Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
Darbepoetin alfa, Quantity: 200 microgram/mL
Amgen Australia Pty Ltd
Darbepoetin alfa
Injection, solution
Excipient Ingredients: dibasic sodium phosphate; sodium chloride; monobasic sodium phosphate monohydrate; water for injections; polysorbate 80
Subcutaneous, Intravenous
4 x syringes with automatic needle guard, 1 x syringe with automatic needle guard
(S4) Prescription Only Medicine
Aranesp is indicated for the treatment of anaemia associated with chronic renal failure (CRF). Aranesp is also indicated for the treatment of anaemia and reduction of transfusion requirements in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy
Visual Identification: Clear colourless solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2010-06-17
ARANESP ® _darbepoetin alfa_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Aranesp (darbepoetin alfa). It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Aranesp against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE YOU START ARANESP AND KEEP IT WITH THE MEDICINE. You may need to read it again. WHAT ARANESP IS USED FOR Aranesp is used to treat anaemia that comes about because of chronic renal failure (kidney failure). Anaemia is when your blood does not contain enough red blood cells. In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin. Erythropoietin encourages your bone marrow to produce more red blood cells. Kidney failure can often cause anaemia, which may require you to have blood transfusions. Aranesp is a recombinant erythropoietic protein produced by special mammalian cells. Your doctor has given you Aranesp to treat your anaemia. It will reduce your need for blood transfusions. Aranesp will help your bone marrow to produce more red blood cells, like your natural erythropoietin. The active ingredient of Aranesp is darbepoetin alfa that works in exactly the same way as the natural hormone erythropoietin. It will take your body a short time to make red blood cells, so it will be about 4 weeks before you notice any effect. If you are on dialysis, your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia. Your doctor may have prescribed Aranesp for another reason. Ask your doctor if you have any questions about why Aranesp has been prescribed for you. BEFORE YOU USE IT _WHEN YOU MUST NOT USE IT_ DO NOT USE ARANESP IF YOU HAVE: • High blood pressure that is not controlled by other medicines Baca dokumen lengkap
PRODUCT INFORMATION – ARANESP darbepoetin alfa Sponsor address (10/03/2022) PAGE 1 OF 32 AUSTRALIAN PRODUCT INFORMATION ARANESP ® (DARBEPOETIN ALFA) 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 120 g/L (see section 4.4 Special warnings and precautions for use). 1. NAME OF THE MEDICINE Darbepoetin alfa 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ARANESP darbepoetin alfa (rch) 10 µg/0.4mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 15 µg/0.38mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 20 µg/0.5mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 30 µg/0.3mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 40 µg/0.4mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 50 µg/0.5mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 60 µg/0.3mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 80 µg/0.4mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 100 µg/0.5mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 150 µg/0.3mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 200 µg/0.4mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 300 µg/0.6mL injection syringe within a pen injector ARANESP darbepoetin alfa (rch) 500 µg/1.0mL solution for injection syringe within a pen injector PRODUCT INFORMATION – ARANESP darbepoetin alfa Sponsor address (10/03/2022) PAGE 2 OF 32 ARANESP darbepoetin alfa (rch) 15 µg/0.38mL injection syringe with automatic needle guard ARANESP darbepoetin alfa (rch) 20 µg/0.5mL injection syringe with Baca dokumen lengkap