VAXZEVRIA (previously COVID-19 Vaccine AstraZeneca) (ChAdOx1-S) solution for injection multidose vial

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

ChAdOx1-S, Quantity: 100000000000 vp/mL

Boleh didapati daripada:

AstraZeneca Pty Ltd

Borang farmaseutikal:

Injection, solution

Komposisi:

Excipient Ingredients: histidine; magnesium chloride hexahydrate; sucrose; disodium edetate; polysorbate 80; sodium chloride; histidine hydrochloride monohydrate; ethanol absolute; water for injections

Laluan pentadbiran:

Intramuscular

Unit dalam pakej:

5mL (10 x 0.5mL dose) in 6mL, 10mL or 10R vial - 10 vials per pack

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

VAXZEVRIA has provisional approval for the indication:,Active immunisation of individuals greater than or equal to 18 years old for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.,The use of this vaccine should be in accordance with official recommendations.,The decision has been made on the basis of short term efficacy and safety data. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Ringkasan produk:

Visual Identification: Clear to slightly opaque, colourless to slightly brown, particle free solution in clear glass vial, elastomeric stopper & aluminium overseal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 9 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status kebenaran:

Registered (Provisional)

Tarikh kebenaran:

2021-02-16

Risalah maklumat

VAXZEVRIA
® (PREVIOUSLY COVID-19 VACCINE
ASTRAZENECA)
V
a
x
z
e
v
r
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a
®
This vaccine has PROVISIONAL APPROVAL in Australia to protect people
aged 18 years and older against COVID-19 disease. The
approval has been granted on the basis of short-term efficacy and
safety data. Evidence of longer term efficacy and safety from
ongoing clinical trials and vaccination in the community continues to
be gathered and assessed.
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this vaccine, speak to your healthcare provider (e.g.
doctor, nurse or pharmacist).
▼
This vaccine is new. Please report side effects. See the full CMI for
further details.
1.
WHY AM I BEING GIVEN VAXZEVRIA?
VAXZEVRIA contains the active ingredient ChAdOx1-S. This vaccine is
used to protect people aged 18 years and older against
COVID-19. For more information, see Section 1. Why am I being given
VAXZEVRIA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN VAXZEVRIA?
You should not receive VAXZEVRIA if you have ever had an allergic
reaction to VAXZEVRIA or any of the ingredients listed at the
end of the CMI, have had a major blood clot occurring at the same time
as having low levels of platelets (thrombocytopenia) after
receiving any COVID-19 vaccine or have had capillary leak syndrome (a
condition causing fluid leakage from small blood vessels).
TALK TO YOUR HEALTHCARE PROVIDER IF YOU HAVE OR HAVE HAD ANY OTHER
MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE
PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
VAXZEVRIA should not be given to children under 18 years.
For more information, see Section 2. What should I know before I am
given VAXZEVRIA? in the full CMI.
3.
WHAT IF I AM TAKING, HAVE RECENTLY TAKEN OR MIGHT TAKE OTHER MEDICINES
OR VACCINES?
Medicines (including other vaccines) that may impact whether you
should be given this vaccine or not are listed in Section 3. What if
I am taking, have recently taken or might take other medicines or
vaccines?

Ciri produk

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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
VAXZEVRIA
® (PREVIOUSLY COVID-19 VACCINE ASTRAZENECA)
(CHADOX1-S) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
ChAdOx1-S
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains 5x10
10
viral particles (vp) of ChAdOx1-S
a, b, c
.
a
Recombinant, replication-deficient chimpanzee adenovirus vector
encoding the SARS-CoV-2 Spike (S) glycoprotein (GP)
b
The vaccine is manufactured using material originally sourced from a
human embryo (Human Embryonic Kidney cells:
HEK293)
c
Corresponding to not less than 2.5 × 10
8
infectious units (Inf.U)
There are two multi-dose vial presentations:
•
8 dose: 4x10
11
vp of ChAdOx1-S in 4 mL.
•
10 dose: 5x10
11
vp of ChAdOx1-S in 5 mL.
This product contains genetically modified organisms (GMOs).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear to slightly opaque, colourless to slightly brown, particle free
with a pH of 6.1 – 7.1.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VAXZEVRIA has
PROVISIONAL APPROVAL
for the indication:
Active immunisation of individuals ≥18 years old for the prevention
of coronavirus disease 2019
(COVID-19) caused by SARS-CoV-2.
The use of this vaccine should be in accordance with official
recommendations.
The decision has been made on the basis of short term efficacy and
safety data. Continued approval
is dependent upon the evidence of longer-term efficacy and safety from
ongoing clinical trials and
post-market assessment.
▼
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4.2
DOSE AND METHOD OF ADMINISTRATION
The VAXZEVRIA primary vaccination course consists of two separate
doses of 0.5 mL each. The
second dose should be administered between 4 and 12 weeks after the
first dose (see Section 5.1
Pharmacodynamic properties).
I