Ferinject Solution for Injection 50mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FERRIC CARBOXYMALTOSE 180 mg EQV IRON

Available from:

VIFOR PHARMA ASIA PACIFIC PTE. LTD.

ATC code:

B03AC01

Dosage:

50mg

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

FERRIC CARBOXYMALTOSE 180 mg EQV IRON 50 mg/ml

Administration route:

INTRAVENOUS DRIP, INTRAVENOUS BOLUS

Prescription type:

Prescription Only

Manufactured by:

IDT Biologika GmbH

Authorization status:

ACTIVE

Authorization date:

2011-10-19

Patient Information leaflet

FERINJECT
®

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. 

One ml of solution contains up to 5.5 mg (0.24
mmol) sodium, see section 4.4. For a 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 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 closely observed for signs and
sympotms of hypersensitivity 
reactions during and for at least 30 minutes following each
Ferinject injection. 
_ _
_Determination of the cumulative iron dose _

The cumulative dose for repletion of iron using Ferinject is
determined based on the patient’s 
body weight and haemoglobin level and must not be exceeded.
The following table should be 
used to determine the cumulative iron dose: 

140808 SPC-YV007/YV080/SG/E05  
 Vifor (International) Inc   

       Page 1/9 

Hb (g/dL)

Patients with body 
weight  
35 kg�

Summary of Product characteristics

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BUSINESS USE
FERINJECT
®
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.
Excipient(s) with known effect
One ml of solution contains up to 5.5 mg (0.24 mmol) sodium, see
section 4.4. For a 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 the treatment of iron deficiency when (see
section 5.1)
-oral iron preparations are ineffective.
-oral iron preparations cannot be used.
-there is a clinical need to deliver iron rapidly
The diagnosis 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 closely observed for signs and sympotms
of hypersensitivity
reactions during and for at least 30 minutes following each Ferinject
administration .
_ _
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:
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BUSINESS USE
_Step 1: Determination of the iron need_
The individual iron need for repletion using Ferinject is determined
based on the patient’s body weight
and haemoglobin (Hb) level. Refer to Table 1 for determination of the
iron need:
TABLE 1:
DET