Eprex PFS 6.000 IU/0.6ml

Страна: Йордания

Език: английски

Източник: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Активна съставка:

Erythropoietin Alfa 6.000 IU/0.6ml

Предлага се от:

مستودع ادوية شاوي و رشيدات و مسنات - Shawi & Rushedat Drug Store

АТС код:

B03XA01

INN (Международно Name):

Erythropoietin Alfa 6.000 IU/0.6ml

дозиране:

6.000 IU/0.6ml

Броя в опаковка:

6PFS X 0.6ml

Произведено от:

فيتير فارما (المانيا)

Листовка

PRODUCT NAME
EPREX
®
(Epoetinum alfa) Pre-filled Syringe
DOSAGE FORMS AND STRENGTHS
Epoetinum alfa, a glycoprotein produced by recombinant DNA technology,
is the active
ingredient.
Epoetinum alfa is a sterile, clear, colorless, buffered parenteral
solution for intravenous or
subcutaneous injection.
EPOETINUM ALFA IN PRE-FILLED SYRINGES WITH NEEDLE GUARD (PROTECS
™
)
Concentration of Epoetinum alfa

g
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
0.75
40000
336.0
1.0
For excipients, see _List of Excipients_.
CLINICAL INFORMATION
INDICATIONS
EPREX
®
is indicated for the treatment of anemia associated with chronic renal
failure in adult
patients on hemodialysis and peritoneal dialysis, and in pediatric
patients on hemodialysis.
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 with non-myeloid malignancies receiving
chemotherapy.
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 scheduled major elective surgery
requires a large volume of
b