国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
Epoetin beta, Quantity: 6666.66 IU/mL
Roche Products Pty Ltd
Epoetin beta
Injection
Excipient Ingredients: calcium chloride dihydrate; dibasic sodium phosphate dodecahydrate; water for injections; glutamic acid; isoleucine; urea; monobasic sodium phosphate; polysorbate 20; glycine; phenylalanine; leucine; sodium chloride; threonine
Intravenous, Subcutaneous
6
(S4) Prescription Only Medicine
Neorecormon is indicated for the treatment of anaemia associated with chronic kidney disease (CKD) in patients on dialysis and symptomatic patients not yet undergoing dialysis. To increase the yield of autologous blood from patients in pre-donation programme initiated to avoid the use of homologous blood. For the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks. For the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate.
Visual Identification: 1 mL ready to use syringe containing colourless, clear to slightly opalescent solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2006-01-09
NEORECORMON ® _epoetin beta [recombinant human erythropoietin]_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NeoRecormon. 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. Your doctor has weighed the risks of you using NeoRecormon against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NEORECORMON IS USED FOR NeoRecormon is used to treat anaemia caused by chronic kidney disease. Anaemia is caused by a lack of red blood cells or haemoglobin which transport oxygen in the blood. If you have anaemia, your body's tissues might not receive enough oxygen. Symptoms may include tiredness, weakness and shortness of breath. NeoRecormon may also be used: • If you are planning to have major surgery and you are going to have your own blood collected for use during the surgery. • To prevent anaemia in premature babies. • If you have anaemia after being treated with chemotherapy for cancer and you can't have a blood transfusion. In some studies, people with cancer treated with medicines like NeoRecormon for anaemia did not live as long as people not receiving these medicines. NeoRecormon contains the active ingredient epoetin beta (pronounced ee-poe-tin bee-ta). Epoetin beta is also known as recombinant human erythropoietin (pronounced ee-rith- roe-poy-tin). NeoRecormon belongs to a group of medicines known as hormones. The kidneys produce the natural hormone erythropoietin, which stimulates the production of red blood cells in the bone marrow and spleen. Like erythropoietin, NeoRecormon works by increasing the number of red blood cells and the haemoglobin level in your blood. Your doctor, however, may have prescribed NeoRecormon for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY NEOREC 完全なドキュメントを読む
ropneore10220 1 AUSTRALIAN PRODUCT INFORMATION NEORECORMON ® (EPOETIN BETA) 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. NAME OF THE MEDICINE Epoetin beta 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NeoRecormon 2000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 2000 international units (IU) epoetin beta. NeoRecormon 3000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 3000 international units (IU) epoetin beta. NeoRecormon 4000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 4000 international units (IU) epoetin beta. NeoRecormon 5000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 5000 international units (IU) epoetin beta NeoRecormon 6000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 6000 international units (IU) epoetin beta NeoRecormon 10,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 10,000 international units (IU) epoetin beta NeoRecormon (epoetin beta _rch_ ) is a sterile, purified, stable recombinant human erythropoietin concentrate produced from genetically engineered Chinese hamster ovary (CHO) cells containing a cloned human erythropoietin gene. The active ingredient, epoetin beta _rch_ , is a highly purified glycoprotein, identical in amino acid sequence to endogenous erythropoietin, with a mean m 完全なドキュメントを読む