natgillin/translations-raw huggingface dataset:
Single or multiple actinic keratosis growths may be treated in one session, while basal cell carcinoma lesions will need two treatment sessions about one week apart.
Ena ali več aktiničnih keratoz se lahko zdravi med enim obsevanjem, za zdravljenje lezij bazalnoceličnega karcinoma pa sta potrebni dve obsevanji s približno enotedenskim razmikom.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom the photosensitising agent is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom za svetlobo (snov, ki se spremeni, če je izpostavljena svetlobi z določeno valovno dolžino).
When treating actinic keratosis growths, Ameluz can also be activated by exposure to full daylight.
Pri zdravljenju rašč aktinične keratoze se lahko delovanje zdravila Ameluz sproži tudi z izpostavljenostjo močni dnevni svetlobi.
Actinic keratosis cleared up in 78% (194 out of 248) of patients treated with Ameluz, compared with 64% (158 out of 246) of patients treated with Metvix and 17% (13 out of 76) of patients treated with placebo.
Aktinične keratoze so izginile pri 78 % (194 od 248) bolnikov, ki so jih zdravili z zdravilom Ameluz, v primerjavi s 64 % (158 od 246) bolnikov, ki so jih zdravili z zdravilom Metvix, in 17 % (13 od 76) bolnikov, ki so prejemali placebo.
In the third study involving 87 patients with field cancerisation (an area of sun damage with several actinic keratosis growths), Ameluz was compared with placebo used for one together with a red light or two treatment sessions.
V tretji študiji, v kateri je sodelovalo 87 bolnikov s polji kancerizacije (predeli kože, poškodovanimi zaradi izpostavljanja soncu, na katerih so se pojavile številne rašče aktinične keratoze), so zdravilo Ameluz primerjali s placebom, pri čemer je bilo v enem ali dveh ciklih zdravljenja uporabljeno skupaj z rdečo svetlobo.
When Ameluz is applied to the abnormal skin growths or lesions, the active substance in the medicine, 5-aminolaevulinic acid, is absorbed by cells where it acts as a photosensitising agent (a substance that changes when exposed to light of a certain wavelength).
Ko se zdravilo Ameluz nanese na nenormalne kožne rašče ali lezije, se zdravilna učinkovina v zdravilu, 5-aminolevulinska kislina, absorbira v celice, v katerih deluje kot učinkovina, ki povečuje občutljivost
How is Ameluz used?
Kako se zdravilo Ameluz uporablja?
In the first main study involving 571 patients, Ameluz was compared with placebo and Metvix, a product containing methylaminolaevulinate, used together with a red light for one or two treatment sessions.
V prvi glavni študiji, ki je vključevala 571 bolnikov, so zdravilo Ameluz primerjali s placebom in zdravilom Metvix, ki vsebuje metilaminolevulinat, pri čemer je bilo v enem ali dveh ciklih zdravljenja uporabljeno skupaj z rdečo svetlobo.
Actinic keratosis cleared up in 66% (53 out of 80) of patients treated with Ameluz, compared with 13% (5 out of 40) of patients treated with placebo.
Aktinične keratoze so izginile pri 66 % (53 od 80) bolnikov, zdravljenih z zdravilom Ameluz, v primerjavi s 13 % (5 od 40) bolnikov, zdravljenih s placebom.
The condition cleared up in 91% (50 out of 55) of patients given Ameluz, compared with 22% (7 out of 32) given placebo.
Aktinične keratoze so izginile pri 91 % (50 od 55) bolnikov, zdravljenih z zdravilom Ameluz, v primerjavi z 22 % (7 od 32) bolnikov, zdravljenih s placebom.
In the second main study involving 122 patients, Ameluz was compared with placebo used together with a red light for one or two treatment sessions.
V drugi glavni študiji, ki je zajela 122 bolnikov, so zdravilo Ameluz primerjali s placebom, pri čemer se je v enem ali dveh ciklih zdravljenja uporabilo skupaj z rdečo svetlobo.
How does Ameluz work?
Kako zdravilo Ameluz deluje?
Ameluz was more effective than placebo (a dummy treatment) or a comparator medicine when used in photodynamic therapy to treat actinic keratosis or basal cell carcinoma.
Pri fotodinamičnem zdravljenju aktiničnih keratoz ali bazalnoceličnega karcinoma je bilo zdravilo Ameluz učinkovitejše od placeba (zdravila brez zdravilne učinkovine) in primerjalnega zdravila.
Further information on Elebrato Ellipta can be found on the Agency's website: ema.europa.eu/ medicines/human/EPAR/elebrato-ellipta.
Več informacij o zdravilu Elebrato Ellipta je na voljo na spletni strani agencije: ema.europa.eu/ medicines/human/EPAR/elebrato-ellipta.
Elebrato Ellipta receiveda marketing authorisation valid throughout the EU on 15 November 2017.
Za zdravilo Elebrato Ellipta je bilo 15. novembra 2017 izdano dovoljenje za promet, veljavno po vsej EU.
It is available as an inhalation powder, which the patient inhales through the mouth using a portable inhaler device; the patient should inhale the medicine once a day at around the same time each day.
Na voljo je kot prašek za inhaliranje, ki ga bolnik inhalira skozi usta s prenosnim inhalatorjem; bolnik inhalira zdravilo enkrat na dan, vsak dan ob približno istem času.
The European Medicines Agency therefore decided that Elebrato Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Elebrato Ellipta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Elebrato Ellipta is used for maintenance (regular) treatment on a daily basis.
Zdravilo Elebrato Ellipta se uporablja za vzdrževalno (redno) vsakodnevno zdravljenje.
After 24 weeks, patients taking Elebrato Ellipta had their FEV1 (the maximum volume of air they could breathe out in one second) improve by 142 ml.
Po 24 tednih se je pri bolnikih, ki so jemali zdravilo Elebrato Ellipta, vrednost FEV1 (največja količina zraka, ki jo lahko oseba izdihne v eni sekundi) izboljšala za 142 ml.
What measures are being taken to ensure the safe and effective use of Elebrato Ellipta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Elebrato Ellipta?
Elebrato Ellipta (fluticasone furoate / umeclidinium bromide / vilanterol)
Elebrato Ellipta (flutikazonfuroat/umeklidinijev bromid/vilanterol)
In this study, Elebrato Ellipta reduced the rate of moderate and severe exacerbations over one year by 15% compared with treatment with vilanterol and fluticasone furoate, and by 25% compared with treatment with vilanterol and umeclidinium bromide.
V tej študiji je zdravilo Elebrato Ellipta zmanjšalo stopnjo zmernih in resnih poslabšanj bolezni v enem letu za 15 % v primerjavi z zdravljenjem z vilanterolom in flutikazonfuroatom in za 25 % v primerjavi z zdravljenjem z vilanterolom in umeklidinijevim bromidom.
The most common side effects with Elebrato Ellipta (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), headache and upper respiratory tract infection (nose and throat infection).
Najpogostejši neželeni učinki zdravila Elebrato Ellipta (ki se lahko pojavijo pri največ 1 bolniku od 10) so nazofaringitis (vnetje nosu in žrela), glavobol in okužba zgornjih dihal (okužba nosu in grla).
Patients treated with Elebrato Ellipta also reported improved health compared with those treated with the comparator treatment.
Bolniki, ki so jemali zdravilo Elebrato Ellipta, so poročali tudi o izboljšanju zdravja v primerjavi z bolniki, ki so bili zdravljeni s primerjalnim zdravilom.
For more information about using Elebrato Ellipta, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Elebrato Ellipta glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Elebrato Ellipta are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Elebrato Ellipta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
As for all medicines, data on the use of Elebrato Ellipta are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Elebrato Ellipta stalno spremljajo.
Other information about Elebrato Ellipta
Druge informacije o zdravilu Elebrato Ellipta
An overview of Elebrato Ellipta and why it is authorised in the EU
Pregled zdravila Elebrato Ellipta in zakaj je odobreno v EU
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elebrato Ellipta have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Elebrato Ellipta upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
What benefits of Elebrato Ellipta have been shown in studies?
Kakšne koristi zdravila Elebrato Ellipta so se pokazale v študijah?
Regarding the safety profile of the medicine, the most frequent side effects reported with Elebrato Ellipta were similar to those with the individual active substances of the medicine and are well known.
Glede varnostnega profila zdravila Elebrato Ellipta so bili najpogostejši neželeni učinki, o katerih so poročali pri uporabi tega zdravila, podobni kot pri posameznih učinkovinah zdravila in so dobro znani.
Elebrato Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Zdravilo Elebrato Ellipta se uporablja za lajšanje simptomov zmerne do hude kronične obstruktivne pljučne bolezni (KOPB).
Why is Elebrato Ellipta authorised in the EU?
Zakaj je bilo zdravilo Elebrato Ellipta odobreno v EU?
Elebrato Ellipta contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.
Zdravilo Elebrato Ellipta vsebuje tri učinkovine, ki različno delujejo na širjenje dihalnih poti in izboljšanje dihanja pri KOPB.
Elebrato Ellipta is used in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a longacting muscarinic antagonist.
Zdravilo Elebrato Ellipta se uporablja pri odraslih, pri katerih bolezen ni dovolj dobro nadzorovana s kombinacijo inhalacijskih zdravil, ki jo sestavljajo dolgodelujoč agonist adrenergičnih receptorjev beta-2 in kortikosteroid ali dolgodelujoč muskarinski antagonist.
What is Elebrato Ellipta and what is it used for?
Kaj je zdravilo Elebrato Ellipta in za kaj se uporablja?
What are the risks associated with Elebrato Ellipta?
Kakšna tveganja so povezana z zdravilom Elebrato Ellipta?
Another study involving 1,810 patients whose COPD was not satisfactorily controlled with a daily maintenance treatment for their COPD found Elebrato Ellipta more effective at improving patients' breathing than an inhaled combination of budesonide, a corticosteroid, and formoterol, a long-acting beta-2 agonist.
Druga študija s 1 810 bolniki, pri katerih KOPB ni bila zadostno nadzorovana z dnevnim vzdrževalnim zdravljenjem, je pokazala, da je zdravilo Elebrato Ellipta pri izboljšanju dihanja bolnikov učinkovitejše od inhalirane kombinacije budezonida, kortikosteroida in formoterola, dolgodelujočega agonista adrenergičnih receptorjev beta-2.
When inhaled, vilanterol activates the beta-2 receptors in the airways.
Pri inhaliranju vilanterol aktivira receptorje beta-2 v dihalnih poteh.
For the full list of side effects and restrictions with Elebrato Ellipta, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Elebrato Ellipta glejte navodilo za uporabo.
Elebrato Ellipta improves lung function as well as the quality of life of patients with moderate to severe COPD.
Zdravilo Elebrato Ellipta izboljšuje delovanje pljuč in kakovost življenja bolnikov z zmerno do hudo KOPB.
Elebrato Ellipta can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Elebrato Ellipta je le na recept.
How is Elebrato Ellipta used?
Kako se zdravilo Elebrato Ellipta uporablja?
How does Elebrato Ellipta work?
Kako zdravilo Elebrato Ellipta deluje?
Elebrato Ellipta was shown to improve patients' breathing and reduce exacerbations (flare-ups) of the disease in 2 main studies.
V dveh glavnih študijah je bilo dokazalo, da zdravilo Elebrato Ellipta izboljša bolnikovo dihanje in zmanjša poslabšanja (izbruhe) bolezni.
A study compared Elebrato Ellipta with either vilanterol given with fluticasone furoate or vilanterol with umeclidinium bromide, in 10,355 patients with advanced COPD who were at risk of exacerbations and whose disease was not satisfactorily controlled with a daily maintenance treatment.
V študiji, ki je vključevala 10 355 bolnikov z napredovalim KOPD, pri katerih je obstajalo tveganje za poslabšanje bolezni in pri katerih bolezen ni bila zadostno nadzorovana z dnevnim vzdrževalnim zdravljenjem, so zdravilo Elebrato Ellipta primerjali z vilanterolom, danim s flutikazonfuroatom, ali z vilanterolom, danim z umeklidinijevim bromidom.
Further information on Senstend can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/senstend.
Nadaljnje informacije za zdravilo Senstend so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/senstend.
This medicine is the same as Fortacin, which is already authorised in the EU.
To zdravilo je enako zdravilu Fortacin, ki je že odobreno v EU.
There were also positive psychological benefits to patients and their partners, and side effects were local and generally manageable.
Pri bolnikih in njihovih partnerjih so bile opažene tudi pozitivne psihološke koristi, stranski učinki pa so bili lokalni in na splošno obvladljivi.
Other information about Senstend
Druge informacije o zdravilu Senstend
The Agency therefore decided that Senstend's benefits are greater than its risks and it can be authorised for use in the EU.
Agencija je zato zaključila, da so koristi zdravila Senstend večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Senstend?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Senstend?
What benefits of Senstend have been shown in studies?
Kakšne koristi zdravila Senstend so se pokazale v študijah?
Senstend must also not be used in patients whose partners are hypersensitive to these substances.
Prav tako se zdravilo Senstend ne sme uporabljati pri bolnikih, katerih partnerji so preobčutljivi za te snovi.
What is Senstend and what is it used for?
Kaj je zdravilo Senstend in za kaj se uporablja?
Why is Senstend authorised in the EU?
Zakaj je bilo zdravilo Senstend odobreno v EU?
As for all medicines, data on the use of Senstend are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Senstend stalno spremljajo.
The most common side effects with Senstend (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their female sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men.
Najpogostejši neželeni učinki z zdravilom Senstend (ki se lahko pojavijo pri največ 1 od 10 oseb) so hipestezija (zmanjšan občutek) in pekoč občutek na genitalnem območju tako pri moških kot pri ženskih spolnih partnerkah in erektilna disfunkcija (nezmožnost vzdrževanja običajne erekcije) pri moških.
An overview of Senstend and why it is authorised in the EU
Pregled zdravila Senstend in zakaj je odobreno v EU
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Senstend 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 Senstend upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
In both studies, patients given the medicine reported substantially greater improvements in reported control, sexual satisfaction and distress than patients given the placebo.
V obeh študijah so bolniki, ki so prejemali zdravilo, poročali o bistveno večjih izboljšavah glede sporočenega nadzora, spolnega zadovoljstva in nelagodja, kot tisti, ki so prejemali placebo.
Side effects reported with Senstend are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Senstend, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.
Nekatere bolnike so spremljali do devet mesecev po začetni študiji.
It is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).
Uporablja se za zdravljenje moških s primarno (vseživljenjsko) prezgodnjo ejakulacijo (kadar se ejakulacija redno zgodi pred penetracijo ali je ejakuliranje med penetracijo prezgodnje).
For more information about using Senstend, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Senstend glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The main measures of effectiveness were the time taken to ejaculate after penetration and the amount of control over ejaculation, sexual satisfaction and distress reported by the patients.
Glavna merila učinkovitosti so bila čas do ejakulacije po penetraciji in količina nadzora nad ejakulacijo, spolno zadovoljstvo in nelagodje, o katerih so poročali uporabniki.
Senstend can only be obtained with a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray.
Predpisovanje in izdaja zdravila Senstend je le na recept, na voljo pa je kot dermalno razpršilo, ki dovede 7,5 mg lidokaina in 2,5 mg prilokaina na potisk.
The company that makes Fortacin has agreed that its scientific data can be used for Senstend (‘informed consent').
Podjetje, ki proizvaja zdravilo Fortacin, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Senstend („uporaba dokumentacije s soglasjem“).
The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by reversibly blocking the transmission of signals in the nerves.
Zdravilni učinkovini v zdravilu, lidokain in prilokain, sta lokalna anestetika, ki začasno omrtvita območje, s katerim sta v stiku, z blokiranjem prenosa živčnih signalov.
The European Medicines Agency considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole.
Evropska agencija za zdravila je menila, da sta učinkovini dobro znana kombinacija lokalnih anestetikov, uporaba lokalnega razpršila pa zmanjšuje količino absorbirane učinkovine in s tem tveganje neželenih učinkov, ki vplivajo na telo kot celoto.
Senstend is a medicine containing the active substances lidocaine and prilocaine.
Senstend je zdravilo, ki vsebuje učinkovini lidokain in prilokain.
This reduces sensitivity to stimulation, and when applied onto the head of the penis this will help to increase the time taken to ejaculate.
Tako se zmanjša občutljivost na stimulacijo in ko se zdravilo nanese na glavico penisa pripomore k podaljšanju časa pred ejakulacijo.
What are the risks associated with Senstend?
Kakšna tveganja so povezana z zdravilom Senstend?
Senstend must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a structure related to the active ingredients (amidetype local anaesthetics).
Zdravilo Senstend se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) katero koli sestavino zdravila ali na druge lokalne anestetike, sestavljene podobno kot učinkovini (lokalni anestetiki amidnega tipa).
Doses should not be repeated more frequently than every 4 hours, and no more than three doses should be used in 24 hours.
V 24 urah se lahko uporabi največ tri odmerke v razmiku najmanj štirih ur.
How is Senstend used?
Kako se zdravilo Senstend uporablja?
The recommended dose is three sprays onto the head (glans) of the penis before intercourse.
Priporočeni odmerek je tri potiske, s katerimi se prekrije glavico penisa pred spolnim odnosom.
The effectiveness of Senstend has been shown in two main studies involving 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks.
Učinkovitost zdravila Senstend je bila izkazana v dveh glavnih študijah, v kateri je sodelovalo 256 oziroma 300 heteroseksualnih odraslih moških s prezgodnjo ejakulacijo.
For the full list of side effects reported with Senstend, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Senstend, glejte navodilo za uporabo.
How does Senstend work?
Kako zdravilo Senstend deluje?
In the first study, the average time to ejaculation in patients treated with Senstend was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study,
prejemali zdravilo Senstend, 2,6 minut, v primerjavi z 0,8 minut pri tistih, ki so prejemali placebo.
The response was sustained for at least 48 weeks;
Odziv se je ohranjal najmanj 48 tednov;
This was switched to a full marketing authorisation on 14 July 2009.
To je bilo 14. julija 2009 spremenjeno v običajno dovoljenje za promet.
Further information on Isentress can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Nadaljnje informacije za zdravilo Isentress so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Therefore, the effectiveness observed in adults is also expected in children.
Zato se učinkovitost, opažena pri odraslih, pričakuje tudi pri otrocih;
Equivalent doses of these different forms do not all produce the same levels of raltegravir in the body, so they must not be used interchangeably.
Enakovredni odmerki teh različnih oblik zdravila ne proizvedejo vsi enakih ravni raltegravirja v telesu, zato jih ne smemo uporabljati izmenjaje.
What measures are being taken to ensure the safe and effective use of Isentress?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Isentress?
Side effects in children were comparable to those in adults.
Neželeni učinki pri otrocih so bili primerljivi s tistimi pri odraslih.
This study looked at viral loads after 24 and 48 weeks.
V tej študiji so proučevali virusno breme po 24 oziroma 48 tednih.
The European Medicines Agency therefore decided that Isentress's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Isentress večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
• Additional supportive studies established doses that provide similar effective levels of Isentress in newborn infants as in young children.
• Dodatne podporne študije so določile doze, s katerimi se dosežejo podobne učinkovite ravni zdravila Isentress pri novorojenčkih in majhnih otrocih.
Isentress has been studied in six main studies.
Zdravilo Isentress so proučevali v šestih glavnih študijah:
Isentress received a conditional marketing authorisation valid throughout the European Union for Isentress on 20 December 2007.
Promet z zdravilom Isentress je bil pogojno dovoljen po vsej Evropski uniji od 20. decembra 2007.
As for all medicines, data on the use of Isentress are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Isentress stalno spremljajo.