HUMIRA adalimumab 80 mg/0.8 mL injection solution pre-filled pen

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Adalimumab, Quantity: 100 mg/mL

Tilgjengelig fra:

Abbvie Pty Ltd

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: polysorbate 80; water for injections; mannitol

Administreringsrute:

Subcutaneous

Enheter i pakken:

3 x Pre-filled PEN, 1 x Pre-filled PEN

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

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.,Juvenile Idiopathic Arthritis: - Polyarticular Juvenile Idiopathic Arthritis: Humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - Enthesitis-Related Arthritis: Humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,Psoriatic Arthritis: Humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.,Ankylosing Spondylitis: Humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,Crohn's Disease in adults and Children (6 years and older): Humira is indicated for the treatment of moderate to severe Crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or are intolerant of infliximab.,Ulcerative colitis: Humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see CLINICAL TRIALS).,Psoriasis in adults and children: Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,Hidradenitis Suppurativa in Adults and Adolescents (from 12 years of age): Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,Uveitis: Humira is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis 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.

Produkt oppsummering:

Visual Identification: Aqueous solution practically free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2018-01-03

Informasjon til brukeren

HUMIRA
®
H
U
M
I
R
A
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING HUMIRA?
Humira contains the active ingredient adalimumab. Humira is used to
treat various inflammatory conditions.
For more information, see Section 1. Why am I using Humira? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE HUMIRA?
Check the list of ingredients at the end of the CMI. Do not use Humira
if you have ever had an allergic reaction to any of them.
TALK TO YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE IF HE/SHE IS NOT
AWARE THAT YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE
ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Humira? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Humira and affect how it works, or
Humira may interfere with other medicines and affect how
they work.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE HUMIRA?
Humira is injected under the skin (subcutaneous).
More instructions can be found in Section 4. How do I use Humira? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING HUMIRA?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist or pharmacist you visit that you are
using Humira.
•
Keep all your appointments, including for blood tests.
•
Tell your doctor if you develop an infection or you notice new or
changed spots on your skin.
•
Tell your doctor if you are scheduled for any vaccines.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or change the dose unless your doctor
tells you to.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines until you know how
Humira affects you. The effects on
your ability to drive or use machines whilst taking Humira are not
known.
DRINKING
ALCOHOL
•
There is no information on the

Preparatomtale

HUMIRA PI
Version 49
10 February 2021
Page 1 of 84
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) or 20 mg
adalimumab per 0.2 mL (100
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 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 49
10 February 2021
Page 2 of 84
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