Nimbex 2 mg/ml solution for injection/infusion.

  • Name:

    Nimbex 2 mg/ml solution for injection/infusion.

  • Company:
    info
  • Active Ingredients:

    Cisatracurium Besilate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/10/17

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 10/5/2018
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Aspen

Aspen

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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 10 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 October 2017 PIL

Reasons for updating

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

Updated on 24 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 August 2017 SmPC

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

Text in red = new text
Text strikethrough = deleted text

 

7.         MARKETING AUTHORISATION HOLDER

           

GlaxoSmithKline (Ireland) Limited

12 Riverwalk,

Citywest Business Campus,

Dublin 24

Aspen Pharma Trading Limited,

3016 Lake Drive,

Citywest Business Campus,

Dublin 24,

Ireland

 

 

8.         MARKETING AUTHORISATION NUMBER

 

PA 1077/72/1 PA 1691/030/001

 

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

 

            01 July 2015August 2017

Updated on 15 August 2017 PIL

Reasons for updating

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

Updated on 1 July 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

To delete the 2.5 ml pack size from the licence.

However, the HPRA requested that the following text be reinstated in the SPC: Section 2 - One ampoule of 2.5 ml contains 5 mg of cisatracurium / Section 6.5 - 2.5 ml in ampoule (glass): box of 5 as this is an MRP procedure.

 


The PIL was updated to remove the 2.5ml pack size.

 

Updated on 20 May 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

Section 2 – Deletion of 2.5 ml

Section 6.5 – Deletion of 2. 5 ml

Updated on 19 May 2016 PIL

Reasons for updating

  • Change to date of revision
  • Deletion of a pack size

Updated on 15 July 2015 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

Section 7 - change to Ireland MAH address

Updated on 15 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 31 October 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.2 – Remove reference to 5 mg/ml and provide infusion delivery rate of Nimbex Injection 2 mg/ml in ICU patients
Section 4.8 – Reporting details updated

Updated on 3 October 2014 PIL

Reasons for updating

  • Change of active ingredient
  • Change of inactive ingredient
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 23 June 2014 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 4.5 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

Section of SPC

Change

2. Qualitative and Quantitative Composition

Administrative Update

4.1 Therapeutic Indications

Clarification of the indication

4.2 Posology & Method of Administration

Minor Editorial Updates e.g. table heading, expansion of abbreviated words, referring to table numbers rather than “below”

4.5 Interaction with other medicinal products and other forms of interaction

Re-arranged interaction section into 3 subheadings – No effect, decrease effect and increased effect

Correction to spelling errors

4.6 Fertility, pregnancy and lactation

Administrative updates

Confirmation that no fertility studies have been performed

4.8 Undesirable effects

Administrative updates

Update to adverse reaction reporting

5.1 Pharmacodynamic properties

Administrative updates

5.2 Pharmacokinetic properties

Administrative updates

5.3 Preclinical safety data

Reference to section 4.9

6.6 Special precautions for disposal and other handling

Administrative updates

Updated on 20 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Change of special precautions for disposal
  • Addition of information on reporting a side effect.
  • Improved electronic presentation

Updated on 26 April 2011 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change due to harmonisation of PIL
  • Change due to user-testing of patient information

Updated on 23 February 2011 SmPC

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 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

 

1.         NAME OF THE MEDICINAL PRODUCT

 

Nimbex 2mg/ml solution for injection/infusion.

 

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Cisatracurium 2mg as cisatracurium besilate 2.68 mg per 1 ml

 

one ampoule of 2.5 ml contains 5 mg of cisatracurium

one ampoule of 5 ml contains 10 mg of cisatracurium

one ampoule of 10 ml contains 20 mg of cisatracurium

one ampoule of 25 ml contains 50 mg of cisatracurium

 

For a full list of excipients, see section 6.1.

 

 

3.         PHARMACEUTICAL FORM

 

Solution for injection/infusion.

 

Colourless to pale yellow or greenish yellow solution. Practically free from visible particulate matter.

 

 

4.1       Therapeutic Indications

 

Nimbex is indicated for use during surgical and other procedures and in intensive care in adults and children aged 1 month and over. Nimbex can be used as an adjunct to general anaesthesia, or sedation in the Intensive Care Unit (ICU) to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation.

 

4.2       Posology and Method of Administration

 

Nimbex should be only administered by or under the supervision of anaesthetists or other clinicians who are familiar with the use and action of neuromuscular blocking agents. Facilities for tracheal intubation, and maintenance of pulmonary ventilation and adequate arterial oxygenation have to be available.

 

Please note that Nimbex should not be mixed in the same syringe or administered simultaneously through the same needle as propofol injectable emulsion or with alkaline solutions such as sodium thiopentone (see section 6.2).

 

………………….etc

 

 

6.4       Special Precautions for Storage

 

Store in a refrigerator (2oC - 8°C).  Do not freeze.  Keep ampoules in the outer carton.
Protect from light.

Store in the original package in order to protect from light.

For storage conditions of the diluted medicinal product see section 6.3.

 

6.5       Nature and Contents of Container

 

Nimbex 2mg/ml, solution for injection/infusion

2.5ml in ampoule (glass): box of 5

5ml in ampoule (glass): box of 5

10ml in ampoule (glass): box of 5

25ml in ampoule (glass: box of 2

 

Type I, clear, neutral glass ampoules.

 

NOT ALL PACK SIZES MAY BE MARKETED

Updated on 13 May 2009 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 4.7 - Effects on ability to drive and use machines

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

Free text change information supplied by the pharmaceutical company

Changes highlighted in blue:

 

 4.4      Special Warnings and Special Precautions for Use

 

Product specific topics

 

Cisatracurium paralyses the respiratory muscles as well as other skeletal muscles but has no known effect on consciousness or pain threshold. Nimbex should be only administered by or under the supervision of anaesthetists or other clinicians who are familiar with the use and action of neuromuscular blocking agents. Facilities for tracheal intubation, and maintenance of pulmonary ventilation and adequate arterial oxygenation have to be available.

 

Caution should be exercised when administering Nimbex to patients who have shown hypersensitivity to other neuromuscular blocking agents since a high rate of cross-sensitivity (greater than 50%) between neuromuscular blocking agents has been reported (see section 4.3).

 

………………..

 

4.5       Interaction with Other Medicinal Products and Other Forms of Interaction

 

………………..

 

Rarely, certain drugs may aggravate or unmask latent myasthenia gravis or actually induce a myasthenic syndrome; increased sensitivity to non-depolarising neuromuscular blocking agents might result. Such drugs include various antibiotics, b-blockers (propranolol, oxprenolol), anti-arrhythmic drugs (procainamide, quinidine), anti-rheumatic drugs (chloroquine, D-penicillamine), trimetaphan, chlorpromazine, steroids, phenytoin and lithium.

 

Treatment with anticholinesterases, commonly used in the treatment of Alzheimer’s disease e.g. donepezil, may shorten the duration and diminish the magnitude of neuromuscular blockade with cisatracurium.

 

4.7       Effects on Ability to Drive and Use Machines

 

This precaution is not relevant to the use of Nimbex.  Nimbex will always be used in combination with a genereal anaesthetic and therefore the usual precautions relating to performance of tasks following general anaesthesia apply.

 

Updated on 21 April 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to information about driving or using machinery

Updated on 9 March 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 March 2006 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 26 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 December 2003 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 7 July 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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