Humira
Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Foglio illustrativo
(PIL)
06-07-2020
Scheda tecnica
(SPC)
10-07-2020
Principio attivo:
Adalimumab 50 mg/mL; ;
Commercializzato da:
AbbVie Limited
INN (Nome Internazionale):
Adalimumab 10 mg (in 0.2mL)
Dosaggio:
10 mg/0.2 mL
Forma farmaceutica:
Solution for injection
Composizione:
Active: Adalimumab 50 mg/mL Excipient: Citric acid monohydrate Dibasic sodium phosphate dihydrate Mannitol Monobasic sodium phosphate dihydrate Polysorbate 80 Sodium chloride Sodium citrate Sodium hydroxide Water for injection
Tipo di ricetta:
Prescription
Prodotto da:
Lonza Biologics Porrino S L
Indicazioni terapeutiche:
Humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients aged 2 years of age and older. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Dettagli prodotto:
Package - Contents - Shelf Life: Syringe, glass, 2 x 0.2mL - 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
Data dell'autorizzazione:
2013-06-20
Foglio illustrativo
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_Humira Pre-filled Syringe _
_Version 06 _
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_18 June 2020 _
_Page 1 of 9 _
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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
The active ingredient in this medicine is
adalimumab, which is a fully human
monoclonal antibody. Monoclonal
antibodies are proteins made by a type
of blood cell to fight a foreign protein in
the body. Adalimumab recognises and
binds to a specific protein (tumour
necrosis factor or TNF-alpha), which is
present at higher levels in some
inflammatory diseases.
Humira is used for the treatment of a
number of inflammatory diseases:
•
Rheumatoid arthritis
Rheumatoid arthritis is an
inflammatory disease of the joints.
Signs and symptoms of rheumatoid
arthritis include joint pain, tenderness,
swelling and stiffness.
Humira is used to reduce the signs and
symptoms of moderate to severely
active rheumatoid arthritis as well as to
slow down and protect the joints from
further damage.
•
Polyarticular juvenile idiopathic
arthritis (pJIA)
pJIA is an inflammatory disease of the
joints. Humira is used to reduce the
signs and symptoms of moderately to
severely active pJIA in patients 2 years
of age and older.
•
Enthesitis-related arthritis (ERA)
ERA is an inflammatory disease of the
joints and the places where tendons join
the bone. Humira is used to treat ERA
in patients 6 years of age and older.
•
Psoriatic arthritis (PsA)
PsA is an inflammatory disease of th
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Scheda tecnica
Humira Data Sheet
18 June 2020
Page 1 of 82
Version 50
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, pen or vial
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
methotrex
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