Comirnaty should not be given<\/h2>\n\n\n\n- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before giving the vaccine if:<\/p>\n\n\n\n
- you have ever had a severe allergic reaction or breathing problems after other vaccine injections or after you have received Comirnaty before<\/li>
- you have ever fainted after a needle injection<\/li>
- you have a serious illness or infection with a high fever. However, it is possible to get the vaccine if you have a mild fever or a mild upper respiratory tract infection such as a cold.<\/li>
- you have a bleeding disorder, easily get bruises, or use medicines for blood clots<\/li>
- you have a weakened immune system, due to a disease such as. HIV or using drugs such as corticosteroids that affect the immune system.<\/li><\/ul>\n\n\n\n
Like all vaccines, the 2- dose vaccination series Comirnaty may not provide full protection to all people who receive it and it is not known how long the protection will last.
<\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Comirnaty is not recommended for children under 16 years of age.
<\/p>\n\n\n\n
Other medicines and Comirnaty<\/h2>\n\n\n\n
Tell your doctor or nurse if you are taking, have recently taken, or might take any other vaccines.
<\/p>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Some of the side effects of the vaccination mentioned in section 4 (Possible side effects ) may temporarily affect the ability to drive and use machines. Wait until these effects have disappeared before driving or using machines.
<\/p>\n\n\n\n
Comirnaty contains potassium and sodium<\/h2>\n\n\n\n
This vaccine contains less than 1 mmol (39 mg) potassium per dose, ie essentially ‘potassium’. is almost “potassium-free”.
<\/p>\n\n\n\n
This vaccine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
<\/p>\n\n\n\n
3. How to get Comirnaty<\/h2>\n\n\n\n
Comirnaty is given after dilution as an injection of 0.3 ml into a muscle in the upper arm.
<\/p>\n\n\n\n
You will receive 2 injections.
<\/p>\n\n\n\n
It is recommended that you receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination series.
<\/p>\n\n\n\n
If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist, or nurse.
<\/p>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
Like all vaccines, Comirnaty can cause side effects, although not everybody gets them.
<\/p>\n\n\n\n
Very common side effects:<\/strong> may affect more than 1 in 10 people<\/p>\n\n\n\n- at the injection site: pain, swelling<\/li>
- fatigue<\/li>
- headache<\/li>
- muscle aches<\/li>
- joint pain<\/li>
- chills, fever<\/li><\/ul>\n\n\n\n
Common side effects:<\/strong> may affect up to 1 in 10 people<\/p>\n\n\n\n- redness at the injection site<\/li>
- nausea<\/li><\/ul>\n\n\n\n
Uncommon side effects:<\/strong> may affect up to 1 in 100 people<\/p>\n\n\n\n- enlarged lymph nodes<\/li>
- feeling sick<\/li>
- pain in arms or legs<\/li>
- insomnia<\/li>
- itching at the injection site<\/li><\/ul>\n\n\n\n
Rare side effects:<\/strong> may affect up to 1 in 1,000 people<\/p>\n\n\n\n- temporary unilateral facial paralysis<\/li><\/ul>\n\n\n\n
Has been reported<\/strong> (occurs in an unknown number of users)<\/p>\n\n\n\n- severe allergic reaction<\/li><\/ul>\n\n\n\n
<\/p>\n\n\n\n
Reporting of side effects<\/em><\/p>\n\n\n\nIf 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address<\/p>\n\n\n\n
5. How to store Comirnaty<\/h2>\n\n\n\n
Keep this medicine out of the sight and reach of children.
<\/p>\n\n\n\n
The following information about storage, expiration date, and use and handling is intended for healthcare professionals.
<\/p>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
<\/p>\n\n\n\n
The store is frozen at -90 \u00b0 C to -60 \u00b0 C.
<\/p>\n\n\n\n
Store in the original package. Sensitive to light.
<\/p>\n\n\n\n
After thawing, the vaccine should be diluted and used immediately. However, post-opening stability data have shown that undiluted vaccine taken out of the freezer can be stored before use for up to 5 days at 2-8 \u00b0 C, and up to 2 hours at temperatures up to 30 \u00b0 C.
<\/p>\n\n\n\n
After dilution, store the vaccine at 2-30 \u00b0 C and use it within 6 hours. Discard any unused vaccine.
<\/p>\n\n\n\n
Vials taken out of the freezer and diluted should be marked with a new date\/time of disposal. After thawing, the vaccine cannot be re-frozen.
<\/p>\n\n\n\n
Do not use if the vaccine contains particles or is discolored.
<\/p>\n\n\n\n
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
<\/p>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before giving the vaccine if:<\/p>\n\n\n\n
- you have ever had a severe allergic reaction or breathing problems after other vaccine injections or after you have received Comirnaty before<\/li>
- you have ever fainted after a needle injection<\/li>
- you have a serious illness or infection with a high fever. However, it is possible to get the vaccine if you have a mild fever or a mild upper respiratory tract infection such as a cold.<\/li>
- you have a bleeding disorder, easily get bruises, or use medicines for blood clots<\/li>
- you have a weakened immune system, due to a disease such as. HIV or using drugs such as corticosteroids that affect the immune system.<\/li><\/ul>\n\n\n\n
Like all vaccines, the 2- dose vaccination series Comirnaty may not provide full protection to all people who receive it and it is not known how long the protection will last.
<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Comirnaty is not recommended for children under 16 years of age.
<\/p>\n\n\n\nOther medicines and Comirnaty<\/h2>\n\n\n\n
Tell your doctor or nurse if you are taking, have recently taken, or might take any other vaccines.
<\/p>\n\n\n\nPregnancy and breastfeeding<\/h2>\n\n\n\n
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Some of the side effects of the vaccination mentioned in section 4 (Possible side effects ) may temporarily affect the ability to drive and use machines. Wait until these effects have disappeared before driving or using machines.
<\/p>\n\n\n\nComirnaty contains potassium and sodium<\/h2>\n\n\n\n
This vaccine contains less than 1 mmol (39 mg) potassium per dose, ie essentially ‘potassium’. is almost “potassium-free”.
<\/p>\n\n\n\nThis vaccine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
<\/p>\n\n\n\n3. How to get Comirnaty<\/h2>\n\n\n\n
Comirnaty is given after dilution as an injection of 0.3 ml into a muscle in the upper arm.
<\/p>\n\n\n\nYou will receive 2 injections.
<\/p>\n\n\n\nIt is recommended that you receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination series.
<\/p>\n\n\n\nIf you have any further questions on the use of Comirnaty, ask your doctor, pharmacist, or nurse.
<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
Like all vaccines, Comirnaty can cause side effects, although not everybody gets them.
<\/p>\n\n\n\nVery common side effects:<\/strong> may affect more than 1 in 10 people<\/p>\n\n\n\n
- at the injection site: pain, swelling<\/li>
- fatigue<\/li>
- headache<\/li>
- muscle aches<\/li>
- joint pain<\/li>
- chills, fever<\/li><\/ul>\n\n\n\n
Common side effects:<\/strong> may affect up to 1 in 10 people<\/p>\n\n\n\n
- redness at the injection site<\/li>
- nausea<\/li><\/ul>\n\n\n\n
Uncommon side effects:<\/strong> may affect up to 1 in 100 people<\/p>\n\n\n\n
- enlarged lymph nodes<\/li>
- feeling sick<\/li>
- pain in arms or legs<\/li>
- insomnia<\/li>
- itching at the injection site<\/li><\/ul>\n\n\n\n
Rare side effects:<\/strong> may affect up to 1 in 1,000 people<\/p>\n\n\n\n
- temporary unilateral facial paralysis<\/li><\/ul>\n\n\n\n
Has been reported<\/strong> (occurs in an unknown number of users)<\/p>\n\n\n\n
- severe allergic reaction<\/li><\/ul>\n\n\n\n
<\/p>\n\n\n\n
Reporting of side effects<\/em><\/p>\n\n\n\n
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address<\/p>\n\n\n\n
5. How to store Comirnaty<\/h2>\n\n\n\n
Keep this medicine out of the sight and reach of children.
<\/p>\n\n\n\nThe following information about storage, expiration date, and use and handling is intended for healthcare professionals.
<\/p>\n\n\n\nDo not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
<\/p>\n\n\n\nThe store is frozen at -90 \u00b0 C to -60 \u00b0 C.
<\/p>\n\n\n\nStore in the original package. Sensitive to light.
<\/p>\n\n\n\nAfter thawing, the vaccine should be diluted and used immediately. However, post-opening stability data have shown that undiluted vaccine taken out of the freezer can be stored before use for up to 5 days at 2-8 \u00b0 C, and up to 2 hours at temperatures up to 30 \u00b0 C.
<\/p>\n\n\n\nAfter dilution, store the vaccine at 2-30 \u00b0 C and use it within 6 hours. Discard any unused vaccine.
<\/p>\n\n\n\nVials taken out of the freezer and diluted should be marked with a new date\/time of disposal. After thawing, the vaccine cannot be re-frozen.
<\/p>\n\n\n\nDo not use if the vaccine contains particles or is discolored.
<\/p>\n\n\n\nMedicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
- severe allergic reaction<\/li><\/ul>\n\n\n\n
- temporary unilateral facial paralysis<\/li><\/ul>\n\n\n\n