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Baxter Healthcare Ltd

Caxton Way, Thetford, Norfolk, IP24 3SE, UK
Telephone: +44 (0)1635 206 345
Fax: +44 (0)1635 206071
Medical Information Direct Line: +44 (0)1635 206345
Medical Information e-mail: medinfo_uki@baxter.com
Medical Information Facsimile: +44 (0)1635 206071
Summary of Product Characteristics last updated on medicines.ie: 18/07/2017
SPC Cernevit, Powder for Solution for Injection or Infusion

When a pharmaceutical company changes an SPC or PIL, 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 18/07/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   03-Jul-2017
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 01/09/2016 and displayed until 18/07/2017
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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