Revestive 1.25 mg powder and solvent for solution for injection

*
Pharmacy Only: Prescription
  • Company:

    Takeda Products Ireland Ltd
  • Status:

    No Recent Update
  • Legal 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 2023

File name

Revestive 1.25 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+.

Administrative changes in section 5.

Date of revision updated,

Updated on 12 July 2023

File name

Revestive 1.25 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 1.25 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 1.25 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 1.25 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 1.25 mg IRELAND SPC -clean-MAT-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 1.25 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 1.25 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
  • 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 January 2022

File name

Revestive 1.25 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 date of revision

Updated on 26 July 2021

File name

Revestive 1.25 mg joint UK and Ireland PIL May 2020.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 January 2021

File name

Revestive 1.25 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 1.25 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

 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.

Updated on 04 July 2019

File name

PIL-Revestive-1.25 mg.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 July 2019

File name

SmPC-Revestive 1.25 mg.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)