Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Epoetin lambda, Quantity: 6000 IU
Sandoz Pty Ltd
Epoetin lambda
Injection, solution
Excipient Ingredients: monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate; polysorbate 80; dilute hydrochloric acid; water for injections; sodium hydroxide; glycine; sodium chloride
Intravenous, Subcutaneous
6, 1
(S4) Prescription Only Medicine
Treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions.. Treatment of anaemia in patients with nonmyeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy, where blood transfusion is not considered appropriate. Adult patients with mild to moderate anaemia (haemoglobin > 100 to less than or equal to 130g/L) scheduled for elective surgery with an expected moderate blood loss (two to four units or 900 to 1,800mL) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery.. Augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to predeposit their complete perioperative blood needs.
Visual Identification: Clear, colourless solution, practically free of visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2010-01-27
NOVICRIT ® 1 NOVICRIT ® _epoetin lambda (rch) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Novicrit. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.SANDOZ.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Novicrit against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NOVICRIT IS USED FOR Novicrit is used: • to treat anaemia associated with kidney disease • to treat anaemia in patients receiving chemotherapy for certain types of cancer • in patients with anaemia who are about to undergo surgery as an alternative to a blood transfusion where there is the likelihood of moderate blood loss • in patients with anaemia who face major elective surgery and who, prior to it, donate blood so that their own blood can be given to them during and after surgery. Novicrit stimulates the production of red blood cells and hence, a higher volume of blood can be taken from these patients. Novicrit contains the active ingredient epoetin lambda (rch). Epoetin lambda (rch) is man-made and works in exactly the same way as the natural hormone produced in your kidneys. Epoetin lambda is a hormone which works by stimulating the production of red blood cells. It is used to treat anaemia, a condition in which there is a decreased number of red blood cells. ASK YOUR DOCTOR IF YO Read the complete document
210930-Novicrit-pi Page 1 of 24 AUSTRALIAN PRODUCT INFORMATION NOVICRIT SOLUTION FOR INJECTION (EPOETIN LAMBDA (_RCH_)) 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 PRECAUTIONS). 1 NAME OF THE MEDICINE Epoetin lambda _(rch)_ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient of Novicrit Solution for Injection is Epoetin lambda _(rch)_ . Erythropoietin is an endogenous glycoprotein that stimulates red blood cell production. It is normally produced by the kidney and regulated by the level of tissue oxygenation. Epoetin lambda (rch) (CHO) is purified from a Chinese hamster ovary (CHO) cell line into which the gene coding for human erythropoietin has been inserted. Epoetin lambda (rch) is indistinguishable from human erythropoietin in biological activity and immunological reactivity. Epoetin lambda (rch) has been developed as a similar biological medicinal product to epoetin alfa. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Novicrit is supplied in a pre-filled syringe as a clear, colourless solution for injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Novicrit is indicated for the treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions. Novicrit is indicated for the treatment of anaemia in patients with nonmyeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. Novicrit is also indic Read the complete document