Lokelma 10 g powder for oral suspension * Pharmacy Only: Prescription
Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)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 25 July 2022
File name
62de7b5997188.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 4.5 Interaction with other medicinal products and other forms of interaction - section on interaction of Lokelma with tacrolimus added:
In another drug-drug interaction study in healthy volunteers, co-administration of Lokelma 15 g with tacrolimus 5 mg resulted in a decreased tacrolimus AUC and Cmax by 37% and 29% respectively.
Therefore, tacrolimus should be taken at least 2 hours before or after Lokelma. In the same study, co-administration of Lokelma and cyclosporin did not show a clinically meaningful interaction.
Update to section 10. Date of revision of the text : revision date updated to 21 July 2022.
Updated on 25 July 2022
File name
62de781abd97e.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to section 2. What you need to know before you take Lokelma - Other medicines and Lokelma :
Also, tell your doctor or nurse if you are taking any of the following:
- tacrolimus (medicines used to suppress your body’s immune system to prevent organ transplant rejection)
Update to section 6. Contents of the pack and other information - revision date updated to 07/2022
Updated on 26 January 2021
File name
20210121 SPC IE Lokelma 5g 10g CMC Var CV 21 0003_1611680366.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 January 2021
File name
20210121 Package Leaflet IE Lokelma 5g 10g CMC Var 21 0004_1611680222.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 29 May 2020
File name
20200428 SPC IE Lokelma 5g 10g DIALIZE CV 20 0024_1590745876.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 May 2020
File name
20200428 SPC IE Lokelma 5g 10g DIALIZE CV 20 0024_1590744162.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 May 2020
File name
20200428 SPC IE Lokelma 5g 10g DIALIZE CV 20 0024_1590698559.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 May 2020
File name
20200428 Package Leaflet IE Lokelma 5g 10g DIALIZE CV 20 0025_1590698054.pdf
Reasons for updating
- New PIL for new product