Revestive 5 mg powder and solvent for solution for injection
*Company:
Takeda Products Ireland LtdStatus:
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 12 July 2024
File name
Revestive 5 mg IRELAND SPC - clean CCDS8 - July04.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)
Updated on 12 July 2024
File name
Revestive 5 mg IRELAND SPC - clean CCDS8 - July04.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)
Updated on 12 July 2023
File name
Revestive 5 mg joint Ireland and N.Ireland PIL - clean - age extension.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
change of indicated patient age from 1 year to 4 months+.
Administration changes in section 5.
Change to date of revision.
Updated on 12 July 2023
File name
Revestive 5 mg IRELAND SPC - clean - age extension.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 7 - Marketing authorisation holder
- 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
Section 4.1: change of indicated patient age from 1 year to 4 months+
Section 4.2: updates to reflect the paediatric population of >4 months
Section 4.8: added the clinical study data in paediatric subjects
Section 5.1: added the clinical study data in patients aged 4 months to <12 months and between 1 and 17 years
Section 5.2: updates on the data for paediatric population aged 4 months to 17 years
Section 6 (6.3 and 6.4): administrative changes
Section 7: added the medical information email address
Section 10: updates to date of revision
Updated on 07 March 2023
File name
Revestive 5 mg IRELAND SPC -clean Feb 23.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 07 March 2023
File name
Revestive 5 mg joint Ireland and N.Ireland PIL-clean Feb 23 .pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 August 2022
File name
Revestive 5 mg Joint N. Ireland and Ireland PIL clean Aug 22.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 25 May 2022
File name
Revestive 5 mg IRELAND SPC -clean-May22.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 25 May 2022
File name
Revestive 5 mg joint Ireland and N.Ireland PIL-clean-MAT-May22.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 04 January 2022
File name
Revestive 5 mg IRELAND SPC - var.53 -Nov-21 clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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 04 January 2022
File name
Revestive 5 mg joint Ireland and N.Ireland PIL Nov-21-clean.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 07 January 2021
File name
Revestive 5 mg IRELAND SPC May 2020-clean.pdf
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
UK and IE joint SmPC now split into individual territory SmPCs due to Brexit – no other changes were made. [change in section 4.8: reporting of adverse events]
Updated on 08 June 2020
File name
Revestive 5 mg joint UK and Ireland SPC May 2020-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
in section 4.4. Special warnings and precautions for use
text revision/addition highlighted in red:
Fluid overload and Electrolyte Balance
To avoid fluid overload or dehydration, careful adjustment of parenteral support is required in patients taking Revestive. Electrolyte balance and fluid status should be carefully monitored throughout treatment, especially during initial therapeutic response and discontinuation of Revestive treatment
Fluid overload:
Fluid overload has been observed in clinical trials. Fluid overload adverse events occurred most frequently during the first 4 weeks of therapy and decreased over time.
Due to increased fluid absorption, patients with cardiovascular disease, such as cardiac insufficiency and hypertension, should be monitored with regard to fluid overload, especially during initiation of therapy. Patients should be advised to contact their physician in case of sudden weight gain, face swelling, swollen ankles and/or dyspnoea. In general, fluid overload can be prevented by appropriate and timely assessment of parenteral nutrition needs. This assessment should be conducted more frequently within the first months of treatment.
Dehydration:
Patients with SBS are susceptible to dehydration that may lead to acute renal failure.
Section 4.8
Information on reporting of adverse reactions for Ireland was updated
10. date of revision of text
20 May 2020
Updated on 08 June 2020
File name
Revestive 5 mg joint UK and Ireland PIL May 2020-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 08 June 2020
File name
Revestive 5 mg joint UK and Ireland SPC May 2020-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 04 July 2019
File name
PIL-Revestive-5mg.pdf
Reasons for updating
- New PIL for new product
Updated on 04 July 2019
File name
smPC-Revestive 5 mg.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Takeda Products Ireland Ltd
Address:
5 Riverwalk Citywest Business Campus Dublin 24Medical Information E-mail:
medinfoemea@takeda.comMedical Information Direct Line:
1800 937970 , +44 3333 000 181