FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Cystadrops 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 Cystadrops je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Cystinosis is an inherited disease where a natural substance called cystine builds up in the body forming damaging crystals, particularly in the kidneys and cornea (the transparent layer in front of the eye).
Slovenian: Cistinoza je dedna bolezen, pri kateri se naravna snov, imenovana cistin, kopiči v telesu in tvori škodljive kristale, zlasti v ledvicah in roženici (prosojni plasti na sprednjem delu očesa).
English: Mercaptamine eye drop solutions made up locally in pharmacies or hospitals have been used for many years for the management of eye symptoms of cystinosis.
Slovenian: Raztopina merkaptamina v obliki kapljic za oko, pripravljena v lokalnih lekarnah ali bolnišnicah, se že več let uporablja za obvladovanje simptomov cistinoze.
English: What benefits of Cystadrops have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Cystadrops izkazalo v študijah?
English: Cystadrops has been compared with another less concentrated mercaptamine eye drop solution in one main study involving 32 patients from 2 years of age with cystinosis.
Slovenian: Zdravilo Cystadrops so primerjali z drugimi kapljicami za oko, ki vsebujejo nižjo koncentracijo merkaptamina, v eni glavni študiji, v kateri je sodelovalo 32 bolnikov s cistinozo, ki so bili starejši od dveh let.
English: Cystadrops is an eye medicine used in patients from 2 years of age who have cystinosis.
Slovenian: Cystadrops je zdravilo za oči za uporabo pri bolnikih, starejših od dveh let, ki imajo cistinozo.
English: For practical information about using Cystadrops, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Cystadrops naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: What are the risks associated with Cystadrops?
Slovenian: Kakšna tveganja so povezana z zdravilom Cystadrops?
English: The main measure of effectiveness was based on the reduction in corneal cystine crystals as seen under the microscope and quantified using a score called the IVCM score.
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje cistinskih kristalov v roženici, kar so ugotavljali z mikroskopom na podlagi ocenjevalne lestvice IVCM.
English: Why is Cystadrops approved?
Slovenian: Zakaj je bilo zdravilo Cystadrops odobreno?
English: Cystadrops is used to reduce the build-up of cystine crystals in the cornea.
Slovenian: Zdravilo Cystadrops se uporablja za zmanjševanje tvorjenja cistinskih kristalov v roženici.
English: When it is applied to the eye, the amount of cystine in the cells of the cornea decreases, limiting damage to the eye.
Slovenian: Po vnosu zdravila v oko se količina cistina v celicah roženice zmanjša, s čemer se zmanjša tudi obseg poškodb očesa.
English: For the full list of all side effects and restrictions with Cystadrops, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cystadrops glejte navodilo za uporabo.
English: Cystadrops can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the management of cystinosis.
Slovenian: Predpisovanje in izdaja zdravila Cystadrops je le na recept, zdravljenje z njim pa se sme uvesti in izvajati samo pod nadzorom zdravnika z izkušnjami z zdravljenjem cistinoze.
English: In addition, Cystadrops has been shown in a study to be effective at decreasing corneal cystine crystals.
Slovenian: Poleg tega je študija pokazala, da je zdravilo Cystadrops učinkovito pri zmanjševanju cistinskih kristalov v roženici.
English: How is Cystadrops used?
Slovenian: Kako se zdravilo Cystadrops uporablja?
English: How does Cystadrops work?
Slovenian: Kako zdravilo Cystadrops deluje?
English: Cystadrops is available as eye drops.
Slovenian: Na voljo je v obliki kapljic za oko.
English: It is available as tablets (50 and 150 mg).
Slovenian: Na voljo je v obliki tablet (50 in 150 mg).
English: Patients should also take vitamin D and calcium supplements if they do not get enough from their diet.
Slovenian: Bolniki bi morali jemati tudi dodatke vitamina D in kalcija, če slednjih ne dobivajo v zadostni količini s prehrano.
English: The full EPAR for Ibandronic Acid Teva 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 Ibandronic Acid Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day.
Slovenian: Tableto je treba vedno vzeti zjutraj na tešče, ko bolnik ni jedel vsaj šest ur, in vsaj 30 minut pred prvim zaužitjem hrane ali pijače.
English: The patient must also not lie down for one hour after taking the tablets.
Slovenian: Poleg tega bolnik eno uro po zaužitju tablete ne sme leči.
English: Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Slovenian: Zdravila so biološko enakovredna, ko dosegajo enake ravni zdravilne učinkovine v telesu.
English: This means that Ibandronic Acid Teva is similar to a ‘reference medicine' already authorised in the European Union (EU).
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki je že odobreno v Evropski uniji (EU).
English: It stops the action of osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Slovenian: Ta zavira delovanje osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
English: The tablet must always be taken after an overnight fast, one hour before any food or drink except for water.
Slovenian: Tableto je treba vedno vzeti zjutraj na tešče po celonočnem postu, eno uro pred zaužitjem hrane ali pijače (razen vode).
English: For treating osteoporosis, one 150-mg tablet is taken once a month.
Slovenian: Pri zdravljenju osteoporoze se jemlje ena 150-miligramska tableta enkrat na mesec.
English: For more information about treatment with Ibandronic Acid Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ibandronic Acid Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Teva on 17 September 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ibandronic Acid Teva, veljavno po vsej Evropski uniji, izdala 17. septembra 2010.
English: For the prevention of skeletal events, one 50-mg tablet is taken once a day.
Slovenian: Pri preprečevanju z okostjem povezanih dogodkov se jemlje ena 50-miligramska tableta enkrat dnevno.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases and in women with osteoporosis.
Slovenian: Zmanjšanje izgube kostne mase pripomore k manjši verjetnosti zloma, kar pomaga preprečiti zlome pri bolnikih z rakom in kostnimi metastazami ter ženskah z osteoporozo.
English: This is a summary of the European public assessment report (EPAR) for Ibandronic Acid Teva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ibandroic Acid Teva.
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 Ibandronic Acid Teva.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because Ibandronic Acid Teva is a generic medicine and is bioequivalent to the reference medicines, its benefits and risks are taken as being the same as the reference medicines's.
Slovenian: Ker je zdravilo Ibandronic Acid Teva generično zdravilo in je biološko enakovredno referenčnima zdraviloma, so njegove koristi in tveganja enaki kot pri referenčnih zdravilih.
English: The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Teva has been shown to have comparable quality and to be bioequivalent to Bondronat and Bonviva.
Slovenian: Odbor CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ibandronic Acid Teva primerljivo raven kakovosti kot zdravili Bondronat in Bonviva ter da jima je biološko enakovredno.
English: Ibandronic Acid Teva 150 mg is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures.
Slovenian: Zdravilo Ibandronic Acid Teva v odmerku 150 mg se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah v obdobju po menopavzi, pri katerih obstaja tveganje za pojav zlomov.
English: Because Ibandronic Acid Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicines.
Slovenian: Ker je zdravilo Ibandronic Acid Teva generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnima zdraviloma.
English: The reference medicines for Ibandronic Acid Teva are Bondronat and Bonviva.
Slovenian: Referenčni zdravili za zdravilo Ibandronic Acid Teva sta Bondronat in Bonviva.
English: Ibandronic Acid Teva 50 mg is used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Slovenian: Zdravilo Ibandronic Acid Teva se uporablja za preprečevanje z okostjem povezanih dogodkov (zlomov kosti ali z okostjem povezanih zapletov, ki zahtevajo zdravljenje) pri bolnicah z rakom dojke in kostnimi metastazami (ko se rak razširi na kosti).
English: What are the benefits and risks of Ibandronic Acid Teva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Ibandronic Acid Teva?
English: Other information about Ibandronic Acid Teva:
Slovenian: Druge informacije o zdravilu Ibandronic Acid Teva:
English: Therefore, the CHMP's view was that, as for Bondronat and Bonviva, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi, tako kot pri zdravilih Bondronat in Bonviva, odtehtajo znana tveganja.
English: Ibandronic Acid Teva ibandronic acid
Slovenian: Ibandronic Acid Teva ibandronska kislina
English: The Committee recommended that Ibandronic Acid Teva be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Ibandronic Acid Teva izda dovoljenje za promet.
English: Ibandronic Acid Teva is a ‘generic medicine'.
Slovenian: Ibandronic Acid Teva je generično zdravilo.
English: Ibandronic Acid Teva must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed.
Slovenian: Zdravilo Ibandronic Acid Teva je treba vzeti v stoječem ali sedečem položaju in popiti poln kozarec navadne (ne mineralne) vode.
English: Ibandronic Acid Teva is a medicine that contains the active substance ibandronic acid.
Slovenian: Ibandronic Acid Teva je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
English: The active substance in Ibandronic Acid Teva, ibandronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina v zdravilu Ibandronic Acid Teva, ibandronska kislina, je difosfonat.
English: Why has Ibandronic Acid Teva been approved?
Slovenian: Zakaj je bilo zdravilo Ibandronic Acid Teva odobreno?
English: How has Ibandronic Acid Teva been studied?
Slovenian: Kako je bilo zdravilo Ibandronic Acid Teva raziskano?
English: What is Ibandronic Acid Teva?
Slovenian: Kaj je zdravilo Ibandronic Acid Teva?
English: How does Ibandronic Acid Teva work?
Slovenian: Kako zdravilo Ibandronic Acid Teva deluje?
English: How is Ibandronic Acid Teva used?
Slovenian: Kako se zdravilo Ibandronic Acid Teva uporablja?
English: What is Ibandronic Acid Teva used for?
Slovenian: Za kaj se zdravilo Ibandronic Acid Teva uporablja?
English: The following studies are the most important.
Slovenian: Najpomembnejše so naslednje študije.
English: These measures will help the environment.
Slovenian: Taki ukrepi pomagajo varovati okolje.
English: The reason for this is not known.
Slovenian: Razlog za to ni znan.
English: Take this medicine one or two times a day every day with food.
Slovenian: Zdravilo vzemite enkrat ali dvakrat na dan s hrano.
English: Some people had other illnesses or were taking other medicines.
Slovenian: Nekateri so imeli druge bolezni ali so jemali še druga zdravila.
English: In some patients additional factor VIII was given.
Slovenian: Nekaterim bolnikom so dali dodatni faktor VIII.
English: If it is nearly time for the next dose, just take that one.
Slovenian: Če pa je že skoraj čas za naslednji odmerek, vzemite samo tega naslednjega.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 November 2017
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 10 November 2017
English: There are some other medicines that can only be used under certain circumstances as described below.
Slovenian: Nekatera druga zdravila pa smete uporabljati le v določenih okoliščinah, kot je opisano spodaj.
English: After first opening, use within 100 days.
Slovenian: Po prvem odprtju porabite v roku 100 dni.
English: To be taken with food.
Slovenian: Zaužije se s hrano.
English: ~3 to 5
Slovenian: ~3 do 5
English: The possibility of medicinal product interaction cannot be excluded.
Slovenian: Možnosti za medsebojno delovanje zdravil ni mogoče izključiti.
English: If you think you are pregnant or you are planning to become pregnant, it is very important that you discuss this with your doctor.
Slovenian: Če domnevate, da ste noseči, ali če načrtujete nosečnost, je zelo pomembno, da se o tem pogovorite z zdravnikom.
English: Appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Slovenian: Ustrezni odmerki te kombinacije, kar zadeva učinkovitost in varnost, niso ugotovljeni.
English: The expiry date refers to the last day of that month.
Slovenian: Roka uporabnosti zdravila se nanaša na zadnji dan navedenega meseca.
English: Symptoms of infection - inform your doctor immediately.
Slovenian: simptomi okužbe - nemudoma obvestite svojega zdravnika.
English: Children (2 - 12 years of age) will start with a dose smaller than this and continue up to the maximum allowed for their size.
Slovenian: Otroci (stari od 2 do 12 let) začnejo z manjšim odmerkom od navedenega in nadaljujejo do največjega dovoljenega odmerka za svojo velikost.
English: AUC12 or 24
Slovenian: AUC12 ali 24
English: Tell your doctor as soon as possible if this applies to you.
Slovenian: Zdravniku čim prej povejte, če se vam to zgodi.
English: Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Slovenian: Podatki, ki so trenutno na razpolago, so opisani v poglavjih 5.1 in 5.2, toda priporočil glede odmerjanja ni mogoče postaviti.
English: A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Slovenian: Izkazalo se je, da gre za vzročno razmerje, čeprav mehanizem delovanja ni razjasnjen.
English: Discuss with your physician the precautions needed to avoid infecting other people.
Slovenian: Posvetujte se s svojim zdravnikom o ukrepih, ki so potrebni, da se izognete okužbi drugih ljudi.
English: This was consistent with the observations in animal studies.
Slovenian: To se sklada z opažanji študij na živalih.
English: Therefore, an alternative, effective and safe method of contraception should be used during treatment.
Slovenian: Zato je treba med zdravljenjem uporabiti drug, učinkovit in varen način kontracepcije.
English: Digoxin (heart medicine).
Slovenian: Digoksin (zdravilo za srce).
English: Currently, there are no data specific to this patient population and therefore specific dosage recommendations cannot be made.
Slovenian: Specifičnih podatkov za to skupino bolnikov trenutno ni, zato ni mogoče dati specifičnih priporočil za odmerjanje.
English: Therefore concomitant use is not recommended.
Slovenian: Sočasna uporaba zato ni priporočljiva.
English: Ritonavir can be used during pregnancy if clinically needed.
Slovenian: Ritonavir se lahko uporabi med nosečnostjo, če je to klinično potrebno.
English: The mechanism of this interaction is not clear, but may be the result of transporter inhibition.
Slovenian: Mehanizem tega medsebojnega delovanja ni jasen, vendar je možno, da gre za posledico zaviranja transporterja.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data).
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti: zelo pogosti  1/10; pogosti  1/100 do < 1/10; občasni  1/1.000 do < 1/100; redki  1/10.000 do < 1/1.000; neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Your doctor will discuss with you the best combination of medicines for you.
Slovenian: Zdravnik se bo z vami pogovoril o tem, katera kombinacija zdravil je za vas najboljša.
English: Sildenafil or tadalafil for impotence (erectile dysfunction).
Slovenian: Sildenafil ali tadalafil za impotenco (erektilno disfunkcijo).
English: The time to maximum concentration (Tmax) remained constant at approximately 4 hours with increasing dose.
Slovenian: Čas do maksimalne koncentracije (tmax) je z naraščajočimi odmerki ostal stalen, približno 4 ure.
English: Regular blood tests may be required to check your liver is working properly.
Slovenian: Morda bodo potrebne redne preiskave krvi za preverjanje, ali vam jetra delujejo normalno.
English: Ritonavir was the first protease inhibitor (approved in 1996) for which efficacy was proven in a study with clinical endpoints.
Slovenian: Ritonavir je bil prvi zaviralec proteaz (odobren leta 1996), katerega učinkovitost je bila dokazana v študiji s kliničnimi končnimi točkami.
English: Cl/F (L/h) 1 Values expressed as geometric means.
Slovenian: Oč/F (l/uro) 1 Vrednosti so izražene kot geometrične sredine.
English: Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may be required over a longer period.
Slovenian: Poleg tega utegne biti v primeru opustitve glukokortikoidov potrebno postopno zmanjševanje odmerka v daljšem obdobju.
English: It is believed that this happens because the body's immune response improves and helps the body to fight these infections.
Slovenian: Domnevno se to zgodi, ker si imunski sistem opomore in telesu pomaga premagovati te okužbe.
English: Reduction in the antiretroviral activity of ritonavir is primarily associated with the protease mutations V82A/F/T/S and I84V.
Slovenian: Zmanjšanje protiretrovirusnega delovanja ritonavirja je v prvi vrsti povezano z mutacijami proteaz V82A/F/T/S in I84V.
English: Consideration should be given to official guidance on the appropriate treatment of tuberculosis in HIV-infected patients.
Slovenian: Upoštevati je treba uradne smernice za ustrezno zdravljenje tuberkuloze pri bolnikih, okuženih s HIV.
English: There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.
Slovenian: Ni podatkov o učinkih ritonavirja na dojenega otroka ali o učinkih zdravila na proizvodnjo mleka.
English: These interactions are noted in the medicinal product interaction tables below.
Slovenian: Ta medsebojna delovanja so navedena v spodnjih tabelah interakcij.
English: Tell your doctor if you are taking tadalafil for pulmonary arterial hypertension.
Slovenian: Povejte svojemu zdravniku, če jemljete tadalafil za pljučno arterijsko hipertenzijo.
English: Talk to your doctor or pharmacist if you need five or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, če potrebujete pet ali več tablet dnevno daljše časovno obdobje, še zlasti, če so vam svetovali dieto z majhnim vnosom soli (natrija).
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Slovenian: Še vedno lahko prenašate HIV medtem, ko jemljete to zdravilo, čeprav je tveganje zmanjšano z učinkovitim protivirusnim zdravljenjem.
English: On rare occasions these muscle disorders have been serious (rhabdomyolysis).
Slovenian: V redkih primerih so bile te mišične motnje resne (rabdomioliza).
English: If you miss a dose, take the missed dose as soon as possible.
Slovenian: Če ste pozabili vzeti odmerek, izpuščeni odmerek vzemite čimprej.
English: In more than a half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Slovenian: V več kot polovici opisanih primerov so zdravljenje z zaviralci proteaz nadaljevali oz. ga znova vpeljali, če je bilo pred tem prekinjeno.
English: Should this happen to you, seek immediate advice from your doctor.
Slovenian: Če se to zgodi vam, morate svojega zdravnika nemudoma vprašati za nasvet.
English: Some patients with advanced HIV infection (AIDS) who then start anti-HIV treatment may develop the symptoms of infections they have had in the past even if they didn't know they had had them.
Slovenian: Nekaterim bolnikom, ki imajo napredovalo okužbo s HIV (AIDS) in začnejo jemati zdravila proti HIV, se lahko pojavijo simptomi okužb, ki so jih imeli kdaj v preteklosti, tudi če sploh ne vedo, da so jih imeli.
English: Do not use this medicine after the expiry date on the carton or bottle label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali steklenici poleg oznake »EXP«.
English: Tell your doctor if you have/had:
Slovenian: Povejte svojemu zdravniku, če imate ali ste kdaj imeli:
English: This should be particularly taken into account for those on a low sodium diet.
Slovenian: To je treba še posebej upoštevati pri tistih, ki so na dieti z majhno vsebnostjo natrija.
English: Treatment of overdose with ritonavir should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Slovenian: Zdravljenje prevelikega odmerjanja ritonavirja mora obsegati splošne podporne ukrepe, vključno z nadziranjem vitalnih znakov in opazovanjem bolnikovega kliničnega stanja.
English: Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Slovenian: V poštev pride prilagoditev odmerjanja midazolama, zlasti če je uporabljen več kot en sam odmerek midazolama.
English: Component of a multipack can't be sold separately.
Slovenian: Sestavni deli skupnega pakiranja niso v prodaji ločeno.
English: If you have any other health concerns, discuss these with your doctor as soon as you can.
Slovenian: če imate kakšne druge zdravstvene pomisleke, se o njih čimprej posvetujte z zdravnikom.
English: During episodes of diarrhoea your doctor may decide that extra monitoring is needed.
Slovenian: Med obdobji driske bo zdravnik morda presodil, da potrebujete dodatno spremljanje.