Diafer 50 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IRON (III)

Available from:

Pharmacosmos A/S

ATC code:

B03AC

INN (International Name):

IRON (III)

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Iron, parenteral preparations

Authorization status:

Marketed

Authorization date:

2014-05-09

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAFER
® 50 MG/ML SOLUTION FOR INJECTION
Iron
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Diafer is and what it is used for
2.
What you need to know before you receive Diafer
3.
How Diafer is given
4.
Possible side effects
5.
How to store Diafer
6.
Contents of the pack and other information
1.
WHAT DIAFER IS AND WHAT IT IS USED FOR
Diafer contains a combination of iron and derisomaltose (a chain of
sugar molecules). The type of iron
in Diafer is the same as that found naturally in the body.
Diafer is used for low levels of iron (called ‘iron deficiency’)
if you have chronic kidney disease and
are on dialysis provided oral iron cannot be used.
Diafer is used to replenish and maintain body iron stores by repeated
treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE DIAFER
YOU MUST NOT RECEIVE DIAFER

if you have anaemia that is not caused by low levels of iron
(deficiency), such as
‘haemolytic’ anaemia

if you have too much iron (overload) or a problem in the way your body
uses iron

if you are allergic (hypersensitive) to the product or any of the
other ingredients of the
medicine (listed in section 6)

if you have experienced serious allergic (hypersensitive) reactions to
other injectable iron
preparations

if you have active liver disease
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before receiving Diafer:

if you have a history of medicine allergy

if you have systemic lupus erythematosus

if you have rheumatoid arthritis

if you have severe asthma, eczema or other allergies

if you have an ongoing bacterial infection in your blood
2
One ml of undiluted Diafer contains up to 4.6 mg
_ _
(

Summary of Product characteristics

Health Products Regulatory Authority
08 April 2022
CRN00CQXP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diafer 50 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One millilitre of solution contains 50 mg iron as ferric
derisomaltose.
A 2 ml ampoule contains 100 mg iron as ferric derisomaltose.
One ml of solution contains up to 4.6 mg (0.2 mmol) sodium, see
section 4.4.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Dark brown, non transparent solution with pH 5.0-7.0 and an
approximate osmolarity of 400 mOsm/l.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diafer is indicated in adults for the treatment of iron deficiency in
patients with chronic kidney disease on dialysis, when oral
iron preparations are ineffective or cannot be used.
The diagnosis of iron deficiency should be based on appropriate
laboratory tests (e.g. serum ferritin, serum iron, transferrin
saturation or hypochromic red cells).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Diafer may be administered as an up to 200 mg dosage with a maximum
weekly administration of 1000 mg.If higher doses
than 200 mg of iron are needed, other iron medicinal products intended
for intravenous use should be used.
The iron dose must be individualised based on the clinical response to
treatment including evaluation of haemoglobin, ferritin
and tranferrin saturation, concommittant treatment with an
erythropoiesis stimulating agent (ESA) and the dosis of ESA
treatment. Targets may vary from patient to patient and depending on
local guidelines.
Maintenance therapy with iv iron treatment may be given as small doses
administered at regular intervals to maintain iron
status tests stable within specific limits with the intent of avoiding
development of iron deficiency or decline of iron test
parameters below specific levels.
_Paediatric population:_
Diafer is not recommended for use in children and adolescents < 18
years due to insufficient data on safety