País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Filgrastim
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Filgrastim
0.5ml mL; 0.5ml mL; 0.5ml mL; 0.5ml mL
IDT BIOLOGIKA GMBH
1 _Consumer Medication Information Leaflet (RiMUP) _ ZARZIO ® SOLUTION FOR INJECTION OR INFUSION Filgrastim (30MU/0.5ml and 48MU/0.5ml) WHAT IS IN THIS LEAFLET 1. What ZARZIO ® is used for 2. How ZARZIO ® works 3. Before you use ZARZIO ® 4. How to use ZARZIO ® 5. While you are using ZARZIO ® 6. Side effects 7. Storage and disposal of ZARZIO ® 8. Product description ni 9. Manufacturer and product registration holder 10. Date of revision WHAT ZARZIO ® IS USED FOR ZARZIO ® is used mainly for reducing the duration of neutropenia and to prevent the occurrence of neutropenia associated with fever for those who undergo treatment with medicines for cancer. Neutropenia means reduction in neutrophils (type of white blood cell important in the body’s fight against infection). It is also used for reducing the duration of neutropenia in patients undergoing myeloablative therapy (therapy aimed at reducing the bone marrow cells) which is followed by bone marrow cell transplantation. It is used for mobilization of blood progenitor cells (progenitor cells are nothing but the cells that can differentiate into a specific type of cells). It is also used for reducing the duration of neutropenia in patients (children or adults), with neutropenia less than or equal to the count of 0.5 x 10 9 /L who present this condition by birth and those who have severe infections. It is also used in patients with persistent neutropenia whose count is less than or equal to 1.0 x 10 9 /L like in patients with HIV infection. HOW ZARZIO ® WORKS ZARZIO ® is a man-made form of granulocyte colony-stimulating factor (G-CSF). Human G-CSF is a substance produced by our body which regulates the production and release of neutrophils from the bone marrow. ZARZIO ® stimulates the growth of neutrophils along with a minor increase in other type of blood cells like monocytes, eosinophils and basophils BEFORE YOU USE ZARZIO ® - _When you must not use it_ _ _ Do not take ZARZIO ® if you are allergic to filgrastim or any of the other ingredients in ZARZ Leer el documento completo
1 1. NAME O F TH E M ED IC INAL PR O DUC T Z arz io 30 MU/0.5 m l s o lu tion f or in je cti on or in fu si on in p re -fil le d s yri nge Z arz io 48 MU/0.5 ml so lu tion for in jec tion or in fus ion in pr e-fill ed syri nge 2. QUAL ITA TIVE AND QUANT ITA TIVE CO M PO SIT IO N Z arz io 30 MU/0.5 m l - Each m l of s o lu tion cont ain s 60 m illi on un its ( MU) [ equ iv a le nt t o 6 00 mic ro gra m s ( μ g)] fil gra stim *. Each p re -fill ed syr in ge con ta ins 3 0 M U ( e qu iv a lent t o 300 μ g) fil gra sti m i n 0.5 m l. Z arz io 48 MU/0.5 ml - Each ml of so lu tion cont ains 96 milli on unit s (MU) [equ iv a lent t o 960 mic ro gra m s (μ g)] fil gra sti m*. Each p re -filled syri nge con ta ins 48 MU (equi va lent to 480 μg) fil gra sti m in 0.5 ml. * re co mbinant m ethi ony la ted hum an g ranul ocyte -co lo ny sti mula ting fa cto r (G -C SF) p rodu ced in E . co li by r e co m binant DNA t ech no lo gy. Exc ip ie nt: Each m l of s o lu tion cont ains 50 m g s o rb ito l (E420). For a f u ll lis t o f ex cip ie nts , s ee se cti o n 6.1. 3. PH ARM ACEUT IC AL FOR M Si milar b io lo gical m edi cinal p roduct to N eupog en ®. Sol ution for in je cti on or inf usi on in p re -fill ed syr in ge . C lear , c o lo url ess t o sli gh tly y e llo w is h s o lu tion. 4. CLINICA L PART IC ULAR S 4.1 Therapeu tic i ndi ca tions - Redu ction in the dura tion of neu tropen ia and the in cide nce of fe bril e neu tr ope nia in p ati ents trea te d w ith e sta blis hed cyto to xic ch em oth erapy fo r m alig nancy (w ith th e e xc eption of ch ro n ic mye lo id l e u kaem ia and m ye lody sp la sti c s ynd ro m es) a nd re du cti on in the dura tion of neu trope nia in pa tie nts und erg o ing mye loabl ative th e ra py fo llo wed by bone m arr ow transp lant ation con sid ered to be at i n cre a se d r is k of p ro long ed se ve re neu tr ope nia. The sa fe ty and effic acy of fil g ra sti m ar e sim ilar in adult s and ch ild re n re ce iv ing cyto to xic chem oth era p y. - Mobilis ation of p e ri phe ra Leer el documento completo