EPREX epoetin alfa (rch) 30000IU/0.75mL injection syringe

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

Epoetin alfa, Quantity: 40000 IU/mL

Saatavilla:

Janssen-Cilag Pty Ltd

INN (Kansainvälinen yleisnimi):

Epoetin alfa

Lääkemuoto:

Injection, solution

Koostumus:

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

Antoreitti:

Intravenous, Subcutaneous

Kpl paketissa:

6 x 0.75mL

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

Eprex 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. Eprex is also indicated for the prevention and treatment of anaemia in adult patients with non-myeloid malignancies, where anaemia is anticipated to develop and develops as a result of concomitantly administered chemotherapy. Eprex is indicated to decrease the need for transfusion in patients who will continue to receive concomitant chemotherapy for a minimum of two months. Eprex is also indicated in adult patients with mild-to-moderate anaemia (haemoglobin >10 <=13 g/dL) scheduled for elective surgery with an expected moderate blood loss (2-4 units to 900 to 1800mL) to reduce exposure to allogenic blood transfusion and to facilitate erythropoietic recovery. EPREX is also indicated to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adults patients who are scheduled for major elective surgery and who are not expected to predeposit their complete perioperative blood needs.

Tuoteyhteenveto:

Visual Identification: Clear, colourless solution, virtually free from foreign particulates.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2008-01-14

Pakkausseloste

EPREX
®
PREFILLED SYRINGE
1
EPREX
® PREFILLED
SYRINGES
_(Epoetin alfa (rch)) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EPREX prefilled
syringes. 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.
CURRENT AND UPDATED INFORMATION
ABOUT BENEFITS AND SIDE EFFECTS OF
EPREX IS CONTAINED IN THIS LEAFLET.
Your doctor has weighed the risks of
you using EPREX against the
benefits this medicine is expected to
have for you.
If you have any concerns about using
EPREX ask your doctor or
pharmacist.
IT IS IMPORTANT THAT YOU READ THIS
LEAFLET.
Keep this leaflet with your medicine.
WHAT EPREX IS USED
FOR
EPREX prefilled syringes contain the
active ingredient epoetin alfa, a
protein that stimulates bone marrow
to produce more red blood cells.
Red blood cells are responsible for
carrying oxygen to all parts of your
body. A decrease in the number of
red blood cells can cause anaemia.
Some symptoms of anaemia are
tiredness, breathlessness when
exercising, and feeling cold.
Anaemia may have many causes,
including decreased production of a
hormone called erythropoietin by the
kidneys due to kidney failure, or as a
result of chemotherapy treatments for
cancer. EPREX is virtually identical
to your body's erythropoietin, and
has a similar effect to naturally
occurring erythropoietin in your
body.
EPREX is used to treat the anaemia
associated with kidney disease. If
you have kidney disease, your kidney
may not produce enough
erythropoietin (necessary for red
blood cell production) and your
doctor may wish to correct this by
prescribing EPREX. This medicine
stimulates your bone marrow to
produce more red blood cells,
helping to treat your anaemia.
EPREX can also be used to treat
anaemia if you are receiving
chemotherapy for cancer and your
doctor decides that a blood
transfusion is not appropriate.
Doctors can also prescribe EPREX
for mildly anaemic patients who are
going

Valmisteyhteenveto

CCDS(201216v11)
1
EPREX(210701)API
AUSTRALIAN PRODUCT INFORMATION
EPREX
® EPOETIN ALFA (RCH)
INTRAVENOUS & SUBCUTANEOUS INJECTION
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 alfa (rch)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
EPREX epoetin alfa (rch) 1,000 IU/0.5 mL injection syringe
EPREX epoetin alfa (rch) 2,000 IU/0.5 mL injection syringe
EPREX epoetin alfa (rch) 3,000 IU/0.3 mL injection syringe
EPREX epoetin alfa (rch) 4,000 IU/0.4 mL injection syringe
EPREX epoetin alfa (rch) 5,000 IU/0.5 mL injection syringe
EPREX epoetin alfa (rch) 6,000 IU/0.6 mL injection syringe
EPREX epoetin alfa (rch) 8,000 IU/0.8 mL injection syringe
EPREX epoetin alfa (rch) 10,000 IU/1.0 mL injection syringe
EPREX epoetin alfa (rch) 20,000 IU/0.5 mL injection syringe
EPREX epoetin alfa (rch) 30,000 IU/0.75 mL injection syringe
EPREX epoetin alfa (rch) 40,000 IU/1.0 mL injection syringe
Epoetin alfa is recombinant human erythropoietin (EPO). It is
expressed in Chinese hamster
ovary cells (rch) and has a 165 amino acid sequence identical to that
of human urinary EPO;
the two are indistinguishable on the basis of functional assays. The
apparent molecular weight
of erythropoietin is about 30,400 daltons.
EPREX
®
is a sterile preservative-free phosphate buffered protein solution of
Epoetin alfa (rch)
in pre-filled syringes of 1,000 IU in 0.5 mL, 2,000 IU in 0.5 mL,
3,000 IU in 0.3 mL, 4,000 IU in
0.4 mL, 5000 IU in 0.5 mL, 6000 IU in 0.6 mL, 8000 IU in 0.8 mL,
10,000 IU in 1.0 mL,
20,000 IU in 0.5 mL, 30,000 IU in 0.75 mL and 40,000 IU (336
micrograms) in 1 mL. The
formulation is stabilised with glycin