Cernevit, Powder for Solution for Injection or Infusion
*Company:
Baxter Holding B.V.Status:
No Recent UpdateLegal 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 09 August 2023
File name
Cernevit_labelling_ IE.pdf
Reasons for updating
- New PIL for new product
Updated on 23 January 2023
File name
ie-spc Cernevit -clean-2019-06-0005.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 September 2019
File name
ie-spc Cernevit -clean-2019-06-0005.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.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.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
- New SPC for new product
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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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
Free text change information supplied by the pharmaceutical company
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 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
Updated on 01 September 2016
Reasons for updating
- New SPC for medicines.ie