Venofer 20 mg iron/mL solution for injection or concentrate for solution for infusion, ampoule
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-03-2022
Summary of Product characteristics
(SPC)
23-03-2022
Active ingredient:
IRON (III)
Available from:
Vifor France
ATC code:
B03AB; B03AB02
INN (International Name):
IRON (III)
Dosage:
20 milligram(s)/millilitre
Pharmaceutical form:
Solution for injection/infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Iron trivalent, oral preparations; saccharated iron oxide
Authorization status:
Not marketed
Authorization date:
2000-03-20
Patient Information leaflet
2021-12-13 PIL-VEN/MRP/E12 T IE01
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PACKAGE LEAFLET: INFORMATION FOR THE USER
VENOFER 20 MG IRON /ML
SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION
IRON SUCROSE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Venofer is and what it is used for
2.
What you need to know before Venofer is given to you
3.
How Venofer is given
4.
Possible side effects
5.
How to store Venofer
6.
Contents of the pack and other information
1.
WHAT VENOFER IS AND WHAT IT IS USED FOR
Venofer
is a medicine that contains iron.
Medicines that contain iron are used when you do not have enough iron
in your body. This is
called “iron deficiency”.
Venofer is given when:
-
You cannot take iron by mouth - such as when iron tablets make you
feel ill.
-
You have taken iron by mouth - and it has not worked.
2.
WHAT YOU NEED TO KNOW BEFORE VENOFER IS GIVEN TO YOU
YOU MUST NOT RECEIVE VENOFER IF:
-
You are allergic (hypersensitive) to the product or any of the other
ingredients of this
medicine (listed in section 6).
-
You have experienced serious allergic (hypersensitive) reactions to
other injectable iron
preparations.
-
You have anaemia which is not caused by a shortage of iron.
-
You have too much iron in your body or a problem in the way your body
uses iron.
You must not be given Venofer if any of the above apply to you. If you
are not sure, talk to your
doctor before having Venofer.
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WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before receiving Venofer if:
-
You have a history of medicine allergy.
-
You have systemic lupus erythematosus.
-
You have rheumatoid arthritis.
-
You have severe asthma, eczema or other allergies.
-
You have any
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
22 March 2022
CRN00CRK4
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venofer 20 mg iron/mL solution for injection or concentrate for
solution for infusion, ampoule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One millilitre of solution contains 20mg of iron as iron sucrose
(iron(III)-hydroxide sucrose complex).
Each 5 mL ampoule of Venofer contains 100 mg iron as iron sucrose
(iron(III)-hydroxide sucrose complex).
Excipient with known effect
Venofer contains up to 7 mg sodium per mL.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or concentrate for solution for infusion.
Venofer is a dark brown, non transparent, aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Venofer is indicated for the treatment of iron deficiency in the
following indications:
- Where there is a clinical need for a rapid iron supply,
- In patients who cannot tolerate oral iron therapy or who are
non-compliant,
- In active inflammatory bowel disease where oral iron preparations
are ineffective,
- In chronic kidney disease when oral iron preparations are less
effective than Venofer.
The diagnosis of iron deficiency must be based on appropriate
laboratory tests (e.g. Hb, serum ferritin, TSAT, serum iron, etc.).
(Hb haemoglobin, TSAT transferrin saturation).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during and following each administration of
Venofer.
Venofer should only be administered when staff trained to evaluate and
manage anaphylactic reactions is immediately
available, in an environment where full resuscitation facilities can
be assured. The patient should be observed for adverse
effects for at least 30 minutes following each Venofer administration
(see section 4.4).
Posology
The cumulative dose of Venofer must be calculated for each patient
individually and must not be exceeded.
_Calculation of dosage_
The total cumulative dos
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