VENOFER iron 100mg/5mL (as iron(III) hydroxide sucrose complex) injection

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

iron sucrose, Quantity: 540 mg/mL (Equivalent: iron, Qty 20 mg/mL)

Tilgjengelig fra:

Seqirus Pty Ltd

Legemiddelform:

Injection, concentrated

Sammensetning:

Excipient Ingredients: sodium hydroxide; water for injections

Administreringsrute:

Intravenous

Enheter i pakken:

5 x 5mL ampoules

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

VENOFER is indicated for the treatment of iron deficiency anaemia in patients undergoing chronic haemodialysis and who are receiving supplemental erythropoietin therapy.,The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. serum ferritin, serum iron, transferrin saturation and hypochromic red cells).

Produkt oppsummering:

Visual Identification: Dark brown, non-transparent aqueous solution contained in a 5 mL glass ampoule.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2004-05-19

Informasjon til brukeren

Venofer Consumer Medicine Information v06
VENOFER
®
_ _
_iron sucrose _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
VENOFER.
It does not contain all the
available information. It
does not take the place of
talking to your doctor.
All medicines have risks
and benefits.
Your doctor has weighed
the risks of you being given
VENOFER against the
benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT RECEIVING
VENOFER ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it
again.
WHAT VENOFER IS
USED FOR
VENOFER provides a
source of iron that can help
to replenish a shortage of
iron in patients with iron
deficiency.
ASK YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS ABOUT
WHY VENOFER HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
reason.
This medicine is only
available with a doctor's
prescription.
There is no evidence that it
is addictive.
BEFORE YOU ARE
GIVEN VENOFER
_ _
_ _
_When you must not be _
_given it _
YOU MUST NOT BE GIVEN
VENOFER IF:
•
you are known to be
sensitive to any of the
ingredients of this
medicine listed at the
end of this leaflet
•
your anaemia is not due
to a shortage of iron
•
you are in the first
trimester of a
pregnancy
•
you have a condition
known as haemo-
chromatosis (an excess
of iron in the body) or a
genetic tendency
towards this condition.
VENOFER should not be
used after the expiry date
printed on the label.
IF YOU ARE NOT SURE
WHETHER YOU SHOULD BE
GIVEN VENOFER, TALK TO
YOUR DOCTOR.
_Before you are given it _
_ _
YOU SHOULD BE AWARE THAT:
•
a blood test should
have been carried out
to ensure treatment
with this medicine is
appropriate
•
if you have a history of
asthma, eczema or
other atopic allergies
you are more
susceptible to
experience allergic
reactions
•
intravenous iron
preparations can cause
severe allergic
reactions. These
allergic reactions may
include chest pain. Tell
your doctor
immediately if you
experience it.
TELL YOUR DOCTOR IF YOU

Preparatomtale

20210825 - SPC-YA539/AU/E07
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION - VENOFER (IRON
SUCROSE)
1
NAME OF THE MEDICINE
Iron sucrose
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each VENOFER 5 mL ampoule contains 20 mg/mL iron as iron sucrose
(iron(III)
hydroxide sucrose complex) as the active ingredient corresponding to
100 mg iron per
5 mL ampoule.
For the full list of excipients see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Concentrated injection for intravenous use.
VENOFER is a dark brown, non-transparent, aqueous solution with a pH
of 10.5–11.0
and an osmolarity of 1250 mOsmol/L.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VENOFER is indicated for the treatment of iron deficiency anaemia in
patients
undergoing chronic haemodialysis and who are receiving supplemental
erythropoietin
therapy.
The diagnosis of iron deficiency must be based on appropriate
laboratory tests (e.g.
serum ferritin, serum iron, transferrin saturation and hypochromic red
cells).
4.2
DOSAGE AND METHOD OF ADMINISTRATION
The dosage of VENOFER is expressed in terms of mg of iron. Each mL
contains 20
mg of iron.
Since a test dose without incident does not indicate that subsequent
doses will also
be reaction free, test doses may still be carried out but are not
required.
20210825 - SPC-YA539/AU/E07
Page 2 of 12
TREATMENT OF IRON DEFICIENCY IN HAEMODIALYSIS PATIENTS RECEIVING
ERYTHROPOIETIN:
The recommended dosage of VENOFER for the treatment of iron deficiency
in
haemodialysis patients receiving erythropoietin therapy is 100 mg of
iron (5 mL of
VENOFER) delivered intravenously during the dialysis session.
Frequency of dosing
should not be more than three times per week. Most patients will
require a minimum
cumulative dose of 1000 mg of iron, administered over 10 sequential
dialysis sessions,
to achieve a favourable haemoglobin or haematocrit response. Patients
may continue
to require therapy with VENOFER at the lowest dose necessary to
maintain target
levels of haemoglobin, haematocrit and laboratory parameters of iron
sto