Eprex

দেশ: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Epoetin alfa 336 µg/mL

থেকে পাওয়া:

Janssen-Cilag (New Zealand) Ltd

INN (আন্তর্জাতিক নাম):

Epoetin alfa 336 µg/mL

ডোজ:

40000 IU/mL

ফার্মাসিউটিকাল ফর্ম:

Solution for injection

রচনা:

Active: Epoetin alfa 336 µg/mL Excipient: Dibasic sodium phosphate dihydrate Glycine Monobasic sodium phosphate dihydrate Polysorbate 80 Sodium chloride Water for injection

প্যাকেজ ইউনিট:

Syringe, glass, 6 x 0.75 mL, 4.5 mL

শ্রেণী:

Prescription

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Ortho Biologicals LLC

থেরাপিউটিক ইঙ্গিত:

EPREX is indicated for: · The treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients with renal insufficiency not yet undergoing dialysis. · Anaemia associated with chronic renal failure in paediatric and adult patients on dialysis. · Anaemia in patients with non-myeloid malignancies where anaemia is due to the effect of concomitantly administered chemotherapy. · Adult patients with mild-to-moderate anaemia (haemoglobin > 100 to < 130g/L) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800mL) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. · To augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients undergoing major surgery who are not expected to pre-deposit their complete peri-operative blood needs.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Syringe, glass, 6 x 0.75 mL - 4.5 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Can include up to 7 days at or below 25 °C immediately prior to use

অনুমোদন তারিখ:

2007-02-05

তথ্য লিফলেট

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

পণ্য বৈশিষ্ট্য

CCDS(210910v12)
1
EPREX(211203)ADS
EPREX
®
EPOETIN ALFA (R-HUEPO CHO)
DATA SHEET
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. PRODUCT NAME
EPREX 1,000 IU/0.5 mL solution for injection in pre-filled syringe.
EPREX 2,000 IU/0.5 mL solution for injection in pre-filled syringe.
EPREX 3,000 IU/0.3 mL solution for injection in pre-filled syringe.
EPREX 4,000 IU/0.4 mL solution for injection in pre-filled syringe.
EPREX 5,000 IU/0.5 mL solution for injection in pre-filled syringe.
EPREX 6,000 IU/0.6 mL solution for injection in pre-filled syringe.
EPREX 8,000 IU/0.8 mL solution for injection in pre-filled syringe.
EPREX 10,000 IU/1.0 mL solution for injection in pre-filled syringe.
EPREX 20,000 IU/0.5 mL solution for injection in pre-filled syringe
EPREX 30,000 IU/0.75 mL solution for injection in pre-filled syringe
EPREX 40,000 IU/1.0 mL solution for injection in pre-filled syringe.
EPREX
®
is a sterile, preservative-free buffered protein solution of epoetin
alfa (rch) in pre-filled
syringes. The pre-filled syringes are fitted with the PROTECS™
needle guard device.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Epoetin alfa (r-HuEPO CHO), produced in Chinese Hamster Ovary (CHO)
cells by recombinant DNA
technology.
A pre-filled syringe of 0.5 mL contains 1,000 IU (8.4 micrograms) of
epoetin alfa.
A pre-filled syringe of 0.5 mL contains 2,000 IU (16.8 micrograms) of
epoetin alfa.
A pre-filled syringe of 0.3 mL contains 3,000 IU (25.2 micrograms) of
epoetin alfa.
A pre-filled syringe of 0.4 mL contains 4,000 IU (33.6 micrograms) of
epoetin alfa.
A pre-filled syringe of 0.5 mL contains 5,000 IU (42.0 micrograms) of
epoeti