FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder (MAH) shall agree the details of a controlled distribution system for the 20 ml vial of Revatio 0.8 mg/ml solution for injection with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Revatio 0.8 mg/ml solution for injection are provided with the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora podrobnosti sistema nadzorovane distribucije za 20 ml vialo zdravila Revatio 0,8 mg/ml raztopina za injiciranje uskladti s pristojnimi nacionalnimi organi in tak program izvajati na nacionalni ravni tako, da bodo pred predpisovanjem zdravila vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali in/ali izdajali zdravilo Revatio 0,8 mg/ml raztopina za injiciranje, prejeli:
English: In study A1481262 Cmax, CL and AUC (0-8) of 248 ng/ml, 30.3 l/h and 330 ng h/ml, were observed respectively.
Slovenian: V študiji A1481262 so ugotovili naslednje vrednosti: Cmax 248 ng/ml, CL 30,3 l/h in AUC (0-8) 330 ng h/ml.
English: Revatio should not be used during pregnancy unless strictly necessary.
Slovenian: Zdravila Revatio ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: This concentration range covers the increase in sildenafil exposure observed in specifically designed drug interaction studies with CYP3A4 inhibitors (except with the most potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir).
Slovenian: Ta razpon koncentracij zajema povečanje izpostavljenosti sildenafilu, ki so jo opazili v specifično zasnovanih študijah interakcij z zaviralci CYP3A4 (razen najmočnejših zaviralcev CYP3A4, kot so ketokonazol, itrakonazol, ritonavir).
English: Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Slovenian: Učinkovitost je dokazana pri primarni pljučni hipertenziji in pljučni hipertenziji, ki spremlja bolezni vezivnega tkiva.
English: In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n = 9), sildenafil (single dose, 100 mg) demonstrated no significant changes in visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
Slovenian: V majhni, s placebom nadzorovani študiji pri bolnikih s potrjeno zgodnjo starostno degeneracijo makule (n = 9) sildenafil v enkratnem 100 mg odmerku ni povzročil pomembnih sprememb na opravljenih preiskavah vida (ostrina vida, Amslerjeva mrežica, ločevanje barv na simuliranem semaforju, Humphreyev perimeter in fotostres).
English: The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as addon therapy, and neither was arginine supplementation.
Slovenian: Uporaba prostaciklina, prostaciklinskih analogov in antagonistov endotelinskih receptorjev kot dodatno zdravljenje ni bilo dovoljeno, prav tako ne dodajanje arginina.
English: Revatio solution for injection is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.
Slovenian: Revatio raztopina za injiciranje je druga možna oblika zdravila Revatio za bolnike, ki začasno ne morejo jemati tablet zdravila Revatio.
English: If you have an erection, which lasts continuously for more than 4 hours, stop taking Revatio and contact your doctor immediately (see also section 4).
Slovenian: Če imate erekcijo, ki nepretrgano traja dlje kot 4 ure, prenehajte jemati zdravilo Revatio in nemudoma obvestite zdravnika (glejte tudi poglavje 4).
English: See section 6.6 for instructions of use.
Slovenian: Za navodila za uporabo glejte poglavje 6.6.
English: • Blood thinning medicines (for example warfarin) although these did not result in any side effects.
Slovenian: • zdravila proti strjevanju krvi (npr. varfarin), čeprav ta niso povzročila nobenih neželenih učinkov.
English: Since there are limited data for intravenous Revatio use and since pharmacokinetic models predict that 20 mg oral and 10 mg intravenous formulations will yield similar plasma exposures, the safety information for intravenous Revatio is supported by that of oral Revatio.
Slovenian: Ker ni zadosti podatkov o intravenski uporabi zdravila Revatio, in ker farmakokinetični model predvideva, da povzročita odmerka 20 mg peroralno in 10 mg intravensko podobno plazemsko izpostavljenost, so varnostne informacije o peroralni obliki v podporo varnostnim informacijam o intravenski obliki zdravila Revatio.
English: No clinical studies have been performed to demonstrate that these formulations have comparable efficacy
Slovenian: Klinične študije za potrditev primerljive učinkovitosti teh oblik niso bile izvedene.
English: The magnitude of the interaction is expected to be reduced for intravenous sildenafil, as interactions for oral sildenafil are due, at least in part, to effects on oral first pass metabolism.
Slovenian: Obseg medsebojnega delovanja naj bi bil pri intravenskem sildenafilu po pričakovanjih manjši, ker so medsebojna delovanja pri peroralnem sildenafilu vsaj deloma posledica presnove prvega prehoda po peroralni uporabi.
English: It is recommended that a pharmacist constitutes Revatio oral suspension prior to its dispensing to the patient.
Slovenian: Priporočljivo je, da farmacevt peroralno suspenzijo zdravila Revatio pripravi pred izdajo bolniku.
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Revatio, before driving or using machines.
Slovenian: V kliničnih preskušanjih s sildenafilom so poročali o omotici in spremembah vida, zato morajo biti bolniki pred vožnjo ali upravljanjem strojev seznanjeni, kako lahko zdravilo Revatio nanje vpliva.
English: Instructions to reconstitute the oral suspension It is recommended that your pharmacist reconstitutes (makes up) the oral suspension before giving it to you.
Slovenian: Priporočljivo je, da vaš farmacevt rekonstituira (pripravi) peroralno suspenzijo, preden vam jo izroči.
English: • Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.
Slovenian: • zdravila, ki vsebujejo eritromicin, klaritromicin, telitromicin (antibiotiki za zdravljenje določenih bakterijskih okužb), sakvinavir (za HIV) ali nefazodon (za depresijo), kajti morda bo treba prilagoditi odmerek.
English: A total of 207 patients were treated with Revatio in the pivotal study, and their long term survival status was assessed for a minimum of 3 years.
Slovenian: V ključni študiji je skupno 207 bolnikov dobivalo zdravilo Revatio, njihovo dolgoročno preživetje pa je bilo ocenjeno na minimalno 3 leta.
English: Of those sildenafil treated subjects developmentally able to perform the CPET 59/114 subjects (52 %) had not shown any deterioration in Peak VO2 from start of sildenafil.
Slovenian: Izmed tistih preiskovancev, zdravljenih s sildenafilom, ki so bili glede na razvoj sposobni opraviti CPET, pri 59 izmed 114 preiskovancev (52 %) niso ugotovili nobenih odstopanj pri največji vrednosti VO2 od začetka uporabe sildenafila.
English: The oral suspension must be shaken vigorously for a minimum of 10 seconds before use.
Slovenian: Pred uporabo je treba peroralno suspenzijo dobro pretresati najmanj 10 sekund.
English: These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
Slovenian: Ta zdravila se pogosto uporabljajo za olajšanje pri angini pektoris ali bolečini v prsnem košu (glejte poglavje
English: While the bottle is upright, on a flat surface, insert the tip of the oral dosing syringe into the adaptor (figure 7).
Slovenian: Medtem, ko steklenica pokončno stoji na ravni podlagi, vstavite konico peroralne odmerne brizge v nastavek (slika 7).
English: If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (eg, epoprostenol) should be considered (see section 4.2).
Slovenian: Če se klinično stanje poslabša, je treba razmisliti o uporabi zdravil, ki pridejo v poštev v hudi fazi bolezni (npr. epoprostenol) (glejte poglavje 4.2).
English: Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse France
Slovenian: Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse Francija
English: Children and adolescents Revatio should not be given to children and adolescents under the age of 18.
Slovenian: Otroci in mladostniki, mlajši od 18 let, ne smejo jemati zdravila Revatio.
English: The recommended dose is 10 mg (corresponding to 12.5 ml) three times a day administered as an intravenous bolus injection (see section 6.6).
Slovenian: Priporočeni odmerek je 10 mg (kar ustreza 12,5 ml) trikrat na dan v intravenski bolusni injekciji (glejte poglavje 6.6).
English: Revatio contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Slovenian: Zdravilo Revatio vsebuje učinkovino sildenafil, ki sodi med zdravila, ki jih imenujemo zaviralci fosfodiesteraze tipa 5 (PDE5).
English: Your doctor may reduce the dose over a few days before stopping completely.
Slovenian: Zdravnik vam bo morda pred popolno opustitvijo zdravila odmerek nekaj dni postopoma zmanjševal.
English: The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (eg, ambrisentan, iloprost) has not been studied in controlled clinical trials.
Slovenian: Učinkovitost in varnost sočasne uporabe sildenafila in drugih zdravil za pljučno arterijsko hipertenzijo (npr. ambrisentana, iloprosta) nista bili raziskani v nadzorovanih kliničnih preskušanjih.
English: Subjects on active sildenafil therapy continued on the same treatment regimen, while those in the placebo group in the short-term study were randomly reassigned to sildenafil treatment.
Slovenian: Preiskovanci, ki so se zdravili z učinkovino sildenafil, so nadaljevali z enakim režimom zdravljenja, medtem ko so bili preiskovanci, ki so v kratkoročni študiji prejemali placebo, randomizirani v skupine, ki so se zdravile s sildenafilom.
English: The tablets are provided in blister packs containing 90 tablets, 90 x 1 tablets as perforated unit dose blisters and in blister packs containing 300 tablets.
Slovenian: Tablete so na voljo v pretisnih omotih po 90 tablet, perforiranih enoodmernih pretisnih omotih po 90 x 1 tablet in v pretisnih omotih po 300 tablet.
English: Slowly pull back the plunger of the oral dosing syringe to the graduation mark that marks the dose for you (withdrawing 1 ml provides a 10 mg dose, withdrawing 2 ml provides a 20 mg dose).
Slovenian: Počasi izvlecite bat peroralne odmerne brizge do oznake, ki označuje vaš odmerek (odvzem 1 ml vsebuje 10 mg odmerek, odvzem 2 ml pa vsebuje 20 mg odmerek).
English: Measure 30 ml of water by filling the measuring cup (included in the carton) to the marked line then pour the water into the bottle.
Slovenian: Odmerite 30 ml vode tako, da napolnite merico (vključena v pakiranju) do označbe, nato vlijte vodo v steklenico.
English: In this trial, 63 of 234 (27 %) patients were < 7 years old (sildenafil low dose = 2; medium dose = 17; high dose = 28; placebo = 16) and 171 of 234 (73 %) patients were 7 years or older (sildenafil low dose = 40; medium dose = 38; and high dose = 49; placebo = 44).
Slovenian: V tem preskušanju je bilo 63 od 234 (27 %) bolnikov starih < 7 let (majhen odmerek sildenafila = 2; srednji odmerek = 17; velik odmerek = 28; placebo = 16), 171 od 234 (73 %) bolnikov pa je bilo starih 7 let ali več (majhen odmerek sildenafila = 40; srednji odmerek = 38; in velik odmerek = 49; placebo = 44).
English: This medicinal product does not require dilution or reconstitution before use.
Slovenian: Zdravila pred uporabo ni potrebno redčiti ali rekonstituirati.
English: White, round, biconvex film-coated tablets marked “PFIZER” on one side and “RVT 20”on the other.
Slovenian: filmsko obložena tableta bele, okrogle, na obeh straneh izbočene filmsko obložene tablete z oznako "PFIZER" na eni in "RVT 20" na drugi strani
English: Subjects (38 % male and 62 % female) had a body weight  8 kg, and had primary pulmonary hypertension (PPH) [33 %], or PAH secondary to congenital heart disease [systemic-to-pulmonary shunt 37 %, surgical repair 30 %].
Slovenian: Preiskovanci (38 % moških in 62 % žensk) so imeli telesno maso  8 kg, in so imeli primarno pljučno hipertenzijo (PPH) [33 %] ali PAH kot posledico prirojenega srčnega obolenja [sistemsko-pljučni spoj 37 %, odprava težave s kirurškim posegom 30 %].
English: To measure the dose accurately, the top edge of the plunger should be lined up with the appropriate graduated mark on the oral dosing syringe (figure 8).
Slovenian: Za natančno odmerjanje mora biti zgornji rob bata poravnan z ustrezno oznako na peroralni odmerni brizgi (slika 8).
English: If you experience sudden decrease or loss of vision, stop taking Revatio and contact your doctor immediately (see also section 4).
Slovenian: Če doživite nenadno poslabšanje ali izgubo vida, prenehajte jemati zdravilo Revatio in nemudoma obvestite zdravnika (glejte tudi poglavje 4).
English: Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90 % higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Slovenian: Zdravi starejši prostovoljci (stari 65 let ali več) so imeli manjši očistek sildenafila, zato je bila koncentracija sildenafila in aktivnega N-dezmetilnega presnovka v plazmi pri njih približno 90 % večja kot pri mlajših zdravih prostovoljcih (starih od 18 do 45 let).
English: 5 % glucose solution sodium chloride 9 mg/ml (0.9 %) solution Lactated Ringer's solution 5 % glucose/0.45 % sodium chloride solution 5 % glucose/lactated Ringer's solution 5 % glucose/20 mEq potassium chloride solution
Slovenian: 9 mg/ml (0,9 %) raztopina natrijevega klorida Ringerjeva laktatna raztopina raztopina 5 % glukoze in 0,45 % natrijevega klorida raztopina 5 % glukoze in Ringerjevega laktata raztopina 5 % glukoze in 20 mEq kalijevega klorida
English: You should not take more medicine than your doctor tells you to.
Slovenian: Ne vzemite več zdravila, kot vam je naročil zdravnik.
English: Patients with left ventricular ejection fraction < 45 % or left ventricular shortening fraction < 0.2 were not studied.
Slovenian: Študija ni proučevala bolnikov z iztisnim deležem levega prekata < 45 % ali skrčitvenim deležem levega prekata < 0,2.
English: 175 patients (63 %) included were diagnosed with primary pulmonary hypertension, 84 (30 %) were diagnosed with PAH associated with connective tissue disease and 18 (7 %) of the patients were diagnosed with PAH following surgical repair of congenital heart lesions.
Slovenian: 175 vključenih bolnikov (63 %) je imelo diagnosticirano primarno pljučno hipertenzijo, 84 (30 %) PAH, povezano z boleznimi vezivnega tkiva, in 18 (7 %) PAH po kirurški popravi prirojenih srčnih hib.
English: Side effects reported in a clinical trial with intravenous Revatio were similar to those reported in clinical trials with Revatio tablets.
Slovenian: Neželeni učinki, opisani v kliničnih preskušanjih z intravenskim zdravilom Revatio, so bili podobni kot v kliničnih preskušanjih s tabletami zdravila Revatio.
English: Note: Expires 30 days after reconstitution.
Slovenian: Opomba: rok uporabe je 30 dni po rekonstituciji.
English: Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Slovenian: Pri bolnikih, ki so izgubili vid na enem očesu zaradi nearteritične anteriorne ishemične optične nevropatije (NAION), tudi če ta dogodek ni bil povezan s predhodnim jemanjem zaviralcev PDE5 (glejte poglavje 4.4).
English: Put the tip of the oral dosing syringe into the mouth.
Slovenian: Vstavite konico peroralne odmerne brizge v usta.
English: Combination with the most potent of the CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) (see section 4.5).
Slovenian: Kombinacija z najmočnejšimi zaviralci CYP3A4 (npr. ketokonazolom, itrakonazolom, ritonavirjem) (glejte poglavje 4.5).
English: Once reconstituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Slovenian: Po rekonstituciji je treba peroralno suspenzijo uporabljati le s peroralno odmerno brizgo, ki je priložena vsakemu pakiranju.
English: In healthy volunteers, the plasma levels of the N-desmethyl metabolite following intravenous dosing are significantly lower than those observed following oral dosing.
Slovenian: Pri zdravih prostovoljcih je koncentracija N-dezmetilnega presnovka v plazmi po intravenski uporabi bistveno manjša kot po peroralni uporabi.
English: Remove the cap again, press the bottle adaptor into the neck of the bottle.
Slovenian: Ponovno odstranite zaporko in potisnite nastavek v vrat steklenice.
English: The estimated difference between the medium sildenafil dose and placebo was 11.33 % (95 % CI: 1.72 to 20.94) (see Table 2).
Slovenian: Ocenjena razlika med povprečnim odmerkom sildenafila in placebom je znašala 11,33 % (95 % IZ: 1,72 do 20,94) (glejte Preglednico 2).
English: Doses up to 80 mg three times a day (4 times the recommended dose of 20 mg three times a day) were administered and after 3 years 87 % of 183 patients on study treatment were receiving Revatio 80 mg TID.
Slovenian: Proučevali so odmerke do 80 mg trikrat na dan (4-kratni priporočeni odmerek 20 mg trikrat na dan) in po 3 letih je 87 % od 183 bolnikov v študiji prejemalo zdravilo Revatio v odmerku 80 mg trikrat na dan.
English: Limited data suggest that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension.
Slovenian: Omejeni podatki kažejo, da nenadne prekinitve uporabe zdravila Revatio ne spremlja povratno poslabšanje pljučne arterijske hipertenzije.
English: In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70 % stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7 % and 6 % respectively compared to baseline.
Slovenian: V študiji hemodinamskih učinkov posamičnega 100 mg peroralnega odmerka sildenafila pri 14 bolnikih s hudo boleznijo koronarnih arterij (> 70 % stenoza vsaj ene koronarne arterije) se je povprečni sistolični tlak v mirovanju v primerjavi z izhodiščem znižal za 7 %, povprečni diastolični v mirovanju pa za 6 %.
English: The overall frequency of discontinuations in sildenafil/epoprostenol treated patients due to adverse events was 5.2 % compared to 10.7 % in the placebo/epoprostenol treated patients.
Slovenian: Skupna pogostnost prekinitev zaradi neželenih učinkov je bila med bolniki, ki so dobivali sildenafil/epoprostenol, 5,2 % in pri tistih, ki so dobivali placebo/epoprostenol, 10,7 %.
English: Revatio with food and drink You should not drink grapefruit juice while you are being treated with Revatio.
Slovenian: Med zdravljenjem z zdravilom Revatio ne smete piti grenivkinega soka.
English: What you need to know before you take Revatio
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Revatio
English: Revatio powder for oral suspension is for oral use only.
Slovenian: Zdravilo Revatio prašek za peroralno suspenzijo je le za peroralno uporabo.
English: Manufacturer: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Slovenian: Izdelovalec: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Francija
English: Powder: Do not store above 30°C.
Slovenian: Prašek: Shranjujte pri temperaturi do 30 °C.
English: Before withdrawing the required dose, shake the bottle vigorously for a minimum of 10 seconds.
Slovenian: Pred odvzemom zahtevanega odmerka steklenico močno stresajte vsaj 10 sekund.
English: Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with pulmonary arterial hypertension compared to healthy volunteers.
Slovenian: Oba izsledka kažeta, da je pri bolnikih s pljučno arterijsko hipertenzijo očistek sildenafila manjši in/ali njegova peroralna biološka uporabnost večja kot pri zdravih prostovoljcih.
English: Due to lack of data, Revatio should not be used in pregnant women unless strictly necessary.
Slovenian: Zaradi pomanjkanja podatkov zdravila Revatio pri nosečnicah ne smete uporabljati, če to ni nujno potrebno.
English: Two subjects experienced a total of 3 adverse reactions (flushing, flatulence and hot flush).
Slovenian: Dvema preiskovancema so se pojavili skupno 3 neželeni učinki (zardevanje, flatulenca in vročinski oblivi).
English: Revatio contains lactose
Slovenian: Zdravilo Revatio vsebuje laktozo
English: Revatio is contraindicated in patients with severe hepatic impairment (Child-Pugh class C), (see section 4.3).
Slovenian: Revatio je kontraindiciran pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) (glejte poglavje 4.3).
English: For patients with a baseline walking distance ≥ 325 metres, the treatment effect was 38.4 metres in favour of sildenafil; for patients with a baseline walking distance < 325 metres, the treatment effect was 2.3 metres in favour of placebo.
Slovenian: Pri bolnikih z izhodiščno prehojeno razdaljo ≥ 325 metrov je bil učinek zdravljenja 38,4 metra v korist sildenafila; pri bolnikih z izhodiščno prehojeno razdaljo < 325 metrov je bil učinek zdravljenja 2,3 metra v korist placeba.
English: If you experience any of the following side effects you should stop taking Revatio and contact a doctor immediately (see also section 2): - if you experience sudden decrease or loss of vision (frequency not known) - if you have an erection, which lasts continuously for more than 4 hours.
Slovenian: Če se vam pojavi kateri od naslednjih neželenih učinkov, nemudoma prenehajte z jemanjem zdravila Revatio in obvestite zdravnika (glejte tudi poglavje 2): - če doživite nenadno poslabšanje ali izgubo vida (pogostnost ni znana).
English: Turn the bottle back upright with the oral dosing syringe still in place.
Slovenian: Obrnite steklenico s še vedno nameščeno peroralno odmerno brizgo nazaj v pokončni položaj.
English: Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Slovenian: Imetnik dovoljenja za promet: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija
English: This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50 % that of the parent drug.
Slovenian: Selektivnost tega presnovka za fosfodiesteraze je podobna selektivnosti sildenafila, njegov vpliv na PDE5 pa in vitro pomeni približno 50 % vpliva matičnega zdravila.
English: Results were generally consistent in subgroups according to aetiology (primary and connective tissue disease-associated PAH), WHO functional class, gender, race, location, mean PAP and PVRI.
Slovenian: Rezultati so bili po podskupinah praviloma skladni glede na etiologijo (primarna PAH in PAH, povezana z boleznimi vezivnega tkiva), funkcijski razred po SZO, spol, raso, lokacijo, povprečni pljučni arterijski tlak in indeks pljučne žilne upornosti.