Bg pattern

ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION

Prescription review online

Prescription review online

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

Talk to a doctor about this medicine

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 ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION

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.

Show original

Introduction

Package Leaflet: Information for the User

Elaprase 2mg/ml concentrate for solution for infusion

idursulfase

?This medicine is subject to additional monitoring, which will help to quickly identify new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

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 and other information

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

1. What is Elaprase and what is it used for

Elaprase is used as enzyme replacement therapy to treat children and adults with Hunter syndrome (Mucopolysaccharidosis II) when the level of the enzyme iduronate-2-sulfatase in the body is lower than normal, helping to improve the symptoms of the disease. When you have Hunter syndrome, a carbohydrate called glycosaminoglycan, which is normally metabolized by the body, is not metabolized and slowly accumulates in various cells of the body. This causes abnormal functioning of these cells, and consequently causes problems in several organs that can lead to tissue destruction and organ dysfunction and failure. The typical organs where glycosaminoglycan accumulates are the spleen, liver, lungs, heart, and connective tissue. In some patients, glycosaminoglycan also accumulates in the brain. Elaprase contains an active substance called idursulfase, which acts as a replacement for the enzyme that is at a low level, and thus breaks down this carbohydrate in the affected cells.

Enzyme replacement therapy is usually given as long-term treatment.

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 Elaprase

Do not use Elaprase

  • if you have had severe or life-threatening allergic reactions to idursulfase or any of the other ingredients of this medicine (listed in section 6) that could not be controlled with medical treatment.

Warnings and precautions

Talk to your doctor or nurse before you start using this medicine.

If you are being treated with Elaprase, you may experience side effects during or after the infusion (see section 4, Possible side effects). The most common symptoms are itching, rash, hives, fever, headache, increased blood pressure, and flushing of the face. In most cases, this medicine can still be given to you even if these symptoms occur. If you experience an allergic reaction after receiving this medicine, you should contact your doctor immediately. You may be given other medicines, such as antihistamines and corticosteroids, to treat or help prevent allergic reactions.

Your doctor will stop the infusion immediately if severe allergic reactions occur and will start the appropriate treatment. You may need to stay in the hospital.

The nature of your genotype (a genetic makeup of all active genes in human cells, which determines individual characteristics and specific features of each person) may influence your therapeutic response to this medicine, as well as your risk of developing antibodies and experiencing infusion-related side effects. In individual cases, so-called "neutralizing antibodies" may develop, which may decrease the activity of Elaprase and your response to treatment. The long-term effects of antibody development on treatment response have not been established. Talk to your doctor for more information.

Keeping a record

In order to improve the traceability of biological medicinal products, the name and batch number of the product administered should be clearly recorded. Talk to your healthcare professional if you have any questions.

Other medicines and Elaprase

No interactions of this medicine with other medicines are known.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

Elaprase contains sodium

This medicine contains 11.1 mg of sodium (a major component of table salt/cooking salt) in each vial. This is equivalent to 0.6% of the maximum daily intake of sodium recommended for an adult.

3. How to use Elaprase

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, talk to your doctor again.

This medicine will be given to you under the supervision of a doctor or nurse with experience in the treatment of Hunter syndrome or other inherited metabolic disorders.

The recommended dose is an infusion of 0.5 mg (half a milligram) per kilogram of body weight.

Elaprase must be diluted in a 9 mg/ml (0.9%) sodium chloride solution for infusion before use. After dilution, this medicine is given through a vein (by drip). The infusion usually lasts between 1 to 3 hours and will be given to you every week.

Use in children and adolescents

The recommended dose in children and adolescents is the same as for adults.

If you use more Elaprase than you should

Talk to your doctor if you have taken too much of this medicine.

If you miss a dose of Elaprase

If you miss an infusion of Elaprase, contact your doctor.

If you have any other questions on the use of this medicine, ask your doctor 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.

Most side effects are mild or moderate and are related to the infusion; however, some side effects can be serious. Over time, the number of these infusion-related reactions decreases.

If you have difficulty breathing,with or without blue discoloration of the skin, tell your doctor immediately and seek immediate medical attention.

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

  • Headache
  • Flushing of the face
  • Shortness of breath, wheezing
  • Abdominal pain, nausea, vomiting, frequent and/or soft stools
  • Chest pain
  • Hives, rash, itching, redness of the skin
  • Fever
  • Infusion-related reaction (see section "Warnings and precautions")

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

  • Dizziness, tremors
  • Rapid heart rate, irregular heart rate, blue discoloration of the skin
  • Increased blood pressure, decreased blood pressure
  • Difficulty breathing, cough, low oxygen levels in the blood
  • Swelling of the tongue, indigestion
  • Joint pain
  • Inflammation at the infusion site, inflammation of the limbs, facial swelling

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

  • Rapid breathing

Rare side effects (cannot be estimated from the available data):

  • Severe allergic reactions

Reporting of side effects

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

5. Storage of Elaprase

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.

Do not use this medicine if you notice discoloration or the presence of foreign particles.

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 other information

Composition of Elaprase

The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase. Idursulfase is produced in a human cell line using genetic engineering techniques (which involves introducing genetic information into human cells in the laboratory, which will then produce the desired product).

Each vial of Elaprase contains 6 mg of idursulfase. Each ml contains 2 mg of idursulfase.

The other ingredients are Polysorbate 20, sodium chloride, disodium phosphate dihydrate, sodium phosphate monohydrate, and water for injections.

Appearance and pack contents

This medicine is a concentrate for solution for infusion. It is provided in a glass vial as a clear to slightly opalescent solution.

Each vial contains 3 ml of concentrate for solution for infusion.

Elaprase is available in pack sizes of 1, 4, and 10 vials. Not all pack sizes may be marketed.

Marketing authorisation holder

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50-58 Baggot Street Lower

Dublin 2

D02 HW68

Ireland

Manufacturer

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50-58 Baggot Street Lower

Dublin 2

D02 HW68

Ireland

Date of last revision of this leaflet: 11/2022.

This medicine has been authorised under "exceptional circumstances". This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicine.

The European Medicines Agency will review any new information that may become available every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other web sites about rare diseases and orphan medicines.

The leaflet can be found on the European Medicines Agency web site in all EU/EEA languages.

------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Instructions for use, handling, and disposal

  1. Calculate the total dose to be administered and the number of Elaprase vials needed.
  1. Dilute the required total volume of Elaprase concentrate for solution for infusion in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion. It is recommended to administer the total infusion volume using an in-line filter of 0.2 µm. Precautions should be taken to ensure the sterility of the prepared solutions, as Elaprase does not contain preservatives or bacteriostatic agents; aseptic technique should be observed. Once diluted, the solution should be mixed gently but not shaken.
  1. The solution should be inspected visually for particulate matter and discoloration prior to administration. It should not be shaken.
  1. It is recommended to start administration as soon as possible. The chemical and physical stability of the diluted solution has been demonstrated for 8 hours at 25°C.
  1. Elaprase should not be infused concomitantly in the same intravenous line with other medicines.

For single use only. Disposal of unused product and all materials that have come into contact with it should be done according to local regulations.

Online doctors for ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION

Discuss questions about ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

0.0 (0)
Doctor

Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

Camera Book a video appointment
€55
0.0 (0)
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.
Camera Book a video appointment
€58
5.0 (181)
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.

Camera Book a video appointment
€50
0.0 (17)
Doctor

Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

Camera Book a video appointment
€55
0.0 (0)
Doctor

Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

  •  Neuroimaging
  •  Musculoskeletal system (MSK)
  •  Angiography
  •  Abdomen and pelvis
  •  Soft tissues

Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

Camera Book a video appointment
€60

Frequently Asked Questions

Is a prescription required for ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION?
ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION 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 ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION?
The active ingredient in ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION is idursulfase. This information helps identify medicines with the same composition but different brand names.
Who manufactures ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION?
ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION is manufactured by Takeda Pharmaceuticals International Ag Ireland Branch. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION 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 ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION 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 ELAPRASE 2 mg/ml CONCENTRATE for SOLUTION for INFUSION?
Other medicines with the same active substance (idursulfase) include ALDURAZYME, 100 U/mL Concentrate for Infusion Solution, BRINEURA 150 MG SOLUTION FOR INFUSION, CEREZYME 400 units powder for concentrate for infusion 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.
bg-pattern-dark

Stay informed about Oladoctor

News about new services, product updates and useful information for patients.

Follow us on social media