Iscover Europska Unija - hrvatski - EMA (European Medicines Agency)

iscover

sanofi winthrop industrie - klopidogrel - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - antitrombotska sredstva - sekundarne prevencije атеротромботических eventsclopidogrel prikazan:odrasli pacijenti koji pate инфарктом miokarda (od nekoliko dana do manje od 35 dana), ishemijski moždani udar (od 7 dana prije manje od 6 mjeseci) ili instaliranim bolest perifernih arterija. odraslih pacijenata oboljelih od akutne коронарным sindroma:bez elevacije segmenta st akutna koronarna sindrom (nestabilna angina, ili ne-q-инфарктом miokarda), uključujući i bolesnike koji su patili ugradnje stenta nakon чрескожного koronarne intervencije, u kombinaciji s ацетилсалициловой kiselinom (ask). st segment elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. sprječavanje атеротромботических i тромбоэмболических događaja kada фибрилляции fibrillationin odraslih pacijenata s фибрилляцией vrlo značajan, koje imaju najmanje jedan faktor rizika za razvoj srčanih događaja, nisu pogodni za liječenje антагонистами vitamina k (ВКА) i koji imaju nizak rizik od krvarenja, клопидогрел prikazan u kombinaciji s ask za prevenciju атеротромботических i тромбоэмболических događaja, uključujući i moždani udar.

Nivestim Europska Unija - hrvatski - EMA (European Medicines Agency)

nivestim

pfizer europe ma eeig  - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - Иммуностимуляторы, - filgrastim je indiciran za smanjenje trajanja neutropenije i incidencije febrilne neutropenije u bolesnika s utvrđenom citotoksičnom kemoterapijom zbog zloćudne bolesti (uz iznimku kronične mijeloične leukemije i mijelodisplastični sindromi) i za smanjenje trajanja neutropenije u bolesnika koji primaju mijeloablativnu terapiju nakon transplantacije koštane srži smatra se pod povećanim rizikom od razvoja produljene teške neutropenije. sigurnost i učinkovitost filgrastima slične su kod odraslih i djece s citotoksičnim kemoterapijom. Филграстимом što je prikazano za mobilizaciju stanica prethodnika periferne krvi (pbpcs). kod bolesnika, djece i odraslih s teške urođene, ciklički ili idiopatskom нейтропении apsolutni broj neutrofila (anc) ≤0. 5 x 109/l i povijest teških ili рецидивирующих infekcije, produljena primjena филграстима ukazuje na povećanje neutrofila i smanjenje učestalosti i trajanja zaraznih događaja. Филграстим je indiciran za liječenje uporni нейтропения (anc ≤1. 0 x 109/l) u bolesnika s poodmakloj fazi hiv-infekcije za smanjenje rizika od bakterijske infekcije, kada su druge opcije za upravljanje нейтропения zagubljen.

Noxafil Europska Unija - hrvatski - EMA (European Medicines Agency)

noxafil

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotika za sustavnu uporabu - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 i 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Pregabalin Pfizer Europska Unija - hrvatski - EMA (European Medicines Agency)

pregabalin pfizer

upjohn eesv - pregabalin - anxiety disorders; epilepsy - antiepileptici sredstva, - Нейропатическая painpregabalin pfizer je indiciran za liječenje periferne i centralne neuropatske boli u odraslih. epilepsypregabalin "pfizer" prikazan je kao dodatna terapija kod osoba s парциальными судорогами sa ili bez sekundarne generalizacije. disorderpregabalin postati generalizirani anksioznosti pfizer je indiciran za liječenje generalizirani anksiozni poremećaj (gap) kod odraslih.

Qutenza Europska Unija - hrvatski - EMA (European Medicines Agency)

qutenza

grunenthal gmbh - kapsaicin - neuralgija - anestetici - qutenza je indicirana za liječenje periferne neuropatske boli u odraslih osoba sam ili u kombinaciji s drugim lijekovima za bol.

Zarzio Europska Unija - hrvatski - EMA (European Medicines Agency)

zarzio

sandoz gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - Иммуностимуляторы, - smanjenje trajanja нейтропении i frekvencije фебрильной нейтропении kod pacijenata s utvrđenim цитотоксической kemoterapije na maligni tumori (osim kroničnog миелоидного leukemije i миелодиспластических sindromi), kao i smanjenje trajanja нейтропении pacijenti koji primaju миелоаблативную terapiju s naknadnim transplantacija koštane srži se smatra rizičnim duge teške нейтропении. sigurnost i učinkovitost filgrastima slične su kod odraslih i djece s citotoksičnim kemoterapijom. mobilizacija stanica prethodnika periferne krvi (pbpc). kod djece i odraslih osoba s teškim urođenim, ciklički ili idiopatskom нейтропении apsolutni broj neutrofila (anc) ≤0. 5 x 109/l, a u prošlosti teških ili рецидивирующих infekcijama, dugoročno korištenje филграстима ukazuje na povećanje neutrofila i smanjenje učestalosti i trajanja zaraznih događaja. liječenje otpornog нейтропении (cnd ≤ 1. 0 x 109/l) u bolesnika s poodmakloj fazi hiv-infekcije za smanjenje rizika od bakterijske infekcije, kada su druge terapijske opcije zagubljen.

Pregabalin Zentiva k.s. Europska Unija - hrvatski - EMA (European Medicines Agency)

pregabalin zentiva k.s.

zentiva k.s. - pregabalin - anxiety disorders; neuralgia; epilepsy - antiepileptici sredstva, - Нейропатическая painpregabalin Зентива k.. je indiciran za liječenje periferne i središnje neuropatske boli kod odraslih osoba. epilepsypregabalin Зентива k.. prikazuje se kao dodatna terapija kod osoba s парциальными судорогами sa ili bez sekundarne generalizacije. postati generalizirani anksioznosti disorderpregabalin Зентива k.. indiciran za liječenje generalizirani anksiozni poremećaj (gap) kod odraslih.

Pregabalin Mylan Europska Unija - hrvatski - EMA (European Medicines Agency)

pregabalin mylan

mylan pharmaceuticals limited - pregabalin - anxiety disorders; epilepsy - antiepileptici sredstva, - Нейропатическая painpregabalin mylan u indiciran za liječenje periferne i centralne neuropatske boli u odraslih. epilepsypregabalin mylan u naznačeno kao dodatni terapija u odraslih s парциальными судорогами sa ili bez sekundarne generalizacije. postati generalizirani anksioznosti disorderpregabalin mylan u indiciran za liječenje generalizirani anksiozni poremećaj (gap) kod odraslih.

Pregabalin Sandoz Europska Unija - hrvatski - EMA (European Medicines Agency)

pregabalin sandoz

sandoz gmbh - pregabalin - anxiety disorders; neuralgia; epilepsy - antiepileptici sredstva, - Нейропатическая painpregabalin Сандоз indiciran za liječenje periferne i centralne neuropatske boli u odraslih. epilepsypregabalin Сандоз prikazan kao dodatna terapija kod osoba s парциальными судорогами sa ili bez sekundarne generalizacije. postati generalizirani anksioznosti disorderpregabalin Сандоз indiciran za liječenje generalizirani anksiozni poremećaj (gap) kod odraslih.

Ratiograstim Europska Unija - hrvatski - EMA (European Medicines Agency)

ratiograstim

ratiopharm gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - Иммуностимуляторы, - ratiograstim je indiciran za smanjenje trajanja neutropenije i incidencije febrilne neutropenije u bolesnika s utvrđenom citotoksičnom kemoterapijom zbog zloćudne bolesti (uz iznimku kronične mijeloične leukemije i mijelodisplastični sindromi) i za smanjenje trajanja neutropenije u bolesnika koji primaju mijeloablativnu terapiju nakon transplantacije koštane srži smatra se pod povećanim rizikom od razvoja produljene teške neutropenije. sigurnost i učinkovitost filgrastima slične su kod odraslih i djece s citotoksičnim kemoterapijom. ratiograstim dizajniran za mobilizaciju stanica prethodnika periferne krvi (pbpc). kod bolesnika, djece i odraslih s teške urođene, ciklički ili idiopatskom нейтропении apsolutni broj neutrofila (anc) ≤ 0. 5 x 109/l, a u prošlosti teških ili рецидивирующих infekcije, dugoročno uprave ratiograstim ukazuje na povećanje neutrofila i smanjenje učestalosti i trajanja zaraznih događaja. ratiograstim je indiciran za liječenje uporni нейтропения (anc ≤ 1. 0 x 109/l) u bolesnika s poodmakloj fazi hiv-infekcije za smanjenje rizika od bakterijske infekcije, kada su druge opcije za upravljanje нейтропения zagubljen.