NOVICRIT epoetin lambda (rch) 10,000 IU/1.0 mL solution for injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Epoetin lambda, Quantity: 10000 IU

Available from:

Sandoz Pty Ltd

INN (International Name):

Epoetin lambda

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; monobasic sodium phosphate dihydrate; dilute hydrochloric acid; glycine; dibasic sodium phosphate dihydrate; polysorbate 80; water for injections; sodium hydroxide

Administration route:

Subcutaneous, Intravenous

Units in package:

1, 6

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions.. Treatment of anaemia in patients with nonmyeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. Adult patients with mild to moderate anaemia (haemoglobin > 100 to less than or equal to 130g/L) scheduled for elective surgery with an expected moderate blood loss (two to four units or 900 to 1,800mL) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery.. Augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to predeposit their complete perioperative blood needs.

Product summary:

Visual Identification: Clear, colourless solution, practically free of visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-01-27

Patient Information leaflet

NOVICRIT
®
1
NOVICRIT
®
_epoetin lambda (rch) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Novicrit.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.SANDOZ.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Novicrit
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NOVICRIT IS USED
FOR
Novicrit is used:
•
to treat anaemia associated with
kidney disease
•
to treat anaemia in patients
receiving chemotherapy for
certain types of cancer
•
in patients with anaemia who are
about to undergo surgery as an
alternative to a blood transfusion
where there is the likelihood of
moderate blood loss
•
in patients with anaemia who face
major elective surgery and who,
prior to it, donate blood so that
their own blood can be given to
them during and after surgery.
Novicrit stimulates the production
of red blood cells and hence, a
higher volume of blood can be
taken from these patients.
Novicrit contains the active
ingredient epoetin lambda (rch).
Epoetin lambda (rch) is man-made
and works in exactly the same way as
the natural hormone produced in
your kidneys.
Epoetin lambda is a hormone which
works by stimulating the production
of red blood cells. It is used to treat
anaemia, a condition in which there
is a decreased number of red blood
cells.
ASK YOUR DOCTOR IF YO

Summary of Product characteristics

210930-Novicrit-pi
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
NOVICRIT
 SOLUTION FOR INJECTION (EPOETIN LAMBDA (_RCH_))
USE IN CANCER
In some studies, use of Erythropoiesis Stimulating Agents (ESAs) to
treat anaemia in patients
with cancer has been associated with increased mortality. ESAs should
only be used to treat
anaemia that has developed as a result of concomitantly administered
chemotherapy, and
only when blood transfusion is not considered appropriate. Haemoglobin
levels should not
exceed 120g/L (see PRECAUTIONS).
1
NAME OF THE MEDICINE
Epoetin lambda
_(rch)_
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of Novicrit

Solution for Injection is Epoetin lambda
_(rch)_
.
Erythropoietin is an endogenous glycoprotein that stimulates red blood
cell production. It is
normally produced by the kidney and regulated by the level of tissue
oxygenation. Epoetin
lambda (rch) (CHO) is purified from a Chinese hamster ovary (CHO) cell
line into which the
gene
coding
for
human
erythropoietin
has
been
inserted.
Epoetin
lambda
(rch)
is
indistinguishable
from
human
erythropoietin
in
biological
activity
and
immunological
reactivity.
Epoetin lambda (rch) has been developed as a similar biological
medicinal product to epoetin
alfa.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Novicrit is supplied in a pre-filled syringe as a clear, colourless
solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Novicrit is indicated for the treatment of patients with symptomatic
or transfusion requiring
anaemia associated with chronic renal failure to improve their quality
of life by improving
energy levels, exercise performance, fatigue and sleep patterns and by
reducing the need for
blood transfusions.
Novicrit is indicated for the treatment of anaemia in patients with
nonmyeloid malignancies
where anaemia develops as a result of concomitantly administered
chemotherapy, and where
blood transfusion is not considered appropriate.
Novicrit is also indic