Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
Lenograstim
Pfizer Australia Pty Ltd
Registered
________________________________________________________________________________ GRANOCYTE page 1 GRANOCYTE Lenograstim_ (len-o-GRA-stim)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GRANOCYTE. 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 being given GRANOCYTE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE._ _ You may need to read it again. WHAT GRANOCYTE IS USED FOR GRANOCYTE is a synthetic (man- made) version of a substance called granulocyte colony-stimulating factor (G-CSF) which is produced naturally by the human body. G-CSF is produced by certain cells within the bone marrow to stimulate the production of neutrophils (a type of white blood cell). Neutrophils help the body to prevent or fight infection. A low neutrophil level increases your risk of infection. GRANOCYTE is therefore used to (help) increase the neutrophil count in those with low white blood cell counts, a condition known as neutropenia. A low number of neutrophils in your blood (neutrophil count) often occurs after bone marrow transplantation or chemotherapy. On rare occasions, infants have a low neutrophil count present at birth (congenital neutropenia). Stem Cell Transplantation Some chemotherapy drugs have toxic effects on the bone marrow. Your doctor may collect stem cells (the parent cells of all blood cells) from your blood before you have chemotherapy. There are normally only a small number of stem cells in the blood. GRANOCYTE can be used to increase the number of stem cells in the blood. The stem cells are then collected by a procedure, called leukapheresis, done in hospital. The stem cells collected from the blood are stored until after you have had your chemotherapy. They are then given ba Perskaitykite visą dokumentą
Version: pfpgranv10521 Supersedes pfpgranv10320 Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION – GRANOCYTE ® (LENOGRASTIM) 1. NAME OF THE MEDICINE Lenograstim 2. QUALITATIVE AND QUANTITATIVE COMPOSITION GRANOCYTE contains lenograstim, a recombinant glycoprotein equivalent to the human granulocyte colony stimulating factor (G-CSF). GRANOCYTE 13 contains 105 µg (13.4 million International Units ) (IU) lenograstim in 1 mL of reconstituted product. GRANOCYTE 34 contains 263 µg (33.6 million International Units ) (IU) lenograstim in 1 mL of reconstituted product. The reconstituted product for both strengths of GRANOCYTE is formulated with a hydrochloric acid buffer at pH 6.5 and contains 2.5% mannitol, 1% arginine, 1% phenylalanine, 0.1% methionine and 0.01% polysorbate 20. EXCIPIENT(S) WITH KNOWN EFFECT Phenylalanine For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM GRANOCYTE is presented as white cake of lyophilised powder for injection in a glass vial with a rubber stopper and a flip off cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GRANOCYTE is indicated • to reduce the duration of neutropenia and the severity of infections in patients with non- myeloid malignancy who have either undergone autologous or allogeneic bone marrow transplantation or undergone treatment with established cytotoxic chemotherapy. as measured by the GNFS-60 _in vitro _ bioassay in comparison with the WHO International Standard for human G-CSF) Version: pfpgranv10521 Supersedes pfpgranv10320 Page 2 of 21 • to reduce the incidence of infection associated with established cytotoxic chemotherapy. • to mobilise peripheral blood progenitor cells (PBPCs) either with GRANOCYTE alone, or after myelosuppressive chemotherapy, in order to accelerate haematopoietic recovery by infusion of such cells, after myelosuppressive or myeloablative therapy in patients with non-myeloid malignancies. GRANOCYTE is also indicated to accelerate the engraftment of these cells after their rein Perskaitykite visą dokumentą