IMVANEX no less than 50,000,000 iu/ vial

• 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.

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

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

Talk to your doctor or nurse before receiving IMVANEX:

• if you have atopic dermatitis (see section 4).
• if you have HIV infection or any other condition or treatment leading to a weakened immune system.
• If you are feeling nervous about the vaccination process or have ever fainted following any needle injection.

The protective efficacy of IMVANEX against smallpox, mpox and disease caused by vaccinia virus has not been studied in humans.

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

IMVANEX may not fully protect all people who are vaccinated.

Prior vaccination with IMVANEX may modify the cutaneous response (‘take’) to subsequently administered replication-competent smallpox vaccine resulting in a reduced or absent take.

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

If you are a pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask to your doctor for advice. The use of this vaccine during pregnancy and breast-feeding is not recommended. However, your doctor will assess whether the possible benefit in terms of preventing smallpox, mpox and disease caused by vaccinia virus would outweigh the potential risks to you and your foetus/baby.

There is no information on the effect of IMVANEX on your ability to drive or use machines. However, it is possible that if you experience any of the side effects listed in section 4, then some of these may affect your ability to drive or use machines (e.g. dizziness).

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ’sodium-free’.

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

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

If you miss a scheduled injection, tell your doctor or nurse and arrange another visit.

Contact a doctor immediately, or go immediately to the emergency department of your nearest hospital if you experience any of the following symptoms:

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

These symptoms may be a sign of a serious allergic reaction.

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, feeling sick or tired), as well as a flare-up or worsening of your skin condition.

The most common side effects reported were at the site of injection. Most of them were mild to moderate in nature and resolved without any treatment within seven days.

If you get any of the following side effects, tell your doctor.

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

• headache,
• aching muscles,
• feeling sick,
• tiredness,
• pain, redness, swelling, hardness or itching at the injection site.

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

• chills,
• fever,
• joint pain, pain in extremities,
• loss of appetite,
• lump, discolouration, bruising or warmth at the injection site.

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

• nose and throat infection, upper respiratory tract infection,
• swollen lymph nodes,
• abnormal sleep,
• dizziness, abnormal skin sensations,
• muscle stiffness,
• sore throat, runny nose, cough,
• diarrhea, vomiting,
• rash, itch, skin inflammation,
• bleeding, irritation,
• underarm swelling, feeling unwell, flushing, chest pain, pain in the armpit,
• increase of cardiac laboratory values (like Troponin I), liver enzyme increased, white blood cell count decreased, mean platelet volume decreased.

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

• sinus infection,
• influenza,
• redness and discomfort in the eye,
• hives (nettle rash),
• skin discolouration,
• sweating,
• skin bruising,
• night sweats,
• lump in skin,
• back pain,
• neck pain,
• muscle cramps,
• muscle pain,
• muscle weakness,
• swelling of the ankles, feet or fingers,
• faster heartbeat,
• ear and throat ache,
• abdominal pain,
• dry mouth,
• spinning sensation (vertigo),
• migraine,
• nerve disorder causing weakness, tingling or numbness,
• drowsiness,
• scaling, inflammation, abnormal skin sensation, reaction at the injection site, rash, numbness, dryness, movement impairment, vesicles at the injection site,
• weakness,
• influenza like illness,
• swelling of the face, mouth and throat,
• white blood cell count increased,
• bruising.

Unknown (cannot be estimated from the available data):

• temporary one-sided facial drooping (Bell’s palsy).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or App Store. By reporting side effects you can help provide more information on the safety of this vaccine.

One dose (0.5 ml) contains:

The active substance is Modified Vaccinia Ankara – Bavarian Nordic Live virus¹, no less than 5 x 10⁷ Inf.U*

*infectious units

¹Produced in chick-embryo cells

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

This vaccine contains trace residues of chicken protein, benzonase, gentamicin and ciprofloxacin.

Once the frozen vaccine has been thawed, IMVANEX is a light yellow to pale white, milky suspension for injection.

IMVANEX is provided as a suspension for injection in a vial (0.5 ml).

IMVANEX is available in pack containing 10 single dose vials or 20 single dose vials.

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