Comirnaty Authentic/Omicron BA.4-5 Drug / Medication Info

Client Medication Info (CMI) abstract

Energetic components:
tozinameran and famtozinameran

This vaccine has provisional approval in Australia as a booster dose to forestall COVID-19 illness attributable to SARS-CoV-2 virus
in people 12 years of age and older. This approval has been granted on the premise
of quick time period security and efficacy information. Proof of long run efficacy and security
from ongoing medical trials and vaccination locally continues to be gathered
and assessed.

Client Medication Info (CMI)

This leaflet gives vital details about utilizing COMIRNATY Authentic/Omicron
BA.4-5. You also needs to converse to your physician or pharmacist if you need additional info
or in case you have any issues or questions on receiving COMIRNATY Authentic/Omicron
BA.4-5.

The place to seek out info on this leaflet:

COMIRNATY Authentic/Omicron BA.4-5 comprises the lively components tozinameran and
famtozinameran. COMIRNATY Authentic/Omicron BA.4-5 is an mRNA (messenger ribonucleic acid) vaccine.

COMIRNATY Authentic/Omicron BA.4-5 is a vaccine given as a booster dose to forestall
COVID-19 illness attributable to SARS-CoV-2 virus in people 12 years of age and older.

COMIRNATY Authentic/Omicron BA.4-5 is simply given as booster doses. For main vaccination,
ask your physician or pharmacist.

COMIRNATY Authentic/Omicron BA.4-5 works by triggering your immune system to supply
antibodies and blood cells that work towards the virus, to guard towards COVID-19
illness.

Warnings

COMIRNATY Authentic/Omicron BA.4-5 shouldn’t be given:

Test along with your physician in case you have:

had a extreme allergic response or respiratory issues after some other vaccine or after
being given COMIRNATY previously.

fainted following any needle injection.

a extreme sickness or an infection with excessive fever. Nevertheless, you may have your vaccination
in case you have a light fever or higher airway an infection like a chilly.

a weakened immune system, corresponding to because of HIV an infection or are on a drugs that impacts
your immune system.

a bleeding dysfunction, bruise simply or are on a blood thinning medication.

Very uncommon circumstances of myocarditis (irritation of the center muscle) and pericarditis
(irritation of the liner outdoors the center) have been reported after vaccination
with COMIRNATY. The circumstances have largely occurred inside two weeks following vaccination,
extra usually after the second vaccination, and extra usually occurred in youthful males. Following
vaccination, you have to be alert to indicators of myocarditis and pericarditis, corresponding to
breathlessness, palpitations and chest ache, and search rapid medical consideration
ought to these happen.

Chances are you’ll develop a short lived, stress-related response related to the method of
receiving your injection. This may increasingly embrace dizziness, fainting, sweating, elevated
coronary heart charge and/or nervousness. When you begin to really feel faint at any time through the course of
of receiving your injection, let your physician, nurse or pharmacist know and take actions
to keep away from falling and injuring your self, corresponding to sitting or mendacity down.

As with every vaccine, COMIRNATY Authentic/Omicron BA.4-5 could not absolutely shield all these
who obtain it, and it isn’t identified how lengthy you may be protected.

Being pregnant and breastfeeding

If you’re pregnant or breast-feeding, assume you could be pregnant or are planning to
have a child, ask your physician or pharmacist for recommendation earlier than you obtain this vaccine.

Kids and adolescents

COMIRNATY Authentic/Omicron BA.4-5 shouldn’t be given to kids beneath 12 years.

Inform your physician or pharmacist if you’re taking, have not too long ago taken or may take
some other medicines, together with any medicines, nutritional vitamins or dietary supplements that you simply purchase
with out a prescription out of your pharmacy, grocery store or well being meals store.

Inform your physician or pharmacist in case you have not too long ago obtained some other vaccine.

Test along with your physician or pharmacist if you’re undecided about what medicines, nutritional vitamins
or dietary supplements you take and if these have an effect on, or are affected by, COMIRNATY
Authentic/Omicron BA.4-5.

COMIRNATY Authentic/Omicron BA.4-5 can be given as an injection into the muscle of
your higher arm by a health care provider, nurse or pharmacist.

An preliminary dose of COMIRNATY Authentic/Omicron BA.4-5 could also be given as a booster at
least 3 months after the first vaccination for folks 12 years of age and older.

A physician, nurse or pharmacist will observe you for a minimum of quarter-hour after being
given COMIRNATY Authentic/Omicron BA.4-5.

COMIRNATY Authentic/Omicron BA.4-5 is simply given as booster doses. For main vaccination,
ask your physician or pharmacist.

Issues it’s best to know

An preliminary dose of COMIRNATY Authentic/Omicron BA.4-5 could also be given as a booster at
least 3 months after the first vaccination for folks 12 years of age and older.

COMIRNATY Authentic/Omicron BA.4-5 may be given to people 12 years of age
and older a minimum of 3 months after a earlier booster dose of any COVID 19 vaccine.

Driving or utilizing machines

Watch out earlier than you drive or use any machines or instruments till you understand how COMIRNATY
Authentic/Omicron BA.4-5 impacts you.

A number of the uncomfortable side effects of COMIRNATY Authentic/Omicron BA.4-5 could quickly have an effect on
your capability to drive or use machines.

Storage of the vaccine

A physician, nurse or pharmacist will put together the injection for you earlier than you might be given
it.

Eliminating any undesirable vaccine

A physician, nurse or pharmacist will get rid of any unused vaccine.

All medicines can have uncomfortable side effects. When you do expertise any uncomfortable side effects, most of
them are minor and momentary. Nevertheless, some uncomfortable side effects might have medical consideration.

See the knowledge beneath and, if it’s essential to, ask your physician or pharmacist in case you
have any additional questions on uncomfortable side effects.

Different uncomfortable side effects (frequency unknown)

Inform your physician or pharmacist in case you discover the rest that could be making you
really feel unwell.

Different uncomfortable side effects not listed right here could happen in some folks.

Reporting uncomfortable side effects

What COMIRNATY Authentic/Omicron BA.4-5 comprises

Don’t obtain this vaccine if you’re allergic to any of those components.

What COMIRNATY Authentic/Omicron BA.4-5 seems like

COMIRNATY Authentic/Omicron BA.4-5 is a white to off-white suspension.

COMIRNATY Authentic/Omicron BA.4-5 is offered in packs of 10 and 195 in multidose
clear glass vials with gray flip-off caps. Every dose is 0.3 mL and every vial comprises
6 doses of vaccine (2.25 mL fill).

AUST R 400874.

Not all displays could also be obtainable.

Who distributes COMIRNATY Authentic/Omicron BA.4-5

Pfizer Australia Pty Ltd

Sydney NSW

Toll Free Quantity: 1800 675 229

COMIRNATY^® is a registered trademark of BioNTech SE. Used beneath license.

This leaflet was ready in January 2023.

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