Ferinject 100mg/2ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ferric carboxymaltose

Available from:

Vifor Pharma UK Ltd

ATC code:

n/a

INN (International Name):

Ferric carboxymaltose

Dosage:

50mg/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: 7640114720444

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FERINJECT 50 MG IRON/ML SOLUTION FOR INJECTION/INFUSION
Ferric carboxymaltose
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 Ferinject is and what it is used for
2.
What you need to know before you receive Ferinject
3.
How Ferinject is given
4.
Possible side effects
5.
How to store Ferinject
6.
Contents of the pack and other information
1.
WHAT FERINJECT IS AND WHAT IT IS USED FOR
Ferinject is an antianaemic preparation, a medicine that is used to
treat anaemia. It contains iron in the
form of an iron carbohydrate. Iron is an essential element required
for the oxygen-carrying capacity of
haemoglobin in red blood cells and of myoglobin in muscle tissue.
Moreover, iron is involved in
many other functions necessary for maintenance of life in the human
body.
Ferinject is used for the treatment of patients with iron deficiency,
when oral iron preparations are
ineffective or cannot be used. The aim of the therapy is to replenish
body iron stores and to remedy
anaemia, a lack of red blood cells due to iron deficiency.
Before administration, your doctor will perform a blood test to
determine the dose of Ferinject you
require.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FERINJECT
YOU MUST NOT RECEIVE FERINJECT
-
if you are allergic (hypersensitive) to the product or any of the
other ingredients of this medicine
(listed in section 6).
-
if you have experienced seriou

Summary of Product characteristics

OBJECT 1
FERINJECT (FERRIC CARBOXYMALTOSE)
Summary of Product Characteristics Updated 23-May-2017 | 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
Ferinject 50 mg iron/mL solution for injection/infusion.
2. Qualitative and quantitative composition
One mL of solution contains 50 mg of iron as ferric carboxymaltose.
Each 2 mL vial contains 100 mg of iron as ferric carboxymaltose.
Each 10 mL vial contains 500 mg of iron as ferric carboxymaltose.
Each 20 mL vial contains 1,000 mg of iron as ferric carboxymaltose.
One mL of solution contains up to 5.5 mg (0.24 mmol) sodium, see
section 4.4.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection/infusion. Dark brown, non-transparent, aqueous
solution.
4. Clinical particulars
4.1 Therapeutic indications
Ferinject is indicated for treatment of iron deficiency when oral iron
preparations are ineffective or cannot
be used. The diagnosis of iron deficiency must be based on laboratory
tests.
4.2 Posology and method of administration
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during and following
each administration of Ferinject.
Ferinject 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 Ferinject administration (see
section 4.4).
Posology
The posology of Ferinject follows a stepwise approach: [1]
determination of the individual iron need, [2]
calculation and administration of the iron dose(s), and [3] post-iron
repletion assessments. These steps are
outlined below:
_Step 1: Determination of the iron need_
The ind