Vaxzevria

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/04/21

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Summary of Product Characteristics last updated on medicines.ie: 9/4/2021
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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Medicine Name Faslodex Active Ingredients Fulvestrant
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1 - 0 of 47 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 9 April 2021 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 9 April 2021 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 31 March 2021 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Change in the Nijmegen legal entity from MedImmune to AstraZeneca

6.       Contents of the pack and other information

[...]

Manufacturer

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

Lagelandseweg 78

Nijmegen, 6545CG

Netherlands

Updated on 29 March 2021 SPC

Reasons for updating

  • Change to product name

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Updated on 29 March 2021 PIL

Reasons for updating

  • Change of trade or active ingredient name

Free text change information supplied by the pharmaceutical company

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

Updated on 19 March 2021 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Inserted text - green

4.4 Special warnings and precautions for use

.....

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.

.....

10. DATE OF REVISION OF THE TEXT

19 March 2021

Updated on 19 March 2021 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Inserted text - green

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

....

Warnings and precautions

....

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.

Updated on 5 February 2021 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 February 2021 PIL

Reasons for updating

  • New PIL for new product