Humira

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Adalimumab 100 mg/mL;  ;  ;  

Доступна с:

AbbVie Limited

дозировка:

20 mg/0.2mL

Фармацевтическая форма:

Solution for injection

состав:

Active: Adalimumab 100 mg/mL       Excipient: Mannitol Polysorbate 80 Water for injection

Тип рецепта:

Prescription

Терапевтические показания :

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 diagnosed moderate to severely active disease who have not received methotrexate. Humira can be used alone or in combination with methotrexate.

Обзор продуктов:

Package - Contents - Shelf Life: Syringe, glass, (Type I), with a bromobutyl rubber stopper, plunger rod and needle, 0.2 mL fill - 2 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light

Дата Авторизация:

2018-05-02

Характеристики продукта

Humira Data Sheet
21 February 2022
Page 1 of 84
Version 53
NEW ZEALAND DATA SHEET
1.
HUMIRA
®
ADALIMUMAB (RCH) SOLUTION FOR INJECTION.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
HUMIRA 20 mg: each 0.4 mL single-use pre-filled syringe contains 20 mg
of adalimumab.
HUMIRA 20 mg: each 0.2 mL single-use pre-filled syringe contains 20 mg
of adalimumab.
HUMIRA 40 mg: each 0.8 mL single-use pre-filled syringe or pen
contains 40 mg of adalimumab.
HUMIRA 40mg: each 0.4mL single-use pre-filled syringe or pen contains
40mg of adalimumab.
HUMIRA 80 mg: each 0.8 mL single use pre-filled syringe or pen
contains 80mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody expressed in
Chinese Hamster Ovary
cells.
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.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Humira is supplied as a sterile, preservative-free solution of
adalimumab for subcutaneous administration.
The solution of Humira is clear and colourless with a pH of 5.2.
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
diagnosed
moderate
to
severely
active
disease
who
have
not
received
methotrexate.