FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the finding that ⇒ Crestor 10 mg daily dose leads to a higher reduction in LDL-C compared with 5 mg ⇒ No important safety or tolerability difference between rosuvastatin 5 mg and 10 mg is evident on the basis of post-marketing or clinical trial data
Slovenian: ⇒ dnevni odmerki zdravila Crestor 10 mg povzročijo večje znižanje ravni LDL-C v primerjavi z odmerkom 5 mg ⇒ iz postmarketinških podatkov in podatkov iz kliničnih preskušanj, niso razvidne pomembne razlike v varnosti in toleranci med odmerkoma rosuvastatina 5 mg in 10 mg sledi zaključek, da je razmerje med koristmi in tveganji za zdravili Crestor 5 mg ali Crestor 10 mg kot alternativnima začetnima odmerkoma ugodno.
English: Musculoskeletal, connective tissue and bone disorders Common: myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti: mialgija redki: miopatija in rabdomioliza
English: The main metabolites identified are the N-desmethyl and lactone metabolites.
Slovenian: Glavna presnovka sta N-demetilni in laktonski.
English: Subjects with severe impairment (CrCl <30 ml/min) had a 3-fold increase in plasma concentration and a 9-fold increase in the N-desmethyl metabolite concentration compared to healthy volunteers.
Slovenian: < 30 ml/min) je bila plazemska koncentracija rosuvastatina trikrat večja kot pri zdravih prostovoljcih,
English: Common: constipation, nausea, abdominal pain
Slovenian: Bolezni prebavil pogosti: zaprtje, slabost, bolečine v trebuhu
English: CK levels should be measured in these patients.
Slovenian: Pri takih bolnikih je treba meriti vrednost CK. Zdravljenje je treba ustaviti,
English: Skin and subcutaneous tissue disorders Uncommon: pruritus, rash and urticaria
Slovenian: Bolezni kože in podkožja občasni: srbečica, izpuščaji in koprivnica
English: Renal Effects: Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with Crestor.
Slovenian: Vpliv na ledvice: Pri bolnikih, ki so dobivali Crestor, se je pojavila proteinurija, ki so jo odkrili s testiranjem s testnimi lističi in je bila v glavnem tubulna.
English: In clinical trials there was no evidence of increased skeletal muscle effects in the small number of patients dosed with Crestor and concomitant therapy.
Slovenian: V kliničnih preskušanjih, v katerih je majhno število bolnikov sočasno s Crestorjem prejemalo še druga zdravila, niso dokazali zvečanja vpliva Crestorja na skeletne mišice.
English: - personal or family history of hereditary muscular disorders - previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate - alcohol abuse - situations where an increase in plasma levels may occur - Japanese and Chinese patients - concomitant use of fibrates.
Slovenian: - ledvična okvara - hipotiroidizem - osebna ali družinska anamneza dednih mišičnih motenj - toksično delovanje drugega zaviralca reduktaze HMG-CoA ali fibrata na mišice v preteklosti - zloraba alkohola
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
English: The 40 mg dose is contraindicated with concomitant use of a fibrate (see Section 4.3 Contraindications and Section 4.4 Special warnings and special precautions for use).
Slovenian: 40 mg odmerka je kontraindicirana pri sočasni uporabi fibratov (glejte poglavji 4.3 Kontraindikacije in 4.4.
English: ratios.
Slovenian: reduktaze.
English: Gemfibrozil increases the risk of myopathy when given concomitantly with some HMG-CoA reductase inhibitors.
Slovenian: Gemfibrozil zveča nevarnost pojava miopatije ob sočasni uporabi nekaterih zaviralcev reduktaze HMG-CoA. Zaradi tega kombinirano zdravljenje s Crestorjem in gemfibrozilom ni priporočeno.
English: Liver Effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in transaminases has been observed in a small number of patients taking rosuvastatin; the majority of cases were mild,
Slovenian: Vpliv na jetra: Serumska vrednost transaminaz se je pri majhnem številu bolnikov, ki so jemali rosuvastatin - tako kot pri uporabi drugih zaviralcev reduktaze HMG-CoA - v skladu z velikostjo odmerka zvečala; v večini primerov je bilo zvečanje blago, asimptomatsko in prehodno.
English: An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40 mg.
Slovenian: Med rutinskim spremljanjem bolnikov, ki jemljejo 40-miligramski odmerek zdravila, je smiselno tudi ocenjevanje delovanja ledvic.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: TG nonHDLC
Slovenian: TG holesterol neHDL
English: Titanium dioxide (E171) Ferric oxide, yellow (E172) 6.2 Incompatibilities Not applicable.
Slovenian: železov oksid, rumeni (E172)
English: Undesirable effects.)
Slovenian: Kontraindikacije).
English: Specialist supervision is recommended when the 40 mg dose is initiated.
Slovenian: Pri uvedbi zdravljenja s 40 mg odmerkom je priporočljiv nadzor zdravnika specialista.
English: Lactose monohydrate Microcrystalline cellulose
Slovenian: 6.1 Seznam pomožnih snovi jedro tablete laktoza monohidrat mikrokristalna celuloza kalcijev fosfat krospovidon magnezijev stearat obloga tablete laktoza monohidrat hipromeloza gliceriltriacetat titanov dioksid (E171)
English: Liver function and CK levels should be monitored.
Slovenian: Spremljati je treba delovanje jeter in vrednosti CK. Hemodializa verjetno ni učinkovita.
English: (ULN).
Slovenian: LDL.
English: As with other HMG-CoA reductase inhibitors, the hepatic uptake of rosuvastatin involves the membrane transporter OATP-C.
Slovenian: sodeluje tudi pri privzemu rosuvastatina v jetra membranski prenosnik OATP-C.
English: Paediatric use
Slovenian: Uporaba
English: However, an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives including gemfibrozil, cyclosporin, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics.
Slovenian: Pri sočasni uporabi zaviralcev HMG-CoA-redukaze in gemfibrozila, fenofibrata, drugih fibratov in niacina
English: - in patients with myopathy.
Slovenian: bolnikov, ki so se zdravili s Crestorjem.
English: The recommended start dose is 5 mg in patients with predisposing factors to myopathy (see Section 4.4
Slovenian: Odmerjanje pri bolnikih s predispozicijskimi dejavniki za miopatijo Priporočen začetni odmerek za bolnike s predispozicijskimi dejavniki za miopatijo je 5 mg (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: Discontinuation or down titration of Crestor may result in a decrease in INR.
Slovenian: Ta se lahko zmanjša, če se zdravljenje s Crestorjem ustavi ali če se zmanjša njegov odmerek.
English: In a rat pre- and postnatal study, reproductive toxicity was evident from reduced litter sizes, litter weight and pup survival.
Slovenian: V pre in ponatalni raziskavi pri podganah so odkrili toksično delovanje na reproduktivno sposobnost:
English: Crestor-treated patients with all doses and in particular with doses > 20 mg.
Slovenian: Pri jemanju zdravila Crestor so pri bolnikih opazili učinke na skeletne mišice, npr. mialgijo, miopatijo in v redkih primerih tudi rabdomiolizo, pri vseh odmerkih, predvsem pa pri odmerkih > 20 mg.
English: - personal or family history of hereditary muscular disorders - previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate - alcohol abuse - age >70 years - situations where an increase in plasma levels may occur (see section 5.2 Pharmacokinetic properties)
Slovenian: - zmerna ledvična okvara (čistek kreatinina < 60 ml/min) - hipotiroidizem - osebna ali družinska anamneza dednih mišičnih obolenj - predhoden pojav toksičnih učinkov na mišice pri uporabi drugih zaviralcev HMG-CoA-reduktaze ali fibratov
English: There is no specific treatment in the event of overdose.
Slovenian: Specifičnega zdravljenja v primeru prevelikega odmerjanja ni. Zdravljenje je simptomatsko; zagotoviti je treba delovanje vitalnih organov.
English: Crestor, as with other HMG-CoA reductase inhibitors, should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis.
Slovenian: Tako kot druge zaviralce reduktaze HMG-CoA je treba tudi Crestor predpisati zelo previdno bolnikom,
English: Tablet coat
Slovenian: Filmsko obložena tableta.
English: Calcium phosphate Crospovidone
Slovenian: skupni holesterol holesterol HDL
English: The recommended start dose is 5 mg in patients with moderate renal impairment (creatinine clearance
Slovenian: Pri bolnikih z zmerno ledvično odpovedjo (očistek kreatinina < 60 ml/min) je priporočen začetni odmerek 5 mg. Odmerek 40 mg je kontraindiciran pri bolnikih z zmerno ledvično odpovedjo.Uporaba
English: Child-Pugh scores above 9.
Slovenian: N-demetilnega presnovka pa devetkrat večja.
English: Table 1 Dose response in patients with primary hypercholesterolaemia (type IIa and IIb)
Slovenian: holesterol LDL/HDL, skupni holesterol/holesterol HDL, holesterol neHDL /HDL ter ApoB/ ApoA-I. Preglednica 1: Učinkovitost odmerka pri bolnikih s primarno hiperholesterolemijo (tipa IIa in
English: This dose can be continued for up to 13 weeks.
Slovenian: Ta odmerek se lahko jemlje do 13 tednov.
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: irritability, nervousness, restlessness, insomnia, abnormal dreams, anxiety, migraine, lethargy (lack of energy), psychomotor hyperactivity (restlessness with increased activity), dizziness, somnolence (sleepiness), hypertension (high blood pressure), abdominal pain (stomach ache), dyspepsia (heartburn), mouth ulcers, dry mouth, hyperbilirubinaemia (high blood levels of bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes), dermatitis (skin inflammation), night sweats, pruritus (itching), rash, dry skin, pain in the extremities (arms and legs), symptoms of the menopause, asthenia (weakness), chest pain, glycosuria (sugar in the urine), proteinuria (protein in the urine), abnormal liver function tests and increased weight.
Slovenian: Vendar so bili pri 1 do 10 bolnikih izmed 1 000 opaženi naslednji neželeni učinki: razdražljivost, nervoza, nemirnost, nespečnost, nenavadne sanje, anksioznost, migrena, letargija (pomanjkanje energije), psihomotorična hiperaktivnost (nemirnost s povečano aktivnostjo), omotica, zaspanost, hipertenzija (visok krvni tlak), bolečine v trebuhu, dispepsija (zgaga), razjede v ustih, suha usta, hiperbilirubinemija (povečane ravni bilirubina v krvi, produkta razgradnje rdečih krvnih celic, ki lahko povzroči rumeno obarvanje kože in oči), dermatitis (vnetje kože), nočno potenje, pruritus (srbenje), izpuščaj, suha koža, bolečine v okončinah (rokah in nogah), znaki menopavze, astenija (šibkost), bolečina v prsih, glikosurija (sladkor v urinu), proteinurija (beljakovine v urinu), neobičajni rezultati testov delovanja jeter in povečana telesna masa.
English: ‘Primary' means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.
Slovenian: „Primarna“ pomeni, da nespečnost nima znanih vzrokov, ne kakršnih koli drugih zdravstvenih, duševnih ali okoljskih vzrokov.
English: It is available as white prolongedrelease tablets (2 mg).
Slovenian: Na voljo je v obliki belih tablet s podaljšanim sproščanjem (2 mg).
English: Patients should avoid alcohol before, during and after taking Circadin.
Slovenian: Bolniki se morajo izogibati alkoholu pred, med in po jemanju zdravila Circadin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Circadin to Rad Neurim Pharmaceuticals EEC Limited on 29 June 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Circadin, veljavno po vsej Evropski uniji, odobrila družbi Rad Neurim Pharmaceuticals EEC Limited dne 29. junija 2007.
English: When the results of all three studies were looked at together, 32% of the patients taking Circadin (86 out of 265) reported a significant improvement in symptoms after three weeks, compared with 19% of those taking placebo (51 out of 272).
Slovenian: Pri obravnavi rezultatov vseh treh študij skupaj se je izkazalo, da je 32 % bolnikov (86 od 265), ki so jemali zdravilo Circadin, po treh tednih občutilo bistveno izboljšanje simptomov, v primerjavi z 19 % bolnikov (51 od 272), ki so jemali placebo.
English: Circadin can cause drowsiness, so it should be used with caution if this could pose a risk to safety, including in people who need to drive or use machines.
Slovenian: Zdravilo Circadin lahko povzroči zaspanost, zato ga je treba uporabljati previdno, če lahko vpliva na varnost, med drugim tudi pri ljudeh, ki vozijo ali upravljajo stroje.
English: Other information about Circadin:
Slovenian: Druge informacije o zdravilu Circadin:
English: For more information about treatment with Circadin, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Circadin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night.
Slovenian: Njegove ravni v krvi se navadno povečajo po nastopu teme in dosežejo vrh sredi noči.
English: The recommended dose of Circadin is one tablet a day, taken one to two hours before bedtime and after food.
Slovenian: Priporočeni odmerek zdravila Circadin je ena tableta na dan, eno do dve uri pred spanjem, in sicer po obroku.
English: This document is a summary of the European Public Assessment Report (EPAR) for Circadin.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Circadin.
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 Circadin.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Circadin, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Circadin should not be used in people who may be hypersensitive (allergic) to melatonin or any of the other ingredients.
Slovenian: Zdravila Circadin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) melatonin ali katero koli drugo sestavino zdravila.
English: The CHMP decided that, although Circadin has only been shown to have a small effect in a relatively small number of patients, its benefits are greater than its risks.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Circadin kljub temu, da je izkazalo majhen učinek pri razmeroma majhnem številu bolnikov, večje od z njim povezanih tveganj.
English: Circadin is used on its own for the short-term treatment of primary insomnia (poor quality of sleep) in patients aged 55 years or over.
Slovenian: Zdravilo Circadin se uporablja samostojno za kratkotrajno zdravljenje primarne nespečnosti (slabe kakovosti spanca) pri bolnikih, starih 55 let ali več.
English: Melatonin is involved in co-ordinating the body's sleep cycle by acting on cells in specific areas of the brain and helping to bring about sleep.
Slovenian: Melatonin sodeluje pri usklajevanju cikla spanja v telesu tako, da učinkuje na celice v določenih predelih možganov in spodbuja spanje.
English: What benefit has Circadin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Circadin izkazalo med študijami?
English: The additional study showed that Circadin was more effective than placebo for at least 13 weeks.
Slovenian: Dodatna študija je pokazala, da je zdravilo Circadin učinkovitejše od placeba vsaj 13 tednov.
English: Circadin is a medicine that contains the active substance melatonin.
Slovenian: Circadin je zdravilo, ki vsebuje zdravilno učinkovino melatonin.
English: ‘Prolonged-release' means that melatonin is released slowly from the tablet over a few hours.
Slovenian: „Podaljšano sproščanje“ pomeni, da se melatonin iz tablete sprošča počasi več ur.
English: Circadin was more effective than placebo at improving quality of sleep and the patients' ability to function normally on the following day.
Slovenian: Zdravilo Circadin je bilo pri izboljšanju kakovosti spanja in sposobnosti normalnega delovanja bolnikov naslednji dan učinkovitejše od placeba.
English: Side effects with Circadin are not common.
Slovenian: Neželeni učinki zdravila Circadin niso pogosti.
English: An additional study compared the effects of Circadin and placebo for up to six months.
Slovenian: V dodatni študiji so do šest mesecev primerjali učinke zdravila Circadin z učinki placeba.
English: The Committee recommended that Circadin be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Circadin odobri dovoljenje za promet.
English: Older people may produce less melatonin, leading to the development of insomnia.
Slovenian: Pri starejših ljudeh se tvori manj melatonina, kar vodi v pojav nespečnosti.
English: What is the risk associated with Circadin?
Slovenian: Kakšna tveganja so povezana z zdravilom Circadin?
English: Circadin has been compared with placebo (a dummy treatment) in three main studies involving a total of 681 patients aged over 55 years with primary insomnia.
Slovenian: Zdravilo Circadin so primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh glavnih študijah s skupno 681 bolniki s primarno nespečnostjo, starimi nad 55 let.
English: The active substance in Circadin, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland.
Slovenian: Zdravilna učinkovina zdravila Circadin, melatonin, je naravno prisoten hormon, ki ga navadno proizvaja žleza v možganih, imenovana češerika (epifiza).
English: The main measure of effectiveness was the number of patients who reported a significant improvement in their quality of sleep and ability to function normally on the following day, after three weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so po treh tednih zdravljenja občutili bistveno izboljšanje kakovosti spanja in sposobnosti normalnega delovanja naslednji dan. Bolniki so resnost svojih simptomov ocenjevali s pomočjo standardnega vprašalnika.
English: By replacing the hormone, Circadin increases blood levels of melatonin, helping them to sleep.
Slovenian: Zdravilo Circadin z nadomeščanjem hormona poveča ravni melatonina v krvi, to pa olajša spanec.
English: Because Circadin tablets release melatonin slowly over a few hours, they mimic the natural production of melatonin in the body.
Slovenian: Ker se melatonin iz tablet zdravila Circadin počasi sprošča več ur, posnema naravno tvorbo melatonina v telesu.
English: For the full list of all side effects reported with Circadin, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Circadin, glejte navodilo za uporabo.
English: Why has Circadin been approved?
Slovenian: Zakaj je bilo zdravilo Circadin odobreno?
English: What is Circadin used for?
Slovenian: Za kaj se zdravilo Circadin uporablja?
English: The full EPAR for Circadin can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Circadin je na voljo tukaj.
English: How has Circadin been studied?
Slovenian: Kako je bilo zdravilo Circadin raziskano?
English: How does Circadin work?
Slovenian: Kako zdravilo Circadin deluje?
English: What is Circadin?
Slovenian: Kaj je zdravilo Circadin?
English: How is Circadin used?
Slovenian: Kako se zdravilo Circadin uporablja?
English: Date of latest renewal: 4 September 2014
Slovenian: Datum zadnjega podaljšanja: 4. september 2014
English: · Risk Management Plan (RMP) Not applicable.
Slovenian: · Načrt za obvladovanje tveganja (RMP) Navedba smiselno ni potrebna.
English: Swallow the tablet whole with a glass of water.
Slovenian: Tableto pogoltnite celo s kozarcem vode.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 December 2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 10.december 2009
English: Most, but not all, of these patients had pre-existing cardiovascular risk factors.
Slovenian: Večina teh bolnikov, vendar ne vsi, je imela že obstoječe kardiovaskularne dejavnike tveganja.
English: - If you have problems with your heart.
Slovenian: - če imate težave s srcem.
English: It is not possible to determine whether these events are related directly to these factors or to other factors.
Slovenian: Ali so ti dogodki neposredno povezani s temi dejavniki ali s kakšnimi drugimi, ni mogoče ugotoviti.
English: Doses above 100 mg do not increase the efficacy.
Slovenian: Odmerki, večji od 100 mg, ne povečajo učinkovitosti.
English: Further information on clinical trials
Slovenian: Dodatne informacije o kliničnih preskušanjih
English: - If you have recently had a stroke or a heart attack, or if you have low blood pressure.
Slovenian: - če ste nedavno doživeli možgansko kap ali srčni infarkt ali če imate nizek krvni tlak.
English: See leaflet for further information.
Slovenian: Glejte navodilo za dodatne informacije.
English: - If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Slovenian: - če imate kakšno redko dedno očesno bolezen (npr. retinitis pigmentosa).
English: Because not all adverse reactions are reported the frequencies of these reactions cannot be reliably determined.
Slovenian: Ker niso prijavljeni vsi neželeni učinki, njihove pogostosti ni mogoče zanesljivo določiti.
English: - If you have a deformity of your penis or Peyronie's Disease.
Slovenian: - če imate deformacijo spolnega uda ali Peyroniejevo bolezen.
English: In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
Slovenian: V kliničnih preskušanjih je sildenafil dobilo več kot 8000 bolnikov, starih od 19 do 87 let.
English: Your doctor may decide on a lower dose for you.
Slovenian: Morda vam bo predpisal manjši odmerek.
English: Do not take Sildenafil Actavis with other medicines unless your doctor tells you that you can.
Slovenian: Zdravila Sildenafil Actavis ne jemljite skupaj z drugimi zdravili, razen če vam zdravnik pove, da ga lahko.
English: - Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people)
Slovenian: · Dolgotrajne in včasih boleče erekcije - to se zgodi redko (pojavi se lahko pri največ 1 od 1000
English: Very common (may affect more than 1 in 10 people): headache.
Slovenian: Zelo pogost (pojavijo se lahko pri več kot 1 od 10 bolnikov) je glavobol.
English: The amount of time Sildenafil Actavis takes to work varies from person to person, but it normally takes between half an hour and one hour.
Slovenian: Čas do začetka delovanja zdravila Sildenafil Actavis se od človeka do človeka razlikuje, a po navadi traja od pol ure do eno uro.
English: Elderly Dosage adjustments are not required in elderly patients (≥ 65 years old).
Slovenian: Starejši Starejšim bolnikom odmerka ni treba prilagajati (≥ 65 let).
English: The mean absolute oral bioavailability is 41% (range 25-63%).
Slovenian: Povprečna absolutna peroralna biološka uporabnost je 41% (razpon: od 25 do 63%).
English: Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of sildenafil without sexual activity.
Slovenian: Številni dogodki so se zgodili kmalu po spolnem odnosu, nekateri pa kmalu po uporabi sildenafila, brez spolne dejavnosti.
English: Periodic Safety Update Reports
Slovenian: Redno posodobljena poročila o varnosti zdravila
English: You should not take Sildenafil Actavis more than once a day.
Slovenian: Zdravila Sildenafil Actavis ne smete vzeti več kot enkrat na dan.