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RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION

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Prescription review online

A doctor will review your case and decide whether a prescription is medically appropriate.

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Talk to a doctor about this medicine

Discuss your symptoms and possible next steps in a quick online consultation.

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

How to use RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION

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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Introducción

Prospecto: información para el paciente

Ruconest 2100 unidades en polvo para solución inyectable

conestat alfa

Lea todo el prospecto detenidamente antes de empezar a usar este medicamento, porque contiene información importante para usted.

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico.
  • Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.
  • Si experimenta efectos adversos, consulte a su médico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto

  1. Qué es Ruconest y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar Ruconest
  3. Cómo usar Ruconest
  4. Posibles efectos adversos
  5. Conservación de Ruconest
  6. Contenido del envase e información adicional

1. Qué es Ruconest y para qué se utiliza

Ruconest contiene conestat alfa como principio activo. El conestat alfa es una forma recombinante (no hemoderivada) del inhibidor de C1 humano (rhC1-INH).

Ruconest debe ser usado por adultos, adolescentes y niños (a partir de 2 años) con un trastorno sanguíneo hereditario raro que se denomina angioedema hereditario (AEH). Estos pacientes presentan escasez de la proteína inhibidora de C1 en su sangre, lo cual puede provocar episodios repetidos de hinchazón, dolor en el abdomen, dificultad para respirar y otros síntomas.

La administración de Ruconest resuelve la escasez de inhibidor de C1 y permite una reducción de los síntomas de las crisis agudas de AEH.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber antes de empezar a usar Ruconest

No use Ruconest

  • Si es o se considera alérgico a los conejos.
  • Si es alérgico a conestat alfa o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).

Advertencias y precauciones

Consulte a su médico antes de empezar a usar Ruconest.

Si experimenta reacciones alérgicas, como habones, exantema, picor, mareo, sibilancias, dificultad para respirar o hinchazón de la lengua tras la administración de Ruconest, solicite asistencia médica de emergencia para que se traten urgentemente los síntomas de la reacción alérgica.

Niños y adolescentes

No administre este medicamento a niños menores de 2 años. Ruconest no ha sido estudiado en niños menores de 5 años. Su médico determinará si el tratamiento con Ruconest es apropiado para su hijo. Se requiere supervisión adicional de su hijo para detectar síntomas de reacciones alérgicas durante y después de la administración.

Uso de Ruconest con otros medicamentos

Informe a su médico si está utilizando, ha utilizado recientemente o podría tener que utilizar cualquier otro medicamento.

Si recibe activador tisular del plasminógeno como tratamiento agudo para la prevención de coágulos sanguíneos (tratamiento anticoagulante), no debe usar Ruconest al mismo tiempo.

Embarazo y lactancia

No se recomienda administrar Ruconest durante el embarazo o la lactancia.

Si tiene intención de quedarse embarazada, consulte a su médico antes de utilizar Ruconest.

Conducción y uso de máquinas

No conduzca ni maneje máquinas si se siente mareado o le duele la cabeza después de utilizar Ruconest.

Ruconest contiene sodio (19,5 mg por vial)

Los pacientes con dietas pobres en sodio deben tener en cuenta que este medicamento contiene 19,5 mg de sodio por vial.

3. Cómo usar Ruconest

El tratamiento con Ruconest lo iniciará un médico especializado en el diagnóstico y tratamiento de angioedema hereditario.

Su médico o una enfermera le administrarán Ruconest directamente en una vena durante 5 minutos aproximadamente. La dosis, 2 viales como máximo, dependerá de su peso.

La mayor parte de las veces basta con una dosis. Su médico puede decidir la administración de una dosis adicional si sus síntomas no mejoran después de 120 minutos (para adultos y adolescentes) o 60 minutos (para niños). No se podrán administrar más de dos dosis en un plazo de 24 horas.

Las instrucciones de uso se describen claramente en la hoja de información del médico y figuran adjuntas.

Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o enfermero.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

Si sus síntomas empeoran y/o presenta exantema, hormigueo, dificultad para respirar o hinchazón de la cara o la lengua, acuda al médico inmediatamente. Estos síntomas pueden indicar que ha desarrollado alergia a Ruconest.

Durante el tratamiento con Ruconest pueden aparecer algunos efectos secundarios:

Frecuentes: pueden afectar hasta 1 de cada 10 personas

  • Náuseas

Poco frecuentes: pueden afectar hasta 1 de cada 100 personas

  • Dolor abdominal, diarrea
  • Sensación de hormigueo, pinchazos o entumecimiento en la boca
  • Dolor de cabeza, mareo
  • Disminución del sentido del tacto o la sensibilidad en la piel o las extremidades
  • Irritación de garganta
  • Urticaria (habones)
  • Hinchazón de las orejas o de la zona alrededor de las orejas

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del sistema nacional de notificación incluido en el Apéndice V. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

5. Conservación de Ruconest

Mantener este medicamento fuera de la vista y del alcance de los niños.

No utilice este medicamento después de la fecha de caducidad que aparece en el envase y en la etiqueta del vial después de CAD/EXP. La fecha de caducidad es el último día del mes que se indica.

No conservar a temperatura superior a 25ºC.

Conservar en el embalaje original para protegerlo de la luz.

Ruconest se debe disolver en agua para preparaciones inyectables antes de su administración por un profesional sanitario.

Una vez reconstituido, el producto debe utilizarse de inmediato.

No utilice este medicamento si observa que la solución contiene partículas o si la solución está descolorida.

6. Contenido del envase e información adicional

Composición de Ruconest

El principio activo es conestat alfa. Un vial contiene 2100 unidades (U) de conestat alfa. Esto equivale a 2100 unidades por 14 ml después de la reconstitución, o a una concentración de 150 unidades/ml.

Los demás componentes son sacarosa, citrato de sodio (E331) y ácido cítrico.

Aspecto del producto y contenido del envase

Ruconest se presenta en un único vial de vidrio que contiene un polvo blanco a blanquecino para solución inyectable. Después de la disolución del polvo en agua para preparaciones inyectables, la solución es transparente e incolora.

Ruconest se suministra en una caja que contiene un vial.

Titular de la autorización de comercialización y responsable de la fabricación

Titular de la autorización de comercialización:

Pharming Group N.V.

Darwinweg 24

2333 CR Leiden

Países Bajos

Responsable de la fabricación:

Pharming Technologies B.V.

Darwinweg 24

2333 CR Leiden

Países Bajos

Fecha de la última revisión de este prospecto:

La información detallada de este medicamento está disponible en la página web de la Agencia Europea de Medicamentos: https://www.ema.europa.eu/.

Esta información está destinada únicamente a profesionales del sector sanitario:

POSOLOGÍA Y FORMA DE ADMINISTRACIÓN

Posología

Peso corporal hasta 84 kg

  • Una inyección intravenosa de 50 U/kg de peso corporal.

Peso corporal de 84 kg o mayor

  • Una inyección intravenosa de 4200 U (dos viales).

En la mayor parte de los casos, una sola inyección de Ruconest es suficiente para el tratamiento de una crisis aguda de angioedema.

Si la respuesta clínica es insuficiente, podrá administrarse una segunda dosis (50 U/kg de peso corporal hasta 4200 U).

No se podrán administrar más de dos dosis en un plazo de 24 horas.

Cálculo de la dosis

Determinar el peso corporal del paciente.

Peso corporal hasta 84 kg

  • En los pacientes de hasta 84 kg de peso, el volumen de administración necesario se calculará con la siguiente fórmula:

Volumen a administrar (ml)

=

Peso corporal (kg) x 50 (U/kg)

150 (U/ml)

=

Peso corporal (kg)

3

Peso corporal de 84 kg o mayor

  • En los pacientes de 84 kg o superior, el volumen de administración necesario es de 28 ml, equivalente a 4200 U (2 viales).

Reconstituya cada vialcon 14 ml de agua para preparaciones inyectables (ver sección Reconstitución más adelante).

La solución reconstituida en cada vial contiene 2100 U de conestat alfa a 150 U/ml.

El volumen necesario de la solución reconstituida se debe administrar mediante inyección intravenosa lenta durante aproximadamente 5 minutos.

PRECAUCIONES ESPECIALES DE ELIMINACIÓN Y OTRAS MANIPULACIONES

Cada vial de Ruconest es para un solo uso.

Se utilizará una técnica aséptica para la reconstitución, la combinación y la mezcla de soluciones.

Reconstitución

Cada vial de Ruconest (2100 U) se debe reconstituir con 14 ml de agua para preparaciones inyectables. El agua para preparaciones inyectables se debe añadir lentamente para evitar un impacto fuerte en el polvo y mezclar suavemente para minimizar la formación de espuma. La solución reconstituida en cada vial contiene 2100 U de conestat alfa, equivalente a 150 U/ml, y es transparente e incolora.

La solución reconstituida en cada vial se debe examinar en busca de partículas y cambios de color. No se debe utilizar una solución que presente partículas o cambios de color. Este medicamento se debe utilizar de inmediato.

Cualquier medicamento no usado o material de desecho se deben eliminar de acuerdo con los requisitos locales.

Online doctors for RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION

Discuss questions about RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Doctor

Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

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.

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€50
5.0 (41)
Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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€60

Frequently Asked Questions

Is a prescription required for RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION?
RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION?
The active ingredient in RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION is conestat alfa. This information helps identify medicines with the same composition but different brand names.
Who manufactures RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION?
RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION is manufactured by Pharming Group N.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION 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 RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION 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 RUCONEST 2100 U POWDER FOR INJECTABLE SOLUTION?
Other medicines with the same active substance (conestat alfa) include RUCONEST 2100 U POWDER AND SOLVENT FOR INJECTABLE SOLUTION, ANDEMBRY 200 mg INJECTABLE SOLUTION IN PRE-FILLED PEN, BERINERT 1500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION. 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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