natgillin/translations-raw huggingface dataset:
19 sepsis treated with Xigris had a more rapid decline in interleukin-6 levels, a global marker of inflammation, consistent with a reduction in the inflammatory response.
Poleg tega so bolniki s hudo sepso, zdravljeni z zdravilom Xigris, kazali hitrejši padec ravni interlevkina- 6, splošnega pokazatelja vnetja, kar je v skladu z zmanjšanjem vnetnega odziva.
Exclusion criteria encompassed patients at high risk of bleeding (see sections 4.3 and 4.4), patients who were not expected to survive for 28 days due to a pre-existing, non-sepsis related medical condition, HIV positive patients whose most recent CD4 count was ≤ 50/ mm3, patients on chronic dialysis, and patients who had undergone bone marrow, lung, liver, pancreas or small bowel transplantation, and patients with acute clinical pancreatitis without a proven source of infection.
Merila za izključitev so obsegala bolnike z velikim tveganjem za krvavitev (glejte poglavji 4. 3 in 4. 4), bolnike, za katere niso pričakovali, da bodo preživeli 28 dni zaradi predhodnih zdravstvenih stanj, ki niso bila povezana s sepso, HIV pozitivne bolnike, katerih zadnja koncentracija CD4 je bila ≤ 50/ mm3, bolnike zdravljene s kronično dializo, bolnike, ki so imeli
20 Further Clinical Experience In a Phase 3b international, single-arm, open-label clinical trial (ENHANCE), 2378 adult patients with severe sepsis received drotrecogin alfa (activated).
Nadaljnje klinične izkušnje V mednarodnem kliničnem preskušanju (ENHANCE) faze 3b z enim krakom in znanim zdravilom je 2378 odraslih bolnikov s hudo sepso prejemalo drotrekogin alfa (aktiviran).
A total of 2640 adult patients with severe sepsis who were at low risk of death (e. g. patients with APACHE II < 25 or with only one sepsis-induced organ failure) were enrolled in a randomised, double- blind, placebo-controlled trial (ADDRESS).
V randomiziranemu dvojno slepemu s placebom kontroliranemu preskušanju (ADDRESS) je sodelovalo skupno 2640 odraslih bolnikov s hudo sepso z nizkim tveganjem za smrt (denimo, bolniki s številom točk po lestvici APACHE II < 25 ali s sepso povzročenim okvarjenim delovanjem samo enega organa).
25) and were more likely to have two organ dysfunctions (76% vs.
V primerjavi z bolniki z okvarjenim delovanjem večih organov v preskušanju PROWESS je bilo delovanje organov pri bolnikih v preskušanju ADDRESS pred prejemanjem preiskovanega zdravila okvarjeno dlje časa (mediana 25 ur v primerjavi z 18 urami), bolniki v preskušanju ADDRESS so 21 imeli nižje število točk po lestvici APACHE II (mediana 20 v primerjavi s 25), zanje je bilo tudi bolj verjetno, da imajo okvarjeno delovanje dveh organov (76% v primerjavi s 43%).
21 In patients with severe sepsis, the plasma clearance of drotrecogin alfa (activated) was significantly decreased by renal impairment and hepatic dysfunction, but the magnitude of the differences in clearance (< 30%) does not warrant any dosage adjustment.
Pri bolnikih s hudo sepso je bil plazemski očistek drotrekogina alfa (aktiviranega) zaradi okvarjenega delovanja ledvic in jeter značilno znižan, vendar velikost razlik očistka (< 30%) ne upravičuje prilagoditve odmerka.
Carcinogenicity studies and animal reproduction studies have not been conducted with Xigris.
22 Z zdravilom Xigris niso opravljali študij kancerogenosti in študij razmnoževanja pri živalih.
Sucrose, Sodium chloride Sodium citrate Citric acid Hydrochloric acid Sodium hydroxide
saharoza natrijev klorid natrijev citrat citronska kislina klorovodikova kislina natrijev hidroksid
Prior to administration, 5 mg vials of Xigris must be reconstituted with 2.5 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ ml drotrecogin alfa (activated).
Pred dajanjem morate 5 mg vialo zdravila Xigris pripraviti (rekonstituirati) z 2, 5 ml vode za injekcije, kar da raztopino s koncentracijo približno 2 mg/ ml drotrekogina alfa (aktiviranega).
Slowly withdraw the appropriate amount of reconstituted drotrecogin alfa (activated) solution from the vial.
Počasi potegnite ustrezno količino pripravljene (rekonstituirane) raztopine drotrekogina alfa
24 ANNEX II
24 Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE( UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
101 International Drive Portsmouth New Hampshire 03801-2815 USA
101 International Drive Portsmouth New Hampshire 03801- 2815 ZDA
KG Teichweg 3 D-35396 Giessen Germany
KG Teichweg 3 D- 35396 Giessen Nemčija
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version dated 18 April 2006 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici z dne, 18. aprila 2006, načrta za obvladovanje tveganja (RMP), predstavljenem v Modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP s katerimi soglaša CHMP.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljen RMP predložiti: • ko so znane nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja • v 60 dneh, potem ko je dosežen pomemben mejnik (pri farmakovigilanci ali zmanjševanju tveganja) • na zahtevo EMEA- e
26 The Marketing Authorisation Holder will continue to submit yearly PSURs.
27 Imetnik dovoljenja za promet bo nadalje predajal letne PSUR- je.
Clinical aspects 1. “ Further to uncertain conclusions of the XPRESS study investigating the possible interaction between Xigris and heparin, additional clarifications on the benefit/ risk balance of Xigris are required.
Klinični vidiki 1. “ Poleg nejasnih zaključkov študije XPRESS, ki raziskuje možne interakcije med zdravilom Xigris in heparinom, so potrebna dodatna pojasnila glede razmerja med koristmi in tveganji za zdravilo Xigris.
Therefore the MAH has committed to performing a placebo-controlled study in patients (who were either on low-dose prophylactic heparin or not receiving any thrombosis prophylaxis) with severe sepsis and documented organ failure (e. g.
Za zagotovitev profila koristi/ tveganja za zdravilo Xigris, se je imetnik dovoljenja za promet zavezal k izvedbi s placebom kontrolirane študije pri bolnikih (ki so bodisi prejemali nizke odmerke profilaktičnega heparina ali niso prejemali nobene trombozne profilakse) s hudo sepso in dokazano odpovedjo organov (npr.
MOD or vasopressor dependent septic shock) when treated within a strictly defined time window, to assert the benefit/ risk profile of Xigris .”
MOD ali vazopresorsko odvisen septični šok) pri zdravljenju v strogo določenem časovnem obdobju. ”
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
OZNAČEVANJE
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL TEXT
32 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH BESEDILO NA VIALI
Xigris 20 mg powder for infusion For intravenous infusion after reconstitution and dilution
Xigris 20 mg prašek za infundiranje
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
33 PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ZUNANJI ŠKATLI
34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL TEXT
35 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH BESEDILO NA VIALI
Xigris 5 mg powder for infusion For intravenous infusion after reconstitution and dilution
Xigris 5 mg prašek za infundiranje
What Xigris is and what it is used for 2.
Kaj je zdravilo Xigris in za kaj ga uporabljamo 2.
Before you are given Xigris 3.
Kaj morate vedeti, preden boste prejeli zdravilo Xigris 3.
How Xigris is used 4.
Kako uporabljati zdravilo Xigris 4.
How to store Xigris 6.
Shranjevanje zdravila Xigris 6.
BEFORE YOU ARE GIVEN XIGRIS
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO XIGRIS
You should not be given Xigris:
Zdravila Xigris ne smete prejeti:
- if you are allergic (hypersensitive) to drotrecogin alfa (activated) or any of the other ingredients
- če ste alergični na (preobčutljivi za) drotrekogin alfa (aktiviran) ali katerokoli sestavino zdravila
of Xigris, or bovine (cattle-derived) thrombin (protein)
Xigris ali goveji trombin (beljakovino)
- if you have internal bleeding
- če imate notranjo krvavitev
- if you have a brain tumour, or pressure on the brain
- če imate možganski tumor ali tvorbo, ki pritiska na možgane
- if you are being given heparin at the same time (≥ 15 International Units/ kg/ hr)
- če sočasno prejemate heparin (≥ 15 Mednarodnih enot/ kg/ h)
- if you have a bleeding tendency which is not related to sepsis
- če kažete nagnjenost h krvavitvam, ki niso povezane s sepso
- if you have a long-standing, severe problem with your liver
- če imate dolgotrajne hude težave z jetri
- if your platelet (a type of cell in your blood) count is low, even if this has been increased by a
- če je vaše število trombocitov (vrste celic v vaši krvi) nizko, tudi če je bilo povišano s
transfusion
transfuzijo
- if you are at high risk of bleeding (for example):
- če je pri vas povečano tveganje za krvavitev (na primer):
you have had surgery within the last twelve hours before you receive Xigris, or you are bleeding from a previous surgery, or you might have surgery while you receive Xigris
če so vam v zadnjih dvanajstih urah pred prejemanjem zdravila Xigris opravili operacijski poseg, če krvavite od predhodnega operacijskega posega ali bi lahko med prejemanjem zdravila Xigris potrebovali operacijo
you have been in hospital with a severe injury to your head, or you have had surgery on your brain or spine, or you have had a bleed in your brain (haemorrhagic stroke) within the past three months, or you have abnormal blood vessels in your brain, or a mass in your head; you have an epidural catheter (a tube in your spine)
če ste bili v zadnjih treh mesecih v bolnišnici zaradi hude poškodbe glave, so vam operirali možgane ali hrbtenico, ste v zadnjih treh mesecih doživeli krvavitev v možgane
37
38 (hemoragično kap), če imate nenormalne krvne žile v možganih ali tvorbo v glavi; če imate epiduralni kateter (cevko v hrbtenici)
you have been born with bleeding tendencies you have bled from your bowels within the last six weeks, unless treated adequately you have had a major accident and are at increased risk of bleeding
če ste od rojstva nagnjeni h krvavitvam če ste v zadnjih šestih tednih krvaveli iz prebavil, razen če so bile krvavitve uspešno pozdravljene
- if you are taking other medicines which affect how your blood clots (for example medicines that
- če jemljete druga zdravila, ki vplivajo na strjevanje krvi (na primer zdravila, ki raztapljajo krvne
dissolve blood clots, thin the blood, or medicines that inhibit platelets such as aspirin)
strdke, redčijo kri ali zdravila, ki zavirajo trombocite, kot je aspirin)
- if within the last three months, you have had a stroke caused by a blood clot
- če ste v zadnjih treh mesecih doživeli kap, ki jo je povzročil krvni strdek
- if you have a known problem with bleeding
- če ste že imeli težave s krvavitvijo
Xigris is not recommended in children below the age of 18 and therefore it should not be used in children.
Zdravilo Xigris ni priporočeno pri otrocih mlajših od 18 let in ga zato pri otrocih ne smemo uporabljati.
Pregnancy and breast-feeding It is not known whether drotrecogin alfa (activated) causes damage to an unborn child or affects your ability to have babies.
Nosečnost in dojenje Ni znano, ali drotrekogin alfa (aktiviran) škodi nerojenemu otroku ali vpliva na vašo zmožnost imeti otroke.
The recommended dose of Xigris is 24 micrograms (µg) per kilogram (kg) of body weight each hour for 96 hours.
Priporočeni odmerek zdravila Xigris je 24 mikrogramov (µg) na kilogram (kg) telesne teže vsako uro 96 ur.
Serious bleeding during the infusion period occurred in 1% (1 in 100) of patient with severe sepsis and in 2.4% (roughly 1 in 40) of patients treated with Xigris, with most bleeding in both groups occurring in the stomach and bowel.
Resne krvavtitve med infuzijo so se pojavljale pri 1% (1 od 100) bolnikov s hudo sepso in 2, 4% (približno 1 od 40) bolnikov, zdravljenih z zdravilom Xigris, pri tem je bila večina krvavitev v obeh skupinah v želodec in črevo.
Bleeding into the brain was uncommon, occurring in 0.2% (1 in 500) of patients treated with Xigris.
Krvavitve v možgane so bile redke in so se pojavljale pri 0, 2% (1 od 500) bolnikov, zdravljenih z zdravilom Xigris.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
39 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Xigris contains
Kaj vsebuje zdravilo Xigris
- The active substance is 20 mg of drotrecogin alfa (activated) in each vial.
- Zdravilna učinkovina je 20 mg drotrekogina alfa (aktiviranega) v vsaki viali.
(activated) is a version of a natural protein in the blood called Activated Protein C and it is produced by recombinant technology.
(aktiviran) je različica naravne beljakovine v krvi, imenovane aktivirani protein C, ki jo izdelujejo z rekombinantno tehnologijo.
and sodium hydroxide.
kislina in natrijev hidroksid.
Eli Lilly Nederland B. V., Grootslag 1-5, 3991 RA, Houten, The Netherlands Manufacturer:
Eli Lilly Nederland B. V., Grootslag 1- 5, 3991 RA, Houten, Nizozemska Izdelovalec:
KG, Teichweg 3, D- 35396 Giessen, Germany.
KG, Teichweg 3, D- 35396 Giessen, Nemčija
Tél/ Tel: + 32-(0)2 548 84 84 България ТП "Ели Лили Недерланд "Б .В. - България тел. + 359 2 491 41 40 Č eská republika ELI LILLY Č R, s. r. o.
Tél/ Tel: + 32 - (0) 2 548 84 84 България ТП "Ели Лили Недерланд" Б. В. - България тел. + 359 2 491 41 40
Tel.: +48 (0) 22 440 33 00
Tel.: +48 (0) 22 440 33 00 Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351- 21- 4126600 România
Tel: +34- 91 749 76 98 France Lilly France SAS Tél: +33-(0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 Ísland Eli Lilly Danmark A/ S, Útibú á Íslandi Sími: + 354 520 34 00 Italia Eli Lilly Italia S. p. A.
Lilly France SAS Tél: +33 - (0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353 - (0) 1 661 4377 Ísland Eli Lilly Danmark A/ S, Útibú á Íslandi Sími: + 354 520 34 00 Italia Eli Lilly Italia S. p. A.
Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600 România Eli Lilly România S. R. L.
Eli Lilly România S. R. L.
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40 The following information is intended for medical or healthcare professionals only:
41 Naslednje informacije so namenjene samo zdravstvenemu osebju:
Prior to administration, 20 mg vials of Xigris must be reconstituted with 10 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ ml drotrecogin alfa (activated).
Pred dajanjem je treba 20 mg viale zdravila Xigris pripraviti z 10 ml vode za injekcije, kar da raztopino s koncentracijo približno 2 mg/ ml drotrekogina alfa (aktiviranega).
The solution of reconstituted Xigris must be further diluted with sterile 0.9% Sodium Chloride Injection.
Raztopino pripravljenega zdravila Xigris je treba nadalje razredčiti s sterilno 0, 9% raztopino natrijevega klorida.
The solution of reconstituted Xigris should be diluted into an infusion bag containing sterile 0.9% Sodium Chloride Injection to a final concentration of between 100 µg/ ml and 200 µg/ ml.
Raztopino pripravljenega zdravila Xigris moramo razredčiti s sterilno 0, 9% raztopino natrijevega klorida v infuzijski vrečki do končne koncentracije med 100 µg/ ml in 200 µg/ ml.
When administering drotrecogin alfa (activated) at low flow rates (less than approximately 5 ml/ hr), the infusion set must be primed for approximately 15 minutes at a flow rate of approximately 5 ml/ hr.
Pri dajanju drotrekogina alfa (aktiviranega) pri nizkih hitrostih pretoka (manj kot približno 5 ml/ h) je treba infuzijski sistem pripravljati približno 15 minut s hitrostjo pretoka približno 5 ml/ h.
The ONLY other solutions that can be administered through the same line are 0.9% Sodium Chloride Injection, Lactated Ringer’ s Injection, Dextrose or Dextrose and Saline mixtures.
EDINE raztopine, ki se jih sme dajati po istem katetru, so 0, 9% raztopina natrijevega klorida, raztopina Ringerjevega laktata, raztopina dekstroze ali raztopina dekstroze in fiziološke raztopine.
41 The use of other types of infusion sets could have a negative impact on the amount and potency of drotrecogin alfa (activated) administered.
Uporaba drugih vrst kompletov za infuzije bi lahko negativno vplivala na količino in jakost danega drotrekogina alfa (aktiviranega).
INFORMATION FOR THE USER
43 NAVODILO ZA UPORABO
You should not be given:
Zdravila Xigris ne smete prejeti:
you have been in hospital with a severe injury to your head, or you have had surgery on your brain or spine, or you have had a bleed in your brain (haemorrhagic stroke) within the past three months, or you have abnormal blood vessels in your brain, or a mass in your head; you have an epidural catheter (a tube in your spine)
če ste bili v zadnjih treh mesecih v bolnišnici zaradi hude poškodbe glave, so vam operirali možgane ali hrbtenico, ste v zadnjih treh mesecih doživeli krvavitev v možgane (hemoragično kap), če imate nenormalne krvne žile v možganih ali tvorbo v glavi; če imate epiduralni kateter (cevko v hrbtenici) 44
you have been born with bleeding tendencies you have bled from your bowels within the last six weeks, unless treated adequately you have had a major accident and are at increased risk of bleeding
če ste imeli hudo nezgodo in imate povečano tveganje za krvavitev
44 5.
45 5.
- The active substance is 5 mg of drotrecogin alfa (activated) in each vial.
- Zdravilna učinkovina je 5 mg drotrekogina alfa (aktiviranega) v vsaki viali.
After reconstitution with 2.5 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Po pripravi z 2, 5 ml vode za injekcije vsak ml vsebuje 2 mg drotrekogina alfa (aktiviranega).
Tel.: +48 (0) 22 440 33 00
Tel.: +48 (0) 22 440 33 00 Portugal
45 España Lilly S. A.
Tel: +34 - 91 749 76 98 France
46 The following information is intended for medical or healthcare professionals only:
47 Naslednje informacije so namenjene samo zdravstvenemu osebju:
Prior to administration, 5 mg vials of Xigris must be reconstituted with 2.5 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ ml drotrecogin alfa (activated).
Pred dajanjem je treba 5 mg viale zdravila Xigris pripraviti z 2, 5 ml vode za injekcije, kar da raztopino s koncentracijo približno 2 mg/ ml drotrekogina alfa (aktiviranega).
47 The use of other types of infusion sets could have a negative impact on the amount and potency of drotrecogin alfa (activated) administered.
Uporaba drugih vrst kompletov za infuzije bi lahko negativno vplivala na količino in jakost danega drotrekogina alfa (aktiviranega).
Xiliarx is a medicine containing the active substance vildagliptin.
Xiliarx je zdravilo, ki vsebuje zdravilno učinkovino vildagliptin.
The company that makes Galvus has agreed that its scientific data can be used for Xiliarx.
Družba, ki proizvaja zdravilo Galvus, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Xiliarx.
Xiliarx is used to treat type 2 diabetes mellitus (non-insulin-dependent diabetes).
Zdravilo Xiliarx se uporablja za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisna sladkorna bolezen).
Xiliarx can be used with metformin, a thiazolidinedione or a sulphonylurea, but it is only used in combination with a sulphonylurea in patients who cannot take metformin.
Zdravilo Xiliarx se lahko uporablja z metforminom, tiazolidindionom ali sulfonilsečnino, vendar se v kombinaciji s sulfonilsečnino uporablja samo pri bolnikih, ki ne morejo jemati metformina.
In adults, the recommended dose of Xiliarx is:  one tablet in the morning and another in the evening when used with metformin or a thiazolidinedione;  one tablet in the morning when taken with a sulphonylurea.
Priporočeni odmerek zdravila Xiliarx za odrasle je:  ena tableta zjutraj in druga zvečer, če zdravilo uporabljate skupaj z metforminom ali tiazolidindionom,  ena tableta zjutraj, če zdravilo jemljete skupaj s sulfonilsečnino.
Xiliarx can be taken with or without food.
Bolnik lahko zdravilo Xiliarx vzame s hrano ali brez nje.
Xiliarx is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease.
Jemanje zdravila Xiliarx ni priporočljivo pri bolnikih, ki imajo zmerne do hude težave z ledvicami, vključno z bolniki, ki se zdravijo s hemodializo (tehniko čiščenja krvi), in s končno ledvično odpovedjo.
Xiliarx is not recommended for patients with liver problems.
Jemanje zdravila Xiliarx prav tako ni priporočljivo pri bolnikih z jetrnimi obolenji.
The active substance in Xiliarx, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Zdravilna učinkovina zdravila Xiliarx, vildagliptin, je zaviralec dipeptidil peptidaze 4 (DPP- 4).
The effects of Xiliarx were first tested in experimental models before being studied in humans.
Učinki zdravila Xiliarx so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Xiliarx has also been studied in seven main studies involving a total of over 4,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Zdravilo Xiliarx so raziskovali tudi v sedmih glavnih študijah, ki so skupaj vključevale več kot 4 000 bolnikov s sladkorno boleznijo tipa 2 in nezadostno nadzorovanimi ravnmi krvne glukoze.
Three of these studies looked at the effects of Xiliarx taken alone in a total of 2,198 patients who had not taken diabetes treatment before, comparing it to placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).
V treh od teh študij so opazovali učinke zdravila Xiliarx, uporabljenega samostojno pri skupno 2 198 bolnikih, ki pred tem niso jemali zdravil proti sladkorni bolezni, v primerjavi s placebom (zdravilom brez zdravilne učinkovine), metforminom ali rosiglitazonom (tiazolidindion).
The other four studies compared the effects of Xiliarx, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
V preostalih štirih študijah so primerjali učinke zdravila Xiliarx v odmerku 50 ali 100 mg na dan v 24 tednih z učinki placeba, kadar se zdravilo uporablja kot dodatek obstoječemu zdravljenju z metforminom (544 bolnikov), pioglitazonom (tiazolidindionom, 463 bolnikov), glimepiridinom (sulfonilsečnino, 515 bolnikov) ali insulinom (296 bolnikov).
Xiliarx reduced levels of HbA1c in all studies.
Zdravilo Xiliarx je zmanjšalo vrednosti HbA1c v vseh študijah.