COMIRNATY PBS

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

COVID-19 MRNA VACCINE

Fáanlegur frá:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC númer:

J07BX03

Lyfjaform:

CONCENTRATE FOR DISPERSION FOR INJECTION

Samsetning:

COVID-19 MRNA VACCINE 0.5 MG/ML

Stjórnsýsluleið:

I.M

Gerð lyfseðils:

Required

Framleitt af:

PFIZER INC, USA

Lækningarsvæði:

COVID-19 VACCINES

Ábendingar:

Comirnaty is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.

Leyfisdagur:

2021-09-13

Upplýsingar fylgiseðill

Comirnaty PIL CC 150223
P
fleet 2022-0079021, 2022-0079929, 2022-0082402, 2022-0075548,
2022-0080972
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
COMIRNATY
®
CONCENTRATE FOR DISPERSION FOR INTRAMUSCULAR INJECTION
ACTIVE INGREDIENT: COVID-19 MRNA VACCINE
Inactive ingredients and allergens: See section 2 under “Important
information about some of this
medicine’s ingredients” and section 6 “Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Comirnaty is an active vaccine intended to prevent COVID-19 caused by
SARS-CoV-2 coronavirus,
in adults and adolescents from 12 years of age and older.
THERAPEUTIC GROUP: vaccines, other viral vaccines.
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.
The vaccine does not contain the virus so it cannot give you COVID-19
(corona).
2. BEFORE USING THIS MEDICINE
DO NOT USE COMIRNATY IF:
•
You or your child is sensitive (allergic) to the active ingredients or
to any of the other
ingredients in this medicine (listed in section 6).
SPECIAL WARNINGS REGARDING USE OF COMIRNATY
BEFORE RECEIVING THE VACCINE, TELL YOUR DOCTOR OR NURSE IF:
•
you have ever had a severe allergic reaction or breathing problems
after receiving any other
vaccine or after receiving Comirnaty in the past.
•
you are feeling nervous about the vaccination process or have ever
fainted following any needle
injection.
•
you have a severe illness or infection with high fever. However, you
can have your vaccination

Vara einkenni

Comirnaty LPD CC 281123
2023-0086009
1
COMIRNATY™
1.
NAME OF THE MEDICINAL PRODUCT
Comirnaty
COVID-19 mRNA Vaccine (nucleoside modified)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a multidose vial with a purple cap and must be diluted before
use.
One vial (0.45 mL) contains 6 doses of 0.3 mL after dilution, see
sections 4.2 and 6.6.
One dose (0.3 mL) contains 30 micrograms of tozinameran, a COVID-19
mRNA Vaccine (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
Concentrate for dispersion for injection (sterile concentrate).
The vaccine is a white to off-white frozen dispersion (pH: 6.9 - 7.9).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Comirnaty is indicated for active immunisation to prevent COVID-19
caused by SARS-CoV-2 virus, 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 after dilution as a course
of 2 doses (0.3 mL each). It is
recommended to administer the second dose 3 weeks after the first dose
(see sections 4.4 and 5.1).
_Interchangeability _
The interchangeability of Comirnaty with other COVID-19 vaccines from
other manufacturers to
complete the vaccination course has not been established. Individuals
who have received 1 dose of
Comirnaty should receive a second dose of Comirnaty to complete the
vaccination course.
Doses of Comirnaty (supplied in a vial with a purple cap) and
Comirnaty TRIS 30 (supplied in a vial
with a grey cap) are considered interchangeable.
Comirnaty LPD CC 281123
2023-0086009
2
_Paediatric population _
There is a paediatric formulation available for individuals 5 to 11
years of age (i.e. 5 to