Naropin 10 mg/ml solution for injection
- Name:
Naropin 10 mg/ml solution for injection
- Company:
Aspen
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Aspen
Company Products
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 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
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 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
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 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
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)