Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

actavis group ptc ehf    - pioglitazon hidroklorid - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below:as monotherapy:in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination with:metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;as triple oral therapy in combination with:metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone također pokazala da kombinacija inzulina u tip-2 dijabetesa kod odraslih pacijenata s nedostatnim nadzorom glukoze na inzulin, za koje je metformin nepraktično zbog kontraindikacija ili netolerancije. nakon početka terapije s пиоглитазоном, pacijenti moraju biti revidirani kroz 3-6 mjeseci za procjenu adekvatnosti odgovora na liječenje (e. smanjenje pokazatelja hba1c). kod bolesnika koji ne pokazuju adekvatan odgovor treba da se ukine pioglitazone. u svjetlu potencijalnih rizika za dugotrajno liječenje, propisane lijekove treba potvrditi u kasnijim rutinske inspekcije da dobro pioglitazone sprema.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. učinak иматиниба na ishod transplantacije koštane srži nije određena. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. iskustvo s иматинибом u bolesnika s mds/rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen. nema kontroliranih istraživanja pokazuju kliničku korist ili povećanje preživljavanja za te bolesti.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

actavis group ptc ehf - sildenafil - poremećaj erekcije - urologicals - liječenje muškaraca s erektilnom disfunkcijom, što je nemogućnost postizanja ili održavanja erekcije penisa dovoljnih za zadovoljavajuće seksualne rezultate. kako bi sildenafil Актавис biti učinkovit, potrebno seksualnu stimulaciju .

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

actavis group ptc ehf   - pioglitazon hidroklorid - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination withmetformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin. a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as triple oral therapy in combination withmetformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4. nakon početka terapije s пиоглитазоном, pacijenti moraju biti revidirani kroz 3-6 mjeseci za procjenu adekvatnosti odgovora na liječenje (e. smanjenje pokazatelja hba1c). kod bolesnika koji ne pokazuju adekvatan odgovor treba da se ukine pioglitazone. u svjetlu potencijalnih rizika za dugotrajno liječenje, propisane lijekove treba potvrditi u kasnijim rutinske inspekcije da dobro pioglitazone sprema (vidi odjeljak 4.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

actavis group ptc ehf - telmisartan - hipertenzija - sredstva koja djeluju na sustav renin-angiotenzina - hypertensiontreatment эссенциальной hipertenzije u odraslih. kardiovaskularne preventionreduction kardiovaskularnog morbiditeta kod pacijenata s:manifest атеротромботических kardiovaskularne bolesti (povijest bolesti koronarnih arterija, moždani udar ili periferne vaskularne bolesti) ili dijabetes tipa 2 s dokumentiranim poraza organa-mete.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

actavis group ptc ehf   - monohidrat zoledronske kiseline - prijelom, kosti - lijekovi za liječenje bolesti kostiju - prevencija koštanog događaja (patološki prijelomi, spinalne kompresije, zračenja ili operacije na kostima, ili hiperkalcijemije) u odraslih bolesnika s uznapredovalim zloćudnim bolestima koje uključuju kosti. liječenje odraslih bolesnika s tumorom-induced гиперкальциемии.

Kroazja - Kroat - HALMED (Agencija za lijekove i medicinske proizvode)

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - cytarabinum - otopina za injekciju ili infuziju - 100 mg/ml - urbroj: 1 ml otopine sadrži 100 mg citarabina

Kroazja - Kroat - HALMED (Agencija za lijekove i medicinske proizvode)

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - linezolidum - filmom obložena tableta - 600 mg - urbroj: svaka tableta sadrži 600 mg linezolida

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

actavis group ptc ehf - dcsloratadin - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - antihistaminici za sistemsku primjenu, - liječenje alergijskog rinitisa i urtikarije.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

actavis group ptc ehf - topotekan - uterine cervical neoplasms; small cell lung carcinoma - antineoplastična sredstva - monoterapija topotekan je indicirana za liječenje bolesnika s relapsirajućim karcinomom pluća malih stanica [sclc] za koje ponovno liječenje s režimom prvog reda nije prikladno. Топотекана u kombinaciji s цисплатином je indiciran u bolesnika s карциномой relaps grlića maternice nakon radioterapije i za pacijente sa fazi bolesti instituta svjetske banke . pacijenti s preliminarnim utjecajem cisplatinu, zahtijevaju stalnu besplatno liječenje interval, da se opravda liječenje kombinacije.