Remicade powder lyophilized for concentrate for solution for infusion

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

infliximab

Disponible des:

Cilag AG

Codi ATC:

L04AB02

Designació comuna internacional (DCI):

infliximab

Dosis:

100mg

formulario farmacéutico:

powder lyophilized for concentrate for solution for infusion

Unidades en paquete:

(1) 20ml glass vial

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2018-07-11

Fitxa tècnica

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
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:

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
Remicade 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).
Paediatric Crohn’s disease
Remicade 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 corticoste