natgillin/translations-raw huggingface dataset:
In the placebo-controlled study of sildenafil in patients 1 to 17 years of age with pulmonary arterial hypertension, a total of 174 patients were treated three times a day with either low (10 mg in patients > 20 kg; no patients ≤ 20 kg received the low dose), medium (10 mg in patients ≥ 8-20 kg; 20 mg in patients ≥ 20-45 kg; 40 mg in patients > 45 kg) or high dose (20 mg in patients ≥ 8-20 kg; 40 mg in patients ≥ 20-45 kg; 80 mg in patients > 45 kg) regimens of sildenafil and 60 were treated with placebo.
V s placebom nadzorovani študiji sildenafila pri bolnikih, starih od 1 leta do 17 let, s pljučno arterijsko hipertenzijo, je skupno 174 bolnikov trikrat na dan prejemalo bodisi majhen odmerek (10 mg pri bolnikih s telesno maso > 20 kg; noben bolnik s telesno maso  20 kg ni prejemal majhnega odmerka), ali srednji odmerek (10 mg pri bolnikih s telesno maso  8 - 20 kg; 20 mg pri bolnikih s telesno maso  20 - 45 kg; 40 mg pri bolnikih s telesno maso > 45 kg), bodisi velik odmerek (20 mg pri bolnikih s telesno maso  8 - 20 kg; 40 mg pri bolnikih s telesno maso  20 - 45 kg; 80 mg pri bolnikih s telesno maso > 45 kg) sildenafila, 60 bolnikov pa je prejemalo placebo.
• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).
- če ste kadar koli izgubili vid zaradi motene prekrvavitve očesnega živca; to motnjo imenujemo nearteritična anteriorna ishemična optična nevropatija (NAION).
Efficacy and safety in adult patients with PAH (when used in combination with bosentan) A randomised, double-blind, placebo controlled study was conducted in 103 clinically stable subjects with PAH (WHO FC II and III) who were on bosentan therapy for a minimum of three months.
Učinkovitost in varnost pri odraslih bolnikih s PAH (uporabljen v kombinaciji z bosentanom) Randomizirana, dvojno slepa, s placebom nadzorovana študija je bila narejena pri 103 klinično stabilnih preiskovancih s PAH (funkcijskega razreda II in III po SZO), ki so se z bosentanom zdravili najmanj tri mesece.
Adverse reactions which occurred in > 1% of sildenafil-treated patients and were more frequent (> 1% difference) on sildenafil in the pivotal study or in the sildenafil combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1 /1,000 to < 1/100) and not known (cannot be estimated from the available data).
Neželeni učinki, ki so se pojavili pri > 1% bolnikov, zdravljenih s sildenafilom, ter so bili v ključni študiji oziroma v združenih podatkih iz obeh s placebom nadzorovanih študij pljučne arterijske hipertenzije ob odmerkih 20, 40 ali 80 mg trikrat na dan pogostejši pri jemanju sildenafila (razlika > 1%), so prikazani v spodnji preglednici po organskem sistemu in pogostnosti: zelo pogosti ( 1/10), pogosti ( 1/100 do <1/10), občasni ( 1/1.000 do ≤ 1/100) in neznana (ni mogoče oceniti iz podatkov, ki so na voljo).
Mysildecard brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Zdravilo Mysildecard širi žile v pljučih in s tem zniža krvni tlak v pljučih.
Adverse reactions reported in >10% of 229 subjects treated with sildenafil (combined dose group, including 9 patients that did not continue into the long-term study) were upper respiratory infection (31%), headache (26%), vomiting (22%), bronchitis (20%), pharyngitis (18%), pyrexia (17%), diarrhoea (15%), and influenza, epistaxis (12% each).
Neželeni učinki, o katerih so poročali pri > 10% od 229 preiskovancev, zdravljenih s sildenafilom (skupina z vsemi odmerki, vključno z 9 bolniki, ki niso nadaljevali v dolgoročno študijo), so bili okužba zgornjih dihal (31%), glavobol (26%), bruhanje (22%), bronhitis (20%), faringitis (18%), pireksija (17%), diareja (15%), gripa in epistaksa (oba 12%).
Other medicines and Mysildecard
Druga zdravila in zdravilo Mysildecard
The estimated difference between the medium sildenafil dose and placebo was 11.33% (95% CI: 1.72 to 20.94) (see Table 2).
Ocenjena razlika med povprečnim odmerkom sildenafila in placebom je znašala 11,33% (95% IZ: 1,72 do 20,94) (glejte Preglednico 2).
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1134/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1134/001
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.
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%.
If you experience sudden decrease or loss of vision, stop taking Mysildecard and contact your doctor immediately (see also section 4).
Če doživite nenadno poslabšanje ali izgubo vida, prenehajte jemati zdravilo Mysildecard in nemudoma obvestite zdravnika (glejte tudi poglavje 4).
After chronic dosing of 80 mg three times a day to patients with pulmonary arterial hypertension lesser effects in blood pressure reduction were observed (a reduction in both systolic and diastolic pressure of 2 mmHg).
Po kroničnem odmerjanju 80 mg trikrat na dan pri bolnikih s pljučno arterijsko hipertenzijo so opažali manjše učinke na znižanje krvnega tlaka (znižanje sistoličnega in diastoličnega tlaka za 2 mm Hg).
• currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
- imate trenutno razjedo na želodcu, ste nagnjeni h krvavitvam (npr. imate hemofilijo) ali imate težave s krvavitvami iz nosu.
In a study of healthy volunteers sildenafil at steady state (80 mg three times a day) resulted in a 50% increase in bosentan AUC (125 mg twice daily).
V študiji pri zdravih prostovoljcih je sildenafil v stanju dinamičnega ravnovesja (80 mg trikrat na dan) povzročil 50% povečanje AUC bosentana (125 mg dvakrat na dan).
Co-administration of oral contraceptives (ethinyloestradiol 30 μg and levonorgestrel 150 μg) did not affect the pharmacokinetics of sildenafil.
Sočasna uporaba peroralnih kontraceptivov (30 g etinilestradiola in 150 g levonorgestrela) ni vplivala na farmakokinetiko sildenafila.
A population pharmacokinetic analysis of sildenafil data from adult PAH patients in clinical trials including a 12 week study to assess the efficacy and safety of oral sildenafil 20 mg three times a day when added to a stable dose of bosentan (62.5 mg - 125 mg twice a day) indicated a decrease in sildenafil exposure with bosentan co-administration, similar to that observed in healthy volunteers (see sections 4.4 and 5.1).
Populacijska farmakokinetična analiza podatkov o sildenafilu pri odraslih bolnikih s PAH iz kliničnih preskušanj, vključno z 12-tedensko študijo za oceno učinkovitost in varnost peroralnega sildenafila 20 mg trikrat na dan, kadar so ga dodajali stabilnemu odmerku bosentana (62,5 - 125 mg dvakrat na dan), je pokazala zmanjšanje izpostavljenosti sildenafilu ob sočasni uporabi z bosentanom, kar je podobno ugotovitvam pri zdravih prostovoljcih (glejte poglavji 4.4 in 5.1).
This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug.
Selektivnost tega presnovka za fosfodiesteraze je podobna selektivnosti sildenafila, njegov vpliv na PDE5 pa in vitro pomeni približno 50% vpliva matičnega zdravila.
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 sildenafil 80 mg TID.
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 sildenafil v odmerku 80 mg trikrat na dan.
In patients with pulmonary arterial hypertension, the average steady state concentrations were 20-50% higher over the investigated dose range of 20-80 mg three times a day compared to healthy volunteers.
Pri bolnikih s pljučno arterijsko hipertenzijo je bila povprečna koncentracija v stanju dinamičnega ravnovesja v proučevanem območju od 20 do 80 mg trikrat na dan od 20 do 50% večja kot pri zdravih prostovoljcih.
In pulmonary arterial hypertension patients, the oral bioavailability of sildenafil after 80 mg three times a day was on average 43% (90% CI: 27% - 60%) higher compared to the lower doses.
Pri bolnikih s pljučno arterijsko hipertenzijo je bila peroralna biološka uporabnost sildenafila ob 80 mg trikrat na dan v povprečju za 43% (90% IZ: od 27 do 60%) večja kot ob manjših odmerkih.
Marketing Authorisation Holder: Mylan S.A.S
Imetnik dovoljenja za promet: Mylan S.A.S
Of the 94 subjects reporting a serious adverse event, 14/55 (25.5%) subjects were in the low dose group, 35/74 (47.3%) in the medium dose group, and 45/100 (45%) in the high dose group.
Od 94 preiskovancev, pri katerih so poročali o resnem neželenem učinku, je bilo 14/55 (25,5%) preiskovancev iz skupine z majhnim odmerkom, 35/74 (47,3%) iz skupine s srednjim odmerkom in 45/100 (45%) iz skupine z velikim odmerkom.
Mysildecard should not be given to women of child bearing potential unless using appropriate contraceptive methods.
Ženske v rodni dobi ne smejo uporabljati zdravila Mysildecard, razen če uporabljajo ustrezno kontracepcijsko metodo.
Cimetidine (800 mg), a cytochrome P450 inhibitor and a non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Cimetidin (800 mg), zaviralec citokroma P450 in nespecifičen zaviralec CYP3A4, je ob sočasni uporabi s sildenafilom (50 mg) pri zdravih prostovoljcih povzročil 56% povečanje koncentracije sildenafila v plazmi.
• have a problem with the pumping chambers of your heart.
- imate težave s črpalnimi prekati srca.
Doses up to 80 mg TID were administered and after 3 years 68% of 133 patients on study treatment were receiving sildenafil 80 mg TID.
Prejemali so odmerke do 80 mg trikrat na dan in po 3 letih je 68% od 133 bolnikov v študiji prejemalo sildenafil v odmerku 80 mg trikrat na dan.
Subjects who had been in the placebo group in the short-term study were randomly reassigned to sildenafil treatment; subjects weighing ≤ 20 kg entered the medium or high dose groups (1:1), while subjects weighing > 20 kg entered the low, medium or high dose groups (1:1:1).
Preiskovanci, ki so v kratkoročni študiji prejemali placebo, so bili randomizirani v skupine, ki so se zdravile s sildenafilom: preiskovanci s telesno maso ≤ 20 kg so nadaljevali v skupinah s srednjim ali velikim odmerkom (1 : 1), preiskovanci s telesno maso > 20 kg pa v skupinah z majhnim, srednjim ali velikim odmerkom (1 : 1 : 1).
Sildenafil exposure was 5-fold higher at a dose of 80 mg three times a day compared to the exposure at a dose of 20 mg three times a day.
Izpostavljenost sildenafilu je bila ob odmerku 80 mg trikrat na dan 5-krat večja kot ob odmerku 20 mg trikrat na dan.
This drug is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots).PDE5 inhibitors, such as sildenafil have been shown to increase the hypotensive effects of this medicine.
To zdravilo se uporablja za zdravljenje pljučne arterijske hipertenzije (tj. visokega krvnega tlaka v pljučih) in kronične trombembolične pljučne hipertenzije (tj. visokega krvnega tlaka v pljučih, ki nastane zaradi krvnih strdkov).
there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
Pri zdravih moških prostovoljcih ni bilo opaziti učinkov azitromicina (3 dni po 500 mg na dan) na AUC, Cmax, tmax, konstanto hitrosti eliminacije ali na poznejši razpolovni čas sildenafila oz.
Kaplan-Meier estimates of survival at 3 years in patients > 20 kg in weight at baseline were 94%, 93% and 85% in the low, medium and high dose groups, respectively; for patients ≤ 20 kg in weight at baseline, the survival estimates were 94% and 93% for subjects in the medium and high dose groups respectively (see sections 4.4 and 4.8).
Kaplan-Meierjeva ocena preživetja po 3 letih pri bolnikih, pri katerih je telesna masa na začetku znašala > 20 kg, je bila ocenjena kot 94%, 93% in 85% pri preiskovancih v skupinah z majhnim, srednjim oziroma velikim odmerkom; pri bolnikih, pri katerih je telesna masa na začetku znašala ≤ 20 kg, je bila ocena preživetja 94% in 93% pri preiskovancih v skupinah s srednjim oziroma velikim odmerkom (glejte poglavji 4.4 in 4.8).
The most commonly reported adverse reactions that occurred (greater or equal to 10%) on sildenafil compared to placebo were headache, flushing, dyspepsia, diarrhoea and pain in extremity.
Najpogosteje opisani neželeni učinki, ki so se pojavili (več ali enako 10%) med uporabo sildenafila v primerjavi s placebom, so bili glavobol, zardevanje, dispepsija, driska in bolečine v okončinah.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 20 mg sildenafila v obliki sildenafilijevega citrata.
The most common serious adverse events that occurred with a frequency ≥ 1% in sildenafil patients (combined doses) were pneumonia (7.4%), cardiac failure, pulmonary hypertension (each 5.2%), upper respiratory tract infection (3.1%), right ventricular failure, gastroenteritis (each 2.6%), syncope, bronchitis, bronchopneumonia, pulmonary arterial hypertension (each 2.2%), chest pain, dental caries (each 1.7%), and cardiogenic shock, gastroenteritis viral, urinary tract infection (each 1.3%).
Najpogostejši resni neželeni učinki, ki so se pri bolnikih, ki so se zdravili s sildenafilom (vsi odmerki), pojavili s pogostnostjo ≥ 1%, so bili pljučnica (7,4%), srčno popuščanje, pljučna hipertenzija (oba 5,2%), okužba zgornjih dihal (3,1%), popuščanje desnega ventrikla, gastroenteritis (oba 2,6%), sinkopa, bronhitis, bronhopnevmonija, pljučna arterijska hipertenzija (vsi 2,2%), bolečina v prsnem košu, zobni karies (oba 1,7%), kardiogeni šok, virusni gastroenteritis in okužba sečil (vsi 1,3%).
Most patients were WHO Functional Class II (68/267, 26%) or III (175/267, 66%); fewer patients were Class I (3/267, 1%) or IV (16/267, 6%) at baseline; for a few patients (5/267, 2%), the WHO Functional Class was unknown.
Večina bolnikov je bila izhodiščno v funkcijskem razredu II (68/267, 26%) ali III (175/267, 66%) po razvrstitvi SZO; manj bolnikov je bilo v razredu I (3/267, 1%) ali IV (16/267, 6%); za nekaj bolnikov (5/267, 2%) funkcijski razred po SZO ni bil znan.
Sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 µg and levonorgestrel 150 µg).
Sildenafil nima klinično pomembnega vpliva na koncentracijo peroralnih kontraceptivov (30 g etinilestradiola in 150 g levonorgestrela) v plazmi.
In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) sildenafil clearance was reduced, resulting in increases in AUC (85%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.
Pri prostovoljcih z blago do zmerno cirozo jeter (razred A in B po Child-Pughu) je bil očistek sildenafila manjši, zato je bila AUC za 85% večja, Cmax pa za 47% večja kot pri prostovoljcih primerljive starosti brez okvare jeter.
A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favour of sildenafil (95% CI: -5.7, -2.1) (p = 0.00003).
Ugotovljeni povprečni za placebo korigirani učinek zdravljenja je bil -3,9 mm Hg v korist sildenafila (95% IZ: -5,7, -2,1) (p = 0,00003).
- The other ingredients are: Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate anhydrous, croscarmellose sodium and magnesium stearate.
Jedro tablete: mikrokristalna celuloza (PH 102), brezvodni kalcijev hidrogenfosfat, premreženi natrijev karmelozat in magnezijev stearat.
What Mysildecard looks like and contents of the pack
Izgled zdravila Mysildecard in vsebina pakiranja
Among these 37 deaths, the number (%) of deaths was 5/55 (9.1%), 10/74 (13.5%), and 22/100 (22%) in the sildenafil low, medium, and high dose groups, respectively.
Med temi 37 primeri smrti je bilo število smrti (%) v skupini z majhnim odmerkom sildenafila 5/55 (9,1%), v skupini s srednjim odmerkom 10/74 (13,5%) in v skupini z velikim odmerkom 22/100 (22%).
Odds ratios for the sildenafil low, medium and high dose groups compared to placebo were 0.6 (95% CI: 0.18, 2.01), 2.25 (95% CI: 0.75, 6.69) and 4.52 (95% CI: 1.56, 13.10), respectively.
Razmerja obetov za skupine z majhnim, srednjim in velikim odmerkom v primerjavi s placebom so znašala 0,6 (95% IZ: 0,18, 2,01), 2,25 (95% IZ: 0,75, 6,69) oziroma 4,52 (95% IZ: 1,56, 13,10).
Table 2: Placebo Corrected % Change from Baseline in Peak VO2 by Active Treatment Group Treatment group
Preglednica 2: S placebom korigiran % spremembe glede na izhodiščno vrednost pri največji vrednosti VO2 v skupini, ki je prejemala aktivno zdravilo
The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including the combined use of sildenafil for erectile dysfunction has not been studied in PAH patients and such concomitant use is not recommended (see section 4.5).
Varnosti in učinkovitosti sildenafila, uporabljenega hkrati z drugimi zaviralci PDE5, vključno s sočasno uporabo sildenafila za erektilno disfunkcijo, pri bolnikih s PAH niso raziskali, zato sočasna uporaba ni priporočljiva (glejte poglavje 4.5).
The most common adverse reactions that occurred (with a frequency ≥ 1%) in sildenafil patients (combined doses) and with a frequency > 1% over placebo patients were pyrexia, upper respiratory tract infection (each 11.5%), vomiting (10.9%), erection increased (including spontaneous penile erections in male subjects) (9.0%), nausea, bronchitis (each 4.6%), pharyngitis (4.0%), rhinorrhoea (3.4%), and pneumonia, rhinitis (each 2.9%).
Najpogostejši neželeni učinki, ki so se pojavljali (s pogostnostjo  1%) pri bolnikih, zdravljenih s sildenafilom (vsi odmerki), in pri katerih je bila pogostnost pojavljanja > 1% večja kot pri placebu, so bili pireksija, okužba zgornjega dela dihal (oba 11,5%), bruhanje (10,9%), močnejša erekcija (vključno s spontanimi erekcijami penisa pri bolnikih) (9,0%), navzea, bronhitis (oba 4,6%), faringitis (4,0%), rinoreja (3,4%) in pljučnica ter rinitis (oba
In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 92%, 81% and 74%, respectively.
Pri tej populaciji je 1-, 2- in 3-letno preživetje, ocenjeno po metodi Kaplan-Meier, znašalo 92%, 81% in 74%.
• have low blood pressure at rest.
- imate znižan krvni tlak v mirovanju.
After chronic dosing of 80 mg three times a day to patients with systemic hypertension the mean change from baseline in systolic and diastolic blood pressure was a decrease of 9.4 mmHg and 9.1 mm Hg respectively.
Po kroničnem odmerjanju 80 mg trikrat na dan pri bolnikih s sistemsko hipertenzijo je bila povprečna sprememba sistoličnega krvnega tlaka v primerjavi z izhodiščem znižanje za 9,4 mm Hg, diastoličnega pa znižanje za 9,1 mm Hg.
Most subjects were WHO Functional Class I (75/234, 32%) or II (120/234, 51%) at baseline; fewer patients were Class III (35/234, 15%) or IV (1/234, 0.4%); for a few patients (3/234, 1.3%), the WHO Functional Class was unknown.
Večina preiskovancev se je na začetku uvrščala v funkcijski razred I po razvrstitvi SZO (75/234, 32%) ali razred II (120/234, 51%); manj bolnikov se je uvrščalo v razred III (35/234, 15%) ali IV (1/234, 0,4%); pri nekaj bolnikih (3/234, 1,3%) funkcijski razred po SZO ni bil znan.
Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125 mg twice daily with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease of sildenafil AUC.
Sočasna uporaba bosentana (zmeren induktor CYP3A4, CYP2C9 in morda CYP2C19) v odmerku 125 mg dvakrat na dan in sildenafila v odmerku 80 mg trikrat na dan (v stanju dinamičnega ravnovesja), 6 dni pri zdravih prostovoljcih je povzročila 63% zmanjšanje AUC sildenafila.
In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96%, 91% and 82%, respectively.
Pri tej populaciji je 1-, 2- in 3-letno preživetje, ocenjeno po metodi Kaplan-Meier, znašalo 96%, 91% oz. 82%.
Children Mysildecard should not be given to children below 1 year of age.
Otroci Otroci, mlajši od 1 leta, ne smejo jemati zdravila Mysildecard.
If you forget to take Mysildecard
Če ste pozabili vzeti zdravilo Mysildecard
Improvements were observed with cardiac index with all three sildenafil groups over placebo, 10%, 4% and 15% for the low, medium and high dose groups respectively.
Izboljšanja so opažali pri srčnem indeksu pri vseh treh skupinah, ki so prejemale sildenafil v primerjavi s placebom, in sicer za 10% pri skupini, ki je prejemala majhen odmerek, za 4% pri skupini, ki je prejemala srednji odmerek, oziroma za 15% pri skupini, ki je prejemala velik odmerek.
Survival in patients of WHO functional class II at baseline at 1, 2 and 3 years was 99%, 91%, and 84% respectively, and for patients of WHO functional class III at baseline was 94%, 90%, and 81%, respectively.
razreda po razvrstitvi SZO je 1-, 2- in 3-letno preživetje v osnovi znašalo 99%, 91% oz. 84%, pri bolnikih iz III. razreda po razvrstitvi SZO pa 94%, 90% oz. 81%.
Mysildecard 20 mg film-coated tablets sildenafil
Mysildecard 20 mg filmsko obložene tablete sildenafil
Subjects were allocated to one of three sildenafil treatment groups, low (10 mg), medium (10-40 mg) or high dose (20-80 mg) regimens of sildenafil given three times a day, or placebo.
Preiskovanci, zdravljeni s sildenafilom, so bili razporejeni v eno izmed treh skupin, režim zdravljenja z majhnimi odmerki (10 mg), srednjimi (10 - 40 mg) ali velikimi odmerki (20 - 80 mg) sildenafila, ki so ga prejemali trikrat na dan, ali s placebom.
The tablets are provided in blisters in packs containing 90, 300 and (90 x 1) tablets.
Tablete so na voljo v pretisnih omotih v pakiranjih po 90, 300 filmsko obloženih tablet in (90 x 1) filmsko obložena tableta.
At 3 years 68% of the patients were receiving a dose of 80 mg TID.
Po 3 letih je 68% bolnikov prejemalo zdravilo v odmerku 80 mg trikrat na dan.
Due to lack of data, Mysildecard should not be used in pregnant women unless strictly necessary.
Zaradi pomanjkanja podatkov zdravila Mysildecard pri nosečnicah ne smete uporabljati, če to ni nujno potrebno.
INFORMATION IN BRAILLE Mysildecard 20 mg tablets
PODATKI V BRAILLOVI PISAVI Mysildecard 20 mg tablete
A mean placebo corrected increase in walk distance of 26 metres was observed in favour of sildenafil (95% CI: 10.8, 41.2) (p = 0.0009).
Povprečno za placebo korigirano podaljšanje prehojene razdalje je bilo s sildenafilom 26 metrov (95% IZ: 10,8, 41,2) (p = 0,0009).
In the pivotal placebo-controlled study of sildenafil in pulmonary arterial hypertension, a total of 207 patients were randomised to and treated with 20 mg, 40 mg, or 80 mg TID doses of sildenafil and 70 patients were randomised to placebo.
V ključni, s placebom nadzorovani študiji sildenafila za zdravljenje pljučne arterijske hipertenzije, je bilo skupno 207 bolnikov randomiziranih in zdravljenih s sildenafilom v odmerkih 20 mg, 40 mg ali 80 mg trikrat na dan, 70 bolnikov pa je bilo randomiziranih na placebo.
If you stop taking Mysildecard
Če ste prenehali jemati zdravilo Mysildecard
At 3 years 87% of the patients were receiving a dose of 80 mg TID.
Po 3 letih je 87% bolnikov prejemalo zdravilo v odmerku 80 mg trikrat na dan.
The overall frequency of discontinuation in sildenafil treated patients at doses of 20 mg, 40 mg and 80 mg TID was 2.9%, 3.0% and 8.5% respectively, compared to 2.9% with placebo.
Skupna pogostnost prekinitev je bila pri bolnikih, ki so prejemali sildenafil v odmerku 20 mg trikrat na dan 2,9%, 40 mg trikrat na dan 3,0% in 80 mg trikrat na dan 8,5%, v primerjavi s placebom, kjer je znašala 2,9%.