Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - 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 .

Europska Unija - hrvatski - EMA (European Medicines Agency)

actavis group ptc ehf - topotekan - uterine cervical neoplasms; small cell lung carcinoma - antineoplastična sredstva - topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5. 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 . patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

actavis group ptc ehf - reteplaza - infarkt miokarda - antitrombotska sredstva - rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent st elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (ami) symptoms.

Europska Unija - hrvatski - EMA (European Medicines Agency)

actavis group ptc ehf - rivastigmin vodik tartarat - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - simptomatsko liječenje blage do umjereno teške alzheimerove demencije. simptomatsko liječenje blage do umjereno teške demencije kod pacijenata sa idiopatskom parkinsonovom bolešću.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pfizer europe ma eeig - respiratory syncytial virus, subgroup a, stabilized prefusion f protein / respiratory syncytial virus, subgroup b, stabilized prefusion f protein - infekcije respiratornih sincicijskih virusa - cjepiva - abrysvo is indicated for:passive protection against lower respiratory tract disease caused by respiratory syncytial virus (rsv) in infants from birth through 6 months of age following maternal immunisation during pregnancy. pogledajte odjeljke 4. 2 i 5. active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by rsv. korištenje ovog cjepiva mora se provoditi u skladu sa službenim preporukama.

Europska Unija - hrvatski - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - thiotepa - hematopoietic stem cell transplantation; neoplasms - antineoplastična sredstva - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.