CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 mRNA VACCİNE ( NUCLEOSIDE MODIFIED)


This medicine is subject to additional. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.

. Keep this leaflet. You may need to read it again.

. If you have any further questions, aş your doctor, pharmacist or nurse.

. If you get any side effects, talk to your doctor, pharmaticst or nurse.

. If you get any side effects, talk to your doctor, pharmaticst or nurse. This includes any possible side effects not listes in this leaflet. See section 4.

What is in this leaflet

. What Comirnaty iş and what it iş user for

. What you need to know before you receive Comirnaty

. How comirnaty is given

. Possible side effects

. How to store Comirnaty

. Contents of the pack and other information

WHAT COMIRNATY IŞ AND WHAT IT IS USED FOR

Comirnaty iş a vaccine user for preventing Covid-19 caused by SARS-COV-2 virus.

Comirnaty iş given to adults and adolescents from 16 years of age and older.

The vaccine causes the ilmine system ( the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.

As comirnaty does not contain the virus to produce immunity, it cannot give you COVID-19.

WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE COMIRNATY

Comirnaty should not be given

. If you are allergic to the active substance or any of the other ingredients of this medicine ( listed in section 6.)

Warnings and precautions

Talk to your doctor, pharmaticst or nurse before you are given the vaccine if:

. You have ever had a şecere allergic reaction ör breathing problems after any other vaccine injection or after you were given comirnaty in the past.

. You have ever fainted following any needle injection.

. You have a şecere illness ör infection with high fever. However, you can have your vaccination if you have a mold fever or upper airway infection like a cold.

. You have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots.

. You have a weakened immune system, becauce of a disease such aş HIV infection or a medicine such aş corticosteroid that affects your immune system.

As with any vaccine, the 2 dose vaccination course of Comirnaty may not fully protect all this who receive it and it is not known how long you will be protected.

Children and Adolescents

Comirnaty is not recommended for children aged under 16 years.

Other Medicines and Comirnaty

Tell your doctor or pharmaticst if you are using, have recently user or might use any other medicines or have recently receiver any other vaccine.

Pregnancy and Breast-feeding

If you are pregnant or Breast-feeding, think you mat be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine.

Driving and Using Machines

Some of the effects of vaccination mentioned in section 4 (possible side effects ) may temporarily affect your ability to drive or use machines. Wait until these affects have worn off before you drive or use machines.

Comirnaty Contains Potassium and Sodium

This vaccine contains less than 1 mmol potassium ( 39 mg ) per dose, that is to say essentially ‘potassium-free’.

This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’

How Comirnaty Is Given

Comirnaty is given after dilution as an injection 0.3 mL into a muscle of your upper arm.

You will receive 2 injections.

It is recommended to receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination course. If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse.

Possible Side Effects

Like all vaccines, Comirnaty can cause side effects, although not everybody gets them.

Very common side effects: may affects more than 1 in 10 people

. Injection site: pain, swelling

. Tiredness

. Headache

. Muscle pain

. Chills

. Joint pain

. Diarrhoea

. Fever

Common side effects: may affects up to 1 in 1 people

. Injection site redness

. Nausea

. Vomiting

Uncommon side effects: may affects up to 1 in 100 people

. Enlarged lymph nodes

. Feeling umwell

. Arm pain

. Insomnia

. Injection site itching

. Allergic reactions suc as rash or itching

Rate side effects: may affects up to 1 in 100 people

. Temporary one sided facial drooping.

. Allergic reactions such as hives or swelling of the face

Not known (cannot be estimated from the available data)

. Severe allergic reaction

Reporting of Side Effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below and include batch/lot number if available. By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE COMIRNATY

Keep this medicine out of the sight and reach of children.

The following information about storage, expiry and use and handling is intended for healtcare professionals.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Store in freezer at -90 C to -60 C. Within the 6 months shelf-life unopened vials may be stored and transported at -25 C to -15 C for a single period of up to 2 weeks and can be returned to -90 C to -60 C.

Store in the original package in order to protect from light.

Transfers of frozen vials stored at ultra-low temparature ( < -60 C )

Closed-lid vial trays containing 195 vials removed from ultra-low temparature frozen storage (< -60 C) may be at temparature up to 25 C for up to 5 minutes.

Open-air vial trays, or vial trays containing less than 195 vials, removed from ultra-low temparature frozen storage ( < -60 C) may be at temparatures up to 25 C for up to 3 minutes.

After vial trays are returned to frozen storage following temparature exposure up to 25 C, they must remain in frozen storage for at least 2 hours before they can be removed again.

Transfer of frozen vials stored at -25 C to -15 C

Closed-lid vial trays containing 195 vials removed from frozen storage ( -25 C to -15 C) may be a temparatures up to 25 C for up to 3 minutes.

Open-lid vial trays, or vial trays containing less than 195 vials, removed from frozen storage (-25 C to -15 C ) may be at temparatures up to 25 C for up to 1 minute.

Önce a vial is removed from the vial tray, it should be thawed for use.

After thawing, the vaccine should be diluted and used immediately. However, in use stability data have demonstrated that once removed from freezer, the undiluted vaccine can be stored for up to 5 days at 2 C to 8 C. Within the 5 days shelf-life at 2 C to 8 , up to 12 hours may be used for transportation. Prior to use, the unopened vaccine can be stored for up to 2 hours at temparatures up to 30 C.

After dilution, store and transport the vaccine at 2 C to 30 C and use within 6 hours. Discard any unused vaccine.

Once removed from the freezer and diluted, the vials should be marked with the new discard date and time. Once thawed, the vaccine cannot be re-frozen.

Do not use this vaccine if you notice particulates in the dilution or discolouration.

Do not throw away any medicines via wastewater or household waste. Aşk your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Handling Instructions

Comirnaty should be prepared by a health-care professional using aseptic technique to ensure the sterility of the prepared dispersion.

THAWING PRIOR TO DILUTION

The multidose vial is stored frozen and must be thawed prior to dilution. Frozen vials should be transferred to an environment of 2 C to 8 C to thaw, a 195 vial pack may take 3 hours to thaw. Alternatively, frozen vials may also be thawed for mo minutes at temparatures up to 30 C for immediate use.

The unopened vial can be stored for up to 5 days at 2 C to 8 C. Within the 5 days shelf-life at 2 C to 8 C, up to 12 hours may be used for transportation.

Allow the thawed vial to come to room temparature and gently invert it 10 times prior to dilution. Do not shake.

Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.

DILUTION

The thawed vaccine must be diluted in its original vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.

Equalise vial pressure before removing the needle from the vial stopper bu withdrawing 1.8 mL air into the empty diluent syringe.

Gently invert the diluted dispersion 10 times. Do not shake.

The diluted vaccine should present as an off-white dispersion with no particulates visible. Do not use the diluted vaccine ıf particulates or discolouration are present.

The diluted vials should be marked with the appropriate date and time.

After dilution, store at 2 C to 30 C and use within 6 hours, including any transportation time. Do not freeze or shake the diluted dispersion. If refrigareted, allow the diluted dispersion to come to room temparature prior to use.

PREPARATION OF INDIVIDUAL 0.3 ML DOSES OF COMIRNATY

After dilution vial contains 2.25 mL from which 6 doses of 0.3 mL can be extracted.

Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.

Withdraw 0.3 mL of comirnaty.

Low dead-volume syringes and/ör needles should be used in order to extract 6 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.

If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.

Each dose must contain 0.3 mL of vaccine. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.

Discard any unused vaccine within 6 hours after dilution.

DISPOSAL

Any unused medicinal product or waste meterial should be disposed of in accordance with local requirements.

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