natgillin/translations-raw huggingface dataset:
Any remaining oral suspension should be discarded 30 days after constitution.
Preostalu oralnu suspenziju treba baciti 30 dana nakon pripreme.
If reconstituted, the oral suspension is in a liquid form.
Ako je pripremljena, oralna suspenzija je tekućina.
Revatio 20 mg tablets Sildenafil
Revatio 20 mg tablete sildenafil
The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension (functional class IV).
Nije utvrđena djelotvornost lijeka Revatio u bolesnika s teškom plućnom arterijskom hipertenzijom (funkcionalni stupanj IV).
*These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED).
*Ove nuspojave koje su prijavljene u bolesnika koji su uzimali sildenafil za liječenje muške erekcijske disfunkcije.
The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as addon therapy, and neither was arginine supplementation.
Nije bila dopuštena primjena prostaciklina, analoga prostaciklina ni antagonista endotelinskih receptora kao dodatne terapije, kao ni nadomještanje arginina.
Store below 30°C or in refrigerator at 2ºC to 8°C.
Čuvati na temperaturi ispod 30°C ili u hladnjaku na temperaturi od 2°C do 8°C.
An additional 5 deaths were reported subsequently.The causes of deaths were related to PAH.
Naknadno je prijavljeno još 5 smrtnih slučajeva.
Effects of other medicinal products on intravenous sildenafil Predictions based on a pharmacokinetic model suggest that drug-drug interactions with CYP3A4 inhibitors should be less than observed after oral sildenafil administration.
Učinci drugih lijekova na sildenafil primijenjen intravenski Predviđanja na temelju farmakokinetičkog modela upućuju na to da bi interakcije s inhibitorima CYP3A4 trebale biti manje od onih zabilježenih nakon peroralne primjene sildenafila.
5 % glucose solution sodium chloride 9 mg/ml (0.9 %) solution Lactated Ringer's solution 5 % glucose/0.45 % sodium chloride solution 5 % glucose/lactated Ringer's solution 5 % glucose/20 mEq potassium chloride solution
5 %-tnom otopinom glukoze/ 0,45 %-tnom otopinom natrijevog klorida 5 %-tnom otopinom glukoze/ otopinom Ringerovog laktata 5 %-tnom otopinom glukoze/ otopinom kalijevog klorida od 20 mEq
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.
Izloženost sildenafilu u bolesnika koji su uzimali supstrate CYP3A4 bila je 43% veća, a u onih koji su uzimali supstrate CYP3A4 s beta-blokatorima 66% veća u usporedbi s bolesnicima koji nisu uzimali lijekove iz navedenih skupina.
• 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).
lijekove koji sadrže gospinu travu (biljni lijek), rifampicin (koristi se za liječenje bakterijskih infekcija), karbamazepin, fenitoin i fenobarbital (koriste se, između ostalog, za liječenje epilepsije).
Using the cup measure another 30 ml of water and add this to the bottle.
Pomoću odmjerne čašice odmjerite novih 30 ml vode i dodajte je u bocu.
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.
U ispitivanju hemodinamičkih učinaka jedne peroralne doze od 100 mg sildenafila u 14 bolesnika s teškom bolešću koronarnih arterija (stenoza > 70% u barem jednoj koronarnoj arteriji), srednja vrijednost sistoličkog krvnog tlaka u mirovanju snižena je za 7%, a dijastoličkog za 6% u odnosu na početne vrijednosti.
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.
Ukupna učestalost prekida liječenja u bolesnika liječenih sildenafilom u dozama od 20 mg, 40 mg i 80 mg TID iznosila je 2,9%, 3,0% odnosno 8,5%, u odnosu na 2,9% kod primjene placeba.
Efficacy of sildenafil should be closely monitored in patients using concomitant potent CYP3A4 inducers, such as carbamazepine, phenytoin, phenobarbital, St John's wort and rifampicine.
Mora se pomno nadzirati djelotvornost sildenafila u bolesnika koji istodobno uzimaju jake induktore CYP3A4, poput karbamazepina, fenitoina, fenobarbitala, gospine trave i rifampicina.
23 subjects experienced clinical worsening events in the placebo group (17.6 %) compared with 8 subjects in the sildenafil group (6.0 %).
U skupini koja je primala placebo, epizode kliničkog pogoršanja doživjela su 23 ispitanika (17,6%) u usporedbi s 8 ispitanika u skupini liječenoj sildenafilom (6,0%).
Consequently, should signs of pulmonary oedema occur when sildenafil is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered.
Stoga, pojave li se znakovi plućnog edema kod primjene sildenafila u bolesnika s plućnom hipertenzijom, mora se uzeti u obzir mogućnost pridružene vensko-okluzivnom bolesti.
Using the cup measure another 30 ml of water and add this to the bottle (figure 1).
Pomoću odmjerne čašice odmjerite novih 30 ml vode i dodajte je u bocu. (slika 1)
Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers (see section 4.5).
Možda će biti potrebno prilagoditi dozu sildenafila kada se primjenjuje istodobno s induktorima CYP3A4 (vidjeti dio 4.5).
After reconstitution: Store below 30°C or in refrigerator at 2°C to 8°C.
Nakon pripreme: Čuvati na temperaturi ispod 30°C ili u hladnjaku na temperaturi od 2°C do 8°C.
If you experience sudden decrease or loss of vision, stop taking Revatio and contact your doctor immediately (see also section 4).
Ako osjetite iznenadno smanjenje ili gubitak vida, prestanite uzimati Revatio i odmah se javite svom liječniku (pogledajte i dio 4).
In post-marketing experience with sildenafil for male erectile dysfunction, serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported in temporal association with the use of sildenafil.
Nakon stavljanja u promet sildenafila u liječenju muške erekcijske disfunkcije prijavljeni su ozbiljni kardiovaskularni događaji, uključujući infarkt miokarda, nestabilnu anginu, iznenadnu srčanu smrt, ventrikularnu aritmiju, cerebrovaskularno krvarenje, prolaznu ishemijsku ataku, hipertenziju i hipotenziju, koji su bili vremenski povezani s primjenom sildenafila.
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).
Populaciju uključenu u ispitivanje činilo je 68 (25%) muškaraca i 209 (75%) žena, prosječne dobi od 49 godina (raspon: 18 do 81 godina), a početna 6-minutna postignuta udaljenost hodom bila je između 100 i 450 metara (prosječno: 344 metra).
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.
Najčešće prijavljene nuspojave koje su se javile (10% ili više) kod liječenja lijekom Revatio u odnosu na placebo bile su glavobolja, navale crvenila, dispepsija, proljev i bol u ekstremitetu.
Revatio contains sorbitol
Revatio sadrži sorbitol
Put the tip of the oral dosing syringe into the mouth.
Stavite vrh štrcaljke u usta.
The adaptor is provided so that you can fill the oral dosing syringe with medicine from the bottle.
Nastavak za bocu priložen je zato da lijek iz boce možete napuniti u štrcaljku za usta.
Solution for injection 1 vial 10 mg/12.5 ml
1 bočica 10 mg/12,5 ml
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
Najčešća ozbiljna nuspojava koje se pojavila s učestalošću od ≥1% bolesnika koji su primali sildenafil (kombinirane doze) bila je pneumonija (7,4%), srčano zatajenje, plućna hipertenzija (svaki 5,2%), infekcije gornjeg dišnog sustava (3,1%), zatajenje desnog ventrikula, gastroenteritis (svaki 2,6%), sinkopa, bronhitis, bronhopneumonija, plućna arterijska hipertenzija (svaki 2,2%), bol u prsnom košu, zubni karijes (svaki 1,7%) i kardiogeni šok, virusni gastroenteritis, infekcija urinarnog trakta (svaki
Revatio is used to treat adults with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).
Revatio se koristi za liječenje odraslih bolesnika koji imaju visok krvni tlak u krvnim žilama u plućima (plućnu arterijsku hipertenziju).
Revatio 10 mg/ml powder for oral suspension
Revatio 10 mg/ml prašak za oralnu suspenziju
Efficacy of oral sildenafil in adult patients with PAH (when used in combination with epoprostenol)
Djelotvornost u odraslih bolesnika s PAH-om (kada se primjenjuje u kombinaciji s epoprostenolom)
A total of 207 patients were treated with Revatio in the pivotal study, and their long term survival status was assessed for a minimum of 3 years.
U pivotalnom je ispitivanju lijekom Revatio liječeno ukupno 207 bolesnika te je procjenjivano njihovo dugoročno preživljenje tijekom najmanje 3 godine.
Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), the enzyme that is responsible for degradation of cGMP.
Sildenafil je jak i selektivan inhibitor fosfodiesteraze tipa 5 (PDE5) specifične za ciklički gvanozin monofosfat (cGMP).
Two subjects experienced a total of 3 adverse reactions (flushing, flatulence and hot flush).
U dva su ispitanika nastupile ukupno 3 nuspojave (navale crvenila, flatulencija i valunzi).
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.
U bolesnika s plućnom arterijskom hipertenzijom je bioraspoloživost sildenafila nakon peroralne primjene doze od 80 mg tri puta na dan bila u prosjeku 43% (90% CI: 27% - 60%) veća u usporedbi s nižim dozama.
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.
U placebom kontroliranom ispitivanju lijeka Revatio u bolesnika u dobi od 1 do 17 godina s plućnom arterijskom hipertenzijom ukupno su 174 bolesnika tri puta na dan primala nisku (10 mg u bolesnika tjelesne težine > 20 kg; niti jedan bolesnik tjelesne težine ≤ 20 kg nije primao nisku dozu), srednju (10 mg u bolesnika tjelesne težine ≥ 8-20 kg, 20 mg u bolesnika tjelesne težine ≥ 20-45 kg, 40 mg u bolesnika tjelesne težine > 45 kg) ili visoku dozu (20 mg u bolesnika tjelesne težine ≥ 8-20 kg, 40 mg u bolesnika tjelesne težine ≥ 20-45 kg; 80 mg u bolesnika tjelesne težine > 45 kg) lijeka Revatio, dok je 60 bolesnika primalo placebo.
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 intravenous exposure at 10 mg three times a day.
U mladunčadi štakora koji su prije i nakon okota primali 60 mg/kg sildenafila opaženi su smanjena veličina legla, manja težina mladunaca 1. dana te smanjeno 4-dnevno preživljenje, pri razinama izloženosti koje su bile približno 50 puta veće od očekivane izloženosti u ljudi pri intravenskoj dozi od 10 mg tri puta na dan.
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 otopina za injekciju daje se bolesnicima kojima je već propisan peroralni oblik lijeka Revatio kao zamjena za peroralnu terapiju u okolnostima kada bolesnici privremeno nisu u stanju uzimati peroralni oblik lijeka Revatio.
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.
Ukupna učestalost prekida liječenja zbog nuspojava iznosila je 5,2% u bolesnika liječenih sildenafilom/epoprostenolom, u odnosu na 10,7% u bolesnika koji su primali placebo/epoprostenol.
These were the only factors with a statistically significant impact on oral sildenafil pharmacokinetics in patients with pulmonary arterial hypertension.
To su bili jedini faktori sa statistički značajnim utjecajem na farmakokinetiku peroralno primijenjenog sildenafila u bolesnika s plućnom arterijskom hipertenzijom.
Caution is advised when sildenafil is administered to patients taking an alpha-blocker as the co-administration may lead to symptomatic hypotension in susceptible individuals (see section 4.5).
Savjetuje se oprez kada se sildenafil primjenjuje u bolesnika koji uzimaju alfa-blokatore jer istodobna primjena može u osjetljivih osoba dovesti do simptomatske hipotenzije (vidjeti dio 4.5).
- if you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
- ako uzimate lijekove koji sadrže nitrate ili donore dušikovog oksida poput amil nitrata.
In single dose volunteer studies of oral doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased.
U ispitivanjima na dobrovoljcima s primjenom jedne peroralne doze do 800 mg nuspojave su bile slične onima opaženima pri nižim dozama, ali se povećala stopa incidencije i težina.
Once reconstituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Nakon rekonstitucije, oralna suspenzija se mora primjenjivati isključivo pomoću štrcaljke za usta priložene u svakom pakiranju lijeka.
What you need to know before you take Revatio
Što morate znati prije nego počnete uzimati Revatio
• 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 of low blood pressure (e.g. dizziness, lightheadedness).
alfa-blokatore (npr. doksazosin) za liječenje visokog krvnog tlaka ili tegoba s prostatom, jer kombinacija ovih dvaju lijekova može izazvati simptome niskog krvnog tlaka (npr. omaglicu, ošamućenost).
Studies with sildenafil have been performed in forms of pulmonary arterial hypertension related to primary (idiopathic), connective tissue disease associated or congenital heart disease associated forms of PAH (see section 5.1).
Ispitivanja sildenafila provedena su u sljedećim oblicima plućne arterijske hipertenzije: primarnoj (idiopatskoj), onoj povezanoj s bolešću vezivnog tkiva i onoj povezanoj s prirođenom bolešću srca (vidjeti dio 5.1).
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).
Nuspojave prijavljene u >10% od 229 ispitanika liječenih sildenafilom (skupina koja je primala kombiniranu dozu, uključujući 9 bolesnika koji nisu nastavili u dugotrajnom ispitivanju) bile su infekcija gornjih dišnih puteva (31%), glavobolja (26%), povraćanje (22%), bronhitis (20%), faringitis (18%), pireksija (17%), proljev (15%), gripa i epistaksa (svaki 12%).
What Revatio is and what it is used for What you need to know before you are given Revatio How Revatio is given
Što je Revatio i za što se koristi Što morate znati prije nego počnete primati Revatio Kako primjenjivati Revatio Moguće nuspojave
Revatio is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Revatio je kontraindiciran u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) (vidjeti dio 4.3).
Of the 277 subjects treated in the pivotal study, 259 entered a long-term extension study.
Od 277 ispitanika liječenih u pivotalnom ispitivanju, njih je 259 ušlo u dugoročno produljeno ispitivanje.
The mean postural changes in systolic and diastolic blood pressure over time were small (< 10 mmHg) and returned towards baseline beyond 2 hours.
Srednje vrijednosti posturalnih promjena sistoličkog i dijastoličkog krvnog tlaka tijekom vremena su bile male (< 10 mmHg) i vratile su se prema početnim vrijednostima nakon 2 sata.
This can happen if you are sick with a fever, vomiting, or diarrhoea - have a rare inherited eye disease (retinitis pigmentosa) - 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.
To se može dogoditi ako ste bolesni i imate vrućicu, povraćate ili imate proljev - imate rijetku nasljednu bolest oka (retinitis pigmentosa) - imate poremećaj crvenih krvnih stanica (anemiju srpastih stanica), rak krvnih stanica
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).
Opaženo je prosječno, za placebo korigirano povećanje prehodane udaljenosti od 26 metara u korist sildenafila (95% CI: 10,8; 41,2) (p = 0,0009).
figure 1
slika 1
Mean baseline peak volume of oxygen consumed (VO2) values were comparable across the sildenafil treatment groups (17.37 to 18.03 ml/kg/min), and slightly higher for the placebo treatment group (20.02 ml/kg/min).
Srednja vrijednost vršnog volumena potrošnje kisika (VO2) na početku ispitivanja bila je usporediva u svim skupinama liječenima sildenafilom (17,37 do 18,03 ml/kg/min), a nešto veći u skupini koja je primala placebo (20,02 ml/kg/min).
Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients (see section 4.3).
Na temelju ovih farmakokinetičkih rezultata kontraindicirana je istodobna primjena sildenafila s ritonavirom u bolesnika s plućnom arterijskom hipertenzijom (vidjeti dio 4.3).
The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitors has not been studied in pulmonary arterial hypertension patients (see section 4.4).
Sigurnost i djelotvornost istodobne primjene sildenafila i drugih inhibitora PDE5 nije ispitana u bolesnika s plućnom arterijskom hipertenzijom (vidjeti dio 4.4).
Point the tip of the oral dosing syringe towards the inside of the cheek.
Usmjerite vrh štrcaljke za usta na unutarnju stranu obraza.
Revatio 10 mg/ml powder for oral suspension Sildenafil
Revatio 10 mg/ml prašak za oralnu suspenziju sildenafil
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 vrijednosti promjena krvnog tlaka u sjedećem položaju u odnosu na početne vrijednosti bile su najveće 1 sat nakon primjene doze: -9,1 mmHg (SD ± 12,5) za sistolički te -3,0 mmHg (SD ± 4,9) za dijastolički krvni tlak.
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.
U bolesnika koji su na početku ispitivanja mogli prehodati udaljenost od ≥325 metara, učinak liječenja iznosio je 38,4 metra u korist sildenafila; u bolesnika koji su na početku ispitivanja mogli prehodati udaljenost od < 325 metara, učinak liječenja iznosio je 2,3 metra u korist placeba.
No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Nisu opažene značajne interakcije kada je sildenafil (50 mg) primijenjen istodobno s tolbutamidom (250 mg) ili varfarinom (40 mg), koji se oba metaboliziraju pomoću CYP2C9.
OUTER PACKAGING/CARTON
VANJSKO PAKIRANJE/KUTIJA
figure 8
slika 8
Skin and subcutaneous tissue disorders Common alopecia, erythema, night sweats
Poremećaji kože i potkožnog tkiva često alopecija, eritem, noćno znojenje nepoznato osip
This concentration range covers the increase in sildenafil exposure observed in specifically designed drug interaction studies with CYP3A4 inhibitors (except with the most potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir).
Ovaj raspon koncentracija obuhvaća povećanje izloženosti sildenafilu opaženo u posebno dizajniranim ispitivanjima interakcija s inhibitorima CYP3A4 (osim sa najjačim CYP3A4 inhibitorima, primjerice ketokonazolom, itrakonazolom, ritonavirom).
Remove the cap again, press the bottle adaptor into the neck of the bottle.
Ponovno skinite zatvarač i utisnite nastavak za bocu u grlo boce.
Remove the oral dosing syringe from the bottle.
Izvadite štrcaljku za usta iz boce.
Revatio is for oral use only.
Revatio je namijenjen samo za peroralnu primjenu.
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.
U bolesnika sa SZO funkcionalnim stupnjem II na početku ispitivanja jednogodišnje je preživljenje iznosilo 99%, dvogodišnje 91%, a trogodišnje 84%, dok je u bolesnika sa SZO funkcionalnim stupnjem III jednogodišnje preživljenje iznosilo 94%, dvogodišnje 90%, a trogodišnje 81%.
Adverse reactions that resulted from intravenous Revatio use are similar to those associated with oral Revatio use.
Nuspojave koje su se javile nakon intravenske primjene lijeka Revatio slične su onima povezanima s njegovom peroralnom primjenom.
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.
Jedno pakiranje lijeka Revatio otopina za injekciju sadrži jednu prozirnu staklenu bočicu od 20 ml, koja je zatvorena klorobutilnim gumenim čepom i aluminijskim zaštitnim zatvaračem
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), inhibitor citokroma P450 i nespecifični inhibitor CYP3A4, izazvao je povećanje koncentracije sildenafila u plazmi od 56% kada je primijenjen istodobno sa sildenafilom (50 mg) u zdravih dobrovoljaca.
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).
Istodobna primjena s PDE5 inhibitiorima, uključujući sildenafil, zajedno sa stimulatorima gvanilat ciklaze, kao što je riociguat, je kontraindicirana i može potencijalno dovesti do simptomatske hipotenzije (vidjeti dio 4.5).
Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Nositelj odobrenja za stavljanje lijeka u promet: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija.
figure 5
slika 5