EPREX 40000 PREFILLED SYRINGE 40000 iuml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

EPOETIN ALFA

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

B03XA01

Dosage:

40000 iu/ml

Pharmaceutical form:

INJECTION

Composition:

EPOETIN ALFA 40000 iu/ml

Administration route:

INTRAVENOUS, SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

CILAG AG

Authorization status:

ACTIVE

Authorization date:

2001-11-19

Patient Information leaflet

1
PRODUCT NAME
EPREX
®
(Epoetin alfa)
DOSAGE FORMS AND STRENGTHS
Epoetin alfa, a glycoprotein produced by recombinant DNA technology,
is the active
ingredient.
Not all presentations may be available locally.
HUMAN
SERUM
ALBUMIN-FREE
(HSA)
FREE,
PHOSPHATE-BUFFERED,
FORMULATIONS
EPREX
® IN PRE-FILLED SYRINGES
Concentration of EPREX
®
mcg
Volume per syringe (mL)
International Units
1,000
8.4
0.5
2,000
16.8
0.5
3,000
25.2
0.3
4,000
33.6
0.4
5,000
42.0
0.5
6,000
50.4
0.6
8,000
67.2
0.8
10,000
84.0
1.0
20,000
168.0
0.5
40,000
336.0
1.0
EPREX
®
is a sterile, clear, colorless, buffered parenteral solution for
intravenous or
subcutaneous injection. For chronic renal failure patients including
end stage renal disease
patients, only intravenous injection should be used.
CLINICAL INFORMATION
INDICATIONS
EPREX
®
is indicated for the
treatment of anemia associated with chronic renal failure in
pediatric and
adult patients on
hemodialysis and peritoneal dialysis.
EPREX
®
is indicated for the
treatment of severe anemia of renal origin accompanied by
clinical symptoms in adult patients with renal insufficiency not yet
undergoing dialysis.
EPREX
®
is indicated for the
treatment of anemia and reduction of transfusion requirements
in adult cancer patients receiving chemotherapy.
2
EPREX
®
is indicated for the
treatment of anemia in adult HIV-infected patients being treated
with zidovudine having endogenous erythropoietin levels

500 mU/mL.
EPREX
®
is indicated in adults to facilitate autologous blood collection
within a predeposit
program and decrease the risk of receiving allogeneic blood
transfusions in patients with
moderate anemia (hematocrits of 33-39%, hemoglobin of 10-13 g/dL,
[6.2-8.1 mmol/L], no
iron deficiency), 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
®
. Treatment should only be given to patients if blood saving
procedures are not available or insufficient when the

Summary of Product characteristics

1
PRODUCT NAME
EPREX
®
(Epoetin alfa)
DOSAGE FORMS AND STRENGTHS
Epoetin alfa, a glycoprotein produced by recombinant DNA technology,
is the active
ingredient.
Not all presentations may be available locally.
HUMAN
SERUM
ALBUMIN-FREE
(HSA)
FREE,
PHOSPHATE-BUFFERED,
FORMULATIONS
EPREX
® IN PRE-FILLED SYRINGES
Concentration of EPREX
®
mcg
Volume per syringe (mL)
International Units
1,000
8.4
0.5
2,000
16.8
0.5
3,000
25.2
0.3
4,000
33.6
0.4
5,000
42.0
0.5
6,000
50.4
0.6
8,000
67.2
0.8
10,000
84.0
1.0
20,000
168.0
0.5
40,000
336.0
1.0
EPREX
®
is a sterile, clear, colorless, buffered parenteral solution for
intravenous or
subcutaneous injection. For chronic renal failure patients including
end stage renal disease
patients, only intravenous injection should be used.
CLINICAL INFORMATION
INDICATIONS
EPREX
®
is indicated for the
treatment of anemia associated with chronic renal failure in
pediatric and
adult patients on
hemodialysis and peritoneal dialysis.
EPREX
®
is indicated for the
treatment of severe anemia of renal origin accompanied by
clinical symptoms in adult patients with renal insufficiency not yet
undergoing dialysis.
EPREX
®
is indicated for the
treatment of anemia and reduction of transfusion requirements
in adult cancer patients receiving chemotherapy.
2
EPREX
®
is indicated for the
treatment of anemia in adult HIV-infected patients being treated
with zidovudine having endogenous erythropoietin levels

500 mU/mL.
EPREX
®
is indicated in adults to facilitate autologous blood collection
within a predeposit
program and decrease the risk of receiving allogeneic blood
transfusions in patients with
moderate anemia (hematocrits of 33-39%, hemoglobin of 10-13 g/dL,
[6.2-8.1 mmol/L], no
iron deficiency), 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
®
. Treatment should only be given to patients if blood saving
procedures are not available or insufficient when the