Diafer 50 mg/ml solution for injection

IV iron. Essential Prescription and Administration Information to Minimise the Risk of Serious Hypersensitivity Reactions

Intravenous (IV) Iron Important Information for Patients about the Possible Risk of Serious Allergic Reactions with IV iron treatment (iron given by injection or infusion into a vein)

Removal of black triangle and the following associated text: "This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects." 

Removal of black triangle and the following associated text: "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." 

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

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

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

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

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

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

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) 

Section 4.4: Special warnings and precautions for use

Added in 7^th paragraph (2^nd 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