Israel - English - Ministry of Health

pharmalogic ltd - bupivacaine as hydrochloride monohydrate - solution for injection - bupivacaine as hydrochloride monohydrate 5 mg / 1 ml - bupivacaine - spinal anaesthesia for surgery, e.g. urological surgery and surgery, on the lower limbs, lasting 2-3 hours, abdominal surgery lasting 45-60 minutes.

Israel - English - Ministry of Health

pharmalogic ltd - dexmedetomidine as hydrochloride - concentrate for solution for infusion - dexmedetomidine as hydrochloride 100 mcg / 1 ml - dexmedetomidine - dexmedetomidine ever pharma is indicated:for sedation of adult icu (intensive care unit) patients requiring sedation level not deeper than arousal in response to verbal stimulation (corresponding to richmond agitation-sedation scale (rass) 0 to -3).for sedation of non-intubated adult patients prior to and/or during diagnostic or surgicalprocedures requiring sedation, i.e. procedural/awake sedation.

Israel - English - Ministry of Health

pharmalogic ltd - terlipressin acetate - solution for injection - terlipressin acetate 0.2 mg/ml - terlipressin - bleeding oesophageal varices. treatment of type i hepatorenal syndrome.

Israel - English - Ministry of Health

novartis israel ltd - docetaxel - concentrate for solution for infusion - docetaxel 10 mg / 1 ml - docetaxel - docetaxel - breast cancer: docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer. docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. docetaxel monotherapy is indicated for the treatment of patients with metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent. docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress her2 and who previously have not received chemotherapy for metastatic disease. docetaxel in combination with capecitabine is indicated for the treatment of patients with metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an an

Israel - English - Ministry of Health

novartis israel ltd - mitoxantrone as hydrochloride - concentrate for solution for infusion - mitoxantrone as hydrochloride 2 mg/ml - mitoxantrone - mitoxantrone - treatment of advanced breast cancer, non-hodgkin's lymphomas, acute non lymphocytic leukemia palliation of non resectable primary hepatocellular carcinoma. mitoxantrone in combination with corticosterolds is indicated for inital chemotherapy in patients with pain due to advanced hormone-refractory prostate cancer. for reduction of neurologic disability and/or frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remmitting multiple sclerosis (patients whose neurologic status is significantly abnormal between relapses), for patients 18-55 years old.בקשה לשינוי התוויה: 5/1/2021mitoxantrone is indicated in the treatment of metastatic breast cancer.mitoxantrone is indicated in the treatment of non-hodgkin’s lymphoma.mitoxantrone is indicated for the treatment of acute myeloid leukaemia (aml) in adults.mitoxantrone in combination regimens is indicated in the remission-induction treatment of blast crisis in chronic myeloid leukaemia.mitoxantrone is indicated in combination with corticosteroids for palliation (e.g. pain relief) related to advanced castrate resistant prostate cancer.mitoxantrone is indicated for treatment of patients with highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist.

Israel - English - Ministry of Health

pharmalogic ltd - enoxaparin sodium - solution for injection - enoxaparin sodium 100 mg / 1 ml - enoxaparin - enoxaparin is indicated in adults for:• prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. • prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. • treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), excluding pe likely to require thrombolytic therapy or surgery. • prevention of thrombus formation in extra corporeal circulation during haemodialysis. • acute coronary syndrome: - treatment of unstable angina and non st-segment elevation myocardial infarction (nstemi), in combination with oral acetylsalicylic acid. - treatment of acute st-segment elevation myocardial infarction (stemi) including patients to be managed medically or with subsequent percutaneous coronary intervention (pci).

Israel - English - Ministry of Health

pharmalogic ltd - piperacillin as sodium 2 g; tazobactam as sodium 250 mg - powder for solution for infusion - tazobactam - antibiotic for the treatment of systemic and/or local bacterial infections caused by susceptible organisms. pipoeracillin/tazobactam in combination with an aminoglycoside is indicated for suspected bacterial infections in neutropenic adults or children above 2 years. appencicitis complicated by rupture with peritonitis and/or abscess formation in children aged 2-12 years.

Israel - English - Ministry of Health

pharmalogic ltd - ceftriaxone as sodium - powder for solution for inj/inf - ceftriaxone as sodium 1 g/vial - ceftriaxone - ceftriaxone - ceftriaxone panpharma is indicated for the treatment of the following infections in adults and children including term neonates (from birth):- bacterial meningitis- community acquired pneumonia- hospital acquired pneumonia- acute otitis media- intra-abdominal infections- complicated urinary tract infections (including pyelonephritis)- infections of bones and joints- complicated skin and soft tissue infections- gonorrhoea- syphilis- bacterial endocarditisceftriaxone panpharma may be used:- for treatment of acute exacerbations of chronic obstructive pulmonary disease in adults- for treatment of disseminated lyme borreliosis (early (stage ii) and late (stage iii) in adults and children including neonates from 15 days of age.- for pre-operative prophylaxis of surgical site infections- in the management of neutropenic patients with fever that is suspected to be due to a ceftriaxone- susceptible bacterial infection- in the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above ceftriaxone panpharma should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum.consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Israel - English - Ministry of Health

pharmalogic ltd - methotrexate 10 mg/ml - solution for injection - methotrexate - antineoplastic chemotherapy: treatment of gestational choriocarcinoma, chorioadenoma destruents and hydatidiform mole. palliation of acute lymphocytic leukemia. in the treatment and prophylaxis of meningeal leukemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukemias in children. in combination with other anticancer agents, methotrexate may be used for the induction of remission, but is most commonly used in maintenance of induced remissions. abitrexate may be used alone or in combination with other antineoplastics in the management of breast cancer, epidermoid cancers of the head and neck, lung cancer (particularly squamous cell and small cell types), bladder cancer and osteogenic cancer. methotrexate is effective in the treatment of the advanced stages (iii and iv peter's staging system) of lymphosarcoma, particularly in children, and in advanced cases of mycosis fungoides. psoriasis: because of the high risk attending its use, methotrexate is indicated only in the

Israel - English - Ministry of Health

novartis israel ltd - methotrexate - solution for injection - methotrexate 20 mg/ml - methotrexate - methotrexate - psoriasis: methotrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. rheumatoid arthritis: methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well established according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose nsaids and usually a trial of at least one or more disease- modifying antirheumatic drugs.juvenile idiopathic arthritis:treatment of polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (nsaids) has been inadequatecrohn’s disease: mild to moderate crohn's disease either alone or in combination with corticosteroids in adult patients ref