Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Epoetin alfa 336 µg/mL
Janssen-Cilag (New Zealand) Ltd
Epoetin alfa 336 µg/mL
40000 IU/mL
Solution for injection
Active: Epoetin alfa 336 µg/mL Excipient: Dibasic sodium phosphate dihydrate Glycine Monobasic sodium phosphate dihydrate Polysorbate 80 Sodium chloride Water for injection
Syringe, glass, 6 x 0.75 mL, 4.5 mL
Prescription
Prescription
Ortho Biologicals LLC
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.
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
2007-02-05
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 Διαβάστε το πλήρες έγγραφο
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 Διαβάστε το πλήρες έγγραφο