FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was the response rate, which was the proportion of patients with a reduction of the levels of virus in the blood (viral load) to fewer than 50 copies of HIV RNA per ml.
Slovenian: Glavno merilo učinkovitosti je bila stopnja odziva, opredeljena kot delež bolnikov, pri katerih se je koncentracija virusa v krvi (virusno breme) zmanjšala na manj kot 50 kopij HIV RNA na ml.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Triumeq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Triumeq večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Other information about Triumeq
Slovenian: Druge informacije o zdravilu Triumeq
English: The CHMP concluded that the medicine had demonstrated its effectiveness in previously untreated patients, and that similar benefits are expected in patients who have received previous treatment.
Slovenian: Odbor CHMP je zaključil, da je bila dokazana učinkovitost zdravila pri predhodno nezdravljenih bolnikih in da je podobne koristi mogoče pričakovati tudi pri predhodno že zdravljenih bolnikih.
English: Triumeq dolutegravir / abacavir / lamivudine
Slovenian: Triumeq dolutegravir/abakavir/lamivudin
English: Results from this study showed that Triumeq was absorbed into the body in the same way as the separate medicines.
Slovenian: Rezultati iz te študije so pokazali, da se zdravilo Triumeq v telesu absorbira na enak način kot ločeni zdravili.
English: Triumeq is available as tablets (50 mg dolutegravir / 600 mg abacavir /300 mg lamivudine) and the recommended dose is one tablet a day, taken with or without food.
Slovenian: Zdravilo Triumeq je na voljo v obliki tablet (50 mg dolutegravirja/600 mg abakavirja/300 mg lamivudina), priporočeni odmerek pa je ena tableta na dan, ki se vzame s hrano ali brez nje.
English: The CHMP also considered the fact that Triumeq can be taken with or without food as an additional advantage compared with other similar medicines which have to be taken strictly either with food or on an empty stomach.
Slovenian: Odbor CHMP je prav tako menil, da je dejstvo, da se lahko zdravilo Triumeq jemlje s hrano ali brez nje, dodatna prednost v primerjavi z drugimi podobnimi zdravili, ki se morajo obvezno jemati bodisi s hrano ali na prazen želodec.
English: The combination of abacavir and lamivudine has been authorised as Kivexa since 2004.
Slovenian: Kombinacija abakavirja in lamivudina je odobrena od leta 2004 kot zdravilo Kivexa.
English: The most common side effects with Triumeq (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), diarrhoea and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki zdravila Triumeq (ki lahko prizadenejo več kot 1 osebo od 10) so nespečnost (težave s spanjem), glavobol, navzeja (slabost), driska in utrujenost.
English: Data from this study had already been used in the authorisation of Tivicay.
Slovenian: Podatke iz te študije so že predložili v postopku za pridobitev dovoljenja za promet z zdravilom Tivicay.
English: All three active substances in Triumeq are already available in the European Union (EU) as singlecomponent medicines: abacavir has been authorised as Ziagen since 1999, lamivudine as Epivir since 1996, and dolutegravir as Tivicay since January 2014.
Slovenian: Vse tri zdravilne učinkovine v zdravilu Triumeq so v Evropski uniji (EU) že na voljo kot enokomponentna zdravila: abakavir je odobren od leta 1999 kot zdravilo Ziagen, lamivudin od leta 1996 kot zdravilo Epivir, dolutegravir pa od januarja 2014 kot zdravilo Tivicay.
English: The combination of dolutegravir, abacavir and lamivudine (as found in Triumeq) was evaluated in one main study involving 833 previously untreated patients.
Slovenian: Kombinacijo dolutegravirja, abakavirja in lamivudina (ki jo vsebuje zdravilo Triumeq) so ovrednotili v eni glavni študiji, v kateri je sodelovalo 833 bolnikov, ki se pred tem še niso zdravili.
English: A risk management plan has been developed to ensure that Triumeq is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Triumeq je bil pripravljen načrt obvladovanja tveganj.
English: Triumeq does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Triumeq ne ozdravi okužbe z virusom HIV ali aidsa, vendar lahko upočasni slabšanje imunskega sistema in razvoj okužb ter bolezni, povezanih z aidsom.
English: What is Triumeq and what is it used for?
Slovenian: Kaj je zdravilo Triumeq in za kaj se uporablja?
English: The CHMP also noted that giving the combination of dolutegravir, abacavir and lamivudine as a single tablet is an additional treatment option for patients with HIV infection and without the HLA-B (type 5701) gene.
Slovenian: Odbor CHMP je prav tako izpostavil, da je dajanje kombinacije dolutegravirja, abakavirja in lamivudina v eni tableti dodatna možnost zdravljenja za bolnike, ki so okuženi z virusom HIV in nimajo gena HLAB (tip 5701).
English: What benefits of Triumeq have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Triumeq izkazalo v študijah?
English: What are the risks associated with Triumeq?
Slovenian: Kakšna tveganja so povezana z zdravilom Triumeq?
English: They both work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Slovenian: Ti dve učinkovini delujeta na podoben način, in sicer zavirata delovanje reverzne transkriptaze, tj. encima, ki ga proizvaja virus HIV, da lahko okuži celice in tvori še več virusov.
English: Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Triumeq.
Slovenian: Pri bolnikih s tem genom obstaja veliko tveganje za pojav alergijske reakcije na abakavir, zato zdravila Triumeq ne smejo jemati.
English: Regarding Triumeq's safety profile, this was expected to be similar to the safety profile of the single components and comparable to that of other HIV treatments.
Slovenian: Kar zadeva varnostni profil zdravila Triumeq, naj bi bil podoben varnostnemu profilu posameznih učinkovin in primerljiv z varnostnim profilom drugih zdravil proti virusu HIV.
English: In addition, the company that markets Triumeq will provide educational material for healthcare professionals expected to prescribe Triumeq that addresses the risk of abacavir-associated hypersensitivity.
Slovenian: Poleg tega bo družba, ki trži zdravilo Triumeq, zagotovila izobraževalno gradivo za zdravstvene delavce, ki naj bi predpisovali zdravilo Triumeq, v katerem bo obravnavano tveganje za preobčutljivost, povezano z abakavirjem.
English: For more information about treatment with Triumeq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Triumeq preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Triumeq approved?
Slovenian: Zakaj je bilo zdravilo Triumeq odobreno?
English: This is an antiviral medicine that blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
Slovenian: To je protivirusno zdravilo, ki zavira encim, imenovan integraza, ki ga virus HIV potrebuje za to, da se v telesu lahko podvaja.
English: The company also looked at the way Triumeq was absorbed in the body in comparison with two separate tablets (dolutegravir and abacavir/lamivudine) containing the three medicines that make it up.
Slovenian: Družba je prav tako proučila, kako se zdravilo Triumeq absorbira v telesu v primerjavi z dvema ločenima tabletama (dolutegravir in abakavir/lamivudin), ki vsebujeta enake tri učinkovine kot omenjeno zdravilo.
English: The other two active substances, abacavir and lamivudine, are nucleoside reversetranscriptase inhibitors (NRTIs).
Slovenian: Drugi dve zdravilni učinkovini, abakavir in lamivudin, sta nukleozidna zaviralca reverzne transkriptaze (nucleoside reverse-transcriptase inhibitors - NRTI).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Triumeq, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Triumeq in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Triumeq contains three active substances: dolutegravir, abacavir and lamivudine.
Slovenian: Zdravilo Triumeq vsebuje tri zdravilne učinkovine: dolutegravir, abakavir in lamivudin.
English: In patients taking some of the components of Triumeq, certain serious side effects have been seen including hypersensitivity (allergic).
Slovenian: Pri bolnikih, ki so jemali nekatere učinkovine, ki jih vsebuje zdravilo Triumeq, so opazili določene resne neželene učinke, vključno s preobčutljivostjo (alergijo).
English: It is not intended to provide practical advice on how to use Triumeq.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Triumeq is an antiviral medicine used to treat patients with human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS).
Slovenian: Zdravilo Triumeq je protivirusno zdravilo, ki se uporablja za zdravljenje bolnikov z virusom humane imunske pomanjkljivosti, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
English: For practical information about using Triumeq, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Triumeq naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Triumeq can only be obtained with a prescription and treatment should be prescribed by a doctor who is experienced in managing HIV infections.
Slovenian: Izdaja zdravila Triumeq je le na recept, zdravljenje z njim pa mora predpisati zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
English: Triumeq must not be used together with dofetilide, a medicine used to control cardiac arrhythmia (unstable heartbeat).
Slovenian: Zdravilo Triumeq se ne sme uporabljati sočasno z dofetilidom, tj. zdravilom, ki se uporablja za obvladovanje srčne aritmije (neenakomernega bitja srca).
English: Patients were either given the Triumeq combination or a different three-drug combination (Atripla) that did not include an integrase inhibitor.
Slovenian: Bolniki so prejemali bodisi kombinacijo, ki jo vsebuje zdravilo Triumeq, ali drugo kombinacijo treh zdravil (Atripla) brez zaviralca integraze.
English: One of the active substances in Triumeq, dolutegravir, is an integrase inhibitor.
Slovenian: Ena od zdravilnih učinkovin v zdravilu Triumeq, dolutegravir, je zaviralec integraze.
English: For the full list of restrictions with Triumeq, see the package leaflet.
Slovenian: Za celoten seznam omejitev pri uporabi zdravila Triumeq glejte navodilo za uporabo.
English: How does Triumeq work?
Slovenian: Kako zdravilo Triumeq deluje?
English: How is Triumeq used?
Slovenian: Kako se zdravilo Triumeq uporablja?
English: For the full list of all side effects reported with Triumeq, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Triumeq, glejte navodilo za uporabo.
English: It is important to treat these types of conditions as soon as possible.
Slovenian: Pomembno je, da se tovrstna stanja začnejo zdraviti čim prej.
English: The procedure should be carried out under sterile conditions.
Slovenian: Postopek je treba izvesti v sterilnih pogojih.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Macugen on 31 January 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Macugen, veljavno po vsej Evropski uniji, odobrila dne 31. januarja 2006.
English: The main measure of effectiveness was the proportion of patients losing less than 15 letters in a standard eye test.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki so izgubili manj kot 15 črk na standardnem testu vida.
English: This causes the gradual loss of the central part of a person's vision.
Slovenian: To povzroči postopno izgubo osrednjega vida.
English: This improvement lasted for two years in patients who were given Macugen.
Slovenian: Izboljšanje je pri bolnikih, ki so prejeli zdravilo Macugen, trajalo dve leti.
English: The full EPAR for Macugen 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 Macugen je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The 3 mg dose did not bring any additional benefit.
Slovenian: 3-miligramski odmerek ni prinesel dodatnega izboljšanja.
English: EPAR summary for the public pegaptanib
Slovenian: Povzetek EPAR za javnost pegaptanib
English: Macugen has been studied in two main clinical studies involving a total of 1,190 patients and lasting up to two years.
Slovenian: Zdravilo Macugen so proučevali v okviru dveh glavnih kliničnih študij, ki sta vključevali skupno 1 190 bolnikov in trajali do dve leti.
English: The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces.
Slovenian: Rumena pega zagotavlja centralni vid, ki je potreben pri izvajanju vsakdanjih opravil, na primer pri vožnji avtomobila, branju in prepoznavanju obrazov.
English: What measures are being taken to ensure the safe use of Macugen?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Macugen?
English: This is a summary of the European public assessment report (EPAR) for Macugen.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Macugen.
English: Other information about Macugen
Slovenian: Druge informacije o zdravilu Macugen
English: The pre-filled syringe contains more than the recommended dose, therefore when preparing the injection, the doctor must expel a certain volume and ensure the injection of the correct dose.
Slovenian: Predhodno napolnjena injekcijska brizga vsebuje več zdravila, kot je priporočeni odmerek, zato mora zdravnik pri pripravi injekcije izbrizgati določeno količino in zagotoviti vbrizganje pravilnega odmerka.
English: An aptamer is a single strand of molecules called nucleotides that has been designed to attach to a specific molecule in the body.
Slovenian: Aptamer je enojna veriga molekul, imenovanih nukleotidi, ki je bila oblikovana tako, da se veže na določene molekule v telesu.
English: The company that makes Macugen will provide educational material for doctors (to minimise the risks associated with the injection in the eye) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor).
Slovenian: Družba, ki proizvaja zdravilo Macugen, bo zagotovila izobraževalno gradivo za zdravnike (da bi čim bolj zmanjšali tveganja, povezana z injiciranjem v oko) ter bolnike (da bi lahko prepoznali morebitne resne neželene učinke ter tako vedeli, kdaj naj poiščejo nujno pomoč pri zdravniku).
English: The symptoms of these conditions and instructions about what to do if a patient has these symptoms are explained in the package leaflet.
Slovenian: Simptomi teh stanj ter navodila za ukrepanje, če jih bolnik opazi pri sebi, so razloženi v navodilu za uporabo.
English: For more information about treatment with Macugen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Macugen preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: If, after two injections, no benefit is seen on the patient's eyesight, the treatment should be stopped or withheld.
Slovenian: Če se po dveh injiciranjih bolnikov vid ne izboljša, je treba z zdravljenjem prenehati.
English: After one year of treatment, about 70% of the patients treated with Macugen 0.3 and 1 mg lost less than 15 letters in the eye test compared with about 55% of those who received the sham injection.
Slovenian: Po enem letu zdravljenja je približno 70 % bolnikov, zdravljenih z zdravilom Macugen v odmerkih 0,3 mg in1 mg na testu vida izgubilo manj kot 15 črk v primerjavi s 55 % tistih, ki so prejeli navidezno injekcijo.
English: It must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes).
Slovenian: Ne sme se uporabljati pri bolnikih, ki imajo okularne ali periokularne okužbe (okužbe v očeh ali okoli njih) ali pri katerih obstaja sum nanje.
English: Before each injection, a local anaesthetic will be given to reduce or prevent any pain from the injection.
Slovenian: Pred vsako injekcijo bo bolnik prejel lokalen anestetik, kar bo zmanjšalo ali preprečilo bolečine, ki bi se lahko pojavile med injiciranjem.
English: What benefit has Macugen shown during the studies?
Slovenian: Kakšne koristi je zdravilo Macugen izkazalo med študijami?
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 Macugen.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Macugen, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The CHMP decided that Macugen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zaključil je, da so koristi zdravila Macugen večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The most common side effects with Macugen (seen in more than 1 patient in 10) are anterior chamber inflammation (inflammation of the front part of the eye), pain in the eye, raised intraocular pressure (increased pressure inside the eye), punctate keratitis (small marks on the eye surface) and vitreous floaters or opacities (small particles or spots in the vision).
Slovenian: Najpogostejši neželeni učinki zdravila Macugen (opaženi pri več kot 1 bolniku od 10) je vnetje notranjega očesnega prostora (vnetje sprednjega dela očesa), bolečina v očesu, povišan intraokularni tlak (tlak znotraj očesa), punctuate keratitis (majhne pikice na površini očesa), delci v steklovini ali motnjave (pikice pri vidu).
English: The patients were given either Macugen (0.3 mg, 1 mg or 3 mg) or a ‘sham' injection.
Slovenian: Bolniki so prejeli zdravilo Macugen (0,3 mg, 1 mg ali 3 mg) ali navidezno injekcijo.
English: This reduces the growth of blood vessels in the eye and controls the leakage and swelling.
Slovenian: S tem se zmanjša rast žil v očesu in vzpostavi nadzor nad prepuščanjem in otekanjem.
English: What is the risk associated with Macugen?
Slovenian: Kakšna tveganja so povezana z zdravilom Macugen?
English: Macugen must not be used in people who are hypersensitive (allergic) to pegaptanib or any of the other ingredients.
Slovenian: Zdravila Macugen ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) pegaptanib ali katero koli drugo sestavino zdravila.
English: Macugen is given as one injection of 0.3 mg into the affected eye every six weeks.
Slovenian: Zdravilo Macugen se v odmerku 0,3 mg daje z enkratnim injiciranjem v prizadeto oko vsakih šest tednov.
English: Pegaptanib has been designed to attach to and block a protein called vascular endothelial growth factor (VEGF).
Slovenian: Pegaptanib je bil razvit tako, da se veže na beljakovino, imenovano žilni endotelijski rastni faktor (VEGF) in jo zavira.
English: For the full list of all side effects reported with Macugen, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Macugen, glejte navodilo za uporabo.
English: The wet form of AMD is caused by the abnormal growth of blood vessels under the macula, which may leak fluid and blood and cause swelling.
Slovenian: Do vlažne oblike starostne degeneracije rumene pege pride zaradi nenormalne rasti krvnih žil pod rumeno pego, ki zaradi tega začnejo prepuščati tekočino in kri ter povzročijo otekline.
English: The active substance in Macugen, pegaptanib, is an ‘aptamer'.
Slovenian: Zdravilna učinkovina zdravila Macugen, pegaptanib, je aptamer.
English: It is available as a prefilled syringe.
Slovenian: Na voljo je v predhodno napolnjenih injekcijskih brizgah.
English: Why has Macugen been approved?
Slovenian: Zakaj je bilo zdravilo Macugen odobreno?
English: Macugen is used to treat adults with the ‘wet' form of age-related macular degeneration (AMD).
Slovenian: Macugen se uporablja za zdravljenje odraslih, ki imajo vlažno obliko starostne degeneracije rumene pege (AMD).
English: The CHMP noted that in patients with wet AMD Macugen 0.3 mg had similar effects on vision loss as Macugen 1 mg, therefore the lower dose was selected for approval.
Slovenian: CHMP je ugotovil, da ima pri bolnikih z vlažno obliko starostne degeneracije rumene pege zdravilo Macugen v odmerku 0,3 mg podobne učinke kot isto zdravilo v odmerku 1 mg, zato je bil za odobritev izbran nižji odmerek.
English: Macugen is a solution for injection into the eye that contains the active substance pegaptanib.
Slovenian: Zdravilo Macugen je raztopina za injiciranje v oko, ki vsebuje zdravilno učinkovino pegaptanib.
English: As Macugen when given by intravitreal injection can raise the pressure and cause bleeding within the eye, patients should be appropriately monitored after each injection.
Slovenian: Zdravilo Macugen lahko, kadar je dano kot intravitrealna injekcija, povzroči povišanje tlaka in krvavitev v očesu, zato je treba bolnike po injiciranju skrbno spremljati.
English: Macugen should only be given by an ophthalmologist (eye specialist) who is experienced in giving intravitreal injections (injections into the vitreous humour, the jelly-like fluid in the eye).
Slovenian: Zdravilo Macugen mora dati usposobljen oftalmolog (specialist za oči), ki ima izkušnje pri dajanju intravitrealnih injekcij (injiciranje v steklovino, želatinasto tekočino v očesu).
English: In the body, VEGF is involved in the growth of blood vessels and in making them more permeable.
Slovenian: VEGF v telesu sodeluje pri rasti žil in povečuje njihovo prepustnost.
English: This disease affects the central part of the retina called the macula at the back of the eye.
Slovenian: Ta bolezen prizadene osrednji del mrežnice (imenovan makula ali rumena pega), ki se nahaja na zadnji strani očesa.
English: Pegaptanib injected into the eye blocks VEGF.
Slovenian: Pegaptanib, injiciran v oko, zavre delovanje VEGF.
English: This is a procedure that is similar to a Macugen injection, but with no Macugen and no needle, in which a syringe is pressed against the eye but nothing is actually injected.
Slovenian: To je postopek, podoben injiciranju zdravila Macugen, vendar brez zdravila in brez igle.
English: What is Macugen used for?
Slovenian: Za kaj se zdravilo Macugen uporablja?
English: Sometimes, endophthalmitis (an infection inside the eye), vitreous haemorrhage (bleeding into the eye) and retinal damage can occur after Macugen treatment.
Slovenian: Občasno se lahko po zdravljenju z zdravilom Macugen pojavijo endoftalmitis (okužba v očesu), krvavitev v steklovini (v očesu) in poškodbe mrežnice.
English: How has Macugen been studied?
Slovenian: Kako je bilo zdravilo Macugen raziskano?
English: How is Macugen used?
Slovenian: Kako se zdravilo Macugen uporablja?
English: What is Macugen?
Slovenian: Kaj je zdravilo Macugen?