Humira 40mg0.4ml solution for injection pre-filled pen

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Adalimumab

Διαθέσιμο από:

AbbVie Ltd

Φαρμακολογική κατηγορία (ATC):

L04AB04

INN (Διεθνής Όνομα):

Adalimumab

Δοσολογία:

100mg/1ml

Φαρμακοτεχνική μορφή:

Solution for injection

Οδός χορήγησης:

Subcutaneous

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: ; GTIN: 8054083010045

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HUMIRA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
adalimumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
Your doctor will also give you a PATIENT ALERT CARD, which contains
important safety information
that you need to be aware of before you begin using Humira and during
treatment with Humira.
Keep this PATIENT ALERT CARD with you.
−
If you have any questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Humira is and what it is used for
2.
What you need to know before you use Humira
3.
How to use Humira
4.
Possible side effects
5
How to store Humira
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT HUMIRA IS AND WHAT IT IS USED FOR
Humira contains the active substance adalimumab.
Humira is used to treat
•
Rheumatoid arthritis
•
Polyarticular juvenile idiopathic arthritis
•
Enthesitis-related arthritis
•
Ankylosing spondylitis
•
Axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis
•
Psoriatic arthritis
•
Plaque psoriasis
•
Hidradenitis suppurativa
•
Crohn’s disease
•
Ulcerative colitis
•
Non-infectious uveitis
The active ingredient in Humira, adalimumab, is a human monoclonal
antibody. Monoclonal antibodies
are proteins that attach to a specific target.
The target of adalimumab is a protein called tumour necrosis factor
(TNFα), which is involved in the
immune (defence) system and is present at increased levels in the
inflammatory diseases listed above. By
attaching to TNFα, Humira decreases the process of inflammation in
these dise

Αρχείο Π.Χ.Π.

OBJECT 1
HUMIRA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
Summary of Product Characteristics Updated 05-Jul-2018 | AbbVie
Limited
1. Name of the medicinal product
Humira 40 mg solution for injection in pre-filled syringe
Humira 40 mg solution for injection in pre-filled pen
2. Qualitative and quantitative composition
Humira 40 mg solution for injection in pre-filled syringe
Each 0.4 ml single dose pre-filled syringe contains 40 mg of
adalimumab.
Humira 40 mg solution for injection in pre-filled syringe with
automatic needle guard
Each 0.4 ml single dose pre-filled syringe contains 40 mg of
adalimumab.
Humira 40 mg solution for injection in pre-filled pen
Each 0.4 ml single dose pre-filled pen contains 40 mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody produced in
Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection. (injection)
Clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Rheumatoid arthritis
Humira in combination with methotrexate, is indicated for:
▪ the treatment of moderate to severe, active rheumatoid arthritis
in adult patients when the response to
disease-modifying anti-rheumatic drugs including methotrexate has been
inadequate.
▪ the treatment of severe, active and progressive rheumatoid
arthritis in adults not previously treated with
methotrexate.
Humira can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment
with methotrexate is inappropriate.
Humira has been shown to reduce the rate of progression of joint
damage as measured by X-ray and to
improve physical function, when given in combination with
methotrexate.
Juvenile idiopathic arthritis
_Polyarticular juvenile idiopathic arthritis_
Humira in combination with methotrexate is indicated for the treatment
of active polyarticular juvenile
idiopathic arthritis, in patients from the age of 2 years who have had
an inadequate response to one or
more disease-modifying anti-rheum