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Generated Narrative: Bundle TEST PURPOSES ONLY - vaxzevria

Document Subject

Generated Narrative: MedicinalProductDefinition mpcde7ce8acabc194cf70fa2b3b251f6cb

identifier: http://ema.europa.eu/identifier/EU/1/21/1529/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Vaxzevria suspension for injection

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part: nan

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-cde7ce8acabc194cf70fa2b3b251f6cb

identifier: http://ema.europa.eu/identifier/EU/1/21/1529/002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - vaxzevria

Attesters

What is in this leaflet

1. What Vaxzevria is and what it is used for
2. What you need to know before you are given Vaxzevria
3. How Vaxzevria is given
4. Possible side effects
5. How to store Vaxzevria
6. Contents of the pack and other information

Vaxzevria is used for preventing COVID-19 caused by the SARS-CoV-2 virus. Vaxzevria is given to adults aged 18 years and older. The vaccine causes the immune system (the body s natural defences) to produce antibodies and specialised white blood cells that work against the virus, so giving protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19.

The vaccine must not be given:

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

If you have had a blood clot occurring at the same time as having low levels of blood platelets (thrombosis with thrombocytopenia syndrome, TTS) after receiving Vaxzevria.

If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given Vaxzevria:

If you have ever had a severe allergic reaction after any other vaccine injection or after you were given Vaxzevria in the past.

If you have ever fainted following any needle injection.

If you have a severe infection with a high temperature (over 38 C). However, you can have your vaccination if you have a mild fever or upper airway infection like a cold.

If you have a problem with bleeding or bruising, or if you are taking an anticoagulant medicine (to prevent blood clots).

If your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines).

If you previously had Guillain-Barr syndrome (temporary loss of feeling and movement) after being given Vaxzevria.

If you previously had transverse myelitis (inflammation of the spinal cord) after being given Vaxzevria.

If you have risk factors for blood clots in your veins (venous thromboembolism (VTE)). If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before you are given the vaccine. As with any vaccine, the 2-dose vaccination course of Vaxzevria may not fully protect all those who receive it. It is not known how long you will be protected for. Blood disorders Very rare blood clots in combination with low level of blood platelets, in some cases together with bleeding, has been observed following vaccination with Vaxzevria. This included some severe cases with blood clots in different or unusual locations (e.g., brain, bowel, liver, spleen) and excessive clotting or bleeding throughout the body. The majority of these cases occurred within the first three weeks following vaccination. Some cases had a fatal outcome. Fewer cases have been reported after the second dose compared to after the first dose. Blood clots in the brain, not associated with low level of blood platelets have been observed very rarely following vaccination with Vaxzevria. The majority of these cases occurred within the first four weeks following vaccination. Some cases had a fatal outcome. Blood clots in veins (venous thromboembolism (VTE)) have been observed following vaccination with Vaxzevria. Very low levels of blood platelets (immune thrombocytopenia), that can be associated with bleeding, have been reported very rarely, usually within the first four weeks following vaccination with Vaxzevria. Seek immediate medical attention if you develop shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal pain following vaccination (see section 4). Also, seek immediate medical attention if you experience after a few days following vaccination severe or persistent headaches, blurred vision, confusion or seizures (fits) after vaccination, or experience unexplained bleeding or skin bruising or pinpoint round spots beyond the site of vaccination which appears after a few days (see section 4). Capillary leak syndrome Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with Vaxzevria. Some affected patients had a previous diagnosis of CLS. CLS is a serious, potentially fatal condition causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint (low blood pressure). Seek immediate medical attention if you develop these symptoms in the days following vaccination. Neurological events Guillain-Barr syndrome (GBS): Seek immediate medical attention if you develop weakness and paralysis in the extremities that can progress to the chest and face (Guillain-Barr syndrome). This has been reported very rarely after vaccination with Vaxzevria. Inflammation of the spinal cord (transverse myelitis, TM): Seek immediate medical attention if you develop signs of weakness in the arms or legs, sensory symptoms (such as tingling, numbness, pain or loss of pain sensation) and urinary or bowel dysfunction. This has been reported very rarely after vaccination with Vaxzevria. Risk of severe adverse events after a booster dose The risk of severe adverse events (such as blood disorders including thrombosis with thrombocytopenia syndrome, VTE, CLS, GBS, TM) after a booster dose of Vaxzevria is unknown. Children and adolescents Vaxzevria is not recommended for children aged below 18 years. Currently there is not enough information available on the use of Vaxzevria in children and adolescents younger than 18 years of age. Other medicines and Vaxzevria 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 breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you receive this vaccine. Driving and using machines Some of the side effects of Vaxzevria listed in section 4 (Possible side effects) may temporarily reduce your ability to drive and use machines. If you feel unwell after vaccination, do not drive or use machines. Wait until any effects of the vaccine have worn off before you drive or use machines. Vaxzevria contains sodium and alcohol (ethanol) This medicine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, that is to say essentially sodium-free . This medicine contains 2 mg of alcohol (ethanol) per 0.5 ml dose. The small amount of alcohol in this medicine will not have any noticeable effects.

Vaxzevria is given as an injection of 0.5 ml into a muscle (usually in the upper arm). During and after each injection of the vaccine, your doctor, pharmacist or nurse will watch over you for around 15 minutes to monitor for signs of an allergic reaction. Primary vaccination course You will receive 2 injections of Vaxzevria. The second injection can be given between 4 and 12 weeks after the first injection. You will be told when you need to return for your second injection. If you miss an appointment for your second injection of Vaxzevria If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. It is important that you return for your second injection of Vaxzevria. If you miss a scheduled injection, you may not be fully protected against COVID-19. Booster dose You may receive a booster injection of Vaxzevria. The booster injection may be given at least 3 months after you have completed the primary vaccination course with Vaxzevria or an mRNA COVID-19 vaccine.

Like all medicines, this vaccine can cause side effects, although not everybody gets them. In clinical studies, most side effects were mild to moderate in nature and resolved within a few days. Fewer side effects were reported after the second dose. After vaccination, you may have more than one side effect at the same time (for example, muscle/joint aches, headaches, chills and generally feeling unwell). If any of your symptoms are persistent, please seek advice from your doctor, pharmacist or nurse. Blood clots in combination with low levels of blood platelets (thrombosis with thrombocytopenia syndrome, TTS) have been reported very rarely, see section 2. Get medical attention immediately if within three weeks of vaccination you get any of the following symptoms:

experience a severe or persistent headache, blurred vision, confusion or seizures (fits)

develop shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal pain

notice unusual skin bruising or pinpoint round spots beyond the site of vaccination Get urgent medical attention if you get symptoms of a severe allergic reaction. Such reactions may include a combination of any of the following symptoms:

feeling faint or light-headed

changes in your heartbeat

shortness of breath

wheezing

swelling of your lips, face, or throat

hives or rash

nausea or vomiting

stomach pain The following side effects may occur with Vaxzevria: Very Common (may affect more than 1 in 10 people)

tenderness, pain, warmth, itching, or bruising where the injection is given

feeling tired (fatigue) or generally feeling unwell

chills, fever or feeling feverish

headache

feeling sick (nausea)

joint pain or muscle ache Common (may affect up to 1 in 10 people)

swelling or redness where the injection is given

being sick (vomiting), diarrhoea or abdominal pain

mild and transient decreased level of blood platelets (laboratory findings)

pain in legs or arms

flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills

physical weakness or lack of energy

feeling dizzy Uncommon (may affect up to 1 in 100 people)

sleepiness or deep unresponsiveness and inactivity

decreased appetite

enlarged lymph nodes

excessive sweating, itchy skin, rash or hives

muscle spasms

unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)

decreased feeling or sensitivity, especially in the skin (hypoaesthesia)

persistent ringing in the ears (tinnitus) Rare (may affect up to 1 in 1,000 people)

one-sided facial drooping Very Rare (may affect up to 1 in 10,000 people)

blood clots often in unusual locations (e.g., brain, bowel, liver, spleen) in combination with low level of blood platelets

serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr
syndrome [GBS]) Not known (cannot be estimated from the available data)

severe allergic reaction (anaphylaxis)

hypersensitivity

rapid swelling under the skin in areas such as the face, lips, mouth and throat (which may cause difficulty in swallowing or breathing)

capillary leak syndrome (a condition causing fluid leakage from small blood vessels)

very low levels of blood platelets (immune thrombocytopenia) that can be associated with bleeding (see section 2, Blood disorders)

blood clots in the brain, not associated with low level of blood platelets (see section 2, Blood disorders)

blood clots in veins (venous thromboembolism (VTE))

inflammation of the spinal cord (transverse myelitis)

inflammation of blood vessels in the skin, often with a rash or small red or purple, flat, round spots under the skin s surface or bruising (cutaneous vasculitis) 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 in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. The following information about storage, expiry, 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. Store in a refrigerator (2 C 8 C). Do not freeze. Keep vials in outer carton in order to protect from light. From the time of vial opening (first needle puncture) use within 6 hours when stored at temperatures up to 30 C. After this time, the vial must be discarded. Do not return it to the refrigerator. Alternatively, an opened vial may be stored in a refrigerator (2 C 8 C) for a maximum of 48 hours if it is immediately returned to the refrigerator following each puncture. Discard the vial if the suspension is discoloured or particles are observed. Do not shake.

What Vaxzevria contains One dose (0.5 ml) contains: Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein ChAdOx1-S*, not less than 2.5 108 infectious units *Produced in genetically modified human embryonic kidney (HEK) 293 cells and by recombinant DNA technology. This product contains genetically modified organisms (GMOs). The other excipients are L-histidine, L-histidine hydrochloride monohydrate, magnesium chloride hexahydrate, polysorbate 80 (E 433), ethanol, sucrose, sodium chloride, disodium edetate (dihydrate), water for injections (see section 2 Vaxzevria contains sodium and alcohol ). What Vaxzevria looks like and contents of the pack Suspension for injection (injection). The suspension is colourless to slightly brown, clear to slightly opaque. 10-dose multidose vial (5 ml) with stopper (elastomeric with aluminium overseal) in a pack of 10 vials. Each vial contains 10 doses of 0.5 ml. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca Nijmegen B.V. Lagelandseweg Nijmegen, 6545CG Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 2 44 55 Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 85 808 9Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 900 200 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Other sources of information Scan the QR code with a mobile device to get this information in different languages. www.azcovid-19.com Detailed information on this medicine is available on the European Medicines Agency web site: