Comirnaty

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Viambatanisho vya kazi:

Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2

Inapatikana kutoka:

BioNTech Manufacturing GmbH

ATC kanuni:

J07BN01

INN (Jina la Kimataifa):

tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified)

Kundi la matibabu:

Vaccines

Eneo la matibabu:

COVID-19 virus infection

Matibabu dalili:

Comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. Comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. Comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. Comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years. Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19.Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years. Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years.The use of this vaccine should be in accordance with official recommendations.

Bidhaa muhtasari:

Revision: 45

Idhini hali ya:

Authorised

Idhini ya tarehe:

2020-12-21

Taarifa za kipeperushi

306
B. PACKAGE LEAFLET
307
PACKAGE LEAFLET: INFORMATION FOR THE USER
COMIRNATY 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION
ADULTS AND ADOLESCENTS FROM 12 YEARS
COVID-19 MRNA VACCINE
tozinameran
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, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Comirnaty is and what it is used for
2.
What you need to know before you receive Comirnaty
3.
How Comirnaty is given
4.
Possible side effects
5.
How to store Comirnaty
6.
Contents of the pack and other information
1.
WHAT COMIRNATY IS AND WHAT IT IS USED FOR
Comirnaty is a vaccine used for preventing COVID-19 caused by
SARS-CoV-2.
Comirnaty 30 micrograms/dose dispersion for injection is given to
adults and adolescents from
12 years of age and older.
The vaccine causes the immune system (the body’s natural defences)
to produce antibodies and blood
cells that work against the virus, so giving protection against
COVID-19.
As Comirnaty does not contain the virus to produce immunity, it cannot
give you COVID-19.
The use of this vaccine should be in accordance with official
recommendations.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE COMIRNATY
COMIRNATY SHOULD NOT BE GIVEN
•
if you are allergic to the active substance or any of the other
ingredients of this medicine (listed
in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given the
vaccine if:
•
you have ever had a severe allergic reaction or breathing problems
after any ot

Tabia za bidhaa

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
Comirnaty 30 micrograms/dose dispersion for injection
COVID-19 mRNA Vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a single dose or a multidose vial with a grey cap. Do not
dilute prior to use.
One single dose vial contains 1 dose of 0.3 mL, see sections 4.2 and
6.6.
One multidose vial (2.25 mL) contains 6 doses of 0.3 mL, see sections
4.2 and 6.6.
One dose (0.3 mL) contains 30 micrograms of tozinameran, a COVID-19
mRNA Vaccine (nucleoside
modified, embedded in lipid nanoparticles).
Tozinameran is a single-stranded, 5’-capped messenger RNA (mRNA)
produced using a cell-free
_in vitro_ transcription from the corresponding DNA templates,
encoding the viral spike (S) protein of
SARS-CoV-2.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersion for injection.
The vaccine is a white to off-white frozen dispersion (pH: 6.9 - 7.9).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Comirnaty 30 micrograms/dose dispersion for injection is indicated for
active immunisation to prevent
COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and
older.
The use of this vaccine should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Individuals 12 years of age and older _
Comirnaty is administered intramuscularly as a single dose of 0.3 mL
for individuals 12 years of age
and older regardless of prior COVID-19 vaccination status (see
sections 4.4 and 5.1).
For individuals who have previously been vaccinated with a COVID-19
vaccine, Comirnaty should be
administered at least 3 months after the most recent dose of a
COVID-19 vaccine.
3
_Severely immunocompromised aged 12 years and older _
Additional