FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Ritonavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Ritonavir Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Ritonavir Mylan can be used as a ‘pharmacokinetic enhancer' (booster) to increase the blood levels of other antiviral medicines that belong to the same group as Ritonavir Mylan (protease inhibitors) including amprenavir, atazanavir, darunavir, fosamprenavir, lopinavir, saquinavir, and tipranavir.
Slovenian: Zdravilo Ritonavir Mylan se uporablja kot „farmakokinetični stopnjevalec“, ki v krvi povečuje raven drugih protivirusnih zdravil iz iste skupine kot zdravilo Ritonavir Mylan (zaviralci proteaz), kar vključuje amprenavir, atazanavir, darunavir, fosamprenavir, lopinavir, sakvinavir in tipranavir.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Norvir, and do not need to be repeated for Ritonavir Mylan.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih načinih uporabe so že bile izvedene z referenčnim zdravilom Norvir, zato jih ni treba ponoviti za zdravilo Ritonavir Mylan.
English: What measures are being taken to ensure the safe and effective use of Ritonavir Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ritonavir Mylan?
English: This means that Ritonavir Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Norvir.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Norvir.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Norvir.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ritonavir Mylan primerljivo raven kakovosti kot referenčno zdravilo Norvir ter da mu je biološko enakovredno.
English: Ritonavir Mylan is used in combination with other medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Ritonavir Mylan se uporablja v kombinaciji z drugimi zdravili za zdravljenje bolnikov, starejših od dveh let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: The Agency recommended that Ritonavir Mylan be approved for use in the EU.
Slovenian: Priporočila je, da se zdravilo Ritonavir Mylan odobri za uporabo v EU.
English: Ritonavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Ritonavir Mylan v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
English: For more information, see the package leaflet provided with the other medicine.
Slovenian: Za več informacij glejte navodilo za uporabo, priloženo drugemu zdravilu.
English: What are the benefits and risks of Ritonavir Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Ritonavir Mylan?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ritonavir Mylan have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ritonavir Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Ritonavir Mylan does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Ritonavir Mylan ne ozdravi okužbe z virusom HIV ali aidsa, vendar pa lahko upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: For more information about treatment with Ritonavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ritonavir Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Ritonavir Mylan
Slovenian: Druge informacije o zdravilu Ritonavir Mylan
English: Therefore, the Agency's view was that, as for Norvir, the benefit outweighs the identified risk.
Slovenian: Zato je menila, da njegove koristi enako kot pri zdravilu Norvir odtehtajo znana tveganja.
English: For practical information about using Ritonavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ritonavir Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Ritonavir Mylan contains the active substance ritonavir and is a ‘generic medicine'.
Slovenian: Zdravilo Ritonavir Mylan vsebuje zdravilno učinkovino ritonavir in je „generično zdravilo“.
English: What is Ritonavir Mylan and what is it used for?
Slovenian: Kaj je zdravilo Ritonavir Mylan in za kaj se uporablja?
English: As a ‘booster', the active substance ritonavir slows the breakdown of other protease inhibitor antivirals.
Slovenian: Zdravilna učinkovina ritonavir kot „stopnjevalec“ upočasnjuje razpad drugih protivirusnih zdravil, zaviralcev proteaz.
English: Ritonavir Mylan can only be obtained with a prescription and treatment with Ritonavir Mylan should be given by a doctor who has experience in the treatment of HIV infection.
Slovenian: Predpisovanje in izdaja zdravila Ritonavir Mylan je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: Ritonavir Mylan can also be used in larger doses for a direct antiviral effect on HIV.
Slovenian: Zdravilo Ritonavir Mylan je za neposredni protivirusni učinek na virus HIV mogoče uporabljati tudi v večjih odmerkih.
English: It is not intended to provide practical advice on how to use Ritonavir Mylan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Ritonavir Mylan approved?
Slovenian: Zakaj je bilo zdravilo Ritonavir Mylan odobreno?
English: The usual dose of Ritonavir Mylan for adults is 100 or 200 mg, once or twice a day.
Slovenian: Običajni odmerek zdravila Ritonavir Mylan za odrasle je 100 ali 200 mg enkrat ali dvakrat na dan. Odmerek je odvisen od drugega zaviralca proteaz, ki ga bolnik jemlje.
English: At higher antiviral doses, ritonavir is a ‘protease inhibitor'.
Slovenian: Ritonavir je pri večjih protivirusnih odmerkih „zaviralec proteaze“.
English: How has Ritonavir Mylan been studied?
Slovenian: Kako je bilo zdravilo Ritonavir Mylan raziskano?
English: How is Ritonavir Mylan used?
Slovenian: Kako se zdravilo Ritonavir Mylan uporablja?
English: How does Ritonavir Mylan work?
Slovenian: Kako zdravilo Ritonavir Mylan deluje?
English: If possible, show them the medicine pack.
Slovenian: Če je mogoče, mu pokažite pakiranje zdravila.
English: Suicide risk
Slovenian: Tveganje samomora
English: The duration of the maintenance phase was 8 or 12 weeks.
Slovenian: Vzdrževalna faza je trajala 8 ali 12 tednov.
English: At first, these changes might not affect your sight but, over time, it may get worse.
Slovenian: Sprva te spremembe morda ne vplivajo na vaš vid, vendar se lahko s časom poslabšajo.
English: • hallucinations (seeing or hearing things that are not there).
Slovenian: • halucinacije (videnje ali slišanje stvari, ki jih ni).
English: Symptoms include:
Slovenian: Med simptomi so:
English: Look out for serious symptoms
Slovenian: Bodite pozorni na resne simptome
English: Study (n=population in double-blind phase; n=population in maintenance phase)
Slovenian: Študija (n = populacija v dvojno slepi fazi, n = populacija v vzdrževalni fazi)
English: • difficulty in reading, writing or saying what you mean, or difficulty in understanding words
Slovenian: • težave pri branju, pisanju ali pripovedovanju tistega, kar mislite, ali težave z razumevanjem
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for retigabine.
Slovenian: Mehanizem tega tveganja ni znan in razpoložljivi podatki ne izključujejo možnosti večjega tveganja z retigabinom.
English: See 'Look out for serious symptoms' in section 4.
Slovenian: Glejte "Bodite pozorni na resne simptome" v poglavju 4.
English: The physician's guide should include the following key messages:
Slovenian: Navodilo za predpisovanje za zdravnike naj vključuje naslednja ključna sporočila:
English: Elderly (65 years of age and above)
Slovenian: Starejši (stari 65 let in več)
English: The doctor may decide to give you a reduced dose.
Slovenian: Zdravnik se lahko odloči, da vam bo dal manjši odmerek.
English: It is recommended that patients are advised about the risk of these possible effects.
Slovenian: Bolnike je priporočljivo seznaniti s tveganjem teh možnih učinkov.
English: Patients could not be seizure-free for ≥21 days.
Slovenian: Bolniki niso smeli biti brez napadov ≥ 21 dni.
English: The clinical significance of this finding is not known.
Slovenian: Klinični pomen tega izsledka ni znan.
English: Further management should be as recommended by the national poisons centre, where available.
Slovenian: Nadaljnje ukrepanje mora upoštevati priporočila nacionalnega centra za zastrupitve, če so ta na voljo.
English: Interaction with digoxin
Slovenian: Medsebojno delovanje z digoksinom
English: The relevance of these models to human epilepsy, however, is not known.
Slovenian: Vendar pomen teh modelov za epilepsijo pri človeku ni znan.
English: • changes in liver function, which will show up in blood tests.
Slovenian: • spremembe v delovanju jeter; to se pokaže pri preiskavah krvi.
English: If you are going to have an operation under a general anaesthetic:
Slovenian: Če imate predvideno operacijo v splošni anesteziji:
English: Do not use this medicine after the expiry date which is stated on the pack.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju.
English: • effects on heart rhythm.
Slovenian: • vpliv na srčni ritem.
English: The safety and efficacy are not yet known in this age group.
Slovenian: Varnost in učinkovitost v tej starostni skupini še nista znani.
English: • psychotic disorders (severe mental health problems)
Slovenian: • psihotične motnje (hude težave z duševnim zdravjem),
English: Extremadura 3, 09400 Aranda De Duero, Burgos, Spain.
Slovenian: Extremadura 3, 09400 Aranda De Duero, Burgos, Španija.
English: Your doctor should recommend that you have an eye examination before starting treatment.
Slovenian: Zdravnik vam bo svetoval, da pred začetkom zdravljenja opravite očesni pregled.
English: If you are over 65 years you will usually be given a reduced starting dose and your doctor may limit the maximum dose to 900 mg a day.
Slovenian: Če ste starejši od 65 let, vam bodo ponavadi dali zmanjšan začetni odmerek; vaš zdravnik lahko zmanjša največji odmerek na 900 mg na dan.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katero koli zdravilo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 March 2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 28.3.2011
English: Interaction with alcohol
Slovenian: Medsebojno delovanje z alkoholom
English: The long-term prognosis of these findings is currently unknown, but some of the reports have been associated with visual impairment.
Slovenian: Dolgoročna prognoza teh izsledkov trenutno ni znana, a nekateri opisani primeri so bili povezani z okvaro vida.
English: Laboratory tests
Slovenian: Laboratorijske preiskave
English: Currently available pharmacokinetic data are described in section 5.2, but no recommendation on a posology can be made.
Slovenian: Farmakokinetični podatki, ki so trenutno na voljo, so opisani v poglavju 5.2, vendar priporočil o odmerjanju ni mogoče podati.
English: Only 14% of retigabine is excreted in the faeces.
Slovenian: Samo 14 % retigabina se izloči v blatu.
English: In some cases changes to the pigmentation in the eyes may improve after you stop taking Trobalt.
Slovenian: V nekaterih primerih se lahko spremembe v pigmentaciji v očeh izboljšajo, ko prenehate jemati zdravilo Trobalt.
English: Doses greater than 900 mg/day are not recommended (see sections 4.4 and 5.2).
Slovenian: Odmerki nad 900 mg/dan niso priporočljivi (glejte poglavji 4.4 in 5.2).
English: Treatment will be stopped if any problems are found unless no other suitable treatments are available.
Slovenian: Če se pojavijo nepravilnosti, boste zdravljenje končali, razen če ni na voljo nobenih drugih ustreznih zdravil.
English: Trobalt must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.
Slovenian: Odmerjanje Zdravilo Trobalt je treba titrirati glede na odziv posameznega bolnika, da bi optimizirali ravnovesje med učinkovitostjo in prenašanjem.
English: Trobalt can affect the results of some tests.
Slovenian: Zdravilo Trobalt lahko vpliva na izvide nekaterih preiskav.
English: You must talk to your doctor about the effect of your epilepsy on driving and using machines.
Slovenian: Z zdravnikom se morate posvetovati o vplivu vaše epilepsije na sposobnost upravljanja vozil in strojev.
English: Glaxo Wellcome, S.A, Avda.
Slovenian: Izdelovalec Glaxo Wellcome, S.A, Avda.
English: Then leave at least 3 hours before your next dose.
Slovenian: Po tem morajo preteči najmanj 3 ure, preden vzamete naslednji odmerek.
English: Elderly If you are 65 years or older, you may be more likely than a younger adult to get the following symptoms:
Slovenian: Če ste stari 65 let ali več, je večja verjetnost pri vas kot pri mlajših odraslih bolnikih, da boste dobili naslednje simptome:
English: A substantial fraction of the retigabine dose is converted to inactive N-glucuronides.
Slovenian: Znaten delež odmerka retigabina se spremeni v neaktivne N-glukuronide.
English: This is more likely to affect you:
Slovenian: Verjetnost, da se to zgodi, je večja:
English: In addition, retigabine and NAMR did not induce CYP1A2 or CYP3A4/5 in human primary hepatocytes.
Slovenian: Poleg tega retigabin in NAMR nista inducirala CYP1A2 ali CYP3A4/5 v človeških primarnih hepatocitih.
English: Trobalt is not recommended for children and adolescents aged under 18.
Slovenian: Zdravilo Trobalt ni priporočljivo za otroke in mladostnike, mlajše od 18 let.
English: Your doctor may gradually adjust your dose over a few weeks so that your seizures are better controlled, and side effects are kept to a minimum.
Slovenian: Zdravnik vam lahko odmerek v nekaj tednih postopoma prilagodi, tako da so vaši napadi bolje obvladani in je neželenih učinkov čim manj.
English: Uncertainties about the impact of this risk on patients remain as there is a possibility of functional abnormalities associated with retinopathy including potentially severe visual impairment.
Slovenian: Ostajajo negotovosti glede vpliva tega tveganja na bolnike, kajti obstaja možnost funcionalnih motenj povezanih z retinopatijo, vključno s potencialno hudo okvaro vida.
English: In open-label extensions of the three placebo-controlled studies, persistence of efficacy was maintained over an evaluation period of at least 12 months (365 patients).
Slovenian: V odprtih podaljšanjih treh s placebom kontroliranih študij se je učinkovitost ohranila v vsaj 12-mesečnem obdobju ocenjevanja (365 bolnikov).
English: The effect of food on Cmax under usual clinical conditions is not expected to be clinically relevant.
Slovenian: Ni pričakovati, da bi bil vpliv hrane na Cmax pod normalnimi kliničnimi pogoji klinično pomemben.
English: If you suddenly stop taking Trobalt, your seizures may come back or get worse.
Slovenian: Če nenadoma nehate jemati zdravilo Trobalt, se vam napadi lahko povrnejo ali poslabšajo.
English: In the event of overdose, it is recommended that the patient is given appropriate supportive therapy as clinically indicated, including electrocardiogram (ECG) monitoring.
Slovenian: V primeru prevelikega odmerjanja je bolniku priporočljivo zagotoviti podporno zdravljenje, kot je klinično indicirano, vključno z elektrokardiografskim (EKG) spremljanjem.
English: Take extra care until you know how Trobalt and alcohol affect you.
Slovenian: Bodite posebej pozorni, dokler ne veste, kako zdravilo Trobalt in alkohol vplivata na vas.
English: Therefore, based upon the safety profile of Trobalt the CHMP concluded that the MAH should submit one additional renewal application in 5 years.
Slovenian: Na osnovi varnostnega profila zdravila Trobalt CHMP zato zaključuje, da mora imetnik DzP predložiti še eno dodatno vlogo za podaljšanje dovoljenja za promet čez 5 let.
English: Don't take more than one dose at a time to make up for missed doses.
Slovenian: Ne vzemite več kot en odmerek naenkrat, da bi nadomestili pozabljenega.
English: Tell the person who orders the test that you are taking Trobalt.
Slovenian: Povejte osebi, ki je naročila preiskavo, da jemljete zdravilo Trobalt.
English: The maternal toxicities interfered with higher dosing of the dams and hence deduction of safety margins with regard to human therapy.
Slovenian: Maternalni toksični učinki so ovirali večje odmerjanje pri samicah in s tem sklepanje o varnostnih mejah, kar zadeva zdravljenje pri človeku.
English: Don't drive or use machines until you know how Trobalt affects you.
Slovenian: Ne upravljajte vozil ali strojev, dokler ne veste, kako zdravilo Trobalt vpliva na vas.
English: Your doctor may decide that Trobalt is not suitable for you.
Slovenian: Zdravnik se lahko odloči, da zdravilo Trobalt za vas ni primerno.
English: If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember.
Slovenian: Če bolnik izpusti enega ali več odmerkov, je priporočljivo, da vzame en odmerek, takoj ko se spomni.
English: If you need a blood or urine test
Slovenian: Če morate opraviti preiskavo krvi ali urina
English: Retigabine mg/day mg/day mg/day
Slovenian: Retigabin mg/dan mg/dan mg/dan
English: If you miss any doses, just take one dose as soon as you remember.
Slovenian: Če ste pozabili vzeti katerikoli odmerek, preprosto vzemite pozabljeni odmerek, čim se spomnite.
English: Trobalt may be taken with or without food (see section 5.2).
Slovenian: Zdravilo Trobalt se lahko jemlje s hrano ali brez nje (glejte poglavje 5.2).
English: The studies were not designed to evaluate specific combinations of antiepileptic medicinal products.
Slovenian: Študije niso bile oblikovane tako, da bi raziskale specifične kombinacije aniepileptičnih zdravil.
English: Trobalt is one of a group of medicines called antiepileptics.
Slovenian: Zdravilo Trobalt spada v skupino zdravil, imenovanih antiepileptiki.
English: In women being treated for epilepsy, sudden discontinuation of antiepileptic medicine therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Slovenian: Pri ženskah, ki se zdravijo zaradi epilepsije, se je treba izogniti nenadni prekinitvi antiepileptikov, kajti to namreč lahko povzroči izbruh napadov, ki imajo lahko resne posledice za žensko in nerojenega otroka.
English: If you have kidney or liver problems, your doctor may give you a reduced dose of Trobalt.
Slovenian: Če imate težave z ledvicami ali jetri, vam zdravnik lahko predpiše manjši odmerek zdravila Trobalt.
English: • if you are 65 years of age or above
Slovenian: • če ste stari 65 let ali več,
English: This is most likely to happen during the first few months of treatment with Trobalt.
Slovenian: Verjetnost tega je največja v prvih mesecih zdravljenja z zdravilom Trobalt.
English: The percentage decrease in plasma concentration during dialysis ranged from 34% to 60% except for one subject who had a 17% reduction.
Slovenian: Odstotek znižanja koncentracije v plazmi med dializo je segal od 34 % do 60 % razen pri enem preiskovancu, pri katerem je bilo znižanje 17 %.
English: Other medicines and Trobalt
Slovenian: Druga zdravila in zdravilo Trobalt
English: Prior to launch in each Member State, and also after changes to the key elements in the educational material the MAH shall agree the final educational material with the National Competent Authority.
Slovenian: Pred dajanjem zdravila na trg in po spremembah ključnih elementov v izobraževalnem gradivu se mora imetnik dovoljenja za promet v vsaki državi članici dogovoriti o končnem izobraževalnem gradivu z nacionalnim prisojnim organom.
English: It works by preventing the brain overactivity that causes epileptic seizures (also called fits).
Slovenian: Deluje tako, da prepreči prekomerno dejavnost možganov, ki povzroči epileptične napade (imenujemo jih tudi "napadi krčev").
English: If continued, the patient should be monitored more closely.
Slovenian: V primeru nadaljevanja zdravljenja je treba bolnika natančneje spremljati.
English: The increase did not appear to be dependent on retigabine dose and is not considered clinically relevant.
Slovenian: Ni bilo videti, da bi bilo povečanje odvisno od odmerka retigabina in zato ne velja za klinično pomembno.
English: It is recommended that patients are advised about the risk of such adverse reactions at treatment initiation and following each titration step, and that they are advised not to drive or operate machinery until they have established how Trobalt affects them.
Slovenian: Bolnike je priporočljivo seznaniti s tveganji takšnih neželenih učinkov na začetku zdravljenja in po vsaki stopnji titriranja odmerka ter jim svetovati, naj ne vozijo in ne upravljajo s stroji, dokler ne ugotovijo, kako zdravilo Trobalt vpliva nanje.
English: The rate of progression of vitelliform maculopathy and its impact on retinal and macular function and vision is unclear.
Slovenian: Hitrost napredovanja viteliformne makulopatije in njenega vpliva na funkcijo mrežnice in makule ter vida ni jasna.
English: In a population pharmacokinetic analysis, retigabine clearance increased with increasing body surface area.
Slovenian: V populacijski farmakokinetični analizi se je očistek retigabina povečeval s povečevanjem telesne površine.
English: These effects generally occurred within the first 8 weeks of treatment, and frequently led to treatment withdrawal in affected patients.
Slovenian: Ti učinki so se na splošno pojavili v prvih 8 tednih zdravljenja in so pri prizadetih bolnikih pogosto povzročili prenehanje zdravljenja.
English: Patients (and caregivers of patients) should be advised to seek medical advice if signs of suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in skrbnikom bolnikov) je treba naročiti, da morajo poiskati zdravniško pomoč, če bi se pojavile samomorilne misli ali samomorilno vedenje.
English: If you need a blood or urine test:
Slovenian: Če morate opraviti preiskavo krvi ali urina:
English: • if you have kidney or liver problems.
Slovenian: • če imate težave z ledvicami ali jetri.
English: Risk related to Trobalt
Slovenian: Tveganje, povezano z zdravilom Trobalt
English: Trobalt can make you feel dizzy or drowsy and cause double or blurred vision.
Slovenian: Zdravilo Trobalt vam lahko povzroči omotico ali zaspanost in povzroči dvojen ali zamegljen vid.