פברזיים 35 - Fabrazyme 35
| ××× ×× ×× × ×ספ×× | ||||||
|---|---|---|---|---|---|---|
| ק×××¦× ×¤×¨×ק×××××ת (ATC4) | A16AB Enzymes | |||||
| ×ר××× ×¤×¢×× (ATC5) | Â
| |||||
| צ×רת ××ª× | ת××-×ר××× - I.V | |||||
| צ×רת ××× ×× | ×××§× ×××× ×ª ת×××¡× ×ר×××ת ××¢×ר××, POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר×× | |||||
| ×ת×××× | Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. (alfa - galactosidase A deficiency).
| |||||
× ×ª×× × ×¡× [ ×צ×× ]
| ||||||
| ×¢××× ×ר××¤× ××××ר×ת ××¢××× |
 Â
| |||||
| ×¢××× ×צר×× |  |
|---|
| ער××× ××××ק×רפ××× | ער××× ×§×©×ר×× ××××ק×רפ××× |
|---|---|
| פ×ר×××× 35 ×"× ××××ר ××©×¨× ××ר×××ת |
| ××פ×ש ×××ר×× | ×××ר×× ×-PubMed |
|---|---|
| ××××¢ ×רשת | RxList WebMD Drugs.com |
| ×©× ××¦×¨× | GENZYME EUROPE B.V., NETHERLANDS |
| ×©× ××¢× ×ר×ש×× | SANOFI - AVENTIS ISRAEL LTD |
| ר×ש××× | ת×ר×× ××ש×: 06/2001. ר×ש××× ×ת×ר××: 05/2017 |
| ת×ר×× ×¢×××× ××ר×× | 14/05/19 |
××¨× ×ת×
×תר××¤× × ××ª× ×ª ××ר×× ×רפ××× ×××פ×, ××רפ××ת ק×פ×ת ×××××× ×× ×××צע×ת ××¢×¨× ××פ××× ××ת.
××× ×× ××
×תר××¤× ×ש××קת ××ק××ק×× ×× ×©× 5 ×"× ×× 35 ×"×. ×××× ×× ××ת×××ª× ××××××¥ ××××× ××××ר (××¢× ××× 16) ××× 1 ×"× ×ק"× ×¤×¢× ×ש×××¢×××. ×תר××¤× × ××ª× ×ª ××¢×ר×× ××ר××.
×ת××××ת × ××
ר××ש×ת ×תר (ת×××× ×× ×¤××ק××ת) ×ס×× ×ª ×××× ×××× ×××ר××××× ×פע×××× ×תר×פ×. ר×× ×ª×פע×ת ×××××× ×ת×צ×× ××××פ×× ×פ×ר×××× ××פ××¢× ×××× ××¢×ר×× ×× ××× ×§×¦×¨ ×××ר××. ×× ×××××ת ×××©×ª× ×ת ××××ת ×××××¨× ×©×××. ש××××ת ת×פע×ת ××××× ××× ××ר×ת ×¢× ×××× ×ש×××ש ×××ר ×פ×ר××××. (×××××¢ × ×סף ×ש ××סת×× ××¢××× ×ר×פ×) ×××¢× ×× ×××××× ×פת××× × ×××× ×× ×× ×× ×¤×ר×××× ×ש××שת ××××ש×× ×ר×ש×× ×× ×××פ××. ×××¨× ×××, ×ר×× ×××××× ×××ת ×× ×××× ×× ××ר×ת ×¢× ××××. ×× ×××××¥ ×תת ×ת פ×ר×××× ×ש×××× ×¢× ×תר×פ×ת ××××ת: Chloroquine, Amiodaron, Benoquin ×× Gentamycin ×¢×§× ×פשר×ת ת×××ר××ת ×ת×××× ×¢× ××פ×-××ק××××××× ×ª×× ×ª××. ×ש×××ש ×פ×ר×××× ×צר×× ××¢×§× ×©× ×¨××¤× ×××××.
×××ר×× ×××ª× ×¤×¢××××
- Mannitol
- Sodium phosphate monobasic, monohydrate
- Sodium phosphate dibasic, heptahydrate
ש×××ש ×××ר×××
××× ×ספ×ק ××××¢ ×××× ×ש×××ש ×פ×ר×××× ××§×¨× × ×©×× ×××ר×××.
××קר×× ×©× ×¢×©× ×××¢×× ×××× ××× × ×ר××× ×שפע×ת ×××ק×ת ×ש×ר×ת ×× ×¢×§×פ×ת ×¢× ×תפת××ת ××¢××ר.
פ×ר×××× ××× × ×××××¥ ×ש×××ש ××××× ×××ר××× ××× ×× ×× ×ש צ××¨× ×ר×ר ×××.
×××× ××× ×§×, פ×ר×××× ×¢×©×× ××××ת ××פרש ××××. ×××××× ×©××× × ×ª×× ×× ×××× ×× ×¢× ×ª×פע×ת ××××××× ××ש×פ×× ×פ×ר×××× ××¨× ××× ××, ×××××¥ ××פס×ק ×ת ××× ×§× ××שר ת×ת ש×××ש ×פ×ר××××.
×××ר××
- Eng CM et al. A phase 1/2 clinical trial of enzyme replacement in Fabry disease: pharmacokinetic, substrate clearance, and safety studies. Am J Hum Genet 2001;68:711-22.
- Eng CM, et al. Safety and efficacy of recombinant human alpha-galactosidase A--replacement therapy in Fabry's disease. New Engl J Med 2001;345:9-16.
- Germain DP et al. Sustained, long-term renal stabilization after 54 months of agalsidase beta therapy in patients with Fabry disease. J Am Soc Nephrol 2007;18:1547-57.
- Banikazemi M et al. Agalsidase-beta therapy for advanced Fabry disease: a randomized trial. Ann Intern Med 2007; 146:77-86.
- Lubanda JC et al. Evaluation of a low dose, after a standard therapeutic dose, of agalsidase beta during enzyme replacement therapy in patients with Fabry disease. Genet Med 2009; 11:256-64.
- Wraith JE, et al. Safety and efficacy of enzyme replacement therapy with agalsidase beta: an international, open-label study in pediatric patients with Fabry disease. J Pediatr 2008; 152:563-70.
- Schaefer RM, et al. Enzyme replacement therapy for Fabry disease: a systematic review of available evidence. Drugs 2009; 69(16):2179-205.