YUFLYMA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MGML

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

Adalimumab

Prieinama:

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

ATC kodas:

L04AB04

Vaisto forma:

INJECTION, SOLUTION

Sudėtis:

Adalimumab 100.00 mg/ml

Vartojimo būdas:

SUBCUTANEOUS

Recepto tipas:

Prescription Only

Pagaminta:

Catalent Belgium S.A.

Autorizacija statusas:

ACTIVE

Leidimo data:

2022-06-09

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
YUFLYMA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100
MG/ML
adalimumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Yuflyma is and what it is used for
2.
What you need to know before you use Yuflyma
3.
How to use Yuflyma
4.
Possible side effects
5.
How to store Yuflyma
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT YUFLYMA IS AND WHAT IT IS USED FOR
Yuflyma contains the active substance adalimumab, a medicine that acts
on your body’s immune (defence)
system.
Yuflyma is intended for the treatment of the following inflammatory
diseases:
•
Rheumatoid arthritis
•
Polyarticular juvenile idiopathic arthritis
•
Enthesitis-related arthritis
•
Ankylosing spondylitis
•
Psoriatic arthritis
•
Plaque psoriasis
•
Hidradenitis suppurativa
•
Crohn’s disease
•
Ulcerative colitis
•
Non-infectious uveitis
The active ingredient in Yuflyma, adalimumab, is a human monoclonal
antibody. Monoclonal antibodies are
proteins that attach to a specific target in the body.
2
The target of adalimumab is a protein called tumour necrosis factor
(TNFα), which is involved in the
immune (defence) system and is present at increased levels in the
inflammatory diseases listed above. By
attaching to TNFα, Yuflyma decreases the process of inflammation in
these diseases.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an inflammatory disease of the joints.
Yuflyma is used to treat moderate to severe rheumatoid arthritis in
adults

Prekės savybės

YUFLYMA
®
Adalimumab
PRODUCT NAME
Adalimumab solution for injection in pre-filled pen
TRADE NAME
Yuflyma
®
Yuflyma (adalimumab) is a recombinant human immunoglobulin (IgG1)
monoclonal antibody produced in Chinese Hamster
Ovary cells.
Yuflyma is supplied as a sterile, preservative-free solution of
adalimumab for subcutaneous administration. The solution of
Yuflyma is clear to slightly opalescent and colorless to pale brown.
The drug product is supplied as a single-use pre-filled Pen
(Yuflyma Pen). Enclosed within the Pen is a single-use, 1 mL
pre-filled glass syringe.
Inactive ingredients for Yuflyma 40 mg per 0.4 mL and 80 mg per 0.8 mL
(100 mg/mL) include: acetic acid, sodium acetate
trihydrate, glycine, polysorbate 80, and water for injection.
CLINICAL PHARMACOLOGY
GENERAL
Adalimumab binds specifically to TNF and neutralizes the biological
function of TNF by blocking its interaction with the p55 and
p75 cell surface TNF receptors. TNF is a naturally occurring cytokine
that is involved in normal inflammatory and immune
responses. Elevated levels of TNF are found in the synovial fluid of
rheumatoid arthritis, including juvenile idiopathic arthritis,
psoriatic arthritis and ankylosing spondylitis patients and play an
important role in both the pathologic inflammation and the joint
destruction that are hallmarks of these diseases. Increased levels of
TNF are also found in hidradenitis suppurativa (HS)
lesions. The relationship between these pharmacodynamic activities and
the mechanism(s) by which adalimumab exerts its
clinical effects is unknown.
Adalimumab also modulates biological responses that are induced or
regulated by TNF, including changes in the levels of
adhesion molecules responsible for leukocyte migration (ELAM-1,
VCAM-1, and ICAM-1 with an IC
50
of 1-2 X 10
-10
M).
PHARMACODYNAMICS
After treatment with adalimumab, a rapid decrease in levels of acute
phase reactants of inflammation (C-reactive protein (CRP)
and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6)
was observed compared