SUCROFER Iron Sucrose Injection USP 20mgml

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

IRON (III)- HYDROXIDE SUCROSE COMPLEX

Commercializzato da:

BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.

INN (Nome Internazionale):

IRON (III)- HYDROXIDE SUCROSE COMPLEX

Confezione:

5ml X 5 Vials; 5ml X 10 Vials

Prodotto da:

BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED

Foglio illustrativo

Not Applicable

Scheda tecnica

SUCROFER DOSE
(MG OF IRON)
SUCROFER DOSE
(ML OF SUCROFER)
MAXIMUM DILUTION
VOLUME OF STERILE 0.9%
M/V NACL SOLUTION
MINIMUM
INFUSION
TIME
400 mg
100 mg
500 mg
200 mg
300 mg
5 ml
15 ml
25 ml
10 ml
20 ml
300 ml
500 ml
400 ml
200 ml
100 ml
15 minutes
30 minutes
1.5 hours
2.5 hours
3.5 hours
PHARMACEUTICAL FORM
PHARMACOLOGICAL PROPERTIES
Water for Injection USP q.s.
Iron Sucrose Injection USP (20 mg/ml) Sucrofer
The volume of distribution of the central compartment
corresponded well to the volume of plasma (approximately 3
litres).
Pharmacotherapeutic group: Anti-anaemic preparation, iron,
parenteral preparation, ATC code: B03 AC
Solution for injection or concentrate for solution for infusion.
Mechanism of action
Following intravenous administration, the polynuclear iron core
from the complex is taken up predominantly by the
reticuloendothelial system in the liver, spleen, and bone marrow.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml Contains:
NAME OF THE MEDICINAL PRODUCT
equivalent to elemental iron 20 mg
Ferric Hydroxide in Complex with Sucrose
Iron Sucrose Injection USP (20 mg/ml) – Sucrofer, is Dark brown
viscous aqueous solution.
PHARMACODYNAMIC PROPERTIES
Iron sucrose, the active ingredient of Sucrofer, is composed of a
polynuclear iron (III)-hydroxide core surrounded by a large
number of non-covalently bound sucrose molecules. The complex
has a weight average molecular weight (Mw) of approximately
43kDa. The polynuclear iron core has a structure similar to that of
the core of the physiological iron storage protein ferritin. The
complex is designed to provide, in a controlled manner, utilisable
iron for the iron transport and storage proteins in the body (i.e.,
transferrin and ferritin, respectively).
In a second step, the iron is used for the synthesis of Hb,
myoglobin and other iron-containing enzymes, or stored primarily
in the liver in the form of ferritin.
PHARMACOKINETIC PROPERTIES
Distribution
Biotransformation
Upon injection, sucrose largely dissociates and the polynuclear
iron core is mainly tak