الاتحاد الأوروبي - السلوفانية - EMA (European Medicines Agency)

les laboratoires servier - ivabradinijev klorid - angina pectoris; heart failure - srčna terapija - simptomatsko zdravljenje kronične stabilne angine pektoris ivabradine je indicirano za simptomatsko zdravljenje kronične stabilne angine pektoris pri koronarne bolezni odraslih s običajen sinusni ritem in srčni utrip ≥ 70 bpm. ivabradine is indicated :in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. zdravljenje kroničnega srčnega popuščanja ivabradine navedena v kronično srčno popuščanje nyha ii do iv razreda z sistolični disfunkcija, pri bolnikih v sinusni ritem in katerih srčni utrip je ≥ 75 bpm, v kombinaciji s standardno zdravljenje, vključno z zdravljenjem s beta-blocker ali kdaj je terapija beta-blocker kontraindiciran ali ne prenaša.

الاتحاد الأوروبي - السلوفانية - EMA (European Medicines Agency)

sandoz gmbh - rituksimab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - antineoplastična sredstva - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. samo omejeni so na voljo podatki o učinkovitosti in varnosti za bolnike predhodno zdravljenih z monoklonalna protitelesa, vključno z rituksimabom ali bolniki, ognjevzdržni, da prejšnji rituksimabom plus kemoterapijo. glej oddelek 5. 1 za nadaljnje informacije. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituksimabom je dokazano, da zmanjša stopnjo napredovanja skupno škodo, merjeno z x-ray in izboljšati telesno funkcijo, če bi imeli v kombinaciji z metotreksatom. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

الاتحاد الأوروبي - السلوفانية - EMA (European Medicines Agency)

zoetis belgium s.a. - leptospira interrogans serogroup australis serovar bratislava, sev, mslb 1088, l. interrogans serogroup icterohaemorrhagiae serovar icterohaemorrhagiae, sev, mslb 1089, l. interrogans serogroup canicola serovar canicola, sev, mslb 1090, l. kirschneri serogroup grippotyphosa serovar grippotyphosa, sev, mslb 1091 (vse inaktivirano) - inaktivirano bakterijska cepiva (vključno z mikroplazma, toxoid in chlamydia), immunologicals za canidae - psi - aktivno imunizacijo psov iz šestih tednih starosti, da se prepreči kliničnih znakov bolezni, okužbe sečil, izločanje, povzročeno s leptospira serovars bratislava, canicola, grippotyphosa in icterohaemorrhagiae. začetek imunosti: imuniteta je dokazana 4 tedne po zaključku osnovnega tečaja. trajanje imunitete: vsaj eno leto po osnovnem cepljenju.

الاتحاد الأوروبي - السلوفانية - EMA (European Medicines Agency)

teva b.v. - salmeterol, fluticasone propionat - pulmonary disease, chronic obstructive; asthma - zdravila za obstruktivne pljučne bolezni, - airexar spiromax je indicirano za uporabo pri odraslih, starih 18 let in več, samo. asthmaairexar spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist. kronična obstruktivna pljučna bolezen (kopb)airexar spiromax je primerna za simptomatsko zdravljenje bolnikov s kopb s fev1.

الاتحاد الأوروبي - السلوفانية - EMA (European Medicines Agency)

valneva sweden ab - rekombinantne kolera toksin b podenote, vibrio cholerae 01 - cholera; immunization - cepiva - zdravilo dukoral je indicirano za aktivno imunizacijo proti bolezni, ki jo povzroča serotip skupine vibrio cholerae o1 pri odraslih in otrocih, starih od 2 let, ki bodo obiskali endemične / epidemične površine. uporaba dukoral je treba določiti na podlagi uradnih priporočil, ob upoštevanju variabilnosti epidemiologija in tveganje stranke bolezni v različnih geografskih področjih in potujejo pogoji. dukoral ne sme nadomestiti standardne zaščitne ukrepe. v primeru driske ukrepov za rehidracijo, je treba začeti.

الاتحاد الأوروبي - السلوفانية - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - pri odraslih bolnikih z diabetes tipa 2 bolezni, januvia je pokazala, da izboljšanje glycaemic nadzor:kot monotherapy:pri bolnikih, neustrezno nadzorovane z dieto in telesno vadbo sami in za katere metformin ni primeren zaradi kontraindikacije ali nestrpnosti;kot dvojno oralna terapija v kombinaciji z:metformin, ko dieto in telesno vadbo plus metformin sam ne zagotavljajo ustrezne glycaemic nadzor;sulfonil sečnine, ko dieto in telesno vadbo plus maksimalne dopustne odmerek sulfonil sečnine sam ne zagotavljajo ustrezne glycaemic nadzor in, če metformin ni primeren zaradi kontraindikacije ali nestrpnosti;a peroksisomski-proliferator-activated-receptor-gama (ppary) agonist (i. a thiazolidinedione) pri uporabi ppary agonist je to primerno in ko dieto in telesno vadbo plus ppary agonist sam ne zagotavljajo ustrezne glycaemic nadzoru;ppary agonist (i. a thiazolidinedione) pri uporabi ppary agonist je to primerno in ko dieto in telesno vadbo plus ppary agonist sam ne zagotavljajo ustrezne glycaemic nadzor;kot trojna oralna terapija v kombinaciji z:sulfonil sečnine in metforminom, ko dieto in telesno vadbo plus dvojno zdravljenje s temi zdravili ne zagotavljajo ustrezne glycaemic nadzor;ppary agonist in metforminom pri uporabi ppary agonist je to primerno in ko dieto in telesno vadbo plus dvojno zdravljenje s temi zdravili ne zagotavljajo ustrezne glycaemic nadzor. januvia je prikazano tudi kot dodatek na inzulinu (z metforminom ali brez), ko dieto in telesno vadbo plus stabilen odmerek insulina ne zagotavljajo ustrezne glycaemic nadzor.

الاتحاد الأوروبي - السلوفانية - EMA (European Medicines Agency)

zoetis belgium sa - eno od teh inaktivirano bolezni modrikastega jezika virus sevov:inaktivirano bolezni modrikastega jezika virus, serotip 1, sev btv-1/alg2006/01 e1inactivated bolezni modrikastega jezika virus, serotip 8, sev btv-8/bel2006/02inactivated bolezni modrikastega jezika virus, serotip 4, sev spa-1/2004 - immunologicals, immunologicals za bovidae, inaktivirano virusna cepiva, bolezen modrikastega jezika virus, ovce - sheep; cattle - aktivno imunizacijo ovc od 6 tednov starosti za preprečevanje viraemia zaradi bolezni modrikastega jezika virus, serotypes 1 in 8, in za zmanjšanje viraemia zaradi bolezni modrikastega jezika virus, serotip 4 in aktivno imunizacijo goveda (od 12. tedna starosti za preprečevanje viraemia zaradi bolezni modrikastega jezika virus, serotypes 1 in 8.

الاتحاد الأوروبي - السلوفانية - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - eptacog beta (activated) - hemophilia a; hemophilia b - antihemoragije - cevenfacta is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with high-responding inhibitors to coagulation factors viii or ix (i. ≥5 bethesda units (bu)); in patients with congenital haemophilia with low titre inhibitors (bu.

الاتحاد الأوروبي - السلوفانية - EMA (European Medicines Agency)

laboratorios hipra s.a. - escherichia coli j5 inactivated, staphylococcus aureus (cp8) strain sp 140 inactivated, expressing slime-associated antigenic complex - imunologija za bovidae - govedo (krave in telice) - za črede imunizacijo zdravih krav in telic, v mlekarice čred z ponavljajoče se vnetje vimena težav, da se zmanjša pojavnost sub-klinično vnetje vimena in pogostnost in resnost kliničnih znakov klinični vnetje vimena, ki jih povzročajo bakterije staphylococcus aureus, coliforms in coagulase-negativni stafilokoki. celotna imunizacijska shema povzroči imuniteto od približno 13 dni po prvi injekciji do približno 78 dni po tretji injekciji (kar ustreza 130 dni po porodu).

الاتحاد الأوروبي - السلوفانية - EMA (European Medicines Agency)

ceva santé animale - inaktivirana cepiva coxiella burnetii, sev devet milj - immunologicals for bovidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - goats; cattle - cattle: , for the active immunisation of cattle to lower the risk for non-infected animals vaccinated when non-pregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of coxiella burnetii in these animals via milk and vaginal mucus. , onset of immunity: not established. , duration of immunity: 280 days after completion of the primary vaccination course. , goats: , for the active immunisation of goats to reduce abortion caused by coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta. , onset of immunity: not established. , duration of immunity: one year after completion of the primary vaccination course.