Humira

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Adalimumab 100 mg/mL;  ;  ;  

Commercializzato da:

AbbVie Limited

INN (Nome Internazionale):

Adalimumab 100 mg/mL

Dosaggio:

40 mg/0.4mL

Forma farmaceutica:

Solution for injection

Composizione:

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

Tipo di ricetta:

Prescription

Prodotto da:

AbbVie Bioresearch Centre

Indicazioni terapeutiche:

Uveitis Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Dettagli prodotto:

Package - Contents - Shelf Life: Syringe, glass, Type I, with bromobutyl rubber stopper and needle. 0.4mL - 1 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 - Syringe, glass, Type I, with bromobutyl rubber stopper and needle. 0.4mL - 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 - Syringe, glass, Type I, with bromobutyl rubber stopper and needle. 0.4mL - 4 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 - Syringe, glass, Type I, with bromobutyl rubber stopper and needle. 0.4mL - 6 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

Data dell'autorizzazione:

2016-04-04

Foglio illustrativo

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_Humira Pre-filled Syringe _
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_28 March 2019 _
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HUMIRA PRE-FILLED SYRINGE
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_ADALIMUMAB (RCH) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Humira.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using this medicine against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE YOU
USE
HUMIRA
AND
KEEP
IT
WITH
THE
MEDICINE.
You may need to read it again.
WHAT HUMIRA IS USED FOR
Humira is intended for the treatment of:
•
Rheumatoid arthritis
Humira is used to reduce the signs and
symptoms of moderately to severely
active rheumatoid arthritis, a painful
disease of the joints, as well as slow
down and protect against damage to
joints. Signs and symptoms of
rheumatoid arthritis include joint pain,
tenderness, swelling and stiffness.
•
Polyarticular juvenile idiopathic
Arthritis
Humira is used for reducing the signs
and symptoms of moderately to severely
active polyarticular juvenile idiopathic
arthritis, which is an inflammatory
disease, involving multiple joints, with
diagnosis typically occurring in children
2 years of age and older.
•
Enthesitis-related arthritis
Humira is used to treat enthesitis-related
arthritis, an inflammatory disease of the
joints that begins before the 16
th
birthday, in patients from 6 years of age.
•
Psoriatic arthritis
Humira is used to reduce the signs and
symptoms, as well as inhibit the
progression of joint damage of
moderately to severely active psoriatic
arthritis, a disease of the joints and skin,
with some similarities to rheumatoid
arthritis, as well as psoriasis and other
factors.
•
Ankylosing spondylitis
Humira is used to reduce the signs and
symptoms in patients with active
anky

Scheda tecnica

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.