HUMIRA adalimumab (rch) 10 mg solution for injection pre-filled syringe (27 G)

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

Adalimumab

Commercializzato da:

Abbvie Pty Ltd

INN (Nome Internazionale):

Adalimumab

Stato dell'autorizzazione:

Registered

Scheda tecnica

HUMIRA PI
Version 47
17 June 2019
Page 1 of 87
AUSTRALIAN PI – HUMIRA
®
(ADALIMUMAB) – SOLUTION FOR SUBCUTANEOUS INJECTION
1
NAME OF THE MEDICINE
Adalimumab (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
tumour necrosis factor (TNF), and human IgG1 heavy chain and kappa
light chain sequences. Humira
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 1330 amino acids and has a
molecular weight of approximately
148 kilodaltons.
Adult presentations contain 80 mg adalimumab per 0.8 mL (100 mg/mL),
40 mg adalimumab per 0.8
mL (50 mg/mL) or 40 mg adalimumab per 0.4 mL (100 mg/mL).
Presentations for paediatric use only
contain either 20 mg adalimumab per 0.4 mL (50 mg/mL), 20 mg
adalimumab per 0.2 mL (100
mg/mL) or 10 mg adalimumab per 0.2 mL (50 mg/mL).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Humira
is
supplied
as
a
sterile,
preservative-free
solution
of
adalimumab
for
subcutaneous
administration. The solution of Humira is clear and colourless and
isotonic with a pH of 5.2. The drug
product is supplied as either a single-use pre-filled glass syringe,
vial or as a single use, pre-filled pen
(Humira Pen). Enclosed within the pen is a single-use, pre-filled
glass syringe.
HUMIRA PI
Version 47
17 June 2019
Page 2 of 87
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid Arthritis
Humira 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