Nozinan 25mg/ml Solution for Injection/Infusion

  • Name:

    Nozinan 25mg/ml Solution for Injection/Infusion

  • Company:
    info
  • Active Ingredients:

    levomepromazine hydrochloride

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/05/16

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Summary of Product Characteristics last updated on medicines.ie: 12/10/2017
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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 12 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 12 October 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

4.5 added:-

There is a possible pharmacokinetic interaction between inhibitors of CYP2D6, such as phenothiazines, and CYP2D6 substrates.

Updated on 15 March 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

TII Update to product info (SPC only) with Levomepromazine CCSI v1.

Updated on 2 June 2016 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.6

Fertility, Ppregnancy and lactation

 

Pregnancy

In humans, the teratogenic risk of levomepromazine has not been evaluated. Different prospective epidemiological studies conducted with other phenothiazines have yielded contradictory results regarding teratogenic risk. Nozinan is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

 

Breast-feeding

Levomepromazine is excreted in breast milk in low amounts in human milk. A risk to the suckling child cannot be excluded.

 

Fertility

 

In humans, because of the interaction with dopamine receptors, levomepromazine may cause hyperprolactinaemia which can be associated with impaired fertility in women. Some data suggest that levomepromazine treatment is associated with impaired fertility in men.



Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’, in addition to the traditional post-paid ‘yellow card’ option.

FREEPOSTHPRA

Pharmacovigilance, Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace, IRL -

Dublin 2;

Tel: +353 1 6764971

Fax: +353 1 6762517Website: www.hpraimb.ie;

Updated on 27 May 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 May 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 6 January 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Type II C.1.4 to update the SPC sections 4.4 & 4.8 to reflect the updated Levomepromazine GLU version 8 & 9.

Updated on 18 December 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 22 November 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Type IAIN B.II.f.1.a.1 variation to reduce the shelf life of the finished product from 60 months to 36 months without change of the storage conditions (below 25°C protect from light).

Updated on 9 August 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Type 1B No. A.2 b to update the product name to Nozinan 25mg/ml Solution for Injection/Infusion, in line with the standard terms.

Updated on 8 August 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 30 May 2013 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Type II variation to update the SPC and PL to reflect the changes in the recent PSUR submission (CRN 2104815).

Updated on 29 May 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 21 November 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 10 March 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 1 February 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Information relating to hyperglycaemia

Updated on 19 August 2009 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 18 March 2009 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update Sections 4.3, 4.4, 4.5, 4.8 of SPC

Updated on 13 May 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to restricted prescription (C)

Updated on 7 April 2008 PIL

Reasons for updating

  • Change to packaging

Updated on 7 April 2008 SmPC

Reasons for updating

  • 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update Section 6.5 of SPC Nature and Contents of Container

Updated on 13 August 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to restricted prescription (C)

Updated on 6 June 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 May 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to restricted prescription (C)

Updated on 19 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 13 November 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Update Section 10 - Change date of revision.
 

Updated on 13 November 2006 PIL

Reasons for updating

  • Change of licence holder

Updated on 27 June 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 20 June 2006 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to restricted prescription (C)

Updated on 2 December 2005 SmPC

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 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Updated on 2 December 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 July 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 May 2005 SmPC

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 4.3 - Contraindications
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Updated on 10 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to restricted prescription (C)