Vaccine covid-19 injection , suspension
(ChAdOx1-S [recombinant])
1. What COVID ‑ 19 Vaccine AstraZeneca is and what it is used for
COVID ‑ 19 Vaccine AstraZeneca is a vaccine used to prevent covid ‑ 19 caused by the SARS ‑ CoV virus 2 virus.
It is given to adults who are 18 years and older.
The vaccine stimulates the body’s natural defense mechanisms (the immune system). The vaccine works by causing the body to produce protection ( antibodies and specialized white blood cells ) against the virus that causes covid ‑ 19, which provides protection against covid ‑ 19. None of the ingredients in this vaccine can cause covid ‑ 19.
2. What you need to know before you are given COVID ‑ 19 AstraZeneca Vaccine
The vaccine must not be given to you:
- if you are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before giving you COVID ‑ 19 Vaccine AstraZeneca:
- if you have previously had a severe, life-threatening allergic reaction to another vaccine or if you have had an allergic reaction to the first injection one with COVID ‑ 19 Vaccine AstraZeneca;
- if you have ever fainted after a needle injection;
- if you have a high fever (above 38 ° C) or severe infection. However, you can get your vaccination if you have a mild fever or a mild upper respiratory tract infection such as a cold;
- if you have problems with bleeding or bruising easily, or if you are taking anticoagulants (to prevent blood clots);
- if your immune system is not working properly (immune deficiency) or if you are taking medicines that weaken the immune system (such as high-dose corticosteroids, so-called immunosuppressive drugs, or cancer drugs).
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist, or nurse before giving you the vaccine.
As with all vaccines, vaccination with 2 doses of COVID ‑ 19 Vaccine AstraZeneca may not protect everyone who is vaccinated. It is also not known how long the protection lasts.
There is currently limited data on the efficacy of COVID ‑ 19 Vaccine AstraZeneca in individuals 55 years of age and older.
Children and young people
COVID ‑ 19 AstraZeneca vaccine is not recommended for children under 18 years of age. There are currently insufficient data available on the use of COVID ‑ 19 Vaccine AstraZeneca in children and adolescents under 18 years of age.
Other medicines and COVID ‑ 19 Vaccine AstraZeneca
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines or vaccines.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this vaccine.
Driving and using machines
Some of the side effects of COVID ‑ 19 Vaccine AstraZeneca listed in section 4 (Possible side effects ) may temporarily impair your ability to drive and use machines. If you feel unwell after vaccination, do not drive or use machines. Wait until any side effects from the vaccine have passed before driving or using machines.
COVID ‑ 19 Vaccine AstraZeneca contains sodium and alcohol (ethanol)
This medicine contains less than 1 mmol (23 mg) sodium per dose of 0,5 ml, ie essentially ‘sodium-free’.
This medicine contains 2 mg of alcohol ( ethanol ) per dose of 0.5 ml. The low amount of alcohol in this medicine does not produce any noticeable effects.
3. How COVID ‑ 19 AstraZeneca Vaccine is given
COVID ‑ 19 Vaccine AstraZeneca is given as a 0.5 ml injection into a muscle (usually in the upper arm).
During and after each injection of the vaccine, your doctor, pharmacist or nurse will keep you under surveillance for about 15 minutes to check for signs of an allergic reaction.
You will receive 2 injections of COVID-19 Vaccine AstraZeneca. The second injection can be given between 4 and 12 weeks after the first injection. You will be informed when to return for your second injection.
When COVID ‑ 19 Vaccine AstraZeneca is given as the first injection, the second injection should also be with COVID ‑ 19 Vaccine AstraZeneca to complete the vaccination series.
If you miss a booked visit for your second injection of COVID ‑ 19 Vaccine AstraZeneca
If you miss a scheduled vaccination, ask your doctor, pharmacist, or nurse for advice. It is important that you return to receive your second injection of COVID ‑ 19 Vaccine AstraZeneca. If you miss a scheduled vaccination session, you may not be fully protected against covid ‑ 19.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them. If you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse.
Seek medical attention immediately if you experience symptoms of a severe allergic reaction. Such reactions may involve one or more of the following symptoms:
- feeling faint or dizzy
- changes in your heart rhythm
- respiratory distress
- hissing breathing
- swelling of the lips, face, or throat
- hives or skin rash
- nausea or vomiting
- abdominal pain.
The following side effects may occur with COVID ‑ 19 Vaccine AstraZeneca:
Very common (may affect more than 1 user in 10)
- tenderness, pain, warmth, itching, or bruising where the injection is given
- fatigue or general malaise
- chill or feel feverish
- headache
- nausea
- joint pain or muscle aches
Common (may affect up to 1 in 10 people)
- swelling or redness where the injection is given
- fever (> 38 ° C)
- vomiting or diarrhea
Uncommon (may affect up to 1 in 100 people)
- feel sleepy or dizzy
- decreased appetite
- enlarged lymph nodes
- excessive sweating, itchy skin, or rash
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 to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store COVID-19 Vaccine AstraZeneca
Keep this medicine out of the sight and reach of children.
A doctor, pharmacist, or nurse is responsible for storing the vaccine and for disposing of unused medicines correctly. The following information about storage, expiration date, use, and handling as well as disposal is intended for healthcare professionals.
Do not use this vaccine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C ‑ 8 ° C).
Do not freeze.
Store the vials in the outer carton. Sensitive to light.
From the time of opening the vial (first needle puncture) to administration, the vial can be stored for a maximum of 48 hours in a refrigerator (2 ° C – 8 ° C). Within this time period, the product can be stored and used at temperatures up to 30 ºC for up to 6 hours during a continuous period. After this time, the product should be discarded. Do not put it back in the refrigerator.
Discard the vial if the suspension is discolored or contains visible particles. Do not shake.
COVID-19 Vaccine AstraZeneca genetically modified organism’s (GMO). Any unused vaccine or waste material should be disposed of in accordance with local requirements for genetically modified organisms or biological hazardous waste. Spills should be disinfected with antiviral agents that are effective against adenovirus.
6. Contents of the packaging and other information
Content declaration
One dose (0.5 ml) contains:
Chimpanzee adenovirus encoding SARS-CoV-2 spike glycoprotein and ChAdOx1 ‑ S *, at least 2.5 × 10 8 infectious devices
* Produced in genetically modified human embryonic kidney cells (HEK 293 ‑ cells) and by recombinant DNA technology.
This product contains genetically modified organisms (GMOs).
The other ingredients are L ‑ histidine, L ‑ histidine hydrochloride monohydrate, magnesium chloride hexahydrate, Polysorbate 80 (E 433), sucrose, disodium edetate (dihydrate), water for injections (see section 2 “COVID-19 Vaccine AstraZeneca” contains sodium ).
What the medicine looks like and the contents of the pack
Injection, suspension ( for injection ). Suspension one is colorless to light brown, clear to slightly opaque.
Pack sizes:
- Multi-dose vial of 8 doses (4 ml) with stopper (elastomer with aluminum seal) in a pack of 10 vials. Each vial contains 8 doses of 0.5 ml.
- Multi-dose vial of 10 doses (5 ml) with a stopper (elastomer with aluminum seal) in a pack of 10 vials. Each vial contains 10 doses of 0.5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Manufacturer
MedImmune Pharma BV, Nijmegen
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 808 53 06 | LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2141423 |
| BulgariaAstrology Bulgaria BODYTel: +359 (2) 90 60 798 | Luxembourg / LuxemburgAstraZeneca SA / NVTel: +352 2 7863166 |
| Czech RepublicAstraZeneca Czech Republic sroTel: +420 228 882 054 | HungaryAstraZeneca Kft.Tel .: +3680 180 007 |
| DenmarkAstraZeneca A / STel: +45 89 87 04 78 | MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8134 |
| GermanyAstraZeneca GmbHTel: 0800 22 88 660 (free of charge) | The NetherlandsAstraZeneca BVTel: 0800 70 11 (free)+31 79 363 2222 |
| EestiAstraZenecaTel: +372 6549 600 | NorwayAstraZeneca ASTel: +47 23 96 23 13 |
| GreeceAstraZeneca AE:Ηλ: +30 211 1983792 | AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0 |
| SpainAstraZeneca Pharmacéutica Spain, SATel: +34 93 220 20 14 | PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 104 60 80 |
| FranceAstraZenecaTel: 0 800 08 92 44 (green number) | PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 30 880 17 68 |
| CroatiaAstraZeneca dooTel: +385 1 4628 000 | RomaniaAstraZeneca Pharma SRLTel: +40 31 630 03 18 |
| IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: 1800 812456 (toll-free) | SloveniaAstraZeneca UK LimitedTel: +386 1 60 03 197 |
| IcelandVistor hf.Phone: +354 519 3643 | Slovak RepublicAstraZeneca AB, ozTel: +421 2 3321 5491 |
| ItalyAstraZeneca SpATel: +39 02 9801 4221 | Finland / FinlandAstraZeneca OyPuh / Tel: +358 94 24 55072 |
| ΚύπροςΦλ .κτωρ Φαρµακετική ήτδ:Ηλ: +357 22090050 | AstraZeneca ABTel: +46 3 130 11 892 |
| LatviaSIA AstraZeneca LatvijaTel: +371 68688132 | United Kingdom (Northern Ireland)AstraZeneca UK LtdTel: +44 8000 541 028 |