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: 04/09/20

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Summary of Product Characteristics last updated on medicines.ie: 4/9/2020
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
1 - 0 of 4 items.Total: Infinity pages

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 4 September 2020 SmPC

Reasons for updating

  • Change to product name

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

Free text change information supplied by the pharmaceutical company

INN name changed from iron(III) isomaltoside 1000 to ferric derisomaltose.

Updated on 4 September 2020 PIL

Reasons for updating

  • Change to name of medicinal product

Free text change information supplied by the pharmaceutical company

INN name changed from iron(III) isomaltoside 1000 to ferric derisomaltose.

Updated on 14 May 2020 SmPC

Reasons for updating

  • 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

The only change is the date of revision of the text, no other changes. 

Updated on 14 May 2020 PIL

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Date of revision was updated. No other changes in PIL. 

Updated on 24 January 2020 SmPC

Reasons for updating

  • 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 4.8 – 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

In 4.4 Special warnings and precautions for use: Addition of following text at the end of first paragraph =

"There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8)."

In 4.6 Fertility, pregnancy and lactation: in Pregnancy section addition of following text as third paragraph 

"Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women."

In section 4.8 Undesirable effects: In Cardiac disorders addition of following 

"Not known: Kounis syndrome"


In section 4.8 Undesirable effects: Reporting of suspected adverse reactions; 

Changed from:

HPRA Pharmacovigilance
Earlsfort Terrace 
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Changed to:

HPRA Pharmacovigilance
Website: www.hpra.ie


In section 10 Date of Revision of the text: 

Deleted: 18.10.2019

and

Added : 23.01.2020

Updated on 24 January 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2  Warning and Precautions: following text were deleted 

"You should tell your doctor immediately so that they can stop the injection if necessary if you experience symptoms of angioedema, such as • swollen face, tongue or pharynx • difficulty to swallow • hives and difficulties to breath"

 

Section 4: Possible Sife effects; Following were added 

"Allergic reactions
Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction: swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath, and chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome."

 

Section 4: how to report a side effect 

Changed from: 
HPRA Pharmacovigilance
Earlsfort Terrace 
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie 

Changed to: 

HPRA Pharmacovigilance
Website: www.hpra.ie

 

Section 6: This leaflet was revised in 

deleted: 2019/06 

added: 01/2020

 

 

Updated on 24 January 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

In Section 2 warning and precautions: the following text was deleted after the bullet points

"You should tell your doctor immediately so that they can stop the injection if necessary, if you experience symptoms of angioedema, such as

• swollen face, tongue or pharynx

• difficulty to swallow

• hives and difficulties to breath" 

 

In Section 4: Second line following text was added

"Allergic reactions
Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction: swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath, and chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome."

 

Section 6: This leaflet was last revised in

2019/06 (deleted)

and

01/2020 (added) 

 

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