Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - canakinumab - cryopyrin-associated periodic syndromes; arthritis, juvenile rheumatoid; arthritis, gouty - interleukin inhibitorji, - redno vročina syndromesilaris je indicirano za zdravljenje naslednjih autoinflammatory redno vročina sindromov, pri odraslih, mladostnikih in otrocih, starih 2 leti in več:cryopyrin-associated periodic syndromesilaris je primerna za zdravljenje cryopyrin-associated periodic sindromov (caps), vključno z:muckle-sindrom wells (mws),novorojenčku-nastop multisystem vnetne bolezni (nomid) / kronične infantilne nevrološke, kožne, sklepni sindrom (cinca),hude oblike družinsko hladno autoinflammatory sindrom (fcas) / družinsko hladno urtikarija (fcu) predstavitev z znaki in simptomi, ki presegajo hladno-induced urticarial izpuščaj na koži,. tumor nekroze faktor receptor, povezanih redno sindrom (pasti)ilaris je primerna za zdravljenje tumor nekroze faktor (tnf), receptor, povezanih redno sindrom (pasti). hyperimmunoglobulin d sindrom (hids)/mevalonate kinaza pomanjkljivosti (mkd)ilaris je primerna za zdravljenje hyperimmunoglobulin d sindrom (hids)/mevalonate kinaza pomanjkljivosti (mkd). družinsko sredozemlju kuge (fmf)ilaris je primerna za zdravljenje družinsko sredozemlju kuge (fmf). ilaris je treba v kombinaciji z colchicine, če je primerno. ilaris je prikazano tudi za zdravljenje:še vedno je diseaseilaris je primerna za zdravljenje aktivnega še vedno je bolezen odraslih, vključno z nastopom še vedno je bolezen (aosd) in sistemsko mladoletnike idiopatsko artritis (sjia) pri bolnikih, starih 2 leti in več, ki so se odzvali neustrezno na prejšnje zdravljenje s nesteroidna protivnetna zdravila (nesteroidnih protivnetnih zdravil) in sistemski kortikosteroidi. ilaris lahko podana kot monotherapy ali v kombinaciji z metotreksatom. uričnim arthritisilaris je primerna za simptomatsko zdravljenje odraslih bolnikov s pogostimi uričnega artritisa napadov (vsaj za 3 napade v zadnjih 12 mesecih) pri katerih nesteroidna protivnetna zdravila (nesteroidnih protivnetnih zdravil) in colchicine so kontraindicirana, se ne prenaša ali ne zagotavlja ustreznega odgovora, in v kateri je ponovil tečaji kortikosteroidi niso primerne.

Evropska unija - slovenščina - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - anakinra - arthritis, rheumatoid; covid-19 virus infection - imunosupresivi - revmatoidni artritis (ra)kineret je navedeno pri odraslih za zdravljenje znakov in simptomov ra v kombinaciji z metotreksatom, z nezadosten odziv na sam metotreksat. covid-19kineret is indicated for the treatment of coronavirus disease 2019 (covid-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (supar) ≥ 6 ng/ml. periodic fever syndromeskineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above:cryopyrin-associated periodic syndromes (caps)kineret is indicated for the treatment of caps, including:neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca)muckle-wells syndrome (mws)familial cold autoinflammatory syndrome (fcas)familial mediterranean fever (fmf)kineret is indicated for the treatment of familial mediterranean fever (fmf). kineret je treba v kombinaciji z colchicine, če je primerno. Še vedno je diseasekineret je navedeno pri odraslih, mladostnikov, otrok in dojenčkov, starih od 8 mesecev in več s telesno maso 10 kg ali več, za zdravljenje še vedno je bolezen, vključno s sistemsko mladoletnike idiopatsko artritis (sjia) in odrasle-nastop še vedno je bolezen (aosd), z aktivnim sistemske značilnosti zmerno do visoko aktivnosti bolezni, ali pri bolnikih s nadaljevanje aktivnosti bolezni po zdravljenju z nesteroidna protivnetna zdravila (nesteroidnih protivnetnih zdravil) ali glucocorticoids. kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (dmards).

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - ceftolozane sulfat, tazobactam natrijev - bakterijske okužbe - antibacterials za sistemsko uporabo, - zerbaxa is indicated for the treatment of the following infections in adults:complicated intra abdominal infections;acute pyelonephritis;complicated urinary tract infections;hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap). upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Evropska unija - slovenščina - EMA (European Medicines Agency)

intervet international b.v. - cell-associated live recombinant turkey herpesvirus (strain hvt/ndv/ilt) expressing the fusion protein of newcastle disease virus and the glycoproteins gd and gi of infectious laryngotracheitis virus - imunologija za aves - embryonated chicken eggs; chicken - for active immunisation of one-day-old chicks or embryonated chicken eggs:to reduce mortality and clinical signs caused by newcastle disease (nd) virus,to reduce mortality, clinical signs and lesions caused by avian infectious laryngotracheitis (ilt) virus and marek’s disease (md) virus.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - imipenem monohidrat, cilastatin natrij, relebactam monohidrat - gram-negativne bakterijskih okužb - carbapenems, antibacterials for systemic use, - recarbrio is indicated for:- treatment of hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap), in adults (see sections 4. 4 in 5. - treatment of bacteraemia that occurs in association with, or is suspected to be associated with hap or vap, in adults. - treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options (see sections 4. 2, 4. 4 in 5. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Evropska unija - slovenščina - EMA (European Medicines Agency)

regeneron uk limited - rilonacept - cryopyrin-associated periodic sindromov - imunosupresivi - rilonacept regeneron je indicirano za zdravljenje povezano s cryopyrin periodično sindromi (caps) s hudimi simptomi, vključno z družinsko hladno auto-vnetni sindrom (fcas) in muckle-wells sindrom (mws ki deluje), v odrasli in otroci, stari 12 let in starejši.

Evropska unija - slovenščina - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - multiple myeloma - antineoplastična sredstva - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):za zdravljenje okužbe z virusom hiv-1 okužba v protiretrovirusno zdravljenje (art)-izkušeni odraslih bolnikih, vključno s tistimi, ki so bili zelo pre-obravnava. za zdravljenje okužbe z virusom hiv-1 okužba pri pediatričnih bolnikih od starosti 3 let in najmanj 15 kg telesne teže. pri odločanju za uvedbo zdravljenja z darunavir co-daje z nizkim odmerkom ritonavir, previdni, upoštevati je treba zdravljenje zgodovino posameznih bolnikov in vzorcev mutacije, povezane z različnimi agenti. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 in 5. darunavir co-daje z nizkim odmerkom ritonavir je navedeno v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje bolnikov z virusom humane imunske pomanjkljivosti (hiv-1) okužbe.  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. pri odločanju za uvedbo zdravljenja z darunavir v takih art-izkušeni bolniki, genotipa testiranje mora vodnik za uporabo darunavir (glej točki 4. 2, 4. 3, 4. 4 in 5.

Evropska unija - slovenščina - 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).