REMICADE POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 mgvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

INFLIXIMAB

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

L04AB02

Dosage:

100 mg/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

INFLIXIMAB 100 mg/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Patheon Italia S.p.A.

Authorization status:

ACTIVE

Authorization date:

2002-11-11

Patient Information leaflet

 
1
1. 
NAME OF THE MEDICINAL PRODUCT 

Remicade 100 mg powder for concentrate for solution for infusion. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each  vial  of  Remicade  contains  100 mg  of infliximab,  a  chimeric IgG1 monoclonal  antibody 
manufactured  from  a  recombinant  cell  line  cultured  by  continuous  perfusion.  Upon 
reconstitution each ml contains 10 mg of infliximab. For excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Powder for concentrate for solution for infusion. 
The powder is a freeze-dried white pellet. 

4. 
CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

Rheumatoid arthritis: 
Remicade, in combination with methotrexate, is indicated for:  
The reduction of signs and symptoms as well as the improvement in physical function in  
• 
patients  with  active  disease  when  the  response  to  disease-modifying  drugs,  including 
methotrexate, has been inadequate.  
• 
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).  

Crohn’s disease 
Remicade is indicated for: 
• 
Treatment of moderately to severely, active Crohn’s disease, in patients who have not 
responded  despite  a full  and  adequate  course  of  therapy  with  a  corticosteroid  and  an 
immunosuppressant; or who are intolerant to or have medical contraindications for such 
therapies. 
• 
Treatment of fistulising Crohn’s disease, in patients who have not responded despite a 
full  and  adequate  course  of  therapy  with  conve

Summary of Product characteristics

1
PRODUCT NAME
REMICADE
®
(infliximab) 100 mg powder for concentrate for solution for infusion.
DOSAGE FORMS AND STRENGTHS
REMICADE
®
is available as a powder for concentrate for solution for infusion.
The powder is a freeze-dried white pellet.
Each
vial
of
REMICADE
®
contains
100 mg
of
infliximab,
a
chimeric
human-murine
IgG1 monoclonal
antibody
produced
in
murine
hybridoma
cells
by
recombinant
DNA
technology. Upon reconstitution, each ml contains 10 mg of infliximab.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
RHEUMATOID ARTHRITIS
REMICADE
®
, in combination with methotrexate (MTX), is indicated for:
The reduction of signs and symptoms as well as the improvement in
physical function in
•
patients with active disease when the response to disease-modifying
drugs, including
methotrexate, has been inadequate.
•
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
_Pharmacodynamic Properties_
).
CROHN’S DISEASE
REMICADE
®
is indicated for:
•
Treatment of moderately to severely, active Crohn’s disease, in
patients who have not
responded despite a full and adequate course of therapy with a
corticosteroid and an
immunosuppressant; or who are intolerant to or have medical
contraindications for such
therapies.
•
Treatment of fistulising Crohn’s disease, in patients who have not
responded despite a full
and adequate course of therapy with conventional treatment (including
antibiotics,
drainage and immunosuppressive therapy).
PEDIATRIC CROHN’S DISEASE
REMICADE
®
is indicated for:
Treatment of severe, active Crohn’s disease, in pediatric patients
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.
REMICADE
®
has b