Ferinject 500mg/10ml (as Ferric Carboxymaltose) 500 mg/10ml

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Iron (as Ferric Carboxymaltose) 500 mg/10ml

Available from:

شركة أدوية الحكمة - Hikma Pharmaceuticals

ATC code:

B03AC01

INN (International Name):

Iron (as Ferric Carboxymaltose) 500 mg/10ml

Dosage:

(as Ferric Carboxymaltose) 500 mg/10ml

Units in package:

1 Vial/Pack (1 X 10ml)

Manufactured by:

Bipso GmbH (المانيا)

Product summary:

128.99 :سعر الجمهور + الضريبة

Patient Information leaflet

Ferinject
®
Composition
_Active substance_
Iron as ferric carboxymaltose
_Excipients_
Sodium hydroxide, hydrochloric acid, water for injection to make
up the solution
Pharmaceutical form and quantity of active substance per unit
Solution for intravenous administration.
1 ml of solution contains 50 mg iron as ferric carboxymaltose.
One 10 ml vial contains 500 mg iron as ferric carboxymaltose.
Indications / Possible therapeutic uses
Iron deficiency in patients in whom oral iron therapy is not
sufficiently effective, is ineffective or cannot be undertaken,
such as cases where oral iron preparations cannot be tolerated
or in the presence of inflammatory gastrointestinal diseases,
e.g. ulcerative colitis, which may be exacerbated by oral iron
therapy, or in the case of treatment-refractory iron-deficiency
states where it is suspected that the oral iron preparations are
being taken unreliably. Ferinject
®
should only be administered
if the diagnosis of iron deficiency has been established and
confirmed through appropriate laboratory investigations
(e.g. plasma ferritin levels, transferrin saturation (TSAT),
haemoglobin, haematocrit, red cell count, MCV and MCH).
Dosage / Use
A single dose of Ferinject
®
should not exceed 1000 mg iron
(20 ml) per day or 20 mg iron (0.4 ml) per kg body weight. The
maximum total weekly dose is 1000 mg (20 ml).
In patients with chronic kidney disease requiring haemodialysis,
a maximum dose of 200 mg iron injected once daily must not
be exceeded.
The cumulative total dose of Ferinject
®
(in mg iron) must be
individually calculated and must not be exceeded. The total
cumulative dose is calculated as follows for each patient using
the Ganzoni formula:
Total iron deficit [mg] = cumulative total dose [mg] =
body weight [kg] × (target Hb – actual Hb) [g/dl] × 2.4 + iron
stores [mg]
For body weight below 35 kg: Target Hb = 13 g/dl (8.1 mmol/l)
and iron stores = 15 mg/kg
For body weight of 35 kg and over: Target Hb = 15 g/dl (9.3
mmol/l) and iron stores = 500 mg
To convert Hb [mM] into Hb