Simponi

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Golimumab 50mg;  

Доступно од:

Janssen-Cilag (New Zealand) Ltd

INN (Међународно име):

Golimumab 50 mg

Дозирање:

50 mg

Фармацеутски облик:

Solution for injection

Састав:

Active: Golimumab 50mg   Excipient: Histidine Polysorbate 80 Sorbitol Water for injection

Јединице у пакету:

Syringe, glass, Type I, clear, pre-filled, 0.5 mL fill volume with UltraSafe passive delivery system 1 per pack, 1 dose unit

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Janssen Sciences Ireland UC

Терапеутске индикације:

Rheumatoid arthritis: Simponi, in combination with MTX, is indicated for: · the treatment of active rheumatoid arthritis in adult patients when the response to DMARD therapy has been inadequate. · the treatment of active rheumatoid arthritis in adult patients not previously treated with MTX. Simponi has also been shown to reduce the rate of progression of joint damage as measured by X-ray, improve physical function and health related quality of life. Simponi can be used in patients previously treated with one or more TNF inhibitor(s).

Резиме производа:

Package - Contents - Shelf Life: Syringe, glass, Type I, clear, pre-filled, 0.5 mL fill volume with UltraSafe passive delivery system 1 per pack - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days not refrigerated stored at or below 25°C protect from light. Single period. Do not re-refrigerate. - Syringe, glass, Type I, clear, pre-filled, 0.5 mL fill volume with UltraSafe passive delivery system 3 per pack - 3 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days not refrigerated stored at or below 25°C. Single period. Do not re-refrigerate.

Датум одобрења:

2008-07-09

Информативни летак

SIMPONI
®
 (130212) NZ ACMI  
1 
SIMPONI
®

_Golimumab (rmc) _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about SIMPONI.  It does 
not contain all the available 
information.  It does not take the 
place of talking to your doctor, nurse 
or pharmacist. 
All medicines have risks and 
benefits.  Your doctor has weighed 
the risks of you using SIMPONI 
against the benefits it is expected to 
have for you. 
IF YOU HAVE ANY CONCERNS ABOUT 
USING THIS MEDICINE, ASK YOUR 
DOCTOR, NURSE OR PHARMACIST. 
KEEP THIS LEAFLET. 
You may need to read it again. 
WHAT SIMPONI IS USED 
FOR 
SIMPONI contains the active 
ingredient golimumab.  Golimumab 
is a human monoclonal antibody that 
is produced by recombinant 
technology. Monoclonal antibodies 
are proteins that recognise and bind 
to other specific proteins in the body. 
Golimumab acts by binding to a 
specific protein in the body called 
tumour necrosis factor (TNF) alpha.  
In people with diseases such as 
rheumatoid arthritis, psoriatic 
arthritis and ankylosing spondylitis, 
the body produces too much TNF, 
which can cause the body's immune 
system to attack normal healthy parts 
of the body. SIMPONI can block the 
damage caused by too much TNF. 
SIMPONI is used to treat: 
  rheumatoid arthritis 
  psoriatic arthritis 
  ankylosing spondylitis. 
RHEUMATOID ARTHRITIS 
Rheumatoid arthritis is an 
inflammatory disease of the joints. 
SIMPONI is used in patients who 
have not responded well enough to 
previous treatments with other 
disease-modifying medicines. 
SIMPONI is used with a disease-
modifying medicine called 
methotrexate. 
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, 
a

Карактеристике производа

SIMPONI(190320)ADS
Page 1 of 32
CCDS190211
SIMPONI
®
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
SOLUTION FOR INJECTION IN A PRE-FILLED PEN, SMARTJECT
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SIMPONI 50 mg Solution for Injection in a pre-filled syringe
SIMPONI 50 mg Solution for Injection in a pre-filled pen, SmartJect
SIMPONI 100 mg Solution for Injection in a pre-filled syringe
SIMPONI 100 mg Solution for Injection in a pre-filled pen, SmartJect
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL single-use pre-filled syringe or pre-filled pen contains
50 mg of golimumab*.
Each 1.0mL single-use pre-filled syringe or pre-filled pen contains
100mg of golimumab*.
* Human IgG1κ monoclonal antibody produced by a murine hybridoma cell
line with recombinant DNA technology.
_Excipient(s) with known effect: _
Each pre-filled pen contains 20.5 mg sorbitol per 50 mg dose or 41 mg
sorbitol per 100 mg
dose.
Each pre-filled syringe contains 20.5 mg sorbitol per 50 mg dose or 41
mg sorbitol per 100 mg
dose.
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe (injection)
Solution for injection in pre-filled pen (injection), SmartJect
The solution is clear to slightly opalescent, colourless to light
yellow.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS (RA)
SIMPONI, in combination with methotrexate (MTX), is indicated for:
•
the treatment of active rheumatoid arthritis in adult patients when
the response to
DMARD therapy has been inadequate.
•
the treatment of active rheumatoid arthritis in adult patients not
previously treated with
MTX.
SIMPONI(190320)ADS
Page 2 of 32
CCDS190211
SIMPONI has also been shown to reduce the rate of progression of joint
damage as measured
by X-ray, improve physical function and health related quality of
life. SIMPONI can be used in
patients previously treated with one or more TNF inhibitor(s).
PSORIATIC ARTHRITIS (PSA)
SIMPONI, alone or in combination with MTX, is indicated for:
The treatment of