Európai Unió - máltai - EMA (European Medicines Agency)

roche registration gmbh - methoxy polyethylene glycol-epoetin beta - anemia; kidney failure, chronic - preparazzjonijiet antianemiċi - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.

Európai Unió - máltai - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Európai Unió - máltai - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - doxorubicin hydrochloride - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - aġenti antineoplastiċi - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Európai Unió - máltai - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - gotta - preparazzjonijiet antigout - krystexxa huwa indikat għall-kura ta ' severi gout debilitanti tophaceous kronika fil-pazjenti adulti li jistgħu wkoll ikollhom l-involviment konġunt erosive u li jkunu naqsu milli joqogħdu normalizzati serum uric acid b ' xanthine oxidase inibituri fil-massimu xieraq tad-doża jew li għalihom huma contraindicated dawn il-mediċini.

Európai Unió - máltai - EMA (European Medicines Agency)

recordati rare diseases - tocofersolan - cholestasis; vitamin e deficiency - vitamini - vedrop huwa indikat fl-defiċjenza ta ' vitamina-e minħabba l-malassorbazzjoni tad-diġestjoni fil-pazjenti pedjatriċi li jsofru minn cholestasis kronika konġenitali jew cholestasis kronika ereditarji, mit-twelid (fil-kelma newborns) sa 16 jew 18-il sena, skond ir-reġjun.

Európai Unió - máltai - EMA (European Medicines Agency)

merck sharp & dohme b.v. - peginterferon alfa-2b - epatite Ċ, kronika - immunostimulanti, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. jekk jogħġbok irreferi għall-ribavirin u boceprevir-sommarji tal-karatteristiċi tal-prodott (smpcs) meta pegintron ikun ser jintuża flimkien ma ' dawn il-mediċini. adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. pegintron f'kombinazzjoni ma 'ribavirin (bitherapy) huwa indikat għall-kura ta chc infezzjoni fil-pazjenti adulti li ma kienux trattati qabel inkluż pazjenti b'hiv klinikament stabbli ko-infezzjoni u f'pazjenti adulti li jkunu fallew it-trattament preċedenti bl-interferon-alpha (pegilata jew mhux pegilata) u terapija kombinata b'ribavirin jew ma' interferon-alpha monoterapija. il-monoterapija b'interferon, li tinkludi pegintron, tintuża l-aktar f'każ ta 'intolleranza jew ta' kontra-indikazzjoni għal ribavirin. jekk jogħġbok irreferi għall-ribavirin smpc meta pegintron ikun ser jintuża flimkien ma ' ribavirin. paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna. meta tiddeċiedi li ma li tipposponi it-trattament sakemm il-ħajja adulta, huwa importanti li wieħed jikkunsidra li l-terapija kombinata indotta-inibizzjoni tat-tkabbir li jista'jkun irriversibbli f'xi pazjenti. id-deċiżjoni li l-kura għandha tittieħed każ b'każ. jekk jogħġbok irreferi għall-ribavirin smpc għal kapsuli jew soluzzjoni orali meta pegintron ikun ser jintuża flimkien ma ' ribavirin.

Európai Unió - máltai - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - stavudine - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - iebes capsuleszerit huwa indikat flimkien ma ' prodotti mediċinali antiretrovirali oħra għat-trattament ta infettati bl-hiv pazjenti adulti u pazjenti pedjatriċi ('l fuq minn l-età ta'tliet xhur) biss meta l-mediċini antiretrovirali oħra ma jistgħux jintużaw. it-tul tat-terapija b'zerit għandha tiġi limitata għall-iqsar żmien possibbli. trab għall-ħalq solutionzerit huwa indikat flimkien ma ' prodotti mediċinali antiretrovirali oħra għat-trattament ta infettati bl-hiv pazjenti adulti u pazjenti pedjatriċi (mit-twelid) biss meta l-mediċini antiretrovirali oħra ma jistgħux jintużaw. it-tul tat-terapija b'zerit għandha tiġi limitata għall-iqsar żmien possibbli.

Európai Unió - máltai - EMA (European Medicines Agency)

glaxo group ltd. - amprenavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - agenerase, flimkien ma 'mediċini antiretrovirali oħra, huwa indikat għall-kura ta' impeditur protease (pi) b'esperjenza ta 'adulti infettati bl-hiv-1 u tfal' l fuq minn 4 snin. il-kapsuli ta 'agenerase għandhom normalment jiġu amministrati b'doża baxxa ta' ritonavir bħala stimulant farmakokinetiku ta 'amprenavir (ara sezzjonijiet 4. 2 u 4. l-għażla ta 'amprenavir għandha tkun ibbażata fuq ittestjar ta' reżistenza virali individwali u l-istorja tal-kura tal-pazjenti (ara sezzjoni 5. il-benefiċċju ta 'agenerase ma' ritonavir ma ntwerewx f'pi nave-pazjenti (ara sezzjoni 5.

Európai Unió - máltai - EMA (European Medicines Agency)

astrazeneca ab - ticagrelor - peripheral vascular diseases; acute coronary syndrome - aġenti antitrombotiċi - possia, ko amministrati bl-aċidu aċetilsaliċiliku (asa), huwa indikat għall-prevenzjoni ta ' l-avvenimenti ta ' atherothrombotic fil-pazjenti adulti ma sindromi coronary akuta (anġina instabbli, mhux-st-elevazzjoni myocardial infarzjoni [nstemi]-tnaqqis jew il-st-elevazzjoni myocardial infarzjoni [stemi]); inklużi pazjenti amministrati medikament, u dawk li huma amministrati bl-intervent coronary perkutanja (pci) jew coronary artery by-pass tilqim (cabg).

Európai Unió - máltai - EMA (European Medicines Agency)

diurnal europe b.v. - hydrocortisone - adrenal hyperplasia, congenital - kortikosterojdi għal użu sistemiku - treatment of congenital adrenal hyperplasia (cah) in adolescents aged 12 years and over and adults.