Ferinject® 50 mg ironmL solution for injectioninfusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Ferric Carboxymaltose

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

Ferric Carboxymaltose

Units in package:

10 ml; 20 ml

Manufactured by:

IDT BIOLOGIKA GMBH

Patient Information leaflet

Not Applicable

Summary of Product characteristics

200716_SPC-YV007/YV080/YV013/MR/E30 T UK01-MY
1/10
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 10 mL vial contains 500 mg of iron as ferric carboxymaltose.
Each 20 mL vial contains 1,000 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 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 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 of iron deficiency must be based on laboratory tests.
[e.g., plasma ferritin levels,
haemoglobin, haematocrit, red cell count, MCV, MCH and transferrin
saturation (TSAT).]
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 individual iron need for repletion using Ferinject is determined
based on the patient’s body weight
and haemoglobin (Hb) level. Refer to T