Recarbrio Unione Europea - sloveno - EMA (European Medicines Agency)

recarbrio

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.

Sivextro Unione Europea - sloveno - EMA (European Medicines Agency)

sivextro

merck sharp & dohme b.v. - tedizolidolidov fosfat - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, , other antibacterials - sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and adolescents 12 years of age and older.

Vaxelis Unione Europea - sloveno - EMA (European Medicines Agency)

vaxelis

mcm vaccine b.v. - davica toxoid, tetanus toxoid, bordetella oslovskemu kašlju antigenov: oslovskemu kašlju toxoid, nitastih haemagglutinin, pertactin, fimbriae vrste 2 in 3, hepatitis b surface antigen, proizvedene v kvas celice, poliovirus (inaktivirano): tip 1 (mahoney), tip 2 (mef-1), tip 3 (saukett), ki v chicagu celic/ haemophilus influenzae tipa b polysaccharide (polyribosylribitol fosfat) konjugiran na meningococcal beljakovin. - meningitis, haemophilus; poliomyelitis; tetanus; diphtheria; whooping cough; hepatitis b - cepiva - vaxelis (dtap-hb-ipv-hib) je indicirano za osnovno in obnovitveno cepljenje pri dojenčkih in malčkih od starosti 6 tednov, proti davici, tetanus, oslovski kašelj, hepatitis b, otroški ohromelosti in invazivnih bolezni, ki povzroča haemophilus influenzae tipa b (hib). uporaba zdravila vaxelis mora biti v skladu z uradnimi priporočili.

Zerbaxa Unione Europea - sloveno - EMA (European Medicines Agency)

zerbaxa

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.

Cubicin Unione Europea - sloveno - EMA (European Medicines Agency)

cubicin

merck sharp & dohme b.v. - daptomicin - gram-positive bacterial infections; bacteremia; soft tissue infections; endocarditis, bacterial - antibacterials za sistemsko uporabo, - cubicin je indiciran za zdravljenje naslednjih okužb. odraslih in pediatričnih (1 do 17 let) pri bolnikih z zapleteno kože in mehkega tkiva okužb (cssti). odraslih bolnikih z desno-sided (obojestransko), infektivnih endocarditis (rie) zaradi staphylococcus aureus. priporočljivo je, da je odločitev za uporabo daptomycin je treba upoštevati, da protibakterijsko dovzetnost organizma in je treba na podlagi strokovno svetovanje. odraslih in pediatričnih (1 do 17 let) pri bolnikih s staphylococcus aureus bacteraemia (sab). pri odraslih, uporabite v bacteraemia bi morala biti povezana z rie ali z cssti, medtem ko so pri pediatričnih bolnikih, uporabite v bacteraemia bi morala biti povezana z cssti. daptomycin je aktiven proti gram pozitivne bakterije le. v mešanih okužb, kjer je za gram negativne in/ali določene vrste anaerobnih bakterij, ki so osumljene, cubicin je treba co-daje z ustrezno protibakterijsko zastopnik (- i). upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Edistride Unione Europea - sloveno - EMA (European Medicines Agency)

edistride

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - zdravila, ki se uporabljajo pri diabetesu - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. poleg drugimi zdravili za zdravljenje diabetesa tipa 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 in 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Forxiga Unione Europea - sloveno - EMA (European Medicines Agency)

forxiga

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - zdravila, ki se uporabljajo pri diabetesu - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. poleg drugimi zdravili za zdravljenje diabetesa tipa 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 in 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Gardasil Unione Europea - sloveno - EMA (European Medicines Agency)

gardasil

merck sharp & dohme b.v.  - human papillomavirus tip 6 l1 beljakovin, human papillomavirus tip 11 l1 beljakovin, human papillomavirus tip 16 l1 beljakovin, human papillomavirus 18. vrsta beljakovine l1 - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - cepiva - gardasil je cepivo za uporabo v starosti od 9 let, za preprečevanje:premalignant genitalni lezije (materničnega vratu, vulvar in nožnice), premalignant analni poškodb, raka materničnega vratu in analni raka vzročno povezane z določenimi oncogenic human papillomavirus (hpv) tipov;genitalni bradavice (condyloma acuminata) vzročno povezane s specifičnimi hpv tipov. glej poglavja 4. 4 in 5. 1 za pomembne podatke o podatkih, ki podpirajo to indikacijo. uporaba gardasil je treba v skladu z uradnimi priporočili.

Jardiance Unione Europea - sloveno - EMA (European Medicines Agency)

jardiance

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - zdravila, ki se uporabljajo pri diabetesu - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 in 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Refludan Unione Europea - sloveno - EMA (European Medicines Agency)

refludan

celgene europe ltd. - lepirudin - thromboembolism; thrombocytopenia - antitrombotična sredstva - antikoagulacijo pri odraslih bolnikih s heparinom povzročene trombocitopenije tipa ii in trombemboličnih bolezni, obveznost parenteralne terapije. diagnoza mora biti potrjena z heparina-induced trombocitov aktiviranje testa ali enakovredno test.