natgillin/translations-raw huggingface dataset:
The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products containing zolpidem identified in Annex I remains favourable, subject to the changes to the product information set out in Annex III. 
je PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo zolpidem in so navedena v Prilogi I, še naprej ugodno pod pogojem, da se upoštevajo spremembe informacij o zdravilu, navedene v Prilogi III.
Following this, the PRAC requested the MAH of the reference medicinal product for zolpidem to submit a cumulative review of spontaneous cases, clinical studies and published literature of ‘impaired driving ability', ‘Road traffic accidents' and ‘Somnambulism' associated with zolpidem. 
Zatem je odbor PRAC od imetnika dovoljenja za promet z referenčnim zdravilom za zolpidem zahteval, naj predloži kumulativni pregled spontanih primerov, kliničnih študij in objavljene literature za „poslabšano sposobnost vožnje“, „prometne nesreče“ in „somnambulizem“, ki so povezani z zolpidemom.
With regards to the effects on the ability to drive and use machines, the PRAC recommended that vehicle drivers and machine operators are warned that in addition to the possible risk of drowsiness, prolonged reaction time and impaired driving the morning after therapy, there is also the possibility of dizziness, sleepiness, blurred/double vision and reduced alertness. 
Glede učinkov na sposobnost vožnje in upravljanja strojev je odbor PRAC priporočil opozorilo za voznike in upravljavce strojev, da poleg morebitnega tveganja dremavosti, podaljšanega reakcijskega časa in poslabšane sposobnosti vožnje jutro po zdravljenju prav tako obstaja nevarnost omotice,
Based on the totality of the data available on the safety and the efficacy of zolpidem, and considering all the risk minimisation measures proposed during assessment, the PRAC concluded that the benefitrisk balance of zolpidem-containing medicinal products remains favourable subject to changes to the product information. 
Na podlagi vseh razpoložljivih podatkov o varnosti in učinkovitosti zolpidema in ob upoštevanju vseh ukrepov za zmanjšanje tveganja, ki so bili predlagani med postopkom ocenjevanja, je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo zolpidem, še naprej ugodno pod pogojem, da se upoštevajo spremembe informacij o zdravilu.
• The PRAC considered that the data from post-marketing spontaneous case reports, clinical trials, published literature and other available information have shown that the use of zolpidemcontaining products is associated with an increased risk of impaired driving and somnambulism; 
• odbor PRAC je menil, da so podatki iz poročil o spontanih primerih iz obdobja trženja, kliničnih preskušanj, objavljene literature in drugi razpoložljivi podatki pokazali, da je uporaba zdravil, ki vsebujejo zolpidem, povezana s povečanim tveganjem poslabšane sposobnosti vožnje ter somnambulizma;
Amongst the risk factors for impaired driving and somnambulism were, concomitant intake of other CNS depressants, sleep-deprivation and alcohol or illicit drugs consumption. 
Med dejavniki tveganja poslabšane sposobnosti vožnje in somnambulizma so bili sočasno jemanje drugih zdravil, ki povzročajo depresijo osrednjega živčevja, pomanjkanje spanja in uživanje alkohola ali prepovedanih drog.
The PRAC reviewed the safety and efficacy data relating to the risk of impaired driving and somnambulism following treatment with zolpidem. 
Odbor PRAC je pregledal podatke o varnosti in učinkovitosti, povezane s tveganjem poslabšane sposobnosti vožnje in somnambulizma po zdravljenju z zolpidemom.
In light of the data provided in the cumulative review performed by the MAH, and taking into consideration the recent Food and Drug Administration (FDA) approved label changes specifying new dosing recommendations for zolpidem-containing medicinal products, AIFA considered that it was in the interest of the EU to refer the matter to the PRAC for a benefit-risk review of zolpidem-containing medicinal products. 
Na podlagi podatkov iz kumulativnega pregleda, ki ga je opravil imetnik dovoljenja za promet, in nedavnih sprememb informacij o zdravilu glede novih priporočil za odmerjanje zdravil, ki vsebujejo zolpidem, ki jih je priporočila Uprava za hrano in zdravila (FDA), je italijanska agencija AIFA menila, da v interesu EU zadevo napoti na odbor PRAC, ki bo opravil presojo razmerja med tveganji in koristmi zdravil, ki vsebujejo zolpidem.
Discrepancies about drug-drug interactions information were observed in different product information of zolpidem containing products, notably on the interaction of zolpidem with CNS depressant. 
V različnih informacijah o zdravilih, ki vsebujejo zolpidem, so opazili odstopanja pri informacijah o medsebojnem delovanju zdravil, predvsem pri medsebojnem delovanju zolpidema in zdravil, ki povzročajo depresijo osrednjega živčevja.
• The PRAC reviewed all available data provided by the MAHs on the safety and efficacy of zolpidemcontaining medicines with regards the risk of impaired driving ability and somnambulism following treatment with zolpidem; 
• odbor PRAC je pregledal vse razpoložljive podatke o varnosti in učinkovitosti, ki so jih predložili imetniki dovoljenj za promet z zdravili, ki vsebujejo zolpidem, glede tveganja poslabšane sposobnosti vožnje in somnambulizma po zdravljenju z zolpidemom;
The provided data did not consistently show that a lower dose would be effective or that a lower dose would significantly reduce the risk of impaired driving and somnambulism, and it was considered that reducing the daily recommended dose would likely result in in-effective doses being used, in turn resulting in additional doses being taken in the middle of the night and in an increased risk of accidents the following day. 
Menili so, da bi zmanjšanje dnevnega odmerka verjetno povzročilo neučinkovito odmerjanje in posledično jemanje dodatnih odmerkov sredi noči ter povečano tveganje prometnih nesreč naslednji dan.
The CMDh, having considered the PRAC recommendation dated 6 March 2014 with regards to zolpidem-containing medicinal products, agrees with the recommendation therein as stated below: 
Usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirani postopek, CMDh,se je po proučitvi priporočila, ki ga je za zdravila, ki vsebujejo zolpidem, 6. marca 2014 izdal odbor PRAC, strinjala s priporočilom, ki je navedeno v nadaljevanju:
• The PRAC considered that the above-mentioned risks of impaired driving ability and somnambulism could be mitigated by changes to the product information of zolpidem-containing medicines, in particular that zolpidem should be taken as a single intake immediately at bedtime and not exceed the recommended dose, without being re-administered during the same night, as well as highlighting the risks regarding impaired driving and somnambulism, warnings and precautions aimed at decreasing this risk and also the risks of co-administration with CNS depressants and alcohol, and/ or illicit drugs; 
• odbor PRAC je menil, da se lahko zgoraj navedena tveganja poslabšane sposobnosti vožnje in somnambulizma zmanjšajo s spremembo informacij o zdravilih, ki vsebujejo zolpidem, in sicer je treba vnesti podatek, da je treba enkratni odmerek zolpidema zaužiti tik pred spanjem in da se priporočeni odmerek ne sme preseči ter ponovno vzeti v isti noči.
This will take about one hour. 
To traja približno eno uro.
Date of first authorisation: 20 November 2018 
Datum prve odobritve: 20. november 2018
EXP After reconstitution: use immediately. 
EXP Po rekonstituciji: uporabite takoj.
Frequency not known (cannot be estimated from the available data): 
neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov):
Uncommonly these can lead to severe allergic shock. 
Občasno lahko povzročijo resen alergijski šok.
Do not drive or use machines if you have these symptoms. 
Ne upravljajte vozil ali strojev, če imate te simptome.
Take the desired number of vials from the refrigerator. 
Vzemite želeno število vial iz hladilnika.
Additional experience from clinical studies 
Dodatne izkušnje iz kliničnih študij
Number of deaths, n (%) 
Število smrti, n (%)
• regular blood tests to ensure it is safe for you to continue treatment 
• opravljali bodo redne preiskave krvi za zagotovitev, da je za vas nadaljevanje zdravljenja varno;
• excessive water loss (dehydration) 
• čezmerna izguba vode (dehidracija);
The use of gloves, goggles and protective clothing is recommended. 
Priporočljiva je uporaba rokavic, zaščitnih očal in zaščitne obleke.
There is very little information available on whether the elimination of paclitaxel differs between races. 
Na voljo je zelo malo informacij o tem, ali se izločanje paklitaksela razlikuje med rasami.
Steps 3 to 6 should not be more than 30 minutes. 
Koraki od 3 do 6 ne smejo trajati več kot 30 minut.
PFS and OS results in the PP population are summarised in Figures 3 and 4. 
Rezultati PFS in OS v populaciji PP so povzeti v sliki 3 in 4.
• allergic reactions to other medicines, such as penicillin 
• alergijske reakcije na druga zdravila, kot je penicilin;
The following information is intended for healthcare professionals only: Administration precautions 
Naslednje informacije so namenjene samo zdravstvenemu osebju: Previdnostni ukrepi pri dajanju zdravila
These reactions are more common on the first infusion and may be improved by slowing the rate of infusion. 
Te reakcije so pogostejše pri prvi infuziji in se lahko izboljšajo z upočasnitvijo hitrosti infundiranja.
• low body temperature 
• nizka telesna temperatura;
Patients 65 years and older 
Bolnice, stare 65 let in več
The expiry date refers to the last day of that month. 
Rok uporabnosti zdravila se nanaša na zadnji dan navedenega meseca.
The average time to onset was 53 days from the first dose. 
Povprečni čas do pojavitve je bil 53 dni od prvega odmerka.
You will be observed closely during treatment: 
Med zdravljenjem vas bodo skrbno spremljali:
Continue to swirl the vial until the powder is completely dissolved. 
Z vialo še naprej krožite, dokler se prašek v celoti ne raztopi.
• multi-organ failure which can lead to death 
• odpoved več organov, ki lahko povzroči smrt;
In both groups, the majority of the serious adverse events were haematological toxicities. 
V obeh skupinah so večino resnih neželenih dogodkov predstavljale hematološke toksičnosti.
Further it has been shown that the rate of paclitaxel elimination increased with increasing body size. 
Nadalje se je pokazalo, da se je stopnja izločanja paklitaksela povečala s povečanjem telesne velikosti.
• epileptic fit lasting longer than five minutes or more than one fit within five minutes 
• epileptični napad, ki traja več kot pet minut, ali več kot en napad v petih minutah;
Talk to your doctor or nurse, if you are not sure if any of the above applies to you. 
Pogovorite se z zdravnikom ali medicinsko sestro, če niste prepričani, ali kaj od zgoraj navedenega velja za vas.
6.2 Incompatibilities 
6.2 Inkompatibilnost
Probability of survival 
Verjetnost preživetja
Range (mmol/L) 
Razpon (mmol/l)
Apealea is not recommended for children and adolescents under 18 years, because it has not been studied in this age group. 
Zdravilo Apealea ni priporočljivo za otroke in mladostnike, mlajše od 18 let, ker ga v tej starostni skupini niso proučevali.
Steps c and to f should not be more than 30 minutes. 
Koraki od c do f ne smejo trajati več kot 30 minut.
Thus, the distribution phase is essentially complete at 2 hours after the end of infusion. 
To pomeni, da se porazdelitvena faza zaključi dve uri po zaključku infuzije.
Ask your doctor or nurse about hair loss and what can be done to avoid it. 
Pozanimajte se pri zdravniku ali medicinski sestri glede izgube las ter kaj lahko naredite, da to preprečite.
The dose is based on your body surface area (worked out from your height and weight) and blood test results. 
Odmerek je odvisen od vaše telesne površine (ta se izračuna glede na višino in telesno maso) in rezultatov preiskav krvi.
In view of this, and of the potential for frailty and co-morbidities, elderly patients should be carefully monitored. 
Ob upoštevanju tega in možnosti slabotnosti in soobolevnosti je treba starejše bolnice skrbno spremljati.
Your doctor may wish to delay further treatment with Apealea or reduce the dose. 
Zdravnik bo morda želel odložiti nadaljnje zdravljenje z zdravilom Apealea ali vam zmanjšati odmerek.
After reconstitution 
Po rekonstituciji
Additional subgroup analyses were conducted to investigate efficacy by relapse (first and second) in the PP and the ITT population. 
Dodatne analize podskupine so bile izvedene za raziskovanje učinkovitosti glede na recidiv (prvi in drugi) v populacijah PP in ITT.
Paclitaxel should not be used during pregnancy unless the clinical condition requires this treatment. 
Paklitaksel se ne sme uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva takšno zdravljenje.
• are allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6) 
• če ste alergični na paklitaksel ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
There was no marked difference in overall tolerability between the 65-74 age group and younger patients. 
Ni opazne razlike v celokupnem prenašanju med starostno skupino 65-74 let in mlajšimi bolnicami.
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Če zdravilo ni porabljeno takoj, je za čas shranjevanja in pogoje med uporabo odgovoren uporabnik.
Total plasma levels of paclitaxel were similar after infusion of the two formulations. 
Skupne ravni paklitaksela v plazmi so bile po infundiranju obeh formulacij podobne.
For appropriate use of carboplatin, the prescriber is advised to consult the prescribing information for carboplatin as well. 
Za zagotovitev ustrezne uporabe karboplatina se priporoča, da zdravnik, ki predpisuje zdravilo, pregleda tudi informacije o predpisovanju karboplatina.
• cognitive disorder (difficulty thinking or processing thoughts, difficulty remembering) 
• kognitivne motnje (oteženo razmišljanje ali predelava misli, otežen priklic spomina);
This is equivalent to 80% of the recommended maximum daily dietary intake of sodium for an adult. 
To je enako 80 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
• toxicity to the nervous system 
• toksičnost za živčni sistem;
The recommended dose of carboplatin is AUC = 5-6 mg/mL×min. 
Priporočeni odmerek karboplatina je AUC = 5-6 mg/ml × min.
Patients were stratified based on relapse (first or second) and CA125 values. 
Bolnice so bile stratificirane glede na recidiv (prvi ali drugi) in vrednosti CA125.
Patients should be advised not to drive or use machines if they feel tired or dizzy. 
Bolnicam je treba odsvetovati vožnjo ali upravljanje strojev, če se počutijo utrujene ali omotične.
Stabilisation results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions. 
Rezultat stabilizacije je zaviranje normalne dinamične reorganizacije mreže mikrotubulov, ki je bistvena za vitalne celične funkcije med interfazo in mitozo.
In the event of an overdose, the patient should be closely monitored. 
Pri prevelikem odmerjanju je treba bolnico skrbno spremljati.
non-inferiority margin (1.2) 
Meja neinferiornosti (1,2)
The solution should be administered by an intravenous infusion over approximately one hour (120−140 drops/min). 
Raztopina se daje z intravensko infuzijo približno eno uro (120−140 kapljic/min).
Paclitaxel affects or stops growth of rapidly dividing cells, such as tumour cells. 
Paklitaksel zavira ali zaustavi rast celic, ki se hitro delijo, kot so tumorske celice.
Stop breast-feeding while being treated, as paclitaxel passes into breast milk and may harm the child. 
Med zdravljenjem prenehajte dojiti, saj paklitaksel prehaja v materino mleko in lahko škodi dojenčku.
In some of the cases, the patients had previously been exposed to cardiotoxic medicinal products such as doxorubicin or had underlying cardiac history. 
V nekaterih primerih so bile bolnice predhodno izpostavljene kardiotoksičnim zdravilom, kot je doksorubicin, ali so imele v anamnezi osnovno srčno bolezen.
Inject the required amount of reconstituted Apealea into an empty, sterile ethylene-vinyl acetate (EVA) bag. 
Injicirajte potrebno količino rekonstituiranega zdravila Apealea v prazno, sterilno vrečko iz etilen-vinil acetata (EVA).
Chromosomal aberrations have also been detected in in vivo studies in mice and monkeys. 
Kromosomske aberacije so odkrili tudi v študijah in vivo pri miših in opicah.
Patients who had pre-existing neuropathy of grade ≥ 2 or serious medical risk factors involving any of the major organ systems were not allowed to enter the study. 
Bolnice, ki so imele predhodno prisotno nevropatijo stopnje ≥ 2 ali resne zdravstvene dejavnike tveganja, ki vključujejo enega izmed glavnih organskih sistemov, niso smele sodelovati v študiji.
non-inferiority margin (1.185) 
Meja neinferiornosti (1,185)
Further, it has been demonstrated that peripheral neuropathies can persist beyond 6 months of paclitaxel discontinuation. 
Nadalje je bilo dokazano, da lahko periferne nevropatije vztrajajo tudi več kot 6 mesecev po prekinitvi zdravljenja s paklitakselom.
Limited data are available on use in patients ≥ 75 years. 
Glede uporabe pri bolnicah ≥ 75 let je na voljo le malo podatkov.
The median number of cycles with paclitaxel/carboplatin treatment for patients receiving GCSF was 6 in both groups. 
Mediano število ciklov zdravljenja s paklitakselom/karboplatinom za bolnice, ki so prejemale GCSF je bilo v obeh skupinah 6.
Contact your doctor immediately, if during treatment you develop: 
Takoj se posvetujte z zdravnikom, če se med zdravljenjem pojavijo:
• blood poisoning 
• zastrupitev krvi;
Alopecia is a very common adverse reaction and occurs early in treatment. 
Alopecija je zelo pogost neželeni učinek in se pojavi zgodaj med zdravljenjem.
There were no differences in Eastern Cooperative Oncology Group (ECOG) performance score between the two study groups at any time during or after treatment (mainly score 0 or 1). 
V stanju zmogljivosti po lestvici ameriškega združenja ECOG (Eastern Cooperative Oncology Group) ni bilo razlik med obema študijskima skupinama, ne kadar koli med zdravljenjem ne po njem (rezultat večinoma 0 ali 1).
Delayed reactions related to paclitaxel occurring during or after infusion of carboplatin cannot be excluded. 
Zapoznelih reakcij, povezanih s paklitakselom, ki se pojavijo med infundiranjem karboplatina ali po njem, ni mogoče izključiti.
• painful severe swelling of deep skin layers, mainly in the face 
• boleče močne otekline globokih slojev kože, predvsem na obrazu;
b Can persist beyond 6 months of paclitaxel discontinuation.c c As reported in the post-marketing surveillance of paclitaxel. 
b Lahko traja še več kot 6 mesecev po prekinitvi zdravljenja s paklitakselom.c c Kot so poročali v okviru nadzora po dajanju zdravil, ki vsebujejo paklitaksela na trg.
It can have a marked impact on the patients' self-image and quality of life and patients should be counselled about the likelihood of this adverse effect and on what measures might be available to mitigate it, for example the use of cold caps. 
Lahko ima pomemben vpliv na bolničino samopodobo in kakovost življenja, zato je treba bolnice seznaniti z verjetnostjo tega neželenega učinka in ukrepi, s katerimi ga je mogoče zmanjšati, na primer z uporabo hladilnih kap.
Since renal elimination is a minor pathway for paclitaxel, increased plasma levels are not expected in this patient group. 
Ker predstavlja ledvično izločanje manjši delež izločanja paklitaksela, v tej skupini bolnic ni pričakovati povečanih ravni v plazmi.
PFS as the primary endpoint was evaluated by blinded assessment of computerised tomography images using Response Evaluation Criteria in Solid Tumours (RECIST) 1.0. 
PFS kot primarniizid so ocenjevali s slepim ocenjevanjem računalniških tomografskih slik z uporabo meril za ocenjevanje odziva pri trdih tumorjih (Response Evaluation Criteria in Solid Tumours - RECIST) 1.0.
Proportions of patients who received premedication prior to infusion of paclitaxel or carboplatin or overall (safety population) 
Deleži bolnic, ki so prejele premedikacijo pred infundiranjem paklitaksela ali karboplatina ali na splošno (varnostna populacija)
Repeat dose toxicity studies have shown non-reversible, toxic effects on male reproductive organs. 
Študije toksičnosti ponavljajočih odmerkov so pokazale ireverzibilne, toksične učinke na moške reproduktivne organe.
Administration sets containing a 15 µm polyamide fluid filter should be used. 
Uporabiti je treba sisteme, ki vsebujejo 15-µm poliamidni filter za tekočino.
Pack size: 1 vial. 
Velikost pakiranja: 1 viala.
Once opened, Apealea is recommended to be used immediately. 
Po odprtju zdravila Apealea je priporočljivo, da ga takoj porabite.
Thus, the results in the subgroup of patients with first relapse are consistent with the results in the overall population and in addition, there was an indication of PFS benefit for Apealea. 
Rezultati v podskupini bolnic s prvim recidivom so torej skladni z rezultati celotne populacije, poleg tega je bila ugotovljena korist zdravila Apealea za PFS.
The solution should be clear and greenish-yellow without visible particles or precipitates. 
Raztopina mora biti bistra in zelenkasto rumena, brez vidnih delcev ali oborine.
There are very limited data on the use of paclitaxel in pregnant women. 
Podatkov o uporabi paklitaksela pri nosečnicah je zelo malo.
Paclitaxel is distributed equally between plasma and blood as described in published in vitro data. 
Paklitaksel je enakovredno porazdeljen med plazmo in krvjo, kot navajajo objavljeni podatki in vitro.
− low blood pressure 
− nizek krvni tlak;
The solution should be injected during approximately one minute towards the inner wall of the vial and not directly onto the powder as this will result in foaming. 
Injiciranje raztopine naj traja približno eno minuto, usmerite jo v notranjo steno viale in ne neposredno na prašek, saj se sicer začne peniti.
If neuropathy is observed, follow dose reduction recommendations in Table 1. 
Če opazite nevropatijo, upoštevajte priporočila za zmanjšanje odmerka iz preglednice 1.
As a result of the combined treatment, it is not possible to determine whether this observation is due to Apealea or to other factors, and delayed reactions related to paclitaxel cannot be excluded. 
Zaradi kombiniranega zdravljenja ni mogoče dokazati, ali je to zaradi zdravila Apealea ali drugih dejavnikov, poleg tega ni mogoče izključiti zapoznelih reakcij, povezanih s paklitakselom.
• primary peritoneal cancer - a cancer of the cells lining the space between the wall of the belly and the internal organs 
• primarni peritonealni rak - rak celic, ki obdajajo prostor med trebušno steno in notranjimi organi;
• blood vessel disorders, such as: 
• okvare krvnih žil, kot so:
Patients with low neutrophil count should be made aware of the increased risk of infections. 
Bolnice z nizkim številom nevtrofilcev je treba opozoriti na povečano tveganje okužb.
Withhold treatment until symptoms resolve to grade ≤ 1 
Odložite zdravljenje, dokler se simptomi ne izboljšajo do stopnje ≤ 1
Thus, only about 1% of the paclitaxel in the body is located in plasma during the elimination phase. 
To pomeni, da je v fazi izločanja v plazmi le približno 1 % paklitaksela v telesu.
Standard dose: 
Standardni odmerek:
These patients should be vigilantly monitored by physicians for the occurrence of cardiac events. 
Zdravniki morajo te bolnice skrbno spremljati glede pojavitve srčnih dogodkov.
A non-inferiority analysis was conducted for PFS in the per-protocol (PP) population with pre-specified non-inferiority margin. 
Analizo neinferiornosti so izvedli za PFS v populaciji po protokolu (PP) z vnaprej določeno mejno vrednostjo neinferiornosti.
Number at risk 
Število ogroženih
If the solution contacts the skin, the skin should be washed immediately and thoroughly with soap and water. 
Če raztopina pride v stik s kožo, jo takoj in temeljito umijte z milom in vodo.