Diafer 50 mg/ml solution for injection

  • Name:

    Diafer 50 mg/ml solution for injection

  • Company:
    info
  • Active Ingredients:

    Iron (III) isomaltoside 1000

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/08/19

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Summary of Product Characteristics last updated on medicines.ie: 9/8/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Pharmacosmos UK Limited

Pharmacosmos UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Cosmofer Active Ingredients Iron (III) hydroxide dextran complex (iron dextran)
Medicine Name Diafer 50 mg/ml solution for injection Active Ingredients Iron (III) isomaltoside 1000
Medicine Name Monover 100mg/ml solution for injection/infusion Active Ingredients Iron (III) isomaltoside 1000
Medicine Name Phosex 1000mg Tablet Active Ingredients Calcium Acetate
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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 9 August 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to date of revision

Updated on 9 August 2019 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 - how to report a side effect
  • 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

Section 4.4: Special warnings and precautions for use

Added in 7th paragraph (2nd last para): Caution should be exercised to avoid paravenous leakage when administrating Diafer. Paravenous leakage of Diafer at the injection site may lead to irritation of the skin and potentially long lasting brown discolouration at the site of injection. In case of paravenous leakage, the administration of Diafer must be stopped immediately.

 

Section 4.5

Changed from “Interaction with other medicinal products and other forms of interaction

Changed to “Interaction with other medicinal products and other forms of interactions

 

Section 4.8 Undesirable side effects

In General disorders and administration site conditions

Added: “Not known: Influenza like illness whose onset may vary from a few hours to several days

 

Section 10 Date of revision of the text

June 2019

Updated on 29 September 2014 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 September 2014 PIL

Reasons for updating

  • New PIL for new product