Sandoz Pharmaceuticals Israel Ltd

TNF Blocking Agent. Adalimumab 20 mg, 40 mg.
PRE FILLED SYR, 1 or 2 X 20/40 mg, PRE FILL PEN 1 or 2 X 40 mg
SC admin. of 40-160 mg as per indication. See full prescription info.
Rheumatoid arthritis (RA)
in combin. with MTX for:
tmt of mod. to sev., act. RA in adlts when the response to DMARDs incl. MTX has been inadeq.
the tmt of sev., act. and progress. RA in adlts not prev. treated with MTX.
Can be given as monother. in case of intol. to MTX or when continued tmt with MTX is inappropriate.
Shown to reduce the rate of progress. of joint damage as measured by X-ray and to improve physical function, when given in combin.with MTX.
Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis
in combin. with MTX for active polyarticular juvenile idiopathic arthritis, in pts > 2 yrs who have had an inadeq. response to one or more DMARDs. Can be given as monother. in case of intol. to MTX or when continued tmt with MTX is inappropriate
Enthesitis-related arthritis
Tmt of active enthesitis-related arthritis in pts >6 years, who have had an inadeq. response to, or who are intolerant of, convent. ther.
Axial spondyloarthritis
Ankylosing spondylitis: tmt of adults with sev. active AS who have had an inadeq. response to convent. ther.
Axial spondyloarthritis without radiogr. evidence of AS: tmt of adults with sev. axial spondyloarthritis without radiogr. evidence of AS, but with objective signs of inflamm. by radiological and/or lab. tests incl. MRI and serum CRP levels, who have had an inadeq. response to, or are intolerant to, NSAIDS.
Psoriatic arthritis (PA)
For active and progress. PA in adults when the response to previous DMARD ther. has been inadeq.
Shown to reduce the rate of progress. of peripheral joint damage as measd by X-ray in pts with polyarticular symmetrical subtypes of the dis. and to improve physical function.
Psoriasis
For mod. to sev. chronic plaque psoriasis in adlts who are candidates for syst. ther.
Paediatric plaque psoriasis
tmt of sev. chronic plaque psoriasis in pts.>4 yrs who have had an inadeq. response to or are inappropriate candidates for topical ther. and photother.
Hidradenitis suppurativa (HS)
tmt of active mod. to sev. HS (acne inversa) in pts. > 12 yrs with an inadeq. response to convent. systemic HS ther.
Crohn’s dis.
for reducing signs and symptoms and inducing and maint. clin. remission in adlts with mod. to sev. active Crohn’s dis. who have had an inadeq. response to convent. ther. Indic. for reducing signs and symptoms and inducing clin. remission in these pts if they have also lost response to or are intol. to infliximab.
Paediatric Crohn's dis.
tmt of mod. to sev. active Crohn's dis. in pts> 6 yrs who have had an inadeq. response to convent. ther. including primary nutrition ther. and corticosteroid, and/or an immunomodulator, or who are intol. to or have contraindic. for such ther.
Ulcerative colitis (UC)
tmt of mod.to sev. active UC in pts >6 who have had an inadeq. response to convent. ther. including corticosteroids and 6-MP or AZA, or who are intol. to or have medical contraindic. for such ther.
Uveitis
tmt of non-infectious intermediate, posterior and panuveitis in adult pts who have had an inadeq. response to corticosteroids, in pts in need of corticosteroid-sparing, or in whom corticosteroid tmt is inappropriate.
Paediatric Uveitis
tmt of chronic non-infectious uveitis in pts > 2 yrs who have had an inadeq. response to or are intol. to convent. ther., or in whom convent. ther. is inappropriate.
Intestinal Behcet’s dis.
tmt of intestinal Behcet’s dis. in pts who have had an inadeq. response to convent. ther.
C/I: Hypersens. /Active TB or other sev. infect. such as sepsis, and opportunistic infect. /Mod to sev. HF (NYHA class III / IV)

Monoclonal Antibody. Denosumab 60 mg/ml.
Prefilled syr. 1 X 1ml
60 mg to be admin as a single SC inject. once every 6 mo. into the thigh, abdomen or upper arm. Pts must be adequately supplemented with calcium and vitamin D. Reassess need periodically
For osteoporosis in postmenopausal women and in men at incr. risk of fractures. In postmenopausal women denosumab signif. reduces the risk of vertebral, non-vertebral and hip fractures.
For bone loss associated with hormone ablation in men with prostate cancer at incr. risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab signif. reduces the risk of vertebral fractures.
For bone loss associated with long-term systemic glucocorticoid therapy of a ddd equiv. to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 3 months, in adults at high risk of fracture.
C/I: Hypersens, Hypocalcemia.

Monoclonal Antibody. Denosumab 120 mg / 1.7 ml (70 mg/ml).
VIAL. Sol for inj. 1 X 1.7 ml
120 mg admin. as a single SC inject. once every 4 weeks. See full prescription info.
 Prevent. of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with multiple myeloma and in adults with bone metastases from solid tumours. Tmt. of adult and skeletally mature adolesc. with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in sev. morbidity.
C/I: Hypersens./ Sev., untreated hypocalcemia/
Unhealed lesions from dental or oral surgery