Indications : התוויות

4.1    Therapeutic indications

Plaque psoriasis
Ustekinumab Kamada is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or Psoralen plus UV (PUVA) (see section 5.1).

Paediatric plaque psoriasis
Ustekinumab Kamada is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older (weighing at least 60 kg), who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).

Psoriatic arthritis (PsA)
Ustekinumab Kamada , alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti- rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).

Crohn’s Disease
Ustekinumab Kamada is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Ulcerative colitis
Ustekinumab Kamada is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies (see section 5.1).