natgillin/translations-raw huggingface dataset:
Note: Expires 30 days after reconstitution.
Opomba: rok uporabe je 30 dni po rekonstituciji.
Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Pri bolnikih, ki so izgubili vid na enem očesu zaradi nearteritične anteriorne ishemične optične nevropatije (NAION), tudi če ta dogodek ni bil povezan s predhodnim jemanjem zaviralcev PDE5 (glejte poglavje 4.4).
Put the tip of the oral dosing syringe into the mouth.
Vstavite konico peroralne odmerne brizge v usta.
Combination with the most potent of the CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) (see section 4.5).
Kombinacija z najmočnejšimi zaviralci CYP3A4 (npr. ketokonazolom, itrakonazolom, ritonavirjem) (glejte poglavje 4.5).
Once reconstituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Po rekonstituciji je treba peroralno suspenzijo uporabljati le s peroralno odmerno brizgo, ki je priložena vsakemu pakiranju.
In healthy volunteers, the plasma levels of the N-desmethyl metabolite following intravenous dosing are significantly lower than those observed following oral dosing.
Pri zdravih prostovoljcih je koncentracija N-dezmetilnega presnovka v plazmi po intravenski uporabi bistveno manjša kot po peroralni uporabi.
Remove the cap again, press the bottle adaptor into the neck of the bottle.
Ponovno odstranite zaporko in potisnite nastavek v vrat steklenice.
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).
Doses up to 80 mg three times a day (4 times the recommended dose of 20 mg three times a day) were administered and after 3 years 87 % of 183 patients on study treatment were receiving Revatio 80 mg TID.
Proučevali so odmerke do 80 mg trikrat na dan (4-kratni priporočeni odmerek 20 mg trikrat na dan) in po 3 letih je 87 % od 183 bolnikov v študiji prejemalo zdravilo Revatio v odmerku 80 mg trikrat na dan.
Limited data suggest that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension.
Omejeni podatki kažejo, da nenadne prekinitve uporabe zdravila Revatio ne spremlja povratno poslabšanje pljučne arterijske hipertenzije.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70 % stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7 % and 6 % respectively compared to baseline.
V študiji hemodinamskih učinkov posamičnega 100 mg peroralnega odmerka sildenafila pri 14 bolnikih s hudo boleznijo koronarnih arterij (> 70 % stenoza vsaj ene koronarne arterije) se je povprečni sistolični tlak v mirovanju v primerjavi z izhodiščem znižal za 7 %, povprečni diastolični v mirovanju pa za 6 %.
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 %.
Revatio with food and drink You should not drink grapefruit juice while you are being treated with Revatio.
Med zdravljenjem z zdravilom Revatio ne smete piti grenivkinega soka.
What you need to know before you take Revatio
Kaj morate vedeti, preden boste vzeli zdravilo Revatio
Revatio powder for oral suspension is for oral use only.
Zdravilo Revatio prašek za peroralno suspenzijo je le za peroralno uporabo.
Manufacturer: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Izdelovalec: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Francija
Powder: Do not store above 30°C.
Prašek: Shranjujte pri temperaturi do 30 °C.
Before withdrawing the required dose, shake the bottle vigorously for a minimum of 10 seconds.
Pred odvzemom zahtevanega odmerka steklenico močno stresajte vsaj 10 sekund.
Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with pulmonary arterial hypertension compared to healthy volunteers.
Oba izsledka kažeta, da je pri bolnikih s pljučno arterijsko hipertenzijo očistek sildenafila manjši in/ali njegova peroralna biološka uporabnost večja kot pri zdravih prostovoljcih.
Due to lack of data, Revatio should not be used in pregnant women unless strictly necessary.
Zaradi pomanjkanja podatkov zdravila Revatio pri nosečnicah ne smete uporabljati, če to ni nujno potrebno.
Two subjects experienced a total of 3 adverse reactions (flushing, flatulence and hot flush).
Dvema preiskovancema so se pojavili skupno 3 neželeni učinki (zardevanje, flatulenca in vročinski oblivi).
Revatio contains lactose
Zdravilo Revatio vsebuje laktozo
Revatio is contraindicated in patients with severe hepatic impairment (Child-Pugh class C), (see section 4.3).
Revatio je kontraindiciran pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) (glejte poglavje 4.3).
For patients with a baseline walking distance ≥ 325 metres, the treatment effect was 38.4 metres in favour of sildenafil; for patients with a baseline walking distance < 325 metres, the treatment effect was 2.3 metres in favour of placebo.
Pri bolnikih z izhodiščno prehojeno razdaljo ≥ 325 metrov je bil učinek zdravljenja 38,4 metra v korist sildenafila; pri bolnikih z izhodiščno prehojeno razdaljo < 325 metrov je bil učinek zdravljenja 2,3 metra v korist placeba.
If you experience any of the following side effects you should stop taking Revatio and contact a doctor immediately (see also section 2): - if you experience sudden decrease or loss of vision (frequency not known) - if you have an erection, which lasts continuously for more than 4 hours.
Če se vam pojavi kateri od naslednjih neželenih učinkov, nemudoma prenehajte z jemanjem zdravila Revatio in obvestite zdravnika (glejte tudi poglavje 2): - če doživite nenadno poslabšanje ali izgubo vida (pogostnost ni znana).
Turn the bottle back upright with the oral dosing syringe still in place.
Obrnite steklenico s še vedno nameščeno peroralno odmerno brizgo nazaj v pokončni položaj.
Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Imetnik dovoljenja za promet: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija
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.
Results were generally consistent in subgroups according to aetiology (primary and connective tissue disease-associated PAH), WHO functional class, gender, race, location, mean PAP and PVRI.
Rezultati so bili po podskupinah praviloma skladni glede na etiologijo (primarna PAH in PAH, povezana z boleznimi vezivnega tkiva), funkcijski razred po SZO, spol, raso, lokacijo, povprečni pljučni arterijski tlak in indeks pljučne žilne upornosti.
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).
Tap the bottle to release the powder and remove the cap.
Rahlo udarite po steklenici, da sprostite prašek, in odstranite zaporko.
• Medicines containing St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy).
• zdravila, ki vsebujejo šentjanževko (zeliščno zdravilo), rifampicin (uporablja se za zdravljenje bakterijskih okužb), karbamazepin, fenitoin ali fenobarbital (med drugim se uporabljata za zdravljenje epilepsije).
Doses up to 80 mg TID were administered and after 3 years 68 % of 133 patients on study treatment were receiving Revatio 80 mg TID.
Prejemali so odmerke do 80 mg trikrat na dan in po 3 letih je 68 % od 133 bolnikov v študiji prejemalo zdravilo Revatio v odmerku 80 mg trikrat na dan.
Adverse reactions that resulted from intravenous Revatio use are similar to those associated with oral Revatio use.
Neželeni učinki po intravenski uporabi zdravila Revatio so podobni tistim, ki so povezani s peroralno uporabo zdravila Revatio.
Tap the bottle to release the powder.
Rahlo udarite po steklenici, da sprostite prašek.
Sildenafil had no significant effect on atorvastatin exposure (AUC increased 11 %), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Sildenafil ni pomembno vplival na izpostavljenost atorvastatinu (AUC se je povečala za 11 %), kar kaže, da nima klinično pomembnega vpliva na CYP3A4.
The mean absolute oral bioavailability is 41 % (range 25-63 %).
Povprečna absolutna peroralna biološka uporabnost je 41 % (razpon: od 25 do 63 %).
If you forget to take Revatio
Če ste pozabili vzeti zdravilo Revatio
- The other ingredients are: Powder for oral suspension: sorbitol, citric acid anhydrous, sucralose, sodium citrate, xanthan gum, titanium dioxide (E171), sodium benzoate (E211), silica, colloidal anhydrous; Grape flavour: maltodextrin, grape juice concentrate, gum acacia, pineapple juice concentrate, citric acid anhydrous, natural flavouring
- Druge sestavine zdravila so: prašek za peroralno suspenzijo: sorbitol, brezvodna citronska kislina, sukraloza, natrijev citrat, ksantanski gumi, titanov dioksid (E171), natrijev benzoat (E211), brezvodni koloidni silicijev dioksid; aroma grozdja: maltodekstrin, koncentrat grozdnega soka, gumi akacije, koncentrat ananasovega soka, brezvodna citronska kislina, naravna aroma.
Oral suspension Store below 30°C or in refrigerator (2°C to 8°C).
Peroralna suspenzija Shranjujte pri temperaturi do 30 °C ali v hladilniku (2 °C - 8 °C).
The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including Viagra, 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 z zdravilom Viagra, pri bolnikih s PAH niso raziskali, zato sočasna uporaba ni priporočljiva (glejte poglavje 4.5).
Point the tip of the oral dosing syringe towards the inside of the cheek.
Usmerite konico peroralne odmerne brizge proti notranji strani lica.
Limited data suggest that the abrupt discontinuation of oral Revatio is not associated with rebound worsening of pulmonary arterial hypertension.
Omejeni podatki kažejo, da nenadne prekinitve uporabe peroralne oblike zdravila Revatio ne spremlja povratno poslabšanje pljučne arterijske hipertenzije.
An additional 5 deaths were reported subsequently.The causes of deaths were related to PAH.
Pozneje so poročali o dodatnih 5 primerih smrti.
If you receive more Revatio than you should If you are concerned that you may have been given too much Revatio, tell your doctor or nurse immediately.
Če vas skrbi, da ste dobili preveč zdravila Revatio, to nemudoma povejte zdravniku ali medicinski sestri.
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Sočasno dajanje zaviralcev PDE5, vključno s sildenafilom, skupaj s stimulatorji gvanilat-ciklaze, kot je riociguat, je kontraindicirano, saj lahko privede do simptomatske hipotenzije (glejte poglavje 4.5).
The most common adverse reactions that occurred (with a frequency ≥ 1 %) in Revatio 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 z zdravilom Revatio (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 2,9 %).
After reconstitution: Store below 30°C or in refrigerator at 2°C to 8°C.
Po rekonstituciji: Shranjujte pri temperaturi do 30 °C ali v hladilniku pri 2 °C do 8 °C.
Store below 30°C or in refrigerator at 2ºC to 8°C.
Shranjujte pri temperaturi do 30 °C ali v hladilniku pri 2 °C do 8 °C.
Each pack also contains a polypropylene measuring cup (graduated to indicate 30 ml), polypropylene oral dosing syringe (3 ml) with HDPE plunger and a LDPE press-in bottle adaptor.
Pakiranje vsebuje tudi polipropilensko merico (z označbo za 30 ml), polipropilensko peroralno odmerno brizgo (3 ml) z batom iz HDPE in nastavek, ki se potisne v vrat steklenice, iz LDPE.
Powder for oral suspension
prašek za peroralno suspenzijo
Oral sildenafil had no significant effect on atorvastatin exposure (AUC increased 11 %), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Peroralni sildenafil ni pomembno vplival na izpostavljenost atorvastatinu (AUC se je povečala za 11 %), kar kaže, da nima klinično pomembnega vpliva na CYP3A4.
• Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).
• zaviralce alfa (npr. doksazosin) za zdravljenje visokega krvnega tlaka ali težav s prostato, saj lahko kombinacija teh dveh zdravil povzroči simptome znižanega krvnega tlaka (npr. omotica, vrtoglavica).
No clinical data is available for sildenafil IV administration in patients who are clinically or haemodynamically unstable.
Kliničnih podatkov o intravenski uporabi sildenafila pri klinično ali hemodinamsko nestabilnih bolnikih ni.
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).
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 mmHg v korist sildenafila (95 % IZ: -5,7, -2,1) (p = 0,00003).
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.
The known adverse events headache, flushing, pain in extremity and oedema were noted in a higher frequency in sildenafil/epoprostenol treated patients compared to placebo/epoprostenol treated patients.
Znani neželeni učinki glavobol, zardevanje, bolečine v udih in edemi so bili pogostejši pri bolnikih, ki so dobivali sildenafil/epoprostenol, kot pri tistih, ki so dobivali placebo/epoprostenol.
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
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 %).
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.
90 x 1 tablets in PVC/Aluminium perforated unit dose blisters.
90 x 1 tableta v perforiranem enoodmernem pretisnem omotu iz PVC/aluminija.
Skin and subcutaneous tissue disorders Common alopecia, erythema, night sweats
Bolezni kože in podkožja pogosti neznana alopecija, eritem, nočno znojenje izpuščaj
PVC/Aluminium blisters of 300 tablets.
Pretisni omoti iz PVC/aluminija s 300 tabletami.
Subjects who had been in the placebo group in the shortterm 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).
Infections and infestations Common cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
Infekcijske in parazitske bolezni pogosti flegmona, gripa, bronhitis, sinuzitis, rinitis, gastroenteritis
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).
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 3letno preživetje, ocenjeno po metodi Kaplan-Meier, znašalo 92 %, 81 % in 74 %.
Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate, glycerol triacetate
Filmska obloga: hipromeloza, titanov dioksid (E171), laktoza monohidrat, triacetin.
The mean absolute oral bioavailability for sildenafil is 41 % (range 25-63 %).
Srednja absolutna peroralna biološka uporabnost sildenafila je 41 % (razpon od 25 % do 63 %).
The mean changes from baseline in sitting blood pressure were greatest at 1 hour, -9.1 mmHg (SD ± 12.5) and -3.0 (SD ± 4.9) mmHg for systolic and diastolic pressure respectively.
Srednje vrednosti sprememb krvnega tlaka sede so bile v primerjavi z izhodiščem največje po 1 uri; sistoličnega krvnega tlaka -9,1 mmHg (SD ± 12,5) in diastoličnega -3,0 (SD ± 4,9).
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.
In the placebo-controlled study of Revatio 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 Revatio and 60 were treated with placebo.
V s placebom nadzorovani študiji zdravila Revatio 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) zdravila Revatio, 60 bolnikov pa je prejemalo placebo.
The tablets are marked with “PFIZER” on one side and “RVT 20” on the other.
Filmsko obložene tablete Revatio so bele in okrogle oblike; na eni strani imajo oznako “PFIZER” in na drugi “RVT 20”.
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 %.
In healthy male volunteers, 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 oral 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. njegovega glavnega presnovka v obtoku.
The most commonly reported adverse reactions that occurred (greater or equal to 10 %) on Revatio 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 zdravila Revatio v primerjavi s placebom, so bili glavobol, zardevanje, dispepsija, driska in bolečine v okončinah.
Replace the cap and shake the bottle vigorously for a minimum of 30 seconds (figure 4).
Namestite zaporko in steklenico močno stresajte najmanj 30 sekund (slika 4).
Revatio 10 mg/ml powder for oral suspension
Revatio 10 mg/ml prašek za peroralno suspenzijo