Bridion

  • Name:

    Bridion

  • Company:
    info
  • Active Ingredients:

    Sugammadex sodium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/04/19

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Summary of Product Characteristics last updated on medicines.ie: 4/4/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

Company Products

Medicine NameActive Ingredients
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Medicine Name Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate, ezetimibe
Medicine Name Bridion Active Ingredients Sugammadex sodium
Medicine Name Cancidas 50mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cancidas 70mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
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Medicine Name Elocon Cream Active Ingredients Mometasone Furoate
Medicine Name Elocon Ointment Active Ingredients Mometasone Furoate
Medicine Name Elocon Scalp Lotion Active Ingredients Mometasone Furoate
Medicine Name EMEND 125 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80mg, 125mg hard Capsules Active Ingredients Aprepitant
Medicine Name Esmeron Active Ingredients Rocuronium Bromide
Medicine Name EZETROL 10 mg Tablets Active Ingredients ezetimibe
Medicine Name FOSAMAX Once Weekly 70 mg Tablets Active Ingredients Alendronate Sodium Trihydrate
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1 - 0 of 84 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 4 April 2019 PIL

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 4 April 2019 SmPC

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 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 22 March 2019 SmPC

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 PIL

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 SmPC

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 7 September 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 7 September 2016 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 June 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 9 November 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 22 October 2015 SmPC

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 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 29 May 2015 SmPC

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 8 May 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 1 April 2015 SmPC

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

Which SPC sections have changed:  Change to Section 1 - Name of the 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 - Interactions 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

Updated on 2 April 2014 SmPC

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

Sections 5.2 – Pharmacokinetics properties, 10 - Date of revision due to approval of II-019

Updated on 1 April 2014 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 16 August 2013 SmPC

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

Updates to sections 4.4 – Special Warnings and Precautions for use, 9 – Date of first authorisation/Renewal of the authorisation and 10 - date of revision

Updated on 15 August 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 24 July 2013 SmPC

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 PIL

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 5 April 2013 SmPC

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 SmPC

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 PIL

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 SmPC

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

Updates to sections: 2, 4.3, 4.4, 6.6, 9 and 10

Updated on 31 May 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 26 March 2012 SmPC

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 SmPC

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

Approval of a type II variation on drug hypersensitivity, have amended the following sections of the SmPC: 4.4.

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 1 July 2010 SmPC

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

4.4     Special warnings and precautions for use: 
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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 4 June 2010 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 19 February 2010 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 January 2009 SmPC

Reasons for updating

  • New SPC for new product

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