natgillin/translations-raw huggingface dataset:
Xelevia was studied in nine studies, involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled: four of the studies compared Xelevia with placebo (a dummy treatment): Xelevia or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients; two studies compared Xelevia with other antidiabetes medicines.
Zdravilo Xelevia je bilo raziskano v devetih glavnih študijah, ki so vključevale skoraj 6 000 bolnikov s sladkorno boleznijo tipa 2, pri katerih ravni glukoze v krvi niso bile zadostno nadzorovane: v štirih študijah so zdravilo Xelevia primerjali s placebom (zdravilom brez zdravilne učinkovine): zdravilo Xelevia ali placebo so bolniki jemali samostojno v dveh študijah, ki sta vključevali 1 262 bolnikov, kot dodatek metforminu v eni študiji s 701 bolnikom in kot dodatek pioglitazonu (agonistu PPAR–gama) v eni študiji s 353 bolniki; v dveh študijah so zdravilo Xelevia primerjali z drugimi zdravili proti sladkorni bolezni.
Xeloda 150 mg film-coated tablets Capecitabine
Xeloda 150 mg filmsko obložene tablete kapecitabin
Xeloda 500 mg film-coated tablets
Xeloda 500 mg filmsko obložene tablete
Xeloda 500 mg film-coated tablets
Xeloda 500 mg filmsko obložene tablete:
Xeloda 500 mg film-coated tablets Capecitabine
Xeloda 500 mg filmsko obložene tablete kapecitabin
Xeloda can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Zdravilo Xeloda lahko izzove hude kožne reakcije, kot sta Stevens-Johnsonov sindrom in toksična epidermalna nekroliza.
Xeloda dose calculations
Odmerek zdravila Xeloda
Xeloda is a cancer medicine that contains the active substance capecitabine.
Xeloda je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino kapecitabin.
Xeloda is indicated for the treatment of:
Zdravilo Xeloda je indicirano:
Xeloda is not indicated in children and adolescents.
Zdravilo Xeloda ni namenjeno otrokom in mladostnikom.
Xeloda is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient’s height and weight).
Zdravilo Xeloda se jemlje dvakrat na dan v odmerkih med 625 in 1 250 mg na kvadratni meter površine telesa (izračunano na podlagi bolnikove telesne mase in višine).
Xeloda is used to treat:
Zdravilo Xeloda se uporablja za zdravljenje:
Xeloda is used with or without other cancer medicines in patients who have had surgery for ‘stage III’ or ‘Dukes’ stage C’ colon cancer; metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Uporablja se z drugimi zdravili proti raku ali samostojno pri bolnikih po operaciji raka kolona stadija III ali stadija Dukes C; metastatskega kolorektalnega raka (raka debelega črevesa, ki se je razširil na druge dele telesa).
Xeloda is used with or without other cancer medicines; advanced gastric (stomach) cancer.
Zdravilo Xeloda se uporablja z drugimi zdravili za zdravljenje raka ali brez njih; napredovale oblike raka želodca.
Xeloda is used with other cancer medicines, including a platinum-containing cancer medicine such as cisplatin; locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body).
Zdravilo Xeloda se uporablja z drugimi zdravili za zdravljenje raka, vključno z zdravilom proti raku, ki vsebuje platino, kot na primer cisplatin; lokalno napredovalega ali metastatskega raka dojk (ki se je začel širiti na druge dele telesa).
Xeloda should only be prescribed by a doctor who is qualified in the use of cancer medicines.
Zdravilo Xeloda lahko predpiše le zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
Xeloda should only be prescribed by a qualified physician experienced in the utilisation of anti- neoplastic medicinal products.
Zdravilo Xeloda lahko predpiše le zdravnik z ustreznim znanjem in izkušnjami z uporabo zdravil za zdravljenje novotvorb.
Xeloda tablets should be swallowed with water within 30 minutes after a meal.
Tablete zdravila Xeloda je treba pogoltniti z vodo v 30 minutah po obroku.
Xeloda tablets should be swallowed with water within the 30 minutes after a meal.
Tablete zdravila Xeloda je treba pogoltniti z vodo v 30 minutah po obroku.
Xeloda with food and drink
Zdravilo Xeloda skupaj s hrano in pijačo
XELOX was demonstrated to be non-inferior to FOLFOX-4 in terms of progression-free survival in the per- protocol population and intent-to-treat population (see Table 9).
Zdravljenje po shemi XELOX je bilo ne-inferiorno zdravljenju po shemi FOLFOX-4 glede na preživetje brez napredovanja bolezni v populaciji po protokolu in populaciji, ki so jo nameravali zdraviti (glejte preglednico 9).
XELOX+
XELOX +
XELOX/ XELOX+P/ XELOX+BV
XELOX/XELOX + P/ XELOX + BEVACIZUMAB
XELOX/XELOX+P/ XELOX+BV
XELOX/XELOX + P/ XELOX + BEVACIZUMAB
XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
XELOX/XELOX + P/ XELOX + BEVACIZUMAB (EPP*: n = 967; ITT**: n = 1.017)
Xenical 120 mg hard capsules
Xenical 120 mg trde kapsule
Xenical 120 mg hard capsules Orlistat
Xenical 120 mg trde kapsule orlistat
Xenical 120mg hard capsules
Xenical 120 mg trde kapsule orlistat
Xenical capsules are turquoise with the imprint “ROCHE XENICAL 120” and are supplied in blister packs and glass bottles, containing 21, 42 and 84 capsules.
Kapsule zdravila Xenical so turkizne barve z napisom ROCHE XENICAL 120, na voljo so v pretisnih omotih in stekleničkah, ki vsebujejo po 21, 42 in 84 kapsul.
Xenical has no influence on the ability to drive and use machines.
Zdravilo Xenical nima vpliva na sposobnost za vožnjo in upravljanje s stroji.
Xenical has no known effect on your ability to drive a car or operate machinery.
Ni znano, da bi zdravilo Xenical vplivalo na sposobnost za vožnjo avtomobila ali upravljanje strojev.
Xenical is a medicine used to treat obesity.
Zdravilo Xenical je namenjeno zdravljenju debelosti.
Xenical is not intended to be used in children.
Zdravilo Xenical ni namenjeno zdravljenju otrok.
Xenical reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E. You should therefore follow your doctor’s advice in taking a well balanced diet rich in fruit and vegetables.
Zdravilo Xenical zmanjša absorpcijo pripravkov nekaterih v maščobi topnih hranil, zlasti beta karotena in vitamina E, zato morate upoštevati zdravnikov nasvet o uravnovešeni prehrani z veliko sadja in zelenjave.
xeplion 150 mg xeplion 100 mg
xeplion 100 mg xeplion 150 mg
Xeplion can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
Zdravilo Xeplion lahko zviša nivo hormona, ki ga imenujemo "prolaktin" v krvnih preiskavah (ki lahko povzroči simptome ali pa ne).
Xeplion has not been systematically studied in patients with renal impairment (see section 5.2).
Zdravila Xeplion niso sistematično preučevali pri bolnikih z ledvično okvaro (glejte poglavje 5.2).
Xeplion has not been systematically studied in patients with renal impairment (see section 5.2).
ZdravilaXeplion niso sistematično preučevali pri bolnikih z ledvično okvaro (glejte poglavje 5.2).
Xeplion injection
Injicirano zdravilo Xeplion
Xeplion is a white to off-white prolonged release suspension for injection in a pre-filled syringe.
Zdravilo Xeplion je bela do sivkastobela suspenzija za injiciranje s podaljšanim sproščanjem v napolnjeni injekcijski brizgi.
Xeplion is also available in a Treatment initiation pack which contains a second pre-filled syringe and 2 additional safety needles.
Zdravilo Xeplion je na voljo tudi v pakiranju za uvedbo zdravljenja, ki vsebuje dodatno napolnjeno injekcijsko brizgo in 2 dodatni varnostni igli.
Xeplion is designed to deliver paliperidone over a monthly period while prolonged release oral paliperidone is administered on a daily basis.
Zdravilo Xeplion je zasnovano tako, da se daje paliperidon en mesec, medtem ko se peroralni paliperidon s podaljšanim sproščanjem jemlje vsak dan.
Xeplion is designed to deliver paliperidone over a monthly period while prolonged release oral paliperidone is administered on a daily basis.
Zdravilo Xeplion je zasnovano tako, da se daje paliperidon en mesec, medtem ko seperoralni paliperidon s podaljšanim sproščanjem jemlje vsak dan.
Xeplion is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min) (see section 4.4).
Pri bolnikih z zmerno ali hudo ledvično okvaro (očistek kreatinina < 50 ml/min) ne priporočamo uporabe zdravila Xeplion (glejte poglavje 4.4).
Xeplion is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min) (see sections 4.2 and 5.2).
Uporaba zdravila Xeplion pri bolnikih z zmerno ali hudo ledvično okvaro (očistek kreatinina < 50 ml/min) ni priporočena (glejte poglavji 4.2 in 5.2).
Xeplion should be initiated as described at the beginning of section 4.2 above.
Zdravilo Xeplion je treba uvesti, kot je opisano na začetku zgornjega poglavja 4.2.
Xeplion should be used with caution in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction or ischaemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g. dehydration and hypovolemia).
Pri bolnikih z znano srčnožilno boleznijo (npr. srčnim popuščanje, miokardnim infarktom ali ishemijo, motnjami prevajanja), možganskožilnimi boleznimi ali stanji, z zvečanim tveganjem za hipotenzijo (npr. dehidracija in hipovolemija), je treba zdravilo Xeplion uporabljati previdno.
Xeplion should not be used while breast feeding.
Med dojenjem matere ne smejo jemati zdravila xeplion.
Xeplion was also shown to be effective in preventing relapses in the long- term, with fewer patients in the Xeplion group having a relapse compared with the placebo group.
Zdravilo Xeplion se je kot učinkovito izkazalo tudi pri dolgoročnem preprečevanju ponovitev, saj so se ponovitve pojavile pri manjšem številu bolnikov v skupini, ki je prejemala zdravilo Xeplion, v primerjavi s skupino, ki je prejemala placebo.
Xeristar 30 mg hard gastro-resistant capsules
Xeristar 30 mg trde gastrorezistentne kapsule
Xeristar 30 mg hard gastro-resistant capsules Xeristar 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
Xeristar 30 mg trde gastrorezistentne kapsule Xeristar 60 mg trde gastrorezistentne kapsule duloksetin (v obliki duloksetinijevega klorida)
Xeristar 60 mg hard gastro-resistant capsules
Xeristar 60 mg trde gastrorezistentne kapsule
Xeristar 60 mg is available in packs of 28, 56, 84, 98, 100 (Each pack contains 5 cartons of 20 capsules) and 500 capsules (Each pack contains 25 cartons of 20 capsules).
Zdravilo Xeristar 60 mg je na voljo v pakiranjih po 28, 56, 84, 98, 100 (vsako pakiranje vsebuje 5 škatel po 20 kapsul) in 500 kapsul (vsako pakiranje vsebuje 25 škatel po 20 kapsul).
Xeristar contains the active substance duloxetine.
Zdravilo Xeristar vsebuje zdravilno učinkovino duloksetin.
Xeristar is a hard gastro-resistant capsule.
Zdravilo Xeristar je trda gastrorezistentna kapsula.
Xeristar is used in adults to treat:
Zdravilo Xeristar pri odraslih se uporablja za zdravljenje:
Xeristar may be taken with or without food.
Zdravilo Xeristar lahko vzamete s hrano ali brez nje.
Xeristar may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol
Xeristar lahko povzroči tudi neželene učinke, ki se jih morda ne zavedate, kot povišanje jetrnih encimov ali krvnega nivoja kalija, kreatinske fosfokinaze, sladkorja ali holesterola.
Xeristar should not be used in the treatment of children and adolescents under the age of 18 years.
Zdravila Xeristar pri zdravljenju otrok in mladostnikov, mlajših od 18 let, ne smemo uporabljati.
Xeristar showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
Zdravilo Xeristar je pokazalo primerljive rezultate učinkovitosti v primerjavi z venlafaksinom glede izboljšanja skupnega števila točk po HAM- A.
Xeristar with food, drink and alcohol
Zdravilo Xeristar skupaj s hrano, pijačo in z alkoholom
XGEVA 120 mg solution for injection
XGEVA 120 mg raztopina za injiciranje
XGEVA has no or negligible influence on the ability to drive and use machines.
Zdravilo XGEVA nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Xgeva is a solution for injection that contains the active substance denosumab.
Zdravilo Xgeva je raztopina za injiciranje, ki vsebuje zdravilno učinkovino denosumab.
Xgeva is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed.
Zdravilo se uporablja tudi za zdravljenje vrste kostnega raka, imenovane gigantocelularni kostni tumor, pri odraslih in mladostnikih s popolnoma razvitim okostjem.
XGEVA is not recommended for use in pregnant women and women of childbearing potential not using highly effective contraception.
Zdravila XGEVA ni priporočljivo uporabljati pri nosečnicah in tistih ženskah v rodni dobi, ki ne uporabljajo visoko učinkovite kontracepcije.
Xgeva is not recommended in patients with growing skeletons (see section 4.2).
Zdravilo XGEVA ni priporočljivo pri bolnikih, ki se jim skelet še razvija (glejte poglavje 4.2).
XGEVA is used in adults with cancer to prevent serious complications caused by bone metastasis (e.g. fracture, pressure on the spinal cord or the need to receive radiation therapy or surgery).
Zdravilo XGEVA se uporablja pri odraslih bolnikih z rakom za preprečitev resnih zapletov, ki jih povzročijo kostne metastaze (npr. zlomov, pritiska na hrbtenjačo ali potrebe po obsevanju ali operaciji).
Xgeva is used to prevent bone complications in adults with a solid tumour that has spread to the bone.
Zdravilo Xgeva se uporablja za preprečevanje z okostjem povezanih zapletov pri odraslih s solidnim tumorjem, ki se je razširil na kosti.
XGEVA may be stored at room temperature (up to 25°C) for up to 30 days in the original container.
Zdravilo XGEVA se lahko shranjuje pri sobni temperaturi (do 25 °C ) do 30 dni v originalnem vsebniku.
Xgeva must not be used in patients whose wounds from dental or mouth surgery have not yet healed completely, or in people with severe, untreated hypocalcaemia (low blood calcium levels).
Zdravila Xgeva ne smejo uporabljati osebe, pri katerih se rane v ustih zaradi zobozdravstvenih ali drugih posegov še niso zacelile, ali bolniki s hudo, nezdravljeno hipokalciemijo (nizko ravnjo kalcija v krvi).
XGEVA reduced the risk of developing a SRE, and developing multiple SREs (first and subsequent) in patients with bone metastases from solid tumours (see table 2).
Zdravilo XGEVA je bolnikom s kostnimi metastazami solidnih tumorjev zmanjšalo tveganje za pojav SRE in pojav (prvih ali nadaljnjih) multiplih SRE (glejte tabelo 2).
XGEVA should be administered under the responsibility of a healthcare professional.
Zdravilo XGEVA mora injicirati zdravstveni delavec.
Xgeva was compared with zoledronic acid (another medicine used to prevent bone complications) in three main studies in patients with different types of cancer which had spread to the bone.
Zdravilo Xgeva so primerjali z zoledronsko kislino (drugim zdravilom, ki se uporablja za preprečevanje z okostjem povezanih zapletov) v treh glavnih študijah, v katerih so sodelovali bolniki z različnimi vrstami raka, ki se je razširil na kosti.
XGEVA was studied in an open label trial that enrolled 18 skeletally mature adolescents with giant cell tumour of bone.
Zdravilo XGEVA so raziskali v odprtem preskušanju, ki je zajelo 18 skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem.
XIAPEX
Zdravilo XIAPEX
Xiapex (N=249)
Xiapex (n = 249)
Xiapex contains a mixture of two ‘collagenases’, enzymes that break up collagen.
Zdravilo Xiapex vsebuje mešanico dveh kolagenaz, tj. encimov, ki razgrajujejo kolagen.
Xiapex is given as part of a treatment cycle.
Zdravilo Xiapex se daje kot del cikla zdravljenja.
Xiapex is used to treat Dupuytren’s contracture and Peyronie’s disease in adults.
Zdravilo Xiapex se uporablja za zdravljenje Dupuytrenove kontrakture in Peyroniejeve bolezni pri odraslih.
Xiapex may have a major influence on the ability to drive and use machines due to the swelling and pain which may impair the use of the treated hand in Dupuytren’s disease.
Zdravilo Xiapex utegne imeti pomemben vpliv na sposobnost vožnje in upravljanja strojev zaradi otekanja in bolečine, ki lahko ovirata uporabo zdravljene roke pri Dupuytrenovi bolezni.
Xiapex must be administered by a physician appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and management of Dupuytren’s disease.
Zdravilo Xiapex mora dajati zdravnik, ki je ustrezno usposobljen za pravilno dajanje zdravila in ima izkušnje v diagnosticiranju in vodenju zdravljenja Dupuytrenove bolezni.
Xiapex must not be used to treat Peyronie’s disease if the plaque affects the urethra (the tube that carries urine and semen to the outside).
Zdravilo Xiapex se ne sme uporabljati za zdravljenje Peyroniejeve bolezni, če so plaki prizadeli sečnico (cevko, po kateri se izločajo seč in semenčice).
Xiapex must only be injected into the Dupuytren’s cord.
Zdravilo Xiapex je treba injicirati samo v Dupuytrenov vozlič.
XIAPEX N=199
Zdravilo XIAPEX n = 199
Xiapex powder vial label
nalepka na viali praška Xiapex
Xiapex significantly reduced patient-reported bother associated with Peyronie’s disease compared with placebo (Table 10).
Zdravilo Xiapex je v primerjavi s placebom značilno zmanjšalo težave, povezane s Peyroniejevo boleznijo, o katerih so poročali bolniki (preglednica 10).
Xiapex treatment in patients having a calcified plaque that could have interfered with the injection technique, chordee in the presence or absence of hypospadias, thrombosis of the dorsal penile artery and/or vein, infiltration by a benign or malignant mass resulting in penile curvature, infiltration by an infectious agent, such as in lymphogranuloma venereum, ventral curvature from any cause and isolated hourglass deformity of the penis has not been studied and treatment in these patients should be avoided.
Zdravljenje z zdravilom Xiapex pri bolnikih s kalcificiranim plakom, ki bi lahko vplival na tehniko injiciranja, ukrivljenostjo penisa nazvdol v prisotnosti ali odsotnosti hipospadiaze, trombozo dorzalne arterije in/ali vene penisa, infiltracijo benigne ali maligne tvorbe, ki povzroča ukrivljenost penisa, infiltracijo kužne snovi, kot pri lymphogranuloma venereum, ventralno ukrivljenostjo zaradi katerega koli razloga in izolirano deformacijo penisa v obliki peščene ure niso preučili, zato se je treba zdravljenju teh bolnikov izogniti.
Xiapex treatment significantly improved penile curvature deformity in patients with Peyronie’s disease compared with placebo (Table 9).
Zdravljenje z zdravilom Xiapex je značilno izboljšalo deformacijo ukrivljenosti penisa pri bolnikih s Peyroniejevo boleznijo v primerjavi s placebom (preglednica 9).
Xiapex was also more effective than placebo in treating Peyronie’s disease, producing a 38% and 31% improvement in abnormal curvature in the two studies, compared with 21% and 15% respectively for placebo.
Zdravilo Xiapex je bilo učinkovitejše od placeba tudi pri zdravljenju Peyroniejeve bolezni, saj je v obeh študijah izboljšalo nenormalno ukrivljenost za 38 % oziroma 31 % v primerjavi z 21 % oziroma 15 % pri uporabi placeba.
Xiapex was compared with placebo (a dummy treatment) in two main studies involving a total of 374 adult patients with Dupuytren’s contracture.
Zdravilo Xiapex so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v katerih je sodelovalo skupno 374 odraslih bolnikov z Dupuytrenovo kontrakturo.
Xiapex was not associated with shortening of penile length in clinical trials in the treatment of Peyronie’s disease.
Zdravilo Xiapex v kliničnih preskušanjih za zdravljenje Peyroniejeve bolezni ni bilo povezano s skrajšanjem dolžine penisa.
Xiapex was shown to be more effective at treating Dupuytren’s contracture than placebo.
Zdravilo Xiapex se je pri zdravljenju Dupuytrenove kontrakture izkazalo za učinkovitejše od placeba.
Xigduo 5 mg/1,000 mg are 10.5 x 21.5 mm oval, yellow film-coated tablets.
Zdravilo Xigduo 5 mg/1000 mg so 10,5 x 21,5 mm velike, ovalne, rumene filmsko obložene tablete.
Xigduo 5 mg/850 mg are 9.5 x 20 mm oval, brown film-coated tablets.
Zdravilo Xigduo 5 mg/850 mg so 9,5 x 20 mm velike, ovalne, rjave filmsko obložene tablete.
Xigduo can also be used to replace dapagliflozin and metformin taken as separate tablets.
Zdravilo Xigduo se lahko uporablja tudi namesto ločenih tablet dapagliflozina in metformina.
Xigduo combines two anti-hyperglycaemic medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: dapagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Zdravilo Xigduo je kombinacija dveh antihiperglikemičnih učinkovin z različnima in komplementarnima mehanizmoma delovanja, ki izboljšata urejenost glikemije pri bolnikih s sladkorno boleznijo tipa 2: dapagliflozina, zaviralca natrij-glukoznega soprenašalca 2 (SGLT2 – sodium glucose co-transporter 2), in metforminijevega klorida, ki spada v skupino bigvanidov.
Xigduo contains two different active substances, which work in different ways:
Zdravilo Xigduo vsebuje dve različni zdravilni učinkovini, ki delujeta na različna načina:
Xigduo dapagliflozin / metformin
Xigduo dapagliflozin/metformin
Xigduo is a diabetes medicine that contains the active substances dapagliflozin and metformin.
Xigduo je zdravilo za sladkorno bolezen, ki vsebuje zdravilni učinkovini dapagliflozin in metformin.
Xigduo is available as tablets (5 mg dapagliflozin/850 mg metformin and 5 mg dapagliflozin/1,000 mg metformin) and can only be obtained with a prescription.
Zdravilo Xigduo je na voljo v obliki tablet (5 mg dapagliflozina/850 mg metformina in 5 mg dapagliflozina/1 000 mg metformina) in se izdaja le na recept.
Xigris 20 mg powder for infusion
Xigris 20 mg prašek za infundiranje
Xigris 20 mg powder for solution for infusion
Xigris 20 mg prašek za raztopino za infundiranje
Xigris 20 mg powder for solution for infusion drotrecogin alfa (activated)
Xigris 20 mg prašek za raztopino za infundiranje drotrekogin alfa (aktiviran)
Xigris 5 mg powder for infusion
Xigris 5 mg prašek za infundiranje
Xigris 5 mg powder for solution for infusion
Xigris 5 mg prašek za raztopino za infundiranje
Xigris 5 mg powder for solution for infusion drotrecogin alfa (activated)
Xigris 5 mg prašek za raztopino za infundiranje drotrekogin alfa (aktiviran)
Xigris drotrecogin alfa (activated)
drotrekogin alfa (aktiviran)
Xigris has been authorised under ‘Exceptional Circumstances’.
Zdravilo Xigris je bilo odobreno v „izjemnih okoliščinah“.
Xigris has been studied in three studies in severe sepsis: in the PROWESS study, Xigris was compared with placebo (dummy treatment) in 1,690 patients; in the ENHANCE study, over 2,000 patients received Xigris; in the ADDRESS study, Xigris was compared with placebo in almost 3,000 patients who were at a lower risk of death than in the first two studies.
Zdravilo Xigris so proučevali v treh študijah hude sepse: v študiji PROWESS so zdravilo Xigris pri 1 690 bolnikih primerjali s placebom (zdravilom brez zdravilne učinkovine); v študiji ENHANCE je zdravilo Xigris prejelo več kot 2 000 bolnikov; v študiji ADRESS so zdravilo Xigris primerjali s placebom pri skoraj 3 000 bolnikih, ki so bili manj življenjsko ogroženi kot v prvih dveh študijah.
Xigris is not approved for the treatment of patients with single organ dysfunction and should not be used in this particular subgroup of patients, especially if they had recent surgery (within 30 days).
Zdravilo Xigris ni odobreno za zdravljenje bolnikov z okvarjenim delovanjem enega organa in ga pri tej podskupini bolnikov ne smemo uporabljati, zlasti, če so imeli nedavno operacijski poseg (v zadnjih 30 dneh).