FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP acknowledged that identification and exclusion of patients at risk of CV disease is difficult, as obesity itself is a risk factor for CV disease.
Slovenian: CHMP priznava, da je težko opredeliti in izključiti bolnike, pri katerih je prisotno tveganje kardiovaskularne bolezni, saj je sama debelost dejavnik tveganja kardiovaskularne bolezni.
English: The CHMP adopted a List of Questions requesting the MAHs to discuss the results of SCOUT, focusing in particular on drop outs, adverse events, statistical data and the implications of the data on the benefit/risk balance and risk minimisation measures.
Slovenian: CHMP je sprejel seznam vprašanj, na katera so imetniki dovoljenja za promet z zdravilom morali odgovoriti ob upoštevanju rezultatov študije SCOUT; zlasti so vprašanja zadevala delež oseb, ki so prekinile sodelovanje v študiji, neželene učinke, statistične podatke in vpliv podatkov na razmerje med koristmi in tveganji ter ukrepe za zmanjšanje tveganja.
English: However, the MAHs were required to conduct a large cardiovascular outcome study designed to compare sibutramine to placebo under standard care for weight management in overweight or obese subjects aged 55 years or older, who were at risk of cardiovascular (CV) events on the basis of a history of documented disease or the presence of additional CV risk factors such as diabetes.
Slovenian: Vendar so bili imetniki dovoljenj za promet z zdravilom pozvani, naj izvedejo obsežno študijo kardiovaskularnega izida, namenjeno primerjavi sibutramina s placebom ob stalni skrbi za uravnavanje telesne mase pri osebah s prekomerno telesno maso ali debelostjo, starih 55 let ali več, pri katerih je prisotno tveganje kardiovaskularnih dogodkov na podlagi anamneze dokumentirane bolezni ali prisotnosti dodatnih dejavnikov tveganja kardiovaskularne bolezni, kot je sladkorna bolezen.
English: Following the assessment of the MAHs responses, the CHMP considered that the SCOUT results provide evidence of increased cardiovascular and cerebrovascular risks associated with the use of sibutramine in high risk patients.
Slovenian: Po oceni odgovorov imetnikov dovoljenja za promet z zdravilom je CHMP menil, da rezultati študije SCOUT dokazujejo povečano tveganje kardiovaskularne in cerebrovaskularne bolezni v povezavi z uporabo sibutramina pri bolnikih z visokim tveganjem.
English: Data stratified by CV risk group shows that the “CV + DM” (cardiovascular disease plus Type 2 diabetes) group carried the highest risk of POE, followed by the “CV Only” (cardiovascular disease) group and the “DM Only” (Type 2 diabetes) group.
Slovenian: Podatki glede na skupine tveganja kardiovaskularne bolezni kažejo, da je bilo v skupini „kardiovaskularna bolezen + sladkorna bolezen tipa 2“ prisotno največje tveganje dogodkov primarnega izida, sledili sta skupina „samo kardiovaskularna bolezen“ in skupina „samo sladkorna bolezen tipa 2“.
English: Teslova 26, 821 02, Bratislava Slovak Republic
Slovenian: Teslova 26, 821 02, Bratislava
English: Given its modest efficacy and the known risks of sibutramine, the statistically robust evidence of an increased risk of non-fatal MI and stroke in patients with CV disease or Type 2 diabetes with sibutramine treatment compared with placebo is therefore of considerable concern.
Slovenian: Zaradi skromne učinkovitosti in znanih tveganj sibutramina zbujajo statistično robustni dokazi povečanega tveganja miokardnega infarkta in srčne kapi brez smrtnega izida pri bolnikih s kardiovaskularno boleznijo ali sladkorno boleznijo tipa 2, zdravljenih s sibutraminom, v primerjavi s skupino s placebom resne zadržke.
English: Tietgens Boulevard 40 5220 Odense SØ Denmark
Slovenian: Tietgens Boulevard 40 5220 Odense SØ Danska
English: 10237 Prague 10 Dolni Mecholupy Czech Republic
Slovenian: 10237 Praga 10 Dolni Mecholupy Češka
English: SI-1000 Ljubljana Slovenia
Slovenian: SI-1000 Ljubljana Slovenija
English: SCOUT was powered as a superiority study with the aim of showing a decrease in the CV primary outcome event (POE, including, non-fatal myocardial infarction (MI), non-fatal stroke resuscitated cardiac arrest and cardiovascular death due to MI or stroke) rate in the sibutramine treated patients compared to placebo.
Slovenian: Študija SCOUT je imela vlogo študije superiornosti, katere cilj je bil dokazati zmanjšanje pogostosti dogodkov primarnega izida kardiovaskularne bolezni (vključno z miokardnim infarktom (MI) brez smrtnega izida, zastojem srca ob srčni kapi brez smrtnega izida in kardiovaskularno smrtjo zaradi miokardnega infarkta ali srčne kapi) pri bolnikih, zdravljenih s sibutraminom, v primerjavi s placebom.
English: 2710-089 Sintra Portugal
Slovenian: 2710-089 Sintra Portugalska
English: Abbott GmbH Perfektastraße 84A A-1230 Wien Austria
Slovenian: Abbott GmbH Perfektastraße 84A A-1230 Dunaj Avstrija
English: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
Slovenian: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Nemčija
English: In conclusion, the CHMP was of the opinion that the results of the SCOUT study are of concern.
Slovenian: CHMP je naposled menil, da rezultati študije SCOUT zbujajo zadržke.
English: Teva PharmaProdutos Farmacêuticos, Lda.
Slovenian: Produtos Farmacêuticos, Lda.
English: Abott GmbH Perfektastraße 84A A-1230 Wien Austria
Slovenian: Abott GmbH Perfektastraße 84A A-1230 Dunaj Avstrija
English: Luxembourg Abbott Laboratoires 2, rue du Bosquet
Slovenian: Luksemburg Abbott Laboratoires 2, rue du Bosquet
English: The SCOUT study was powered as a superiority study aiming to show a decrease in the POE rate in the sibutramine treated patients compared to placebo.
Slovenian: Študija SCOUT je imela vlogo študije superiornosti, katere cilj je bil dokazati zmanjšanje pogostosti dogodkov primarnega izida pri bolnikih, zdravljenih s sibutraminom, v primerjavi z bolniki, ki so prejemali placebo.
English: 1A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
Slovenian: 1A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Nemčija
English: The CHMP noted that the SCOUT data clearly demonstrates that patients with obesity and known CV disease taking sibutramine are exposed to an increased risk for CV events compared with placebo.
Slovenian: CHMP je opazil, da podatki iz študije SCOUT jasno kažejo, da so bili bolniki z debelostjo in znano kardiovaskularno boleznijo, ki so prejemali sibutramin, izpostavljeni večjemu tveganju kardiovaskularnih dogodkov kot bolniki, ki so prejemali placebo.
English: The CHMP considered that an increased CV risk may also apply to patients for whom sibutramine can be prescribed since overweight or obese patients are likely to be at risk for cardiovascular disease.
Slovenian: CHMP je menil, da so povečanemu tveganju kardiovaskularne bolezni lahko izpostavljeni tudi bolniki, katerim je mogoče predpisati sibutramin, saj so bolniki s prekomerno telesno maso ali debelostjo pogosto izpostavljeni tveganju kardiovaskularne bolezni.
English: C. F. Tietgens Boulevard 40 DK-5220 Odense SØ Denmark
Slovenian: C. F. Tietgens Boulevard 40 DK-5220 Odense SØ Danska
English: Although patients on sibutramine as well as patients on placebo experienced decreased CV event rates when losing weight compared to those who did not, CV events were increased with the use of sibutramine compared to placebo suggesting that the weight loss achieved with sibutramine was not sufficient to counter-balance its adverse CV effects.
Slovenian: Čeprav je bilo tako pri bolnikih, zdravljenih s sibutraminom, kot tudi pri bolnikih, ki so prejemali placebo, opaziti zmanjšanje pogostosti kardiovaskularnih dogodkov ob izgubi telesne mase v primerjavi z bolniki, pri katerih se telesna masa ni zmanjševala, se je pri uporabi sibutramina pogostost kardiovaskularnih dogodkov bolj povečala kot pri uporabi placeba, kar kaže, da izguba telesne mase po zaslugi sibutramina ni bila dovolj velika, da bi odtehtala njegove neželene kardiovaskularne učinke.
English: This was acknowledged, however the CHMP considered that the data shows that the risk of CV events for patients continued on sibutramine was higher than if continued on placebo.
Slovenian: CHMP je to upošteval, vendar je menil, da je iz podatkov razvidno, da je bilo tveganje kardiovaskularnih dogodkov pri bolnikih, ki so nadaljevali zdravljenje s sibutraminom, večje kot pri bolnikih, ki so nadaljevali s placebom.
English: Sibutramine treatment resulted in a higher incidence of POEs (specifically non-fatal myocardial infarction and stroke were the drivers) compared with placebo in patients with a history of a cardiovascular disease (these patients were acknowledged as Summary of Product Characteristics (SPC) non-conformers).
Slovenian: Pri zdravljenju s sibutraminom so opazili večjo pogostost dogodkov primarnega izida (zlasti miokardnega infarkta in srčne kapi brez smrtnega izida) kot pri placebu pri bolnikih z anamnezo kardiovaskularne bolezni (ti bolniki so veljali za nekonformne glede na povzetek glavnih značilnosti zdravila).
English: Teva Pharmaceuticals Europe B.V. European Headquarters Computerweg 10
Slovenian: European Headquarters Computerweg 10
English: Czech Republic TEVA Pharmaceuticals ČR,s.r.o.
Slovenian: TEVA Pharmaceuticals ČR,s.r.o.
English: Abbot Scandinavia AB Box 509
Slovenian: Abbott Scandinavia AB Box 509
English: Teva Pharma B.V. Computerweg 10 3542 Dr Utrecht Netherlands
Slovenian: Computerweg 10 3542 Dr Utrecht Nizozemska
English: 10 mg Film-coated tablet oral use
Slovenian: 10 mg filmsko obložena tableta
English: 15 mg Film-coated tablet oral use
Slovenian: 15 mg filmsko obložena tableta
English: Sibutramine should be used in conjunction with a reduced calorie diet and increased physical activity in - Patients with nutritional obesity and a body mass index (BMI) of 30 kg/m2 or higher.
Slovenian: Sibutramin je namenjen uporabi skupaj z nizkokalorično dieto in povečano fizično aktivnostjo pri - bolnikih s prehransko pogojeno debelostjo in indeksom telesne mase (ITM) 30 kg/m2 ali več, - bolnikih s prehransko pogojeno prekomerno telesno maso in ITM 27 kg/m2 ali več, če so prisotni drugi dejavniki tveganja, povezani z debelostjo, kot je sladkorna bolezen tipa 2 ali dislipidemija.
English: U kabelovny 130, 102 37 Prague 10
Slovenian: U kabelovny 130, 102 37 Praga 10
English: By the end of the Randomization Phase, patients on sibutramine achieved a further mean reduction in weight of 0.91 kg while the placebo group experienced a mean increase of 1.02 kg compared with baseline Randomization Phase measurements.
Slovenian: V fazi uvajanja (v kateri so vse osebe zdravili s sibutraminom) je v populaciji z namenom zdravljenja (ITT) začetna povprečna izguba telesne mase pri zdravljenju s sibutraminom znašala 2,6 kg. Do konca faze randomizacije so pri bolnikih, ki so prejemali sibutramin, opazili nadaljnje povprečno zmanjšanje telesne mase za 0,91 kg, medtem ko se je telesna masa v skupini s placebom v povprečju povečala za 1,02 kg v primerjavi z meritvami na začetku faze randomizacije.
English: SIBUTRAL 10 mg, gélule 10 mg capsule oral use
Slovenian: SIBUTRAL 10 mg, gélule 10 mg kapsula
English: United Kingdom Teva UK Limited Brampton Road
Slovenian: Teva UK Limited
English: Similarly, the proposed yearly PSUR reporting cycle was considered unlikely to promote SPC compliance regarding prescription.
Slovenian: Poleg tega je menil, da predlagano letno poročanje z rednimi posodobljenimi poročili o varnosti zdravila ni ustrezno za zagotovitev skladnosti povzetka glavnih značilnosti zdravila z vidika predpisovanja.
English: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Czech Republic
Slovenian: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Češka
English: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Czech Republic
Slovenian: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Češka
English: SIBUTRAL 15 mg, gélule 15 mg capsule oral use
Slovenian: SIBUTRAL 15 mg, gélule 15 mg kapsula
English: SE-169 29, Solna Sweden
Slovenian: SE-169 29, Solna Švedska
English: Sibutril 15 mg capsules, hard 15 mg Capsule, hard oral
Slovenian: Sibutril 15 mg capsules, hard 15 mg kapsula, trda peroralna
English: Sibutril 10 mg capsules, hard 10 mg Capsule, hard oral
Slovenian: Sibutril 10 mg capsules, hard 10 mg kapsula, trda peroralna
English: Zelium 10 mg Hartkapseln 10 mg Capsule, hard oral use
Slovenian: Zelium 10 mg Hartkapseln 10 mg kapsula, trda
English: Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Slovenian: Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Nemčija
English: U Kabelovny 130 Dolni Mecholupy 102 37 Praha 10 Czech Republic
Slovenian: U Kabelovny 130 Dolni Mecholupy 102 37 Praga 10 Češka
English: Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Slovenian: Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Nemčija
English: 16929 Solna Sweden
Slovenian: 16929 Solna Švedska
English: SE-169 29 Solna Sweden
Slovenian: SE-169 29 Solna Švedska
English: Zelium 15 mg Hartkapseln 15 mg Capsule, hard oral use
Slovenian: Zelium 15 mg Hartkapseln 15 mg kapsula, trda
English: LINDAXA 15 mg, capsule 15 mg Capsule, hard oral use
Slovenian: LINDAXA 15 mg, capsule 15 mg kapsula, trda
English: Sibutramin Sandoz 10 mg 10 mg Capsule, hard oral use
Slovenian: Sibutramin Sandoz 10 mg 10 mg kapsula, trda
English: 15 mg capsule oral use
Slovenian: 15 mg kapsula
English: LINDAXA 10 mg, capsule 10 mg Capsule, hard oral use
Slovenian: LINDAXA 10 mg, capsule 10 mg kapsula, trda
English: Sibutramin Sandoz 15 mg 15 mg Capsule, hard oral use
Slovenian: Sibutramin Sandoz 15 mg 15 mg kapsula, trda
English: 10 mg capsule oral use
Slovenian: 10 mg kapsula
English: 169 29 Solna Sweden
Slovenian: 169 29 Solna Švedska
English: Sibutramina Argam 10 mg Capsule, hard oral use
Slovenian: Sibutramina Argam 10 mg kapsula, trda
English: 1348 Ottignies/LLN Belgium
Slovenian: Abbott SA rue du Bosquet 2 1348 Ottignies/LLN Belgija
English: Sibutramina West Pharma 15 mg Capsule, hard oral use
Slovenian: Sibutramina West Pharma 15 mg kapsula, trda
English: Sibutramina West Pharma 10 mg Capsule, hard oral use
Slovenian: Sibutramina West Pharma 10 mg kapsula, trda
English: U Kabelovny 130 102 37 Praha 10 Czech Republic
Slovenian: U kabelovny 130 102 37 Praga 10 Češka
English: Reductil 15 mg - Hartkapseln 15 mg Capsule, hard oral use
Slovenian: Reductil 15 mg - Hartkapseln 15 mg kapsula, trda peoralna uporaba
English: Reductil 10 mg - Hartkapseln 10 mg Capsule, hard oral use
Slovenian: Reductil 10 mg - Hartkapseln 10 mg kapsula, trda peoralna uporaba
English: Sibutramina Argam 15 mg Capsule, hard oral use
Slovenian: Sibutramina Argam 15 mg kapsula, trda
English: SILUTON 15 mg, capsule 15 mg Capsule, hard oral use
Slovenian: SILUTON 15 mg, capsule 15 mg kapsula, trda
English: SILUTON 10 mg, capsule 10 mg Capsule, hard oral use
Slovenian: SILUTON 10 mg, capsule 10 mg kapsula, trda
English: Sitrane 10 mg hard capsules 10 mg Capsule, hard oral use
Slovenian: Sitrane 10 mg hard capsules 10 mg kapsula, trda
English: MINIMACIN 10 mg, capsule 10 mg Capsule, hard oral use
Slovenian: MINIMACIN 10 mg, capsule 10 mg kapsula, trda
English: MINIMACIN 15 mg, capsule 15 mg Capsule, hard oral use
Slovenian: MINIMACIN 15 mg, capsule 15 mg kapsula, trda
English: Sitrane 15 mg hard capsules 15 mg Capsule, hard oral use
Slovenian: Sitrane 15 mg hard capsules 15 mg kapsula, trda
English: Abbott Scandinavia AB P.O.
Slovenian: Abbott Scandinavia AB P.O. Box 509
English: SIBUTRAMIN SANDOZ 10 mg Capsule, hard oral use
Slovenian: SIBUTRAMIN SANDOZ 10 mg kapsula, trda
English: Reductil 10 mg trde kapsule 10 mg Capsule, hard oral use
Slovenian: Reductil 10 mg trde kapsule 10 mg kapsula, trda
English: SIBUTRAMIN SANDOZ 15 mg Capsule, hard oral use
Slovenian: SIBUTRAMIN SANDOZ 15 mg kapsula, trda
English: Reductil 15 mg trde kapsule 15 mg Capsule, hard oral use
Slovenian: Reductil 15 mg trde kapsule 15 mg kapsula, trda
English: Reductil 10 mg hard capsules 10 mg Capsule, hard oral use
Slovenian: Reductil 10 mg hard capsules 10 mg kapsula, trda
English: Reductil 15 mg hard capsules 15 mg Capsule, hard oral use
Slovenian: Reductil 15 mg hard capsules 15 mg kapsula, trda
English: Sibutramin Teva 15 mg Kapseln
Slovenian: Sibutramin Teva 15 mg Kapseln peoralna uporaba
English: REDUCTIL 10 mg, capsule 10 mg Capsule, hard oral use
Slovenian: REDUCTIL 10 mg, capsule 10 mg kapsula, trda
English: REDUCTIL 15 mg, capsule 15 mg Capsule, hard oral use
Slovenian: REDUCTIL 15 mg, capsule 15 mg kapsula, trda
English: Reduxade 10 mg Hartkapseln 10 mg Capsule, hard oral use
Slovenian: Reduxade 10 mg Hartkapseln 10 mg kapsula, trda
English: SIBUTRAMINA TEVA 15 mg Capsule, hard oral use
Slovenian: SIBUTRAMINA TEVA 15 mg kapsula, trda
English: Sibutramin Teva 10 mg Kapseln
Slovenian: Sibutramin Teva 10 mg Kapseln peoralna uporaba
English: Reduxade 15 mg Hartkapseln 15 mg Capsule, hard oral use
Slovenian: Reduxade 15 mg Hartkapseln 15 mg kapsula, trda
English: Reductil 10 mg Hartkapseln 10 mg Capsule, hard oral use
Slovenian: Reductil 10 mg Hartkapseln 10 mg Kapsula, trda
English: Reductil 15 mg Hartkapseln 15 mg Capsule, hard oral use
Slovenian: Reductil 15 mg Hartkapseln 15 mg Kapsula, trda
English: EU/1/06/334/001 3 vials EU/1/06/334/002 4 vials EU/1/06/334/003 10 vials EU/1/06/334/004 20 vials EU/1/06/334/005 1 vial
Slovenian: EU/1/06/334/001 3 viale EU/1/06/334/002 4 viale EU/1/06/334/003 10 vial EU/1/06/334/004 20 vial EU/1/06/334/005 1 viala
English: From a microbiological point of view, it should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo porabiti takoj.
English: Your doctor will give you Evoltra once every day for 5 days.
Slovenian: Zdravnik vam bo dajal zdravilo Evoltra enkrat na dan 5 dni zaporedoma.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Slovenian: Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okvirju izvesti naslednje ukrepe:
English: Estimates based on non-compartmental analysis (n = 14 / n = 14)
Slovenian: Ocena, ki temelji na nekompartmentalni analizi (n = 14/n = 14)
English: Adults (> 21 and < 65 years old)
Slovenian: Odrasli (stari > 21 in < 65 let)
English: The median age of treated patients (37 males, 24 females) was 12 years old.
Slovenian: Mediana starosti sodelujočih bolnikov (37 moških, 24 ženskih) je bila 12 let.
English: It is a clear, almost colourless solution that is prepared and diluted before it is used.
Slovenian: Je bistra, skoraj brezbarvna raztopina, ki jo je treba pred uporabo pripraviti in razredčiti.
English: 1 vial 3 vials 4 vials 10 vials 20 vials
Slovenian: 1 viala 3 viale 4 viale 10 vial 20 vial
English: Your doctor will tell you when you need to be given this medicine.
Slovenian: Zdravnik vam bo povedal, kdaj vam bodo dali zdravilo.
English: Each box contains 1, 3, 4, 10 or 20 vials.
Slovenian: Vsaka škatla vsebuje 1, 3, 4, 10 ali 20 vial.
English: Your doctor will carry out regular blood tests to check whether your body is working properly; - liver damage (liver failure).
Slovenian: Zdravnik bo opravljal redne krvne preiskave, da bo preveril, ali telo deluje normalno; okvara jeter (odpoved jeter).
English: Genzyme Limited 37 Hollands Road Haverhill Suffolk
Slovenian: Genzyme Ltd 37 Hollands Road Haverhill Suffolk
English: Therefore, Evoltra should not be used during pregnancy, especially not during the first trimester, unless clearly necessary (i.e. only if the potential benefit to the mother outweighs the risk to the foetus).
Slovenian: Zato se zdravilo Evoltra ne sme uporabljati med nosečnostjo, zlasti ne v prvem trimesečju, razen če je nujno potrebno (tj. samo, če koristi zdravljenja matere odtehtajo tveganje za plod).
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke
English: During treatment with Evoltra, your doctor will carry out regular blood tests and other tests to monitor your health.
Slovenian: Med zdravljenjem z zdravilom Evoltra bo zdravnik opravljal redne krvne in druge preiskave, s katerimi bo spremljal vaše zdravstveno stanje.
English: Most of the cardiac adverse events were reported in the first 2 cycles.
Slovenian: Večino neželenih dogodkov, povezanih s srčnimi boleznimi, so poročali med prvima 2 cikloma.
English: • DNA polymerase  inhibition resulting in termination of DNA chain elongation and/or DNA synthesis / repair.
Slovenian: • Inhibicija DNA polimeraze , zaradi katere pride do terminacije elongacije verige DNA in/ali sinteze/popravljanja DNA.
English: (If the use of a 0.2 micrometre syringe filter is not feasible, the concentrate should be pre-filtered with a 5 micrometre filter, diluted and then administered through a 0.22 micrometre in-line filter.)
Slovenian: (Če 0,2-mikrometrskega filtra v brizgi ni mogoče uporabiti, je treba koncentrat predhodno filtrirati s 5-mikrometrskim filtrom, ga razredčiti in nato dajati skozi 0,22-mikrometrski linijski filter.)
English: • An M2 bone marrow ( 5% and ≤ 25% blasts) and appearance of normal progenitor cells
Slovenian: • kostni mozeg M2 ( 5% in ≤ 25% blastov) in pojav normalnih progenitornih celic
English: Each box contains 1, 3, 4, 10 or 20 vials, but not all pack sizes may be marketed.
Slovenian: Vsaka škatla vsebuje 1, 3, 4, 10 ali 20 vial, vendar na trgu mogoče ni vseh navedenih pakiranj.
English: • The use of prophylactic steroids (e.g., 100 mg/m hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak.
Slovenian: • Uporaba profilaktičnih steroidov (npr. 100 mg/m2 hidrokortizona od 1. do 3. dne) lahko koristi pri preprečevanju znakov ali simptomov SIRS ali kapilarne krvavitve.
English: No studies on the effects of clofarabine on the ability to drive and use machines have been performed.
Slovenian: Študij o vplivu klofarabina na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: If you forget to use Evoltra
Slovenian: Če ste pozabili uporabiti zdravilo Evoltra
English: The 12 patients who achieved an overall remission (CR + CRp) had a median survival time of 66.6 weeks as of the data collection cut-off date.
Slovenian: Pri 12 bolnikih, pri katerih je prišlo do skupne remisije (PR + PRt), je bila mediana časa preživetja 66,6 tednov od datuma zbiranja podatkov.
English: Toxicology studies of clofarabine in mice, rats and dogs showed that rapidly proliferating tissues were the primary target organs of toxicity.
Slovenian: Toksikološke študije klofarabina na miših, podganah in psih so pokazale, da so bila hitro proliferajoča tkiva primarni ciljni organi za toksične učinke.
English: * = see below **All adverse reactions occurring at least twice (i.e., 2 or more reactions (1.7%)) are included in this table
Slovenian: * = glejte spodaj ** V tabeli zgoraj so vključeni vsi neželeni učinki, ki so se pojavili najmanj dvakrat (tj., 2 ali več neželenih učinkov (1,7 %))
English: What Evoltra is and what it is used for
Slovenian: Kaj je zdravilo Evoltra in za kaj ga uporabljamo
English: As a result, it is not expected to affect the metabolism of active substances which are known substrates for these enzymes.
Slovenian: Zato ni pričakovati, da bi vplival na presnovo zdravilnih učinkovin, za katere je znano, da so substrati teh encimov.
English: Evoltra must not be mixed with or concomitantly administered using the same intravenous line as other medicinal products (see section 6.2).
Slovenian: Zdravila Evoltra ne smete mešati ali ga istočasno dajati po isti intravenski liniji z drugimi zdravili (glejte poglavje 6.2).
English: Adverse reactions are listed by system organ class and frequency (very common ( 1/10); common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100; rare ( 1/10,000 to < 1/1,000) and very rare (< 1/10,000)) in the table below.
Slovenian: V spodnji tabeli so neželeni učinki navedeni po organskih sistemih in pogostnosti (zelo pogosti (1/10), pogosti (1/100 do <1/10), občasni (1/1.000 do <1/100), redki (1/10.000 do <1/1.000) in zelo redki (<1/10.000).
English: This is equivalent to 3.08 mmol (or 70.77 mg) of sodium.
Slovenian: To ustreza 3,08 mmol (ali 70,77 mg) natrija.