AINIRON (Iron Sucrose Injection 20mgmL)

Country: Malaysia

Language: English

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

Active ingredient:

IRON (III)- HYDROXIDE SUCROSE COMPLEX

Available from:

AIN MEDICARE SDN. BHD.

INN (International Name):

IRON (III)- HYDROXIDE SUCROSE COMPLEX

Units in package:

5 ml

Manufactured by:

AIN MEDICARE SDN. BHD.

Summary of Product characteristics

USER INFORMATION
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AINIRON (Iron Sucrose Injection 20mg/mL)
COMPOSITION:
Each 5mL vial contains 100mg iron as iron sucrose (Iron (iii)
hydroxide sucrose complex).
PRODUCT DESCRIPTION:
AINIRON is a solution for injection or concentrate for solution for
infusion. The solution is dark brown, non transparent, aqueous
solution.
PHARMACODYNAMICS/PHARMACOKINETICS:
Iron sucrose is rapidly cleared from the plasma after intravenous
injection with a terminal half-life of about 6 hours. A competitive
exchange of iron
takes place from the iron sucrose complex to the iron-binding protein
transferrin. About 5% of a dose is eliminated via the kidneys in the
first 4 hours
after a dose.
INDICATION:
AINIRON is indicated for the treatment of iron deficiency anaemia in
the following indications:-
• where there is a clinical need for a rapid iron supply,
• In patients who cannot tolerate oral iron therapy or who are
non-compliant,
• In active inflammatory bowel disease where oral iron preparations
are ineffective.
AINIRON should only be administered where the indication is confirmed
by appropriate investigations (e.g. Hb, serum ferritin, serum iron).
RECOMMENDED DOSAGE:
ADMINISTRATION
AINIRON must only be administered by the intravenous route. This may
be by a slow intravenous injection or by an intravenous drip infusion.
AINIRON must not be used for intramuscular injection.
Before administration the first therapeutic dose, a test dose should
be given. If any allergic reaction or intolerance occurs during
administration, the
therapy must be stop immediately.
INTRAVENOUS DRIP INFUSION
AINIRON must be diluted only in sterile 0.9% w/v sodium chloride
solution:
• 100mg iron (5mL AINIRON) in maximum 100mL sterile 0.9% w/v sodium
chloride solution
• 500mg iron (25mL AINIRON) in maximum 500mL sterile 0.9% w/v sodium
chloride solution
For stability reasons, dilutions to lower AINIRON concentrations are
not permissible.
As infusion, maximum tolerated single dose per day given not more than
once per week:
• Patien