Spikevax 0.20 mgmL dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CX-024414 mRNA

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

CX-024414 mRNA

Unit dalam pakej:

10 Vials

Dikeluarkan oleh:

Rovi Pharma Industrial Services, S.A. San Sebastian de los Reyes

Risalah maklumat

DISCLAIMER:
THIS
PRODUCT
IS
APPROVED
UNDER
MALAYSIA
CONDITIONAL
REGISTRATION
FOR
PHARMACEUTICAL PRODUCTS DURING DISASTER GUIDELINE. THE ADMINISTRATION
OF THE PRODUCT IS
PURELY BASED ON INDIVIDUAL’S PREFERENCE.
SPIKEVAX
0.20
MG/ML
DISPERSION
FOR
INJECTION
COVID-19
mRNA
VACCINE
(NUCLEOSIDE MODIFIED)
Covid-19 mRNA Vaccine (100 mcg)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What Spikevax is used for
2.
How Spikevax works
3.
Before you use Spikevax
4.
How to use Spikevax
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Spikevax
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revision
11. Serial number
What Spikevax is used for
Spikevax is a vaccine used to prevent
COVID-19 caused by SARS-CoV-2. It
is given to adults aged 18 years 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.
How Spikevax 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.
Before you use Spikevax
- When you must not use it
The vaccine must not be given if you
are allergic to the active substance or
any of the other ingredients of this
vaccine.
- Before you start to use it
Talk
to
your
doctor,
pharmacist
or
nurse before you are given Spikevax if:
- you have previously had a severe,
life-threatening
allergic
reaction
after any other vaccine injection or
after you were given Spikevax in the
past.
- you
have
a
very
weak
or
compromised immune system
- you have ever fainte

Ciri produk

Zuellig Pharma Sdn Bhd (4013-D)
No. 15 Persiaran Pasak Bumi, Seksyen U8 Perindustrian Bukit Jelutong,
40150 Shah Alam, Selangor Darul Ehsan, Malaysia
T [phone] | F [phone]
www.zuelligpharma.com
ZUELLIG PHARMA SDN BHD (4013-D)
No. 15 Persiaran Pasak Bumi,
Seksyen U8 Perindustrian Bukit Jelutong,
40150 Shah Alam, Selangor Darul Ehsan, Malaysia
Tel: +(603) 5566 2288 Fax: +(603) 5566 2388
05 September 2022
_Dear Healthcare Professional, _
CONDITIONAL REGISTRATION OF SPIKEVAX 0.20 MG/ML DISPERSION FOR
INJECTION COVID-19
MRNA VACCINE (NUCLEOSIDE MODIFIED) WITH EU APPROVED LABEL
With regards to the matter above, please be informed that detail for
immediate label and outer carton
for Spikevax vaccine are based on global product information approved
by European Medicines
Agency (EMA).
2. There will not be country-specific packs for Malaysia during
pandemic period until commercial
supply stage which has not been determined yet.
3. Enclosed are product information approved in Malaysia for your
reference.
PRODUCT INFORMATION
DETAILS
Full product name of the
vaccine
Spikevax 0.20 mg/mL Dispersion for Injection COVID-19 mRNA
Vaccine (nucleoside modified)
Strength of active ingredient of
the vaccine
100 micrograms of messenger RNA (mRNA) (embedded in SM-
102 lipid nanoparticles).
Malaysian registration number
MAL21086001ACZ
Batch Release site for Malaysia
ROVI PHARMA INDUSTRIAL SERVICES, S.A.
San Sebastián de los Reyes
Paseo de Europa, 50
28703. San Sebastián de los Reyes
Madrid, Spain
Storage condition and shelf life
of the vaccine
Unopened vial:
9 months at -25°C to -15°C.
_ _
The unopened vaccine may be stored refrigerated at 2°C to 8°C,
protected from light, for maximum 30 days. Within this period,
up to 12 hours may be used for transportation.
Once thawed the vaccine should not be re-frozen.
The unopened vaccine may be stored at 8°C to 25°C up to 24
hours after removal from refrigerated conditions.
Zuellig Pharma Sdn Bhd (4013-D)
No. 15 Persiaran Pasak Bumi, Seksyen U8 Perindustrian Bukit Jelutong,