natgillin/translations-raw huggingface dataset:
Sibutramine treatment of all patients during the Lead-in Phase may have contributed to the smaller difference in weight loss between sibutramine and placebo-treated patients observed in the SCOUT trial compared to previous studies. 
Zdravljenje vseh bolnikov s sibutraminom v fazi uvajanja je morda prispevalo k manjši razliki v izgubi telesne mase med bolniki, zdravljenimi s sibutraminom oz. placebom, v preskušanju SCOUT kot v predhodnih študijah.
Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144 8226 JX, Lelystad Netherlands 
Ketelmeerstraat 142-144 8226 JX, Lelystad Nizozemska
In addition, an increase in duration of use tended to increase the risk of non-fatal POE in this subgroup and the point estimate for non-fatal POE tended towards harm at the three year time point. 
Poleg tega je bil namen povečanja trajanja uporabe povečanje tveganja dogodkov primarnega izida brez smrtnega izida v tej podskupini, namen točkovne ocene dogodkov primarnega izida brez smrtnega izida pa je bil določiti škodo na časovni točki treh let.
The MAHs also emphasised the benefit from weight loss induced by sibutramine during the Lead-in period and suggested that this would bias the placebo group results. 
Imetniki dovoljenja za promet z zdravilom so tudi poudarili koristi izgube telesne mase po zaslugi sibutramina v obdobju uvajanja in menili, da bi to izkrivilo rezultate v skupini s placebom.
GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS 
PODLAGA ZA ZAČASNI UMIK DOVOLJENJ ZA PROMET Z ZDRAVILOM
On the other hand, comparing sibutramine responders to placebo responders (a comparison that ignores the finding that more patients achieved 5% weight loss on sibutramine compared to placebo) reveals a number needed to be exposed to sibutramine of 347 for one extra CV event to occur. 
Po drugi strani primerjava odzivnih bolnikov, ki so prejemali sibutramin oz. placebo (primerjava, ki ne upošteva izsledka, da je več bolnikov doseglo 5 % izgubo telesne mase pri zdravljenju s sibutraminom kot pri zdravljenju s placebom), kaže, da bi moralo biti 347 bolnikov več izpostavljenih sibutraminu, da bi prišlo do enega dodatnega kardiovaskularnega dogodka.
Radlická 3185/Ic 
Radlická 3185/Ic 150 00 Praga 5
A revision of the packaging to limit availability to a 1-month supply was not considered to reduce the increased cardiovascular risk associated with sibutramine and restriction to a one month prescription may not be appropriate for a primary care prescribed product for an increasingly prevalent condition. 
Omejitev pakiranja na količino za 1 mesec ne bi bila primerna za zmanjšanje povečanega tveganja kardiovaskularne bolezni, povezane s sibutraminom, poleg tega omejitev recepta na enomesečno jemanje zdravila ne bi bila ustrezna za primere, v katerih se zdravilo predpisuje v primarni oskrbi za močno prevladujoče stanje.
However, although there was no evidence of increased risk of POE or mortality within the DM Only group, the evidence of benefit was considered to be weak. 
Čeprav ni bilo dokazov za povečano tveganje dogodkov primarnega izida ali smrtnost pri skupini „samo sladkorna bolezen tipa 2“, so koristi slabo dokazane.
Although most of the patients included in the SCOUT study would not normally be prescribed sibutramine, as this drug is contra-indicated in patients with known CV disease, an increased CV risk is also relevant to clinical use of sibutramine because overweight or obese patients are likely to be at risk of CV disease. 
Čeprav večini bolnikov, ki so bili vključeni v študijo SCOUT, sibutramin v običajnih okoliščinah ne bi bil predpisan, saj je to zdravilo kontraindicirano pri bolnikih z znano kardiovaskularno boleznijo, je povečano tveganje kardiovaskularne bolezni tudi pomembno za klinično uporabo sibutramina, saj so bolniki s prekomerno telesno maso ali debelostjo pogosto izpostavljeni tveganju kardiovaskularne bolezni.
Sandoz d.d., Verovskova 57 SI - 1000 Ljubljana Slovenia 
Sandoz d.d., Verovškova 57 SI - 1000 Ljubljana Slovenija
For the suspension to be lifted the Marketing Authorisation Holders would need to provide convincing data to identify a patient population in which sustained and clinically-important efficacy of sibutraminecontaining products can be demonstrated, and in which the benefit clearly outweighs its risks (see Annex III) 
Za preklic začasnega umika bodo morali imetniki dovoljenja za promet z zdravilom predložiti prepričljive podatke za opredelitev populacije bolnikov, pri kateri je mogoče dokazati trajno in klinično pomembno učinkovitost zdravil, ki vsebujejo sibutramin, in pri kateri koristi jasno odtehtajo tveganja (glejte Dodatek III).
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. 
CHMP priznava, da je težko opredeliti in izključiti bolnike, pri katerih je prisotno tveganje kardiovaskularne bolezni, saj je sama debelost dejavnik tveganja kardiovaskularne bolezni.
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. 
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.
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. 
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.
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. 
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.
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. 
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“.
Teslova 26, 821 02, Bratislava Slovak Republic 
Teslova 26, 821 02, Bratislava
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. 
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.
Tietgens Boulevard 40 5220 Odense SØ Denmark 
Tietgens Boulevard 40 5220 Odense SØ Danska
10237 Prague 10 Dolni Mecholupy Czech Republic 
10237 Praga 10 Dolni Mecholupy Češka
SI-1000 Ljubljana Slovenia 
SI-1000 Ljubljana Slovenija
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. 
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.
2710-089 Sintra Portugal 
2710-089 Sintra Portugalska
Abbott GmbH Perfektastraße 84A A-1230 Wien Austria 
Abbott GmbH Perfektastraße 84A A-1230 Dunaj Avstrija
1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany 
1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Nemčija
In conclusion, the CHMP was of the opinion that the results of the SCOUT study are of concern. 
CHMP je naposled menil, da rezultati študije SCOUT zbujajo zadržke.
Abott GmbH Perfektastraße 84A A-1230 Wien Austria 
Abott GmbH Perfektastraße 84A A-1230 Dunaj Avstrija
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. 
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.
1A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany 
1A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Nemčija
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. 
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.
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. 
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.
C. F. Tietgens Boulevard 40 DK-5220 Odense SØ Denmark 
C. F. Tietgens Boulevard 40 DK-5220 Odense SØ Danska
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. 
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.
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. 
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.
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). 
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).
Teva Pharma B.V. Computerweg 10 3542 Dr Utrecht Netherlands 
Computerweg 10 3542 Dr Utrecht Nizozemska
10 mg Film-coated tablet oral use 
10 mg filmsko obložena tableta
15 mg Film-coated tablet oral use 
15 mg filmsko obložena tableta
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. 
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.
U kabelovny 130, 102 37 Prague 10 
U kabelovny 130, 102 37 Praga 10
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. 
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.
SIBUTRAL 10 mg, gélule 10 mg capsule oral use 
SIBUTRAL 10 mg, gélule 10 mg kapsula
Similarly, the proposed yearly PSUR reporting cycle was considered unlikely to promote SPC compliance regarding prescription. 
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.
U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Czech Republic 
U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Češka
U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Czech Republic 
U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Češka
SIBUTRAL 15 mg, gélule 15 mg capsule oral use 
SIBUTRAL 15 mg, gélule 15 mg kapsula
SE-169 29, Solna Sweden 
SE-169 29, Solna Švedska
Sibutril 15 mg capsules, hard 15 mg Capsule, hard oral 
Sibutril 15 mg capsules, hard 15 mg kapsula, trda peroralna
Sibutril 10 mg capsules, hard 10 mg Capsule, hard oral 
Sibutril 10 mg capsules, hard 10 mg kapsula, trda peroralna
Zelium 10 mg Hartkapseln 10 mg Capsule, hard oral use 
Zelium 10 mg Hartkapseln 10 mg kapsula, trda
Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Germany 
Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Nemčija
U Kabelovny 130 Dolni Mecholupy 102 37 Praha 10 Czech Republic 
U Kabelovny 130 Dolni Mecholupy 102 37 Praga 10 Češka
Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Germany 
Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Nemčija
16929 Solna Sweden 
16929 Solna Švedska
SE-169 29 Solna Sweden 
SE-169 29 Solna Švedska
Zelium 15 mg Hartkapseln 15 mg Capsule, hard oral use 
Zelium 15 mg Hartkapseln 15 mg kapsula, trda
LINDAXA 15 mg, capsule 15 mg Capsule, hard oral use 
LINDAXA 15 mg, capsule 15 mg kapsula, trda
Sibutramin Sandoz 10 mg 10 mg Capsule, hard oral use 
Sibutramin Sandoz 10 mg 10 mg kapsula, trda
15 mg capsule oral use 
15 mg kapsula
LINDAXA 10 mg, capsule 10 mg Capsule, hard oral use 
LINDAXA 10 mg, capsule 10 mg kapsula, trda
Sibutramin Sandoz 15 mg 15 mg Capsule, hard oral use 
Sibutramin Sandoz 15 mg 15 mg kapsula, trda
10 mg capsule oral use 
10 mg kapsula
169 29 Solna Sweden 
169 29 Solna Švedska
Sibutramina Argam 10 mg Capsule, hard oral use 
Sibutramina Argam 10 mg kapsula, trda
1348 Ottignies/LLN Belgium 
Abbott SA rue du Bosquet 2 1348 Ottignies/LLN Belgija
Sibutramina West Pharma 15 mg Capsule, hard oral use 
Sibutramina West Pharma 15 mg kapsula, trda
Sibutramina West Pharma 10 mg Capsule, hard oral use 
Sibutramina West Pharma 10 mg kapsula, trda
U Kabelovny 130 102 37 Praha 10 Czech Republic 
U kabelovny 130 102 37 Praga 10 Češka
Reductil 15 mg - Hartkapseln 15 mg Capsule, hard oral use 
Reductil 15 mg - Hartkapseln 15 mg kapsula, trda peoralna uporaba
Reductil 10 mg - Hartkapseln 10 mg Capsule, hard oral use 
Reductil 10 mg - Hartkapseln 10 mg kapsula, trda peoralna uporaba
Sibutramina Argam 15 mg Capsule, hard oral use 
Sibutramina Argam 15 mg kapsula, trda
SILUTON 15 mg, capsule 15 mg Capsule, hard oral use 
SILUTON 15 mg, capsule 15 mg kapsula, trda
SILUTON 10 mg, capsule 10 mg Capsule, hard oral use 
SILUTON 10 mg, capsule 10 mg kapsula, trda
Sitrane 10 mg hard capsules 10 mg Capsule, hard oral use 
Sitrane 10 mg hard capsules 10 mg kapsula, trda
MINIMACIN 10 mg, capsule 10 mg Capsule, hard oral use 
MINIMACIN 10 mg, capsule 10 mg kapsula, trda
MINIMACIN 15 mg, capsule 15 mg Capsule, hard oral use 
MINIMACIN 15 mg, capsule 15 mg kapsula, trda
Sitrane 15 mg hard capsules 15 mg Capsule, hard oral use 
Sitrane 15 mg hard capsules 15 mg kapsula, trda
SIBUTRAMIN SANDOZ 10 mg Capsule, hard oral use 
SIBUTRAMIN SANDOZ 10 mg kapsula, trda
Reductil 10 mg trde kapsule 10 mg Capsule, hard oral use 
Reductil 10 mg trde kapsule 10 mg kapsula, trda
SIBUTRAMIN SANDOZ 15 mg Capsule, hard oral use 
SIBUTRAMIN SANDOZ 15 mg kapsula, trda
Reductil 15 mg trde kapsule 15 mg Capsule, hard oral use 
Reductil 15 mg trde kapsule 15 mg kapsula, trda
Reductil 10 mg hard capsules 10 mg Capsule, hard oral use 
Reductil 10 mg hard capsules 10 mg kapsula, trda
Reductil 15 mg hard capsules 15 mg Capsule, hard oral use 
Reductil 15 mg hard capsules 15 mg kapsula, trda
Sibutramin Teva 15 mg Kapseln 
Sibutramin Teva 15 mg Kapseln peoralna uporaba
REDUCTIL 10 mg, capsule 10 mg Capsule, hard oral use 
REDUCTIL 10 mg, capsule 10 mg kapsula, trda
REDUCTIL 15 mg, capsule 15 mg Capsule, hard oral use 
REDUCTIL 15 mg, capsule 15 mg kapsula, trda
Reduxade 10 mg Hartkapseln 10 mg Capsule, hard oral use 
Reduxade 10 mg Hartkapseln 10 mg kapsula, trda
SIBUTRAMINA TEVA 15 mg Capsule, hard oral use 
SIBUTRAMINA TEVA 15 mg kapsula, trda
Sibutramin Teva 10 mg Kapseln 
Sibutramin Teva 10 mg Kapseln peoralna uporaba
Reduxade 15 mg Hartkapseln 15 mg Capsule, hard oral use 
Reduxade 15 mg Hartkapseln 15 mg kapsula, trda
Reductil 10 mg Hartkapseln 10 mg Capsule, hard oral use 
Reductil 10 mg Hartkapseln 10 mg Kapsula, trda
Reductil 15 mg Hartkapseln 15 mg Capsule, hard oral use 
Reductil 15 mg Hartkapseln 15 mg Kapsula, trda
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 
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
From a microbiological point of view, it should be used immediately. 
Z mikrobiološkega stališča je treba zdravilo porabiti takoj.
Your doctor will give you Evoltra once every day for 5 days. 
Zdravnik vam bo dajal zdravilo Evoltra enkrat na dan 5 dni zaporedoma.
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: 
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:
Estimates based on non-compartmental analysis (n = 14 / n = 14) 
Ocena, ki temelji na nekompartmentalni analizi (n = 14/n = 14)
Adults (> 21 and < 65 years old) 
Odrasli (stari > 21 in < 65 let)
The median age of treated patients (37 males, 24 females) was 12 years old. 
Mediana starosti sodelujočih bolnikov (37 moških, 24 ženskih) je bila 12 let.
It is a clear, almost colourless solution that is prepared and diluted before it is used. 
Je bistra, skoraj brezbarvna raztopina, ki jo je treba pred uporabo pripraviti in razredčiti.
1 vial 3 vials 4 vials 10 vials 20 vials 
1 viala 3 viale 4 viale 10 vial 20 vial
Your doctor will tell you when you need to be given this medicine. 
Zdravnik vam bo povedal, kdaj vam bodo dali zdravilo.
Each box contains 1, 3, 4, 10 or 20 vials. 
Vsaka škatla vsebuje 1, 3, 4, 10 ali 20 vial.
Your doctor will carry out regular blood tests to check whether your body is working properly; - liver damage (liver failure). 
Zdravnik bo opravljal redne krvne preiskave, da bo preveril, ali telo deluje normalno; okvara jeter (odpoved jeter).
Genzyme Limited 37 Hollands Road Haverhill Suffolk 
Genzyme Ltd 37 Hollands Road Haverhill Suffolk
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). 
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).
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. 
Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke
During treatment with Evoltra, your doctor will carry out regular blood tests and other tests to monitor your health. 
Med zdravljenjem z zdravilom Evoltra bo zdravnik opravljal redne krvne in druge preiskave, s katerimi bo spremljal vaše zdravstveno stanje.
Most of the cardiac adverse events were reported in the first 2 cycles. 
Večino neželenih dogodkov, povezanih s srčnimi boleznimi, so poročali med prvima 2 cikloma.
• DNA polymerase  inhibition resulting in termination of DNA chain elongation and/or DNA synthesis / repair. 
• Inhibicija DNA polimeraze , zaradi katere pride do terminacije elongacije verige DNA in/ali sinteze/popravljanja DNA.
(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.) 
(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.)
• An M2 bone marrow ( 5% and ≤ 25% blasts) and appearance of normal progenitor cells 
• kostni mozeg M2 ( 5% in ≤ 25% blastov) in pojav normalnih progenitornih celic
Each box contains 1, 3, 4, 10 or 20 vials, but not all pack sizes may be marketed. 
Vsaka škatla vsebuje 1, 3, 4, 10 ali 20 vial, vendar na trgu mogoče ni vseh navedenih pakiranj.
• 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. 
• Uporaba profilaktičnih steroidov (npr. 100 mg/m2 hidrokortizona od 1. do 3. dne) lahko koristi pri preprečevanju znakov ali simptomov SIRS ali kapilarne krvavitve.
No studies on the effects of clofarabine on the ability to drive and use machines have been performed. 
Študij o vplivu klofarabina na sposobnost vožnje in upravljanja s stroji niso izvedli.
If you forget to use Evoltra 
Če ste pozabili uporabiti zdravilo Evoltra