IMVANEX 0.5 ML Zawiesina do wstrzykiwań
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Jak stosować IMVANEX
Treść ulotki
IMVANEX injectable suspension
Smallpox and monkeypox vaccine (modified live vaccinia virus Ankara)
This medicinal product is subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.
Read this leaflet carefully before this vaccine is administered to you because
it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet
- 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 administered
- 4. Possible side effects
- 5. How to store 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 vaccinia disease in adults and adolescents aged 12 years and older.
When a person is given the vaccine, the immune system (i.e. the body's natural defense system) produces its own protective factors, antibodies, directed against the smallpox virus, monkeypox virus and vaccinia viruses.
IMVANEX does not contain the smallpox virus or the monkeypox virus, nor the vaccinia virus. It is not able to spread or cause infection and disease from smallpox, monkeypox or vaccinia virus.
2. What you need to know before you are given IMVANEX
IMVANEX must not be given to you:
- if you are allergic or have had a severe, potentially life-threatening allergic reaction to the active ingredient 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 small amounts.
Warnings and precautions
Talk to your doctor or nurse before you are given IMVANEX:
- if you suffer from atopic dermatitis (see section 4)
- if your immune system is weakened due to HIV infection or any other illness or treatment.
- if you feel nervous about the vaccination process or if you have fainted after an injection with a needle.
Studies in humans have not been conducted to verify the effectiveness of the protection offered by
IMVANEX against smallpox, monkeypox and vaccinia disease.
If you have a high fever, your doctor will postpone the vaccination until you feel better.
A minor infection, such as a cold, should not lead to postponement of the vaccination, but talk to your
doctor or nurse before receiving the vaccine.
It is possible that IMVANEX will not provide complete protection for all vaccinated people.
Previous vaccination with IMVANEX may alter the skin response to a subsequently administered replicating
smallpox vaccine and cause a reduced or absent skin response.
Other medicines or vaccines and IMVANEX
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.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding,
ask your doctor for advice. Use of this vaccine is not recommended during pregnancy and
breastfeeding. However, your doctor will assess whether the possible benefit in terms of
prevention against smallpox, monkeypox and vaccinia disease outweighs the potential risks to you and
the fetus/baby.
Driving and operating machinery
There are no data on the effects of IMVANEX on the ability to drive or operate machinery.
However, it is possible that any of the side effects listed in section 4 may occur and
some of these may impair the ability to drive or operate machinery (e.g. dizziness).
IMVANEX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
3. How IMVANEX is administered
This vaccine can be administered to you regardless of whether you have previously received or
not received a smallpox vaccination in the past.
The vaccine is injected by the doctor or nurse under the skin, preferably in the arm. The
vaccine must not be injected into a blood vessel.
If you have never been vaccinated against smallpox virus, monkeypox virus or vaccinia virus
- you will receive two injections
- the second injection will be administered no less than 28 days after the first
- make sure to complete the vaccination schedule including two injections.
If you have already been vaccinated against smallpox virus, monkeypox virus or vaccinia virus
- you will receive one injection
- if your immune system is weakened, you will receive two injections and the second injection will be administered no less than 28 days after the first.
If you forget an appointment for the IMVANEX injection
If you forget an appointment for the injection, inform the doctor or nurse and request a new
appointment.
If you have any doubts 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.
manifest.
Serious side effects
Contact your doctor immediately or go immediately to the nearest hospital emergency room if any of the
following symptoms appear:
- difficulty breathing
- dizziness
- swelling of the face and neck.
These symptoms may be signs of a serious allergic reaction.
Other side effects
If you already suffer from atopic dermatitis, more intense local skin reactions (such as
redness, swelling and itching) and other general symptoms (such as headache, muscle pain, nausea
or fatigue) may occur, as well as a worsening of skin conditions.
The most commonly reported side effects have been at the injection site. Most have been mild to
moderate in severity and have resolved within seven days without any
treatment.
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, hardening or itching at the injection site.
Common(may affect up to 1 in 10 people)
- chills
- fever
- joint pain, arm or leg pain
- loss of appetite
- nodule, color change, bruising or warmth at the injection site.
Uncommon(may affect up to 1 in 100 people)
- nasal and throat infection, upper respiratory tract infection
- swollen lymph nodes
- sleep disturbances
- dizziness, abnormal skin sensations
- muscle stiffness
- sore throat, runny nose, cough
- diarrhea, vomiting
- skin rash, itching, skin inflammation
- bleeding, irritation
- swelling under the armpit, feeling unwell, hot flashes, chest pain, armpit pain
- increased laboratory parameters related to the heart (such as troponin I), increased liver enzymes, decreased white blood cell count, decreased mean platelet volume.
Rare(may affect up to 1 in 1,000 people)
- sinusitis
- influenza
- redness and discomfort in the eyes
- urticaria
- change in skin color
- sweating
- bruising
- night sweats
- nodule in the skin
- back pain
- neck pain
- muscle cramps
- muscle pain
- muscle weakness
- swelling of ankles, feet or toes
- fast heartbeat
- ear and throat pain
- abdominal pain
- dry mouth
- feeling of loss of balance (vertigo)
- migraine
- nerve disorder causing weakness, tingling or numbness
- drowsiness
- scaling, inflammation, abnormal skin sensation, reaction at the injection site, rash, numbness, dryness, movement disorders, blisters at the injection site
- weakness
- flu-like illness
- swelling of the face, mouth and throat
- increased white blood cell count
- bruising.
Not known(frequency cannot be estimated from available data)
- temporary drooping of one side of the face (Bell's palsy).
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system detailed
in Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store 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 refers to the last day of that month.
Store in a freezer (at -20 °C ± 5 °C or at -50 °C ± 10 °C or at -80 °C ± 10 °C). The expiry
date depends on the storage temperature. Do not refreeze the vaccine after it has been
thawed. After thawing, the vaccine can be stored at 2 °C – 8 °C in the dark for a
maximum of 2 months, within the approved shelf life, before use.
Store in the original packaging to protect the medicine from light.
6. Contents of the pack and other information
What IMVANEX contains
One dose (0.5 mL) contains:
- the active substance is modified vaccinia virus Ankara live - Bavarian Nordic , not less than 5 x 10 U.Inf.* *infectious units 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.
Description of the appearance of IMVANEX and contents of the pack
Once the frozen vaccine has been thawed, IMVANEX is an injectable suspension
milky from light yellow to pale white.
IMVANEX is supplied as an injectable suspension in a vial (0.5 mL).
IMVANEX is available in packs containing 1 single-dose vial, 10 single-dose vials or
20 single-dose vials.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Bavarian Nordic A/S
Philip Heymans Alle 3
DK-2900 Hellerup
Denmark
Manufacturer
Bavarian Nordic A/S
Hejreskovvej 10A,
3490 Kvistgaard
Denmark
An authorisation for this medicinal product has been granted under “exceptional circumstances”. This means that
due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
The European Medicines Agency will review any new information on this
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu
This leaflet is available in all languages of the European Union/European Economic Area on the
website of the European Medicines Agency.
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The following information is intended for healthcare professionals:
Instructions for preparation and administration of the vaccine:
Allow the vial to reach a temperature between 8 °C and 25 °C before use.
Gently rotate before use. IMVANEX is a suspension from clear to milky from yellow
light to pale white. It may contain flocs from light yellow to pale white.
Visually inspect the suspension before administration. If foreign particles
are present and/or the appearance is abnormal, the vaccine must be discarded.
Each vial is for single use only.
Withdraw a dose of 0.5 mL with a syringe for injectable preparations.
After thawing, the vaccine can be stored at 2 °C – 8 °C in the dark for a maximum of
2 months, within the approved expiry period, before use.
Do not refreeze the vaccine after it has been thawed.
In the absence of compatibility studies, this vaccine should not be mixed with other vaccines.
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- Kraj rejestracji
- Postać farmaceutycznaInjectable suspension, 0.5 ML
- Kod ATCJ07BX01
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki IMVANEXPostać farmaceutyczna: Powder and solvent for injectable solution, 0.5 mlSubstancja czynna: respiratory syncytial virus vaccinesProducent: PFIZER EUROPE MA EEIGWymaga receptyPostać farmaceutyczna: Powder and suspension for injectable suspension, 0.5 mlSubstancja czynna: respiratory syncytial virus vaccinesProducent: GLAXOSMITHKLINE BIOLOGICALS S.A.Bez receptyPostać farmaceutyczna: Powder for injectable dispersion, 5 mcgSubstancja czynna: covid-19 vaccinesProducent: SEQIRUS NETHERLANDS B.V.Wymaga recepty
Odpowiedniki IMVANEX w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik IMVANEX w Hiszpania
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Często zadawane pytania
IMVANEX nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w IMVANEX jest smallpox and monkeypox vaccines. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
IMVANEX jest produkowany przez BAVARIAN NORDIC A/S. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie IMVANEX jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić IMVANEX w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (smallpox and monkeypox vaccines) to m.in. ABRYSVO, AREXVY, KOSTAIVE. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
