Kesatuan Eropah - Slovenia - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolakton - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 in 5.

Kesatuan Eropah - Slovenia - EMA (European Medicines Agency)

abz-pharma gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - colony stimulating factors - biograstim je primerna za zmanjšanje trajanja neutropenia in pojavnost febrile neutropenia pri bolnikih s sedežem citotoksična kemoterapija za malignancy (z izjemo kronično mieloično levkemijo in myelodysplastic sindromov) in za zmanjšanje trajanja neutropenia v bolnikov, ki myeloablative terapije sledi kostnega mozga presaditev šteje, da na povečano tveganje za dolgotrajno hudo neutropenia. varnost in učinkovitost filgrastima sta pri odraslih in otrocih, ki prejemajo citotoksično kemoterapijo, podobna. biograstim je primerna za mobilizacijo periferne krvi progenitor celice (pbpc). pri bolnikih, otroci ali odrasli, s hudo prirojeno, ciklično, ali idiopatsko neutropenia z absolutno neutrophil count (anc) 0. 5 x 109/l, in zgodovino hujših ali ponavljajočih se okužb, dolgoročno uprava biograstim je pokazala, da povečanje neutrophil šteje in da se zmanjša pogostost in trajanje okužbe, povezane z dogodki. biograstim je primerna za zdravljenje vztrajno neutropenia (anc manj kot ali enako 1. 0 x 109/l) pri bolnikih z napredno okužbe z virusom hiv, da bi zmanjšali tveganje za bakterijske okužbe, ko so druge možnosti za upravljanje nevtropenija neprimerno.

Kesatuan Eropah - Slovenia - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - nintedanib - idiopatska pljučna fibroza - antineoplastična sredstva - ofev je indiciran pri odraslih za zdravljenje idiopatske pljučne fibroze (ipf).

Kesatuan Eropah - Slovenia - EMA (European Medicines Agency)

cis bio international - depreotid trifluoroacetat - radionuklidno slikanje - diagnostični radiofarmacevtiki - to zdravilo je samo za diagnostično uporabo. za scintigraphic slikanje sum, maligni tumorji, v pljučih po začetnem odkrivanje, incombination s ct ali prsnega koša x-ray, pri bolnikih s samotno pljučne vozliči.

Kesatuan Eropah - Slovenia - EMA (European Medicines Agency)

cis bio international  - besilesomab - osteomyelitis; radionuclide imaging - diagnostični radiofarmacevtiki - to zdravilo je za samo diagnostična uporaba in odobrene indikacije scintigraphic slikanje, v povezavi z druge primerne načine slikanja, za določitev vnetje/okužbe v perifernih kosti pri odraslih z suma osteomielitisa. zdravila scintimun ne smete uporabljati za diagnozo okužbe z diabetičnim nogam.

Slovenia - Slovenia - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

eli lilly farmacevtska druŽba, d.o.o. - insulin, humani - suspenzija za injiciranje - insulin, humani 100 i.e. / 1 ml - humani insulin

Slovenia - Slovenia - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

eli lilly farmacevtska druŽba, d.o.o. - insulin, humani - suspenzija za injiciranje - insulin, humani 100 i.e. / 1 ml - humani insulin

Kesatuan Eropah - Slovenia - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and 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. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric 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-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni. .

Kesatuan Eropah - Slovenia - EMA (European Medicines Agency)

life molecular imaging gmbh - florbetaben (18f) - radionuclide imaging; alzheimer disease - diagnostični radiofarmacevtiki - to zdravilo je samo za diagnostično uporabo. neuraceq je radiofarmacevtski izdelek, ki je navedena za positron emission tomografija (pet) slikanje β amyloid neuritic plošča gostote v možgane odraslih bolnikih z kognitivne motnje, ki so bili ovrednoteni za alzheimerjevo bolezen (ad) in drugih vzrokov kognitivne motnje. neuraceq je treba uporabiti v povezavi s klinično oceno. negativno skeniranja, kaže, redke ali ne, plošče, ki ni v skladu z diagnozo oglasov.

Kesatuan Eropah - Slovenia - EMA (European Medicines Agency)

ge healthcare as - flutemetamol (18f) - radionuclide imaging; alzheimer disease - diagnostični radiofarmacevtiki - to zdravilo je samo za diagnostično uporabo. vizamyl je radiofarmacevtski izdelek, zdravilo, ki je navedena za positron emission tomografija (pet) slikanje β amyloid neuritic plošča gostote v možgane odraslih bolnikih z kognitivne motnje, ki so bili ovrednoteni za alzheimerjevo bolezen (ad) in drugih vzrokov kognitivne motnje. zdravilo vismyl je treba uporabiti v povezavi s klinično oceno. negativno skeniranja, kaže, redke ali ne, plošče, ki ni v skladu z diagnozo oglasov.