IMVANEX Injectable Suspension

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.