HUMIRA

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

ADALIMUMAB

Disponible depuis:

ABBOTT INDONESIA - Indonesia

DCI (Dénomination commune internationale):

ADALIMUMAB

Dosage:

40 MG/0,8 ML

forme pharmaceutique:

CAIRAN INJEKSI

Unités en paquet:

DUS, 1 PRE-FILLED SYRINGE @ 0,8 ML + 1 ALCOHOL PADS

Fabriqué par:

VETTER PHARMA FERTIGUNG GmBH & Co-Germany

Date de l'autorisation:

2018-03-19

Résumé des caractéristiques du produit

HUMIRA
ADALIMUMAB
PRODUCT NAME
Adalimumab solution for injection in pre-filled syringe
TRADE NAME
Humira
DESCRIPTION
Humira (adalimumab) is a recombinant human immunoglobulin (IgG1)
monoclonal antibody
containing only human peptide sequences. Humira was created using
phage display technology
resulting in fully human heavy and light chain variable regions, which
confer specificity to
human tumor necrosis factor (TNF), and human IgG1 heavy chain and
kappa light chain
sequences. Humira binds with high affinity and specificity to soluble
tumor 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 1330
amino acids and has a
molecular weight of approximately 148 kilodaltons.
Humira is supplied as a sterile, preservative-free solution of
adalimumab for subcutaneous
administration. The drug product is supplied as either a single-use 1
mL prefilled glass syringe or
1 mL single-use glass vial. The solution of Humira is clear and
colorless, with a pH of about 5.2.
Each single use pre-filled, syringe, or vial of Humira contains 40 mg
adalimumab per 0.8 mL
(50mg/mL).
Inactive ingredients include: 4.93 mg sodium chloride, 0.69 mg
monobasic sodium phosphate
dihydrate, 1.22 mg dibasic sodium phosphate dihydrate, 0.24 mg sodium
citrate, 1.04 mg citric
acid monohydrate, 9.6 mg mannitol, 0.8 mg polysorbate 80 and water for
injection per 0.8 mL.
INDICATIONS
RHEUMATOID ARTHRITIS
Humira is indicated for reducing signs and symptoms, inducing major
clinical response and
clinical remission, inhibiting
the
progression of structural
damage
and
improving
physical
function in adult patients with moderately to severely active
rheumatoid arthritis (RA).
Humira can be used alone or in combination with methotrexate or other
disease modifying anti-
rheumatic drugs (DMARDs).
PSORIATIC ARTHRITIS
Humira is indicated for reducing the signs and symptoms of active
arthritis in patients with
psoriatic arthritis (PsA). Humira has been shown t