HADLIMA

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

ADALIMUMAB

Sẵn có từ:

SAMSUNG BIOEPIS IL LTD, ISRAEL

Mã ATC:

L04AB04

Dạng dược phẩm:

SOLUTION FOR INJECTION

Thành phần:

ADALIMUMAB 50 MG/ML

Tuyến hành chính:

S.C

Loại thuốc theo toa:

Required

Sản xuất bởi:

FUJIFILM DIOSYNTH BIOTECHNOLOGIES DENMARK APS, DENMARK

Khu trị liệu:

ADALIMUMAB

Chỉ dẫn điều trị:

Rheumatoid arthritisHADLIMA 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.HADLIMA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Adalimumab 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.Axial spondyloarthritisAnkylosing spondylitis (AS):HADLIMA 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:HADLIMA 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 arthritisHADLIMA 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.Adalimumab 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 to improve physical function.PsoriasisHADLIMA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.Hidradenitis suppurativa (HS)HADLIMA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.Crohn’s diseaseHADLIMA 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. HADLIMA 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.Ulcerative colitisHADLIMA 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.UveitisHADLIMA 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 corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.Intestinal Behcet's diseaseHADLIMA is indicated for the treatment of intestinal Behcet’s disease in adult patients who have had an inadequate response to conventional therapy.

Ngày ủy quyền:

2021-02-22

Tờ rơi thông tin

1
PATIENT SAFETY INFORMATION CARD
HADLIMA
ADALIMUMAB
This card contains select important safety information that you need
to know before and during
treatment with Hadlima.

Keep this card with you at all times and for 70 days after your last
injection of Hadlima.

Show this card to any doctor or health care professional that you see.

Record information about any tuberculosis (TB) tests or treatment you
have had on the back
of this card.
1.
INTRODUCTION
Hadlima is a medicine that is intended to treat certain diseases that
affect a part of the immune system.
While Hadlima can be effective in treating these diseases, some people
can have one or more side
effects. It is important to talk to your doctor about the possible
benefits and possible side effects of
taking Hadlima. These can be different for each person.

The purpose of this card is to tell you about some of the possible
side effects of Hadlima.

Some of the serious side effects that could occur include infections,
cancer, and nervous system
problems.

These are not all of the possible side effects of Hadlima.
2.
BEFORE HADLIMA TREATMENT

TELL YOUR DOCTOR ABOUT ANY HEALTH PROBLEMS YOU HAVE AND ANY MEDICINES
YOU TAKE
. This
will help you and your doctor decide if Hadlima is right for you.

Tell your doctor if you:
-
have an infection or have symptoms of an infection (such as fever,
wounds, feeling
tired, dental problems)
-
have tuberculosis or have been in close contact with someone with
tuberculosis
-
have or have had cancer
-
have any numbness or tingling or have a problem that affects your
nervous system,
such as multiple sclerosis.

Your doctor should check you for signs and symptoms of tuberculosis
before starting
Hadlima. You may need to be treated for tuberculosis before starting
Hadlima. Please record
your TB results in the notes section of this card.
3.
VACCINATIONS

You may receive vaccinations except for live vaccines.

If you receive Hadlima while you are pregnant, it is important that
you inform your baby’s
doc

Đặc tính sản phẩm

1
1.
NAME OF THE MEDICINAL PRODUCT
HADLIMA
40 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hadlima 40 mg solution for injection in pre-filled syringe
Each 0.8 ml single dose pre-filled syringe contains 40 mg of
adalimumab.
Hadlima 40 mg solution for injection in pre-filled pen
Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody produced in
Chinese Hamster Ovary cells.
Excipient(s) with known effect
This medicinal product contains 20.0 mg sorbitol.
For the full list of excipients, see section 6.1.
Patient Safety Information Card
The marketing of Hadlima 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.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Rheumatoid arthritis
Hadlima 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.
Hadlima can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
2
Adalimumab 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.
Axial spondyloarthritis
Ankylosing spondylitis (AS)
Hadlima is indicated for the treatment of adults with severe active
ankylosing spondylitis who have
had an inadequate response to conventional therapy.
Axial spondyloarthritis w