Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - ibandronska kislina - wounds and injuries; breast diseases; neoplastic processes; calcium metabolism disorders; water-electrolyte imbalance - zdravila za zdravljenje bolezni kosti - ibandronic acid je navedeno v odrasli forprevention iz skeletne dogodkov (patološki zlomi, kosti zapleti, ki zahtevajo radioterapija ali kirurški poseg) pri bolnikih z rakom dojk in kostni zasevki. zdravljenje tumorja povzroča hypercalcaemia z ali brez zasevki. zdravljenje osteoporoze pri ženskah po menopavzi na povečano tveganje za zlome (glej poglavje 5. zmanjšanje tveganja za zlome vretenc je bilo dokazano, učinkovitosti na vratu femoralne zlome ni bila ugotovljena.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - monohidrat zoledronske kisline - hypercalcemia; fractures, bone; cancer - bisfosfonati - preprečevanje skeletnih povezane dogodke (patološki zlomi, hrbtenice stiskanje, sevanja ali operacijo kosti ali tumor povzroča hypercalcaemia) pri odraslih bolnikih z napredno malignih bolezni, ki vključujejo kosti. zdravljenje odraslih bolnikov z tumor povzroča hypercalcaemia (tih).

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - tigecycline - soft tissue infections; intraabdominal infections; bacterial infections; skin diseases, infectious - antibacterials za sistemsko uporabo, - tygecycline soglasju je navedeno v odrasle in otroke, starejše od osem let za zdravljenje naslednjih okužb (glej točki 4. 4 in 5. 1):zapleteno, kože in mehkih tkiv, okužbe (cssti), razen diabetično stopalo okužbe (glejte poglavje 4. 4)zapletena znotraj trebušne okužb (ciai)tygecycline soglasju naj se uporablja le v primerih, ko druge alternativne antibiotiki niso primerni (glej točki 4. 4, 4. 8 in 5. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - apixaban - venous thromboembolism; stroke; arthroplasty - antitrombotična sredstva - prevention of venous thromboembolic events (vte) in adult patients who have undergone elective hip or knee replacement surgery. preprečevanje kapi in sistemska embolija pri odraslih bolnikih z ne-valvular atrijsko fibrilacijo (nvaf), z eno ali več dejavnikov tveganja, kot so pred možgansko kap ali prehodni ischaemic napad (tia); starost ≥ 75 let; hipertenzija; sladkorna bolezen; simptomatsko srčno popuščanje (nyha razred ≥ ii). zdravljenje globoke venske tromboze (dvt) in pljučna embolija (pe), in preprečevanje ponavljajočih se dvt in pe pri odraslih (glej poglavje 4. 4 za haemodynamically nestabilno pe bolnikov). prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (nvaf), with one or more risk factors, such as prior stroke or transient ischaemic attack (tia); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (nyha class ≥ ii). zdravljenje globoke venske tromboze (dvt) in pljučna embolija (pe), in preprečevanje ponavljajočih se dvt in pe pri odraslih (glej poglavje 4. 4 za haemodynamically nestabilno pe bolnikov).

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - repaglinid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - repaglinide je indicirano pri bolnikih z diabetesom tipa 2 (non-insulina – odvisni diabetes mellitus (niddm)), katere hyperglycaemia ni več mogoče nadzorovati zadovoljivo z prehrana, zmanjšanje telesne teže in telesno vadbo. zdravljenje naj se začne kot dodatek k prehrani in vadbi za znižanje glukoze v krvi glede na obroke.

Evropska unija - slovenščina - 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. .

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - ivabradinijev klorid - angina pectoris; heart failure - srčna terapija - simptomatsko zdravljenje kronično stabilno angino pektoris pectorisivabradine je primerna za simptomatsko zdravljenje kronična stabilna angina pektoris v koronarna bolezen odraslih z normalno sinus ritem in utrip srca ≥ 70 bpm. ivabradine je navedeno :- v odrasli ne morejo prenašati ali kontraindikacij za uporabo beta-blokatorji - ali v kombinaciji z beta blokatorji pri bolnikih neustrezno nadzorovano z optimalno beta-blocker odmerek. zdravljenje kroničnih srce failureivabradine je navedeno v kronično srčno popuščanje nyha ii do iv razred z sistolični motnje, pri bolnikih, pri sinus ritem in katerih srčni utrip ≥ 75 bpm, v kombinaciji s standardno terapijo, vključno z beta-blocker zdravljenja ali pri beta-blocker zdravljenje je kontraindicirano ali ne prenaša. (glejte poglavje 5).

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - for adult patients with type 2 diabetes mellitus:it is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. it is indicated in combination with a sulphonylurea (i. , trojna kombinacija terapija), kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in sulfonil sečnine. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - posakonazol - mycoses - antimikotiki za sistemsko uporabo - posaconazole accord is indicated for use in the treatment of the following fungal infections in adults:invasive aspergillosis;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. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. posaconazole soglasju navede tudi za profilaksa invazivnih glivičnih okužb v naslednjih bolnikov: bolniki, ki prejemajo odpust-indukcijske kemoterapijo za akutno myelogenous levkemijo (aml) ali myelodysplastic sindromov (mds) pričakuje, da bo rezultat v daljšem neutropenia in pri katerih obstaja visoko tveganje za nastanek invazivnih glivičnih okužb;hematopoietic matičnih celic za presajanje (hsct) prejemniki, ki so v visoki odmerki imunosupresivna terapija za cepljene (graft versus host disease in pri katerih obstaja visoko tveganje za nastanek invazivnih glivičnih okužb,.

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

accord healthcare - topotekan - koncentrat za raztopino za infundiranje - topotekan 1 mg / 1 ml - topotekan