Change in the Nijmegen legal entity from MedImmune to AstraZeneca

6.       Contents of the pack and other information

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Manufacturer

MedImmune Pharma B.V., NijmegenAstraZeneca Nijmegen B.V.

Lagelandseweg 78

Nijmegen, 6545CG

Netherlands

Change in the brand name from Covid-19 Vaccine AstraZeneca to Vaxzevria.

Change in the brand name of the product from COVID-19 Vaccine AstraZeneca to Vaxzevria.

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4.4 Special warnings and precautions for use

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Thrombocytopenia and coagulation disorders

A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. This includes severe cases presenting as venous thrombosis, including unusual sites such as cerebral venous sinus thrombosis, mesenteric vein thrombosis, as well as arterial thrombosis, concomitant with thrombocytopenia. The majority of these cases occurred within the first seven to fourteen days following vaccination and occurred in women under 55 years of age, however this may reflect the increased use of the vaccine in this population. Some cases had a fatal outcome.

Healthcare professionals should be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia. Those vaccinated should be instructed to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain following vaccination. Additionally, anyone with neurological symptoms including severe or persistent headaches or blurred vision after vaccination, or who experiences skin bruising (petechia) beyond the site of vaccination after a few days, should seek prompt medical attention.

Risk of bleeding with intramuscular administration

As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

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10. DATE OF REVISION OF THE TEXT

19 March 2021

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2. What you need to know before you are given COVID-19 Vaccine AstraZeneca

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Warnings and precautions

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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.

Blood disorders

A combination of blood clots and low level of platelets, in some cases together with bleeding, has been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. The majority of these cases occurred within the first seven to fourteen days following vaccination and mostly occurred in women under 55 years of age, however more women under 55 received the vaccine than other people. Some cases had a fatal outcome.

Seek immediate medical attention if you develop shortness of breath, chest pain, leg swelling, or persistent abdominal pain following vaccination.

Also, seek immediate medical attention if you experience after a few days severe or persistent headaches or blurred vision after vaccination, or experience skin bruising or pinpoint round spots beyond the site of vaccination which appears after a few days.