natgillin/translations-raw huggingface dataset:
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III. 
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
The arbitration procedure started on 27 April 2006. 
Arbitražni postopek se je začel 27. aprila 2006.
During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. 
Med svojim zasedanjem junija 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem in povezana imena ugodno, ter da podani ugovori ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
The scope of the referral was to agree whether Doxazosin “Winthrop” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food. 
Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic CHMP o načrtovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana.
Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names (Doxazosin) is receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia. 
Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem in povezana imena (Doxazosin) vsebujejo snov, ki blokira receptor alfa in se uporablja za zdravljenje bolnikov z esencialno hipertenzijo in simptomatično zdravljenje bolnikov z benigno hiperplazijo prostate.
Winthrop Pharmaceuticals UK Ltd submitted applications for mutual recognition of Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002. 
Družba Winthrop Pharmaceuticals UK Ltd je podala vloge za medsebojno priznavanje zdravila Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem in povezana imena na podlagi dovoljenja za promet z zdravilom, ki ga je izdala Danska dne 30. septembra 2002.
Supplementary information was provided by the Marketing Authorisation Holder on 23 May 2006. 
Imetnik dovoljenja za promet z zdravilom je predložil dodatne informacije dne 23. maja 2006, ustna pojasnila pa je podal 27. junija 2006.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin 
Doxazosin “Winthrop” 4 mg tablete s podaljšanim sproščanjem in povezana imena Mednarodno nelastniško ime (INN): Doxazosin
The study should be based on an agreed protocol. 
Študija mora temeljiti na dogovorjenem protokolu.
Date of first authorisation: 15 November 2012 Date of latest renewal: 13 July 2017 
Datum prve odobritve: 15. november 2012 Datum zadnjega podaljšanja: 13. julij 2017
The level of efficacy varied between the individual anatomical locations. 
Raven učinkovitosti se je razlikovala med posameznimi anatomskimi lokacijami.
No overall differences in safety or efficacy were observed between younger and older patients. 
Med mlajšimi in starejšimi bolniki niso opazili splošnih razlik v varnosti ali učinkovitosti.
8 weeks after randomisation 
8 tednov po randomizaciji
Results demonstrated no systemic absorption. 
Rezultati niso pokazali sistemske absorpcije.
The final study report shall be submitted: 
Končno poročilo študije je treba predložiti do:
Long term efficacy 
Dolgoročna učinkovitost
to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data). 
do < 1/1.000); zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
This leaflet was last revised in. 
Navodilo je bilo nazadnje revidirano .
Actinic keratosis does not occur in children, and this medicine must not be used in children and adolescents under 18 years of age. 
Aktinična keratoza se ne pojavlja pri otrocih, zato tega zdravila ne smete uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Local skin responses 
Lokalni odzivi kože
d p<0.001; compared to vehicle by logistic regression with treatment, study and anatomical location. 
d p < 0,001; v primerjavi z vehiklom glede na logistično regresijo z zdravljenjem, študijo in anatomsko umestitvijo.
Contact your doctor if these local skin reactions get severe. 
Obrnite se na svojega zdravnika, če te lokalne kožne reakcije postanejo hude.
The tube is for single use only and should be discarded after use (see section 6.6). 
Tuba je namenjena samo enkratni uporabi, zato jo po uporabi zavrzite (glejte poglavje 6.6).
gel 2 tubes 
gel 2 tubi
Patients were followed every 3 months for 12 months (see table 5). 
Bolnike so spremljali 12 mesecev vsake 3 mesece (glejte preglednico 5).
Back of Hand 
Roka Hrbtni del dlani
- If you are allergic to ingenol mebutate or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na ingenolmebutat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Wash the area with soap and water. 
Umijte mesto z milom in vodo.
- Do not apply more gel than your doctor has advised. 
- Ne nanašajte več gela, kot vam je naročil zdravnik.
Treatment effect may not be adequately assessed until resolution of local skin responses. 
Učinka zdravljenja morda ne bo mogoče ustrezno oceniti, dokler se ne pozdravijo lokalni odzivi kože.
- Allow the area to dry for 15 minutes. 
- Počakajte 15 minut, da se posuši.
At 12 months, the complete clearance rates in these groups were 31% and 19% respectively. 
V 12. mesecu sta bili stopnji popolne ozdravitve v teh skupinah 31 % in 19 %.
If you have been prescribed two different strengths for treatment of two different areas you should make sure that you use the prescribed strength on the correct area. 
Če so vam predpisali dve različni jakosti gela za zdravljenje na dveh različnih mestih, morate poskrbeti, da boste uporabljali predpisano jakost na pravem mestu.
Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, other chemotherapeutics, ATC code: D06BX02. 
Farmakoterapevtska skupina: antibiotiki in kemoterapevtiki za uporabo v dermatologiji, drugi kemoterapevtiki, oznaka ATC: D06BX02.
149 patients in the Picato group and 140 in the vehicle group were followed for 12 months. 
149 bolnikov v skupini z zdravilom Picato in 140 v skupini z vehiklom so spremljali 12 mesecev.
The trial included a large group of severely sun-damaged patients. 
Preskušanje je vključevalo veliko skupino bolnikov s hujšimi poškodbami zaradi sonca.
If you use Picato for treatment of the neck 
Če uporabljate zdravilo Picato za zdravljenje vratu
Othera aOther includes shoulder, back, leg. 
Prsni koš Drugoa aDrugo vključuje ramo, hrbet, nogo.
- Avoid sunlight as much as possible (including sunlamps and tanning beds). 
- Čim bolj se izogibajte sončni svetlobi (tudi svetilkam za sončenje in solarijem).
Experience with more than one treatment course 
Izkušnje z več kot enim ciklom zdravljenja
You should avoid the use of Picato if you are pregnant. 
Izogibajte se uporabi zdravila Picato, če ste noseči.
Seek medical attention right away if you experience an allergic reaction that may include swelling of the mouth, tongue or throat when using this medicine. 
Nemudoma poiščite zdravniško pomoč, če ob uporabi tega zdravila doživite alergijsko reakcijo, ki lahko zajema otekanje ustne votline, jezika ali grla.
The PRAC is of the opinion that a thorough review is needed of the impact of all available data related to skin malignancies, including the results of study LP0041-63, on the benefit risk balance of Picato. 
Odbor PRAC meni, da je potreben temeljit pregled vpliva vseh razpoložljivih podatkov, povezanih z malignimi obolenji kože, vključno z rezultati študije LP0041-63, na razmerje med tveganji in koristmi zdravila Picato.
- Do not swallow this medicine. 
- Zdravila ne zaužijte.
Do not apply Picato on open-wounds or damaged skin. 
Ne nanašajte zdravila Picato na odprte rane ali poškodovano kožo.
If you have previously used Picato or other similar medicines tell your doctor before starting the treatment. 
Če ste pred tem uporabljali zdravilo Picato ali druga podobna zdravila, to povejte svojemu zdravniku pred začetkom zdravljenja.
Remove the cap from the tube just before use. 
Pokrovček s tube odstranite tik pred uporabo.
Management of overdose should consist of treatment of clinical symptoms. 
Obravnava prevelikega odmerjanja naj obsega zdravljenje kliničnih simptomov.
Risk of progression to squamous cell carcinoma 
Tveganje za napredovanje v skvamozni karcinom
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
In rabbits there were no major abnormalities. 
Pri kuncih ni bilo večjih nenormalnosti.
The compliance rate was high, with 98% of the patients completing these studies. 
Odstotek bolnikov, ki se redno zdravili, je bil visok, pri čemer je 98 % bolnikov zaključilo študiji.
However, due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised. 
Vendar pa se je treba zaradi narave bolezni izogibati čezmerni izpostavitvi sončni svetlobi (tudi porjavitvenim svetilkam in solarijem) ali izpostavitev čim bolj zmanjšati.
The side effects may get worse for up to 1 week after you have stopped using this medicine. 
Neželeni učinki se lahko slabšajo še 1 teden po prenehanju uporabe tega zdravila.
There are no data from the use of ingenol mebutate in pregnant women. 
Podatkov o uporabi ingenolmebutata pri nosečnicah ni.
Do not re-use the tubes once opened. 
Odprtih tub ne uporabite ponovno.
Elderly population No dose adjustment is required (see section 5.1). 
Starejši bolniki Prilagoditev odmerka ni potrebna (glejte poglavje 5.1).
Picato must not be ingested. 
Zdravila Picato se ne sme zaužiti.
On the treatment area: 
Na zdravljenem mestu:
Additionally, the product information should be varied concerning ingenol mebutate use and the risk of skin malignancy. 
Poleg tega je treba spremeniti informacije o zdravilu v zvezi z uporabo ingenolmebutata in tveganjem za maligno obolenje kože.
c Of these, 38 subjects were previously treated in a vehicle controlled phase 3 study and 38 subjects were previously treated in an uncontrolled phase 3 study. 
c 38 oseb je bilo predhodno zdravljenih v študiji 3. faze, nadzorovani z vehiklom, 38 oseb pa je bilo predhodno zdravljenih v nenadzorovani študiji 3. faze.
What Picato is and what it is used for 
Kaj je zdravilo Picato in za kaj ga uporabljamo
What Picato is and what it is used for What you need to know before you use Picato How to use Picato 
Kaj je zdravilo Picato in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Picato Kako uporabljati zdravilo Picato
Should the symptoms described above intensify beyond the first week after you have stopped using this medicine, or if there is discharge of pus, you might have an infection and should contact your doctor or pharmacist. 
Če se zgoraj opisani simptomi okrepijo po preteku prvega tedna od prenehanja uporabe tega zdravila ali če iz mesta izteka gnoj, imate morda okužbo in morate obiskati svojega zdravnika ali farmacevta.
Other medicines and Picato 
Druga zdravila in zdravilo Picato
The results of the randomised and blinded second treatment course are presented in table 6. 
Rezultati randomiziranega in slepega drugega kroga zdravljenja so predstavljeni v preglednici 6.
Take care not to transfer gel from the treatment area into your eyes. 
Pazite, da ne prenesete gela z zdravljenega predela v oči.
Efficacy, measured as complete and partial clearance rate, as well as median percent reduction, was assessed at day 57 (see table 2). 
Učinkovitost, izmerjena kot popolna in delna ozdravitev lezij, in mediano odstotno zmanjšanje sta bila ocenjena 57. dan (glejte preglednico 2).
- Be vigilant for any new scaly red patches, open sores, elevated or warty growths within the treatment area. 
- Bodite pozorni na morebitne nove luskaste rdeče zaplate, odprte rane, dvignjene ali bradavičaste tvorbe na zdravljenem mestu.
Actinic keratoses are rough areas of skin found in people who have been exposed to too much sunshine over the course of their lifetime. 
Aktinična keratoza so predeli grobe kože pri ljudeh, ki so bili v življenju čezmerno izpostavljeni sončnim žarkom.
Should any occur, talk to your doctor immediately. 
Če se pojavijo, se takoj posvetujte z zdravnikom.
If an area on the face or scalp and another area on the trunk or extremities are simultaneously treated, then patients should be advised to ensure they use the appropriate strengths. 
Če se zdravi mesto na obrazu, lasišču in drugem področju trupa ali okončin istočasno, je treba bolnikom svetovati, da uporabljajo zdravilo ustrezne jakosti.
Only those patients who achieved complete clearance in the treated area at the end of the phase 3 studies (day 57) were eligible for long term follow-up. 
Samo bolniki, pri katerih se je pojavila popolna ozdravitev lezij na zdravljenem mestu ob koncu študij 3. faze (57. dan), so izpolnjevali pogoje za dolgoročno spremljanje.
These results did not change the safety profile of Picato (see section 5.1). 
Ti rezultati niso spremenili varnostnega profila zdravila Picato (glejte poglavje 5.1).
What you need to know before you use Picato Do not use Picato 
Kaj morate vedeti, preden boste uporabili zdravilo Picato Ne uporabljajte zdravila Picato
Caps of HDPE. 
Pokrovčki iz HDPE.
For single use only Read the package leaflet before use. 
Samo za enkratno uporabo Pred uporabo preberite priloženo navodilo!
On each scheduled dosing day, the study gel was applied to the entire treatment area. 
Vsak predviden dan odmerjanja so proučevani gel nanesli na celotno prizadeto mesto.
Paediatric population There is no relevant use of Picato in the paediatric population. 
Pediatrična populacija Zdravilo Picato ni primerno za uporabo pri pediatrični populaciji.
Optimal therapeutic effect can be assessed approximately 8 weeks after treatment. 
Optimalne učinke zdravljenja je mogoče oceniti približno 8 tednov po zdravljenju.
Tubes should be discarded after first opening. 
Odprte tube po prvem odprtju zavrzite.
If you forget to use Picato 
Če ste pozabili uporabiti zdravilo Picato
If you use more Picato than you should 
Če ste uporabili večji odmerek zdravila Picato, kot bi smeli
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
In vivo and in vitro models have shown a dual mechanism of action for the effects of ingenol mebutate: 1) induction of local lesion cell death and 2) promoting an inflammatory response characterised by local production of proinflammatory cytokines and chemokines and infiltration of immunocompetent cells. 
Modeli in vivo ter in vitro so pokazali dvojni mehanizem delovanja za učinke ingenolmebutata: 1) povzročitev smrti celic v lokalni leziji in 2) pospeševanje vnetnega odziva, za katerega sta značilna lokalna tvorba vnetnih citokinov in kemokinov ter infiltracija imunokompetentnih celic.
b Cochran-Mantel-Haenszel test of Picato® gel 150 mcg/g compared to vehicle adjusted for anatomical location (face/scalp) and country. 
b Cochran-Mantel-Haenszelov test z gelom Picato 150 µg/g v primerjavi z vehiklom, prilagojen glede na anatomski predel (obraz ali lasišče) in državo.
Three prospective, observational long term 1 year follow-up studies were conducted to evaluate sustained efficacy by recurrence of actinic keratosis lesions in the treatment field, and safety in patients who had received treatment with Picato. 
Izvedene so bile tri prospektivne dolgotrajne opazovalne študije z 1-letnim sledenjem za ocenitev trajne učinkovitost na podlagi ponovnega nastanka lezij aktinične keratoze na zdravljenem mestu ter varnosti bolnikov, zdravljenih z zdravilom Picato.
Lesions clinically atypical for actinic keratosis or suspicious for malignancy should be biopsied to determine appropriate treatment. 
Pri lezijah, ki so klinično atipične za aktinično keratozo ali so sumljive za malignost, je treba opraviti biopsijo, za določitev primernega zdravljenja.
Necrosis in the dermis was rarely observed. 
Nekroza usnjice je bila redko opažena.
The first treatment course, given open label, resulted in a complete clearance rate of 62% (277/450). 
V prvem krogu zdravljenja, ki je bil odprt, so dosegli 62odstotno stopnjo popolne ozdravitve (277/450).
Localised skin responses are transient and typically occur within 1 day of treatment initiation and peak in intensity up to 1 week following completion of treatment. 
Lokalizirani odzivi kože so prehodni in se običajno pojavijo v 1 dnevu od začetka zdravljenja, največjo intenzivnost pa dosežejo en teden po zaključku zdravljenja.
Overdosing of Picato could result in an increased incidence of local skin responses. 
Preveliko odmerjanje zdravila Picato lahko povzroči povečano incidenco lokalnih odzivov kože.
The gel from the tube should be squeezed onto a fingertip and spread evenly over the entire treatment area, allowing it to dry for 15 minutes. 
Gel iz tube iztisnite na konico prsta, ga enakomerno porazdelite po celotni površini prizadetega mesta in počakajte 15 minut, da se posuši.
This medicine is used for topical (on the skin) treatment of actinic keratosis, also called solar keratosis, in adults. 
To zdravilo se uporablja za topično zdravljenje (na koži) aktinične keratoze, ki se imenuje tudi solarna keratoza, pri odraslih bolnikih.
Partial Clearance( ≥ 75%) 
Delna ozdravitev (≥ 75 %)
Health care professionals should advise patients to be vigilant for any lesions developing within the treatment area and to seek medical advice immediately should any occur. 
Zdravstveni delavci morajo bolnikom svetovati, naj bodo pozorni na morebitne nove lezije, ki se pojavijo na zdravljenem mestu, in naj v primeru nastanka le-teh takoj poiščejo zdravniško pomoč.
In vitro study results demonstrate that ingenol mebutate does not inhibit or induce human cytochrome P450 isoforms. 
Rezultati študije in vitro so pokazali, da ingenolmebutat ne zavira in ne inducira izoform humanega citokroma P450.
As a precautionary measure, it is preferable to avoid the use of Picato during pregnancy. 
Iz previdnostnih razlogov se je uporabi zdravila Picato med nosečnostjo bolje izogibati.
- Squeeze the gel from one tube onto a fingertip. 
- Gel iz ene tube iztisnite na konico prsta.
- Do not apply this medicine internally, to the area near the eyes, to the inside of the nostrils, the inside of the ear or on the lips. 
- Tega zdravila ne našajte na notranje dele, v bližino oči, na notranjo stran nosnic, notranjost ušes ali na ustnice.
Hypersensitivity (including angioedema) 
Bolezni imunskega sistema preobčutljivost (vključno z angioedemom)
On the basis of the scientific conclusions for ingenol mebutate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ingenol mebutate is unchanged subject to the proposed changes to the product information 
Na podlagi znanstvenih zaključkov za ingenolmebutat odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) ingenolmebutat, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
After this period, the treatment area may be washed using mild soap and water. 
Po preteku tega časa lahko zdravljeno mesto umijete z blagim milom in vodo.
To be printed on the inside of the carton lid: 
Natisnjeno na notranji strani pokrovčka škatle:
Of the 1,165 patients treated with Picato in the actinic keratosis clinical studies conducted with ingenol mebutate gel, 656 patients (56%) were 65 years and older, while 241 patients (21%) were 75 years and older. 
Od 1.165 bolnikov, zdravljenih z zdravilom Picato v kliničnih študijah aktinične keratoze z gelom z ingenolmebutatom, je bilo 656 bolnikov (56 %) starih 65 let ali več, 241 bolnikov (21 %) pa je bilo starih 75 let ali več.
- The full effect of Picato can be evaluated approximately 8 weeks after treatment. 
- Polni učinek zdravila Picato je mogoče oceniti po približno 8 tednih zdravljenja.
Picato has no or negligible influence on the ability to drive and use machines. 
Zdravilo Picato nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Following the application of ingenol mebutate, most patients (>95%) experienced one or more local skin response(s). 
Po nanosu gela z ingenolmebutatom se je pri večini bolnikov (> 95 %) pojavil en ali več lokalnih kožnih odzivov.
They will usually get better within 2 weeks from when you started the treatment. 
Običajno se izboljšajo v 2 tednih po začetku zdravljenja.
Ingenol mebutate gel did not demonstrate any potential for photo irritation or photo allergic effects. 
Gel z ingenolmebutatom ni pokazal nobenega potenciala za draženje zaradi svetlobe ali za fotoalergijske učinke.
They will usually get better within 4 weeks from when you started the treatment. 
Običajno se izboljšajo v 4 tednih po začetku zdravljenja.
- Do not apply this medicine immediately after taking a shower or less than 2 hours before bedtime. 
- Tega zdravila ne nanašajte takoj po prhanju ali manj kot 2 uri pred spanjem.
Eleven weeks after baseline which is 8 weeks after Picato gel or vehicle, the complete clearance rate was 61% among patients randomised to Picato gel, and 49% among patients randomised to vehicle. 
Enajst tednov po izhodišču, kar ustreza 8 tednom po uporabi gela Picato ali vehikla, je bila stopnja popolne ozdravitve 61 % pri bolnikih, randomiziranih na gel Picato, in 49 % pri bolnikih, randomiziranih na vehikel.
Contact with the eyes can cause chemical conjunctivitis and corneal burns. 
Izpostavljenost oči Pri stiku z očmi lahko pride do kemično povzročenega vnetja očesne veznice in opeklin roženice.
Experience with treatment of a larger area 
Izkušnje z zdravljenjem večjih predelov