Bridion
*Company:
MSD Ireland (Human Health) LimitedStatus:
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 29 June 2023
File name
BRIDION-H-C-0885-IAIN-045-PIL-IE-UKNI-en-CRT.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Manufacturer and copyright statement updated.
Updated on 30 January 2023
File name
BRIDION-H-C-0885-II-042-SPC-IE-en-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC document format updated to html
Updated on 11 July 2022
File name
BRIDION-H-C-0885-II-042-BRX-NIP-PIL-IE-UKNI-en-CRT.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Addition of United Kingdom (Northern Ireland) details to section 4 and section 6 of the PIL.
Updated on 17 February 2022
File name
BRIDION-H-C-0885-II-042-SPC-IE-en-CRT.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 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
Update to sections 4.2, 4.8, 5.1 and 5.2 of the SmPC in order to change the posology recommendations and update safety, efficacy and pharmacokinetic information in children and adolescents (2-17 years).
Editorial updates made to section 4.4 of the SmPC.
Updated on 17 February 2022
File name
BRIDION-H-C-0885-II-042-PIL-IE-en-CRT.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
Updated on 06 August 2021
File name
BRIDION-H-C-0885-II-039-SPC-IE-en-CRT.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
BRIDION- II/0039 - update of PI with results of P145/CCDS
Updated on 10 July 2020
File name
BRIDION-H-C-0885-II-036-PIL-IE-en-CRT (002).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 15 June 2020
File name
BRIDION-H-C-0885-II-036-SPC-IE-en-CRT (002).pdf.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 4.8 - Undesirable effects
- 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
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to sections 4.2, 4.8, 5.1 & 5.2 of the SmPC with information on morbidly obese patients.
Update to section 4.4 of the SmPC with information related to the excipient sodium.
Update to HPRA details in section 4.8 / Reporting of suspected adverse reactions.
Editorial updates and updates in line with QRD template.
Updated on 15 June 2020
File name
BRIDION-H-C-0885-II-036-PIL-IE-en-CRT (002).pdf.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
- Change to other sources of information section
Updated on 04 April 2019
File name
BRIDION-H-C-0885-IB-031-PIL-IE-en-CRT.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 04 April 2019
File name
BRIDION-H-C-0885-IB-031-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 section 4.6 of the SmPC related to breast-feeding
Updated on 22 March 2019
File name
BRIDION-H-C-0885-T-030-PIL-IE-en-CRT.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 22 March 2019
File name
BRIDION-H-C-0885-T-030-SPC-IE-en-CRT.pdf
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
Editorial updates only
Updated on 22 August 2018
File name
PIL BRIDION-H-C-0885-T-030-PIL-IE-en-CRT (2).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 - date of revision
- Change to other sources of information section
Updated on 22 August 2018
File name
SPC BRIDION-H-C-0885-T-030-SPC-IE-en-CRT (2).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)
Free text change information supplied by the pharmaceutical company
Update to Marketing Authorisation Holder name and address in section 7 of the SPC.
Updated on 07 September 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 September 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
Updates to the SPC highlighted below in red:
2 Qualitative and Quantitative Composition
Excipient(s) with known effect
Each mL contains up to 9.7 mg sodium (see section 4.4).
4.4 Special warnings and precautions for use
Patients on a controlled sodium diet:
Each mL solution contains up to 9.7 mg sodium. A dose of 23 mg sodium is considered essentially ‘sodium-free’. If more than 2.4 mL solution needs to be administered, this should be taken into consideration by patients on a controlled sodium diet.
Updated on 16 June 2016
File name
PIL_14587_267.pdf
Reasons for updating
- New PIL for new product
Updated on 16 June 2016
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 09 November 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 22 October 2015
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 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- 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
Updates to the SPC include sections 4.2, 4.4, 4.8, 5.3, 6.6, 9 & 10
Reasons for submission Approval of EMEA/H/C/000885/II/024 (CCDS Harmonization)
Updated on 16 June 2015
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 29 May 2015
Reasons for updating
- 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
4tion 4.8 - Undesirable effects & Change to Section 10 - Date of revision of the text
Updated on 08 May 2015
Reasons for updating
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 01 April 2015
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 02 April 2014
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 01 April 2014
Reasons for updating
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 29 October 2013
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)
Free text change information supplied by the pharmaceutical company
Sections 7 and 10. - Change of MA Holder from Organon to Merck Sharpe & Dohme UK
Updated on 25 October 2013
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 16 August 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 9 - Date of renewal of authorisation
- 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
Updated on 15 August 2013
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 24 July 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- 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
Updates to SPC 2, 4.1, 4.2, 4.4, 4.5, 4.7, 4.8, 4.9, 5.1, 6.1, 6.5, 9 & 10
Updated on 23 July 2013
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
- Correction of spelling/typing errors
- Removal/change of distributor
Updated on 05 April 2013
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
The typo was on page 5 in the table below and was the “or” was missing.
Updated on 22 November 2012
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
4.2 Posology and method of administration
Posology
The period for potential displacement interactions has been amended from 6 hours to 7.5 hours
The adult waiting times for re-administration of rocuronium or vecuronium after sugammadex has been defined in section 4.4 of the SmPC, the statement “A waiting time of 24 hours should be taken into account” has been deleted.
4.4 Special warnings and precautions for use
In order to provide more accurate guidance with regards to safe timing of re-use of rocuronium and vecuronium after reversal of neuromuscular blockade by Bridion the waiting times for re‑administration with neuromuscular blocking agents, rocuronium and vecuronium after reversal with sugammadex have been defined. Specific advice on patients with mild or moderate renal impairment has been given. The changes made to the potential displacement interactions have also been made to the ‘potential interactions’ section.
Updated on 11 September 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 16 August 2012
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- 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 9 - Date of renewal of authorisation
- 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
Updated on 31 May 2012
Reasons for updating
- Change to side-effects
Updated on 26 March 2012
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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)
Free text change information supplied by the pharmaceutical company
Updates to sections: 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and 10
Updated on 20 July 2011
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 section currently titled 'Allergic reactions' has been amended to reflect the Drug hypersensitivity reactions submission as follows:
Drug hypersensitivity reactions: Clinicians should be prepared for the possibility of drug hypersensitivity reactions (including anaphylactic reactions) and take the necessary precautions (see section 4.8).
4.8 A new paragraph has been added specifically about drug hypersensitivity reactions and other reference to allergic reactions removed:
Drug hypersensitivity reactions: Hypersensitivity reactions have occurred in some patients and volunteers. In clinical trials these reactions were reported uncommonly and for post-marketing reports the frequency is unknown. These reactions varied from isolated skin reactions to serious systemic reactions (i.e. anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex. Symptoms associated with these reactions can include: flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia and swelling of tongue and pharynx.
Updated on 18 July 2011
Reasons for updating
- Change to side-effects
Updated on 01 July 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
A new paragraph detailing the Effect of sugammadex on hemostasis has been added. Reference is also made to prolonged activated partial thromboplastin time (aPTT) and prothrombin time (PT) and pharmacodynamic interactions seen in in vitro experiments as explained in the new paragraph on hemostasis
4.5 Interaction with other medicinal products and other forms of interaction
Reference is also made to prolonged activated partial thromboplastin time (aPTT) and prothrombin time (PT) and pharmacodynamic interactions seen in in vitro experiments as explained in the new paragraph on hemostasis
Updated on 22 June 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 04 June 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
Potential interactions:
removed reference to "flucloxacillin".
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been conducted in adults with sugammadex and other medicinal products.
The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments, clinical studies and simulations using a model taking into account the pharmacodynamic effect of neuromuscular blocking agents and the pharmacokinetic interaction between neuromuscular blocking agents and sugammadex. Based on in-vitro data and taking into consideration pharmacokinetics and other relevant information these data, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following:
For toremifene
, flucloxacillin and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected). For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).Interactions potentially affecting the efficacy of sugammadex (see also section 4.4):
Toremifene:
For toremifene, which has a relatively high affinity constant and relatively high plasma concentrations,
some displacement of vecuronium or rocuronium from the complex with sugammadex could occur.
The recovery of the T
4/T1 ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of the operation.
Intravenous administration of
flucloxacillin and fusidic acid: Intravenous administration of fusidic acid and high dose flucloxacillin (infusion of 500 mg or more),may cause some displacement of rocuronium or vecuronium from sugammadex.
The use of these medicinal products fusidic acid in the pre-operative phase may give some delay in the recovery of theT4/T1 ratio to 0.9. No re-occurrence of neuromuscular blockade is expected in the post-operative phase, since the infusion rate of fucidic acid is over a period of several hours and the blood levels are cumulative over 2-3 days. The use of these medicinal products in the post-operative phase after routine reversal during the surveillance period of 6 hours (see section 4.4) should be avoided. If administration of flucloxacillin or fusidic acid within this time period can not be avoided, ventilation should be closely observed, in particular during the first 15 minutes after dosing. For re-administration of sugammadex see section 4.2.
Updated on 28 May 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 19 February 2010
Reasons for updating
- New PIL for new product
Updated on 30 January 2009
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)