natgillin/translations-raw huggingface dataset:
The CMDh, having considered the PRAC recommendation dated 13 June 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of diclofenac containing medicinal products for which the amendments to the product information are set out in annex III. 
Skupina CMDh je po obravnavi priporočila odbora PRAC z dne 13. junija 2013 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES sprejela stališče glede spremembe dovoljenj za promet z zdravili, ki vsebujejo diklofenak, za katera so spremembe informacij o zdravilu navedene v Prilogi III.
• The PRAC considered the totality of the data available in relation to the cardiovascular safety of diclofenac containing medicinal products, acknowledging the conclusions from previous reviews by the CHMP, the submissions by marketing authorisation holders in writing and at an oral explanation, and emerging data from independent researchers. 
• PRAC je obravnaval vse razpoložljive podatke v zvezi s srčno-žilno varnostjo zdravil, ki vsebujejo diklofenak, in potrdil sklepe odbora CHMP iz predhodnih pregledov, vloge imetnikov dovoljenja za promet z zdravilom v pisni obliki in njihove ustne obrazložitve ter nove podatke, ki so jih priskrbeli neodvisni raziskovalci;
The study, which looked at more than 600 randomised clinical trials, concluded that the vascular risks of high dose diclofenac are comparable to Cox-2 inhibitors. 
V študiji, v kateri so obravnavali več kot 600 randomiziranih kliničnih preskušanj, so zaključili, da so vaskularna tveganja visokega odmerka diklofenaka primerljiva s tveganji zaviralcev Cox-2.
An increased risk with diclofenac was also observed in the SOS nested-cases control studies across all databases and for both myocardial infarction and ischaemic stroke. 
Povečano tveganje z diklofenakom so zabeležili tudi pri ugnezdenih študijah „primer-kontrola‟ SOS v vseh zbirkah podatkov, in sicer tako za miokardni infarkt kot za ishemično kap.
NSAIDs, such as diclofenac, are indicated in the relief of all grades of pain and inflammation associated with a wide range of conditions, including arthritic conditions, acute musculo-skeletal disorders and other painful conditions resulting from trauma. 
Nesteroidna protivnetna zdravila, kakršno je tudi diklofenak, so indicirana za lajšanje vseh stopenj bolečine in vnetja pri različnih bolezenskih stanjih, vključno z artritičnimi obolenji, akutnimi mišično-skeletnimi okvarami in drugimi bolečimi stanji, ki so posledica poškodb.
Diclofenac containing medicinal products (systemic formulations) are available as tablets, capsules for oral administration, suppositories for rectal administration and solutions for intravenous or intramuscular injection. 
Zdravila, ki vsebujejo diklofenak (sistemske formulacije), so na voljo v obliki tablet, kapsul za peroralno uporabo, svečk za rektalno uporabo in raztopin za intravensko ali intramuskularno injiciranje.
1 For more details on the MEDAL programme, including its components, please refer to the assessment report for the review conducted in 2006 at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/01/WC500054344.pdf. 
2 Za več informacij o pregledu, ki ga je odbor izvedel leta 2012, glejte poročilo o oceni postopka na spletni strani http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/11/WC500134717.pdf.
• The PRAC considered that with regards to the arterial thrombotic risks of diclofenac, the data available to date from randomised clinical trials, observational studies and individual epidemiological studies, including meta-analysis thereof, allow the conclusion that diclofenac is associated with increased cardiovascular risks. 
• PRAC je menil, da je na podlagi dotedanjih razpoložljivih podatkov iz randomiziranih kliničnih preskušanj, opazovalnih študij in posameznih epidemioloških študij, vključno z metaanalizo teh študij, v zvezi z arterijskimi trombotičnimi tveganji diklofenaka mogoče zaključiti, da je diklofenak povezan s povečanimi srčno-žilnimi tveganji.
The study by Krum et al 2012, a post hoc analysis of the MEDAL trial, showed that there was no significant differential effect between etoricoxib and diclofenac in relation to cardiovascular events, except for confirmed congestive heart failure. 
in je bila post hoc analiza preskušanja MEDAL, je pokazala, da ni pomembno drugačnega učinka med etorikoksibom in diklofenakom v povezavi s srčno-žilnimi dogodki, razen za potrjeno kongestivno srčno popuščanje.
In addition, patients with certain cardiovascular risk factors (such as hypertension, hyperlipidaemia, diabetes mellitus or smoking) should only use diclofenac after careful consideration and therefore the warnings should also be updated to reflect this. 
Poleg tega lahko bolniki z nekaterimi srčno-žilnimi dejavniki tveganja (kot so hipertenzija, hiperlipidemija, diabetes in kajenje) diklofenak uporabljajo le po temeljitem premisleku, kar je treba vključiti tudi v opozorila.
With regards to cardiovascular risks, the PRAC noted that the initial signal from the MEDAL programme was confirmed by the meta-analyses of randomised clinical trials conducted by Trelle et al (2011) and Chen and Ashcroft (2007). 
V zvezi s srčno-žilnimi tveganji je PRAC zabeležil, da je bilo začetno sporočilo programa MEDAL potrjeno z metaanalizami randomiziranih kliničnih preskušanj, ki so jih izvedli Trelle in sod.
In addition, patients with certain cardiovascular risk factors (hypertension, hyperlipidaemia, diabetes mellitus, and smoking) should only use diclofenac after careful consideration and therefore the warnings should be updated to reflect this. 
Poleg tega lahko bolniki z določenimi srčno-žilnimi dejavniki tveganja (hipertenzija, hiperlipidemija, diabetes in kajenje) diklofenak uporabljajo le po temeljitem premisleku, kar je treba vključiti tudi v opozorila.
The PRAC concluded that the benefit-risk balance for diclofenac containing medicinal products (systemic formulations) remains favourable subject to the agreed restrictions, warnings, other changes to the product information and additional risk minimisation measures, in the form of a communication letter. 
je PRAC zaključil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo diklofenak (sistemske formulacije), ostaja ugodno, če se spoštujejo dogovorjene omejitve, opozorila, druge spremembe informacij o zdravilu in dodatni ukrepi za zmanjšanje tveganja v obliki sporočila.
Schjerning Olsen et al (2011) provided data on risks in relation to duration of exposure and found that the risks associated with diclofenac were very similar to those of coxibs at all time points. 
(2011) so zagotovili podatke o tveganjih v povezavi s trajanjem izpostavljenosti in zabeležili, da so bila tveganja, povezana z diklofenakom, pri vseh časovnih točkah zelo podobna tveganjem koksibov.
• The PRAC concluded that in view of the currently available safety data in order to maintain a favourable benefit/risk, diclofenac containing medicinal products should be contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. 
• na podlagi trenutno razpoložljivih podatkov o varnosti je PRAC zaključil, da je treba zdravila, ki vsebujejo diklofenak, kontraindicirati pri bolnikih z ugotovljenim kongestivnim srčnim popuščanjem (NYHA II-IV), ishemično boleznijo srca, periferno arterijsko boleznijo in/ali cerebrovaskularnim obolenjem, da se ohrani ugodno razmerje med koristmi in tveganji.
The new evidence provided by marketing authorisation holders including evidence from new casecontrol studies and retrospective studies add to the evidence of an increased risk with diclofenac 
Novi dokazi, ki so jih predložili imetniki dovoljenja za promet z zdravilom, vključno z dokazi iz novih študij „primer-kontrola‟ in retrospektivnih študij, potrjujejo dokaze o povečanem tveganju z diklofenakom v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili in da je tveganje z diklofenakom podobno tveganju s koksibi.
Moreover, the general rule that NSAIDs should be used at the lowest dose for the shortest duration possible should be consistently implemented in the posology section of the product information. 
Nadalje je treba v poglavje o odmerjanju v informacijah o zdravilu dosledno dodati splošno pravilo, da se naj nesteroidna protivnetna sredstva uporabljajo pri nizkih odmerkih za čim krajši čas;
The CMDh, having considered the PRAC recommendation dated 13 June 2013 with regards to diclofenac containing medicinal products (systemic formulations), agrees with the recommendation therein as stated below: 
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMDh) se je po preučitvi priporočila, ki ga je za zdravila, ki vsebujejo diklofenak (sistemske formulacije), dne 13. junija 2013 izdal Odbor za oceno tveganja na področju farmakovigilance (PRAC), strinjala s priporočilom, ki je navedeno v nadaljevanju:
Having noted all of the above, the PRAC concluded that the benefit-risk balance for diclofenac containing medicinal products (systemic formulations) remains favourable subject to the agreed restrictions, warnings, other changes to the product information and additional risk minimisation measures, in the form of a DHPC letter. 
V skladu z zgoraj navedenim je odbor PRAC v obliki pisma DHPC (neposrednega sporočila za zdravstvene delavce) zaključil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo diklofenak (sistemske formulacije), ostaja ugodno, če se spoštujejo dogovorjene omejitve, opozorila, druge spremembe informacij o zdravilu in dodatni ukrepi za zmanjšanje tveganja.
Epidemiological and clinical trial data on the cardiovascular risks of NSAIDs, including diclofenac, were previously reviewed by the Committee for Medicinal Products for Human Use (CHMP). 
Odbor za zdravila za uporabo v humani medicini (CHMP) je predhodno pregledal epidemiološke podatke in podatke iz kliničnih preskušanj o srčno-žilnih tveganjih nesteroidnih protivnetnih zdravil.
The case resolved within three days. 
Težava je bila odpravljena v treh dneh.
This is very rare. 
Do tega pride zelo redko.
Children and adolescents This medicine should not be given to children and adolescents less than 18 years of age. 
Otroci in mladostniki To zdravilo se ne sme dajati otrokom in mladostnikom, mlajšim od 18 let.
These infections are usually easily treated. 
Te okužbe so običajno zlahka ozdravljive.
The condition gets better on its own or with treatment of the infection. 
Stanje se izboljša samo od sebe ali pa z zdravljenjem okužbe.
The following terms represent a group of related events that describes a medical condition rather than a single event. 
Naslednji izrazi predstavljajo skupino povezanih dogodkov, ki bolje opisujejo zdravstveno stanje kot pa en sam dogodek.
All these changes were considered to be incidental and probably related to the intravenous administration procedure. 
Vse te spremembe so bile ocenjene kot naključne in verjetno povezane s postopkom intravenskega dajanja.
Submission of final study results: 
Predložitev končnih rezultatov študije:
If your partner becomes pregnant within three months of your treatment, you must immediately tell your doctor. 
Če vaša partnerka v obdobju treh mesecev med vašim zdravljenjem zanosi, morate to takoj sporočiti vašemu zdravniku.
Phase III Study (PCM301) 
Študija III. faze (PCM301)
However, all stages of spermatogenesis have been observed in animal. 
Vendar so pri živalih opazili vse stopnje spermatogeneze.
In this case, you should contact your doctor as you may need further blood or urine analysis and antibiotics treatment. 
V tem primeru morate stopiti v stik s svojim zdravnikom, saj boste morda potrebovali dodatne analize krvi ali urina in zdravljenje z antibiotiki.
Your medical team will decide if you can leave hospital on the evening of your treatment. 
Ekipa vaših zdravnikov se bo odločila, ali lahko bolnišnico zapustite v večernih urah po zdravljenju.
In 5 (2.5 %) patients, the infection was considered serious. 
Pri 5 (2,5 %) bolnikih je okužba veljala za resno.
No specific dosage recommendation can be given. 
Posebnih priporočil za odmerjanje ni mogoče podati.
The targeted zone corresponds to the lobe containing the positive biopsies. 
Ciljano območje ustreza režnju, ki vsebuje pozitivne biopsije.
Some cases of hepatotoxicity (1.5 %), such as elevation of transaminases, were also reported. 
Poročali so tudi o nekaterih primerih hepatotoksičnosti (1,5 %), kot je povišana raven transaminaz.
Your doctor will also advise what medicines may be substituted where appropriate and when these medicines can be re-started after the VTP procedure. 
Vaš zdravnik vam bo tudi svetoval, katera zdravila je mogoče nadomestiti, kjer je to smiselno, in kdaj po postopku VTP je mogoče začeti s ponovnim jemanjem teh zdravil.
• Explain what side effects the Patient might expect and the likelihood of him getting them 
• pojasnilo, katere neželene učinke lahko bolnik pričakuje in verjetnost, da se bodo pri njem pojavili.
Do not use after the expiry date which is stated on the shield label after “EXP”. 
Ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na zaščitni nalepki poleg oznake „EXP“.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili brez recepta.
Co-administration should be done with caution and close monitoring is recommended. 
Sočasno dajanje je treba izvesti previdno in priporočljivo je natančno spremljanje.
mpMRI may be used to improve the decision making but not, at present, to replace biopsy. 
Za boljše odločanje je mogoče uporabiti mpMRI, ki pa zaenkrat ne more nadomestiti biopsije.
Of the 206 subjects randomised TOOKAD-VTP, 10 did not receive treatment for various reasons including study withdrawal, meeting exclusion criteria, non-compliance and other medical events. 
Od 206 oseb, randomiziranih za postopek TOOKAD-VTP, jih 10 ni bilo zdravljenih iz različnih razlogov, med katerimi so umik iz študije, izpolnjevanje pogojev za izključitev, neskladnost in drugi zdravstveni dogodki.
Erectile dysfunction may occur even if radical prostatectomy is avoided. 
Erektilna disfunkcija se lahko pojavi, tudi če ni prišlo do radikalne prostatektomije.
In case of bilateral disease (discovered at entry or during follow-up), bilateral treatment was to be applied, either simultaneously or consecutively. 
Pri bilateralni bolezni (odkriti ob sprejemu ali med kontrolo) je bilo treba sočasno ali zaporedno uporabiti bilateralno zdravljenje.
Patients meeting indication criteria 
Bolniki, ki izpolnjujejo merila indikacije
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Appendix V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
When 48 hours have passed after the procedure, you can resume your normal activities and you can be exposed to direct sunlight. 
Ko od postopka mine 48 ur, lahko ponovno začnete opravljati svoje običajne dejavnosti, pri čemer ste lahko izpostavljeni tudi sončni svetlobi.
None of these patients required an operation for incontinence. 
Operacije zaradi inkontinence ni potreboval nobeden od teh bolnikov.
ITT population 
Populacija ITT
The pharmacokinetic properties of TOOKAD were studied in 42 healthy human male subjects (without photoactivation) and in 70 patients with localised prostate cancer (after photoactivation). 
Farmakokinetične lastnosti zdravila TOOKAD so bile preučevane pri 42 zdravih moških (brez fotoaktivacije) in pri 70 bolnikih z lokaliziranim rakom prostate (po fotoaktivaciji).
The treatment is carried out under general anaesthetic (medicines that send you to sleep to prevent pain and discomfort). 
Zdravljenje se izvaja pod vplivom splošnih anestetikov (zdravil, ki vas uspavajo, da ne čutite bolečine in nelagodja).
You will be given a general anaesthetic to send you to sleep before the VTP procedure. 
Dobili boste splošne anestetike, da boste pred postopkom VTP zaspali.
The injection lasts 10 minutes. 
Infuzija traja 10 minut.
Urinary excretion of padeliporfin in healthy human subjects was very low (< 0.2 % of the dose). 
Izločanje padeliporfina z urinom pri zdravih moških je bilo zelo majhno (< 0,2 % odmerka).
Simultaneous treatment of both prostate lobes was associated with an inferior outcome in clinical trials and should not be performed. 
Sočasno zdravljenje obeh režnjev prostate je bilo v kliničnih študijah povezano s slabšim izidom in se ne sme izvajati.
Only 1 (0.5 %) patient had a severe (Grade 3) urinary incontinence. 
Samo 1 (0,5 %) bolnik je imel resno urinsko inkontinenco (3. stopnje).
However, patients weighing more than 115 kg will receive more than 1 mmol potassium. 
Vendar bodo bolniki, ki tehtajo več kot 115 kg, prejeli več kot 1 mmol kalija.
Those results were improved at Month 3 and back to baseline values at Month 6, with further improvement until Month 24. 
Ti rezultati so se izboljšali v 3. mesecu, nazaj na izhodiščne vrednosti pa so padli v 6. mesecu, pri čemer so se do 24. meseca še izboljšali.
In consequence there is a potential risk of damage to adjacent structures, such as the bladder and/or rectum, and development of a recto-urethral or external fistula. 
Zato obstaja potencialno tveganje za poškodbe sosednjih struktur, kot sta mehur in/ali danka, ter razvoj rektouretralne ali zunanje fistule.
Padeliporfin di-potassium is highly bound to human plasma proteins (99 %). 
Dikalijev padeliporfin se močno veže na humane plazemske proteine (99 %).
OATP1B1 and OATP1B3 transporters 
Prenašalci OATP1B1 in OATP1B3
A secondary objective was to determine the difference between the two arms with regard to the rate of subsequent radical therapy for prostate cancer. 
Sekundarni cilj je bil določitev razlike med obema krakoma glede na stopnjo naknadnega radikalnega zdravljena raka prostate.
The VTP procedure is performed under general anaesthetic after rectal preparation. 
Postopek VTP se izvaja pod vplivom splošnega anestetika po rektalni pripravi.
This event was not considered to be related to a faulty procedure but rather the pre-existing damage to the internal urethral sphincter from the TURP. 
Tega dogodka niso šteli za povezanega z napačnim postopkom, ampak s predhodno poškodbo notranje mišice zapiralke sečnice zaradi TURP.
Difficulties in getting or maintaining an erection 
Težave pri doseganju ali vzdrževanju erekcije
Sunscreen creams do not protect against near infra-red light and, therefore, do not provide adequate protection. 
Kreme za zaščito pred soncem ne varujejo pred svetlobo z valovno dolžino blizu infrardečega spektra in zato ne zagotavljajo zadostne zaščite.
Check with your doctor about the birth control methods to use and how long to use them for. 
Zdravnika povprašajte o oblikah kontracepcije, ki jih lahko uporabite, in o tem, kako dolgo jih uporabljati.
The MAH shall ensure that in each Member State where TOOKAD is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use TOOKAD have access to/are provided with the following educational package: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da imajo v vsaki državi članici, v kateri se zdravilo TOOKAD trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali in uporabljali zdravilo TOOKAD, dostop ali prejmejo naslednji izobraževalni paket:
This resolved with a small defect in the visual field. 
Težava je bila odpravljena, ostala pa je majhna okvara v vidnem polju.
This may also cause bruising, blood in the urine and/or local pain. 
To lahko povzroči tudi podplutbe, kri v urinu in/ali lokalno bolečino.
- The other ingredient is mannitol. 
- Druga sestavina je manitol.
In addition to the side effects listed previously, other side effects can occur. 
Poleg prej naštetih neželenih učinkov se lahko pojavijo tudi drugi.
Adverse reactions reported are listed below in Table 1 by organ class and frequency. 
Neželeni učinki, o katerih so poročali, so našteti v spodnji preglednici 1 glede na klasifikacijo organov in pogostnost.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to 
Pogostnost je opredeljena na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni
In each table are also presented the results of patients meeting the indication criteria (patients with unilateral low-risk localised prostate cancer excluded the very low-risk) 
V vsaki preglednici so predstavljeni tudi rezultati bolnikov, ki izpolnjujejo merila indikacije (bolniki z unilateralnim nizko tveganim lokaliziranim rakom prostate, razen tistih z zelo nizko tveganim rakom prostate).
Taking into account its molecular mass and the very low urinary excretion of the molecule, faecal elimination is the most probable route of elimination in human. 
Ob upoštevanju njegove molekulske mase in zelo majhnega izločanja molekul z urinom, je način izločanja, ki je pri ljudeh najverjetnejši, izločanje z blatom.
However, this will be exceeded in patients heavier than 115 kg. 
Vendar bo pri bolnikih, težjih od 115 kg, ta količina presežena.
Illumination for photoactivation of TOOKAD 
Osvetlitev za fotoaktivacijo zdravila TOOKAD
All of them were mild in intensity. 
Vsi ti učinki so bili blagi.
12-48 hours after VTP procedure 
12-48 ur po postopku VTP
If you get any of the side effects below, tell your doctor immediately: - Urinary retention (not able to pass urine). 
Če se pri vas pojavi kateri koli od spodaj navedenih neželenih učinkov, to takoj sporočite svojemu zdravniku: - Zastajanje urina (nezmožnost uriniranja).
Current or prior treatment for prostate cancer. 
Trenutno ali predhodno zdravljenje raka prostate.
This medicine is stored under the responsibility of the specialist. 
Za shranjevanje tega zdravila je odgovoren zdravnik specialist.
EU/1/17/1228/002 
EU/1/17/1228/001 EU/1/17/1228/002
Patients who have been diagnosed with cholestasis. 
Bolniki, pri katerih je bila diagnosticirana holestaza.
TOOKAD is for intravenous use. 
Zdravilo TOOKAD je namenjeno intravenski uporabi.
Retreatment of lobes found positive for cancer at 12-months follow-up was allowed. 
Dovoljeno je bilo ponovno zdravljenje režnjev, za katere je bilo na kontroli pri 12 mesecih ugotovljeno, da so pozitivni za raka.
Swirl the vial gently for 2 minutes. 
Vialo 2 minuti nežno sukajte.
This is normally avoidable by careful planning but should it occur there is a risk of an abnormal connection forming between the rectum and the bladder or skin. 
Običajno se je temu mogoče izogniti z natančnim načrtovanjem, če pa kljub temu pride do tega, obstaja tveganje za nastanek nenormalne povezave med danko in mehurjem ali kožo.
This includes sunbeds, bright computer monitor screens (see precautions below), and examination lights from medical equipment. 
To vključuje solarije, bleščeče zaslone računalnikov (glejte spodaj navedene previdnostne ukrepe) in luči opreme za medicinske preiskave.
At present TOOKAD-VTP has been shown to defer the need for radical therapy and its associated toxicity. 
Zaenkrat so dokazali, da postopek TOOKAD-VTP odloži potrebo po radikalnem zdravljenju in z njim povezano toksičnost.
Store in a refrigerator (2°C-8°C). 
Shranjujte v hladilniku (pri 2-8 °C).
The following types of medicines may be ones that your doctor will advise you to stop temporarily: 
Vrste zdravil, za katere vam zdravnik lahko svetuje, da jih prenehate jemati, so lahko naslednje:
Therefore, the possibility for some in vivo metabolism of padeliporfin cannot be fully excluded. 
Zato možnosti za določeno presnovo padeliporfina in vivo ni mogoče v celoti izključiti.