EPREX PREFILLED SYRINGE 10000IUML

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Epoetin Alfa

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

Epoetin Alfa

Unit dalam pakej:

ml mL

Dikeluarkan oleh:

CILAG AG

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
EPREX
® PREFILLED SYRINGE
Epoetin alfa (2000IU/0.5ml, 4000IU/0.4ml, 10 000IU/ml, 40 000IU/ml)
1
WHAT IS IN THIS LEAFLET
1.
What EPREX
®
is used for
2.
How EPREX
®
works
3.
Before you use EPREX
®
4.
How to use EPREX
®
5.
While you are using EPREX
®
6.
Side effects
7.
Storage and disposal of EPREX
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT EPREX
® IS USED FOR
EPREX
®
is used to treat symptomatic
anemia caused by kidney disease
-
in children on hemodialysis
-
in adults on hemodialysis, peritoneal
dialysis or not yet undergoing dialysis.
If you have kidney disease, you may be
short of red blood cells if your kidney does
not produce enough erythropoietin
(necessary for red cell production).
EPREX
®
is prescribed to stimulate your
bone marrow to produce more red blood
cells.
EPREX
®
is used to treat anemia if you are
receiving chemotherapy for solid tumors,
malignant lymphoma or multiple myeloma
(bone marrow cancer) and your doctor
decides you may have a need for a blood
transfusion. EPREX
®
can reduce the need
for a blood transfusion.
EPREX
®
is used in moderately anemic
people who donate some of their blood
before surgery, so that it can be given back
to them during or after the operation.
Because EPREX
®
stimulates the
production of red blood cells, doctors can
take more blood from these people.
EPREX
®
is used in moderately anemic
adults about to have major orthopedic
surgery (for example hip or knee
replacement operations), to reduce the
potential need for blood transfusions.
EPREX
®
is used to treat anemia if you are
an adult receiving a medicine called
zidovudine (AZT) used to treat HIV
infection.
EPREX
®
is used to treat anemia in adults
with low- or intermediate-1-risk
myelodysplastic syndromes. EPREX
®
can
reduce the need for a blood transfusion.
HOW EPREX
® WORKS
EPREX
®
contains the active substance
epoetin alfa - a protein that stimulates the
bone marrow to produce more red blood
c

Ciri produk

PRODUCT NAME
EPREX
®
(EPOETIN ALFA)
DOSAGE FORMS AND STRENGTHS
Epoetin alfa, a glycoprotein produced by recombinant DNA technology,
is the active ingredient.
Eprex is a sterile, clear, colorless, buffered parenteral solution for
intravenous or subcutaneous
injection.
HUMAN SERUM ALBUMIN (HSA) FREE, PHOSPHATE-BUFFERED, FORMULATIONS
EPREX IN PRE-FILLED SYRINGES
Concentration of Eprex
mcg
Volume per syringe (mL)
International Units
1000
8.4
0.5
2000
16.8
0.5
3000
25.2
0.3
4000
33.6
0.4
5000
42.0
0.5
6000
50.4
0.6
8000
67.2
0.8
10000
84.0
1.0
20000
168.0
0.5
30000
252.0
0.75
40000
336.0
1.0
For excipients, see
_ List of Excipients. _
CLINICAL INFORMATION
INDICATIONS_ _
•
Treatment of anemia associated with chronic renal failure in adult
hemodialysis, peritoneal
dialysis and predialysis patients and pediatric patients on
hemodialysis.
•
Treatment of anemia and reduction of transfusion in adult cancer
patients with non-myeloid
malignancies receiving chemotherapy.
•
Treatment of anemia in HIV-infected patients being treated with
zidovudine who have
endogenous erythropoietin levels
≤
500 mIU/mL.
•
To facilitate autologous blood collection within a predeposit program
and decrease the risk
of receiving allogeneic blood transfusions in patients with
hematocrits of 33 - 39%, who are
scheduled for major elective surgery and are expected to require more
blood than that which
can be obtained through autologous blood collection techniques in the
absence of Eprex.
•
Eprex is indicated in adult patients with mild to moderate anemia
(hemoglobin > 10 to
≤
13
g/dL) scheduled for elective surgery with an expected moderate blood
loss (2 - 4 units or 900
to
1800
mL)
to
reduce
exposure
to
allogeneic
blood
transfusions
and
to
facilitate
erythropoietic recovery).
•
Eprex is indicated for the treatment of anemia (hemoglobin
concentration of ≤ 10 g/dL) in
adults with low- or intermediate-1-risk myelodysplastic syndromes
(MDS) who have low
serum erythropoietin (< 200 mU/mL).
DOSAGE AND ADMINISTRATION
GENERAL CONSIDERATIONS