natgillin/translations-raw huggingface dataset:
Gynaecomastia Priapism, prolonged erection
ginekomastija priapizem, dolgotrajna erekcija
* Sudden decrease or loss of hearing has been reported in a small number of post-marketing and clinical trial cases with the use of all PDE5 inhibitors, including sildenafil.
* Med uporabo vseh zaviralcev PDE5, vključno s sildenafilom, so med postmarketinškim obdobjem in kliničnimi preskušanji zabeležili majhno število primerov nenadnega poslabšanja sluha ali izgube sluha.
In post marketing surveillance, adverse events/ reactions that have been reported with an unknown frequency in patients taking sildenafil in the treatment of male erectile dysfunction (MED) include:
Neželeni učinki/ reakcije, o katerih so poročali med pomarketinškim spremljanjem pri bolnikih, ki so sildenafil jemali za zdravljenje moške erektilne disfunkcije (MED), in katerih pogostnost ni znana, vključujejo:
Non-arteritic anterior ischaemic optic neuropathy (NAION), retinal vascular occlusion, visual field defect.
Očesne bolezni: nearteritična anteriorna ishemična optična nevropatija (NAION), zapora mrežnične vene in izpad vidnega polja.
At single doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.
Uporabo posamičnih odmerkov 200 mg je spremljala večja incidenca neželenih reakcij (glavobola, zardevanja, omotice, dispepsije, zamašenega nosu, sprememb vida).
9 5.
9 V primeru prevelikega odmerjanja je treba uporabiti standardne podporne ukrepe.
Pharmacotherapeutic group:
Farmakoterapevtska skupina: zdravila za zdravljenje erektilne disfunkcije.
Drugs used in erectile dysfunction, ATC code:
Oznaka ATC:
There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina.
Za PDE5 je 10- krat bolj selektiven kot za PDE6, ki je vključena v fototransdukcijsko pot v mrežnici.
There is an 80-fold selectivity over PDE1, and over 700-fold over PDE 2, 3, 4, 7, 8, 9, 10 and 11.
Selektivnost je 80- kratna v primerjavi s PDE1 in prek 700- kratna v primerjavi s PDE2, 3, 4, 7, 8, 9, 10 in 11.
In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
Selektivnost sildenafila je konkretno za PDE5 več kot 4. 000- krat večja kakor za PDE3 – za cAMP specifično izoobliko fosfodiesteraze, ki sodeluje pri nadzoru krčljivosti srca.
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 mmHg, diastoličnega pa znižanje za 9, 1 mmHg.
Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.
Posamičen peroralni odmerek sildenafila do 100 mg pri zdravih prostovoljcih ni povzročil klinično pomembnih sprememb EKG- ja.
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%.
Mild and transient differences in colour discrimination (blue/ green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
Pri nekaterih preiskovancih so s Farnsworth- Munsellovim testom s 100 barvnimi odtenki 1 uro po 100- mg odmerku ugotovili blage in prehodne spremembe razločevanja barv (modra/ zelena); 2 uri po odmerku ta učinek ni bil več opazen.
In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
V majhni, s placebom kontrolirani študiji pri bolnikih s potrjeno zgodnjo starostno degeneracijo makule (n = 9) sildenafil v enkratnem 100- mg odmerku ni povzročil pomembnih sprememb na opravljenih preiskavah vida (ostrina vida, Amslerjeva mrežica, ločevanje barv na simuliranem semaforju, Humphreyev perimeter in fotostres).
Efficacy in adult patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 278 patients with primary pulmonary hypertension, PAH associated with connective tissue disease (CTD), and PAH following surgical repair of congenital heart lesions.
Bolnike so randomizirali na eno od štirih vrst obravnave: placebo, sildenafil
Patients were randomised to one of four treatment groups: placebo, sildenafil 20 mg, sildenafil 40 mg or sildenafil 80 mg, three times a day.
10 20 mg, sildenafil 40 mg ali sildenafil 80 mg trikrat na dan.
The study population consisted of 68 (25%) men and 209 (75%) women with a mean age of 49 years (range:
Populacijo študije je sestavljalo 68 moških (25%) in 209 žensk (75%).
18-81 years) and baseline 6-minute walk test distance between 100 and 450 metres inclusive (mean:
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:
175 patients (63%) included were diagnosed with primary pulmonary hypertension, 84 (30%) were diagnosed with 10 PAH associated with connective tissue disease (CTD) and 18 (7%) of the patients were diagnosed with PAH following surgical repair of congenital heart lesions.
175 vključenih bolnikov (63%) je imelo diagnosticirano primarno pljučno hipertenzijo, 84 (30%) PAH, povezano z boleznimi vezivnega tkiva, in 18 (7%) PAH po kirurški popravi prirojenih srčnih hib.
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.
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%).
Patients with left ventricular ejection fraction < 45% or left ventricular shortening fraction < 0.2 were not studied.
Študija ni proučevala bolnikov z iztisnim deležem levega prekata < 45% ali skrčitvenim deležem levega prekata < 0, 2.
Sildenafil (or placebo) was added to patients’ background therapy which could have included a combination of anticoagulation, digoxin, calcium channel blockers, diuretics or oxygen.
Sildenafil (ali placebo) so dodali osnovni terapiji bolnikov, ki je lahko vključevala kombinacijo antikoagulantov, digoksina, zaviralcev kalcijevih kanalčkov, diuretikov in kisika.
The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as add-on therapy, and neither was arginine supplementation.
Uporaba prostaciklina, prostaciklinskih analogov in antagonistov endotelinskih receptorjev kot dodatna terapija ni bila dovoljena, prav tako ne dodajanje arginina.
The primary efficacy endpoint was the change from baseline at week 12 in 6-minute walk distance.
Glavni opazovani dogodek učinkovitosti je bila sprememba razdalje, prehojene med 6- minutnim testom hoje, od začetka študije do 12. tedna.
A statistically significant increase in 6-minute walk distance was observed in all 3 sildenafil dose groups compared to those on placebo.
Statistično pomembno povečanje razdalje na 6- minutnem testu hoje so ugotovili v skupinah z vsemi 3 odmerki sildenafila.
Placebo corrected increases in walk distance were 45 metres (p < 0.0001), 46 metres (p < 0.0001) and 50 metres (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg respectively.
Za placebo korigirano povečanje prehojene razdalje je bilo za 20 mg sildenafila 45 metrov (p < 0, 0001), za 40 mg 46 metrov (p < 0, 0001) in za 80 mg 50 metrov (p < 0, 0001).
The improvement in walk distance was apparent after 4 weeks of treatment and this effect was maintained at weeks 8 and 12.
Izboljšanje prehojene razdalje je bilo opazno po 4 tednih zdravljenja in ta učinek se je ohranil 8. in 12. teden.
Results were generally consistent in subgroups according to baseline walking distance, aetiology (primary and CTD-associated PAH), WHO functional class, gender, race, location, mean PAP and PVRI.
Rezultati so bili praviloma konsistentni po podskupinah glede na prehojeno razdaljo v začetku študije, 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.
Patients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) compared to those on placebo.
Bolnikom na vseh treh odmerkih sildenafila se je povprečni pljučni arterijski tlak statistično pomembno znižal v primerjavi z bolniki, ki so dobivali placebo.
The placebo-corrected treatment was – 2.7 mmHg (p=0.04) for sildenafil 20 mg three times a day.
Za placebo korigirano znižanje je bilo ob 20 mg sildenafila trikrat na dan – 2, 7 mmHg (p = 0, 04).
There was no evidence of a difference in effect between sildenafil 20 mg and the higher doses tested.
Razlik med učinkom 20 mg sildenafila in večjih preskušanih odmerkov niso opazili.
The mean change from baseline in pulmonary vascular resistance (PVR) was – 122 dyne. sec/ cm5 for sildenafil 20 mg three times a day.
Povprečna sprememba pljučne žilne upornosti (PVR - pulmonary vascular resistance) od začetka študije je bila ob 20 mg sildenafila trikrat na dan – 122 din. s/ cm5.
The percent reduction at 12 weeks for sildenafil 20 mg in PVR (11.2%) was proportionally greater than the reduction in systemic vascular resistance (SVR) (7.2%).
Odstotek znižanja pljučne žilne upornosti (11, 2%) je bil po 12 tednih ob 20 mg sildenafila proporcionalno večji kot znižanje sistemske žilne upornosti (7, 2%).
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 kontrolirana študija je bila narejena pri 267 bolnikih s PAH, stabiliziranih na intravenskem epoprostenolu.
The PAH patients included those with Primary Pulmonary Arterial Hypertension (212/ 267, 79%) and PAH associated with CTD (55/ 267, 21%).
Med bolniki s PAH so bili takšni s primarno pljučno arterijsko hipertenzijo (212/ 267, 79%) in takšni s PAH, povezano z boleznimi vezivnega tkiva (55/ 267, 21%).
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 Svetovne zdravstvene organizacije; 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.
Patients were randomised to placebo or sildenafil (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day) when used in combination with intravenous epoprostenol.
Bolnike so randomizirali na placebo ali sildenafil (v fiksni titraciji najprej 20 mg, nato 40 mg in 80 mg trikrat na dan), uporabljen v kombinaciji z intravenskim epoprostenolom.
The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance.
11 Glavni opazovani dogodek učinkovitosti je bila sprememba razdalje, prehojene med 6- minutnim testom hoje, od izhodišča do 16. tedna.
A mean placebo corrected increase in walk distance of 26 metres was observed in favour of sildenafil (95% CI:
Povprečno za placebo korigirano podaljšanje prehojene razdalje je bilo s sildenafilom 26 metrov (95% IZ:
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.
For patients with primary PAH, the treatment effect was 31.1 metres compared to 7.7 metres for patients with PAH associated with CTD.
Za bolnike s primarno PAH je bil učinek zdravljenja 31, 1 metra, za bolnike s PAH, povezano z boleznimi vezivnega tkiva, pa 7, 7 metra.
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).
After oral three times a day dosing of sildenafil, AUC and Cmax increase in proportion with dose over the dose range of 20-40 mg.
Po peroralni uporabi sildenafila trikrat na dan se AUC in Cmax v priporočenem razponu odmerkov (od 25 do 40 mg) večata sorazmerno z odmerkom.
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.
When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29% however, the extent of absorption was not significantly affected (AUC decreased by 11%).
Če sildenafil zaužijemo s hrano, se hitrost absorpcije zmanjša s povprečno zakasnitvijo tmax 60 minut in povprečnim zmanjšanjem Cmax za 29%, delež absorpcije pa se pomembneje ne poslabša (zmanjšanje AUC za 11%).
After oral doses of 20 mg three times a day, the mean maximum total plasma concentration of sildenafil at steady state is approximately 113 ng/ ml.
Po peroralnih odmerkih 20 mg trikrat na dan je povprečna največja celotna koncentracija sildenafila v plazmi v stanju dinamičnega ravnovesja približno 113 ng/ ml.
Sildenafil and its major circulating N- desmethyl metabolite are approximately 96% bound to plasma proteins.
Sildenafil in njegov glavni krožeči N- dezmetilni presnovek sta približno 96% - no vezana na beljakovine v plazmi.
The major circulating metabolite results from N-demethylation of sildenafil.
Glavni presnovek v obtoku nastane z N- demetilacijo sildenafila.
The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
N- dezmetilni presnovek se presnovi naprej; razpolovni čas terminalne faze je približno 4 ure.
In patients with pulmonary arterial hypertension, plasma concentrations of N-desmethyl metabolite are approximately 72% those of sildenafil after 20 mg three times a day dosing (translating into a 36% contribution to sildenafil’ s pharmacological effects).
Pri bolnikih s pljučno arterijsko hipertenzijo je koncentracija N- dezmetilnega presnovka v plazmi približno 72% koncentracije sildenafila po uporabi 20 mg trikrat na dan (kar pomeni 36% prispevek k farmakološkim učinkom sildenafila).
The total body clearance of sildenafil is 41 l/ h with a resultant terminal phase half-life of 3-5 h.
Celotni telesni očistek sildenafila je 41 l/ h in razpolovni čas terminalne faze je od 3 do 5 ur.
Pharmacokinetics in special patient groups Elderly:
12 Farmakokinetika v posebnih skupinah bolnikov Starejši:
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Zdravi starejši prostovoljci (stari 65 let ali več) so imeli manjši očistek sildenafila, zato je bila koncentracija sildenafila in aktivnega N- dezmetilnega presnovka v plazmi pri njih približno 90% večja kot pri mlajših zdravih prostovoljcih (starih od 18 do 45 let).
Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40%.
Zaradi starostnih razlik v vezavi na beljakovine v plazmi so se ustrezne plazemske koncentracije prostega sildenafila povečale za približno 40%.
In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/ min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Pri prostovoljcih z blago do zmerno okvaro ledvic (očistek kreatinina = 30 do 80 ml/ min) se farmakokinetika sildenafila po enem posamičnem 50- mg peroralnem odmerku ni spremenila.
In volunteers with severe renal impairment (creatinine clearance < 30 ml/ min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age- matched volunteers with no renal impairment.
Zaradi tega se je v primerjavi s prostovoljci brez okvare ledvic enake starosti AUC povečala za 100% in Cmax za 88%.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 200% and 79% respectively in subjects with severe renal impairment compared to subjects with normal renal function.
Poleg tega sta se pri preiskovancih s hudo okvaro ledvic v primerjavi s preiskovanci z normalnim delovanjem ledvic pomembno povečali AUC (za 200%) in Cmax (za 79%) N- dezmetilnega presnovka.
12 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.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154% and 87%, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Poleg tega so pri preiskovancih s cirozo ugotovili pomembno večji AUC (za 154%) in Cmax (za 87%) N- dezmetilnega presnovka kot pri preiskovancih z normalnim delovanjem jeter.
Population pharmacokinetics:
Populacijska farmakokinetika:
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.
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.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential, fertility and embryonal/ foetal development.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na plodnost ter razvoj zarodka/ plodu ne kažejo posebnega tveganja za človeka.
In pups of rats which were pre- and postnatally treated with 60 mg/ kg sildenafil, a decreased litter size, a lower pup weight on day 1 and a decreased 4-day survival were seen at exposures which were approximately fifty times the expected human exposure at 20 mg three times a day.
Pri izpostavljenosti, ki je približno petdesetkrat presegala pričakovano izpostavljenost ob odmerku 20 mg trikrat na dan pri človeku, so pri mladičih podgan, tretiranih pred skotitvijo in po njej s 60 mg sildenafila/ kg, ugotovili zmanjšanje velikosti legla, manjšo telesno maso mladičev 1. dan in manjše 4- dnevno preživetje.
These effects were observed at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Te učinke so opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
Tablet core: microcrystalline cellulose calcium hydrogen phosphate (anhydrous) croscarmellose sodium magnesium stearate
Jedro tablete: mikrokristalna celuloza kalcijev hidrogenfosfat (brezvodni) premreženi natrijev karmelozat magnezijev stearat
Film coat: hypromellose titanium dioxide (E171) lactose monohydrate glycerol triacetate
13 Filmska obloga: hipromeloza titanov dioksid (E171) laktoza monohidrat triacetin
Do not store above 30 °C.
Shranjujte pri temperaturi do 30° C.
PVC/ Aluminium blisters of 90 tablets (15 tablets per blister strip) in a carton.
Pretisni omoti iz PVC/ aluminija z 90 tabletami (15 tablet na pretisni trak) v škatli.
28 October 2005
28. oktober 2005
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Pfizer PGM Zone Industrielle 29 route des Industries 37530 Poce sur Cisse FRANCE
Pfizer PGM Zone Industrielle 29 route des Industries 37530 Poce sur Cisse Francija
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• POGOJI ALI OMEJITVE GLEDE IZDAJANJA IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 1. 1, predstavljeni v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 2. 1 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
REVATIO 20 mg film-coated tablets Sildenafil
REVATIO 20 mg filmsko obložene tablete sildenafil
Each tablet contains 20 mg of sildenafil (as citrate).
Ena tableta vsebuje 20 mg sildenafila (v obliki citrata).
Contains lactose monohydrate See leaflet for further information
Za dodatne informacije glejte navodilo za uporabo.
Do not store above 30oC.
Shranjujte pri temperaturi do 30° C.
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS IMMEDIATE PACKAGING/ BLISTER
21 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU STIČNA OVOJNINA/ PRETISNI OMOT
22 PACKAGE LEAFLET:
NAVODILO ZA UPORABO