Renflexis

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Infliximab 100mg

Disponível em:

Samsung Bioepis NZ Limited

Dosagem:

100 mg

Forma farmacêutica:

Powder for injection

Composição:

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

Tipo de prescrição:

Prescription

Indicações terapêuticas:

Ulcerative Colitis in Adults and Children and Adolescents (6 to 17 years) Renflexis is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Resumo do produto:

Package - Contents - Shelf Life: Vial, glass, Type I glass vial closed with bromobutyl rubber stopper and flip off cap - 100 mg - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Data de autorização:

2021-10-01

Folheto informativo - Bula

Renflexis
®
(210714) ACMI NZ
RENFLEXIS
®
_Infliximab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Renflexis. 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 Renflexis 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 RENFLEXIS IS USED
FOR
Renflexis 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
(TNFα). In people with diseases such
as Crohn's disease, ulcerative colitis,
rheumatoid arthritis, ankylosing
spondylitis, psoriatic arthritis and
psoriasis, the body produces too
much TNFα, which can cause the
body’s immune system to attack
normal healthy parts of the body.
Renflexis can block the damage
caused by too much TNFα.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an
inflammatory disease of the joints.
Renflexis 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.
Renflexis 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.
Renflexis is used to reduce the signs

Características técnicas

RENFLEXIS
®
POWDER FOR INJECTION
INFLIXIMAB
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Renflexis 100 mg POWDER FOR INJECTION
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of the Renflexis product contains infliximab 100 mg.
Infliximab is a chimeric human-murine IgG1 monoclonal antibody
produced in Chinese Hamster
Ovary (CHO) cells by recombinant DNA technology. After reconstitution
each mL contains 10 mg
of infliximab.
For a full list of excipients, see SECTION 6.1.
Renflexis is a biosimilar medicine. The prescribing physician should
be involved in any decision
regarding interchangeability. For further information, visit
(www.medsafe.govt.nz/profs/RIss/Biosimilars.asp
).
Data comparing Renflexis to Remicade
®
can be found in section 5.1, Clinical Efficacy;
Comparability of Renflexis with Remicade of this datasheet.
3
PHARMACEUTICAL FORM
Powder for injection
Renflexis 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.
Renflexis 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
Renflexis is indicated for:

RHEUMATOID ARTHRITIS
Renflexis 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.
Renflexis should be given in combination with methotrexate.

ANKYLOSING SPONDYLITIS
Renflexis is indicated for the reduction of signs and symptoms and
improvement in physical
function in patients with active disease.

PSORIATIC ARTHRITIS
Renflexis 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 surfa