injection, suspension
smallpox vaccine (live Modified Vaccinia Ankara)
1. What IMVANEX is and what it is used for
IMVANEX is a vaccine used to prevent smallpox infection in adults.
When a person receives the vaccine, the immune system (the body’s natural defense system) produces its own protection in the form of antibodies against the smallpox virus.
IMVANEX does not contain the smallpox virus (variola) and can not spread or cause smallpox.
2. What you need to know before you receive IMVANEX
You should not receive IMVANEX:
- if you have previously had a life-threatening allergic reaction to any of the ingredients of IMVANEX (listed in section 6) or chicken protein, benzonase, gentamicin or ciprofloxacin which may be present in very small amounts in the vaccine.
- if you are ill with a high fever. In that case, the doctor should postpone the vaccination until you feel better. If you have a minor infection , e.g. a cold, the vaccination does not need to be postponed, but talk to your doctor or nurse first.
Warnings and cautions
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 if you are receiving treatment that leads to a weakened immune system.
The protective effect of IMVANEX against smallpox has not been studied.
IMVANEX may not provide adequate protection for all people who are vaccinated.
Previous vaccination with IMVANEX may alter the expected skin reaction (response) to the smallpox vaccine given later, with a weakened or absent reaction as a result.
Other medicines or vaccines and IMVANEX
Tell your doctor or nurse if you are taking, have recently taken any other medicines, 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 for advice. This vaccine should not be used during pregnancy and lactation. However, your doctor will assess whether the possible benefits of preventing smallpox outweigh the possible risks of giving you the vaccine.
Driving and using machines
There is no information on the effect of IMVANEX on the ability to drive or use machines. However, if you experience any of the side effects listed in section 4 (eg dizziness), your ability to drive or use machines may be affected.
IMVANEX contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free.
How IMVANEX is given
You can get this vaccine regardless of whether you have received the smallpox vaccine before.
The vaccine is injected under the skin, preferably into the upper arm, by your doctor or nurse. It must not be injected into a blood vessel.
If you have never been vaccinated against smallpox:
- You get two injections .
- The second injection is given no earlier than 28 days after the first.
- Make sure that you get both injection engines
If you have previously been vaccinated against smallpox:
- You get an injection .
- If your immune system is weakened, you will receive two injections; the second no earlier than 28 days after the first
If you forget to get IMVANEX
If you have missed a scheduled injection, talk to your doctor or nurse and make another appointment.
If you have any further questions on 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 are
Contact a doctor immediately, or go to the emergency department at the nearest hospital if you experience any of the following symptoms:
- difficulty breathing
- dizziness
- swelling of the face and neck.
These symptoms may be a sign of a severe allergic reaction.
Other side effects are
If you already have atopic dermatitis, you may experience more intense local skin reactions (eg redness, swelling, and itching ) and other general symptoms (eg headache, muscle aches, malaise, or fatigue) as well as a flare-up or worsening of the skin problems.
The most commonly reported adverse reactions occurred at the injection site. Most were mild to moderate and disappeared without treatment within seven days.
If you get any of the following side effects, talk to your doctor.
Very common (may affect more than 1 in 10 people):
- headache,
- muscle aches,
- nausea,
- fatigue,
- pain, redness , swelling, hardening or itching at the injection site.
Common (may affect up to 1 in 10 people):
- overindulge,
- fever,
- joint pain, pain in the extremity you,
- reduced appetite,
- lump, discoloration, bruising or heat at the injection site.
Uncommon (may affect up to 1 in 100 people):
- infection of the nose and throat, upper respiratory infection,
- swollen lymph nodes ,
- abnormal sleep pattern,
- dizziness, abnormal sensations in the skin,
- muscle stiffness,
- sore throat, runny nose, cough,
- diarrhea, vomiting,
- rash, itching , dermatitis,
- bleeding, irritation, swelling of the forearm, malaise, swelling, chest pain,
- increase in cardiac laboratory values (eg troponin I), elevated liver enzymes, decreased white blood cell count or decreased platelet volume.
Rare (may affect up to 1 in 1,000 people)
- sinusitis,
- influenza ,
- Red eyes,
- urticaria ( hives ),
- discoloration of the skin,
- sweating,
- bruises on the skin,
- night sweats,
- lump on the skin,
- back pain,
- pain in the neck,
- muscle cramps,
- muscle pain,
- muscle weakness,
- swollen ankles, feet or fingers,
- fast heartbeat,
- sore ears and throat,
- abdominal pain,
- dry mouth ,
- dizziness ( vertigo ),
- migraine ,
- nerve disorders leading to weakness, tingling or numbness,
- drowsiness,
- scaling, inflammation , abnormal sensations of the skin, reaction at the injection site, rash, numbness, dryness, reduced mobility, blisters at the injection site,
- weakness,
- flu-like illness,
- swelling of the face, mouth and throat,
- increased white blood cell count ,
- bruises.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store IMVANEX
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 after EXP. The expiration date is the last day of the specified month.
Store in a frozen state (at -20 ° C +/- 5 ° C or -50 ° C +/- 10 ° C or -80 ° C +/- 10 ° C). The expiration date depends on storage temperature. Do not freeze the vaccine again after thawing. The vaccine should be used immediately after thawing or if it has been previously stored at -20 ° C +/- 5 ° C, the vaccine may be stored at 2 ° C-8 ° C in the dark for up to 8 weeks before use.
Store in the original package. Sensitive to light.
6. Contents of the packaging and other information
Content declaration
One dose (0.5 ml) contains:
The active substance is Modified Vaccinia Ankara – Bavarian Nordic Live virus 1, not less than 5 x 10 7 Inf. E *
* infectious devices
1 Produced in chicken embryo
The other ingredients are trometamol, sodium chloride, and water for injections.
This vaccine contains residues of chicken proteins, benzonase, gentamicin, and ciprofloxacin.
What the medicine looks like and contents of the pack
When the frozen vaccine has thawed is IMVANEX a pale yellow to pale white, milky injection, suspension.
IMVANEX is supplied as a solution for injection in a vial (0.5 ml). IMVANEX is available in packs containing 20 vials.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Bavarian Nordic A / S
Philip Heymans Allé 3
DK-2900 Hellerup
Denmark
tel +45 3326 8383
email regulatory@bavarian-nordic.com
Manufacturer:
Bavarian Nordic A / S
Hejreskovvej 10A
3490 Kvistgaard
Denmark