Nimbex 2 mg/ml solution for injection/infusion.
*Company:
AspenStatus:
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 14 August 2022
File name
MR4833_Cisa_Inj_IE_P_2mg-ml_v6.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 August 2022
File name
MR4833_Cisa_Inj_IE_P_2mg-ml_v5.pdf
Reasons for updating
- Change to other sources of information section
Updated on 27 August 2021
File name
MR4833_Cisa_Inj_IE_S_2mg-ml_v2.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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)
Updated on 27 August 2021
File name
MR4833_Cisa_Inj_IE_P_2mg-ml_v4.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 August 2021
File name
MR4833_Cisa_Inj_UK_P_combined_v4.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
Updated on 26 April 2021
File name
MR4833_Cisa_Inj_IE_P_2mg-ml_v3.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 10 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 October 2017
File name
PIL_9875_234.pdf
Reasons for updating
- New PIL for new product
Updated on 13 October 2017
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 August 2017
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
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 01 July 2016
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
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
Reasons for updating
- Change to date of revision
- Deletion of a pack size
Updated on 15 July 2015
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
Updated on 15 July 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 31 October 2014
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 4.8 – Reporting details updated
Updated on 03 October 2014
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
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
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
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
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
Updated on 13 May 2009
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
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 09 March 2006
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 09 March 2006
Reasons for updating
- Improved electronic presentation
Updated on 26 May 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 15 December 2003
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 07 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 July 2003
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Aspen

Address:
3016 Lake Drive, Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
aspenmedinfo@professionalinformation.co.ukTelephone:
003531 630 8400Medical Information Direct Line:
0080000404142 - Freephone