EPREX 2000

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

RECOMBINANT HUMAN ERYTHROPOIETIN

Disponible depuis:

J-C HEALTH CARE LTD

Code ATC:

B03XA01

forme pharmaceutique:

SOLUTION FOR INJECTION

Composition:

RECOMBINANT HUMAN ERYTHROPOIETIN 2000 IU / 0.5 ML

Mode d'administration:

I.V, S.C

Type d'ordonnance:

Required

Fabriqué par:

CILAG AG, SWITZERLAND

Groupe thérapeutique:

ERYTHROPOIETIN

Domaine thérapeutique:

ERYTHROPOIETIN

indications thérapeutiques:

Treatment of severe anemia associated with chronic renal failure, anemia in Zidovudine treated HIV infected patients, anemia in cancer patients on chemotherapy.To increase the yield of autologous blood from patients in a predonation programme initiated to avoid the use of homologous blood. Treatment is indicated in patients with moderate anemia (packed cell volume (PCV) approximately 33 to 39% , no iron deficiency) if blood conserving procedures are not available or insufficient either: a: when the scheduled major elective surgery requires a large volume of blood ( 4 or more units of blood for females or 5 or more units for males) or b: when the period necessary to obtain the required volume of autologous blood is too short. Perisurgery: Reduction of allogeneic blood transfusion in surgery patients : Eprex is indicated for the treatment of anemic patients (hemoglobin 9-11 g/dl) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. Eprex is indicated for patients at high risk for periopertive transfusions with significant, anticipated blood loss. Eprex is not indicated for anemic patients who are willing to donate autologous blood. The safety of the perioperative use of Eprex has been studied only in patients who are receiving anticoagulant prophylaxis. Eprex is indicated before surgerios known be associated with excessive blood loss (at least 2 units ).

Date de l'autorisation:

2014-11-30

Résumé des caractéristiques du produit

Page 1 of 25
Eprex_Solution for injection_Sep2021_Ref EU SmPC Jun2021
1.
NAME OF THE MEDICINAL PRODUCT
EPREX 2,000 IU/mL solution for injection in pre-filled syringe. EPREX
4,000 IU/mL
solution for injection in pre-filled syringe. EPREX 10,000 IU/mL
solution for
injection in pre-filled syringe. EPREX 40,000 IU/mL solution for
injection in pre-
filled syringe.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
EPREX 2,000 IU/mL solution for injection in pre-filled syringe
Epoetin alfa 2,000 IU/mL (16.8 micrograms per mL), 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. EPREX
4,000 IU/mL solution for injection in pre-filled syringe
Epoetin alfa 4,000 IU/mL (33.6 micrograms per mL), produced in Chinese
Hamster Ovary (CHO) cells
by recombinant DNA technology
A pre-filled syringe of 0.5 mL contains 2,000 IU (16.8 micrograms) of
epoetin alfa.EPREX
10,000 IU/mL solution for injection in pre-filled syringe
Epoetin alfa 10,000 IU/mL (84.0 micrograms per mL), produced in
Chinese Hamster Ovary (CHO)
cells by recombinant DNA technology
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
epoetin alfa A pre-filled
syringe of 0.6 mL contains 6,000 IU (50.4 micrograms) of epoetin alfa
A pre-filled
syringe of 0.8 mL contains 8,000 IU (67.2 micrograms) of epoetin alfa
A pre-filled
syringe of 1.0 mL contains 10,000 IU (84.0 micrograms) of epoetin alfa
EPREX 40,000 IU/mL solution for injection in pre-filled syringe
Epoetin alfa 40,000 IU/mL (336.0 micrograms per mL), produced in
Chinese Hamster Ovary (CHO) cells
by recombinant DNA technology
A pre-filled syringe of 0.5 mL contains 20,000 IU (168.0 micrograms)
of epoetin alfa A
pre-filled syringe of 0.75 mL contains 30,000 IU (252.0 micrograms) of
epoetin alfa A
pre-filled syringe of 1.0 mL contains