Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Darbepoetin alfa, Quantity: 100 microgram/mL
Amgen Australia Pty Ltd
Darbepoetin alfa
Injection, solution
Excipient Ingredients: monobasic sodium phosphate monohydrate; sodium chloride; polysorbate 80; dibasic sodium phosphate; water for injections
Subcutaneous, Intravenous
1 x syringe within a pen injector
(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 malignacies where anaemia develops as a result of concommitantly 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
2006-06-07
ARANESP ® A r a n e s p ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING ARANESP? Aranesp contains the active ingredient darbepoetin alfa. Aranesp is used to treat anaemia that is associated with chronic renal failure (kidney failure) and anaemia in cancer patients who are receiving chemotherapy. For more information, see Section 1. Why am I using Aranesp? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ARANESP? Do not use if you have ever had an allergic reaction to Aranesp or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Aranesp? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Aranesp and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ARANESP? • Following blood tests, your doctor will prescribe the strength of Aranesp that is best for you. • Aranesp can be self-administered by injection under the skin after training from your doctor or nurse. It can also be injected into a vein by a doctor or nurse. More instructions can be found in Section 4. How do I use Aranesp? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ARANESP? THINGS YOU SHOULD DO • Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. • Keep all of your doctor's appointments so that your progress can be monitored. • Remind your doctor, dentist, nurse or pharmacist on your visit that you are using Aranesp. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ