NEORECORMON epoetin beta (rch) 10 000 IU/0.6 mL injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Epoetin beta, Quantity: 16666.67 IU/mL

Available from:

Roche Products Pty Ltd

INN (International Name):

Epoetin beta

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: threonine; polysorbate 20; urea; water for injections; dibasic sodium phosphate dodecahydrate; glutamic acid; leucine; sodium chloride; calcium chloride dihydrate; monobasic sodium phosphate; phenylalanine; glycine; isoleucine

Administration route:

Intravenous, Subcutaneous

Units in package:

6

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Neorecormon is indicated for the treatment of anaemia associated with chronic kidney disease (CKD) in patients on dialysis and symptomatic patients not yet undergoing dialysis. To increase the yield of autologous blood from patients in pre-donation programme initiated to avoid the use of homologous blood. For the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks. For the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate.

Product summary:

Visual Identification: 1 mL ready to use syringe containing colourless, clear to slightly opalescent solution; 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:

Registered

Authorization date:

2006-01-09

Patient Information leaflet

NEORECORMON
®
_epoetin beta [recombinant human erythropoietin]_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NeoRecormon. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using NeoRecormon
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NEORECORMON IS
USED FOR
NeoRecormon is used to treat
anaemia caused by chronic kidney
disease.
Anaemia is caused by a lack of red
blood cells or haemoglobin which
transport oxygen in the blood. If you
have anaemia, your body's tissues
might not receive enough oxygen.
Symptoms may include tiredness,
weakness and shortness of breath.
NeoRecormon may also be used:
•
If you are planning to have major
surgery and you are going to have
your own blood collected for use
during the surgery.
•
To prevent anaemia in premature
babies.
•
If you have anaemia after being
treated with chemotherapy for
cancer and you can't have a blood
transfusion.
In some studies, people with
cancer treated with medicines like
NeoRecormon for anaemia did
not live as long as people not
receiving these medicines.
NeoRecormon contains the active
ingredient epoetin beta (pronounced
ee-poe-tin bee-ta). Epoetin beta is
also known as recombinant human
erythropoietin (pronounced ee-rith-
roe-poy-tin).
NeoRecormon belongs to a group of
medicines known as hormones. The
kidneys produce the natural hormone
erythropoietin, which stimulates the
production of red blood cells in the
bone marrow and spleen.
Like erythropoietin, NeoRecormon
works by increasing the number of
red blood cells and the haemoglobin
level in your blood.
Your doctor, however, may have
prescribed NeoRecormon for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NEOREC

Summary of Product characteristics

ropneore10220
1
AUSTRALIAN PRODUCT INFORMATION
NEORECORMON
® (EPOETIN BETA)
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 section 4.4 Special Warnings and Precautions for Use).
1.
NAME OF THE MEDICINE
Epoetin beta
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NeoRecormon 2000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
2000 international units (IU)
epoetin beta.
NeoRecormon 3000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
3000 international units (IU)
epoetin beta.
NeoRecormon 4000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
4000 international units (IU)
epoetin beta.
NeoRecormon 5000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
5000 international units (IU)
epoetin beta
NeoRecormon 6000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
6000 international units (IU)
epoetin beta
NeoRecormon 10,000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.6 ml solution for injection contains
10,000 international units
(IU) epoetin beta
NeoRecormon
(epoetin beta
_rch_
) is a sterile, purified, stable recombinant human
erythropoietin concentrate produced from genetically engineered
Chinese hamster ovary
(CHO) cells containing a cloned human erythropoietin gene.
The active ingredient, epoetin beta
_rch_
, is a highly purified glycoprotein, identical in amino
acid sequence to endogenous erythropoietin, with a mean m