Amgevita

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Adalimumab 50 mg/mL;  

זמין מ:

Amgen New Zealand Limited

כמות:

40 mg/0.8mL

טופס פרצבטיות:

Solution for injection

הרכב:

Active: Adalimumab 50 mg/mL   Excipient: Glacial acetic acid Polysorbate 80 Sodium hydroxide Sucrose Water for injection

סוג מרשם:

Prescription

סממני תרפויטית:

Rheumatoid Arthritis AMGEVITA is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. AMGEVITA can be used alone or in combination with methotrexate.

leaflet_short:

Package - Contents - Shelf Life: Syringe, glass, (Type I), prefilled (0.8 mL deliverable volume), assembled into an autoinjector pen - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light - Syringe, glass, (Type I), prefilled (0.8 mL deliverable volume), assembled into an autoinjector pen - 2 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light - Syringe, glass, (Type I), prefilled (0.8 mL deliverable volume), assembled into an autoinjector pen - 4 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light - Syringe, glass, (Type I), prefilled (0.8 mL deliverable volume), assembled into an autoinjector pen - 6 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light

תאריך אישור:

2018-05-17

עלון מידע

AMGEVITA® CMI
AMGEVITA®
PRE-FILLED SYRINGE
PRE-FILLED PEN
_ _
_Adalimumab (ada-lim-u-mab) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS CMI
This leaflet answers some common
questions about AMGEVITA.
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 this medicine
against the benefits they expect it
will have for you.
SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING
AMGEVITA.
READ THIS LEAFLET CAREFULLY BEFORE
YOU USE AMGEVITA AND KEEP THIS
LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT AMGEVITA IS
USED FOR
AMGEVITA is a medicine used to
treat the following inflammatory
conditions:
•
Rheumatoid arthritis (RA)
•
Polyarticular juvenile idiopathic
arthritis
(
polyarticular JIA)
•
Enthesitis-related arthritis (ERA)
•
Psoriasis (Ps)
•
Psoriatic arthritis (PsA)
•
Ankylosing spondylitis (AS)
•
Non-radiographic axial
spondyloarthritis (nr-axSpA)
•
Crohn's disease
•
Ulcerative colitis
•
Hidradenitis suppurativa (HS)
and
•
Uveitis.
AMGEVITA contains the active
substance adalimumab. Adalimumab
is a fully human monoclonal
antibody; a protein made by a type of
blood cell to fight a foreign protein in
the body.
Adalimumab recognises and binds to
a specific protein (tumour necrosis
factor or TNF-alpha), which is
present at higher levels in some
inflammatory diseases. By attaching
to the target protein, the active
substance in AMGEVITA decreases
inflammation.
More information about these
conditions is provided below and on
the page 2.
1. RHEUMATOID ARTHRITIS
(RA) is an inflammatory disease
of the joints.
Signs and symptoms of RA
include:
•
joint pain
•
tenderness
•
swelling and
•
stiffness.
AMGEVITA is used to reduce
the signs and symptoms of
moderate to severely active RA,
as well as slow down and protect
the joints from further damage.
AMGEVITA can be used alone
or in combination with another
medi

מאפייני מוצר

NEW ZEALAND DATA SHEET
AMGEVITA NZ DATA SHEET
PAGE 1 OF 93
AMGEVITA
® SOLUTION FOR INJECTION
1.
PRODUCT NAME
AMGEVITA
®
adalimumab (rch) solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
AMGEVITA 20 mg
Each 0.4 mL single-use pre-filled syringe contains 20 mg of
adalimumab.
AMGEVITA 40 mg
Each 0.8 mL single-use pre-filled syringe or pre-filled pen contains
40 mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody expressed in
Chinese Hamster
Ovary cells.
Adalimumab
is
a
recombinant
human
immunoglobulin
(IgG1)
monoclonal
antibody
containing only human peptide sequences. AMGEVITA was created using
phage display
technology resulting in fully human heavy and light chain variable
regions, which confer
specificity to human tumour necrosis factor (TNF), and human IgG1
heavy chain and
kappa light chain sequences. AMGEVITA binds with high affinity and
specificity to soluble
tumour necrosis factor (TNF-alpha) but not lymphotoxin (TNF-beta).
Adalimumab is
produced by recombinant DNA technology in a mammalian cell expression
system. It
consists
of
1,330
amino
acids
and
has
a
molecular
weight
of
approximately
148
kilodaltons.
AMGEVITA is a biosimilar medicine. The prescribing clinician should be
involved in any
decision regarding interchangeability (see
https://medsafe.govt.nz/profs/riss/
Biosimilars.
asp). Data comparing AMGEVITA with the reference product Humira
®
can be found in
sections 4.8 and 5.1 of this data sheet.
EXCIPIENTS
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
SOLUTION FOR INJECTION
AMGEVITA
is
supplied
as
a
sterile,
preservative-free
solution
of
adalimumab
for
subcutaneous administration. The solution of AMGEVITA is clear and
colourless with a pH
of 5.2.
NEW ZEALAND DATA SHEET
AMGEVITA NZ DATA SHEET
PAGE 2 OF 93
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS (RA)
AMGEVITA is indicated for reducing signs and symptoms, as well as
inhibiting the
progression of structural damage in adult patients with mode