Adalimumab BS Subcutaneous Injection 80mg Syringe 0.8mL "MA" (アダリムマブBS皮下注80mgシリンジ0.8mL「MA」)

Country: Japan

Language: English

Source: すりの適正使用協議会 RAD-AR Council, Japan

Active ingredient:

Adalimumab(genetical recombination)[adalimumab biosimilar 3]

Available from:

AYUMI Pharmaceutical Co., Ltd.

INN (International Name):

Adalimumab(genetical recombination)[adalimumab biosimilar 3]

Pharmaceutical form:

colorless and almost limpid or slightly opalescent peculiar to protein injectable solution in a prefilled syringe

Patient Information leaflet

Drug Information Sheet("Kusuri-no-Shiori")
Self-injection
Revised: 07/2022
The information on this sheet is based on approvals granted by the
Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks)
as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To
obtain a better therapeutic response,
patients should understand their medication and cooperate with the
treatment.
BRAND NAME:
ADALIMUMAB BS SUBCUTANEOUS INJECTION
80MG SYRINGE 0.8ML "MA"
ACTIVE INGREDIENT:
Adalimumab(genetical recombination)[adalimumab
biosimilar 3]
DOSAGE FORM:
colorless and almost limpid or slightly opalescent peculiar to
protein injectable solution in a prefilled syringe
IMPRINT OR PRINT ON WRAPPING:
EFFECTS OF THIS MEDICINE
This medicine suppresses the function of TNF (tumor necrosis
factor)-α, which is one of the
possible primary causative substances in rheumatoid arthritis,
psoriasis, ankylosing
spondylitis, intestinal Behcet's disease, Crohn's disease and
ulcerative colitis. TNF is one of the
cytokines existing inside of the body even in a healthy state, and
involved in activities of
immunity and development of inflammation or pain.
It is usually used to treat rheumatoid arthritis (including prevention
of structural joint damage)
and the diseases described below with inadequate response to
conventional therapies:
psoriasis vulgaris, psoriasis arthritis or pustular psoriasis;
ankylosing spondylitis; intestinal
Behcet's disease; non-infectious intermediate/posterior uveitis or
panuveitis; and moderate to
severe ulcerative colitis. It is also used for inducing clinical
remission and maintenance
therapy in patient with moderately to severely active Crohn's disease.
THE FOLLOWING PATIENTS MAY NEED TO BE CAREFUL WHEN USING THIS
MEDICINE.BE SURE TO TELL YOUR DOCTOR
AND PHARMACIST.
・If you have previously experienced any allergic reactions (itch,
rash, etc.) to any medicines
or foods.
If you have or are suspected of having infections such as