Country: Ինդոնեզիա
language: ինդոնեզերեն
source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ADALIMUMAB
ABBOTT INDONESIA - Indonesia
ADALIMUMAB
40 Mg
CAIRAN INJEKSI
DUS, 2 PRE-FILLED SYRINGE @ 0,8 ML + 2 ALCOHOL PADS
VETTER PHARMA-FERTIGUNG GMBH & CO. KG - Federal Republic of Germany
2019-06-12
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 read_full_document