Halimatoz
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
29-01-2021
Vara einkenni
(SPC)
29-01-2021
Opinber matsskýrsla
(PAR)
29-01-2021
Virkt innihaldsefni:
adalimumab
Fáanlegur frá:
Sandoz GmbH
ATC númer:
L04AB04
INN (Alþjóðlegt nafn):
adalimumab
Meðferðarhópur:
Immunosuppressants
Lækningarsvæði:
Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic
Ábendingar:
Rheumatoid arthritisHalimatoz 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.Halimatoz 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.Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritisHalimatoz 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). Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years.Enthesitis-related arthritisHalimatoz 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 spondyloarthritisAnkylosing spondylitis (AS)Halimatoz 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 ASHalimatoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.Psoriatic arthritisHalimatoz 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 and to improve physical function.PsoriasisHalimatoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.Paediatric plaque psoriasisHalimatoz 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)Halimatoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.Crohn’s diseaseHalimatoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.Paediatric Crohn's diseaseHalimatoz 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 a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.Ulcerative colitis/ Uveitis/ Paediatric uveitisFor full indication see 4.1.
Vörulýsing:
Revision: 8
Leyfisstaða:
Withdrawn
Leyfisdagur:
2018-07-26
Upplýsingar fylgiseðill
80
B. PACKAGE LEAFLET
Medicinal product no longer authorised
81
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HALIMATOZ 20 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
adalimumab
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION.
-
Keep this leaflet. You may need to read it again.
-
Your doctor will also give you a
PATIENT REMINDER CARD
, which contains important safety
information that you need to be aware of before your child begins
using Halimatoz and during
treatment with Halimatoz. Keep this
PATIENT REMINDER CARD
with you during your treatment and
for 4 months after your (or your child’s) last injection of
Halimatoz.
-
If you have any further questions, please ask your doctor or
pharmacist.
-
This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same as your child’s.
-
If your child gets 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 Halimatoz is and what it is used for
2.
What you need to know before your child uses Halimatoz
3.
How to use Halimatoz
4.
Possible side effects
5.
How to store Halimatoz
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT HALIMATOZ IS AND WHAT IT IS USED FOR
Halimatoz contains the active substance adalimumab, a medicine that
acts on your body’s immune
(defence) system.
Halimatoz is intended for the treatment of the following inflammatory
diseases:
•
polyarticular juvenile idiopathic arthritis,
•
e
nthesitis-related arthritis
•
paediatric plaque psoriasis,
•
paediatric Crohn’s disease,
•
paediatric non-infectious uveitis.
The active ing
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Halimatoz 20 mg solution for injection in pre-filled syringe
Halimatoz 40 mg solution for injection in pre-filled syringe
Halimatoz 40 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Halimatoz 20 mg solution for injection in pre-filled syringe:
Each 0.4 ml single-dose pre-filled syringe contains 20 mg of
adalimumab.
Halimatoz 40 mg solution for injection in pre-filled syringe:
Each 0.8 ml single-dose pre-filled syringe contains 40 mg of
adalimumab.
Halimatoz 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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection. (injection)
Clear to slightly opalescent, colourless to slightly yellowish
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Halimatoz 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.
Halimatoz can be given as monotherapy in case of intolerance to
methotrexate or when
continued treatment with methotrexate is inappropriate.
Medicinal product no longer authorised
3
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
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