FrancophonIA/ELRC3.0 huggingface dataset:
English: 6, Dervenakion EL-15351 Pallini Attiki Greece
Slovenian: 153 51 Pallini Attiki, Grčija
English: Add-on therapy for children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg
Slovenian: Dopolnilno zdravljenje za otroke (od 4 do 11 let) in mladostnike (od 12 do 17 let), težke manj kot 50 kg
English: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy:
Slovenian: Dopolnilno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti, z epilepsijo:
English: Infants 6 to 23 months, children and adolescents weighing less than 50 kg
Slovenian: Dojenčki od 6. do 23. meseca, otroci in mladostniki s telesno maso manj kot 50 kg normalno delovanje ledvic
English: PHARMACEUTICALPARTICULARS
Slovenian: FARMACEVTSKI PODATKI
English: Film-coating: hypromellose (E464), titanium dioxide (E171), talc, propylene glycol (E1520) colourants*.
Slovenian: Filmska obloga: hipromeloza (E464), titanov dioksid (E171), smukec, propilenglikol (E1520), barvila*.
English: • as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
Slovenian: • kot dopolnilo drugim protiepileptičnim zdravilom za zdravljenje: parcialnih napadov z generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih od 4. leta starosti, miokloničnih napadov (kratkih, šoku podobnih sunkov mišic ali skupin mišic) pri odraslih in mladostnikih od 12. leta starosti z juvenilno mioklonično epilepsijo, primarno generaliziranih tonično-kloničnih napadov (večjih napadov, vključno z izgubo zavesti) pri odraslih in mladostnikih od 12. leta starosti z idiopatsko generalizirano epilepsijo (obliko epilepsije, za katero se predvideva, da je vzrok genetski).
English: 1000 mg 10 ml (two 5 ml vials)
Slovenian: 1000 mg 10 ml (dve 5 ml viali) 100 ml
English: The NOAEL (No Observed Adverse Effect Level) was 3600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m basis) and 1200 mg/kg/day for fetuses.
Slovenian: Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil pri brejih podganah 3600 mg/kg/dan (12-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m in pri plodovih 1200 mg/kg/dan.
English: lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
Slovenian: • konvulzije, motnje ravnotežja, omotica (občutek nesigurnosti), letargija (pomanjkanje energije in navdušenja), tremor (nehoteno tresenje)
English: Matever 250 mg: The film-coated tablets are blue, oblong, biconvex.
Slovenian: Zdravilo Matever 250 mg: filmsko obložene tablete so modre, podolgovate, bikonveksne.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily
Slovenian: 10 do 20 mg/kg (0,10 do 0,20 ml/kg) enkrat na dan
English: Matever 1000 mg film-coated tablets
Slovenian: Matever 1000 mg filmsko obložene tablete
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg)once daily
Slovenian: 7 do 14 mg/kg (0,07 do 0,14 ml/kg) enkrat na dan
English: Matever 750 mg film-coated tablets
Slovenian: Matever 750 mg filmsko obložene tablete
English: The NOAEL was < 200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m basis).
Slovenian: Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil < 200 mg/kg/dan za samice in 200 mg/kg/dan za plodove (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m
English: Muscular weakness, myalgia
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišična oslabelost, mialgija
English: Matever 750 mg: The film-coated tablets are pink, oblong, biconvex.
Slovenian: Zdravilo Matever 750 mg: filmsko obložene tablete so rožnate, podolgovate, bikonveksne.
English: 500 mg tablet: quinoline yellow aluminium lake (E104) 750 mg tablet: indigo carmine aluminum lake (E132), sunset yellow FCF aluminum lake (E110) 1000 mg tablet: (no additional colourant).
Slovenian: 750 mg tableta: indigotin (E132), sončno rumeno FCF (E110) 1000 mg tableta: (ni dodatnega barvila)
English: The 5 ml vial contains 500 mg of levetiracetam.
Slovenian: Ena 5 ml viala vsebuje 500 mg levetiracetama.
English: Matever 1000 mg: The film-coated tablets are white, oblong, biconvex.
Slovenian: Zdravilo Matever 1000 mg: filmsko obložene tablete so bele, podolgovate, bikonveksne.
English: confusion, panic attack, emotional instability/mood swings, agitation;
Slovenian: halucinacije, jeza, zmedenost, napad panike, čustvena nestabilnost/nihanja v razpoloženju,
English: Therefore, a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m
Slovenian: Če je očistek kreatinina < 60 ml/min/1,73 m2, je priporočljivo zmanjšati dnevni vzdrževalni odmerek za
English: 15 minutes Twice daily 3000 mg/day
Slovenian: 15 minut dvakrat na dan 3000 mg/dan
English: In patients aged 4-16 years, a total of 645 patients have been treated with levetiracetam in placebo-controlled and open label extension studies.
Slovenian: razširjenih študijah so zdravili 645 bolnikov, starih od 4 do 16 let; od tega so 233 bolnikov zdravili z levetiracetamom v s placebom nadzorovanih študijah.
English: Matever 250 mg film-coated tablets
Slovenian: Matever 250 mg filmsko obložene tablete
English: Matever 500 mg: The film-coated tablets are yellow, oblong, biconvex.
Slovenian: Zdravilo Matever 500 mg: filmsko obložene tablete so rumene, podolgovate, bikonveksne.
English: A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Slovenian: Prvi dan zdravljenja z levetiracetamom je priporočen začetni odmerek 15 mg/kg (0,15 ml/kg).
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse reactions seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x 6 - 17 the MRHD on a mg/m basis).
Slovenian: V študijah pri novoskotenih živalih in mladičih živali so dokazali, da pri podganah in psih, pri odmerkih do 1800 mg/kg/dan (6-kratna do 17-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2) ni bilo neželenih učinkov na standardne parametre razvoja in dozorevanja.
English: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy:
Slovenian: Dopolnilno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih, od 4. leta starosti, z epilepsijo:
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state, panic attack, affect lability/mood swings, agitation
Slovenian: • poskus samomora in razmišljanje o samomoru, duševne motnje, nenormalno vedenje, halucinacije, jeza, zmedenost, napad panike, čustvena nestabilnost/nihanja v razpoloženju, agitacija (motorični nemir)
English: What you need to know before you are given Matever
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Matever 3.
English: Matever 500 mg film-coated tablets
Slovenian: Matever 500 mg filmsko obložene tablete
English: Contact your doctor if you took more tablets than you should.
Slovenian: Če ste vzeli več tablet kot bi smeli, se posvetujte s svojim zdravnikom.
English: 15 minutes Twice daily 2000 mg/day
Slovenian: 15 minut dvakrat na dan 2000 mg/dan
English: 15 minutes Twice daily 1000 mg/day
Slovenian: 15 minut dvakrat na dan 1000 mg/dan
English: The NOAEL (No Observed Adverse Effect Level) was 3600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2 basis) and 1200 mg/kg/day for fetuses.
Slovenian: Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil pri brejih podganah 3600 mg/kg/dan (12-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2) in pri plodovih
English: • 250 mg: 20, 30, 50, 60, 100 and multipack of 200 (2 packs of 100) film-coated tablets.
Slovenian: • 250 mg: 20, 30, 50, 60, 100 ali skupno pakiranje po 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: • 750 mg: 20, 30, 50, 60, 80, 100, 120 and multipack of 200 (2 packs of 100) film-coated tablets.
Slovenian: • 750 mg: 20, 30, 50, 60, 80, 100, 120 ali skupno pakiranje po 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Slovenian: Pri podganah, starševska in F1 generacija, pri odmerkih do 1800 mg/kg/dan (6-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m ali na osnovno izpostavljenost) niso opazili neželenih učinkov na plodnost samcev ali samic ali na razmnoževanje.
English: Matever 1000 mg film-coated tablets levetiracetam2.
Slovenian: Matever 1000 mg filmsko obložene tablete levetiracetam
English: Matever 750 mg film-coated tablets levetiracetam2.
Slovenian: Matever 750 mg filmsko obložene tablete levetiracetam
English: A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Slovenian: Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 10,5 mg/kg (0,105 ml/kg).
English: • 1000 mg: 10, 20, 30, 50, 60, 100 and multipack of 200 (2 packs of 100) film-coated tablets.
Slovenian: • 1000 mg: 10, 20, 30, 50, 60, 100 ali skupno pakiranje po 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: • 500 mg: 10, 20, 30, 50, 60, 100, 120 and multipack of 200 (2 packs of 100) film-coated tablets.
Slovenian: • 500 mg: 10, 20, 30, 50, 60, 100, 120 ali skupno pakiranje po 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: Matever 250 mg film-coated tablets levetiracetam2.
Slovenian: Matever 250 mg filmsko obložene tablete levetiracetam
English: − This medicine has been prescribed for you only.
Slovenian: Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Coating agent (orange) consisting of: Hypromellose (E464) Indigo carmine aluminum lake (E132) Sunset yellow FCF aluminum lake (E110) Iron oxide red (E172) Macrogol/PEG 4000
Slovenian: Obloga (oranžna), ki jo sestavljajo: hipromeloza (E464), indigotin (E132), sončno rumeno FCF (E110), rdeči železov oksid (E172), makrogol 4000, titanov dioksid (E171).
English: Levetiracetam 100mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets don't allow accurate dose.
Slovenian: Za dojenčke in otroke, mlajše od 6 let, otroke in mladostnike (od 6 do 17 let), lažje od 50 kg, ter kadar se s tabletami ne doseže natančnega odmerjanja, je 100 mg/ml peroralna raztopina levetiracetama primernejša farmacevtska oblika.
English: Rhabdomyolysis and blood creatine phosphokinase increased*
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija/utrujenost rabdomioliza in zvišanje kreatin fosfokinaze v krvi*
English: How to store Matever
Slovenian: Kako se daje zdravilo Matever
English: Matever 500 mg film-coated tablets levetiracetam2.
Slovenian: Matever 500 mg filmsko obložene tablete levetiracetam
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Slovenian: Johnsonov sindrom, multiformni eritem
English: Component of a multipack, can't be sold separately.
Slovenian: Ni namenjen prodaji kot samostojna enota.
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Slovenian: • amnezija (izguba spomina), oslabljen spomin (pozabljivost), poslabšana koordinacija/ataksija (motena usklajenost mišičnih gibov), parestezija (mravljinčenje), motnje pozornosti (izguba koncentracije)
English: Box of 20, 30, 50, 60, 80, 100, 120 multipack containing 200 (2 x 100) [with Blue Box]
Slovenian: Škatla z 20, 30, 50, 60, 80, 100, 120 skupno pakiranje, ki vsebuje 200 (2 x 100) [S PODATKI ZA t.i.
English: 250 mg tablet: indigo carmine aluminum lake (E132), sunset yellow FCF aluminum lake (E110),
Slovenian: 250 mg tableta: indigotin (E132), sončno rumeno FCF (E110), kinolinsko rumeno (E104) 500 mg tableta: kinolinsko rumeno (E104)
English: CLcr (ml/min/1.73 m
Slovenian: CLcr (ml/min/1,73 m koncentracija kreatinina v serumu (mg/dl)
English: Hyponatraemia
Slovenian: hiperkinezija (hiperaktivnost)
English: Box of 10, 20, 30, 50, 60, 100, 120 multipack containing 200 (2 x 100) [with Blue Box]
Slovenian: Škatla z 10, 20, 30, 50, 60, 100, 120 skupno pakiranje, ki vsebuje 200 (2 x 100) [S PODATKI ZA t.i.
English: Pancytopenia,neutropen ia, agranulocytosis
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija levkopenija pancitopenija, nevtropenija, agranulocitoza
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 20, 30, 50, 60, 80, 100, 120 and multipack containing 200 (2 packs of 100) film-coated tablets.
Slovenian: Zdravilo Matever 750 mg filmsko obložene tablete je na voljo v pretisnih omotih aluminij/ PVC/PE/PVDC, v škatlah z 20, 30, 50, 60, 80, 100, 120 in skupnem pakiranju, ki vsebuje 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: Box of 10, 20, 30, 50, 60, 100 multipack containing 200 (2 x 100) [with Blue Box]
Slovenian: Škatla z 10, 20, 30, 50, 60, 100 skupno pakiranje, ki vsebuje 200 (2 x 100) [S PODATKI ZA t.i.
English: Box of 20, 30, 50, 60, 100 multipack containing 200 (2 x 100) [with Blue Box]
Slovenian: Škatla z 20, 30, 50, 60, 100 skupno pakiranje, ki vsebuje 200 (2 x 100) [S PODATKI ZA t.i.
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 and multipack containing 200 (2 packs of 100) film-coated tablets.
Slovenian: Zdravilo Matever 500 mg filmsko obložene tablete je na voljo v pretisnih omotih aluminij/ PVC/PE/PVDC, v škatlah z 10, 20, 30, 50, 60, 100, 120 in skupnem pakiranju, ki vsebuje 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: Pharmathen S.A. Tel.: +30 210 66 04 300
Slovenian: Deutschland Pharmathen S.A Tel.: +30 210 66 04 300
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100 and multipack containing 200 (2 packs of 100) film-coated tablets.
Slovenian: Zdravilo Matever 1000 mg filmsko obložene tablete je na voljo v pretisnih omotih aluminij/ PVC/PE/PVDC, v škatlah z 10, 20, 30, 50, 60, 100 in skupnem pakiranju, ki vsebuje 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 20, 30, 50, 60, 100 and multipack containing 200 (2 packs of 100) film-coated tablets.
Slovenian: Zdravilo Matever 250 mg filmsko obložene tablete je na voljo v pretisnih omotih aluminij/ PVC/PE/PVDC, v škatlah z 20, 30, 50, 60, 100 in skupnem pakiranju, ki vsebuje 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: Coating agent (yellow) consisting of: Hydroxypropylcellulose (E463) Hypromellose (E464) Propylene glycol (E1520) Quinoline yellow aluminium lake (E104) Sorbic acid (E200)
Slovenian: Obloga (rumena), ki jo sestavljajo: hidroksipropilceluloza (E463), hipromeloza (E464), propilenglikol (E1520), kinolinsko rumeno (E104), sorbinska kislina (E200), sorbitan monooleat (E494), titanov dioksid (E171), vanillin.
English: Talk to your doctor before you are given Matever
Slovenian: Pred začetkom jemanja zdravila Matever se posvetujte s svojim zdravnikom
English: The capsules should be taken with food, preferably at the same time every day.
Slovenian: Kapsule je treba vzeti s hrano, najbolje vsak dan ob istem času.
English: It is available as capsules (4 and 8 mg).
Slovenian: Na voljo je v kapsulah (4 in 8 mg).
English: The patients rated the severity of their symptoms themselves.
Slovenian: Bolniki so resnost simptomov ocenili sami.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Silodyx on 29 January 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Silodyx, veljavno po vsej Evropski uniji, izdala dne 29. januarja 2010.
English: They should be swallowed whole, preferably with a glass of water.
Slovenian: Pogoltniti jih je treba cele, najbolje s kozarcem vode.
English: For men with moderate kidney problems, the starting dose should be 4 mg once a day.
Slovenian: Pri moških z zmernimi težavami z ledvicami mora biti začetni odmerek 4 mg enkrat dnevno.
English: The full EPAR for Silodyx 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 Silodyx je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Silodyx.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Silodyx.
English: The recommended dose is one 8 mg capsule once a day.
Slovenian: Priporočeni odmerek je ena 8-miligramska kapsula enkrat dnevno.
English: This may be increased to 8 mg once a day after a week.
Slovenian: Po enem tednu ga je mogoče povečati na 8 mg enkrat dnevno.
English: The main measure of effectiveness in all three studies was the improvement of the patients' international prostate symptom score (IPSS) after 12 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti v vseh treh študijah je bilo izboljšanje ocene IPSS (International Prostate Symptom Score) pri bolnikih po 12 tednih zdravljenja.
English: What measures are being taken to ensure the safe and effective use of Silodyx?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Silodyx?
English: The effects of Silodyx were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Silodyx so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: In the two studies where Silodyx was compared only with placebo, the IPSS was around 21 points at the start of the study.
Slovenian: V dveh študijah, v katerih so zdravilo Silodyx primerjali le s placebom, je bila ocena IPSS na začetku študije približno 21 točk.
English: A risk management plan has been developed to ensure that Silodyx is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Silodyx je bil pripravljen načrt obvladovanja tveganj.
English: After 12 weeks, it had fallen by around 6.4 points in the men who took Silodyx, and by around 3.5 points in the men who took placebo.
Slovenian: Po 12 tednih se je zmanjšala za približno 6,4 točke pri moških, ki so jemali zdravilo Silodyx, in za približno 3,5 točke pri moških, ki so jemali placebo.
English: For more information about treatment with Silodyx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Solodyx preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP decided that Silodyx's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Silodyx večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Silodyx is not recommended for patients with severe kidney problems.
Slovenian: Zdravilo Silodyx ni priporočeno za bolnike s hudimi težavami z ledvicami.
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 Silodyx.
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: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Silodyx, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: In the third study, IPSS was around 19 points before treatment, falling by 7.0 points in the men who took Silodyx after 12 weeks, 6.7 points in the men who took tamsulosin and 4.7 points in the men who took placebo.
Slovenian: V tretji študiji je bila ocena IPSS pred zdravljenjem približno 19 točk, po 12 tednih je pri moških, ki so jemali zdravilo Silodyx, padla za 7,0 točke, pri moških, ki so jemali tamsulozin, za 6,7 točke, pri tistih, ki so jemali placebo, pa za 4,7 točke.
English: IPSS is a rating of the patient's symptoms such as the inability to empty the bladder, and the urge to urinate repeatedly or to strain while urinating.
Slovenian: IPSS je ocena bolnikovih simptomov, kot so nezmožnost praznjenja mehurja, potreba po pogostem mokrenju ali napenjanje med mokrenjem.
English: When enlarged, it can cause problems with the flow of urine.
Slovenian: Če je povečana, lahko povzroča težave pri izločanju seča.
English: The most common side effect with Silodyx (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation.
Slovenian: Najpogostejši neželeni učinek zdravila Silodyx (opažen pri več kot 1 bolniku od 10) je zmanjšanje količine sperme, izločene med ejakulacijo.
English: For the full list of all side effects and restrictions with Silodyx, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Silodyx glejte navodilo za uporabo.
English: It works by blocking receptors called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body).
Slovenian: Deluje tako, da zavira receptorje, imenovane adrenergični receptorji alfa 1A, v prostati, mehurju in sečnici (cevki, ki vodi od mehurja ven iz telesa).
English: The prostate gland is an organ found at the base of the bladder in men.
Slovenian: Prostata je organ, ki se nahaja pod mehurjem pri moških.
English: By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.
Slovenian: Z zaviranjem teh receptorjev silodozin omogoča sprostitev teh mišic, kar olajša mokrenje in simptome BHP.
English: What benefit has Silodyx shown during the studies?
Slovenian: Kakšne koristi je zdravilo Silodyx izkazalo med študijami?
English: Other information about Silodyx
Slovenian: Druge informacije o zdravilu Silodyx
English: In addition, the company that makes Silodyx will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.
Slovenian: Poleg tega bo družba, ki izdeluje zdravilo Silodyx, zagotovila, da bodo v vseh državah članicah, v katerih bo zdravilo na trgu, očesni kirurgi seznanjeni z možnostjo pojava medoperacijskega sindroma ohlapne šarenice (IFIS).
English: Silodyx is a medicine that contains the active substance silodosin.
Slovenian: Silodyx je zdravilo, ki vsebuje zdravilno učinkovino silodozin.
English: One of these studies also compared Silodyx with tamsulosin (another medicine used for BPH).
Slovenian: V eni izmed teh študij so zdravilo Silodyx primerjali tudi s tamsulozinom (drugim zdravilom za zdravljenje BHP).
English: The active substance in Silodyx, silodosin, is an alpha adrenoreceptor antagonist.
Slovenian: Zdravilna učinkovina zdravila Silodyx, silodozin, je antagonist adrenergičnih receptorjev alfa.