voorgevulde spuit
Norway	Icatibant Fresenius
Poland	Icatibant Fresenius
Portugal	Icatibant Fresenius
Slovakia	Icatibant Fresenius 30 mg
Spain	Icatibanto Fresenius 30 mg solución inyectable en jeringa precargada EFG
Sweden	Icatibant Fresenius 30 mg injektionsvätska, lösning i förfylld spruta
United Kingdom (Northern Ireland)	Icatibant 30 mg solution for injection in pre-filled syringe

Date of the last revision of this leaflet: April2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS), http://www.aemps.gob.es/

Country of registration
Spain
Active substance
icatibant
Prescription required
Yes
Manufacturer
Fresenius Kabi España, S.A.U.
This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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Online doctors for ICATIBANTO FRESENIUS 30 mg Injectable Solution in Pre-filled Syringe

Discuss dosage, side effects, interactions, contraindications, and prescription renewal for ICATIBANTO FRESENIUS 30 mg Injectable Solution in Pre-filled Syringe – subject to medical assessment and local rules.

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Tarek Agami

General medicine10 years of experience

Main areas of consultation:

Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
Evaluation of symptoms and guidance on further diagnostic testing
Preventive check-ups and regular health monitoring
Medical support during travel or after relocation
Treatment adjustments and lifestyle recommendations based on your personal history

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

Book a video appointment

Abdullah Alhasan

General medicine10 years of experience

Main areas of consultation:

Chest pain, shortness of breath, heart palpitations, high blood pressure
Hypertension control and cardiovascular disease prevention
Interpretation of ECG, blood tests, and Holter monitor results
Management of heart failure and coronary artery disease
General medical issues: infections, fever, fatigue, gastrointestinal symptoms
Guidance on diagnostics, treatment plans, and medication adjustments

Dr. Alhasan’s approach is based on thorough assessment, clear communication, and personalised care – helping patients understand their health and make informed decisions about their treatment.

Book a video appointment

Duarte Meneses

Family medicine4 years of experience

Dr. Duarte Meneses is a licensed family medicine and general practice doctor based in Portugal, with additional expertise in occupational health. He provides online consultations for adults, offering medical support for both acute symptoms and chronic health conditions.

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Dr. Meneses graduated from the University of Beira Interior and has years of experience working with diverse patient populations. He is fluent in Portuguese, English, Spanish, and French.

His approach is friendly, clear, and focused on delivering practical medical advice tailored to each patient’s needs.

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High blood pressure, type 2 diabetes, cholesterol management
Cold and flu symptoms: fever, cough, sore throat
Fatigue, sleep problems, headaches, general discomfort
Ongoing care for chronic conditions and medication review
Help interpreting test results and lab reports
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Preventive medicine and health screenings.
Development of tailored treatment plans based on clinical guidelines.

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Urinary tract infections and other common infections.
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Acute conditions requiring urgent medical attention.
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Wound care, health check-ups, and ongoing prescriptions.

With a patient-focused and evidence-based approach, Dr. Ben Ami supports individuals at all stages of life — offering clear medical guidance, timely interventions, and continuity of care.

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In addition to pain management, Dr. Popov helps patients with:

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Dr. Popov’s approach is rooted in evidence-based medicine, combined with individualised care tailored to each patient’s history, lifestyle, and clinical needs.

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Yevgen Yakovenko

General surgery11 years of experience

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.
Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

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).
Certified in radiological diagnostics and robotic surgery.
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.

Book a video appointment