natgillin/translations-raw huggingface dataset:
The main measure of effectiveness was the time patients lived until their disease got worse. 
Glavno merilo učinkovitosti je bil čas preživetja bolnikov do poslabšanja bolezni.
This is expected to slow down the growth and proliferation of cancer cells. 
S tem naj bi se upočasnila rast in proliferacija rakavih celic.
Withdrawal of the marketing authorisation application for Jenzyl (ridaforolimus) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Jenzyl (ridaforolimus)
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions. 
Vlogo so umaknili po tem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
The company had not yet responded to the last round of questions at the time of the withdrawal. 
Ob umiku vloge družba še ni odgovorila na zadnji krog vprašanj.
The summary of the opinion of the Committee for Orphan Medicinal Products for Jenzyl can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (soft tissue sarcoma and primary malignant bone tumours). 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Jenzyl je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (sarkom mehkih tkiv in primarni maligni kostni tumorji).
Jenzyl is a medicine that contains the active substance ridaforolimus. 
Jenzyl je zdravilo, ki vsebuje zdravilno učinkovino ridaforolimus.
Since mTOR is involved in the control of cell division and the growth of blood vessels, ridaforolimus prevents the division of tumour cells and reduces their blood supply. 
Ker mTOR sodeluje pri uravnavanju delitve celic in rasti krvnih žil, ridaforolimus preprečuje delitev tumorskih celic in zmanjšuje njihovo oskrbo s krvjo.
What is Jenzyl? 
Kaj je zdravilo Jenzyl?
The CHMP also considered that the somewhat larger effect seen in patients who had received two or three previous regimens of chemotherapy compared with those who received one or more regimens might not reflect the medicine's true effect size, as the reason the medicine would work better at later stages of the disease was unclear. 
CHMP je tudi menil, da nekoliko večji učinek zdravila pri bolnikih, ki so prejeli dva ali tri režime predhodne kemoterapije, v primerjavi z bolniki, ki so prejeli enega ali več režimov, ne odraža nujno dejanskega obsega učinka zdravila, saj ni bilo pojasnjeno, zakaj naj bi bilo zdravilo učinkovitejše v poznejšem obdobju bolezni.
The company presented the results of one main study involving 711 patients with metastatic soft tissue sarcoma or bone sarcoma who have received up to four cycles of one, two or three alternative chemotherapy regimens. 
Družba je predložila rezultate ene glavne študije, ki je zajela 711 bolnikov z metastatskim sarkomom mehkih tkiv ali kostnim sarkomom, ki so prejeli do štiri cikluse enega, dveh ali treh alternativnih režimov kemoterapije.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Jenzyl. 
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Jenzyl.
It was expected to be used as maintenance therapy in patients who have already received two or three regimens of chemotherapy. 
Zdravilo naj bi se uporabljalo za vzdrževalno zdravljenje bolnikov, ki so že bili zdravljeni z dvema ali tremi režimi kemoterapije.
In the body, ridaforolimus first attaches to a protein called FKBP-12 that is found inside cells to make a ‘complex'. 
Ridaforolimus se v telesu najprej veže na beljakovino v celicah, imenovano FKBP-12, in z njo tvori „skupek”.
The study compared Jenzyl with placebo (a dummy treatment). 
V študiji so zdravilo Jenzyl primerjali s placebom (zdravilom brez zdravilne učinkovine).
This complex then blocks mTOR. 
Ta skupek nato zavira encim mTOR.
In terms of safety, the CHMP was concerned by the high frequency of side effects interfering with the patient's wellbeing as well as some uncommon but potentially lifethreatening side effects. 
Pri ocenjevanju varnosti zdravila je bil CHMP zaskrbljen zaradi pogostih stranskih učinkov, ki vplivajo na dobro počutje bolnika, in zaradi občasnih stranskih učinkov, ki so lahko smrtno nevarni.
What was Jenzyl expected to be used for? 
Za kaj naj bi se zdravilo Jenzyl uporabljalo?
The CHMP was concerned that taking Jenzyl only led to a small increase in the time patients lived until their disease got worse compared with placebo (18 versus 15 weeks in patients who had one or more regimens of previous chemotherapy, and 16 versus 10 weeks in patients who had received two or three previous regimens of chemotherapy). 
CHMP je izrazil pomislek, da se je čas preživetja bolnikov do poslabšanja bolezni ob jemanju zdravila Jenzyl zgolj nekoliko podaljšal v primerjavi s placebom (s 15 na 18 tednov pri bolnikih, ki so prejeli enega ali več režimov predhodne kemoterapije, in z 10 na 16 tednov pri bolnikih, ki so prejeli dva ali tri režime predhodne kemoterapije).
Jenzyl was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 August 2005 and 28 October 2005 for the treatment of soft tissue sarcoma and primary malignant bone tumours. 
Zdravilo Jenzyl je bilo dne 26. avgusta 2005 in 28. oktobra 2005 določeno kot „zdravilo sirota” (zdravilo za zdravljenje redkih bolezni) za zdravljenje sarkoma mehkih tkiv in primarnih malignih kostnih tumorjev.
On 27 November 2012, Merck Sharp & Dohme Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Jenzyl, for the maintenance treatment of patients with metastatic soft tissue sarcoma or bone sarcoma previously treated with chemotherapy. 
Družba Merck Sharp & Dohme Limited je dne 27. novembra 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Jenzyl, namenjenim vzdrževalnemu zdravljenju bolnikov z metastatskim sarkomom mehkih tkiv ali kostnim sarkomom, ki so že bili zdravljeni s kemoterapijo.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Jenzyl could not have been approved for the treatment of patients with metastatic soft tissue sarcoma or bone sarcoma as maintenance therapy. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Jenzyl ni mogoče odobriti za vzdrževalno zdravljenje bolnikov z metastatskim sarkomom mehkih tkiv ali kostnim sarkomom.
Jenzyl was expected to be used for the treatment of adults with soft tissue sarcoma (a type of cancer that affects the soft, supporting tissues of the body) or bone sarcoma (bone cancer) that are metastatic (have spread to other parts of the body). 
Zdravilo Jenzyl naj bi se uporabljalo za zdravljenje odraslih s sarkomom mehkih tkiv (vrsto raka, ki prizadene mehka vezivna tkiva v telesu) ali kostnim sarkomom (kostnim rakom), ki je metastaziral (se je razširil v druge dele telesa).
In its letter notifying the Agency of the withdrawal of application, the company stated that it decided to withdraw the application since the CHMP considered that the data provided did not allow the Committee to conclude on a positive benefit-risk balance. 
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila, ker je CHMP presodil, da predloženi podatki ne dokazujejo pozitivnega razmerja med koristmi in tveganji.
The active substance in Jenzyl, ridaforolimus, blocks the action of an enzyme called ‘mammalian target of rapamycin' (mTOR), which regulates the growth and division of cells in the body and which has increased activity in patients with sarcoma. 
Zdravilna učinkovina v zdravilu Jenzyl, ridaforolimus, zavira delovanje encima, imenovanega „tarča rapamicina pri sesalcih” (mTOR), ki uravnava rast in delitev celic v telesu in ki pri bolnikih s sarkomom deluje s povečano aktivnostjo.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Jenzyl did not outweigh its risks. 
Zato je CHMP v času umika menil, da koristi zdravila Jenzyl ne odtehtajo z njim povezanih tveganj.
How is Jenzyl expected to work? 
Kako naj bi zdravilo Jenzyl delovalo?
The CHMP considered this benefit to be modest, when taking into account that patients usually survived for a long time after their disease had progressed. 
Ker so bolniki običajno živeli dolgo časa po tem, ko je bolezen napredovala, je CHMP presodil, da so koristi zdravila majhne.
5 x 2 tablets 
5 x 2 tableti
Package sizes perforated unit dose blister (PVC/Alu) 
Peroralno Perforiran pretisni omot za enkratni odmerek (PVC/Alu)
Invented name Strength Pharmaceutical form Route of administration Packaging 
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
MA (EU) number (Invented) name 
Številka (EU)
Route of Administration 
dovoljenja za promet
Pack size 
Error!
Content (concentration) 
(Izmišljeno)
This difference was not statistically significant. 
Ta razlika ni bila statistično pomembna.
Therefore, these findings are considered to be incidental. 
Iz tega razloga se ta opažanja štejejo za naključna.
The significance for man is unknown. 
Pomen tega opažanja za človeka ni znan.
Mice were maintained for an additional 12 weeks. 
Miši so opazovali še dodatnih 12 tednov.
This includes studies with immunosuppressive medicinal products. 
To vključuje študije z imunosupresivnimi zdravili.
While these changes have tended to improve with time, in some patients they may be permanent. 
Čeprav so se te spremembe s časom izboljšale, pa so lahko nekaterih bolnikih trajne.
• if you have previously used this medicine or other similar preparations in a different concentration. 
- če ste že kdaj uporabljali to zdravilo ali kakšen drug podoben pripravek drugačne koncentracije.
There is also a possibility that existing inflammation may temporarily worsen. 
Obstaja tudi verjetnost začasnega poslabšanja obstoječega vnetja.
This medicine contains 5 mg benzyl alcohol in each sachet. 
To zdravilo vsebuje 5 mg benzil alkohola v vsaki vrečki.
Do not use this medicine until your doctor has shown you the right way to use it. 
Ne uporabljajte tega zdravila, dokler vam zdravnik ne bo pokazal, kako ga pravilno uporabljamo.
These patients should be monitored under the close supervision of an experienced physician. 
Te bolnike je treba spremljati pod skrbnim nadzorom izkušenega zdravnika.
If you go outside during the day use sunscreen and wear protective clothing and a wide-brimmed hat. 
Če greste podnevi na prosto, uporabite sončno kremo ter nosite zaščitna oblačila in klobuk s širokimi krajci.
Leave Zyclara on the skin for about 8 hours. 
Pustite zdravilo Zyclara na koži približno 8 ur.
Frequencies are defined as: 
Pogostnost neželenih učinkov je definirana kot:
It is the lead compound of the imidazoline family. 
Je vodilna spojina družine imidazolinov.
- if you are allergic to imiquimod or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na imikvimod ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
These local skin reactions may be related to the stimulation of local immune response. 
Te lokalne kožne reakcije so lahko povezane s stimulacijo lokalnega imunskega odziva.
This medicine should not be given to children below the age of 18 years because the safety and efficacy in patients below the age of 18 years have not been established. 
Tega zdravila ne smemo dati otrokom, starim do 18 let, ker varnost in učinkovitost pri bolnikih, starih do 18 let, še nista bili dokazani.
Follow-up information suggests that these skin colour changes may be permanent in some patients. 
Spremljanje podatkov nakazuje, da so lahko te spremembe barve kože pri nekaterih bolnikih trajne.
Management of overdose should consist of treatment of clinical symptoms. 
Zdravljenje prevelikega odmerjanja mora vsebovati zdravljenje kliničnih simptomov.
This medicine stimulates your body's own immune system to produce natural substances which help fight your actinic keratosis. 
To zdravilo spodbuja vaš imunski sistem, da proizvaja naravne snovi, ki pomagajo v boju proti aktinični keratozi.
These areas can be the same colour as your skin or are greyish, pink, red or brown. 
Ta področja so lahko enake barve kot koža ali pa sivkaste, rožnate ali rjave barve.
White to faintly yellow cream with a uniform appearance. 
krema Bela do bledo rumena krema z enotnim videzom.
He may advise you to stop applying this medicine for a few days (i.e. to have a short rest from treatment). 
Morda vam bo priporočil, da prekinete uporabo tega zdravila za nekaj dni (t.j.
Fertility No clinical data are available, potential risk for human is unknown. 
Plodnost Kliničnih podatkov ni na voljo, morebitno tveganje za ljudi je neznano.
Studies in animals do not indicate direct or indirect harmful effects in pregnancy. 
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov med nosečnostjo.
Your doctor will discuss the risks and benefits of using Zyclara during pregnancy. 
Zdravnik se bo z vami pogovoril glede tveganj in koristi uporabe zdravila Zyclara med nosečnostjo.
Excipients with known effects: 
Pomožne snovi z znanim učinkom:
These reductions are not considered to be clinically significant in patients with normal haematologic reserve. 
Ta zmanjšanja se ne štejejo za klinično pomembna pri bolnikih z normalnimi hematološkimi vrednostmi.
In some individuals a lowering of blood counts was noted (frequency not known). 
Pri nekaterih posameznikih so opazili zmanjšanje števila krvnih celic (neznana pogostnost).
Hypopigmentation and hyperpigmentation 
Hipopigmentacija in hiperpigmentacija
Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, antivirals, ATC Code: D06BB10 
Farmakoterapevtska skupina: antibiotiki in kemoterapevtiki za uporabo v dermatologiji, protivirusna zdravila, oznaka ATC: D06BB10
Date of first authorisation: 23/08/2012 Date of latest renewal: 22/03/2017 
Datum prve odobritve: 23.08.2012 Datum zadnjega podaljšanja: 22.03.2017
• if you have an abnormal blood count. 
- če imate nenormalno krvno sliko.
• if you have problems with your immune system or if you take medicine to suppress your immune system (e.g. after an organ transplant). 
- če imate težave z vašim imunskim sistemom ali če jemljete zdravila za zaviranje odziva imunskega sistema (npr. po presaditvi organa).
• Only use the cream externally (on the skin of face or scalp). 
- Krema je namenjena samo za zunanjo uporabo (na koži obraza ali na lasišču).
What Zyclara is and what it is used for 
Kaj je zdravilo Zyclara in za kaj ga uporabljamo
Zyclara should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 
Zdravilo Zyclara se lahko uporablja med nosečnostjo le če morebitna korist upravičuje morebitno tveganje za plod.
It is not known whether imiquimod passes into breast milk. 
Ni znano, ali imikvimod prehaja v materino mleko.
The clinical outcome of therapy has to be determined after regeneration of the treated skin, approximately 8 weeks after the end of treatment and on appropriate intervals thereafter based on clinical judgment. 
Klinični izid zdravljenja je treba oceniti po regeneraciji zdravljene kože, približno 8 tednov po končanem zdravljenju in ob primernih časovnih presledkih na osnovi klinične presoje.
If there is pus or another sign of skin infection (frequency not known), discuss this with your doctor. 
Če se pojavi gnoj ali drug znak okužbe kože (neznana pogostnost), se posvetujte z zdravnikom.
There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema). 
Obstaja povezava med stopnjo popolnega izginotja in intenzivnostjo lokalnih kožnih reakcij (npr. eritema).
even if their sign of illness are the same as yours. 
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
Response to treatment cannot be adequately assessed until resolution of local skin reactions. 
Odziva na zdravljenje ni mogoče ustrezno oceniti, dokler se lokalne kožne reakcije ne umirijo.
Only in female mice, the incidences of hepatocellular adenomas were slightly greater than those for controls. 
Le pri samicah je bila pojavnost hepatoceličnih adenomov nekoliko večja kot pri kontrolnih živalih.
Do not shower or bathe the area during this time. 
V tem času se ne prhajte ali kopajte.
During this period, showering and bathing should be avoided. 
V tem času se je treba izogibati prhanju ali kopanju.
Biotransformation Orally administered imiquimod is rapidly and extensively metabolised into two main metabolites. 
Peroralno uporabljen imikvimod se hitro in obsežno presnavlja v dva glavna metabolita.
As imiquimod has low systemic absorption from human skin, and is not mutagenic, any risk to humans from systemic exposure is likely to be low. 
Ker ima imikvimod pri ljudeh majhno sistemsko absorpcijo iz kože in ni mutagen, je tveganje za človeka, ki bi izviralo iz sistemske izpostavitve, verjetno nizko.
Data presented in the table below reflects: - exposure to Zyclara or vehicle in above mentioned studies (frequencies very common to uncommon and at greater frequency after vehicle). 
Podatki, prikazani v spodnji preglednici, odražajo: - izpostavljenost zdravilu Zyclara ali vehiklu v zgoraj omenjenih študijah (pogostnosti: zelo pogosti do občasni in pogostejši po uporabi vehikla).
If you receive immunosuppressive medicinal products which inhibit the immune system, tell your doctor before starting the treatment. 
Če prejemate imunosupresivna zdravila, ki zavirajo imunski sistem, se pred začetkom zdravljenja posvetujte z zdravnikom.
Other medicines and Zyclara 
Druga zdravila in zdravilo Zyclara
There are no data available of the use of imiquimod in children and adolescents. 
Podatkov o uporabi imikvimoda pri otrocih in mladostnikih ni na voljo.
Many of the side effects of this medicine are due to its local action on your skin. 
Številni neželeni učinki tega zdravila izvirajo iz njegovega lokalnega delovanja na kožo.
Patients should continue treatment as prescribed. 
Bolniki naj nadaljujejo s predpisanim načinom zdravljenja.
This medicine may reveal and treat actinic keratosis that have not be seen or felt before, and these may later go away. 
To zdravilo lahko razkrije in zdravi aktinične keratoze, ki pred tem niso bile vidne ali otipljive, in ki lahko pozneje izginejo.
Patients with reduced haematologic reserve should be monitored under the close supervision of an experienced physician (see section 4.8). 
Bolnike z zmanjšano hematološko rezervo je treba spremljati pod skrbnim nadzorom izkušenega zdravnika (glejte poglavje 4.8).
This medicine should only be used for actinic keratosis on the face or scalp if your doctor has decided that it is the most appropriate treatment for you. 
To zdravilo se lahko uporablja samo za zdravljenje aktinične keratoze na obrazu in lasišču, če je zdravnik presodil, da je to za vas najprimernejše zdravljenje.
Maximum daily dose is 2 sachets (500 mg = 2 sachets of 250 mg each). 
Najvišji dnevni odmerek je 2 vrečici (500 mg = 2 vrečici po 250 mg vsaka).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. 
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Study treatments were given as officially recommended. 
Zdravili v študijah sta bili uporabljeni v skladu z uradnimi priporočili.
Persistent topical overdosing of imiquimod cream could result in severe local skin reactions and may increase the risk for systemic reactions. 
Vztrajno prekomerno lokalno odmerjanje imikvimod kreme lahko povzroči hude lokalne reakcije na koži in lahko poveča tveganje za sistemske reakcije.
The small amount of medicinal product which was absorbed into the systemic circulation was promptly excreted by both urinary and faecal routes at a mean ratio of approximately 3 to 1. 
Majhna količina zdravila, ki se je absorbirala v sistemski obtok, je bila hitro izločena tako z urinom kot blatom s povprečnim razmerjem približno 3 proti 1.
- Hair loss A small number of patients have experienced hair loss at the treatment site or surrounding area. 
- izpadanje las Pri manjšem številu bolnikov je prišlo do izpadanja las na zdravljenem predelu ali v njegovi okolici.
EU/1/12/783/001 14 sachets EU/1/12/783/002 28 sachets EU/1/12/783/003 56 sachets 
EU/1/12/783/001 14 vrečic EU/1/12/783/002 28 vrečic EU/1/12/783/003 56 vrečic
Reductions in haematological parameters requiring clinical intervention have been reported from postmarketing experience. 
O znižanju hematoloških parametrov, ki so zahtevali klinično intervencijo, so poročali v obdobju po prihodu zdravila na trg.
Actinic keratosis appears as rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime. 
Aktinična keratoza se pojavi kot področja hrapave kože pri ljudeh, ki so bili v življenju prekomerno izpostavljeni soncu.
Apply this medicine to the affected area once a day just before bedtime. 
Odmerjanje To zdravilo nanesite na prizadeti predel enkrat na dan tik pred spanjem.
In addition, these studies supported the use of up to two additional treatment cycles of imiquimod when the AK lesions are not completely cleared or if the AK lesions recurred after successful initial treatment with imiquimod. 
Poleg tega so te študije podprle uporabo do dveh dodatnih ciklov zdravljenja z imikvimodom v primerih, ko lezije na zdravljenem AK predelu niso v celoti izginile ter v primerih, ko so se AK lezije po uspešnem začetnem zdravljenju z imikvimodom ponovile.
Imiquimod induces the release of interferon alpha (IFN-α) and other cytokines from a variety of human and animal cells (e.g. from human monocytes/macrophages and keratinocytes). 
Imikvimod inducira sproščanje interferona alfa (IFN-α) in drugih citokinov iz različnih človeških in živalskih celic (npr. iz humanih monocitov/makrofagov in keratinocitov).
Skin infections during treatment with imiquimod have been observed. 
Okužbe kože so opazili med zdravljenjem z imikvimodom.
The skin surface area treated should be protected from solar exposure. 
Zdravljene predele kože je treba zaščititi pred sončno svetlobo.
If you use more Zyclara than you should 
Če ste uporabili večji odmerek zdravila Zyclara, kot bi smeli
Imiquimod cream was evaluated in a photocarcinogenicity bioassay in albino hairless mice exposed to simulated solar ultraviolet radiation (UVR). 
Imikvimod krema je bila ovrednotena v biološkem testu fotokarcinogenosti na neporaščenih miših albino, ki so sončnemu ultravijoličnemu sevanju (UVR).
Contact with eyes, lips and nostrils should be avoided as imiquimod has not been evaluated for the treatment of actinic keratosis on the eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border. 
Preprečiti je treba stik zdravila z očmi, ustnicami in nosnicami, saj uporaba imikvimoda ni bila ovrednotena za zdravljenje aktiničnih keratoz na vekah, v nosnicah, v ušesih ali predelu ustnic znotraj meje s kožo.
However, only 11% (17/160) of patients in clinical trials with Zyclara required rest periods (treatment interruption) due to local adverse reactions. 
Vendar pa je bilo treba le pri 11 % (17/160) bolnikov, ki so sodelovali v kliničnih preskušanjih zdravila Zyclara, prekiniti obdobja zdravljenja zaradi lokalnih neželenih učinkov.
The efficacy of Zyclara was studied in two double-blind, randomized, vehicle-controlled clinical studies. 
Učinkovitost zdravila Zyclara so preučevali v dveh randomiziranih, dvojno slepih, z vehiklom nadzorovanih kliničnih študijah.
These reactions can be a sign that the medicine is working as intended. 
Te reakcije so lahko znak, da zdravilo deluje.