natgillin/translations-raw huggingface dataset:
Although lavender oil showed a possible effect on anxiety, stress and insomnia, the number of patients per study was too low to establish an effect. 
Čeprav so pokazale, da bi eterično olje prave sivke lahko imelo učinek na tesnobo, stres in nespečnost, je bilo število bolnikov v teh študijah premajhno za potrditev učinkovitosti.
Further information on the risks associated with lavender oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo eterično olje prave sivke, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of lavender oil. 
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo eteričnega olja prave sivke.
Only few and mild side effects had been reported in studies with lavender oil, including very rare cases of allergic reactions. 
V študijah uporabe eteričnega olja prave sivke je bilo zabeleženih zgolj nekaj blagih neželenih učinkov, vključno z zelo redkimi primeri alergijskih reakcij.
In its assessment, the HMPC also considered studies with lavender oil in patients with different conditions, including anxiety and sleeping disorders. 
Pri oceni je odbor HMPC upošteval tudi študije uporabe eteričnega olja prave sivke pri bolnikih z različnimi težavami, kot so tesnoba in motnje spanja.
Any applications for the licensing of medicines containing lavender oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC. 
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo eterično olje prave sivke, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU). 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi, da so se na navedeni način varno uporabljala že vsaj 30 let (najmanj 15 let tudi v EU).
Information on the use and licensing of lavender oil medicines in EU Member States should be obtained from the relevant national authorities. 
Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo eterično olje prave sivke, v državah članicah EU se obrnite na pristojni nacionalni organ.
The HMPC conclusions on the use of medicines containing lavender oil are based on their ‘traditional use'. 
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo eterično olje prave sivke, temeljijo na njihovi „tradicionalni uporabi“.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing lavender oil. 
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo eterično olje prave sivke.
Further information on the HMPC assessment of lavender oil, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Dodatne informacije o oceni zdravil, ki vsebujejo eterično olje prave sivke, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
Herbal medicines containing lavender oil are usually available in liquid forms to be taken by mouth or as a bath additive. 
Zdravila rastlinskega izvora, ki vsebujejo eterično olje prave sivke, so navadno na voljo v tekočih oblikah, ki se jemljejo peroralno (zaužijejo skozi usta) ali se dodajajo h kopelim.
What evidence supports the use of lavender oil medicines? 
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo eterično olje prave sivke?
How are lavender oil medicines approved in the EU? 
Kako so zdravila, ki vsebujejo eterično olje prave sivke, odobrena v EU?
Detailed instruction on how to take lavender oil medicines and who can use them can be found in the package leaflet that comes with the medicine. 
Podrobne informacije o uporabi zdravil, ki vsebujejo eterično olje prave sivke, in o tem, kdo jih lahko uporablja, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
What is lavender oil? 
Kaj je eterično olje prave sivke?
Therefore, the HMPC conclusions on the use of lavender oil medicines are based on their long-standing use. 
Zato zaključki odbora HMPC glede uporabe zdravil, ki vsebujejo eterično olje prave sivke, temeljijo na njihovi dolgotrajni uporabi.
What are the risks associated with lavender oil medicines? 
Kakšna tveganja so povezana z zdravili, ki vsebujejo eterično olje prave sivke?
For more information about treatment with lavender oil, read the package leaflet that comes with the medicine or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravili, ki vsebujejo eterično olje prave sivke, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using lavender oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist. 
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
Other information about lavender oil medicines 
Druge informacije o zdravilih, ki vsebujejo eterično olje prave sivke
Lavender oil is obtained by a current of steam through the flowering tops of the plant. 
Eterično olje prave sivke se pridobiva s parno destilacijo cvetov rastline.
Further information on Vitrakvi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/vitrakvi. 
Nadaljnje informacije za zdravilo Vitrakvi so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/vitrakvi.
In addition, the tumours shrank quickly (within 2 months). 
Poleg tega je do njihovega zmanjšanja prišlo hitro (v dveh mesecih).
The dose for children is based on their body surface area (weight and height). 
Odmerek za otroke temelji na njihovi telesni površini (telesni masi in višini).
This means that there is more evidence to come about the medicine, which the company is required to provide. 
To pomeni, da se pričakujejo dodatni dokazi o zdravilu, ki jih mora zagotoviti podjetje.
The European Medicines Agency therefore concluded that its benefits are greater than its risks and that it can be authorised for use in the EU. 
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Vitrakvi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
This data will come from the three ongoing studies which aim to confirm the benefits and safety of Vitrakvi and its longer term effect in children. 
Ti podatki bodo izhajali iz treh trenutno potekajočih študij, katerih namen je potrditi koristi in varnost zdravila Vitrakvi in njegov dolgoročnejši učinek pri otrocih.
What measures are being taken to ensure the safe and effective use of Vitrakvi? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vitrakvi?
Vitrakvi is available as a liquid (20 mg per ml) and capsules (25 and 100 mg) and is taken by mouth. 
Zdravilo Vitrakvi je na voljo v obliki tekočine (20 mg/ml) in kapsul (25 mg in 100 mg), jemlje pa se peroralno.
The most common side effects with Vitrakvi (which may affect more than 1 in 5 people) are tiredness, dizziness, constipation, nausea, vomiting, anaemia (low red blood cell counts) and high blood levels of alanine aminotransferase and aspartate aminotransferase (a sign of liver problems). 
Najpogostejši neželeni učinki zdravila Vitrakvi (ki se lahko pojavijo pri več kot 1 bolniku od 5) so utrujenost, omotica, zaprtje, navzea, bruhanje, anemija (nizko število rdečih krvnih celic) in visoke ravni alanin-aminotransferaze in aspartat-aminotransferaze v krvi (znak težav z jetri).
As for all medicines, data on the use of Vitrakvi are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Vitrakvi stalno spremljajo.
Other information about Vitrakvi 
Druge informacije o zdravilu Vitrakvi
In addition, the short time taken to shrink the tumours is important in relieving patients' symptoms. 
Poleg tega je kratek čas, potreben za zmanjšanje tumorjev, pomemben pri lajšanju simptomov pri bolnikih.
Since Vitrakvi has been given conditional authorisation, the company that markets Vitrakvi will provide further data on its effects. 
Ker je zdravilo Vitrakvi pridobilo pogojno dovoljenje, bo podjetje, ki ga trži, zagotovilo nadaljnje podatke o njegovih učinkih.
Adult patients should take 100 mg twice a day for as long as the cancer is stable and the side effects are acceptable. 
Odrasli bolniki morajo jemati 100-miligramski odmerek zdravila dvakrat na dan, dokler ostaja rakavo obolenje stabilno, neželeni učinki pa so znosni.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vitrakvi have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Vitrakvi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Vitrakvi and why it is authorised in the EU 
Pregled zdravila Vitrakvi in zakaj je odobreno v EU
Vitrakvi is used in patients whose tumours are advanced, have spread to other parts of the body or are not amenable to surgery, and who have no satisfactory alternative treatments. 
Zdravilo Vitrakvi se uporablja pri bolnikih, katerih tumorji so napredovali, se razširili na druge dele telesa ali jih ni mogoče kirurško odstraniti, ki nimajo drugih ustreznih možnosti zdravljenja.
Side effects reported with Vitrakvi are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Vitrakvi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Although studies are still underway, the results released so far show that it is effective at reducing the size of patients' tumours. 
Čeprav študije še vedno potekajo, dosedanji rezultati že kažejo, da je zdravilo učinkovito pri zmanjševanju velikosti tumorjev.
Vitrakvi has been given ‘conditional authorisation'. 
Zdravilo Vitrakvi je pridobilo „pogojno dovoljenje za promet“.
What is Vitrakvi and what is it used for? 
Kaj je zdravilo Vitrakvi in za kaj se uporablja?
For more information about using Vitrakvi, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Vitrakvi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Why is Vitrakvi authorised in the EU? 
Zakaj je bilo zdravilo Vitrakvi odobreno v EU?
It contains the active substance larotrectinib. 
Vsebuje učinkovino larotrektinib.
What benefits of Vitrakvi have been shown in studies? 
Kakšne koristi zdravila Vitrakvi so se pokazale v študijah?
Three ongoing studies in 102 patients with solid tumours with NTRK gene fusion showed that Vitrakvi is effective at reducing the size of patients' tumours. 
Tri trenutno potekajoče študije, v katerih sodelujeta 102 bolnika s trdnim tumorjem s prisotno fuzijo gena NTRK, so pokazale, da je zdravilo Vitrakvi učinkovito pri zmanjševanju velikosti tumorjev.
NTRK gene fusion is a rare genetic abnormality that can occur in tumours from different parts of the body such as the lungs, thyroid glands and intestines. 
Fuzija gena NTRK je redka genska nepravilnost, ki se lahko pojavi v tumorjih v različnih delih telesa, kot so pljuča, ščitnične žleze in črevesje.
What are the risks associated with Vitrakvi? 
Kakšna tveganja so povezana z zdravilom Vitrakvi?
Vitrakvi differs from many other cancer medicines by targeting certain tumours with a specific gene arrangement wherever they occur in the body. 
Zdravilo Vitrakvi se razlikuje od številnih drugih zdravil za zdravljenje raka, saj je ciljno usmerjeno na določene tumorje s posebno razporeditvijo genov, ne glede na to, kje v telesu se pojavijo.
Most side effects are mild to moderate. 
Večina neželenih učinkov je bila blaga ali zmerna.
The active substance in Vitrakvi, larotrectinib, blocks the action of this protein, preventing the excessive growth of cancer cells and thereby slowing down the worsening of the cancer. 
Učinkovina v zdravilu Vitrakvi, larotrektinib, zavira delovanje te beljakovine, kar preprečuje prekomerno rast rakavih celic in upočasni napredovanje rakavega obolenja.
What information is still awaited for Vitrakvi? 
Katere informacije o zdravilu Vitrakvi še pričakujemo?
Tumours with NTRK gene fusion produce an abnormal protein (TRK fusion protein), which causes the uncontrolled growth of cancer cells. 
Tumorji s fuzijo gena NTRK tvorijo nenormalno beljakovino (fuzijsko beljakovino TRK), ki povzroča nenadzorovano rast rakavih celic.
Vitrakvi should be started by a doctor experienced in using cancer medicines and can only be obtained with a prescription. 
Zdravljenje z zdravilom Vitrakvi lahko uvede samo zdravnik, ki ima izkušnje z dajanjem zdravil za zdravljenje raka, predpisovanje in izdaja zdravila pa je le na recept.
In these studies, 67% of patients who took Vitrakvi had a reduction in the size of their tumours, and the tumours on average shrank to less than half their original size. 
V teh študijah se je pri 67 % bolnikov, ki so prejemali zdravilo Vitrakvi, velikost tumorjev zmanjšala, pri
Vitrakvi is a cancer medicine for treating solid tumours with NTRK gene fusion. 
Vitrakvi je zdravilo proti raku za zdravljenje trdnih tumorjev s prisotno fuzijo gena nevrotropne receptorske tirozin kinaze (NTRK).
How does Vitrakvi work? 
Kako zdravilo Vitrakvi deluje?
How is Vitrakvi used? 
Kako se zdravilo Vitrakvi uporablja?
As for its safety, the side effects of Vitrakvi appear manageable. 
Kar zadeva varnost zdravila Vitrakvi, veljajo njegovi neželeni učinki za obvladljive.
This overview was last updated in 10-2019. 
Če bo potrebno, bo posodobljen tudi ta povzetek.
This summary was last updated in 08-2015. 
Povzetek je bil nazadnje posodobljen 05-2012.
The patients were followed up for an average of four and a half years. 
Bolnike so spremljali v povprečju štiri leta in pol.
It is available as tablets (20, 40 and 80 mg). 
Na voljo je v obliki tablet (20, 40 in 80 mg).
‘Essential' means that the hypertension has no obvious cause. 
„Esencialna“ pomeni, da ni jasnega vzroka za hipertenzijo.
The European Commission granted a marketing authorisation valid throughout the European Union for Micardis on 16 December 1998. 
Evropska komisija je dovoljenje za promet z zdravilom Micardis, veljavno po vsej Evropski uniji, odobrila dne 16. decembra 1998.
Other information about Micardis 
Druge informacije o zdravilu Micardis
The full EPAR for Micardis is available 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 Micardis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems. 
Srcu omogoča tudi, da lažje črpa kri, kar lahko pomaga zmanjšati tveganje za kardiovaskularne težave v prihodnosti.
The combination of the two medicines was no more effective than either medicine taken alone and was linked to an increased risk of side effects. 
Kombinacija obeh zdravil ni bila učinkovitejša od obeh zdravil, vzetih samostojno, in je bila povezana z večjim tveganjem za pojav neželenih učinkov.
This is a summary of the European public assessment report (EPAR) for Micardis. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Micardis.
Micardis must not be used in women who are more than three months pregnant. 
Ne smejo ga uporabljati ženske, ki so noseče več kot tri mesece.
It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys). 
Uporablja se pri bolnikih, ki so imeli težave zaradi krvnih strdkov v preteklosti (kot so srčno obolenje, možganska kap ali arterijska bolezen) ali ki imajo sladkorno bolezen tipa 2, ki je poškodovala določen organ (npr. oči, srce ali ledvice).
EPAR summary for the public 
Povzetek EPAR za javnost telmisartan
The CHMP decided that Micardis's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Micardis večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Micardis is a medicine that contains the active substance telmisartan. 
Micardis je zdravilo, ki vsebuje zdravilno učinkovino telmisartan.
What benefit has Micardis shown during the studies? 
Kakšne koristi je zdravilo Micardis izkazalo med študijami?
Micardis is used to treat essential hypertension (high blood pressure) in adults. 
Zdravilo Micardis se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
For more information about treatment with Micardis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Micardis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Hypotension may be more common in patients receiving Micardis to prevent cardiovascular problems. 
Hipotenzija je lahko pogostejša pri bolnikih, ki zdravilo Micardis jemljejo za preprečevanje kardiovaskularnih težav.
If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide. 
Če želena vrednost krvnega tlaka ni dosežena, se lahko odmerek poveča na 80 mg ali pa se doda drugo zdravilo za zdravljenje povišanega krvnega tlaka, kot je hidroklorotiazid.
The active substance in Micardis, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. 
Zdravilna učinkovina v zdravilu Micardis, telmisartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
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 (reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown). 
Vendar so bili pri 1 do 10 bolnikih od 1 000 opaženi naslednji neželeni učinki: okužbe zgornjih dihal (prehladi), vključno z vnetjem grla in sinusov, okužbe sečil (okužbe struktur za odvajanje urina), vključno z vnetjem mehurja, anemija (nizko število rdečih krvničk), hiperkaliemija (visoke ravni kalija v krvi), depresija, nespečnost, sinkopa (kratkotrajna izguba zavesti), vrtoglavica, bradikardija (zelo počasen srčni utrip), hipotenzija (nizek krvni tlak), dispneja (oteženo dihanje), bolečine v trebuhu (bolečine v želodcu), driska, dispepsija (zgaga),
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 Micardis. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Micardis, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with Micardis? 
Kakšna tveganja so povezana z zdravilom Micardis?
For the prevention of cardiovascular problems, 80 mg Micardis once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems. 
Za preprečevanje kardiovaskularnih težav so zdravilo Micardis v odmerku 80 mg enkrat dnevno proučevali v eni glavni študiji, v katero je bilo vključenih skoraj 26 000 bolnikov, starih 55 let ali več, ki so imeli srčno ali arterijsko bolezen, so doživeli kap ali imeli sladkorno bolezen in pri katerih je obstajalo veliko tveganje za kardiovaskularne težave.
This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke. 
Zaradi tega se krvni tlak zniža, kar posledično zmanjša tveganja, povezana s previsokim krvnim tlakom, kot sta na primer srčni napad ali možganska kap.
The main measure of effectiveness was the reduction in the number of patients who died or were admitted to hospital, or who had a heart attack or stroke. 
Glavno merilo učinkovitosti je bilo znižanje števila bolnikov, ki so umrli, bili hospitalizirani oziroma so doživeli srčni infarkt ali možgansko kap.
Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day. 
Bolniki z blažje ali zmerno prizadetim delovanjem ledvic ne smejo jemati odmerkov, ki presegajo 40 mg na dan.
Micardis was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines. 
Zdravilo Micardis so primerjali z ramiprilom (drugim zdravilom za preprečevanje kardiovaskularnih težav) in kombinacijo obeh zdravil.
Micardis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes. 
Zdravilo Micardis se uporablja tudi za preprečevanje kardiovaskularnih težav (težav s srcem in krvnimi žilami), kot sta srčni napad ali možganska kap.
Various doses of Micardis were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine). 
Različne odmerke zdravila Micardis so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili za zniževanje krvnega tlaka (atenololom, lizinoprilom, enalaprilom in amlodipinom).
Side effects with Micardis are not common. 
Neželeni učinki zdravila Micardis niso pogosti.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen. 
Ker telmisartan zavira receptorje, na katere se angiotenzin II običajno veže, hormonu prepreči delovanje, zaradi česar se krvne žile lahko razširijo.
Why has Micardis been approved? 
Zakaj je bilo zdravilo Micardis odobreno?