REMSIMA® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MGVIAL

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Infliximab

Commercializzato da:

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

Codice ATC:

L04AB02

Forma farmaceutica:

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

Composizione:

Infliximab 100mg/vial

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

Prescription Only

Prodotto da:

Mustafa Nevzat Ilac Sanayii A.S.

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2016-03-28

Scheda tecnica

PRODUCT NAME
REMSIMA
®
100 mg/vial powder for concentrate for solution for infusion.
DOSAGE FORMS AND STRENGTHS
Each vial of REMSIMA
®
contains 100 mg of infliximab a chimeric lgG1 monoclonal antibody
manufactured from a recombinant cell line cultured by continuous
perfusion. Upon reconstitution
each ml contains 10 mg of infliximab. For excipients, see
List of Excipients
.
Powder for concentrate for solution for infusion.
The powder is a freeze-dried white pellet.
CLINICAL INFORMATION
INDICATIONS
RHEUMATOID ARTHRITIS
REMSIMA
®
, 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
REMSIMA
®
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).
PAEDIATRIC CROHN’S DISEASE
REMSIMA
®
is indicated for:
Treatment of severe, active Crohn’s disease, in paediatric 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. REMSIMA
®
has been studied only in combination with conventional
immunosuppr