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IMVANEX Injectable Suspension

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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 IMVANEX Injectable Suspension

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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 User

IMVANEX injectable suspension

Vaccine against smallpox and monkeypox (modified Ankara vaccinia virus)

This medicine is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you receive this vaccine 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 nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is IMVANEX and what is it used for

IMVANEX is a vaccine used to prevent smallpox, monkeypox, and disease caused by cowpox virus in adults and adolescents from 12 years of age.

When the vaccine is given to a person, the immune system (the body's natural defense system) produces its own protection in the form of antibodies against the smallpox virus, monkeypox virus, and cowpox viruses.

IMVANEX does not contain the smallpox virus (Variola) or the monkeypox virus or the cowpox viruses. It cannot cause or spread infection and disease caused by the smallpox virus, monkeypox virus, or cowpox viruses.

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 are given IMVANEX

You should not receive IMVANEX:

  • if you are allergic or have previously suffered a sudden and potentially life-threatening allergic reaction to the active substance or any of the other ingredients of this medicine (listed in section 6) or to chicken proteins, benzonase, gentamicin, or ciprofloxacin, which may be present in the vaccine in very small amounts.

Warnings and precautions

Talk to your doctor or nurse before receiving IMVANEX:

  • if you have atopic dermatitis (see section 4).
  • if you have an HIV infection or any other disease or treatment that weakens the immune system.
  • if you are nervous about receiving the vaccine or have ever fainted after an injection with a needle.

The efficacy of IMVANEX in protecting against smallpox, monkeypox, and disease caused by cowpox virus has not been studied in humans.

In case of illness with high fever, your doctor will postpone vaccination until you are better. The presence of a minor infection, such as a cold, should not require postponement of vaccination, but consult your doctor or nurse first.

It is possible that IMVANEX may not fully protect all people who receive the vaccine.

Previous vaccination with IMVANEX may alter the skin response ("take") to subsequent smallpox vaccines with replicating viruses and cause reduced or absent take of these vaccines.

Other medicines or vaccines and IMVANEX

Tell your doctor or nurse if you are taking or have recently taken any other medicine or if you have recently received any other vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor. The use of this vaccine is not recommended during pregnancy and breastfeeding. However, your doctor will assess whether the potential benefit of preventing smallpox, monkeypox, and disease caused by cowpox virus outweighs the potential risks to you and your baby.

Driving and using machines

No information is available on the effects of IMVANEX on the ability to drive or use machines. However, if you experience any of the side effects included in section 4, some of them may affect your ability to drive or use machines (e.g., dizziness).

IMVANEX contains sodium

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

3. How IMVANEX is given

You can receive this vaccine whether or not you have been vaccinated against smallpox in the past.

Your doctor or nurse will inject the vaccine under your skin, preferably in the upper arm. It should not be injected into a blood vessel.

If you have never been vaccinated against smallpox, monkeypox, or cowpox viruses:

  • You will receive two injections.
  • The second injection will be given no less than 28 days after the first.
  • Make sure to complete the two-injection vaccination course.

If you have been previously vaccinated against smallpox, monkeypox, or cowpox viruses:

  • You will receive one injection.
  • If your immune system is weakened, you will receive two injections, and the second will be given no less than 28 days after the first.

If you miss an appointment for an IMVANEX injection

If you miss a scheduled injection, talk to your doctor or nurse and schedule another appointment.

If you have any other questions about the use of this vaccine, 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 vaccine can cause side effects, although not everybody gets them.

Serious side effects

Get in touch with a doctor or go immediately to the Emergency Department of the nearest hospital if you experience any of the following symptoms:

  • difficulty breathing
  • dizziness
  • swelling of the face and neck

These symptoms may be indicative of a severe allergic reaction.

Other side effects

If you already have atopic dermatitis, you may experience more intense local skin reactions (such as redness, swelling, and itching) and other general symptoms (such as headache, muscle pain, nausea, or fatigue), as well as an exacerbation or worsening of your skin problem.

The most frequently reported side effects occurred at the injection site. Most were mild to moderate and resolved without treatment within a period of seven days.

Tell your doctor if you experience any of the following side effects:

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

  • headache
  • muscle pain
  • nausea
  • fatigue
  • pain, redness, swelling, induration, or itching at the injection site

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

  • chills
  • fever
  • joint pain, limb pain
  • loss of appetite
  • lump, discoloration, bruising, or warmth at the injection site

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

  • nose and throat infection, upper respiratory tract infection
  • swelling of the lymph nodes
  • sleep disorders
  • dizziness, abnormal skin sensations
  • muscle stiffness
  • sore throat, nasal discharge, cough
  • diarrhea, vomiting
  • rash, itching, skin inflammation
  • bleeding, irritation
  • swelling under the arm, feeling unwell, flushing, chest pain
  • increased cardiac laboratory values (such as troponin I), increased liver enzymes, decreased white blood cell count, decreased platelet volume

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

  • sinus infection
  • flu
  • redness and discomfort in the eye
  • hives (urticaria)
  • skin discoloration
  • sweating
  • skin bruising
  • night sweats
  • skin lump
  • back pain
  • neck pain
  • muscle cramps
  • muscle pain
  • muscle weakness
  • swelling of the ankles, feet, or toes
  • rapid heartbeat
  • ear and throat pain
  • abdominal pain
  • dry mouth
  • feeling of spinning (vertigo)
  • migraine
  • nervous disorder that causes weakness, numbness, or tingling
  • drowsiness
  • flaking, inflammation, abnormal sensation in the skin, reaction at the injection site, rash, numbness, dryness, reduced mobility, blisters at the injection site
  • weakness
  • pseudoinfluenza syndrome
  • swelling of the face, mouth, and throat
  • increased white blood cell count
  • bruising

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

  • temporary facial paralysis (Bell's palsy) on one side

Reporting of side effects

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

5. Storing IMVANEX

Keep this medicine out of the sight and reach of children.

Do not use this vaccine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month shown.

Store in a freezer (at -20°C ± 5°C or -50°C ± 10°C or -80°C ± 10°C). The expiry date depends on the storage temperature. Do not re-freeze the vaccine once thawed. After thawing, the vaccine can be stored between 2°C and 8°C in the dark for a maximum of 2 months, within the approved validity period, before use.

Store in the original package to protect from light.

6. Contents of the pack and other information

What is in IMVANEX

One dose (0.5 ml) contains:

  • The active substance is the modified Ankara vaccinia virus - Bavarian Nordic1, at least 5 x 10^7 IU.*
  • infectious units

1 Produced in chicken embryo cells.

  • The other ingredients are: trometamol, sodium chloride, and water for injections.

This vaccine contains residual traces of chicken proteins, benzonase, gentamicin, and ciprofloxacin.

Appearance and packaging

After thawing, IMVANEX is a milky white to pale yellow injectable suspension.

IMVANEX is supplied as an injectable suspension in a vial (0.5 ml).

IMVANEX is available in packs of 1 vial or 20 vials.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Bavarian Nordic A/S

Philip Heymans Allé 3

DK-2900 Hellerup

Denmark

Phone +45 3326 8383

Email [email protected]

Manufacturer

Bavarian Nordic A/S

Hejreskovvej 10A,

3490 Kvistgaard

Denmark

Date of last revision of this leaflet:

This medicine has been authorised under exceptional circumstances. This means that due to the rarity of this 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.

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

The leaflet is also available in all languages of the European Union/European Economic Area on the European Medicines Agency web site.

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This information is intended for healthcare professionals only:

Instructions for preparation and administration of the vaccine:

The vial should be allowed to reach a temperature between 8°C and 25°C before use. Shake gently before use. Visually inspect the suspension before administration. If particles or an abnormal appearance are observed, the vaccine should be discarded.

Each vial is for single use.

Draw up a dose of 0.5 ml into a syringe for injection.

After thawing, the vaccine can be stored between 2°C and 8°C in the dark for a maximum of 2 months, within the approved validity period, before use.

Do not re-freeze the vaccine once thawed.

In the absence of compatibility studies, this vaccine must not be mixed with other vaccines.

Online doctors for IMVANEX Injectable Suspension

Discuss questions about IMVANEX Injectable Suspension, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (1061)
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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€80
5.0 (184)
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
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.

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€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.

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€60
3
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Frequently Asked Questions

Is a prescription required for IMVANEX Injectable Suspension?
IMVANEX Injectable Suspension requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
Who manufactures IMVANEX Injectable Suspension?
IMVANEX Injectable Suspension is manufactured by Bavarian Nordic A/S. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of IMVANEX Injectable Suspension 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 IMVANEX Injectable Suspension 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 IMVANEX Injectable Suspension?
Other medicines with the same active substance () include ABRYSVO powder and solvent for injectable solution, AREXVY powder and suspension for injectable suspension, MRESVIA DISPERSION INJECTABLE IN PRE-FILLED SYRINGE. 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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