FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy endpoint was the incidence of proven/probable IFIs as determined by an independent, blinded external expert panel during the on-treatment period.
Slovenian: Primarni opazovani dogodekučinkovitosti je bila pojavnostdokazanih oziroma verjetnih invazivnihglivnihokužb,kijihje ugotavljala neodvisna skupina zunanjih strokovnjakov na slep način medobdobjemzdravljenja.Ključnisekundarni opazovani dogodekjebila pojavnostdokazanihoziromaverjetnih invazivnihglivnihokužb 100 dni po randomizaciji.
English: In another study in healthy volunteers, repeat dose administration of posaconazole oral suspension (200 mg twice daily for 7 days) increased the Cmax and AUC of intravenous midazolam (0.4 mg single dose) by an average of 1.3- and 4.6-fold (range 1.7 to 6.4-fold), respectively; Posaconazole oral suspension 400 mg twice daily for 7 days increased the intravenous midazolam Cmax and AUC by 1.6 and 6.2-fold (range 1.6 to 7.6-fold), respectively.
Slovenian: V drugi študiji pri zdravih prostovoljcih je uporaba večkratnih odmerkovperoralne suspenzijeposakonazola (200 mg dvakrat na dan7dni) povečala Cmaxintravenskouporabljenega midazolama(enkratni odmerek0,4 mg) v povprečju za 1,3-krat,njegovoAUC pa za 4,6-krat (razpon od 1,7-kratdo 6,4-krat).
English: Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial (Study 0041).
Slovenian: Vneprimerjalnem preskušanju (študija 0041) zadnje možnosti zdravljenja so za zdravljenje invazivneaspergilozepribolnikih z okužbo,odpornonaamfotericin B (vključno z liposomskimioblikami)aliitrakonazol,oziroma pri bolnikih, ki niso prenašali teh zdravil, ovrednotili peroralno suspenzijoposakonazola 800 mg/dan v deljenih odmerkih.
English: Posaconazole may substantially increase plasma levels of HMG-CoA reductase inhibitors that are metabolised by CYP3A4.
Slovenian: Zaviralci reduktaze HMG-CoA, ki se presnovijo s CYP3A4 (npr. simvastatin, lovastatin inatorvastatin) Posakonazollahko bistveno povečaplazemsko koncentracijo zaviralcev reduktaze HMG-CoA, ki sepresnovijo s CYP3A4.
English: First time treatment of Thrush
Slovenian: Prvo zdravljenje sora
English: which are given with ritonavir) - midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants) - diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure) - digoxin (used to treat heart failure) - Glipizide or other “sulfonylureas” (used to treat high blood sugar).
Slovenian: - diltiazem, verapamil, nifedipin, nizoldipinin drugi zaviralci kalcijevih kanalčkov (uporabljajose za zdravljenje visokega krvnega tlaka),
English: Based on Kaplan-Meier estimates, the probability of survival up to day 100 after randomization, was significantly higher for posaconazole recipients; this survival benefit was demonstrated when the analysis considered all causes of death (P= 0.0354) as well as IFI-related deaths (P = 0.0209).
Slovenian: Ta koristen vpliv na preživetje so dokazali, ko so vanaliziupoštevalivsevzrokesmrti(p = 0,0354), pa tudi smrti, povezane z invazivno glivno okužbo(p
English: Do not breast-feed while taking Posaconazole AHCL.
Slovenian: Ne jemljite zdravila Posakonazol AHCL:
English: How to store Posaconazole AHCL Contents of the pack and other information
Slovenian: Izgled zdravila Posakonazol AHCL in vsebina pakiranja
English: hepatocellular damage, hepatitis, jaundice, hepatomegaly, cholestasis, hepatic toxicity, hepatic function abnormal
Slovenian: okvara jetrnih celic, hepatitis, zlatenica, hepatomegalija, holestaza,
English: Each dose of Posaconazole AHCL should be administered during or immediately after a meal, or a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure.
Slovenian: Bolniki, ki ne prenašajohrane, naj zdravilo vzamejo med ali takoj po zaužitju prehranskegadodatka, da bi povečali peroralno absorpcijo in zagotovili zadostno izpostavljenost zdravilu.
English: c: In 1899, this was the period from randomization to 100 days post-randomization; in 316 it was the period from the baseline day to 111 days post-baseline.
Slovenian: Vštudiji1899jebilotoobdobje od randomizacije do zadnjega odmerka preučevanega zdravilaplus7 dni, v študiji316 pa je bilo to obdobje od prvega odmerka do zadnjega odmerka preučevanega zdravilaplus7dni.
English: These medicines include: - vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer) - ciclosporin (used during or after transplant surgery) - tacrolimus and sirolimus (used during or after transplant surgery) - rifabutin (used to treat certain infections) - medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir,
Slovenian: - rifabutin(uporabljase za zdravljenje določenih okužb), - zdravila za zdravljenje HIV,imenovana zaviralci proteaz (vključno z lopinavirjem inatazanavirjem, ki se dajetaskupaj zritonavirjem), - midazolam, triazolam, alprazolam indrugi benzodiazepini (uporabljajo se kot pomirjevala alizdravila za sprostitev mišic),
English: Concomitant use of posaconazole and efavirenz should be avoided unless the benefit to the patient outweighs the risk.
Slovenian: karbamazepina,fenobarbitala, primidona)se je treba izogibati, razen če korist za bolnika odtehta tveganje.
English: The table below shows the recommended dose and length of treatment which depend on the type of infection that you have and may be individually adapted for you by your doctor.
Slovenian: Spodnja preglednica prikazuje priporočeni odmerek intrajanjezdravljenja gledenavrstookužbe, kijoimate.Zdravnikvamlahkoodmerekintrajanjezdravljenja individualno prilagodi.
English: Of the circulating metabolites, the majority are glucuronide conjugates of posaconazole with only minor amounts of oxidative (CYP450 mediated) metabolites observed.
Slovenian: Posakonazol v obtoku nima nobenega glavnega presnovka in niverjetno, da bi zaviralci encimovCYP450vplivalinanjegovokoncentracijo.Odpresnovkov v obtoku je večina glukuronidnihkonjugatov posakonazola, opazili pa so le majhne količine oksidativnih presnovkov
English: altered medicine levels, blood phosphorus decreased, chest x-ray abnormal * Based on adverse reactions observed with the oral suspension, gastro-resistant tablets, and concentrate for solution for infusion.
Slovenian: *Na podlagi neželenih učinkov, opaženih s peroralno suspenzijo, gastrorezistentnimi tabletami in koncentratom za raztopino za infundiranje.
English: The AUC of posaconazole is: 4 times greater when administered with a high fat meal (~ 50 grams fat) and about 2.6 times greater when administered during a non-fat meal or nutritional supplement (14 grams fat) relative to the fasted state (see sections 4.2 and 4.5).
Slovenian: 2,6-kratvečjaprizaužitju z nemastnimobrokomali s prehranskimdodatkom(14gramovmaščobe)vprimerjavi s stanjem na tešče (glejte poglavji 4.2 in 4.5).
English: In a study of 136 neutropenic paediatric patients 11 months - 17 years treated with posaconazole oral suspension at doses up to 18 mg/kg/day divided TID, approximately 50% met the pre-specified target (Day 7 Cav between 500 ng/mL-2,500 ng/mL).
Slovenian: zdravljenih s peroralno suspenzijo posakonazola v odmerkih do 18 mg/kg/dan,razdeljenih na tri odmerke dnevno, je približno 50 % bolnikov doseglo vnaprej določen cilj (Cav7.
English: Posaconazole AHCL may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood.
Slovenian: Zdravilo Posakonazol AHCL lahko poveča koncentracijo naslednjih zdravil v krvi, to pa lahko povzroči zelo resne motnje srčnega ritma:
English: Efavirenz (400 mg once a day) decreased the Cmax and AUC of posaconazole by 45 % and 50 %, respectively.
Slovenian: Efavirenz(400 mg enkrat na dan) je zmanjšalCmaxposakonazolaza 45 %, njegovoAUC paza 50 %.Sočasni uporabi posakonazola in efavirenza se je treba izogibati, razen če korist za bolnika odtehtatveganje.
English: Posaconazole concentrations may be significantly lowered in combination; therefore, concomitant use with posaconazole should be avoided unless the benefit to the patient outweighs the risk (see section
Slovenian: Zato se je treba izogibati njihovi sočasni uporabi s posakonazolom, razen če korist za bolnika odtehta tveganje (glejte poglavje 4.5).
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA
English: Sirolimus concentrations should be measured upon initiation, during co-administration, and at discontinuation of posaconazole treatment, with sirolimus doses adjusted accordingly.
Slovenian: Koncentracijosirolimusa jetrebaizmeritiob uvedbi zdravljenja, med sočasno uporabo in tudi obukinitvi zdravljenja s posakonazolom in po potrebi ustrezno prilagoditiodmerke sirolimusa.Zavedatisejetreba, da se med sočasno uporabo sirolimusa in posakonazola spremeni razmerje med najnižjokoncentracijo sirolimusa in njegovo AUC.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of oral suspension contains 40 mg of posaconazole.
Slovenian: Učinkovina je posakonazol.En mililiter peroralne suspenzije vsebuje40 miligramovposakonazola.
English: In healthy volunteers under fasting conditions, dividing the total daily dose (800 mg) into 200 mg four times daily compared to 400 mg twice daily, was shown to increase posaconazole exposure by 2.6-fold.
Slovenian: Pri zdravih prostovoljcih na tešče sopokazali,darazdelitevcelotnegadnevnegaodmerka(800mg) na 200mgštirikratnadan v primerjavis
English: Posaconazole AHCL oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Slovenian: - bolnikih, ki prejemajo kemoterapijo za doseganje remisije akutne mieloične levkemije (AML) ali mielodisplastičnih sindromov (MDS) in pri katerih se zato pričakuje dolgotrajnejša nevtropenija ter imajo veliko tveganje za invazivne glivne okužbe,
English: Clinically significant interactions resulting in hospitalisation and/or posaconazole discontinuation were reported in clinical efficacy studies.
Slovenian: AUC za 358 %.Vštudijah klinične učinkovitosti so poročali o klinično pomembnihinterakcijah, ki so zahtevale sprejem v bolnišnico in/ali ukinitev posakonazola.
English: Repeat dose administration of fosamprenavir (700 mg twice daily x 10 days) decreased the Cmax and AUC of posaconazole oral suspension (200 mg once daily on the
Slovenian: Vštudijiprizdravihprostovoljcihje peroralnasuspenzija posakonazola (200 mg enkrat na dan10 dni)
English: Posaconazole oral suspension
Slovenian: Peroralna suspenzijaposakonaz l
English: OTHER SPECIAL WARNING(S), IF NECESSARY Posaconazole oral suspension and posaconazole tablets are NOT interchangeable.
Slovenian: Peroralna suspenzija posakonazola NI medsebojno zamenljiva s tabletami posakonazola.
English: Each dose of Posaconazole AHCL should be administered during or immediately after a meal, or a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure
Slovenian: Bolniki, ki ne prenašajo hrane, naj zdravilo vzamejomed alitakoj po zaužitju prehranskega dodatka, da bi povečali peroralno absorpcijo in zagotovili zadostno izpostavljenost
English: high or low blood pressure - low blood pressure - inflammation of the pancreas (pancreatitis) - this may cause severe stomach pain - oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain - severe kidney problems - signs include passing more or less urine, that is a different colour than usual - high blood levels of creatinine - shown in blood tests - cough, hiccups - nose bleeds - severe sharp chest pain when breathing in (pleurritic pain) - swelling of lymph glands (lymphadenopathy) - reduced feeling of sensitivity especially on the skin - tremor - high or low blood sugar levels - blurred vision, sensitivity to light - hair loss (alopecia) - mouth ulcers - shivering, feeling generally unwell - pain, back or neck pain, pain in arms or legs - water retention (oedema) - menstrual problems (abnormal vaginal bleeding) - inability to sleep (insomnia) - being completely or partially unable to talk - swelling of the mouth - abnormal dreams, or difficulty sleeping - problems with co-ordination or balance - mucosal inflammation - stuffy nose - difficulty breathing - chest discomfort - feeling bloated - mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain - belching - feeling jittery
Slovenian: - prekinitev preskrbe vranice s kisikom (vranični infarkt) - povzročilahkohudebolečine v trebuhu - hude težave zledvicami - med znaki so izločanje več ali manj urina, ki je drugačne barve kot po navadi - visoka koncentracija kreatinina v krvi - pokaže se na preiskavah krvi - kašelj, kolcanje - krvavitve iz nosu
English: When initiating treatment with posaconazole in patients already receiving ciclosporin, the dose of ciclosporin should be reduced (e.g. to about three quarters of the current dose).
Slovenian: odmerekciklosporina zmanjšati (npr.napribližnotričetrtine trenutnega odmerka).
English: Discontinuation of Posaconazole AHCL should be considered if clinical signs and symptoms are consistent with development of liver disease.
Slovenian: Zdravilo Posakonazol AHCL peroralna suspenzija je indicirano tudi za profilakso invazivnih glivnih okužb pri:
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Seznam neželenih učinkov v preglednici
English: EXPIRY DATE
Slovenian: Datumprveodobritve:
English: The safety of posaconazole oral suspension has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
Slovenian: Povzetek varnostnega profila Varnost peroralnesuspenzije posakonazola soocenilipri> 2.400 bolnikih in zdravih prostovoljcih,vključenih v klinična preskušanja, in na podlagi izkušenj med obdobjemtrženja.Mednajpogostejeporočanimi resnimi, z zdravilom povezanimi neželenimi učinki so bili navzea, bruhanje, driska,zvišana telesna temperatura in zvišanaraven bilirubina.
English: Gastrointestinal dysfunction
Slovenian: Bolezni mišično-skeletnega sistemain vezivnega tkiva
English: nd day, then 400 mg twice daily x 8 Days) by 21 % and 23 %, respectively.
Slovenian: Pri uporabiponavljajočihse odmerkovfosamprenavirja (700 mgdvakratnadan 10dni) sta se Cmaxin AUC posakonazola v oblikiperoralne suspenzije (200 mg enkratna dan prvidan, 200 mg dvakrat na dan drugi dan, nato 400 mgdvakratnadan 8dni) zmanjšaliza 21 %oz.
English: The primary efficacy endpoint was the incidence of proven/probable IFIs at 16 weeks post-randomization as determined by an independent, blinded external expert panel.
Slovenian: Primarni opazovani dogodekučinkovitostijebila pojavnostdokazanihoziroma verjetnih invazivnih glivnih okužb 16 tednov po randomizaciji,
English: Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with serious adverse reactions (see section 4.4).
Slovenian: Sočasna uporaba azolskih antimikotikov, vključno s posakonazolom, in vinkristina je bila povezana zresnimineželenimi učinki (glejte poglavje 4.4).Posakonazollahko zviša plazemsko koncentracijo alkaloidovvinkekarlahkovodidonevrotoksičnostiindrugihresnihneželenihučinkov.
English: Since certain adverse reactions (e.g. dizziness, somnolence, etc.) have been reported with posaconazole use, which potentially may affect driving/operating machinery, caution needs to be used.
Slovenian: itd.), ki lahko poslabšajo sposobnost vožnje in upravljanja s stroji, je potrebna previdnost.
English: What Posaconazole AHCL contains
Slovenian: Posakonazol AHCL.
English: In a study in healthy volunteers posaconazole oral suspension (200 mg once daily for 10 days) increased the exposure (AUC) of intravenous midazolam (0.05 mg/kg) by 83 %.
Slovenian: povečala izpostavljenost (AUC) intravensko uporabljenemu midazolamu (0,05 mg/kg)za
English: Vinca alkaloids
Slovenian: Middlesex
English: Posaconazole AHCL can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm: - any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraines.
Slovenian: Zdravilo Posakonazol AHCL vsebuje učinkovino posakonazol.Taučinkovinaspada v skupinozdravil,imenovanih"antimikotiki"(protiglivna zdravila).
English: Possible side effects
Slovenian: Drugi neželeni učinki
English: The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose.
Slovenian: 17%uporabljenegaradioaktivno označenega odmerka.
English: Alternatively, if recommended by your doctor, you may take 400 mg (two 5 mL spoonfuls) twice a day provided that you are able to take both doses during or after food or a nutritional drink.
Slovenian: čeimate možnost, data dva odmerka vzamete medali takojpojediali zaužitju prehranskega dopolnila v obliki napitka.
English: Packaging Package size
Slovenian: Način uporabe Pakiranje Velikost pakiranja
English: It can also be given with an infusion pump.
Slovenian: Daje se lahko tudi z infuzijsko črpalko.
English: This means that it is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: The doctor should instruct the patient on how to use the medicine properly.
Slovenian: Zdravnik mora bolnika poučiti o pravilni uporabi zdravila.
English: Severe hypoglycaemia can lead to loss of consciousness and, in very extreme cases, to death.
Slovenian: Huda hipoglikemija lahko privede do izgube zavesti in v skrajnih primerih do smrti.
English: Hypoglycaemia may be due to the medicine itself or other factors such as diet and exercise.
Slovenian: Hipoglikemija je lahko posledica samega zdravila ali pa drugih dejavnikov, kot sta prehrana in vadba.
English: In some circumstances, such as when blood acid levels are dangerously high (ketoacidosis), the medicine may be given into a vein.
Slovenian: V nekaterih okoliščinah, na primer, kadar so ravni kisline v krvi nevarno visoke (ketoacidoza), se lahko daje v veno.
English: In addition, studies have shown that both medicines produce similar levels of the active substance in the body.
Slovenian: Poleg tega so študije pokazale, da obe zdravili proizvedeta podobno količino zdravilne učinkovine v telesu.
English: It helps control blood glucose levels, thereby alleviating symptoms and reducing the risk of complications of diabetes.
Slovenian: Pripomore k nadzoru ravni glukoze v krvi in s tem olajša simptome ter zmanjša tveganje za zaplete sladkorne bolezni.
English: In diabetes, patients have high levels of blood glucose either because the body does not produce enough insulin or the body is unable to use insulin effectively.
Slovenian: Pri sladkorni bolezni imajo bolniki visoko raven glukoze v krvi, ker telo ne proizvaja dovolj insulina ali pa ga ne more učinkovito izrabiti.
English: The full EPAR for Insulin lispro Sanofi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Insulin lispro Sanofi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In addition, studies show that both medicines have similar effects in reducing blood glucose levels and similar side effects.
Slovenian: Poleg tega so študije pokazale, da imata obe zdravili podoben učinek na zniževanje ravni glukoze v krvi in podobne neželene učinke.
English: In one study, in patients with type 1 diabetes, HbA1c reduced by 0.44 and 0.46 percentage points with Insulin lispro Sanofi and Humalog respectively after 26 weeks; in the second study, in patients with type 2 diabetes, the corresponding figures were 0.93 versus 0.88 percentage points.
Slovenian: V eni študiji pri bolnikih s sladkorno boleznijo tipa 1 se je vrednost HbA1c po 26 tednih znižala za 0,44 odstotne točke z zdravilom Insulin lispro Sanofi in za 0,46 odstotne točke z zdravilom Humalog, v drugi študiji pri bolnikih s sladkorno boleznijo tipa 2 pa sta bili vrednosti 0,93 oziroma 0,88 odstotne točke.
English: The active substance in Insulin lispro Sanofi is a form of insulin which is absorbed more quickly by the body than human regular insulin, and can therefore act faster.
Slovenian: Zdravilna učinkovina v zdravilu Insulin lispro Sanofi je oblika insulina, ki ga telo absorbira hitreje kot običajni humani insulin, zato lahko deluje hitreje.
English: This is a summary of the European public assessment report (EPAR) for Insulin lispro Sanofi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Insulin lispro Sanofi.
English: Because Insulin lispro Sanofi is a fast-acting insulin, it is usually given shortly before a meal and, when necessary, soon after a meal.
Slovenian: Ker je zdravilo Insulin lispro Sanofi hitrodelujoči insulin, se običajno daje tik pred obrokom in po potrebi kmalu po obroku.
English: Insulin lispro Sanofi may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low.
Slovenian: Zdravilo Insulin lispro Sanofi lahko povzroča hipoglikemijo (nizke ravni glukoze v krvi) in se ne sme dajati bolnikom, ki že imajo nizke ravni glukoze v krvi.
English: For more information about treatment with Insulin lispro Sanofi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Insulin lispro Sanofi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What measures are being taken to ensure the safe and effective use of Insulin lispro Sanofi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Insulin lispro Sanofi?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements for biosimilar medicines, Insulin lispro Sanofi has a highly similar structure, purity and biological activity to Humalog and is distributed in the body in the same way.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Insulin lispro Sanofi po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Humalog in da se po telesu enako porazdeli.
English: Insulin lispro Sanofi is a medicine used to control blood glucose (sugar) levels in adults and children with diabetes who need insulin.
Slovenian: Zdravilo Insulin lispro Sanofi se uporablja za uravnavanje ravni glukoze (sladkorja) v krvi pri odraslih in otrocih s sladkorno boleznijo, ki potrebujejo insulin.
English: Therefore, the CHMP's view was that, as for Humalog, the benefits of Insulin lispro Sanofi outweigh its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je odbor CHMP menil, da koristi zdravila Insulin lispro Sanofi enako kot pri zdravilu Humalog odtehtajo z njim povezana tveganja, in priporočil, da se zanj izda dovoljenje za promet.