ישראל - עברית - Ministry of Health

j-c health care ltd - darunavir as ethanolate - טבליות מצופות פילם - darunavir as ethanolate 150 mg - darunavir - darunavir - adult patients : prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv -1) infection. this indication is based on analyses of plasma hiv rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment -experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment -experienced adult patients .pediatric patients :prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of hiv in pediatric patients 6 years of age and older. this indication is based on week 24 analyses of plasma hiv rna levels and cd4+ cell counts from an open-label phase 2 trial in antiretroviral treatment -experienced pediatric patients 6 to < 18 years of age. in treatment-experienced adult and pediatric the following points should be considered when ini

ישראל - עברית - Ministry of Health

j-c health care ltd - etravirine - טבליה - etravirine 100 mg - etravirine - etravirine - intelence is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-experienced adult patients including those with non-nucleoside reverse transcriptase inhibitor (nnrti) resistance. treatment history and when available resistance testing should guide the use of intelence. in patients who have experienced virological failure on an nnrti- and nucleoside or nucleotide reverse transcriptase inhibitor (n[t]rti) - containing regimen intelence is not recommended for use in combination with n(t)rtis only.

ישראל - עברית - Ministry of Health

j-c health care ltd - etravirine - טבליה - etravirine 200 mg - etravirine - etravirine - intelence is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-experienced adult patients including those with non-nucleoside reverse transcriptase inhibitor (nnrti) resistance. treatment history and when available resistance testing should guide the use of intelence. in patients who have experienced virological failure on an nnrti- and nucleoside or nucleotide reverse transcriptase inhibitor (n[t]rti)- containing regimen intelence is not recommended for use in combination with n(t)rtis only.

ישראל - עברית - Ministry of Health

j-c health care ltd - rilpivirine as hydrochloride - טבליה - rilpivirine as hydrochloride 25 mg - rilpivirine - rilpivirine - edurant in combination with other antiretroviral agents for the treatment of hiv-1 infection in treatment-na?ve adult patients.

ישראל - עברית - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir disoproxil as fumarate - טבליות מצופות פילם - tenofovir disoproxil as fumarate 245 mg; rilpivirine as hydrochloride 25 mg; emtricitabine 200 mg - rilpivirine - rilpivirine - eviplera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is indicated for use as a complete regimen for the treatment of hiv-1 infection in antiretroviral treatment-naive adults. this indication is based on week 48 safety and efficacy analyses from 2 randomized, double-blind, active controlled, phase 3 trials in treatment-naive subjects comparing rilpivirine to efavirenz . the following points should be considered when initiating therapy with eviplera: -more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure compared to subjects with hiv-1 rna less than 100,000 copies/ml at the start of therapy. -the observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the nnrti class compared to efavirenz . -more subjects treated with rilpivirine developed lamivudine/emtricitabine associated resistance compared to efavirenz. -eviplera is not recomme

ישראל - עברית - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir disoproxil as fumarate - טבליות מצופות פילם - tenofovir disoproxil as fumarate 245 mg; rilpivirine as hydrochloride 25 mg; emtricitabine 200 mg - rilpivirine - rilpivirine - eviplera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is indicated for use as a complete regimen for the treatment of hiv-1 infection in antiretroviral treatment-naive adults. this indication is based on week 48 safety and efficacy analyses from 2 randomized, double-blind, active controlled, phase 3 trials in treatment-naive subjects comparing rilpivirine to efavirenz . the following points should be considered when initiating therapy with eviplera: -more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure compared to subjects with hiv-1 rna less than 100,000 copies/ml at the start of therapy. -the observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the nnrti class compared to efavirenz . -more subjects treated with rilpivirine developed lamivudine/emtricitabine associated resistance compared to efavirenz. -eviplera is not recomme

ישראל - עברית - Ministry of Health

j-c health care ltd - decitabine - אבקה להכנת תמיסה מרוכזת לעירוי - decitabine 50 mg/vial - decitabine - decitabine - - dacogen is indicated for treatment of patients with myelodysplastic syndromes (mds) including prevviously treated and untreated, de novo and secondary mds of all french-american- british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia ) and intermediate- 1, intermediate- 2, and high-risk international prognostic scoring system groups.- dacogen is indicated for the treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (aml), according to the world health organisation (who) classification, who are not candidates for standard induction chemotherapy

ישראל - עברית - Ministry of Health

megapharm ltd - trabectedin - concentrate for solution for infusion - trabectedin 1 mg/vial - trabectedin - trabectedin - yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.

ישראל - עברית - Ministry of Health

j-c health care ltd - doxorubicin hydrochloride - liposome for infusion - doxorubicin hydrochloride 2.0 mg/ml - doxorubicin - doxorubicin - first or second line therapy of aids related kaposis sarcoma in patients with low cd 4 counts and extensive mucocutaneous or visceral disease the treatment of patients with metastatic carcinoma of the ovary who are refractory to both paclitaxel and platinium-based chemotherapy regimens and who may also be refractory to topotecan. refractory is defined as a patient having progressive disease while on treatment or within 6 months of completing treatmnt. as monotherapy for patients with metastatic breast cancer where there is an increased cardiac risk. in combination with bortezomib for the treatment of progressive multiplemyeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

ישראל - עברית - Ministry of Health

j-c health care ltd - bortezomib - אבקה להכנת תמיסה לזריקה - bortezomib 3.5 mg - bortezomib - bortezomib - velcade (bortezomib) for injection is indicated for the treatment of patients with multiple myeloma.velcade (bortezomib) for injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.