Naropin 7.5mg/ml Solution for Injection
*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 01 November 2023
File name
MR0104_Ropi_Inj_IE_P_2,7.5,10mg-ml_v8.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 November 2023
File name
MR0104_Ropi_Inj_IE_P_2,7.5,10mg-ml_v8.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 November 2023
File name
MR0104_Ropi_Inj_IE_P_2,7.5,10mg-ml_v8.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 October 2023
File name
MR0104_Ropi_Inj_IE_S_7.5mg-ml_v5.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)
Updated on 24 October 2023
File name
MR0104_Ropi_Inj_IE_P_2,7.5,10mg-ml_v7.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 25 July 2023
File name
MR0104_Ropi_Inj_IE_S_7.5mg-ml_v4.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)
Updated on 25 July 2023
File name
MR0104_Ropi_Inj_IE_P_2,7.5,10mg-ml_v6.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 03 November 2022
File name
MR0104_Ropi_Inj_IE_P_2,7.5,10mg-ml_v5.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 05 October 2022
File name
MR0104_Ropi_Inj_IE_S_7.5mg-ml_v3.pdf
Reasons for updating
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 October 2022
File name
MR0104_Ropi_Inj_IE_P_2,7.5,10mg-ml_v5.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 03 October 2022
File name
MR0104_Ropi_Inj_IE_S_7.5mg-ml_v3.pdf
Reasons for updating
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 August 2022
File name
MR0104_ropi_inj_ie_p_combined_v4.pdf
Reasons for updating
- Change to other sources of information section
Updated on 04 November 2021
File name
MR0104_Ropi_Inj_IE_P_Combined_v3.0.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 17 March 2021
File name
MR0104_Ropi_Inj_IE_P_Combined_v2.pdf
Reasons for updating
- New PIL for new product
Updated on 07 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 March 2018
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
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
2 Qualitative and quantitative composition
Excipients with known effect:
For the full list of excipients, see section 6.1.
4.1 Therapeutic indications
Naropin 7.5 mg/ml and 10 mg/ml is indicated in adults and adolescents aged above 12 years of age for:
Naropin 10 mg/ml is indicated in adults and adolescents aged above 12 years of age for:
Surgical anaesthesia:
‑ Epidural blocks for surgery.
4.3 Contraindications
Hypersensitivity to ropivacaine or to any of the excipients listed in section 6.1. ropivacaine or to other local anaesthetics of the amide type.
4.4 Special warnings and precautions for use
Cardiovascular
Epidural and intrathecal anaesthesia may lead to hypotension and bradycardia. Hypotension should be treated promptly with a vasopressor intravenously, and with an adequate vascular filling.
5.2 Pharmacokinetic properties
There is no evidence of in vivo racemisation of ropivacaine.
10. DATE OF REVISION OF THE TEXT
Apr 2017 Mar 2018
Updated on 07 March 2018
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Free text change information supplied by the pharmaceutical company
Text in red = new text
Text strikethrough = deleted text
2 Qualitative and quantitative composition
Excipients with known effect:
For the full list of excipients, see section 6.1.
4.1 Therapeutic indications
Naropin 7.5 mg/ml and 10 mg/ml is indicated in adults and adolescents aged above 12 years of age for:
Naropin 10 mg/ml is indicated in adults and adolescents aged above 12 years of age for:
Surgical anaesthesia:
‑ Epidural blocks for surgery.
4.3 Contraindications
Hypersensitivity to ropivacaine or to any of the excipients listed in section 6.1. ropivacaine or to other local anaesthetics of the amide type.
4.4 Special warnings and precautions for use
Cardiovascular
Epidural and intrathecal anaesthesia may lead to hypotension and bradycardia. Hypotension should be treated promptly with a vasopressor intravenously, and with an adequate vascular filling.
5.2 Pharmacokinetic properties
There is no evidence of in vivo racemisation of ropivacaine.
10. DATE OF REVISION OF THE TEXT
Apr 2017 Mar 2018
Updated on 16 May 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
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland.
AstraZeneca UK Ltd.,
600 Capability Green,
Luton, LU1 3LU, UK.
8.Marketing authorisation number
PA PA 970/47/5 PA 1691/026/002
10. Date of revision of the text
April 2017 January
Updated on 16 May 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
Free text change information supplied by the pharmaceutical company
Text in red = new text
Text strikethrough = deleted text
7. Marketing Authorisation holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland.
AstraZeneca UK Ltd.,
600 Capability Green,
Luton, LU1 3LU, UK.
8.Marketing authorisation number
PA PA 970/47/5 PA 1691/026/002
10. Date of revision of the text
April 2017 January
Updated on 24 November 2015
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 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
Section 4.4 – Editorial changes
Section 4.8 – inclusion of additional side effects (allergic reactions, dyskinesia, back pain, chills) and editorial changes
Section 6.5 – Addition of the statement “Not all pack sizes may be marketed”
Section 10 – update to date of revision
Section 6.6 – editorial changes’
Updated on 24 November 2015
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 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
Free text change information supplied by the pharmaceutical company
Section 4.4 – Editorial changes
Section 4.8 – inclusion of additional side effects (allergic reactions, dyskinesia, back pain, chills) and editorial changes
Section 6.5 – Addition of the statement “Not all pack sizes may be marketed”
Section 10 – update to date of revision
Section 6.6 – editorial changes’
Updated on 16 July 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 4.8 - Inclusion of the statements of ADR reporting
Section 10 – update to date of revision
Updated on 16 July 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.8 - Inclusion of the statements of ADR reporting
Section 10 – update to date of revision
Updated on 28 November 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 4.6 - 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 5.2 - 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
4.1 Therapeutic indications
New indication added with regards to the 2 mg/ml injection (infusion is not licence in Ireland but the injection can also be used for this indication) for peripheral nerve block in infants from 1 year and children up to and including 12 years
4.2 Posology and method of administration
Posology updated with regards to new indication for peripheral nerve block and minor formatting
4.4 Special warnings and precautions for use
Minor formatting and the below texts added in relation to other strengths and indications in a specific age group
- The safety and efficacy of ropivacaine 7.5 mg/ml and 10 mg/ml in children up to and including 12 years has not been established.
- The safety and efficacy of ropivacaine 2 mg/ml for field block in children up to and including 12 years has not been established.
- - The safety and efficacy of ropivacaine 2 mg/ml for peripheral nerve blocks in infants below 1 year has not been established
4.5 Interaction with other medicinal products and other forms of interaction
Minor formatting
4.6 Pregnancy and lactation
Minor formatting
4.7 Undesirable effects
Below text added:
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults except for hypotension which happens less often in children (< 1 in 10) and vomiting which happens more often in children (> 1 in 10).
In children, early signs of local anaesthetic toxicity may be difficult to detect since they may not be able to verbally express them. (See also section 4.4).
4.8 Overdose
Minor formatting
5.2 Pharmacokinetic properties
Below text added:
Simulations on the sum of unbound plasma concentrations of ropivacaine and PPX, based on the PK parameters and their variance in the population analysis, indicate that for 1- to 12- year-old infants and children receiving 3 mg/kg single peripheral (ilioinguinal) nerve block the median unbound peak concentration reached after 0.8 h is 0.0347 mg/L, one-tenth of the toxicity threshold (0.34 mg/L). The upper 90% confidence interval for the maximum unbound plasma concentration is 0.074 mg/L, one-fifth of the toxicity threshold. Similarly, for continuous peripheral block (0.6 mg ropivacaine/kg for 72 h) preceded by a 3 mg/kg single peripheral nerve block, the median unbound peak concentration is 0.053 mg/L. The upper 90% confidence interval for the maximum unbound plasma concentration is 0.088 mg/L, one-quarter of the toxicity threshold.
10 Updated date of revision
Minor formatting and the below texts added in relation to other strengths and indications in a specific age group
- The safety and efficacy of ropivacaine 7.5 mg/ml and 10 mg/ml in children up to and including 12 years has not been established.
- The safety and efficacy of ropivacaine 2 mg/ml for field block in children up to and including 12 years has not been established.
- - The safety and efficacy of ropivacaine 2 mg/ml for peripheral nerve blocks in infants below 1 year has not been established
4.5 Interaction with other medicinal products and other forms of interaction
Minor formatting
4.6 Pregnancy and lactation
Minor formatting
4.7 Undesirable effects
Below text added:
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults except for hypotension which happens less often in children (< 1 in 10) and vomiting which happens more often in children (> 1 in 10).
In children, early signs of local anaesthetic toxicity may be difficult to detect since they may not be able to verbally express them. (See also section 4.4).
4.8 Overdose
Minor formatting
5.2 Pharmacokinetic properties
Below text added:
Simulations on the sum of unbound plasma concentrations of ropivacaine and PPX, based on the PK parameters and their variance in the population analysis, indicate that for 1- to 12- year-old infants and children receiving 3 mg/kg single peripheral (ilioinguinal) nerve block the median unbound peak concentration reached after 0.8 h is 0.0347 mg/L, one-tenth of the toxicity threshold (0.34 mg/L). The upper 90% confidence interval for the maximum unbound plasma concentration is 0.074 mg/L, one-fifth of the toxicity threshold. Similarly, for continuous peripheral block (0.6 mg ropivacaine/kg for 72 h) preceded by a 3 mg/kg single peripheral nerve block, the median unbound peak concentration is 0.053 mg/L. The upper 90% confidence interval for the maximum unbound plasma concentration is 0.088 mg/L, one-quarter of the toxicity threshold.
10 Updated date of revision
Minor formatting
4.7 Undesirable effects
Below text added:
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults except for hypotension which happens less often in children (< 1 in 10) and vomiting which happens more often in children (> 1 in 10).
In children, early signs of local anaesthetic toxicity may be difficult to detect since they may not be able to verbally express them. (See also section 4.4).
4.8 Overdose
Minor formatting
5.2 Pharmacokinetic properties
Below text added:
Simulations on the sum of unbound plasma concentrations of ropivacaine and PPX, based on the PK parameters and their variance in the population analysis, indicate that for 1- to 12- year-old infants and children receiving 3 mg/kg single peripheral (ilioinguinal) nerve block the median unbound peak concentration reached after 0.8 h is 0.0347 mg/L, one-tenth of the toxicity threshold (0.34 mg/L). The upper 90% confidence interval for the maximum unbound plasma concentration is 0.074 mg/L, one-fifth of the toxicity threshold. Similarly, for continuous peripheral block (0.6 mg ropivacaine/kg for 72 h) preceded by a 3 mg/kg single peripheral nerve block, the median unbound peak concentration is 0.053 mg/L. The upper 90% confidence interval for the maximum unbound plasma concentration is 0.088 mg/L, one-quarter of the toxicity threshold.
10 Updated date of revision
Minor formatting
5.2 Pharmacokinetic properties
Below text added:
Simulations on the sum of unbound plasma concentrations of ropivacaine and PPX, based on the PK parameters and their variance in the population analysis, indicate that for 1- to 12- year-old infants and children receiving 3 mg/kg single peripheral (ilioinguinal) nerve block the median unbound peak concentration reached after 0.8 h is 0.0347 mg/L, one-tenth of the toxicity threshold (0.34 mg/L). The upper 90% confidence interval for the maximum unbound plasma concentration is 0.074 mg/L, one-fifth of the toxicity threshold. Similarly, for continuous peripheral block (0.6 mg ropivacaine/kg for 72 h) preceded by a 3 mg/kg single peripheral nerve block, the median unbound peak concentration is 0.053 mg/L. The upper 90% confidence interval for the maximum unbound plasma concentration is 0.088 mg/L, one-quarter of the toxicity threshold.
10 Updated date of revision
Updated on 28 November 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 4.6 - 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 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
4.1 Therapeutic indications
New indication added with regards to the 2 mg/ml injection (infusion is not licence in Ireland but the injection can also be used for this indication) for peripheral nerve block in infants from 1 year and children up to and including 12 years
4.2 Posology and method of administration
Posology updated with regards to new indication for peripheral nerve block and minor formatting
4.4 Special warnings and precautions for use
Minor formatting and the below texts added in relation to other strengths and indications in a specific age group
- The safety and efficacy of ropivacaine 7.5 mg/ml and 10 mg/ml in children up to and including 12 years has not been established.
- The safety and efficacy of ropivacaine 2 mg/ml for field block in children up to and including 12 years has not been established.
- - The safety and efficacy of ropivacaine 2 mg/ml for peripheral nerve blocks in infants below 1 year has not been established
4.5 Interaction with other medicinal products and other forms of interaction
Minor formatting
4.6 Pregnancy and lactation
Minor formatting
4.7 Undesirable effects
Below text added:
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults except for hypotension which happens less often in children (< 1 in 10) and vomiting which happens more often in children (> 1 in 10).
In children, early signs of local anaesthetic toxicity may be difficult to detect since they may not be able to verbally express them. (See also section 4.4).
4.8 Overdose
Minor formatting
5.2 Pharmacokinetic properties
Below text added:
Simulations on the sum of unbound plasma concentrations of ropivacaine and PPX, based on the PK parameters and their variance in the population analysis, indicate that for 1- to 12- year-old infants and children receiving 3 mg/kg single peripheral (ilioinguinal) nerve block the median unbound peak concentration reached after 0.8 h is 0.0347 mg/L, one-tenth of the toxicity threshold (0.34 mg/L). The upper 90% confidence interval for the maximum unbound plasma concentration is 0.074 mg/L, one-fifth of the toxicity threshold. Similarly, for continuous peripheral block (0.6 mg ropivacaine/kg for 72 h) preceded by a 3 mg/kg single peripheral nerve block, the median unbound peak concentration is 0.053 mg/L. The upper 90% confidence interval for the maximum unbound plasma concentration is 0.088 mg/L, one-quarter of the toxicity threshold.
10 Updated date of revision
Minor formatting and the below texts added in relation to other strengths and indications in a specific age group
- The safety and efficacy of ropivacaine 7.5 mg/ml and 10 mg/ml in children up to and including 12 years has not been established.
- The safety and efficacy of ropivacaine 2 mg/ml for field block in children up to and including 12 years has not been established.
- - The safety and efficacy of ropivacaine 2 mg/ml for peripheral nerve blocks in infants below 1 year has not been established
4.5 Interaction with other medicinal products and other forms of interaction
Minor formatting
4.6 Pregnancy and lactation
Minor formatting
4.7 Undesirable effects
Below text added:
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults except for hypotension which happens less often in children (< 1 in 10) and vomiting which happens more often in children (> 1 in 10).
In children, early signs of local anaesthetic toxicity may be difficult to detect since they may not be able to verbally express them. (See also section 4.4).
4.8 Overdose
Minor formatting
5.2 Pharmacokinetic properties
Below text added:
Simulations on the sum of unbound plasma concentrations of ropivacaine and PPX, based on the PK parameters and their variance in the population analysis, indicate that for 1- to 12- year-old infants and children receiving 3 mg/kg single peripheral (ilioinguinal) nerve block the median unbound peak concentration reached after 0.8 h is 0.0347 mg/L, one-tenth of the toxicity threshold (0.34 mg/L). The upper 90% confidence interval for the maximum unbound plasma concentration is 0.074 mg/L, one-fifth of the toxicity threshold. Similarly, for continuous peripheral block (0.6 mg ropivacaine/kg for 72 h) preceded by a 3 mg/kg single peripheral nerve block, the median unbound peak concentration is 0.053 mg/L. The upper 90% confidence interval for the maximum unbound plasma concentration is 0.088 mg/L, one-quarter of the toxicity threshold.
10 Updated date of revision
Minor formatting
4.7 Undesirable effects
Below text added:
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults except for hypotension which happens less often in children (< 1 in 10) and vomiting which happens more often in children (> 1 in 10).
In children, early signs of local anaesthetic toxicity may be difficult to detect since they may not be able to verbally express them. (See also section 4.4).
4.8 Overdose
Minor formatting
5.2 Pharmacokinetic properties
Below text added:
Simulations on the sum of unbound plasma concentrations of ropivacaine and PPX, based on the PK parameters and their variance in the population analysis, indicate that for 1- to 12- year-old infants and children receiving 3 mg/kg single peripheral (ilioinguinal) nerve block the median unbound peak concentration reached after 0.8 h is 0.0347 mg/L, one-tenth of the toxicity threshold (0.34 mg/L). The upper 90% confidence interval for the maximum unbound plasma concentration is 0.074 mg/L, one-fifth of the toxicity threshold. Similarly, for continuous peripheral block (0.6 mg ropivacaine/kg for 72 h) preceded by a 3 mg/kg single peripheral nerve block, the median unbound peak concentration is 0.053 mg/L. The upper 90% confidence interval for the maximum unbound plasma concentration is 0.088 mg/L, one-quarter of the toxicity threshold.
10 Updated date of revision
Minor formatting
5.2 Pharmacokinetic properties
Below text added:
Simulations on the sum of unbound plasma concentrations of ropivacaine and PPX, based on the PK parameters and their variance in the population analysis, indicate that for 1- to 12- year-old infants and children receiving 3 mg/kg single peripheral (ilioinguinal) nerve block the median unbound peak concentration reached after 0.8 h is 0.0347 mg/L, one-tenth of the toxicity threshold (0.34 mg/L). The upper 90% confidence interval for the maximum unbound plasma concentration is 0.074 mg/L, one-fifth of the toxicity threshold. Similarly, for continuous peripheral block (0.6 mg ropivacaine/kg for 72 h) preceded by a 3 mg/kg single peripheral nerve block, the median unbound peak concentration is 0.053 mg/L. The upper 90% confidence interval for the maximum unbound plasma concentration is 0.088 mg/L, one-quarter of the toxicity threshold.
10 Updated date of revision
Updated on 19 February 2013
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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
Section 1 – Deletion of trademark symbol.
Section 4.2 – Removal of tradename of Lidocaine with adrenaline.
Section 4.4 – Addition of Chondrolysis warning.
Section 5.2 – Update pharmacokinetic properties for patients with impaired renal function.
Section 10 – Update to "Date of Revision"
Updated on 19 February 2013
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 1 – Deletion of trademark symbol.
Section 4.2 – Removal of tradename of Lidocaine with adrenaline.
Section 4.4 – Addition of Chondrolysis warning.
Section 5.2 – Update pharmacokinetic properties for patients with impaired renal function.
Section 10 – Update to "Date of Revision"
Updated on 08 May 2012
Reasons for updating
- 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 4.4 - Special warnings and precautions for use
- 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - MA number
- 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 2
Addition of sodium content. Minor editorial changes.
Section 3
Reduced to ‘Solution for injection’.
Section 4.1
Removal of references to infusion. Addition of indications for other strengths.
Section 4.2
Minor editorial changes to table. Removal of references to infusion. Addition of paediatric posology and method of administration to harmonise with other strengths.
Section 4.4
Remove ‘special’ from section heading. Removal of references to infusion. Addition of paediatric warnings to harmonise with other strengths.
Section 4.6
Minor editorial change.
Section 4.7
Minor editorial change.
Section 4.8
Table of adverse drug reactions updated so that it is sorted by system organ class. Removal of references to infusion. Addition of subheadings ‘Neurological complications’ and ‘Total spinal block’.
Section 4.9
Minor editorial changes.
Section 5.1
Minor editorial change. Removal of references to infusion.
Section 5.2
Removal of references to infusion. Addition of paediatric information to harmonise with other strengths.
Section 6.1
Addition of ‘s’ to ‘water for injection’.
Section 6.2
Removal of incompatibility information related to removal of infusion information.
Section 6.6
Change section heading. Addition of statement to visually inspect product before use.
Section 8
Minor editorial change to section heading.
Section 9
Minor editorial change to section heading. Update to “Date of last renewal”.
Section 10
Update of Date of Revision to 20th April 2012.
Updated on 08 May 2012
Reasons for updating
- 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 4.4 - Special warnings and precautions for use
- 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 2
Addition of sodium content. Minor editorial changes.
Section 3
Reduced to ‘Solution for injection’.
Section 4.1
Removal of references to infusion. Addition of indications for other strengths.
Section 4.2
Minor editorial changes to table. Removal of references to infusion. Addition of paediatric posology and method of administration to harmonise with other strengths.
Section 4.4
Remove ‘special’ from section heading. Removal of references to infusion. Addition of paediatric warnings to harmonise with other strengths.
Section 4.6
Minor editorial change.
Section 4.7
Minor editorial change.
Section 4.8
Table of adverse drug reactions updated so that it is sorted by system organ class. Removal of references to infusion. Addition of subheadings ‘Neurological complications’ and ‘Total spinal block’.
Section 4.9
Minor editorial changes.
Section 5.1
Minor editorial change. Removal of references to infusion.
Section 5.2
Removal of references to infusion. Addition of paediatric information to harmonise with other strengths.
Section 6.1
Addition of ‘s’ to ‘water for injection’.
Section 6.2
Removal of incompatibility information related to removal of infusion information.
Section 6.6
Change section heading. Addition of statement to visually inspect product before use.
Section 8
Minor editorial change to section heading.
Section 9
Minor editorial change to section heading. Update to “Date of last renewal”.
Section 10
Update of Date of Revision to 20th April 2012.
Updated on 26 September 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
Section 4.4, 4.8 & 4.9
Changed text to include information on Porphyria and Treatment of Acute Toxicity
Section 10
Date of revision of text: 28 August 2008
Updated on 26 September 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.4, 4.8 & 4.9
Changed text to include information on Porphyria and Treatment of Acute Toxicity
Section 10
Date of revision of text: 28 August 2008
Updated on 21 May 2007
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2007
Reasons for updating
- New SPC for medicines.ie