natgillin/translations-raw huggingface dataset:
In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Pritor must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension). 
Pri bolnikih s sladkorno boleznijo tipa 2 ali bolnikih z zmerno ali hudo okvaro ledvic se zdravilo Pritor ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (zdravilo za zdravljenje esencialne hipertenzije).
In the treatment of essential hypertension, Pritor was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension. 
Kar zadeva zdravljenje esencialne hipertenzije, je bilo zdravilo Pritor pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje hipertenzije.
Side effects with Pritor are not common. 
Neželeni učinki zdravila Pritor niso pogosti.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke. 
Telmisartan z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, prepreči učinek hormona, kar privede do znižanja krvnega tlaka, to pa posledično zmanjša tveganja, povezana s visokim krvnim tlakom, kot sta srčni napad ali možganska kap.
Various doses of Pritor were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine). 
Različne odmerke zdravila Pritor so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili za zniževanje krvnega tlaka (atenololom, lizinoprilom, enalaprilom in amlodipinom).
Pritor was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines. 
Zdravilo Pritor so primerjali z ramiprilom (drugim zdravilom za preprečevanje srčno-žilnih težav) in kombinacijo obeh zdravil.
For the treatment of essential hypertension, Pritor has been studied in 2,647 patients who took Pritor either alone or in combination with hydrochlorothiazide. 
Za zdravljenje esencialne hipertenzije so zdravilo Pritor raziskali pri 2 647 bolnikih, ki so zdravilo Pritor jemali bodisi kot samostojno zdravilo bodisi pa v kombinaciji s hidroklorotiazidom.
The doctor should monitor the patient's blood pressure closely when starting Pritor, and may decide to adjust the patient's blood pressure-lowering medication. 
Ob začetku zdravljenja z zdravilom Pritor mora zdravnik skrbno spremljati bolnikov krvni tlak in se lahko odloči za prilagoditev odmerka zdravila za zniževanje bolnikovega krvnega tlaka.
It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems. 
Hkrati srcu olajša črpanje krvi, kar pripomore k manjšemu tveganju za pojav srčno žilnih težav v prihodnosti.
Pritor is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes. 
Zdravilo Pritor se uporablja tudi za preprečevanje kardiovaskularnih težav (težav s srcem in krvnimi žilami), kot sta srčni infarkt ali možganska kap.
Pritor must not be used in people who have severe liver problems or bile problems. 
Zdravila Pritor prav tako ne smejo uporabljati osebe, ki imajo huda obolenja jeter ali žolčnika.
For the treatment of essential hypertension, the usual recommended dose of Pritor is 40 mg once a day, but some patients may benefit from using 20 mg once a day. 
Običajni priporočeni odmerek zdravila Pritor za zdravljenje esencialne hipertenzije znaša 40 mg enkrat dnevno, čeprav za nekatere bolnike zadostuje že 20-miligramski odmerek enkrat na dan.
However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment 
Vendar so pri 1 do 10 bolnikih od 1 000 opazili okužbe zgornjih dihal (prehlade), vključno z vnetjem grla in sinusov, okužbe sečil (okužbe struktur za odvajanje urina), vključno z vnetjem mehurja, anemijo (nizko število rdečih krvničk), hiperkaliemijo (visoke ravni kalija v krvi), depresijo, nespečnost, sinkopo (kratkotrajno izgubo zavesti), vrtoglavico,
For the full list of all side effects reported with Pritor, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pritor, glejte navodilo za uporabo.
In the prevention of cardiovascular problems, Pritor had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke. 
Pri preprečevanju srčno-žilnih težav je bilo zdravilo Pritor enako učinkovito kot ramipril, pri čemer je okoli 17 % bolnikov umrlo, bilo hospitaliziranih zaradi srčno-žilnih težav oziroma je doživelo srčni napad ali možgansko kap.
How has Pritor been studied? 
Kako je bilo zdravilo Pritor raziskano?
What is Pritor used for? 
Za kaj se zdravilo Pritor uporablja?
What is Pritor? 
Kaj je zdravilo Pritor?
How is Pritor used? 
Kako se zdravilo Pritor uporablja?
(reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown). 
bradikardijo (zelo počasen srčni utrip), hipotenzijo (nizek krvni tlak), dispnejo (oteženo dihanje), kašelj, bolečine v trebuhu (bolečine v želodcu), drisko, dispepsijo (zgago), napenjanje (vetrove), bruhanje, hiperhidrozo (prekomerno potenje), pruritus (srbenje), izpuščaje, mialgijo (bolečine v mišicah), bolečine v hrbtu, krče v mišicah, okvaro ledvic (zmanjšano delovanje ledvic), vključno z njihovo odpovedjo, bolečine v prsih, astenijo (šibkost) in povečane ravni kreatinina v krvi (znak razgradnje mišic).
How does Pritor work? 
Kako zdravilo Pritor deluje?
24 January 2014 
24. januar 2014
The main measure of effectiveness was the change in symptoms such as itching intensity and sleep disturbance after 4 weeks of treatment based on a standard scoring system. 
Glavno merilo učinkovitosti je bila sprememba simptomov, kot sta na primer intenzivnost srbenja in motnje spanca, po 4 tednih zdravljenja, ki so jo določili s standardnim sistemom ocenjevanja.
The effects of Winfuran were first tested in experimental models before being studied in humans. 
Učinki zdravila Winfuran so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EMA/33514/2014 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Winfuran (nalfurafin) EMA/33514/2014
Although an additional analysis showed a modest benefit in a subpopulation of patients with a severe form of uraemic pruritus, the CHMP considered that the clinical relevance had not been shown. 
Dodatna analiza je sicer pokazala skromne koristi pri podskupini bolnikov s hudo obliko uremičnega pruritusa, vendar je odbor CHMP menil, da klinična pomembnost ni bila dokazana.
It was to be available as a concentrate for solution for infusion into a vein. 
Na voljo naj bi bilo v obliki koncentrata za raztopino za infundiranje v žilo.
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes for Winfuran. 
Družba je odbor CHMP obvestila, da trenutno ne potekajo nobena klinična preskušanja ali programi sočutne uporabe zdravila Winfuran.
Although the exact cause of uraemic pruritus is not known it is thought that the itching is linked to an excessive activity of certain receptors called mu-opioid receptors in the brain and skin. 
Natančen vzrok uremičnega pruritusa ni znan, vendar se domneva, da je srbenje povezano s čezmerno dejavnostjo določenih receptorjev v možganih in koži, ki jih imenujemo mu-opioidni receptorji.
The effects of Winfuran were compared with placebo (a dummy treatment) in one main study involving 339 patients with uraemic pruritus who were on regular dialysis. 
Učinke zdravila Winfuran so primerjali s placebom (zdravilom brez zdravilne učinkovine) v eni glavni študiji, v kateri je sodelovalo 339 bolnikov z uremičnim pruritusom, ki so potrebovali redno dializo.
On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis. 
Družba Toray International U.K. Limited je dne 17. januarja 2014 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Winfuran, namenjenim zdravljenju hudega uremičnega pruritusa (oblike srbenja) pri bolnikih s končno odpovedjo ledvic, ki potrebujejo dializo.
Uraemic pruritus is a persisting form of itching that occurs in some patients whose kidneys are not functioning properly. 
Uremični pruritus je trdovratna oblika srbenja, ki se pojavi pri nekaterih bolnikih, katerih ledvice ne delujejo pravilno.
The main study failed to show that Winfuran was more effective than placebo at relieving itching. 
V glavni študiji niso uspeli dokazati, da je zdravilo Winfuran učinkovitejše od placeba pri lajšanju srbenja.
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Winfuran (nalfurafin)
Winfuran is a medicine that contains the active substance nalfurafine. 
Winfuran je zdravilo, ki vsebuje zdravilno učinkovino nalfurafin.
What is Winfuran? 
Kaj je zdravilo Winfuran?
Winfuran activates different opioid receptors, called kappa receptors, which block the activity of the mu-opioid receptors and therefore relieve the itching in patients with uraemic pruritus. 
Zdravilo Winfuran aktivira druge opioidne receptorje, imenovane receptorji kapa, ki zavrejo delovanje opioidnih receptorjev mi in posledično ublažijo srbenje pri bolnikih z uremičnim pruritusom.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Winfuran did not outweigh its risks and it concluded that the medicine could not have been approved on the basis of the data presented by the company. 
Zato je CHMP v času umika menil, da koristi zdravila Winfuran ne odtehtajo z njim povezanih tveganj, in zaključil, da na podlagi podatkov, ki jih je predložila družba, zdravila ni mogoče odobriti.
Winfuran was to be used in patients with end-stage renal disease (when the kidneys have stopped working completely) and who are on dialysis (a technique for removing waste products from the blood). 
Zdravilo Winfuran naj bi se uporabljalo pri bolnikih, ki imajo končno odpoved ledvic (stanje, ko ledvice povsem prenehajo delovati) in potrebujejo dializo (postopek odstranjevanja odpadnih snovi iz krvi).
Winfuran was expected to be used for the treatment of patients with severe uraemic pruritus. 
Zdravilo Winfuran naj bi se uporabljalo za zdravljenje bolnikov s hudim uremičnim pruritusom.
Winfuran was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 September 2002 for uraemic pruritus. 
Zdravilo Winfuran je bilo dne 11. septembra 2002 določeno kot „zdravilo sirota‟ (zdravilo za zdravljenje redkih bolezni) za uremični pruritus.
The CHMP's main concern was that the benefits of Winfuran in the treatment of uraemic pruritus had not been sufficiently shown. 
Glavni zadržek odbora CHMP je bil, da koristi zdravila Winfuran pri zdravljenju uremičnega pruritusa niso bile zadovoljivo dokazane.
What was Winfuran expected to be used for? 
Za kaj naj bi se zdravilo Winfuran uporabljalo?
Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Winfuran for the treatment of severe uraemic pruritus. 
Na podlagi pregleda podatkov je odbor v času umika vloge izrazil negativno mnenje in priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Winfuran za zdravljenje hudega uremičnega pruritusa.
In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance. 
Družba je v uradnem dopisu navedla, da se je za umik vloge odločila, ker je odbor CHMP menil, da na podlagi predloženih podatkov ni mogoče zaključiti, da je razmerje med koristmi in tveganji zdravila pozitivno.
How is Winfuran expected to work? 
Kako naj bi zdravilo Winfuran delovalo?
The recommended dose is one capsule taken once a day with food for 12 or 24 weeks. 
Priporočeni odmerek je ena kapsula, ki se jemlje enkrat na dan skupaj s hrano v obdobju 12 ali 24 tednov.
What measures are being taken to ensure the safe and effective use of Olysio? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Olysio?
This is a summary of the European public assessment report (EPAR) for Olysio. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Olysio.
The full EPAR and risk management plan summary for Olysio 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) in povzetek načrta obvladovanja tveganj za zdravilo Olysio sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Olysio is available as 150 mg capsules. 
Zdravilo Olysio je na voljo v obliki 150-miligramskih kapsul.
The Agency also considered that the data available support the use of Olysio in combination with sofosbuvir. 
Agencija je zato menila, da razpoložljivi podatki podpirajo uporabo zdravila Olysio v kombinaciji s sofosbuvirjem.
What is Olysio and what is it used for? 
Kaj je zdravilo Olysio in za kaj se uporablja?
What benefits of Olysio have been shown in studies? 
Kakšne koristi je zdravilo Olysio izkazalo v študijah?
The European Medicines Agency decided that Olysio's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Olysio večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
What are the risks associated with Olysio? 
Kakšna tveganja so povezana z zdravilom Olysio?
The European Commission granted a marketing authorisation valid throughout the European Union for 
Evropska komisija je dovoljenje za promet z zdravilom Olysio, veljavno po vsej Evropski uniji, izdala
The most common side effects during treatment with Olysio (which may affect more than 1 in 10 people) are nausea (feeling sick), rash, pruritus (itching) and dyspnoea (difficulty breathing). 
Najpogostejši neželeni učinki zdravljenja z zdravilom Olysio (ki lahko prizadenejo več kot 1 osebo od 10) so navzeja (slabost), izpuščaji, pruritus (srbenje) in dispneja (oteženo dihanje).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olysio have also been included in the summary of product characteristics and the 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Olysio upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za
It is not intended to provide practical advice on how to use Olysio. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The study included patients with and without cirrhosis as well as patients who had not responded to previous therapy. 
Študija je zajela bolnike s cirozo ali brez nje ter bolnike, ki se niso odzvali na predhodno zdravljenje.
Olysio is an antiviral medicine that contains the active substance simeprevir. 
Olysio je protivirusno zdravilo, ki vsebuje zdravilno učinkovino simeprevir.
For more information about treatment with Olysio, read the package leaflet (also part of the EPAR) or contact 
Za več informacij o zdravljenju z zdravilom Olysio preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali
Several varieties (genotypes) of hepatitis C virus exist and Olysio is recommended for patients with virus of genotypes 1 and 4. 
Obstaja več vrst (genotipov) virusa hepatitisa C, zdravilo Olysio pa je priporočeno za bolnike z virusom genotipa 1 in 4.
How does Olysio work? 
Kako zdravilo Olysio deluje?
Regarding its safety, Olysio was well tolerated and the side effects were manageable. 
Kar zadeva varnost, so bolniki zdravilo Olysio dobro prenašali, neželeni učinki pa so bili obvladljivi.
This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early. 
Ta študija se izvaja na podlagi podatkov, ki kažejo, da pri bolnikih, ki se zdravijo s temi zdravili in so preboleli raka jeter, obstaja tveganje zgodnje ponovitve raka.
An analysis of these studies showed that Olysio was less effective in a sub-group of patients infected with hepatitis C virus genotype 1a that has the Q80K mutation. 
Analiza teh študij je pokazala, da je bilo zdravilo Olysio manj učinkovito pri podskupini bolnikov, ki so bili okuženi z virusom hepatitisa C genotipa 1a, ki ima mutacijo Q80K.
Three main studies involving 1,178 patients with hepatitis C virus of genotype 1 investigated the combination with peginterferon alfa and ribavirin. 
V treh glavnih študijah pri 1 178 bolnikih z virusom hepatitisa C genotipa 1 so proučevali kombinacijo s peginterferonom alfa in ribavirinom.
Prolonging treatment to 24 weeks resulted in a clearance rate of above 90%. 
Pri podaljšanju zdravljenja na 24 tednov je bil virus odstranjen pri več kot 90 % bolnikov.
Olysio can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C. 
Predpisovanje in izdaja zdravila Olysio je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s kroničnim hepatitisom C.
Before starting treatment with Olysio, patients with genotypes 1a should have a blood test to check whether the virus they are infected with has a mutation (a change in the genetic material of the virus) called Q80K, as Olysio is known to be less effective in these patients. 
Pred začetkom zdravljenja z zdravilom Olysio, je treba pri bolnikih z genotipom 1a opraviti krvne preiskave, da se ugotovi, ali ima virus, s katerim so okuženi, mutacijo (spremembo genetskega materiala virusa) Q80K, ker je pri teh bolnikih zdravilo Olysio manj učinkovito.
The active substance in Olysio, simeprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply. 
Zdravilna učinkovina v zdravilu Olysio, simeprevir, zavira delovanje encima v virusu hepatitisa C, imenovanega „serinska proteaza NS3/4A“, ki ima ključno vlogo pri razmnoževanju virusa.
The Agency concluded that, in both previously untreated patients and patients who had already been treated, adding Olysio to treatment with peginterferon alfa and ribavirin considerably increased the number of patients showing no sign of infection. 
Ugotovila je, da je dodajanje zdravila Olysio k zdravljenju s peginterferonom alfa in ribavirinom pri predhodno nezdravljenih bolnikih in bolnikih, ki so se pred tem že zdravili, znatno povečalo število bolnikov, ki niso imeli nobenih znakov okužbe.
The company that markets Olysio will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Olysio. 
Družba, ki trži zdravilo Olysio, bo za oceno tveganja ponovitve raka jeter po zdravljenju z neposredno delujočimi protivirusnimi zdravili, kot je zdravilo Olysio, izvedla študijo pri bolnikih, ki so preboleli raka jeter.
Several studies show that Olysio in combination with peginterferon alfa and ribavirin or with sofosbuvir is effective in clearing the hepatitis C virus from the blood after 12 or 24 weeks of treatment. 
Več raziskav potrjuje, da zdravilo Olysio v kombinaciji s peginterferonom alfa in ribavirinom ali sofosbuvirjem po 12 ali 24 tednih zdravljenja učinkovito odstranjuje virus hepatitisa C iz krvi.
Additional studies of the combination with peginterferon alfa and ribavirin involving patients with hepatitis C virus of genotype 4 and patients with HIV co-infection showed results consistent with those in patients with genotype 1. 
V dodatnih študijah kombinacije s peginterferonom alfa in ribavirinom, v katere so vključili bolnike z virusom hepatitisa C genotipa 4 in bolnike, ki so bili sočasno okuženi z virusom HIV, so zabeležili rezultate, ki so bili skladni s tistimi pri
For practical information about using Olysio, patients should read the package leaflet or contact their 
Za praktične informacije o uporabi zdravila Olysio naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Olysio taken together with sofosbuvir was investigated in a study involving 167 patients, which showed that the combination (with or without ribavirin) cleared infection with hepatitis C genotype 1 in around 90% of patients 12 weeks after the end of treatment. 
Študija, v kateri so pri 167 bolnikih proučevali jemanje zdravila Olysio v kombinaciji s sofosbuvirjem, je pokazala, da je kombinacija (z ribavirinom ali brez njega) 12 tednov po koncu zdravljenja odpravila okužbo z virusom hepatitisa C genotipa 1 pri približno 90 % bolnikov.
In two additional studies of simeprevir in combination with sofosbuvir in 413 patients, patients without cirrhosis who were taking Olysio together with sofosbuvir had a clearance rate at 12 weeks of 97%, while patients with cirrhosis had a 12 weeks clearance rate of 83%. 
V dveh dodatnih študijah simeprevirja v kombinaciji s sofosbuvirjem pri 413 bolnikih je bil po 12 tednih jemanja zdravila Olysio skupaj s sofosbuvirjem virus odstranjen pri 97 % bolnikih brez ciroze, medtem ko je bil pri bolnikih s cirozo virus odstranjen pri 83 %.
It is used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus. 
Zdravilo Olysio je protivirusno zdravilo, namenjeno zdravljenju odraslih s kroničnim (dolgotrajnim) hepatitisom C, tj. nalezljivo boleznijo, ki prizadene jetra in jo povzroča virus hepatitisa C. Uporablja se v kombinaciji z
Olysio must be used in combination with other medicines used to treat chronic hepatitis C, such as with peginterferon alfa and ribavirin or with sofosbuvir. 
Zdravilo Olysio se mora uporabljati v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C, na primer s peginterferonom alfa
In two of the studies, which involved previously untreated patients, around 80% (419 out of 521) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with 50% (132 out of 264) of patients on placebo. 
V dveh študijah, v katerih so sodelovali prej nezdravljeni bolniki, so bili 12 tednov po končanem zdravljenju izidi preiskav za hepatitis C negativni pri približno 80 % (419 od 521) bolnikov, ki so jemali zdravilo Olysio, v primerjavi s 50 % (132 od 264) bolnikov, ki so