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Esmeron

*
Pharmacy Only: Prescription

  • Company:

    MSD Ireland (Human Health) Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Rocuronium Bromide

    *Additional information is available within the SPC or upon request to the company

Updated on 15 August 2023

File name

IE-Esmeron-en-LFT-IAIN-Haarlem-CRT.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 27 January 2023

File name

IE-Esmeron-en-SPC-WS-296-SLU-CRT.pdf

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

Addition of Mydriasis and Fixed pupils to undesirable effects.

Updated on 27 January 2023

File name

IE-Esmeron-en-LFT-WS-296-SLU-CRT.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 08 March 2022

File name

IE-Esmeron-en-SPC-WS-555-20220217-CRT.pdf

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 8 - Marketing authorisation number(s)
  • 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 PI to implement storage conditions update.

Updated on 08 March 2022

File name

IE-Esmeron-en-LFT-WS-555-20220217-CRT.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 26 January 2021

File name

IE-Esmeron EN-SPC-CRN00C30T-CRT (002).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)

Free text change information supplied by the pharmaceutical company

Inclusion of Statement that the rubber stopper is latex free.

 

Updated on 16 December 2020

File name

Esmeron SPC WS 388 (002).pdf

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

Inclusion of Sodium Excipient statement.

 

Updated on 16 December 2020

File name

ie PIL onlyWS 388 CRT_ (002).pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 28 May 2020

File name

Esmeron ie- SPC-IA-PRAC CRT (002).pdf.pdf

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

Kounis syndrome added as an undesirable effectKounis syndrome added as an undesirable effect

 

Updated on 28 May 2020

File name

Esmeron PL IA-PRAC med.ie (002).pdf.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 July 2018

File name

ESMERON PIL 2204703 FOR MED-IE_ (2).pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 24 July 2018

File name

Esmeron SPC PA transfer 2204703 July 18 (3).pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Change to the PA holder and number

Updated on 25 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 25 January 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

4.4 Observed rare cases of hyperthermia and  4.6 Breastfeeding  

Updated on 24 January 2018

File name

PIL_9395_637.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 January 2018

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 05 July 2016

Reasons for updating

  • Change to section 4.9 - Overdose
  • 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

To update information on the use of sugammadex to reverse neuromuscular blockade.

Updated on 22 December 2015

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

       Changes to sections: 2, Qualitative and Quantitative Composition, 4.4, special warnings and precautions for use,  section 10, date of revision of text

Updated on 22 December 2015

Reasons for updating

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

Updated on 27 February 2015

Reasons for updating

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

Updated on 07 October 2014

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
  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Changes to sections: 4.4, special warnings and precautions for use, 4.8 undesirable effects-how to report a side effect, section 10, date of revision of text and Change to improve clarity and readability

Updated on 06 October 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 11 June 2013

Reasons for updating

  • Change to storage instructions
  • Change to dosage and administration

Updated on 22 May 2013

Reasons for updating

  • 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 4.8 - 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 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Changes to sections: 4.1, 4.2, 4.4, 4.5, 4.8, 4.9, 5.1, 5.2, 6.4.

Updated on 03 June 2011

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 4.9 - Overdose
  • 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

 

Text added:

“(see section 4.5)”

 

Deleted text:

“There are no data to support dose recommendations for the facilitation of mechanical ventilation in pediatric and geriatric patients”

 

4.4       Special warnings and precautions for use

 

Text added:

“In the case of intubation difficulties resulting in a clinical need for immediate reversal of rocuronium induced neuromuscular block, the use of a reversal agent should be considered.”

4.5       Interaction with other medicinal products and other forms of interaction

 

Deleted text:

·        “Theophylline”

 

Deleted text:

“Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.”

 

4.9                Overdose

 

Deleted text:

“Upon start of spontaneous recovery”

 

Text added:

“In this situation there are two options for the reversal of neuromuscular block: (1) Sugammadex can be used for reversal of intense (profound) and deep block. The dose of Sugammadex to be administered depends on the level of neuromuscular block. The use of Sugammadex for the purposes of reversal of rocuronium-induced blockade is recommended for use only in the adult population. There are specific circumstances for which Sugammadex may be useful (refer to section 5.1 Reversal of neuromuscular block). (2) An acetylcholinesterase inhibitor (e.g. neostigmine, edrophonium, pyridostigmine) can be used once spontaneous recovery starts and should be administered in adequate doses.”

 

Addition of new subheading:

“Geriatric patients and patients with hepatic and biliary tract disease and/or renal failure”


Rewording of subheading “Reversal of muscle relaxation”

 

Deleted text:

“Administration of”

 

“antagonises the action of Esmeron”

 

Reworded to read:

“The action of rocuronium can be antagonised either by Sugammadex or by acetylcholinesterase inhibitors (neostigmine, pyridostigmine or edrophonium). Sugammadex can be given for routine reversal (at 1-2 post-tetanic counts to reappearance of T2) or immediate reversal (3 minutes after rocuronium bromide administration). Acetylcholinesterase inhibitors can be administered at reappearance of T2 or at the first signs of clinical recovery. The use of Sugammadex for the purposes of reversal of rocuronium-induced blockade is recommended for use only in the adult population.”

 

 

10: Date of (partial) revision of the text

Deleted text:

“November 2009”


Text added:
March 2011

Updated on 03 June 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 14 July 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

Section 1 - update to trade name
Section 2 - more detail added to qualitative and quantitative composition
Section 3 - update to pharmacetical name
Section 4.2 - additional information included for surgical procedures and ICU procedures
Section 4.3 - rewording of text
Section 4.4 - revision of text and warnings and precautions updated
Section 4.5 - revisioin of interactions
Section 4.6 - update to pregnancy and lactation information
Section 4.7 - rewording of text
Section 4.8 - addition of table of undesirable effects
Section 5.1 - update to pharmacodynamic properties
Section 5.2 - update to pharmacokinetic properties
Section 6.2 - incompatabilities information updated
Section 6.3 - shelf life after opening updated
Section 6.4 - storage precautions updated
Section 6.5 - additional information added
Section 9 - rewording
Section 10 - date of revision of text updated

Updated on 14 July 2008

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration
  • Change of contraindications
  • Changes to therapeutic indications

Updated on 03 January 2007

Reasons for updating

  • Change of active ingredient
  • Change to storage instructions
  • Change to date of revision
  • Improved electronic presentation

Updated on 08 August 2006

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 15 February 2005

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 15 February 2005

Reasons for updating

  • New PIL for medicines.ie