FrancophonIA/ELRC3.0 huggingface dataset:
English: Baraclude is used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Slovenian: Zdravilo Baraclude je namenjeno zdravljenju kroničnega (dolgotrajnega) hepatitisa B (nalezljive bolezni jeter, ki jo povzroča virus hepatitisa B).
English: Baraclude was also shown to be effective in the children's study: 24% of children in the Baraclude group achieved the primary goal of having a viral DNA level of less than 50 IU/ml plus production of antibody to e-antigen and no e-antigen in their blood compared with 2% of children in the placebo group.
Slovenian: Zdravilo Baraclude se je izkazalo za učinkovito tudi v študiji z otroki: 24 % otrok v skupini, ki je prejemala zdravilo Baraclude, je doseglo primarni cilj znižanja ravni virusne DNK na manj kot 50 i.e./ml skupaj s tvorbo protiteles proti antigenu e in odsotnostjo antigena e v krvi v primerjavi z 2 % otrok v skupini, ki je prejemala placebo.
English: In a children's study, 180 children aged 2 to 18 years who had chronic hepatitis B were randomly selected to be given either Baraclude or placebo (a dummy treatment).
Slovenian: V študiji z otroki so med 180 otroki v starosti od 2 do 18 let s kroničnim hepatitisom B naključno izbrali tiste, ki so prejemali zdravilo Baraclude, in tiste, ki so prejemali placebo (zdravilo brez zdravilne učinkovine).
English: The study looked at the reductions in levels of the virus in the blood and the number of patients who developed antibody to a viral protein (known as e-antigen) and no longer had e-antigen in their blood after 48 weeks of treatment.
Slovenian: V tej študiji so preučevali zmanjšanje ravni virusa v krvi ter število bolnikov, ki so razvili protitelesa proti virusni beljakovini (antigenu e) in ki po 48 tednih zdravljenja v krvi niso imeli več tega antigena.
English: Treatment with Baraclude should be started by a doctor with experience in the management of chronic hepatitis B.
Slovenian: Zdravljenje z zdravilom Baraclude mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B.
English: Baraclude was compared with lamivudine in three main studies in adults with chronic hepatitis B who had compensated liver disease.
Slovenian: Zdravilo Baraclude so primerjali z lamivudinom v treh glavnih študijah pri odraslih s kroničnim hepatitisom B, ki so imeli kompenzirano bolezen jeter.
English: For the full list of side effects and restrictions with Baraclude, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Baraclude, in omejitev, ki veljajo zanj, glejte navodilo za uporabo.
English: Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Slovenian: Entekavir ovira delovanje virusnega encima, imenovanega DNK polimeraza, ki je udeležen pri tvorbi virusne DNK.
English: In adults with compensated liver disease, Baraclude was more effective than lamivudine in patients who had not been treated with nucleoside analogues before: an improvement in the condition of the liver was seen in just over 70% of the patients treated with Baraclude, against just over 60% of the patients treated with lamivudine.
Slovenian: V skupini odraslih s kompenzirano boleznijo jeter je bilo zdravilo Baraclude učinkovitejše od lamivudina pri bolnikih, ki predhodno niso bili zdravljeni z nukleozidnimi analogi: izboljšanje stanja jeter je bilo opaziti pri malce več kot 70 % bolnikov, ki so bili zdravljeni z zdravilom Baraclude, v primerjavi z malce več kot 60 % bolnikov, ki so bili zdravljeni z zdravilom lamivudin.
English: The active substance in Baraclude, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Slovenian: Zdravilna učinkovina zdravila Baraclude, entekavir, je protivirusno zdravilo, ki spada v razred nukleozidnih analogov.
English: In adults with decompensated liver disease, there was a greater reduction in viral DNA with Baraclude than with adefovir dipivoxil.
Slovenian: V skupini odraslih z dekompenzirano boleznijo jeter se je pri bolnikih, ki so prejemali zdravilo Baraclude, raven virusne DNK zmanjšala bolj kot pri tistih, ki so jemali adefovir dipivoksil.
English: Baraclude was also more effective than lamivudine in patients refractory to lamivudine: 55% of patients treated with Baraclude had improvements in the condition of their liver, against 28% of those treated with lamivudine.
Slovenian: Zdravilo Baraclude je bilo učinkovitejše od lamivudina tudi pri bolnikih, neodzivnih na lamivudin: 55 % bolnikov, zdravljenih z zdravilom Baraclude, je izkazalo izboljšanje stanja jeter v primerjavi z 28 % tistih, ki so bili zdravljeni z zdravilom lamivudin.
English: Baraclude is an antiviral medicine that contains the active substance entecavir.
Slovenian: Zdravilo Baraclude je protivirusno zdravilo, ki vsebuje zdravilno učinkovino entekavir.
English: For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Baraclude
Slovenian: Pri odraslih s kompenzirano boleznijo jeter je odmerek odvisen od tega, ali je bil bolnik predhodno zdravljen z zdravilom iz iste skupine, kot je zdravilo Baraclude (nukleozidnim analogom, kot je npr. lamivudin).
English: What is Baraclude used for?
Slovenian: Za kaj se zdravilo Baraclude uporablja?
English: How has Baraclude been studied?
Slovenian: Kako je bilo zdravilo Baraclude raziskano?
English: What is Baraclude?
Slovenian: Kaj je zdravilo Baraclude?
English: How is Baraclude used?
Slovenian: Kako se zdravilo Baraclude uporablja?
English: How does Baraclude work?
Slovenian: Kako zdravilo Baraclude deluje?
English: Baraclude was also compared with another medicine, adefovir dipivoxil, in 195 patients with chronic hepatitis B with decompensated liver disease.
Slovenian: Zdravilo Baraclude so pri 195 bolnikih s kroničnim hepatitisom B, ki so imeli dekompenzirano bolezen jeter, primerjali z drugim zdravilom, imenovanim adefovir dipivoksil.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO VZPOSTAVITI DRŽAVE ČLANICE
English: The EU Member States shall ensure that:
Slovenian: Država članica mora zagotoviti naslednje:
English: • Use of antibiotics
Slovenian: • uporabo antibiotikov,
English: • When to seek urgent attention from the health care provider
Slovenian: • v katerih primerih je treba poiskati urgentno zdravstveno pomoč.
English: The Marketing Authorisation Holder (MAH) shall ensure that updated physician information packs are provided to all ophthalmology clinics where Lucentis is expected to be used.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo vsem oftalmološkim klinikam, na katerih je mogoče pričakovati uporabo zdravila Lucentis, priskrbel dopolnjene komplete podatkov za zdravnika.
English: • Sterile techniques, including periocular and ocular disinfection, to minimise risk of infection
Slovenian: • sterilne tehnike, vključno z razkuževanjem očesa in kože okrog njega, za zmanjševanje tveganja za okužbo,
English: • Key signs and symptoms of serious adverse events
Slovenian: • ključni znaki in simptomi resnih neželenih dogodkov,
English: • How to prepare for Lucentis treatment
Slovenian: • kako se pripraviti na zdravljenje z zdravilom Lucentis,
English: The physician information should contain the following key elements:
Slovenian: Podatki za zdravnika morajo vsebovati sledeče ključne vsebine:
English: • Use of povidone iodine or equivalent
Slovenian: • uporabo povidon jodida ali drugega ustreznega sredstva,
English: • What are the steps following treatment with Lucentis
Slovenian: • kaj sledi zdravljenju z zdravilom Lucentis,
English: The patient information pack should be provided in the form of both patient information booklets and audio-CD that contain following key elements:
Slovenian: Komplet podatkov za bolnika mora vsebovati tako brošure kot zvočno zgoščenko, ki vsebujejo sledeče ključne vsebine:
English: The physician information pack should contain the following:
Slovenian: Komplet podatkov za zdravnika mora vsebovati sledeče:
English: • Physician information
Slovenian: • podatke za zdravnika
English: • Intravitreal injection procedure video
Slovenian: • videoposnetek postopka intravitrealnega injiciranja
English: • Key signs and symptoms of IVT injection related adverse events
Slovenian: • ključne znake in simptome neželenih dogodkov v zvezi z intravitrealnim injiciranjem,
English: • Patient information leaflet
Slovenian: • komplete podatkov za bolnika
English: • Techniques for the intravitreal injection
Slovenian: • tehniko intravitrealnega injiciranja,
English: • Management of IVT injection related adverse events
Slovenian: • ukrepe v primerih neželenih dogodkov v zvezi z intravitrealnim injiciranjem.
English: A similar difference was seen between the two groups after two years.
Slovenian: Podobna razlika je bila med tema dvema skupinama ugotovljena po dveh letih.
English: Patients were followed up for at least two years.
Slovenian: Bolnike so spremljali najmanj dve leti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for PhotoBarr on 25 March 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom PhotoBarr, veljavno po vsej Evropski uniji, odobrila dne 25. marca 2004.
English: This will ensure that all doctors and pharmacists who will prescribe or dispense the medicine are provided with information packs for healthcare workers and patients.
Slovenian: Tako bodo vsi zdravniki in farmacevti, ki bodo predpisovali ali izdajali zdravilo, prejeli informativne pakete za zdravstvene delavce in bolnike.
English: This kills the cells by reacting with and destroying their components, such as their proteins and DNA.
Slovenian: Ta uniči celice tako, da reagira z njihovimi komponentami, na primer z njihovimi beljakovinami in DNK, ter jih uniči.
English: The company that makes PhotoBarr is preparing educational materials in agreement with medicines regulatory authorities in Member States.
Slovenian: Družba, ki izdeluje zdravilo PhotoBarr, v soglasju z zdravstvenimi regulativnimi organi držav članic pripravlja izobraževalno gradivo.
English: What measures are being taken to ensure the safe use of PhotoBarr?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila PhotoBarr?
English: This is a summary of the European public assessment report (EPAR) for PhotoBarr.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo PhotoBarr.
English: When it is illuminated with laser light of a specific wavelength, it is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen called ‘singlet oxygen'.
Slovenian: Ko ga osvetlimo z lasersko svetlobo določene valovne dolžine, se porfimer aktivira in reagira s kisikom v celicah, pri čemer se tvori zelo reaktivna in strupena oblika kisika, imenovana singletni kisik.
English: PhotoBarr porfimer sodium
Slovenian: PhotoBarr porfimer-natrij
English: Patients who receive PhotoBarr must be given a special card that summarises the safety information on the medicine.
Slovenian: Bolniki, ki se zdravijo z zdravilom Photobarr, morajo dobiti posebno opozorilno kartico, na kateri so povzeti podatki o varnosti zdravila.
English: The main measure of effectiveness was the number of patients who had no high-grade dysplasia left at least six months after the first course of treatment.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki vsaj šest mesecev po prvi epizodi zdravljenja niso imeli displazije visoke stopnje.
English: By restricting the illumination to the area of dysplasia, only cells in this area are damaged, leaving other areas of the body unaffected.
Slovenian: Če osvetlitev omejimo samo na območje displazije, se poškodujejo samo celice v tem predelu, drugi predeli telesa pa ostanejo nepoškodovani.
English: The type of apparatus used, as well as the duration of the illumination, depends on how large the disease area is.
Slovenian: Vrsta uporabljenega aparata in trajanje osvetljevanja sta odvisna od velikosti obolelega predela.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for PhotoBarr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu PhotoBarr je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The packs will include information on PhotoBarr and how it should be used safely.
Slovenian: Paketi bodo vsebovali informacije o zdravilu PhotoBarr ter o njegovi varni uporabi.
English: PhotoBarr has been studied in one main study involving 208 patients who had Barrett's oesophagus with high-grade dysplasia.
Slovenian: Zdravilo PhotoBarr so proučevali v eni glavni študiji, ki je vključevala 208 bolnikov z Barrettovim požiralnikom z visoko stopnjo displazije.
English: For more information about treatment with PhotoBarr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom PhotoBarr preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Other information about PhotoBarr
Slovenian: Druge informacije o zdravilu PhotoBarr:
English: When PhotoBarr is injected, porfimer is absorbed into cells throughout the body.
Slovenian: Ko zdravilo PhotoBarr injiciramo, se porfimer absorbira v celice po vsem telesu.
English: If necessary, patients may receive a second, shorter laser treatment two to three days later.
Slovenian: Po potrebi se lahko dva do tri dni kasneje pri bolnikih izvede še drugi, krajši laserski poseg.
English: After six months, 72% of the patients using PhotoBarr in combination with omeprazole had no high-grade dysplasia left, compared with 31% of those taking omeprazole alone.
Slovenian: Po šestih mesecih 72 % bolnikov, ki so uporabljali zdravilo PhotoBarr v kombinaciji z omeprazolom, ni imelo displazije visoke stopnje, v primerjavi z 31 % bolnikov, ki so jemali samo omeprazol.
English: What benefit has PhotoBarr shown during the studies?
Slovenian: Kakšne koristi je zdravilo PhotoBarr izkazalo med študijami?
English: Because the number of patients with Barrett's oesophagus is low, the disease is considered ‘rare', and PhotoBarr was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 March 2002.
Slovenian: Ker je število bolnikov z Barrettovim požiralnikom majhno, velja ta bolezen za redko, zato je bilo zdravilo PhotoBarr dne 6. marca 2002 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
English: As all patients receiving PhotoBarr become more sensitive to light, they should take care to avoid exposure of their skin and eyes to bright light for at least three months after injection.
Slovenian: Ker postanejo vsi bolniki, ki prejmejo zdravilo PhotoBarr, občutljivejši na svetlobo, kože in oči vsaj tri mesece po injekciji ne smejo izpostavljati močni svetlobi.
English: Up to two additional treatment courses (one injection and one or two laser treatments) can be given, separated by at least three months, as long as the risk of narrowing of the gullet is taken into account.
Slovenian: Možna sta največ dva dodatna cikla zdravljenja (ena injekcija in en do dva laserska posega) v razmaku najmanj treh mesecev, če je bilo upoštevano tveganje za zoženje požiralnika.
English: Around two days later, the dysplasia, plus small areas of normal tissue above and below it, is illuminated with light from a laser at a specific wavelength using a fibre optic cable through an endoscope.
Slovenian: Približno dva dni pozneje je treba displazijo in majhne dele normalnega tkiva nad in pod njo osvetljevati z lasersko svetlobo z določeno valovno dolžino s pomočjo kabla iz optičnih vlaken, ki je napeljan skozi endoskop.
English: 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 PhotoBarr.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo PhotoBarr, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because it causes difficulty swallowing, including pain, nausea and vomiting, patients should only take liquid food for a few days after laser treatment, and for up to four weeks in some cases.
Slovenian: Ker zdravljenje povzroča težave pri požiranju, vključno z bolečino, slabostjo in bruhanjem, naj bolniki nekaj dni po laserskem posegu, v nekaterih primerih pa do štiri tedne po laserskem posegu, uživajo samo tekočo hrano.
English: It contains the active substance porfimer sodium.
Slovenian: Vsebuje zdravilno učinkovino porfimer-natrij.
English: The full EPAR for PhotoBarr can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo PhotoBarr je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is the risk associated with PhotoBarr?
Slovenian: Kakšna tveganja so povezana z zdravilom PhotoBarr?
English: The CHMP decided that PhotoBarr's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila PhotoBarr večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: PhotoBarr should not be used in people who may be hypersensitive (allergic) to porfimer sodium and other porphyrins, or to any of the other ingredients.
Slovenian: Zdravila PhotoBarr ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) porfimer-natrij in druge porfirine ali katero koli drugo sestavino zdravila.
English: The most common side effects with PhotoBarr (seen in more than 1 patient in 10) are dehydration, oesophageal stenosis (narrowing of the oesophagus), vomiting, dysphagia (difficulty swallowing), constipation, nausea (feeling sick), photosensitivity reactions (sunburn-like reactions) and pyrexia (fever).
Slovenian: Najpogostejši neželeni učinki zdravila PhotoBarr (opaženi pri več kot 1 bolniku od 10) so dehidracija, ezofagealna stenoza (zoženje požiralnika), bruhanje, disfagija (težave pri požiranju), zaprtje, navzeja (slabost), preobčutljivostne reakcije na svetlobo (reakcije, podobne sončnim opeklinam) in pireksija (povišana telesna temperatura).
English: Photodynamic therapy with PhotoBarr should only be carried out or supervised by a doctor who has experience in laser treatment using an endoscope (a thin tube used to look into the body) and who has been trained in photodynamic therapy.
Slovenian: Fotodinamično zdravljenje z zdravilom PhotoBarr lahko izvaja ali nadzoruje samo zdravnik, ki ima izkušnje z laserskim zdravljenjem z endoskopom (ozko cevko, ki omogoča preiskavo notranjosti telesa) in je bil usposobljen za fotodinamično zdravljenje.
English: PhotoBarr is a powder that is made up into a solution for injection.
Slovenian: Zdravilo PhotoBarr je prašek za pripravo raztopine za injiciranje.
English: PhotoBarr should also only be used if experienced staff and material for assessing and treating anaphylaxis (severe allergic reaction) are immediately available.
Slovenian: Zdravilo PhotoBarr se lahko uporablja samo, če je na voljo izkušeno osebje ter oprema za ocenjevanje in zdravljenje anafilakse (hude alergijske reakcije).
English: Why has PhotoBarr been approved?
Slovenian: Zakaj je bilo zdravilo PhotoBarr odobreno?
English: PhotoBarr must not be used in patients with porphyria (an inability to break down porphyrins), severe problems with the liver or kidneys, varices (swollen veins) in the oesophagus or stomach, large ulcers in the oesophagus, fistulae (abnormal passageways) between the oesophagus and either the trachea (windpipe) or the bronchi (airways in the lungs), or suspected damage to major blood vessels.
Slovenian: Ne smejo ga uporabljati osebe s porfirijo (nezmožnostjo razgradnje porfirinov), hudimi težavami z jetri ali ledvicami, varicami (razširjenimi žilami) požiralnika ali želodca, velikimi razjedami požiralnika, fistulami (nenormalnimi prehodi) med požiralnikom in trahejo (sapnikom) oziroma med požiralnikom in bronhiji (dihalnimi kanali v pljučih) ali sumom na poškodbo velikih krvnih žil.
English: PhotoBarr is used in photodynamic therapy (treatment using light) for the ablation (destruction) of high-grade dysplasia (abnormal cells at high risk of turning into cancer) in patients with Barrett's oesophagus.
Slovenian: Zdravilo PhotoBarr se uporablja za fotodinamično zdravljenje (zdravljenje z uporabo svetlobe) za odstranjevanje displazije visoke stopnje (nenormalnih celic z visokim tveganjem, da postanejo rakave) pri bolnikih z Barrettovim požiralnikom.
English: This is a disease where the lining at the lower end of the oesophagus (gullet) has changed because of damage due to acid from the stomach.
Slovenian: Za to bolezen je značilno, da se sluznica na spodnjem koncu požiralnika spremeni zaradi poškodbe, ki jo povzroči kislina iz želodca.
English: Adding photodynamic therapy using PhotoBarr to omeprazole treatment increased the number of patients whose dysplasia was destroyed.
Slovenian: S kombiniranjem fotodinamičnega zdravljenja z zdravilom PhotoBarr in terapije z omeprazolom se je povečalo število bolnikov, pri katerih je bila displazija odpravljena.
English: The effects of photodynamic therapy with PhotoBarr, used in combination with omeprazole (an antacid medicine), were compared with those of omeprazole alone.
Slovenian: Učinke fotodinamičnega zdravljenja z zdravilom PhotoBarr, uporabljenim v kombinaciji z omeprazolom (antacidnim zdravilom), so primerjali z učinki omeprazola kot samostojnega zdravila.
English: The active substance in PhotoBarr, porfimer sodium, is a photosensitising agent (a substance that changes when exposed to light).
Slovenian: Zdravilna učinkovina zdravila PhotoBarr, porfimer-natrij, je na svetlobo občutljiva snov (snov, ki se spremeni, če jo izpostavimo svetlobi).
English: For a more complete list of the side effects reported with PhotoBarr, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PhotoBarr, glejte navodilo za uporabo.
English: How has PhotoBarr been studied?
Slovenian: Kako je bilo zdravilo PhotoBarr raziskano?
English: Treatment with PhotoBarr is a two-step process: the medicine is given first before it is activated using a laser. PhotoBarr is given by slow, careful injection into a vein at a dose of 2 mg per kilogram body weight over three to five minutes.
Slovenian: Injicira se počasi in previdno v veno v odmerku 2 mg na kilogram telesne mase v treh do petih minutah.
English: What is PhotoBarr used for?
Slovenian: Za kaj se zdravilo PhotoBarr uporablja?
English: How is PhotoBarr used?
Slovenian: Kako se zdravilo PhotoBarr uporablja?
English: What is PhotoBarr?
Slovenian: Kaj je zdravilo PhotoBarr?
English: How does PhotoBarr work?
Slovenian: Kako zdravilo PhotoBarr deluje?
English: Use the following formula:
Slovenian: Uporabite naslednjo formulo:
English: If the existing advice is not considered sufficient a proposal for revised text should be submitted.
Slovenian: Če obstoječi nasvet ne zadošča, je treba predložiti predlog za revidirano besedilo.
English: In: Association of Exotic Mammal Veterinarians (AEMV) Sessions, Preceedings, 2006
Slovenian: V: Association of Exotic Mammal Veterinarians (AEMV) Sessions, Preceedings, 2006