Remicade

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Infliximab 100mg;  

זמין מ:

Janssen-Cilag (New Zealand) Ltd

INN (שם בינלאומי):

Infliximab 100 mg

כמות:

100 mg

טופס פרצבטיות:

Powder for injection

הרכב:

Active: Infliximab 100mg   Excipient: Dibasic sodium phosphate dihydrate Monobasic sodium phosphate monohydrate Polysorbate 80 Sucrose

יחידות באריזה:

Vial, glass, 100 mg

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

Janssen Biotech Inc

סממני תרפויטית:

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. Remicade should be given in combination with methotrexate.

leaflet_short:

Package - Contents - Shelf Life: Vial, glass, - 100 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate) 12 months not refrigerated stored at or below 30°C. Single period. Do not return to refrigerator.

תאריך אישור:

1999-03-10

עלון מידע

REMICADE
®
(220531) ACMI NZ
REMICADE
®
_Infliximab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about REMICADE. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using REMICADE
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to
read it again.
WHAT REMICADE IS
USED FOR
REMICADE contains the active
ingredient, infliximab. Infliximab is
a monoclonal antibody that is
produced from human and mouse
proteins by recombinant technology.
Monoclonal antibodies are proteins
that recognise and bind to certain
special proteins in the body.
Infliximab acts by binding to a
special protein in the body called
called tumour necrosis factor alpha
(TNF
α
). In people with diseases
such as Crohn's disease, ulcerative
colitis, rheumatoid arthritis,
ankylosing spondylitis, psoriatic
arthritis and psoriasis, the body
produces too much TNF
α
, which can
cause the body’s immune system to
attack normal healthy parts of the
body. REMICADE can block the
damage caused by too much TNF
α
.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an
inflammatory disease of the joints.
REMICADE is used to reduce the
signs and symptoms of rheumatoid
arthritis and to prevent damage to the
joints. You will also be given a
disease-modifying medicine called
methotrexate.
ANKYLOSING SPONDYLITIS
Ankylosing spondylitis is an
inflammatory disease of the spine.
REMICADE can reduce the signs
and symptoms of ankylosing
spondylitis, thereby improving
physical function.
PSORIATIC ARTHRITIS
Psoriatic arthritis is an inflammatory
disease of the joints in which
psoriasis usually occurs in
association with arthritis. Often the
fingers and toes are affected,
although it may occur in other parts
of the body. REMICADE is used to
reduce the signs and

מאפייני מוצר

22.230811
1
REMICADE (240207) ADS
REMICADE
®
POWDER FOR INJECTION
INFLIXIMAB
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
REMICADE 100 mg POWDER FOR INJECTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of the REMICADE product contains infliximab 100 mg.
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 a full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Powder for injection
REMICADE Powder for Injection is to be reconstituted with 10 mL
sterile Water for Injections
and further diluted in 0.9% sodium chloride solution for infusion.
REMICADE is supplied as a white lyophilised powder in
individually-boxed single-use glass
vials with rubber stoppers and aluminium crimps protected by plastic
caps.
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.
REMICADE should be given in combination with methotrexate.
22.230811
2
REMICADE (240207) ADS

ANKYLOSING SPONDYLITIS
REMICADE is indicated for the reduction of signs and symptoms and
improvement in physical
function 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)
•
prevention of worsening of disability
•
inhibition of the progression of structural damage of active
arthritis, as measured by x-
ray
in patients with active and progressive psoriatic arthritis.
REMICADE should be administered
•
In combination with methotrexate, or
•
Alone in patients w