Cuvitru 200 mg/ml solution for subcutaneous injection
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 February 2024
File name
ie-spc-cuvitru-feb24-clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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
Update to include the secondary immunodeficiency indication
Updated on 21 February 2024
File name
ie-pl-cuvitru-feb24-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to include the secondary immunodeficiency indication
Updated on 21 February 2024
File name
ie-pl-cuvitru-feb24-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to include the secondary immunodeficiency indication
Updated on 02 February 2024
File name
ie-pl-cuvitru-manual push-jan24-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Section 3 how to use Cuvitru, method and route of administration, detailed instructions for use
Updated on 02 February 2024
File name
ie-spc-cuvitru-manual push-Jan24-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Addition of the following content in 4.2 Posology and method of administration:
Infusion rate
Cuvitru can be infused using:
· an infusion device, or
· by manual administration using a syringe.
The recommended initial infusion rate depends on the individual patient’s needs. An increase in the infusion rate of successive infusions may be considered at the discretion of the patient and based on the healthcare professionals’ judgement.
Manual administration infusion:
Cuvitru may be administered using a syringe at a single infusion site. If administration at additional sites is required, a new sterile injection needle should be used.
The proposed maximum infusion rate is approximately 1-2 ml per minute.
The rate of administration should be adjusted for each patient’s local tolerance which may depend on the site of each subcutaneous injection and the amount of the individual patient’s subcutaneous tissue at that site.
The amount of product infused into a particular site varies. In infants and children, infusion site may be changed every 5-15 ml. In adults doses over 30 ml may be divided according to patient preference.
Addition of the following content in 4.4 Special warnings and precautions for use:
An increase in the number and the severity of adverse events may occur when patients begin manual administration. As a consequence, patients considered for manual administration should be medically stable and adequately trained on the recognition and measures to be taken in case of severe adverse reactions.
Amendment of date of revision
Updated on 29 September 2021
File name
ie-pl-cuvitru-Renewal-17.09.2021.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
- Improved presentation of PIL
Updated on 29 September 2021
File name
ie-spc-cuvitru-Renewal-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Removal of a black triangle; addition of information regarding traceability; minor update to terminology.
Updated on 20 April 2021
File name
ie-pl-cuvitru-TII-027-clean.pdf
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 20 April 2021
File name
ie-pl-cuvitru-TII-027-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 20 April 2021
File name
ie-pl-cuvitru-TII-027-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 20 April 2021
File name
ie-spc-cuvitru-TII-027-clean.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 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
The following changes have been made to the SmPC:
|
Description of change |
Changes (in red) |
|||||||||
|
4.4 Special warnings and precautions for use
4.8 Undesirable effects
|
Aseptic Meningitis Syndrome (AMS)
Aseptic meningitis syndrome (AMS) has been reported to occur in association with immune globulin treatments, including Cuvitru (see section 4.8 Undesirable Effects – Postmarketing). AMS may occur more frequently in female patientsTable 1: Frequency of Adverse Reactions (ADRs) in clinical studies with Cuvitru Table 2: Post-Marketing Adverse Reactions (ARs)
|
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10. Date of revision of the text |
April 2021 |
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Updated on 28 May 2020
File name
ie-spc-cuvitru-TIAIN-022-15may20-clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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 28 May 2020
File name
uk-ie-pl-cuvitru-TIAIN-022-may20-clean.pdf
Reasons for updating
- Introduction of new pack/pack size
- Change to date of revision
Updated on 03 December 2019
File name
ie-pl-cuvitru-clean-Jul-19.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
The pack size has changed and not all pack sizes may be marketed now
Updated on 03 December 2019
File name
ie-spc-cuvitru-clean-Oct-19.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change in pack size
Updated on 29 May 2019
File name
ie-pil-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
Updated on 29 May 2019
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2 (QUALITATIVE AND QUANTITATIVE COMPOSITION): To inclue 50 ml/ 10g
Section 6.5 (Nature and contents of container): to include 50ml to the pack size list
Updated on 15 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 August 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In Section 4.2 (posology and method of administration) an update to the "method of administration" has been made that the infusion of Cuvitru must be started immediately upon transfer into the syringe to prevent particulate formation including what to do if an administration shorter than 2 hours is not possible.
- In section 4.4 (special warnings and precautions for use) a warning regarding particulate formation if Cuvitru remains in a siliconized syringe for more than 2 hours has been added.
- Accordingly, the date of revision (section 10) has been updated.
Updated on 08 August 2017
File name
PIL_17078_156.pdf
Reasons for updating
- New PIL for new product
Updated on 08 August 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 28 April 2017
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 February 2017
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
Updated on 08 February 2017
Reasons for updating
- New PIL for new product