natgillin/translations-raw huggingface dataset:
Revatio solution for injection is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti zdravila Revatio raztopina za injiciranje ni priporočljivo uporabljati pri otrocih, mlajših od 18 let.
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 %.
How to take Revatio
Kako jemati zdravilo Revatio
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.
Shake the closed bottle of constituted oral suspension vigorously for a minimum of 10 seconds before use.
Pred uporabo zaprto steklenico rekonstituirane peroralne suspenzije najmanj 10 sekund močno stresajte.
Replace the cap and shake the bottle vigorously for a minimum of 30 seconds (figure 2).
Namestite zaporko in steklenico močno stresajte najmanj 30 sekund (slika 2).
Each pack contains one 20 ml clear, type I glass vial with a chlorobutyl rubber stopper and an aluminium overseal.
Vsako pakiranje vsebuje eno 20 ml prozorno stekleno vialo (tipa I) s klorobutilnim gumijastim zamaškom in aluminijasto zaporko.
The primary endpoint was the placebo-corrected percentage change in peak VO2 from baseline to week 16 assessed by CPET in the combined dose groups (Table 2).
Glavni opazovani dogodek je bil s placebom korigiran odstotek spremembe pri največji vrednosti VO2 glede na izhodiščno vrednost do 16. tedna, kar so ocenjevali s CPET pri skupinah z vsemi odmerki (Preglednica 2).
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.
• Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
• zdravila, ki vsebujejo nitrite, ali dajalce dušikovega oksida, kot je amilnitrat.
Using the cup measure another 30 ml of water and add this to the bottle (figure 1).
S pomočjo merice odmerite naslednjih 30 ml vode in jo dodajte v steklenico (slika 1).
Revatio solution for injection should be administered to patients already prescribed oral Revatio as a replacement for oral administration under conditions where they are temporarily unable to take oral Revatio therapy.
Revatio raztopino za injiciranje je treba uporabiti pri bolnikih, ki že imajo predpisano peroralno obliko zdravila Revatio, in sicer kot nadomestilo za peroralno obliko zdravila v primerih, ko bolniki začasno ne morejo prejemati peroralnega zdravljenja z zdravilom Revatio.
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.
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).
PVC/Aluminium blisters of 90 tablets.
Pretisni omoti iz PVC/aluminija z 90 tabletami.
If you stop use of Revatio
Če ste prenehali uporabljati zdravilo Revatio
If you take more Revatio than you should
Če ste vzeli večji odmerek zdravila Revatio, kot bi smeli
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.
Using the cup measure another 30 ml of water and add this to the bottle.
Z merico ponovno odmerite 30 ml vode in dodajte v steklenico.
The mean postural changes in systolic and diastolic blood pressure over time were small (< 10 mmHg) and returned towards baseline beyond 2 hours.
Srednje vrednosti posturalnih sprememb sistoličnega in diastoličnega krvnega tlaka skozi čas so bile majhne (< 10 mmHg) in vrednosti so se po preteku 2 ur vrnile k izhodišču.
Study A1481262 was a single centre, single dose, open label study to assess the safety, tolerability and pharmacokinetics of a single intravenous dose of sildenafil (10 mg) administered as a bolus injection to patients with Pulmonary Arterial Hypertension (PAH) who were already receiving and stable on oral Revatio 20 mg three times per day.
Študija A1481262 je bila monocentrična odprta študija z enim odmerkom za oceno varnosti, prenašanja in farmakokinetike enkratnega intravenskega odmerka sildenafila (10 mg) v bolusni injekciji pri bolnikih s pljučno arterijsko hipertenzijo (PAH), ki so že dobivali peroralno zdravilo Revatio 20 mg trikrat na dan in so bili pri tem stabilni.
These were the only factors with a statistically significant impact on oral sildenafil pharmacokinetics in patients with pulmonary arterial hypertension.
To so bili edini dejavniki, ki so pri bolnikih s pljučno arterijsko hipertenzijo statistično značilno vplivali na farmakokinetiko peroralnega sildenafila.
Revatio 20 mg film-coated tablets
Revatio 20 mg filmsko obložene tablete
Efficacy in adult patients with PAH (when used in combination with epoprostenol) A randomised, double-blind, placebo controlled study was conducted in 267 patients with PAH who were stabilised on intravenous epoprostenol.
Učinkovitost pri odraslih bolnikih s PAH (uporabljen v kombinaciji z epoprostenolom) Randomizirana, dvojno slepa, s placebom nadzorovana študija je bila narejena pri 267 bolnikih s PAH, stabiliziranih na intravenskem epoprostenolu.
In the two-placebo controlled studies adverse events were generally mild to moderate in severity.
V teh dveh s placebom nadzorovanih študijah so bili neželeni učinki na splošno blagi do zmerni.
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 %.
*These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED).
Splošne težave in spremembe na mestu aplikacije pogosti pireksija * O teh neželenih učinkih/reakcijah so poročali pri bolnikih, ki so sildenafil jemali za zdravljenje moške erektilne disfunkcije (MED).
Most patients were WHO Functional Class II (107/277, 39 %) or III (160/277, 58 %) with a mean baseline 6 minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4 %) or IV (9/277, 3 %) at baseline.
Večina bolnikov je bila izhodiščno v funkcijskem razredu II (107/277, 39 %) ali III (160/277, 58 %) po razvrstitvi SZO, s povprečno doseženo razdaljo 378 metrov oz. 326 metrov na 6-minutnem testu hoje ob začetku študije; manj bolnikov je bilo ob začetku študije v razredu I (1/277, 0,4 %) ali IV (9/277, 3 %).
Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the oral bioavailability of sildenafil.
Posamični odmerki antacida (magnezijev hidroksid/aluminijev hidroksid) niso vplivali na peroralno biološko uporabnost sildenafila.
Revatio 10 mg/ml powder for oral suspension Sildenafil
Revatio 10 mg/ml prašek za peroralno suspenzijo sildenafil
Do not use this medicine after the expiry date which is stated on the bottle after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici poleg oznake »Uporabno do:«.
What Revatio is and what it is used for What you need to know before you take Revatio How to take Revatio
Kaj je zdravilo Revatio in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Revatio Kako jemati zdravilo Revatio Možni neželeni učinki
Study A1481262 was a single centre, single dose, open label study to assess the safety, tolerability and pharmacokinetics of a single intravenous dose of sildenafil (10 mg) administered as a bolus injection to patients with PAH who were already receiving and stable on oral Revatio 20 mg TID.
Študija A1481262 je bila monocentrična odprta študija z enim odmerkom za oceno varnosti, prenašanja in farmakokinetike enkratnega intravenskega odmerka sildenafila (10 mg) v bolusni injekciji pri bolnikih s PAH, ki so že dobivali peroralno zdravilo Revatio 20 mg trikrat na dan in so bili pri tem stabilni.
If you stop taking Revatio
Če ste prenehali jemati zdravilo Revatio
SLOWLY push down the plunger of the oral dosing syringe.
POČASI potisnite bat peroralne odmerne brizge.
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 Revatio 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) zdravila Revatio, ki so ga prejemali trikrat na dan, ali s placebom.
Revatio is used to treat adults with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).
Zdravilo Revatio uporabljamo za zdravljenje visokega krvnega tlaka v pljučnih žilah (pljučne arterijske hipertenzije) pri odraslih.
What Revatio looks like and contents of the pack Each pack of Revatio solution for injection contains one 20 ml clear glass vial, which is closed with a chlorobutyl rubber stopper and an aluminium seal.
Eno pakiranje zdravila Revatio raztopina za injiciranje vsebuje 20 ml prozorno stekleno vialo, zaprto s klorobutilnim gumijastim zamaškom in aluminijasto zaporko.
Revatio brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Zdravilo Revatio širi žile v pljučih in s tem zniža krvni tlak v pljučih.
Revatio 0.8 mg/ml solution for injection Sildenafil
Revatio 0,8 mg/ml raztopina za injiciranje sildenafil
Oral sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
Peroralni sildenafil (50 mg) ni stopnjeval hipotenzivnih učinkov alkohola pri zdravih prostovoljcih, ki so imeli povprečno največjo koncentracijo alkohola v krvi 80 mg/dl.
Efficacy of intravenous sildenafil in adult patients with pulmonary arterial hypertension (PAH) A 10 mg dose of Revatio solution for injection is predicted to provide total exposure of free sildenafil and its N-desmethyl metabolite and their combined pharmacological effects comparable to those of a 20 mg oral dose.
Učinkovitost intravenskega sildenafila pri odraslih bolnikih s pljučno arterijsko hipertenzijo (PAH) Revatio raztopina za injiciranje v odmerku 10 mg predvidoma doseže takšno celotno izpostavljenost prostemu sildenafilu in njegovemu N-dezmetilnemu presnovku ter skupne farmakološke učinke, ki so primerljivi s peroralnim odmerkom 20 mg.
The Cmax and AUC (0-8) of the N-desmethyl metabolite were 30.8 ng/ml and 147 ng h/ml, respectively.
Vrednost Cmax N-dezmetilnega presnovka je bila 30,8 ng/ml, njegova AUC (0-8) pa 147 ng h/ml.
Wash the oral dosing syringe as instructed below.
Peroralno odmerno brizgo očistite po spodnjih navodilih.
Sildenafil (100 mg single dose) did not affect the steady state pharmacokinetics of the HIV protease inhibitor saquinavir, which is a CYP3A4 substrate/inhibitor.
Sildenafil (v posamičnem peroralnem odmerku 100 mg) ni vplival na farmakokinetiko zaviralca proteaze HIV sakvinavirja (ki je substrat/zaviralec CYP3A4) v stanju dinamičnega ravnovesja.
What Revatio is and what it is used for What you need to know before you are given Revatio How Revatio is given
Kaj je zdravilo Revatio in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Revatio Kako uporabljati zdravilo Revatio Možni neželeni učinki
At steady state plasma concentrations of N-desmethyl metabolite are approximately 16 % versus 61 % those of sildenafil after IV and oral dosing, respectively.
V stanju dinamičnega ravnovesja je koncentracija N-dezmetilnega presnovka po intravenski uporabi sildenafila približno 16 %, po peroralni pa 61 %.
When constituted the powder provides a white grape flavoured oral suspension.
Po rekonstituciji iz praška nastane bela peroralna suspenzija z okusom grozdja.
In a study of healthy volunteers oral 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).
Revatio contains sorbitol
Zdravilo Revatio vsebuje sorbitol
The exposure to sildenafil in patients on CYP3A4 substrates and CYP3A4 substrates plus beta-blockers was 43 % and 66 % higher, respectively, compared to patients not receiving these classes of medicines.
V primerjavi z bolniki, ki niso dobivali substratov CYP3A4 oz. substratov CYP3A4 in antagonistov beta, je bila izpostavljenost sildenafilu pri prejemnikih substratov CYP3A4 večja za 43 %, pri prejemnikih substratov CYP3A4 in antagonistov beta pa za 66 %.
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 5krat večja kot ob odmerku 20 mg trikrat na dan.
(p=0.0017) and -320 dyne.sec/cm
5 (p = 0,0017) in za 80 mg trikrat na dan -320 din.s/cm
In clinical trials side effects reported commonly (may affect up to 1 in 10 people) by patients with pulmonary arterial hypertension were facial flushing and nausea.
V kliničnih preskušanjih opisani pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) pri bolnikih s pljučno arterijsko hipertenzijo so zardevanje in občutek siljenja na bruhanje.
Side effects reported uncommonly (may affect up to 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.
Občasno opisani neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) so zmanjšana ostrina vida, dvojni vid, nenormalni občutki v očesu, krvavitev iz penisa, prisotnost krvi v spermi in/ali urinu ter povečanje prsi pri moških.
The study population consisted of 68 (25 %) men and 209 (75 %) women with a mean age of 49 years (range: 1881 years) and baseline 6-minute walk test distance between 100 and 450 metres inclusive (mean: 344 metres).
Povprečna starost je bila 49 let (razpon: od 18 do 81 let), dosežena razdalja na 6-minutnem testu hoje ob začetku študije pa od 100 do vključno 450 metrov (povprečje: 344 metrov).
A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy (62.5 mg - 125 mg twice a day) indicated an increase (20% (95% CI: 9.8 - 30.8)) of bosentan AUC with co-administration of steady-state sildenafil (20 mg three times a day) of a smaller magnitude than seen in healthy volunteers when co-administered with 80 mg sildenafil three times a day (see sections 4.4 and 5.1).
Populacijska farmakokinetična analiza podatkov iz študije pri odraslih bolnikih s PAH na osnovnem zdravljenju z bosentanom (62,5-125 mg dvakrat na dan) je pokazala povečanje (20 %; 95 % IZ: 9,8-30,8) AUC bosentana ob sočasni uporabi s sildenafilom v stanju dinamičnega ravnovesja (20 mg trikrat na dan).
Any remaining oral suspension should be discarded 30 days after constitution.
Preostalo peroralno suspenzijo zavrzite v 30 dneh po rekonstituciji.
What Revatio looks like and contents of the pack Revatio is supplied as a white to off-white powder for oral suspension providing a white, grape flavoured oral suspension when constituted with water.
Zdravilo Revatio je bel do skoraj bel prašek za peroralno suspenzijo, iz katerega po rekonstituciji z vodo dobimo belo peroralno suspenzijo z okusom grozdja.
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 the two-placebo controlled oral Revatio studies adverse events were generally mild to moderate in severity.
V teh dveh s placebom nadzorovanih študijah peroralnega zdravila Revatio so bili neželeni učinki na splošno blagi do zmerni.
In a specific interaction study, where oral sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
V specifični interakcijski študiji, v kateri so hipertenzivni bolniki dobivali peroralni sildenafil (100 mg) sočasno z amlodipinom, se je sistolični krvni tlak v ležečem položaju dodatno znižal za 8 mmHg.
Revatio 20 mg film-coated tablets Sildenafil
Revatio 20 mg filmsko obložene tablete sildenafil
However, for subjects with PAH associated with connective tissue disease (36 subjects) mean changes from baseline were -18.32 m (95% CI:65.66 to 29.02) and 17.50 m (95% CI: -9.41 to 44.41) for the sildenafil and placebo groups, respectively.
Pri preiskovancih z boleznimi vezivnega tkiva povezano PAH (36 preiskovancev) pa je bila povprečna sprememba od izhodišča -18,32 m (95 % IZ: -65,66 do 29,02) v skupini s sildenafilom in 17,50 m (95 % IZ: -9,41 do 44,41) v skupini s placebom.
The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.
O naslednjih resnih neželenih učinkih, za katere menijo, da so povezani z zdravljenjem, so poročali občasno (pojavijo se lahko pri največ 1 od 100 bolnikov): alergijska reakcija (npr. kožni izpuščaj, otekanje obraza, ustnic in jezika, piskajoče dihanje, težave z dihanjem in požiranjem), epileptični krči, neredno bitje srca, okvara sluha, kratka sapa, vnetje prebavnega trakta, piskajoče dihanje zaradi motenega pretoka zraka.
- have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia), cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
- imate nepravilnost rdečih krvnih celic (srpastocelično anemijo), raka krvnih celic (levkemijo),
How to store Revatio
Kako uporabljati zdravilo Revatio
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.
Oral sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
Peroralni sildenafil (50 mg) ni dodatno podaljšal časa krvavitve, podaljšanega zaradi acetilsalicilne kisline (150 mg).
Low dose (n=24)
Majhen odmerek (n = 24)
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale in na zunanji ovojnini poleg oznake »Uporabno do:«.
For patients with a baseline 6MWD < 325 m improved efficacy was observed with higher doses (placebo-corrected improvements of 58 metres, 65 metres and 87 metres for 20 mg, 40 mg and 80 mg doses TID, respectively).
Pri bolnikih z izhodiščnim 6MWD < 325 m je bila pri večjih odmerkih opažena povečana učinkovitost (za placebo korigirano izboljšanje je bilo za 20 mg sildenafila trikrat na dan 58 metrov, za 40 mg trikrat na dan 65 metrov in za 80 mg trikrat na dan 87 metrov).
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.
Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance < 30 ml/min).
Pri bolnikih z okvaro ledvic - tudi pri tistih s hudo okvaro (očistek kreatinina < 30 ml/min) - na začetku zdravljenja odmerka ni treba prilagoditi.
At single oral doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision) was increased.
Uporabo posamičnih odmerkov 200 mg je spremljala večja incidenca neželenih reakcij (glavobola, zardevanja, omotice, dispepsije, zamašenega nosu in sprememb vida).
In patients with pulmonary arterial hypertension, the average steady state concentrations were 20-50 % higher over the investigated oral 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 peroralnega odmerka od 20 do 80 mg trikrat na dan od 20 do 50 % večja kot pri zdravih prostovoljcih.
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 oral sildenafil (50 mg) to healthy volunteers.
Cimetidin (800 mg), zaviralec citokroma P450 in nespecifičen zaviralec CYP3A4, je ob sočasni uporabi s peroralnim sildenafilom (50 mg) pri zdravih prostovoljcih povzročil 56 % povečanje koncentracije sildenafila v plazmi.
At the recommended oral dose of 20 mg three times a day no reductions in systolic or diastolic pressure were seen.
Ob priporočenem peroralnem odmerku 20 mg trikrat na dan niso opazili znižanja sistoličnega ali diastoličnega tlaka.
Note: A total volume of 90 ml (3 x 30 ml) of water irrespective of the dose to be taken should be used to reconstitute the contents of the bottle
Opomba: za rekonstitucijo vsebine steklenice je treba skupno uporabiti 90 ml (3 x 30 ml) vode, ne glede na odmerek, ki bo uporabljen.
The sildenafil medium and high dose groups both showed PVRI reductions compared to placebo, of 18 % (95 % CI: 2 % to 32 %) and 27 % (95 % CI: 14 % to 39 %), respectively; whilst the low dose group showed no significant difference from placebo (difference of 2 %).
Tako v skupini, ki je prejemala srednji odmerek, kot tudi v skupini, ki je prejemala velik odmerek sildenafila, so ugotovili zmanjšanje žilnega upora v pljučih v primerjavi s placebom, in sicer za 18 % (95 % IZ: 2 % do 32 %) oziroma 27 % (95 % IZ: 14 % do 39 %); medtem ko v skupini, ki je prejemala majhen odmerek, niso opazili nobene pomembne razlike v primerjavi s placebom (razlika v obsegu 2 %).
Microcrystalline cellulose Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate
Jedro tablete: mikrokristalna celuloza kalcijev hidrogenfosfat (brezvodni) premreženi natrijev karmelozat magnezijev stearat