Imvanex
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
21-03-2023
Charakterystyka produktu
(SPC)
21-03-2023
Sprawozdanie z oceny publicznego
(PAR)
25-07-2022
Składnik aktywny:
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus
Dostępny od:
Bavarian Nordic A/S
Kod ATC:
J07BX
INN (International Nazwa):
smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)
Grupa terapeutyczna:
Other viral vaccines,
Dziedzina terapeutyczna:
Smallpox Vaccine; Monkeypox virus
Wskazania:
Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4.4 and 5.1).The use of this vaccine should be in accordance with official recommendations.
Podsumowanie produktu:
Revision: 25
Status autoryzacji:
Authorised
Data autoryzacji:
2013-07-31
Ulotka dla pacjenta
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMVANEX SUSPENSION FOR INJECTION
Smallpo
x and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for 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.
WHAT IS IN 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 given
4.
Possible side effects
5.
How to store IMVANEX
6.
Contents of the pack and other information
1.
WHAT IMVANEX IS AND WHAT IT IS USED FOR
IMVANEX is a vaccine used to prevent smallpox, monkeypox and disease
caused by vaccinia virus in
adults.
When a person is given the vaccine, the immune system (the body’s
natural defence system) will
produce its own protection in the form of antibodies against the
smallpox, monkeypox and vaccinia
viruses.
IMVANEX does not contain smallpox virus (Variola) or monkeypox virus
or vaccinia viruses. It
cannot spread or cause smallpox, monkeypox or vaccinia infection and
disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IMVANEX
YOU MUST NOT RECEIVE IMVANEX:
•
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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before receiving IMVANEX:
•
if you have atopic dermatitis (see sec
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
IMVANEX suspension for injection
Smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml) contains:
Modified Vaccinia Ankara – Bavarian Nordic Live virus
1
no less than 5 x 10
7
Inf.U
*
*infectious units
1
Produced in chick embryo cells
This vaccine contains trace residues of chicken protein, benzonase,
gentamicin and ciprofloxacin (see
section 4.3).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Light yellow to pale white, milky suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation against smallpox, monkeypox and disease caused by
vaccinia virus in adults (see
sections 4.4 and 5.1).
The use of this vaccine should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Primary vaccination (individuals previously not vaccinated against
smallpox, mo_
_nkeypox or vaccinia _
_viruses) _
A first dose of 0.5 ml should be administered on an elected date.
A second dose of 0.5 ml should be administered no less than 28 days
after the first dose, see
sections 4.4 and 5.1.
_Booster vaccination (individuals previously vaccinated against
smallpox, mo_
_nkeypox or vaccinia _
_viruses) _
There are inadequate data to determine the appropriate timing of
booster doses. If a booster dose is
considered necessary then a single dose of 0.5 ml should be
administered, see sections 4.4 and 5.1.
3
_Special population _
Immunocompromised patients (e.g. HIV infected, patients under
immunosuppressive therapy) who
have been previously vaccinated against smallpox, monkeypox or
vaccinia viruses should receive two
boost
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