Israel - English - Ministry of Health

mbi pharma ltd., israel - dexamethasone phosphate ( as sodium phosphate ) - solution for injection / infusion - dexamethasone phosphate ( as sodium phosphate ) 4 mg/ml - dexamethasone - dexamethasone kern pharma is indicated in the treatment of:• endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia.• allergy: severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs.• ophtalmic: serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers.• inflammatory bowel dis.: systemic treatment in exacerbations of ulcerative colitis and regional enteritis.• dermatological diseases (pemphigus, stevens johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • respiratory diseases (symptomatic sarcoidosis, berylliosis, loeffler's syndrome)• haematological: acquired )autoimmune( haemolytic anaemia, idiopathic thrombocytopenic purpura in adult, pure red cell aplasia• nephrotic syndrome of the idioplathic type or that due to lupus erythematosus• cerebral edema caused by brain tumor, neurosurgery, brain abscess, bacterial meningitis• collagen diseases: active rheumatoid arthritis with severe progressive course, fast destructive remitting forms and / or extra-articular manifestations, juvenile idiopathic arthritis with severe systemic-onset form (still's disease) or locally with no control, rheumatic fever with carditis, dermatomyositis, polymyositis, sle, temporal arteritis.• infectious diseases: bacterial meningitis – adjunct to antibiotics in suspected pneumococcal meningitis and tb meningitis. severe infectious diseases with toxic states (eg tuberculosis, typhoid, brucellosis;. only with simultaneous anti-infective therapy)• fetal lung maturation• chemotherapy – associated nausea and vomiting• multiple myeloma – part of chemotherapy protocols (eg vad)• prevention and treatment of acute mountain sickness/hace

Israel - English - Ministry of Health

mbi pharma ltd., israel - dexamethasone as sodium phosphate - solution for injection - dexamethasone as sodium phosphate 4 mg/ml - dexamethasone - dexamethasone kern pharma is indicated in the treatment of:• endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia.• allergy: severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs.• ophtalmic: serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers.• inflammatory bowel dis.: systemic treatment in exacerbations of ulcerative colitis and regional enteritis.• dermatological diseases (pemphigus, stevens johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • respiratory diseases (symptomatic sarcoidosis, berylliosis, loeffler's syndrome)• haematologica

Israel - English - Ministry of Health

mbi pharma ltd., israel - azithromycin as dihydrate - powder for solution for infusion - azithromycin as dihydrate 500 mg - azithromycin - treatment of infections caused by susceptible strains of the designated microorganisms in the following conditions: community-acquired pneumonia and pelvic inflammatory disease.

Israel - English - Ministry of Health

mbi pharma ltd., israel - chenodeoxycholic acid - hard capsule - chenodeoxycholic acid 250 mg - chenodeoxycholic acid - the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (ctx)) in infants, children and adolescents aged 1 month to 18 years and adults.

Israel - English - Ministry of Health

mbi pharma ltd., israel - fluconazole - solution for infusion - fluconazole 2 mg / 1 ml - fluconazole - fluconazole is indicated in the following fungal infections (see section 5.1). fluconazole is indicated in adults for the treatment of:• cryptococcal meningitis (see section 4.4).• coccidioidomycosis (see section 4.4).• invasive candidiasis.• mucosal candidiasis (including oropharyngeal candidiasis, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis).• chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.fluconazole is indicated in adults for the prophylaxis of:• relapse of cryptococcal meningitis in patients with high risk of recurrence.• relapse of oropharyngeal or oesophageal candidiasis in patients infected with hiv who are at high risk of experiencing relapse.• prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving haematopoetic stem cell transplantation (see section 5.1)).fluconazole is indicated in term newborn infants, infants, toddlers, children and adolescents aged from 0 to 17 years old:fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence (see section 4.4).therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.consideration should be given to official guidance on the appropriate use of antifungals.

Philippines - English - FDA (Food And Drug Administration)

akums drugs & pharmaceuticals ltd. (plant iii-injectables) - drug - metronidazole - promeddazole

Israel - English - Ministry of Health

mbi pharma ltd., israel - cytarabine - concentrate for solution for infusion - cytarabine 5 g / 50 ml - cytarabine - ara-cell® 100 mg/ml is used in combination with other cytostatic agents in high-dose therapy for:• refractory non-hodgkin’s lymphoma• refractory acute non-lymphocytic leukaemia• refractory acute lymphoblastic leukaemia• recurrent cases of acute leukaemia• types of leukaemia with special risk: – secondary leukaemia following previous chemotherapy and/or radiation treatment – manifest leukaemia following transformation of pre-leukaemia• consolidation of the remission of acute non-lymphocytic leukaemia in patients under 60 years of age.

Israel - English - Ministry of Health

mbi pharma ltd., israel - carmustine - powder and solvent for concentrate for solution for infusion - carmustine 100 mg/vial - carmustine - carmustine is indicated as palliative therapy as a single agent or in established combination therapy with other approved agents in the following:• brain tumors - glioblastoma, medulloblastoma, astrocytoma and metastatic brain tumors.• multiple myeloma - in combination with glucocorticoid such as prednisone. • hodgkin’s disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.• non-hodgkin’s lymphomas - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy

Israel - English - Ministry of Health

omrix biopharmaceuticals ltd, israel - calcium chloride; protein clottable; thrombin - solution - thrombin 800 - 1200 iu / 1 ml; calcium chloride 5.6 - 6.20 mg / 1 ml; protein clottable 50 - 90 mg / 1 ml - combinations - combinations - general haemostasis : evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. efficacy has been demonstrated in liver surgery and orthopaedic surgery.evicel ® is also indicated as suture support for haemostasis for suture line sealing in dura mater closure.

Israel - English - Ministry of Health

padagis israel pharmaceuticals ltd, israel - clotrimazole; dexamethasone acetate; neomycin sulfate - cream - clotrimazole 1 %; neomycin sulfate 0.645 %; dexamethasone acetate 0.044 % - combinations - combinations - treatment of dermatitis involving also a bacterial and/or fungal infection.