REMICADE POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

Infliximab

Inapatikana kutoka:

JOHNSON & JOHNSON SDN BHD

INN (Jina la Kimataifa):

Infliximab

Vitengo katika mfuko:

1Units Units

Viwandani na:

CILAG AG

Taarifa za kipeperushi

NOT APPLICABLE

Tabia za bidhaa

1.
NAME OF THE MEDICINAL PRODUCT
Remicade 100 mg powder for concentrate for solution for infusion.
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
(powder for concentrate).
The powder is a freeze-dried white pellet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Remicade is indicated for:
RHEUMATOID ARTHRITIS
Remicade is a "Disease-Controlling Anti-Rheumatic Therapy" (DCART)
indicated for:

the reduction of signs and symptoms

prevention of structural joint damage (erosions and joint space
narrowing)

improvement in physical function
in patients with active disease despite treatment with methotrexate
(MTX), and patients with active
disease not previously treated with MTX.
ANKYLOSING SPONDYLITIS
Remicade is indicated for:

reduction of signs and symptoms

improvement in physical function

improvement in quality life
in patients with active disease.
PSORIATIC ARTHRITIS
Remicade is indicated for:

the reduction of signs and symptoms of arthritis

improvement in physical function

reduction in psoriasis as measured by PASI (an index which combines
symptom evaluation
and body surface area)
in patients with active psoriatic arthritis.
PSORIASIS
Remicade is indicated for treatment of moderate to severe plague
psioriasis in adults who failed to
respond to or who have a contraindication to, or are intolerant to
other systemic therapy including
cyclosporine, methotrexate or PUVA.
CROHN'S DISEASE
Remicade is indicated for treatment of moderate to severe Crohn's
disease for:

reduction of signs and symptoms

induction and maintenance of clinical remission

induction of mucosal healing

improvement in quality of life
in patients who have an i