Izrael - angličtina - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 40000 iu / 1 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis .- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).binocrit® is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.use should be restricted to patients with moderate anaemia (e.g. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Izrael - angličtina - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy.* adult patients with relapsed or refractory ph + all as monotherapy.* adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration fo chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.* adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Izrael - angličtina - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. * adult patients with relapsed or refractory ph + all as monotherapy. * adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration for chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation. * adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Izrael - angličtina - Ministry of Health

novartis israel ltd - ciprofloxacin as hydrochloride - solution - ciprofloxacin as hydrochloride 3 mg/ml - ciprofloxacin - ciprofloxacin - corneal ulcers and conjunctivitis caused by susceptible gram positive and gram negative microorganisms for adults and pediatric patients above the age of 1 year. for localized or diffuse otitis externa accompanied by a strong inflammatory reaction and of which the strains are susceptible to ciprofloxacin, and for the acute flare-up of a chronic otitis media. in this case, a mucopurulent secretion comes through the perforated eardrum. pseudomonas aeruginosa is one of the organisms most likely to be found in this case. also in other infections of the ear in which pseudomonas aeruginosa and/or other susceptible strains may be demonstrated or suspected (for example with suppurating tympanic tubes), ciloxan can be used under the strict supervision of an ear specialist. it must be understood that this is not a routine treatment and that improper use must be avoided.

Izrael - angličtina - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 8000 iu / 0.8 ml - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis .- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 10 13 g/dl (6.2 8.1 mmol/l), no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).binocrit® is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.use should be restricted to patients with moderate anaemia (e.g. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Izrael - angličtina - Ministry of Health

novartis israel ltd - ceritinib - hard gelatin capsules - ceritinib 150 mg - ceritinib - zykadia is indicated for the treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive.23.04.2018 בקשה לשינוי משטר מינון - dose modification for patients with severe hepatic impairment (child-pugh c), reduce the dose of zykadia by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength- new starting dose - 450 mg taken orally once daily with food (instead of 750mg taken on empty stomach).first dose reduction due to adverse reactions- 300 mg taken orally once daily with food, second dose reduction - 150 mg taken orally once daily with food. discontinue zykadia for patients unable to tolerate 150 mg daily with food.

Izrael - angličtina - Ministry of Health

novartis israel ltd - etanercept - solution for injection - etanercept 25 mg / 0.5 ml - etanercept - rheumatoid arthritiserelzi is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (dmards) including methotrexate (unless contraindicated) has been inadequate. erelzi can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis .etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function.juvenile idiopathic arthritistreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. psoriatic arthritistreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease.axial spondyloarthritisankylosing spondylitis (as)treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.non-radiographic axial spondyloarthritistreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (nsaids).plaque psoriasistreatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. paediatric plaque psoriasistreatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Izrael - angličtina - Ministry of Health

novartis israel ltd - etanercept - solution for injection - etanercept 50 mg / 1 ml - etanercept - rheumatoid arthritiserelzi is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (dmards) including methotrexate (unless contraindicated) has been inadequate. erelzi can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis .etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function.juvenile idiopathic arthritistreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. psoriatic arthritistreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease.axial spondyloarthritisankylosing spondylitis (as)treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.non-radiographic axial spondyloarthritistreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (nsaids).plaque psoriasistreatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. paediatric plaque psoriasistreatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Izrael - angličtina - Ministry of Health

novartis israel ltd - inclisiran as sodium - solution for injection - inclisiran as sodium 189 mg/ml - inclisiran - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:• in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl c goals with the maximum tolerated dose of a statin, or• alone or in combination with other lipid lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.

Izrael - angličtina - Ministry of Health

novartis israel ltd - pazopanib as hydrochloride - film coated tablets - pazopanib as hydrochloride 200 mg - pazopanib - pazopanib - renal cell carcinoma (rcc)votrient is indicated in adults for the first line treatment of advanced renal cell carcinoma (rcc) and for patients who have received prior cytokine therapy for advanced disease.soft tissue sarcoma (sts)votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft tissue sarcoma (sts) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.