REVELLEX 100 mg SOLUTION

البلد: جنوب أفريقيا

اللغة: الإنجليزية

المصدر: South African Health Products Regulatory Authority (SAHPRA)

متاح من:

Janssen Pharmaceutica (Pty) Ltd

جرعة:

See ingredients

الشكل الصيدلاني:

SOLUTION

تركيب:

EACH 10,0 ml VIAL CONTAINS INFLIXIMAB 100,0 mg

الوضع إذن:

Registered

تاريخ الترخيص:

2001-08-10

نشرة المعلومات

JANSSEN PHARMACEUTICA (PTY) LTD.
REVELLEX – PATIENT INFORMATION LEAFLET (Clean copy)
Submission date: 30 June 2016
Reference number: RA/2016/06/038cp
Amendment type: Amended storage instructions, as per MCC letter 12 May
2016 (P&A : Biological section approval)
_____________________________________________________________________________________________
_P&A (BIOLOGICAL SECTION) APPROVAL LETTER 12 MAY 2016 (STORAGE
INSTRUCTIONS) _
_PAGE 1 OF 13 _
FINAL PATIENT INFORMATION LEAFLET
(CLEAN COPY)
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
REVELLEX
®
100 mg Injection
Powder for concentrate for solution for infusion
Active substance: Infliximab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN REVELLEX

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

REVELLEX has been prescribed for you personally and you should not
share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
1.
WHAT REVELLEX CONTAINS
The active substance is infliximab.
The other ingredients are polysorbate, sodium phosphate and sucrose.
JANSSEN PHARMACEUTICA (PTY) LTD.
REVELLEX – PATIENT INFORMATION LEAFLET (Clean copy)
Submission date: 30 June 2016
Reference number: RA/2016/06/038cp
Amendment type: Amended storage instructions, as per MCC letter 12 May
2016 (P&A : Biological section approval)
_____________________________________________________________________________________________
_P&A (BIOLOGICAL SECTION) APPROVAL LETTER 12 MAY 2016 (STORAGE
INSTRUCTIONS) _
_PAGE 2 OF 13 _
2.
WHAT REVELLEX IS USED FOR
REVELLEX is intended for the treatment of rheumatoid arthritis,
ankylosing spondylitis, psoriatic
arthritis, psoriasis, Crohn’s disease and ulcerative colitis, with
the aim to reduce inflammatory
activity.
The
active substance infliximab,
is
a human-mouse monoclonal
antibody.
Monoclonal
antibodies are proteins that recognise and bind to other unique
proteins in the body.
I

خصائص المنتج

JANSSEN PHARMACEUTICA (PTY) LTD.
REVELLEX – CLEAN PACKAGE INSERT
Submission date: 30 June 2016
Reference number: RA/2016/06/038cp
Amendment type: Revised STORAGE INSTRUCTIONS as per MCC approval
letter dated 12 May 2016 (P&A – Biological section)
_____________________________________________________________________________________________
_P&A (BIOLOGICAL SECTION) APPROVAL LETTER 12 MAY 2016 (STORAGE
INSTRUCTIONS) _
_PAGE 1 OF 37 _
FINAL CLEAN PACKAGE INSERT
SCHEDULING STATUS
S4
PROPRIETARY NAME AND DOSAGE FORM
REVELLEX
®
100 mg
COMPOSITION
Each vial of the REVELLEX product contains 100 mg of infliximab. After
reconstitution, each vial of
REVELLEX contains 100 mg of infliximab in 10 m
l.
Inactive ingredients include polysorbate, sodium phosphate and
sucrose.
PHARMACOLOGICAL CLASSIFICATION
A.30.1 Biologicals – Antibodies.
PHARMACOLOGICAL ACTION
Infliximab is a chimeric human-murine monoclonal antibody that binds
with high affinity to both
soluble and transmembrane forms of tumour necrosis factor alpha (TNF

), but not to lymphotoxin

(TNF

). Infliximab inhibits the functional activity of TNF

in a wide variety of _in vitro_ bioassays.
JANSSEN PHARMACEUTICA (PTY) LTD.
REVELLEX – CLEAN PACKAGE INSERT
Submission date: 30 June 2016
Reference number: RA/2016/06/038cp
Amendment type: Revised STORAGE INSTRUCTIONS as per MCC approval
letter dated 12 May 2016 (P&A – Biological section)
_____________________________________________________________________________________________
_P&A (BIOLOGICAL SECTION) APPROVAL LETTER 12 MAY 2016 (STORAGE
INSTRUCTIONS) _
_PAGE 2 OF 37 _
_CLINICAL PHARMACOLOGY _
PHARMACODYNAMIC PROPERTIES: Elevated concentrations of TNF

have been found in the joints of
rheumatoid arthritis patients and correlate with elevated disease
activity. Increased concentrations of
TNF

have also been found in joint fluid/tissue and in psoriatic skin
lesion in patients with psoriatic
arthritis. In rheumatoid arthritis, treatment with infliximab reduced
infiltration of inflammatory cells