natgillin/translations-raw huggingface dataset:
In addition, in the absence of valid statistical evaluations and given the paucity of elements contributing to support the robustness and the strength of the results, the CHMP was, neither able to draw reliable conclusions with regards to the efficacy of Symbioflor 2, nor to establish whether Symbioflor 2 is efficacious in IBS in general or any sub-type of IBS. 
Poleg tega v odsotnosti veljavnega statističnega ovrednotenja in glede na pomanjkanje elementov, ki bi prispevali k podpori robustnosti in moči rezultatov, odbor CHMP ni mogel ne oblikovati zanesljivega sklepa o učinkovitosti zdravila Symbioflor 2 niti ugotoviti, ali je zdravilo Symbioflor 2 učinkovito pri zdravljenju sindroma razdražljivega črevesa na splošno ali pri katerem od njegovih podtipov.
Two reports in support of the claimed indication in the treatment of irritable bowel syndrome (IBS) were submitted in the context of this referral procedure: 
V okviru tega napotitvenega postopka sta bili v podporo predloženi indikaciji za zdravljenje sindroma razdražljivega črevesa predloženi dve poročili:
Indication in the treatment of functional gastrointestinal disorders 
Indikacija za zdravljenje funkcionalnih motenj prebavil
• The CHMP also noted that results of the observational study in children older than 4 years with IBS suggested a possible efficacy of Symbioflor 2. 
• odbor CHMP je ugotovil tudi, da rezultati opazovalne študije pri otrocih, starejših od 4 let, s sindromom razdražljivega črevesa, kažejo na morebitno učinkovitost zdravila Symbioflor 2.
The SmPC was amended to reflect that efficacy in children has not been established. 
Povzetek glavnih značilnosti zdravila je bil popravljen tako, da navaja, da učinkovitost pri otrocih ni bila ugotovljena.
The CHMP also noted that results of the observational study in children older than 4 years with IBS suggested a possible efficacy of Symbioflor 2. 
Odbor CHMP je ugotovil tudi, da rezultati opazovalne študije pri otrocih, starejših od štirih let, s sindromom razdražljivega črevesa, kažejo na morebitno učinkovitost zdravila Symbioflor 2.
Data were not controlled and did thus not account for the contribution of spontaneous fluctuations of IBS symptoms or for a placebo response in the assessment of the benefit-risk of Symbioflor 2. 
Podatki niso bili nadzorovani, zato pri ocenjevanju razmerja med tveganji in koristmi zdravila Symbioflor 2 ne upoštevajo spontanega nihanja simptomov sindroma razdražljivega črevesa ali odziva na zdravljenju s placebom.
The CHMP was of the opinion that a significant number of adverse events would have been expected to be reported in this study due to the underlying disease regardless of the safety profile of Symbioflor 2. 
Odbor CHMP je menil, da bi bilo zaradi osnovne bolezni, ne glede na varnostni profil zdravila Symbioflor 2, v tej študiji pričakovati pomembno število neželenih učinkov.
However, the CHMP concluded that there were no new elements to motivate a change in the established benefit risk balance since the initial marketing authorisation for Symbioflor 2 in adult patients for the treatment of IBS; 
Vendar pa je odbor CHMP zaključil, da od časa prvega dovoljenja za promet z zdravilom za zdravilo Symbioflor 2 pri odraslih bolnikih za zdravljenje sindroma razdražljivega črevesa ni bilo novih elementov, zaradi katerih bi bila potrebna sprememba uveljavljenega razmerja med tveganji in koristmi;
The best dose to use in these patients has not been determined. 
Najboljši odmerek za te bolnike še ni bil določen.
The European Commission granted a marketing authorisation valid throughout the European Union for Iscover on 15 July 1998. 
Evropska komisija je dovoljenje za promet z zdravilom Iscover veljavno po vsej Evropski uniji, odobrila dne 15. julija 1998.
The full EPAR for Iscover can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Iscover je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Iscover is converted into its active form in the body. 
Zdravilo Iscover se v svojo aktivno obliko pretvori v telesu.
For genetic reasons, some patients may not be able to convert Iscover as effectively as others, which could reduce their response to the medicine. 
Zaradi genetskih razlogov nekateri bolniki zdravila Iscover morda ne morejo tako učinkovito pretvarjati, kar lahko zmanjša njihov odziv na zdravilo.
Iscover is used to prevent problems caused by blood clots in adults who have: 
Zdravilo Iscover se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki pri odraslih, ki:
For more information about treatment with Iscover, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Iscover preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Iscover. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Iscover.
The CHMP decided that Iscover's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Iscover večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Iscover can be started between a few days and 35 days after the attack; 
Zdravilo Iscover se lahko začne dajati od nekaj dni po napadu do 35 dni po njem;
In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Iscover instead of aspirin. 
Z drugimi besedami, približno 10 bolnikov od 1 000 se bo izognilo novemu ishemičnemu napadu v dveh letih po pričetku prejemanja zdravila Iscover namesto aspirina.
The standard dose of Iscover is one 75-mg tablet once a day. 
Priporočeni odmerek zdravila Iscover je ena 75-miligramska tableta enkrat dnevno.
This showed that Iscover reduces the risk of an event. 
To je dokaz, da zdravilo Iscover znižuje tveganje za pojav dogodka.
In CAPRIE, there were 939 events in the Iscover group, and 1,020 in the aspirin group. 
V študiji CAPRIE je bilo v skupini, ki je prejemala zdravilo Iscover, 939 dogodkov, v skupini, zdravljeni z aspirinom, pa 1 020.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Iscover. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Iscover, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Iscover was more effective than aspirin at preventing new ischaemic events. 
Zdravilo Iscover je bilo pri preprečevanju novih ishemičnih dogodkov učinkovitejše od aspirina.
What benefit has Iscover shown during the studies? 
Kakšne koristi je zdravilo Iscover izkazalo med študijami?
Iscover should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients. 
Zdravila Iscover ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) klopidogrel ali katero koli drugo sestavino zdravila.
This means that fewer patients will have new ischaemic events if they receive Iscover than if they receive aspirin. 
To pomeni, da bo manj bolnikov doživelo nov ishemični napad, če bodo jemali zdravilo Iscover, kot pa če bodo jemali aspirin.
Iscover can be started between seven days and six months after the stroke; 
Zdravilo Iscover se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
In acute coronary syndrome and atrial fibrillation, Iscover is used together with aspirin, the dose of which should not be higher than 100 mg. 
Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Iscover uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
The most common side effects with Iscover (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured. 
Najpogostejši neželeni učinki zdravila Iscover (opaženi pri 1 do 10 bolnikih izmed 100) so hematomi (kopičenje krvi pod kožo), epistaksa (krvavitve iz nosu), gastrointestinalna hemoragija (krvavitve v želodcu ali črevesju), driska, bolečine v trebuhu, dispepsija (zgaga), podplutbe in krvavitve na mestu predrte kože.
What is the risk associated with Iscover? 
Kakšna tveganja so povezana z zdravilom Iscover?
Iscover is a medicine that contains the active substance clopidogrel. 
Iscover je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
Other information about Iscover 
Druge informacije o zdravilu Iscover:
For the full list of all side effects reported with Iscover, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Iscover, glejte navodilo za uporabo.
In the study in atrial fibrillation patients, Iscover taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke. 
V študiji atrijske fibrilacije so bolniki zdravilo Iscover jemali skupaj z aspirinom, kar je zmanjšalo tveganje za nove dogodke za 11 % v primerjavi s placebom, jemanim skupaj z aspirinom, kjer je bilo največje zmanjšanje opaženo glede kapi (28 %).
Iscover as an anticoagulant has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral artery disease. 
Zdravilo Iscover kot antikoagulant so primerjali z aspirinom v študiji CAPRIE, v katero je bilo vključenih okoli 19 000 bolnikov, ki so nedavno doživeli srčni napad ali ishemično kap ali pri katerih je bilo ugotovljeno periferno arterijsko obolenje.
In the studies of acute coronary syndrome, all of the patients also took aspirin and the main measure of effectiveness was the number of patients who experienced an ‘event' such as a blocked artery, another heart attack or death during the study. 
V študijah akutnega koronarnega sindroma so vsi bolniki jemali aspirin, glavno merilo učinkovitosti pa je bilo število bolnikov z „dogodkom“, kot je zamašena arterija, ponovni srčni napad ali smrt med samo študijo.
In ST segment elevation myocardial infarction, fewer patients on Iscover had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study). 
Pri miokardnem infarktu z dvigom spojnice ST je bilo število bolnikov, pri katerih so se pojavili dogodki, manjše med bolniki, ki so jemali zdravilo Iscover, kot med bolniki, ki so prejemali placebo (262 v primerjavi s 377 v študiji CLARITY ter 2 121 v primerjavi z 2 310 v študiji COMMIT).
Why has Iscover been approved? 
Zakaj je bilo zdravilo Iscover odobreno?
Iscover has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted for up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Iscover with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks. 
Zdravilo Iscover so primerjali tudi s placebom v dveh študijah z bolniki z dvigom spojnice ST: študija CLARITY je vključevala 3 000 bolnikov in je trajala do osem dni, študija COMMIT pa je vključevala skoraj 46 000 bolnikov, ki so do štiri tedne prejemali zdravilo Iscover z metoprololom (drugim zdravilom za težave s srcem ali visok krvni tlak) ali brez njega.
The active substance in Iscover, clopidogrel, is an inhibitor of platelet aggregation. 
Zdravilna učinkovina v zdravilu Iscover, klopidogrel, je zaviralec agregacije trombocitov.
In acute coronary syndrome, Iscover has been compared with placebo (a dummy treatment) in one study involving over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year). 
Pri akutnem koronarnem sindromu so zdravilo Iscover primerjali s placebom (zdravilom brez zdravilne učinkovine) v študiji z 12 000 bolniki brez dviga spojnice ST, od katerih so 2 172 med študijo vstavili stent (študija CURE, ki je trajala do enega leta).
How has Iscover been studied? 
Kako je bilo zdravilo Iscover raziskano?
What is Iscover used for? 
Za kaj se zdravilo Iscover uporablja?
In atrial fibrillation, Iscover has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy. 
Pri atrijski fibrilaciji je bilo zdravilo Iscover primerjano s placebom (oba jemana skupaj z aspirinom) v eni glavni študiji, v kateri je sodelovalo okoli 7 500 bolnikov, ki so imeli vsaj en dejavnik tveganja za vaskularni dogodek in ki ne morejo prejemati zdravljenja z antagonistom vitamina K. Bolniki so bili zdravljeni povprečno tri leta, glavno merilo učinkovitosti pa je bilo število bolnikov, ki so doživeli bodisi srčni napad, ishemično kap ali so umrli.
What is Iscover? 
Kaj je zdravilo Iscover?
How is Iscover used? 
Kako se zdravilo Iscover uporablja?
To retain protection, horses need to be revaccinated. 
Za ohranitev zaščite je treba konje ponovno cepiti.
It contains inactivated (killed) whole virus of two equine influenza (flu) strains (‘A/equine-2/South Africa/4/03' and ‘A/equine-2/Newmarket/2/93') and tetanus toxoid (chemically inactivated toxin from the tetanus bacterium). 
Vsebuje inaktivirana (uničena) cela virusa dveh sevov influence (gripe) konj („A/konjski-2/Južna Afrika/4/03“, „A/konjski-2/Newmarket/2/93“) in toksoid tetanusa (kemično oslabljen toksin iz bakterije tetanusa).
Horses are very susceptible to tetanus. 
Konji so zelo občutljivi na tetanus.
The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza Te on 8 July 2005. 
Evropska komisija je dovoljenje za promet z zdravilom Equilis Prequenza Te, veljavno po vsej Evropski uniji, odobrila dne 8. julija 2005.
The studies also compared the clinical signs and virus excretion of a group of vaccinated animals with those of a control group, (i.e. which did not receive the vaccine or received a competitive product). 
V študijah so primerjali tudi klinične znake in izločanje virusa pri cepljenih živalih in živalih iz kontrolne skupine (tj. tistih, ki niso prejele cepiva ali so prejele konkurenčno cepivo).
The vaccine also stimulates protection against tetanus to prevent mortality. 
Cepivo spodbuja tudi zaščito pred tetanusom za preprečevanje umrljivosti.
The duration of protection was five months after primary vaccination and 12 months after the first revaccination for equine influenza and 17 months after primary vaccination and 24 months after the first revaccination for tetanus. 
Zaščita je trajala pet mesecev po osnovnem cepljenju in 12 mesecev po prvem ponovnem cepljenje za influenco konj ter 17 mesecev po prvem cepljenju in 24 mesecev po prvem ponovnem cepljenju za tetanus.
Other information about Equilis Prequenza Te: 
Druge informacije o zdravilu Equilis Prequenza Te:
When a horse is given the vaccine, the immune system recognises the virus and toxoid as ‘foreign' and makes antibodies against them. 
Ko konj prejme cepivo, imunski sistem prepozna virus in toksoid kot „tujka“ in začne proti njima tvoriti protitelesa.
The vaccine also contains purified tetanus toxoid. 
Cepivo vsebuje tudi prečiščen toksoid tetanusa.
The toxoid is a toxin processed in order to remove its toxic effect, but still allow it to be recognised by the immune system. 
Toksoid je toksin, obdelan tako, da nima več strupenega učinka, vendar ga imunski sistem še vedno prepozna.
Horses developed protective levels of antibodies two weeks after primary vaccination. 
Zaščitne ravni protiteles so se pri konjih razvile dva tedna po osnovnem cepljenju.
Equilis Prequenza Te is a vaccine for use in horses. 
Equilis Prequenza Te je cepivo, ki se uporablja pri konjih.
Tetanus is an acute, often fatal disease caused by the toxin (poison) produced by the bacterium Clostridium tetani. 
Tetanus je akutna bolezen, ki ima pogosto smrten izid, povzroča pa jo toksin (strup) bakterije Clostridium tetani.
For the full vaccination schedule see the package leaflet. 
Za celoten razpored cepljenja glejte navodilo za uporabo.
Equilis Prequenza Te contains inactivated whole virus of the influenza strains against which the vaccine is indicated. 
Zdravilo Equilis Prequenza Te vsebuje inaktivirane cele viruse sevov influence, za katere je cepivo indicirano.
The studies showed that Equilis Prequenza Te is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality, in horses from 6 months of age. 
Študije so pokazale, da je zdravilo Equilis Prequenza Te učinkovito cepivo proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi ter proti tetanusu za preprečevanje umrljivosti pri konjih, starejših od šest mesecev.
The safety of the initial formulation of Equilis Prequenza Te was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age. 
Varnost zdravila prvotne formulacije cepiva Equilis Prequenza Te so raziskovali v več študijah, izvedenih v laboratorijskih in terenskih pogojih na številnih konjih, starejših od dveh mesecev.
The current formulation of Equine Prequenza Te has been shown to produce similar results to those shown in the initial studies. 
Za trenutno formulacijo cepiva Equilis Prequenza Te je bilo dokazano, da ima podobne rezultate, kot so bili doseženi v prvotnih študijah.
Regarding tetanus, the main measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid. 
Pri tetanusu je bilo glavno merilo učinkovitosti tvorjenje zaščitnih ravni protiteles proti toksoidu tetanusa.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza Te exceeded the risks for the approved indications and the Committee recommended that Equilis Prequenza Te be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva Equilis Prequenza Te večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
For ethical reasons no challenge (infection) experiment was performed against tetanus. 
Iz etičnih razlogov za tetanus niso izvedli nobenega poskusa z izzivanjem okužbe.
The viruses included in the current formulation of Equilis Prequenza Te are grown in mammalian cells, unlike those in the initial formulation, which were grown in hens' eggs. 
Viruse, ki so vključeni v trenutno formulacijo cepiva Equilis Prequenza Te, gojijo v celicah sesalcev, virusi v prvotni formulaciji cepiva pa so bili gojeni v kokošjih jajcih.
The effectiveness of Equilis Prequenza Te was initially studied in several trials under laboratory and field conditions. 
Učinkovitost zdravila Equilis Prequenza Te so prvotno raziskali v več preskušanjih, izvedenih v laboratorijskih in terenskih pogojih.
What is the risk associated with Equilis Prequenza Te? 
Kakšna tveganja so povezana s cepivom Equilis Prequenza Te?
What benefit has Equilis Prequenza Te shown during the studies? 
Kakšne koristi je zdravilo Equilis Prequenza Te izkazalo med študijami?
The main measure of effectiveness of Equilis Prequenza Te against equine influenza was the production of protective levels of antibodies against the influenza components. 
Glavno merilo učinkovitosti cepiva Equilis Prequenza Te proti influenci konj je bilo tvorjenje zaščitnih ravni protiteles proti sestavinam influence.
Equilis Prequenza Te is used to vaccinate horses from six months of age against equine influenza and tetanus. 
Cepivo Equilis Prequenza Te se uporablja za cepljenje konj, ki so starejši od šestih mesecev, proti influenci konj in tetanusu.
Why has Equilis Prequenza Te been approved? 
Zakaj je bilo zdravilo Equilis Prequenza Te odobreno?
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to these virus strains or to the unmodified toxin. 
Ob ponovni izpostavitvi sevom virusov ali nespremenjenemu toksinu v prihodnosti bo imunski sistem hitreje izdelal protitelesa.
How has Equilis Prequenza Te been studied? 
Kako je bilo zdravilo Equilis Prequenza Te raziskano?
The antibodies will then help to protect against equine influenza and tetanus. 
Protitelesa pomagajo zaščititi žival pred influenco konj in tetanusom.
The withdrawal period for Equilis Prequenza Te is zero days. 
Karenca za cepivo Equilis Prequenza Te je nič dni.
How does Equilis Prequenza Te work? 
Kako zdravilo Equilis Prequenza Te deluje?
What is Equilis Prequenza Te? 
Kaj je zdravilo Equilis Prequenza Te?
What is Equilis Prequenza Te used for? 
Za kaj se zdravilo Equilis Prequenza Te uporablja?
October 26, 
26. oktober
Then carry on taking your tablets at regular times as usual. 
Nato nadaljujte jemanje tablet ob rednem času, kot po navadi.
If you notice any of the following: 
Če opazite katerega od naslednjih znakov:
You need to know about important symptoms to look out for. 
Poznati morate pomembne simptome, na katere morate biti pozorni.
Steady state was achieved by Day 15. 
Stanje dinamičnega ravnovesja je bilo doseženo 15. dan.
Date of first authorisation: 30 June 2014 Date of latest renewal: 14 February 2019 
Datum prve odobritve: 30. junij 2014 Datum zadnjega podaljšanja: 14. februar 2019
Descriptions of these effects can be found in other sections (see sections 2 and 4). 
Opis teh učinkov lahko najdete v drugih poglavjih (glejte poglavji 2 in 4).
At 1 year At 2 years At 3 years At 4 years At 5 years 
Po 1 letu Po 2 letih Po 3 letih Po 4 letih Po 5 letih
BRAF V600 testing 
Testiranje BRAF V600
Do not stop unless your doctor advises you to. 
Ne prenehajte ga jemati, razen če vam to svetuje zdravnik.
The majority of bleeding events were mild. 
Večina krvavitev je bila blagih.
Read all the information in this leaflet for guidance. 
Za smernice preberite vse informacije v tem navodilu.
• if you are allergic to trametinib or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na trametinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
This means that: 
To pomeni, da:
For October 2011, 47% of subjects had crossed over, while for May 2013, 65% of subjects had crossed over. 
Do oktobra 2011 je prešlo 47 % bolnikov, do maja 2013 pa 65 %.
Binding of trametinib to human plasma proteins is 97.4%. 
Vezava trametiniba na beljakovine v človeški plazmi je 97,4 %.
The safety and efficacy of trametinib have not been established in children and adolescents (<18 years). 
Varnost in učinkovitost trametiniba pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
 Read the information “Possible serious side effects” in section 4 of this leaflet. 
 Preberite informacije "Možni resni neželeni učinki" v poglavju 4 tega navodila.
Liver events were detected in clinical trials with monitoring every four weeks. 
Jetrne dogodke so v kliničnih študijah odkrivali s pregledi na vsake štiri tedne.
Treatment for all patients continued until disease progression, death or withdrawal. 
Zdravljenje vseh bolnikov se je nadaljevalo do napredovanja bolezni, smrti ali umika iz študije.
- The other ingredients are 
- Druge sestavine zdravila so
The increase in exposure (Cmax and AUC) was dose-proportional following repeat dosing. 
Povečanje izpostavljenosti (Cmax in AUC) je bilo po ponavljajočem se odmerjanju sorazmerno odmerku.
Mekinist with food and drink 
Zdravilo Mekinist skupaj s hrano in pijačo
May 20, 
20. maj
Do not take Mekinist: 
Ne jemljite zdravila Mekinist: