FERROSIG

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Iron polymaltose

Available from:

Sigma Company Limited

Class:

Medicine Registered

Patient Information leaflet

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_(Iron polymaltose injection) _
_ _
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET? 
This leaflet answers some 
common questions about 
FERROSIG INJECTION. 
It does not contain all the 
available information. 
It does not take place of 
talking to your doctor or 
pharmacist. 
All medicines have risks 
and benefits. 
Your doctor has weighed 
the risks of using 
FERROSIG INJECTION 
against the benefits this 
medicine is expected to 
have for you. 
IF YOU HAVE ANY CONCERNS 
ABOUT THIS MEDICINE, ASK 
YOUR DOCTOR OR 
PHARMACIST. 
KEEP THIS LEAFLET WITH YOUR 
MEDICINE.  You may need 
to read it again. 
WHAT IS FERROSIG 
INJECTION? 
The name of your medicine 
is FERROSIG Injection.  
FERROSIG injection is an 
iron supplement. 
_It contains iron in a form _
_that can be used by your _
_body to build up iron _
_reserves that are needed for _
_your system to operate _
_properly. _
WHAT IS FERROSIG 
INJECTION USED FOR? 
FERROSIG INJECTION is 
used in cases of iron 
deficiency (too little iron in 
the system).  
FERROSIG INJECTION is 
used when dosage by mouth 
is impractical, the anaemia 
is severe or disturbances in 
the gastro-intestinal tract 
make absorption difficult or 
uncertain. 
FERROSIG INJECTION is 
also used for treating iron 
deficiency states discovered 
in the third trimester of 
pregnancy and in 
circumstances where 
contact between patient and 
doctor only occurs at 
irregular intervals. 
Your doctor however, may 
have prescribed and used 
FERROSIG INJECTION 
for another reason. 
ASK YOUR DOCTOR IF YOU 
HAVE ANY QUESTIONS ABOUT 
WHY FERROSIG 
INJECTION HAS BEEN 
PRESCRIBED FOR YOU. 
A doctor's prescription is 
required for FERROSIG 
INJECTION. 

BEFORE YOU ARE GIVEN 
FERROSIG INJECTION 
_When you must not be given _
_it: _
DO NOT USE FERROSIG 
INJECTION IF YOU HAVE 
EVER HAD AN ALLERGIC 
REACTION TO: 
1.  FERROSIG 

Summary of Product characteristics

Page 1 
PRODUCT INFORMATION 

FERROSIG INJECTION

NAME OF THE DRUG 
Iron polymaltose compound 

DESCRIPTION 
FERROSIG Injection contains a macromolecular spherocolloidal complex
of iron (III) 
hydroxide and the carbohydrate polymaltose. Iron polymaltose is also
considered to be a 
_complex of ferric hydroxide and isomaltose_. 
The substance has an empirical formula of C
120
H
220
O
156
Fe
37
 and the complex has a molecular 
weight of 462,000. 
Each 2 mL ampoule of FERROSIG Injection contains the equivalent of
100 mg of iron.  The 
aqueous colloidal solution is sterile, pyrogen-free and approximates
the pH and tonicity of the 
tissues. 
The excipients are water for injections and hydrochloric acid or
sodium hydroxide (for pH 
adjustment). 

PHARMACOLOGY 
FERROSIG Injection is an aqueous, approximately isotonic solution for
intramuscular 
injection. 
When injected intramuscularly the iron polymaltose evokes a local
inflammatory response 
and is transported via the lymphatics to the regional lymph nodes
without being broken down 
(reactive absorption).  It then enters the blood, reaching its
maximum concentration in about 
24 hours.  The circulating iron polymaltose is taken up by the cells
of the reticulo-endothelial 
system, which slowly ionise it to Fe
3+
 and polymaltose.  The majority of Fe
3+
 is bound to 
transferrin and transported to the bone marrow where it is
incorporated into haemoglobin, the 
remainder is contained within the storage forms, haemosiderin and
ferritin, or incorporated 
into myoglobin or haem-containing enzymes.  Only very small amounts
of iron are excreted. 
The conservation of body iron and the lack of an excretory
mechanism for excess iron may 
lead to iron overload if iron intake is excessive.
 Polymaltose is either metabolised or 
excreted. 
A study was conducted on 12 anaemic women aged from 20-45 years.
 After an intravenous 
infusion of 100 mg elemental iron, comprising 2 mL of FERROSIG
Injection diluted in