Name: Slide 1
Uploaded: 2022-02-18
Duration: 1 min 14 s
Description: Hanya untuk Tenaga Kesehatan. Well known and trusted immunosuppressant… Now available within our reach..

Hanya untuk Tenaga Kesehatan. Well known and trusted immunosuppressant… Now available within our reach.. 

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Well  known  and  trusted  immunosuppressant…   Now  available within  our   reach.

Hanya untuk Tenaga Kesehatan. 1. PT SOHO Industri Pharmasi. Package Insert Celmunos 500 mg. BPOM RI. 2020. 

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1.	 PT  SOHO  Industri  Pharmasi.  Package  Insert Celmunos  500   mg.  BPOM  RI.   2020

Marketed   by Jalan  Rawa  Sumur  II  Kav.  B.  B3   Kawasan  Industri  Pulo Gadung   Jakarta  13930   INDONESIA www.sohoglobalhealth.com

Composition :  Each  film   coated  tablet  contains 500  mg  of   mycophenolate  mofetil  ∙  Therapeutic  indications :  CELMUNOS   is  indicated  for  the prophylaxis  of  acute  organ  rejection  and   increased  graft  and patient  survival  in  patients receiving  allogeneic  cardiac  transplant.  CELMUNOS  should  be  used   concomitantly  with  cyclosporin  and  corticosteroids.  CELMUNOS  is  also  indicated  for  induction  and  maintenance   of  therapy  in   adult  patients with  WHO  Class  III,  IV  and  V  lupus  nephritis ∙   Posology  and  method  of  administration :  Standard  dose  of   prophylaxis  of renal  rejection :  The  initial  dosage  should be  given  orally  as  soon  as  possible  within  72  hours  following   transplantation.  Standard  dosage  of  1  g  given  twice  daily   (maximum  of  2   g  a  day) resulted  in  equal  efficacy  and  better   tolerability  compared  to  the  maximum  3  g  daily  dosage.   Standard  dose  of  prophylaxis  of  cardiac  rejection :  Standard   dosage  of  1.5  g  given  twice  daily  should be  given orally  as  soon   as  possible  within  5  days  following   transplantation.  Lupus   nephritis  patients (Adult),  Initial  dose:  750  mg  –  1.5  g  given  twice   daily.  Maintenance  dose:  500  mg  –  1  g  given  twice  daily∙   Contraindications :  Hypersensitivity  to  mycophenolate  mofetil   or  mycophenolic  acid  (MPA),  pregnancy,  women  with   childbearing  potential  and without  proper  contraceptive  methods  and  women  who  are  breastfeeding  ∙  Special  warnings   and  precautions :  As  with  other  patients  in  immunosuppressive   therapy, patients  who  are  using  CELMUNOS  have an  increased  risk  of  developing  lymphomas  and  other  malignancies,   especially  of  the  skin.  Due  to  increased  risk  in  skin  malignancies,  patients with immunosuppressive  therapy  should  avoid   high   exposure  to   sunlight  and   UV  light.   Over-supression  of  the   immune  system  can  also  increased  the  risk  of  opportunistic  and   fatal  infection,  including  sepsis.  There  is  also  a  risk  of  latent virus   reactivation  such  as  Hepatitis  B  and  C  or  infections  caused  by  polyomaviruses,  JC  virus  (such  as  in  Progressive  Multifocal   Leukoenchelopathy/  PML)  and  BK  virus-associated  nephropathy.   The  use  of  CELMUNOS  might  also  caused  pure  red  cell aplasia   (PRCA)  and  other hematology  disorders.  Although  the   mechanism  underlying  this  conditions  are  unknown  and   reversible with dose  reduction,  patients  using  CELMUNOS  and   other  immunosuppressive  agents are  encourage  to  report  signs   of  infection  and  hematological  disorders  (easy-bruising,  bleeding,  etc.).  Total  hematology  monitoring  should  be  done   regularly  in  patients  using  immunosuppressive agents.   CELMUNOS  has  been  associated  with  increased  digestive  system   adverse  events  (such  as  GI   tract  ulceration,  perforation  and   bleeding),  hence  the  use  of  it should  be  avoided  in  patients with   active  digestive  system  disorders.  CELMUNOS  is  an   inosine   monophosphate  dehydrogenase  (IMPDH)  inhibitor.  Thus  the   usage  should   be  avoided  patients  with rare  hypoxanthine-   gunanin  phosphoribosil   transferase  (HGPRT) such  as  Lesch  –   Nyhan and  Kelley-Seegmiller  Syndriome ∙  Special  Populations :   Dosage  should  be reduced  in  patients  with  neutropenia.  Dose   limitation  below  1  g  per  day  should  be  implemented  to  patients   with  severe  chronic renal  impairment after  renal  transplantation.   No  dosage adjustments  needed  for  patients with  renal   impairment after  cardiac  transplant,  patients  with hepatic   disorders  and  elderly  (≥  65  years).  No  data  available  for  the  use   in   children. Manufactured  by

16 th  Floor,  B-Wing,   Mondeal   Heights    Iscon Cross  Road,   S.G.   Highway    Ahmedabad  –  380015,  Gujarat,   India.

Product   Information 1 Drug  Interactions:  Cautions  should be  taken  when  using   CELMUNOS  with   acyclovir/  ganciclovir,  rifampicin,  telmisartan,  cholestiramine, tacrolimus,  azathioprine,  proton  pump inhibitors   (PPI),  oral  contraceptives,  antibiotics,  other  immunosuppressant   agents (such  as  cyclosporin)  and  live  vaccines  ∙  Undesirable   Effects :  The  principle  adverse  drug  reactions  (ADRs),  occurring   in  patients  using  CELMUNOS  in  combination  with cyclosporin   and  corticosteroids  are  diarrhea,  abdominal  pain,  dyspepsia,   leucopenia,  sepsis, nausea,  vomiting  and  higher  frequency  of   infections∙  Mechanism  of  Action :  Mycophenolate  mofetil   (MMF)  is  the  2-morpholinoethyl  ester  of  mycophenolic  acid   (MPA). MPA  is  a  potent,  selective,  uncompetitive  and  reversible   inhibitor  of  inosine  monophosphate  dehydrigenase  (IMPDH),   and therefore  inhibits  the  de  novo  pathway  of  guanosine   nucleotide  syntesis  without  incorporating  into  the  DNA.  MMF  is   more effective  in  its  cytostatic effects  of  lymphocytes  since  B   and  T  cells  are  heavily  dependent  of  their  de  novo  of  purines   whereas  other  cells  can  use  alternative  salvage  pathways.  MMF   is  effective  in  the prophylaxis  of  organ  rejection  in  patients with  renal  or  cardiac  allogeneic  transplantation ∙  Packaging:   Box,  6   blisters  @  10  film  coated  tablets  ∙  BPOM  Registration  Number :   DKI  2055900109A1.  BEFORE  PRESCRIBING,  PLEASE  CONSULT   FULL  PRESCRIBING   INFORMATION . REFERENCES :

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 Marketed   by Jalan  Rawa  Sumur  II  Kav.  B.  B3   Kawasan  Industri  Pulo Gadung   Jakarta  13930   INDONESIA www.sohoglobalhealth.com

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