Lamzede 10 mg powder for solution for infusion
*Company:
Chiesi LimitedStatus:
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 18 January 2023
File name
Lamzede EU_SmPC - CS0100-5.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 January 2023
File name
Lamzede PIL EU + GB_CP0064-6.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 21 September 2022
File name
OM Lamzede 01.07.2022.pdf
Reasons for updating
- Add New Doc
Updated on 07 September 2022
File name
Lamzede EU_SmPC - CS0100-4.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
Infusion of Lamzede at home may be considered for patients who are tolerating their infusions well. The decision to have a patient move to home infusion should be made after evaluation and recommendation by the treating physician. Patients experiencing infusion-related reactions, including hypersensitivity reactions or anaphylactic reactions, during the home infusion need to immediately reduce the infusion rate or to stop the infusion process considering the severity of the reaction and seek the attention of a healthcare professional. Dose and infusion rate in home setting should remain the same used in the hospital setting; they could be changed only under the supervision of a healthcare professional and treating physician.
Appropriate training should be given by the treating physician and/or nurse to the patient and/or caregiver prior to initiation of home infusion
Updated on 07 September 2022
File name
Lamzede PIL EU + GB_CP0064-5.pdf
Reasons for updating
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Lamzede is only used under the supervision of a doctor who is knowledgeable in the treatment of Alpha Mannosidosis disease. Your doctor may advice that you can be treated at home provided you meet certain criteria. Please contact your doctor if you would like to be treated at home.
Updated on 08 November 2021
File name
Lamzede PIL CP0064-3.pdf
Reasons for updating
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 08 November 2021
File name
Lamzede EU_SmPC - CS0100-3.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 September 2021
File name
Lamzede EU PIL CP0064-2.pdf
Reasons for updating
- New PIL for new product
Updated on 01 September 2021
File name
Lamzede EU CS0100-2.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)