Naropin 10 mg/ml solution for injection * Pharmacy Only: Prescription
Company:
AspenStatus:
UpdatedLegal 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
654253ba6c91d.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 October 2023
File name
6537d788c672c.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
6537d76044e53.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 04 September 2023
File name
64f5786322ea0.pdf
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 July 2023
File name
64bfd8eb2162e.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
64bfd79d4d218.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
63638f81de13f.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 05 October 2022
File name
633d48b0069a9.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
633aa5a46bc67.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 03 October 2022
File name
633aa5775ec7d.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
62ed31cb0441a.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_1636043451.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_1615974783.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 4.4 - 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
- Change to section 4.3 - Contraindications
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 4.4 - 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
- Change to section 4.3 - Contraindications
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
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 May 2017
Reasons for updating
- New SPC for medicines.ie