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

How to use IMVANEX Injectable Suspension

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

What is IMVANEX and what is it used for
What you need to know before you are given IMVANEX
How IMVANEX is given
Possible side effects
Storing IMVANEX
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.

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.

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.

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.

IMVANEX Injectable Suspension

Katia Benko

Antonio Cayatte

Katia Benko

Antonio Cayatte