AMGEVITA

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

ADALIMUMAB

MAH:

AMGEN EUROPE B.V.

ATC_code:

L04AB04

pharmaceutical_form:

SOLUTION FOR INJECTION

composition:

ADALIMUMAB 50 MG / 1 ML

administration_route:

S.C

prescription_type:

Required

manufactured_by:

AMGEN EUROPE B.V., NETHERLANDS

therapeutic_area:

ADALIMUMAB

therapeutic_indication:

Rheumatoid arthritisAMGEVITA 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.AMGEVITA 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):AMGEVITA 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:AMGEVITA 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 arthritisAMGEVITA 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.PsoriasisAMGEVITA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.Hidradenitis suppurativa (HS)AMGEVITA 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 diseaseAMGEVITA 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. AMGEVITA 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 colitisAMGEVITA 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.UveitisAMGEVITA 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 diseaseAmgevita is indicated for the treatment of intestinal Behcet’s disease in patients who have had an inadequate response to conventional therapy.

authorization_date:

2020-10-28

PIL

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed according to a doctor's prescription only
AMGEVITA
®
, SOLUTION FOR SUBCUTANEOUS INJECTION
ADALIMUMAB 50 MG/ML
AMGEVITA 20 mg solution for injection in pre-filled syringe
Each single dose pre-filled syringe contains 20 mg of adalimumab in
0.4 mL (50 mg/mL)
solution.
AMGEVITA 40 mg solution for injection in pre-filled syringe
Each single dose pre-filled syringe contains 40 mg of adalimumab in
0.8 mL (50 mg/mL)
solution.
AMGEVITA 40 mg solution for injection in pre-filled pen
Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL
(50 mg/mL) solution.
For inactive ingredients and allergens in the product - see section 6
"additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any other questions, refer
to the doctor or the
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them even
if it seems to you that their medical condition is similar.
AMGEVITA IS A BIOSIMILAR MEDICINAL PRODUCT. FOR FURTHER INFORMATION
REGARDING
BIOSIMILAR PRODUCTS REFER TO THE ISRAELI MINISTRY OF HEALTH WEBSITE:
HTTPS://WWW.HEALTH.GOV.IL/UNITSOFFICE/HD/MTI/DRUGS/REGISTRATION/PAGES/BIOSIMILARS.AS
PX
FOR YOUR ATTENTION, IT IS IMPORTANT THAT YOU MAKE SURE YOU RECEIVE THE
SAME MEDICINE
PRESCRIBED TO YOU BY YOUR SPECIALIST ATTENDING PHYSICIAN 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 MUST BE DONE ONLY
BY THE
SPECIALIST ATTENDING PHYSICIAN. PLEASE CHECK THAT THE COMMERCIAL NAME
OF THE MEDICINAL
PRODUCT PRESCRIBED TO YOU BY YOUR SPECIALIST PHYSICIAN, IS IDENTICAL
TO THE NAME OF THE
ME

SPC

1
1.
NAME OF THE MEDICINAL PRODUCT
AMGEVITA 20 mg solution for injection in pre-filled syringe.
AMGEVITA 40 mg solution for injection in pre-filled syringe.
AMGEVITA 40 mg solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMGEVITA 20 mg solution for injection in pre-filled syringe
Each single dose pre-filled syringe contains 20 mg of adalimumab in
0.4 mL (50 mg/mL) solution.
AMGEVITA 40 mg solution for injection in pre-filled syringe
Each single dose pre-filled syringe contains 40 mg of adalimumab in
0.8 mL (50 mg/mL) solution.
AMGEVITA 40 mg solution for injection in pre-filled pen
Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL
(50 mg/mL) solution.
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
AMGEVITA 20 mg solution for injection in pre-filled syringe
AMGEVITA 40 mg solution for injection in pre-filled syringe
Solution for injection (injection).
AMGEVITA 40 mg solution for injection in pre-filled pen (SureClick)
Solution for injection (injection).
Clear and colorless to slightly yellow solution.
AMGEVITA is a biosimilar medicinal product, that has been demonstrated
to be similar in quality,
safety and efficacy to the reference medicinal product Humira. Please
be aware of any differences in
the indications between the biosimilar medicinal product and the
reference medicinal product. The
biosimilar is not to be switched with the reference medicinal product
unless specifically stated
otherwise. More detailed information regarding biosimilar medicinal
products is available on the
website of the Ministry of Health:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
AMGEVITA in combination with methotrexate is indicated for:
PATIENT SAFETY INFORMATION CARD
The marketing of
AMGEVITA
is subject to a risk management plan (RMP) includi