HUMIRA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ADALIMUMAB

متاح من:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC رمز:

L04AB04

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

ADALIMUMAB 100 MG / 1 ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ABBVIE DEUTSCHLAND GMBH & CO. KG, GERMANY

المجال العلاجي:

ADALIMUMAB

الخصائص العلاجية:

• 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.• 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-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira has not been studied in patients aged less than 2 years.• Enthesitis-related arthritis:Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.• Axial spondyloarthritis :Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.• Axial spondyloarthritis without radiographic evidence of AS:Humira is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS, but with objective signs of inflammation by radiological and/or laboratory tests including MRI and serum CRP levels , who have had an inadequate response to, or are intolerant to, non - steroidal anti-inflammatory drugs. • Psoriatic arthritis:Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.• Psoriasis:Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.• Paediatric plaque psoriasis:Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.• Hidradenitis suppurativa (HS):Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.• Crohn’s disease:Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Humira is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. • Paediatric Crohn's disease:Humira is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6- years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and corticosteroid, and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies• Ulcerative colitis:Humira is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. • 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.• Intestinal Behcet's disease:Humira is indicated for the treatment of intestinal Behcet’s disease in patients who have had an inadequate response to conventional therapy.• Paediatric UveitisHumira is indicated for the treatment of chronic non-infectious uveitis in paediatric 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.• Paediatric ulcerative colitis Humira is indicated for the treatment of moderately to severely active ulcerative colitis in pediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies

تاريخ الترخيص:

2021-12-31

نشرة المعلومات

PEN
PAD
INJECTABLE AREAS
INJECTABLE AREAS
CAP 1
CAP 2
HUMIRA 40 MG -
10 SECONDS
HUMIRA 80 MG -
15 SECONDS
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
HUMIRA
®
40 MG
80 MG
SOLUTION FOR INJECTION IN A PRE-FILLED PEN
Active ingredient and its concentration: adalimumab 100 mg/ml
Each Humira 40 mg pre-filled pen contains:
adalimumab 40 mg/0.4 ml
Each Humira 80 mg pre-filled pen contains:
adalimumab 80 mg/0.8 ml
For a list of inactive and allergenic ingredients – see section 6
“Further Information” in this leaflet.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed to treat your ailment/for you. Do
not pass it on to others. It may harm them, even if it
seems to you that their ailment/medical condition is similar.
For the sake of simplicity and ease of reading, this leaflet was
written as intended for you. Although, the medicine is intended
for you or for your child.
In addition to the leaflet, Humira has a ‘Patient safety information
card’. This card includes important safety information,
which you should know before starting and during the treatment with
Humira and act accordingly. Read the ‘Patient safety
information card’ and the patient leaflet before starting treatment
with the medicine. Keep the card for further reference if
needed.
For your attention, it is important that you make sure you receive the
same medicine prescribed to you by your specialist
attending doctor each time you receive the medicine at the pharmacy.
If the medicine you received looks different than the
one you are usually getting or the instructions for use had changed,
please turn immediately to the pharmacist to make sure
you received the correct medicine. Each replacement or change of
dosage of a medicine containing adalimumab (the act

خصائص المنتج

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1
of
59
HUM_API JUL22_CL
_ _
HUMIRA
20 MG
40 MG
80 MG
1.
NAME OF THE MEDICINAL PRODUCT
Humira 20 mg solution for injection in pre-filled syringe
Humira 40 mg solution for injection in pre-filled syringe
Humira 40 mg solution for injection in pre-filled pen
Humira 80 mg solution for injection in pre-filled syringe
Humira 80 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Humira 20 mg solution for injection in pre-filled syringe
Each 0.2 ml single dose pre-filled syringe contains 20 mg of
adalimumab.
Humira 40 mg solution for injection in pre-filled syringe
Each 0.4ml single dose pre-filled syringe contains 40 mg of
adalimumab.
Humira 40 mg solution for injection in pre-filled pen
Each 0.4ml single dose pre-filled pen contains 40 mg of adalimumab.
Humira 80 mg solution for injection in pre-filled syringe
Each 0.8 ml single dose pre-filled syringe contains 80 mg of
adalimumab.
Humira 80 mg solution for injection in pre-filled pen
Each 0.8 ml single dose pre-filled pen contains 80 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
PATIENT SAFETY INFORMATION CARD
The marketing of Humira is subject to a risk management plan (RMP)
including a 'Patient
safety information card'. The 'Patient safety information card',
emphasizes important safety
information that the patient should be aware of before and during
treatment. Please explain
to the patient the need to review the card before starting treatment.
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59
HUM_API JUL22_CL
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