REMSIMA 100 MG I.V.

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

INFLIXIMAB

Disponibbli minn:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

Kodiċi ATC:

L04AB02

Għamla farmaċewtika:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Kompożizzjoni:

INFLIXIMAB 100 MG/VIAL

Rotta amministrattiva:

I.V

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

CELLTRION INC., SOUTH KOREA

Żona terapewtika:

INFLIXIMAB

Indikazzjonijiet terapewtiċi:

* Rheumatoid arthritis:Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:• adult patients with active disease when the response to disease modifying antirheumatic drugs (DMARDs),including methotrexate, has been inadequate.• adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X ray,has been demonstrated.* Ankylosing spondylitis:Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.* Psoriatic arthritis:Remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.* Remsima should be administered:• in combination with methotrexate• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease.* Psoriasis:Remsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA)* Adult Crohn’s disease Remsima is indicated for treatment :• of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.• treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).* Ulcerative colitis• Remsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.Paediatric Crohn’s diseaseRemsima is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.Paediatric ulcerative colitisRemsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6 MP or AZA, or who are intolerant to or have medical contraindications for such therapies.

Data ta 'l-awtorizzazzjoni:

2020-09-30

Fuljett ta 'informazzjoni

ﺔﻗﺎﻄﺒﻟا هﺬﻫ ﺮ
ِ
ﻬﻇأ ﺐﻴﺒﻃ ﻞﻜﻟ
.ﻚﺟﻼﻌﺑ كرﺎﺸﻳ
بﺎﻤﯿﺴﻜﯿﻠﻔﻧإ
(INFLIXIMAB) تﺎﻣﻮﻠﻌﻣ ﺔﻗﺎﻄﺑ نﺎﻣﻷا لﻮﺣ
ﺞﻟﺎﻌﺘﻤﻠﻟ
ﺎﻤﻴﺴﻤﻳ
ر
ﻎﻠﻣ 100
ﺪﻳرﻮﻟا ﻞﺧاد نﺎﻣﻷا لﻮﺣ تﺎﻣﻮﻠﻌﳌا ﺔﻗﺎﻄﺑ
يﻮﺤﺗ لﻮﺣ ﺔﻣﺎﻫ تﺎﻣﻮﻠﻌﻣ ﲆﻋ
ﺞﻟﺎﻌﺘﻤﻠﻟ جﻼﻌﻟا ءﺪﺑ ﻞﺒﻗ ﺎﻬﺘﻓﺮﻌﻣ ﻚﻴﻠﻋ
،نﺎﻣﻷا ،ﺪﻳرﻮﻟا ﻞﺧاد ﻎﻠﻣ 100 ﺎﻤﻴﺴﻤﻳر
ـﺑ
.ﻪﻟﻼﺧو
:ﺞﻟﺎﻌﺘﻣ :ﺐﻴﺒﻃ :ﻒﺗﺎﻬﻟا ﻢﻗر
يرﺎﺠﺘﻟا ﻢﺳﻹا ﻚﺒﻴﺒﻃو ﺖﻧأ ﺐﺘﻜﺗ
نأ ﻢﻬﳌا ﻦﻣ
ﺔﻠﻴﻐﺸﺘﻟا
ﻢﻗر ﻚﻟﺬﻛو هﺎﻘﻠﺘﺗ يﺬﻟا
ءاوﺪﻠﻟ
.ﻲﺋاوﺪﻟا راﺪﻘﻤﻠﻟ
:ﴬﺤﺘﺴﳌا ﻢﺳا
:ﺔﻠﻴﻐﺸﺘﻟا ﻢﻗر
ﻞﺧاد ﻎﻠﻣ 100 ﺎﻤﻴﺴﻤﻳر ـﺑ جﻼﻌﻟا
ءﺪﺑ ﺦﻳرﺎﺗ
:ﺪﻳرﻮﻟا
:ﺔﻴﻟﺎﺤﻟا ةروﺪﻟا ﰲ ءاوﺪﻟا ﻲﻘﻠﺗ
ﺦﻳراﻮﺗ
هﺬﻫ ﻆﻔﺣإ ءﺎﺟﺮﻟا ،ةﺪﻳﺪﺟ
ﺔﻗﺎﻄﺒﺑ أﺪﺒﺗ ﺎﻣﺪﻨﻋ
ﺎﻬﺗءاﺮﻘﻟ ،ﺔﻴﻓﺎﺿإ رﻮﻬﺷ ﺔﻌﺑرأ
ةﱰﻔﻟ ﺔﻗﺎﻄﺒﻟا
.ﺔﺟﺎﺤﻟا ﺖﻋد اذإ ﻦﻌﻤﺘﺑ
ـﻟ
"ﻚﻠﻬﺘﺴﳌا
ةﴩﻧ"
ﻦﻌﻤﺘﺑ
أﺮﻗإ
أﺪﺒﺗ نأ ﻞﺒﻗ ﺪﻳرﻮﻟا ﻞﺧاد ﻎﻠﻣ 100
ﺎﻤﻴﺴﻤﻳر
.ءاوﺪﻟا اﺬﻫ لﺎﻤﻌﺘﺳﺈﺑ
ﻦﻋ ةرﺎﺒﻋ ﺪﻳرﻮﻟا ﻞﺧاد ﻎﻠﻣ 100
ﺎﻤﻴﺴﻤﻳر
ﻦﻋ ﺔﻴﻓﺎﺿإ تﺎﻣﻮﻠﻌﳌ .يﻮﻴﺣ
ﻪﺑﺎﺸﻣ ﴬﺤﺘﺴﻣ
ﺢﻔﺼﺗ ﺐﺠﻳ
ً
ﺎﻳﻮﻴﺣ ﺔﻬﺑﺎﺸﳌا
تاﴬﺤﺘﺴﳌا
:ﺔﺤﺼﻟا ةرازو ﻊﻗﻮﻣ
https://www.health.gov.il/UnitsOffice/
HD/MTI/Drugs/Registration/Pages/Bi
osimilars.aspx
ﻞﻳﺪﺒﺗ ءاﺮﺟإ ﲆﻋ ﺔ�

Karatteristiċi tal-prodott

1
1.
NAME OF THE MEDICINAL PRODUCT
Remsima 100 mg I.V.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of infliximab. Infliximab is a chimeric
human-murine IgG1
monoclonal antibody produced in murine hybridoma cells by recombinant
DNA
technology. After reconstitution each ml contains 10 mg of infliximab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
The powder is white.
PATIENT SAFETY INFORMATION CARD
The marketing of Remsima 100 mg I.V. is subject to a risk management
plan (RMP)
including a 'Patient safety information card'.
The 'Patient safety information card', emphasizes important safety
information that the patient
should be aware of before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
Remsima 100 mg I.V. is a biosimilar medicinal product that has been
demonstrated to be similar in
quality, safety and efficacy to the reference medicinal product
Remicade. Please be aware of any
differences in the indications between the biosimilar medicinal
product and the reference medicinal
product. Information regarding interchangeability can be found on the
website of the Ministry of
Health:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Rheumatoid arthritis:
Remsima 100 mg I.V., in combination with methotrexate, is indicated
for the reduction of signs and
symptoms as well as the improvement in physical function in:
•
adult patients with active disease when the response to
disease-modifying antirheumatic drugs
(DMARDs), including methotrexate, has been inadequate.
•
adult patients with severe, active and progressive disease not
previously treated with
methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the
progression of joint damage, as measured
by X-ray, has been demonstrated (see section 5.1).
-
Adult Crohn’s disease:
Remsima 100