SPIKEVAX

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

CX-024414 MRNA

Verfügbar ab:

MEDISON PHARMA LTD

ATC-Code:

J07BX03

Darreichungsform:

DISPERSION FOR INJECTION

Zusammensetzung:

CX-024414 MRNA 1.26 MG/VIAL

Verabreichungsweg:

I.M

Verschreibungstyp:

Required

Hergestellt von:

MODERNA BIOTECH SPAIN, S.L.., SPAIN

Therapiebereich:

COVID-19 VACCINES

Anwendungsgebiete:

Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

Berechtigungsdatum:

2021-12-30

Gebrauchsinformation

Page 1 of 7
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
SPIKEVAX 0.2 MG/ML
DISPERSION FOR INJECTION
ACTIVE INGREDIENT AND ITS QUANTITY:
elasomeran 1.26 mg/vial
mRNA Vaccine encoding the SARS-CoV-2 spike protein
Inactive ingredients and allergens - see section 6 "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START 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 to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Spikevax is an active vaccine used to prevent COVID-19 caused by
SARS-CoV-2 in individuals 18
years of age and older.
The active substance in Spikevax is mRNA encoding the SARS-CoV-2 spike
protein.
The mRNA is embedded in SM-102 lipid nanoparticles.
As Spikevax does not contain the virus, it cannot give you COVID-19.
THERAPEUTIC GROUP: Vaccine, other viral vaccines.
HOW THE VACCINE WORKS
Spikevax stimulates the body
’
s natural defences (immune system).
The vaccine works by causing the
body to produce protection (antibodies) against the virus that
causes COVID-19. Spikevax uses a substance called messenger
ribonucleic acid (mRNA) to carry
instructions that cells in the body can use to make the spike protein
that is also on the virus. The cells
then make antibodies against the spike protein to help fight off the
virus. This will help to protect you
against COVID-19.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients in this
medicine (see section 6 "Additional information").
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE RECEIVING THE VACCINE, TELL YOUR DOCTOR, PHARMACIST OR THE
NURSE IF:
•
you have previously had

Fachinformation

1
1.
NAME OF THE MEDICINAL PRODUCT
Spikevax 0.2 mg/mL
dispersion for injection
elasomeran 1.26 mg/vial
COVID-19 mRNA Vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TABLE 1. QUALITATIVE AND QUANTITATIVE COMPOSITION BY STRENGTH AND TYPE
OF CONTAINER
STRENGTH
CONTAINER
DOSE(S)
COMPOSITION PER DOSE
SPIKEVAX
0.2 MG/ML
DISPERSION FOR
INJECTION
Multidose vial
(red flip-off cap)
Maximum 10 doses
of 0.5 mL each
One dose (0.5 mL) contains
100 micrograms of elasomeran, a
COVID-19 mRNA Vaccine
(nucleoside
modified)
(embedded in lipid
nanoparticles).
Maximum 20 doses
of 0.25 mL each
One dose (0.25 mL) contains
50 micrograms of elasomeran, a
COVID-19 mRNA Vaccine (nucleoside
modified) (embedded in lipid
nanoparticles).
Elasomeran 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 (original).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersion for injection
White to off white dispersion (pH: 7.0
–
8.0).
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Spikevax is indicated for active immunisation to prevent COVID-19
caused by SARS-CoV-2 in
individuals 18 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
Refer to Table 2 for dosing across Spikevax vaccination type.
2
TABLE 2. SPIKEVAX POSOLOGY FOR PRIMARY SERIES, A THIRD DOSE IN
SEVERELY IMMUNOCOMPROMISED AND
BOOSTER DOSES
_ _
_ _
STRENGTH
VACCINATION
TYPE
AGE(S)
DOSE
RECOMMENDATIONS
SPIKEVAX
0.2 MG/ML
DISPERSION FOR
INJECTION
Primary series
Individuals 18 years of
age and older
2 (two) doses
(0.5 mL each,
containing 100
micrograms
mRNA)
It is recommended to
administer the second
dose 28 days after the
first dose.
A dosing window of 3 to
6 weeks for
administration of the
second dose can be
allowed in special cases
(see sections 4.4 and 5.1).
There are limited data
available on the
interc