FERROSIG INJECTION iron 100mg/2mL (as polymaltose) injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

iron polymaltose, Quantity: 318 mg (Equivalent: iron, Qty 100 mg)

Available from:

Sigma Company Limited

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid

Administration route:

Intramuscular, Intravenous

Units in package:

5 X 2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 8 April 2002: For the treatment of iron deficiency anaemia in the following circumstances: * When oral therapy is contraindicated. * When enteric absorption of iron is defective. * When patient non-compliance or persistent gastrointestinal intolerance makes oral therapy impractical.

Product summary:

Visual Identification: A slightly viscous, dark reddish brown liquid. Free of obvious contamination.; Container Type: Ampoule; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2002-04-22

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
wher
e 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
INJECTION or
other iron
preparations.
2.
a n y
of
the
other
ingredients
i n
FERROSIG.
_You must tell your doctor _
_if_
:
1.
YOU
HAVE
HAD
AN
ALLERGIC
REACTION
TO
IRON SUPPLEMEN

Summary of Product characteristics

Page 1
AUSTRALIAN PRODUCT INFORMATION – FERROSIG
(IRON POLYMALTOSE)
1
NAME OF THE MEDICINE
Iron polymaltose (AAN)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carton of 5 x 2 mL ampoules, with each 2 mL ampoule containing 318 mg
iron polymaltose
equivalent to 100 mg iron III (50 mg per mL).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
FERROSIG Injection is an aqueous, approximately isotonic solution for
intravenous and
intramuscular injection. It is a slightly viscous, dark reddish-brown
liquid. Free of obvious
contamination.
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_
.
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).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
FERROSIG is indicated for the treatment of iron deficiency anaemia in
the following
circumstances:
•
When oral therapy is contraindicated.
•
When enteric absorption of iron is defective.
•
When patient non-compliance or persistent gastrointestinal intolerance
makes oral
therapy impractical.
4.2
DOSE AND METHOD OF ADMINISTRATION
INTRAMUSCULAR USE
Technique of injection:
THE TECHNIQUE OF INJECTION IS OF CRUCIAL IMPORTANCE.
Page 2
FERROSIG INJECTION SHOULD NEVER BE INJECTED INTO THE ARM OR
OTHER EXPOSED AREAS. THE WRONG INJECTION TECHNIQUE MAY RESULT IN
PAIN AND PERSISTENT DISCOLOURATION OF THE SKIN.
The
following
method
of
ventro-gluteal
injection
according
to
Hochstetter is recommended instead of the nonnal method of injection
in the top outer quadrant of the gluteus maxi.mus muscle.
a.
The length of the needle should be at least 5-6 cm. The lumen of
the needle should not be too wide.
b.
T