Bimervax

Land: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains

Fáanlegur frá:

Hipra Human Health S.L.

ATC númer:

J07BN

INN (Alþjóðlegt nafn):

COVID-19 Vaccine (recombinant, adjuvanted)

Meðferðarhópur:

Vaccines

Lækningarsvæði:

COVID-19 virus infection

Ábendingar:

Bimervax is indicated as a booster for active immunisation to prevent COVID-19 in individuals 16 years of age and older who have previously received a mRNA COVID-19 vaccine

Vörulýsing:

Revision: 2

Leyfisstaða:

Authorised

Leyfisdagur:

2023-03-30

Upplýsingar fylgiseðill

24
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 national reporting
system listed in Appendix V
and include batch/Lot number if available. By reporting side effects,
you
can help provide more information on the safety of this vaccine.
5.
HOW TO STORE BIMERVAX
Keep this medicine out of the sight and reach of children.
Your doctor, pharmacist, or nurse is responsible for storing this
vaccine and disposing of any unused
product correctly. The following information about storage, expiry,
use and handling as well as
disposal is intended for healthcare professionals.
Do not use this vaccine after the expiry date which is stated on the
label after EXP.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep vials
in outer carton in order to protect from
light.
After first puncture, store at 2 °C – 8 °C, use within 6 hours.
Information on handling are described in the section intended for
healthcare professionals at the end of
the package leaflet.
Any unused medicinal product or waste material should be disposed of
in accordance with local
requirements.
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT BIMERVAX CONTAINS
-
One dose (0.5 mL) contains 40 micrograms of selvacovatein adjuvanted
with SQBA.
-
Selvacovatein
is
SARS-CoV-2
virus
recombinant
spike
(S)
protein
R B D
fusion heterodimer
B.1.351
and
B.1.1.7
strains)
produced
by
recombinant
D N A
technology.
-
SQBA is included in this vaccine as an adjuvant to accelerate and
improve the protective
effects of the vaccine. SQBA contains per 0.5 mL dose: squalene (9.75
mg), polysorbate 80
(1.18 mg), sorbitan trioleate (1.18 mg), sodium citrate (0.66 mg),
citric acid (0.04 mg) and
water for injections.
-
The other ingredients (excipients) are: disodium phosphate
dodecahydrate, potassium
dihydrogen phosphate, sodium chloride, potassium chloride and water
for injections.
BIMERVAX contains potassium and sodium (see section

Vara einkenni

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
BIMERVAX emulsion for injection
COVID-19 Vaccine (recombinant, adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a multidose vial which contains 10 doses of 0.5 mL
One dose (0.5 mL) contains 40 micrograms of selvacovatein adjuvanted
with SQBA.
Selvacovatein is a SARS-CoV-2 virus recombinant spike (S) protein
receptor binding domain (RBD)
fusion heterodimer (B.1.351 and B.1.1.7 strains) produced by
recombinant DNA technology using a
plasmid expression vector in a CHO cell line.
SQBA adjuvant containing per 0.5 mL dose: squalene (9.75 mg),
polysorbate 80 (1.18 mg), sorbitan
trioleate (1.18 mg), sodium citrate (0.66 mg), citric acid (0.04 mg)
and water for injections.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection (injection)
White homogeneous emulsion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BIMERVAX is indicated as a booster for active immunisation to prevent
COVID-19 in individuals
16 years of age and older who have previously received a mRNA COVID-19
vaccine (see sections 4.2
and 5.1).
_ _
The use of this vaccine should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Individuals 16 years of age and older _
A single intramuscular dose (0.5 mL) of BIMERVAX should be
administered. There should be an
interval of at least 6 months between prior receipt of a mRNA vaccine
and administration of
BIMERVAX (see section 5.1).
_Elderly population _
No dose adjustment is required in elderly individuals ≥ 65 years of
age.
_Paediatric population _
3
The safety and efficacy of BIMERVAX in children and adolescents less
than 16 years of age have not
been established yet. No d