Eiropas Savienība - latviešu - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - degarelix - prostatas audzēji - endokrīnā terapija - firmagon is a gonadotrophin releasing hormone (gnrh) antagonist indicated:- for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

instituto grifols s.a. - imūbnglobulīns, normālais, cilvēka - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - un imūnglobulīni, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin - cukura diabēts, 2. tips - cukura diabēts - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

actavis group ptc ehf    - pioglitazona hidrohlorīds - cukura diabēts, 2. tips - cukura diabēts - 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 ir arī norādīts kombinācija ar insulīnu, 2. tipa cukura diabēts pieaugušiem pacientiem ar nepietiekamu glycaemic kontroli uz insulīnu, kam metformīns ir nevietā, jo ir kontrindikācijas vai neiecietību. pēc tam, kad sākta terapija ar pioglitazone, pacientiem būtu jāpārskata pēc 3 līdz 6 mēnešiem, lai novērtētu atbilstību ārstēšanas e. samazinājums hba1c). pacientiem, kas nespēj izrādīt pienācīgu atbildi, pioglitazone būtu jāpārtrauc. Ņemot vērā potenciālos riskus, ar ilgstošu terapiju, prescribers jāapstiprina turpmāk kārtējās atsauksmes, ka labā pioglitazone ir vēsture.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastiski līdzekļi - glivec 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-pdgfra rearrangement. spēkā glivec par rezultātiem, kaulu smadzeņu transplantācija nav noteikta. glivec is indicated for: , 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. pacienti, kuriem ir ar zemu vai ļoti zemu atkārtošanās risku, nevajadzētu saņemt palīgvielu apstrāde;, ārstēšanai pieaugušiem pacientiem ar unresectable dermatofibrosarcoma protuberans (dfsp) un pieaugušiem pacientiem ar recidivējošu un / vai metastātisku dfsp, kas nav tiesīgi operācijas. , pieaugušo un bērnu pacientiem, efektivitāti glivec ir balstīta uz vispārējo hematoloģisko, un cytogenetic atbildes likmes un attīstība-bezmaksas izdzīvošanu cml, hematoloģisko, un cytogenetic atsaucības līmenis ph+ visi, mds / mpd, hematoloģisko atbilde likmes hes / cel un uz objektīviem atbilde likmes pieaugušiem pacientiem ar unresectable un / vai metastātisku bŪtĪba un dfsp un par atkārtošanos-bezmaksas izdzīvošanu palīgvielu bŪtĪba. pieredze ar glivec pacientiem ar mds / mpd, kas saistīti ar pdgfr gēnu re-kārtība ir ļoti ierobežota (skatīt 5. iedaļu. izņemot tikko diagnosticēta cml hroniskā fāzē, nav kontrolētos pētījumos, kas liecina par klīnisko ieguvumu vai palielina izdzīvošanas šo slimību.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

gilead sciences ireland uc - ledipasvir, sofosbuvir - c hepatīts, hronisks - pretvīrusu līdzekļi sistēmiskai lietošanai - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 un 5. hepatīta c vīrusa (hcv) genotipa-īpašas darbības, skatīt 4. 4 un 5.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - b hepatīts, rekombinantā virsmas antigēns - hepatitis b; immunization - vakcīnas - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. ar īpašām riska kategoriju imunitātes līmeni nosaka, pamatojoties uz oficiālās rekomendācijas. sagaidāms, ka hepatīta d būs arī novērst ar vakcināciju ar hbvaxpro kā hepatīta d (ko izraisa delta pārstāvis) nerodas, ja hepatīta-b infekcija. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. ar īpašām riska kategoriju imunitātes līmeni nosaka, pamatojoties uz oficiālās rekomendācijas. sagaidāms, ka hepatīta d būs arī novērst ar vakcināciju ar hbvaxpro kā hepatīta d (ko izraisa delta pārstāvis) nerodas, ja hepatīta-b infekcija. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. sagaidāms, ka hepatīta d būs arī novērst ar vakcināciju ar hbvaxpro kā hepatīta d (ko izraisa delta pārstāvis) nerodas, ja no b hepatīta infekcija.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

csl behring gmbh - cilvēka normālais imūnglobulīns (scig) - imūndeficīta sindromi - un imūnglobulīni, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

pharmathen s.a. - ibandronic acid - hypercalcemia; fractures, bone; neoplasm metastasis; breast neoplasms - zāles kaulu slimību ārstēšanai - concentrate for solution for infusion prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Ārstēšanai audzēju izraisītu hypercalcaemia ar vai bez metastāzēm. film-coated tablets prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, metformīns hidrohlorīds - cukura diabēts, 2. tips - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 un 5. 1 pieejamo datu par dažādām kombinācijām).