EVUSHELD 150 mg + 150 mg solution for injection
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 10 November 2023
File name
20231012 SPC IE MT Evusheld Stormchaser Provent Tackle INF 23 0022.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 October 2023
File name
20230927 Package Leaflet IE MT Evusheld AZ AB Postcode INF 23 0021.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Manufacturer
AstraZeneca AB
Gärtunavägen,
Södertälje, 151 85SE-152 57 Södertälje,
Sweden
Updated on 25 August 2023
File name
20230824 Package Leaflet IE MT Evusheld PBRER PRAC INF 23 0017.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
2. What you need to know before you are given EVUSHELD
(...)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given EVUSHELD
· if you have low numbers of blood platelets (which help blood clotting), any blood clotting problems or are taking a medicine to prevent blood clots (an anticoagulant).
· if you have ever had a severe allergic reaction or breathing problems after you were given EVUSHELD in the past.
Tell a doctor, pharmacist or nurse or get medical help immediately:
· if you notice any symptoms of a cardiac event, such as:
o chest pain;
o shortness of breath;
o a general feeling of discomfort, illness, or lack of well-being;
o feeling lightheaded or faint.
· if you notice any signs of a serioussevere allergic reaction, such as:
o difficulty breathing or swallowing;
o swelling of the face, lips, tongue or throat;
o severe itching of the skin, with a red rash or raised bumps.
4. Possible side effects
(...)
Rare (may affect up to 1 in 1000 people)
· sudden, severe allergic reaction with breathing difficulty, swelling, light headedness, fast heartbeat, sweating and loss of consciousness (anaphylaxis)
Updated on 25 August 2023
File name
20230824 SPC IE MT Evusheld PBRER PRAC INF 23 0016.pdf
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)
Free text change information supplied by the pharmaceutical company
Section 4.4
(..)
Hypersensitivity including anaphylaxis
Serious hypersensitivity reactions, including anaphylaxis, have been observed with monoclonal antibodies.reported following administration of EVUSHELD (see section 4.8). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medicinal products and/or supportive therapy.
Section 4.8
(...)
Anaphylaxis added to table 2 as rare adverse reaction
Updated on 06 April 2023
File name
20230330 SPC IE MT NI 24M shelf life INF 23 0008.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
6.3 Shelf life
Unopened vial
18 months 2 years
10. DATE OF REVISION OF THE TEXT
16th September 2022 30 March 2023
Updated on 23 September 2022
File name
20220916 PIL IE MT Evusheld Mild to Moderate INF 22 0018 No MIL.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for a new product.
Updated on 23 September 2022
File name
20220916 SPC IE MT Evusheld Mild to Moderate INF 22 0017.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New SmPC for a new product.