Cernevit, Powder for Solution for Injection or Infusion *

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 06 September 2019

File name

ie-spc Cernevit -clean-2019-06-0005_1567769821.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 04 April 2019

File name

ie-spc-2019-03-cernevit-PA2299019001_1554365837.pdf

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)

Updated on 09 August 2018

File name

Cernevit ie-spc_1533829994.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 18 July 2017

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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company



Changes to SPC

 

4.3 deletion and addition of text –

·           known hypersensitivity to the active constituents, especially vitamin B1 or to any of the excipients listed in section 6.1, including soy protein/products (lecithin in mixed micelle is soy-derived) or peanutshypersensitivity to the active substances, especially vitamin B1 or to any of the excipients listed in section 6.1, including soy protein/products (lecithin in mixed micelle is soy derived) or peanut protein/products,

4.4 added text –

·           Cross-allergic reactions between soybean and peanut proteins have been observed.

4.6 added and deleted text –

Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing Cernevit.

This product should not be used in pregnancy or in women breast feeding infants.
Vitamins are excreted in breast milk.

Pregnancy
No safety data are available for Cernevit administered during pregnancy or in breastfeeding women. This medicinal product may be prescribed during pregnancy if required, providing the indication and dosages are observed in order to avoid vitamin overdose.

Lactation
Use is not recommended during breastfeeding because of the risk of vitamin A overdose in the neonate.

Fertility
There are no adequate data from the use of Cernevit with regards to fertility in male or female patients.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 18 July 2017

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 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



Changes to SPC

 

4.3 deletion and addition of text –

·           known hypersensitivity to the active constituents, especially vitamin B1 or to any of the excipients listed in section 6.1, including soy protein/products (lecithin in mixed micelle is soy-derived) or peanutshypersensitivity to the active substances, especially vitamin B1 or to any of the excipients listed in section 6.1, including soy protein/products (lecithin in mixed micelle is soy derived) or peanut protein/products,

4.4 added text –

·           Cross-allergic reactions between soybean and peanut proteins have been observed.

4.6 added and deleted text –

Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing Cernevit.

This product should not be used in pregnancy or in women breast feeding infants.
Vitamins are excreted in breast milk.

Pregnancy
No safety data are available for Cernevit administered during pregnancy or in breastfeeding women. This medicinal product may be prescribed during pregnancy if required, providing the indication and dosages are observed in order to avoid vitamin overdose.

Lactation
Use is not recommended during breastfeeding because of the risk of vitamin A overdose in the neonate.

Fertility
There are no adequate data from the use of Cernevit with regards to fertility in male or female patients.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 18 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 01 September 2016

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 01 September 2016

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