SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

elasomeran, Quantity: 0.05 mg/mL; imelasomeran, Quantity: 0.05 mg/mL

Fáanlegur frá:

Moderna Australia Pty Ltd

Lyfjaform:

Injection, suspension

Samsetning:

Excipient Ingredients: heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; water for injections; trometamol; sodium acetate trihydrate; sucrose; distearoylphosphatidylcholine; cholesterol; glacial acetic acid; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; trometamol hydrochloride

Stjórnsýsluleið:

Intramuscular

Einingar í pakka:

10 (5 packs of 2) x 0.5 mL pre-filled syringes

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran/imelasomeran) COVID-19 Vaccine has provisional approval for the indication below: As a booster dose for active immunisation to prevent coronavirus disease 2019 (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. The decision has been made on the basis of immunogenicity and short-term safety data. Continued approval depends on the evidence of longer term benefits and safety from ongoing clinical trials and post-market assessment.

Vörulýsing:

Visual Identification: white to off-white frozen suspension; Container Type: Syringe; Container Material: Other composite material; Container Life Time: 9 Months; Container Temperature: Store between minus 50 - minus 15 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Leyfisstaða:

Registered (Provisional)

Leyfisdagur:

2022-11-22

Upplýsingar fylgiseðill

SPIKEVAX BIVALENT ORIGINAL/OMICRON_CMI_v3.1_23Nov22
1
SPIKEVAX BIVALENT ORIGINAL/OMICRON COVID-19
VACCINE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about being given this vaccine, speak to your healthcare
provider.
This vaccine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I BEING GIVEN SPIKEVAX BIVALENT ORIGINAL/OMICRON?
SPIKEVAX BIVALENT ORIGINAL/OMICRON contains the active ingredients
elasomeran and imelasomeran. It is a vaccine used as
a booster dose to prevent COVID-19 disease caused by SARS-CoV-2 in
individuals aged 18 years and older.
For more information, see Section 1. Why am I being given SPIKEVAX
BIVALENT ORIGINAL/OMICRON? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN SPIKEVAX BIVALENT
ORIGINAL/OMICRON?
You should not be given SPIKEVAX BIVALENT ORIGINAL/OMICRON if you have
ever had an allergic reaction to SPIKEVAX
(original) or SPIKEVAX BIVALENT ORIGINAL/OMICRON or any of the
ingredients listed at the end of the CMI.
Check with your doctor, pharmacist, or nurse before vaccination if
you: have previously had a severe allergic reaction after any
other vaccine injection or after you were given SPIKEVAX (original) in
the past; have a very weak or poorly functioning immune
system; have ever fainted following any needle injection; have a
bleeding disorder; have a high fever or severe infection; have
any serious illness; have anxiety related to injections.
TALK TO YOUR DOCTOR IF YOU HAVE A WEAKENED IMMUNE SYSTEM, HAVE ANY
OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES,
OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
SPIKEVAX BIVALENT ORIGINAL/OMICRON should not be given to children and
adolescents under the age of 18 years.
For more information, see Section 2. What should I know before I am
given SPIKEVAX BIVALENT ORIGINAL/OMICRON? in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor or pharmacist if you are taking any other m

Vara einkenni

SPIKEVAX BIVALENT ORIGINAL/OMICRON_PI_3.0_22Nov22
1
This vaccine is subject to additional monitoring in Australia. This
will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – SPIKEVAX BIVALENT
ORIGINAL/OMICRON (ELASOMERAN/IMELASOMERAN) COVID‐19
VACCINE
1
NAME OF THE MEDICINE
Elasomeran/imelasomeran
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CONCENTRATION
PRESENTATION
DOSE(S)
COMPOSITION
0.1 mg/mL
Multidose
vial
2.5 mL:
5 doses of
0.5 mL each
5 mL:
10 doses of
0.5 mL each
One dose (0.5 mL) contains 25 micrograms of
elasomeran, a COVID-19 mRNA Vaccine
(embedded in lipid nanoparticles), and 25
micrograms of imelasomeran, a COVID-19 mRNA
Vaccine (embedded in lipid nanoparticles).
Pre-filled
syringe
1 dose of 0.5
mL
For single
use only.
One dose (0.5 mL) contains 25 micrograms of
elasomeran, a COVID-19 mRNA Vaccine
(embedded in lipid nanoparticles) and 25
micrograms of imelasomeran, a COVID-19 mRNA
Vaccine (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.
Imelasomeran contains mRNA, 5’-capped, encoding a full-length,
codon-optimised pre-fusion
stabilised conformation variant (K983P and V984P) of the SARSCoV-2
spike (S) glycoprotein (Omicron
variant, B.1.1.529).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Suspension for injection.
White to off white suspension.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
▼
SPIKEVAX BIVALENT ORIGINAL/OMICRON_PI_3.0_22Nov22
2
SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran/imelasomeran) COVID-19
Vaccine has
PROVISIONAL APPROVAL for the indication below:
As a booster dose for active immunisation to prevent coronavirus
disease 2019 (COVID-19) caused
by SARS-CoV-2 in individuals 18 years of age a