Venofer 100mg/5ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Iron sucrose

Available from:

Vifor Pharma UK Ltd

INN (International Name):

Iron sucrose

Dosage:

20mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010102; GTIN: 7640114720307

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VENOFER 20 MG IRON /ML
SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION
IRON SUCROSE
This medicine 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.
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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before receiving Venofer if:
-
You have a history of medicine al

Summary of Product characteristics

OBJECT 1
VENOFER (IRON SUCROSE)
Summary of Product Characteristics Updated 09-Nov-2016 | Vifor Pharma
UK Limited
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.
1. Name of the medicinal product
Venofer 20 mg iron / ml, solution for injection or concentrate for
solution for infusion.
2. Qualitative and quantitative composition
One millilitre of solution contains 20 mg 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).
Each 2.5 ml vial of Venofer contains 50 mg iron as iron sucrose
(iron(III)-hydroxide sucrose complex).
Each 5 ml vial of Venofer contains 100 mg iron as iron sucrose
(iron(III)-hydroxide sucrose complex).
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.
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