Naropin 10 mg/ml solution for injection

  • Name:

    Naropin 10 mg/ml solution for injection

  • Company:
    info
  • Active Ingredients:

    Ropivacaine hydrochloride monohydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/03/21

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Summary of Product Characteristics last updated on medicines.ie: 7/3/2018
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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 17 March 2021 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 March 2018 PIL

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

 

 

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 7 March 2018 SPC

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

 

 

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 7 March 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 16 May 2017 PIL

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 16 May 2017 SPC

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

None provided