natgillin/translations-raw huggingface dataset:
The clinical relevance of these antibodies is not known; nevertheless the pharmacokinetics, efficacy (determined by pathological Complete Response [pCR]) and safety determined by occurrence of administration related reactions (ARRs) of Herceptin intravenous did not appear to be adversely affected by these antibodies.
Klinički značaj tih protutijela nije poznat; međutim, ta protutijela naizgled nisu negativno utjecala na farmakokinetiku, djelotvornost (određenu potpunim patološkim odgovorom [engl. pathological complete response, pCR]) niti sigurnost (određenu na temelju nastupa reakcija povezanih s primjenom lijeka) lijeka Herceptin za intravensku primjenu.
The clinical relevance of these antibodies is not known; neverthelessthe pharmacokinetics, efficacy (determined by pathological Complete Response [pCR]) and safety determined by occurrence of administration related reactions (ARRs) of Herceptin intravenous and Herceptin subcutaneous did not appear to be adversely affected by these antibodies.
Klinički značaj tih protutijela nije poznat; međutim, ta protutijela naizgled nisu negativno utjecala na farmakokinetiku, djelotvornost (određenu potpunim patološkim odgovorom [engl. pathological complete response, pCR]) niti sigurnost (određenu na temelju nastupa reakcija povezanih s primjenom lijeka) lijeka Herceptin za intravensku primjenu niti lijeka Herceptin za supkutanu primjenu.
The clinical relevance of these differences is unclear, as Synflorix was observed to be effective against IPD caused by serotype 6B in a double- blind, cluster-randomized clinical study (see Table 1).
Klinički značaj ovih razlika nije jasan s obzirom da se, u dvostruko slijepom klaster-randomiziranom kliničkom ispitivanju, pokazalo da je Synflorix učinkovit protiv IPB-a uzrokovanog serotipom 6B (vidjeti Tablicu 1).
The clinical relevance of these observations has not been established.
Klinička važnost ovih opažanja nije ustanovljena.
The clinical relevance of these observed effects for animals vaccinated while being administered oclacitinib (in accordance with the recommended dosing regimen) is unclear.
Klinički značaj navedenih učinaka kod životinja koje su cijepljenje dok su bile tretirane oclacitinibom (sukladno sa propisanim količinama koje se primjenjuju) je nejasna.
The clinical relevance of this
Klinički značaj ovog smanjenja
The clinical relevance of this decrease is unknown.
Nije poznato jesu li ovi podaci klinički značajni.
The clinical relevance of this interaction is uncertain.
Klinički značaj te interakcije nije jasan.
The clinical relevance of this is unknown.
Klinički značaj ovih nalaza nije poznata.
The clinical relevance of this observation is not known.
Klinički značaj ovih podataka nije poznat.
The clinical relevance, including the long-term safety, of sustained very low levels of LDL C (i.e.,
Klinički značaj, uključujući i dugoročnu sigurnost, koji se tiče održanih vrlo niskih vrijednosti LDL-C-a (tj.
The clinical results obtained so far do not indicate any interaction of darbepoetin alfa with other substances.
Dosadašnji rezultati kliničkih ispitivanja nisu pokazali nikakve interakcije darbepoetina alfa s drugim tvarima.
The clinical risks associated with over- and under-dosing.
Klinički rizici vezani za premale ili prevelike doze.
The clinical safety and efficacy of Lucentis in patients with visual impairment due to CNV in PM have been assessed based on the 12-month data of the double-masked, controlled pivotal study F2301 (RADIANCE).
Klinička sigurnost i djelotvornost Lucentisa u bolesnika s oštećenjem vida uzrokovanim CNV-om kod PM-a ocijenjene su na temelju 12-mjesečnih podataka iz dvostruko maskiranog, kontroliranog ključnog ispitivanja F2301 (RADIANCE).
The clinical safety and efficacy of Lucentis in patients with visual impairment due to macular oedema secondary to RVO have been assessed in the randomised, double-masked, controlled studies BRAVO and CRUISE that recruited subjects with BRVO (n=397) and CRVO (n=392), respectively.
Sigurnost kliničke primjene i djelotvornost Lucentisa u bolesnika čiji je poremećaj vida nastao zbog makularnoga edema posljedičnoga RVO-u, procjenjivana je u okviru randomiziranih, dvostruko- maskiranih, kontroliranih ispitivanja BRAVO i CRUISE u koje su u prvom slučaju bili uključeni bolesnici s BRVO-om (n=397), a u drugom slučaju bolesnici s CRVO-om (n=392).
The clinical safety and efficacy of sunitinib has been studied in the treatment of patients with GIST who were resistant to imatinib (i.e. those who experienced disease progression during or following treatment with imatinib) or intolerant to imatinib (i.e. those who experienced significant toxicity during treatment with imatinib that precluded further treatment), the treatment of patients with MRCC and the treatment of patients with unresectable pNET.
Klinička sigurnost i djelotvornost sunitiniba ispitivane su u liječenju bolesnika s GIST-om koji su bili otporni na imatinib (tj. oni u kojih je bolest progredirala tijekom ili nakon liječenja imatinibom) ili koji imatinib nisu podnosili (tj. oni u kojih je tijekom liječenja imatinibom nastupila značajna toksičnost zbog koje se liječenje nije moglo nastaviti), liječenju bolesnika s MRCC-om i liječenju bolesnika s neoperabilnim pNET-om.
The clinical safety of OZURDEX in patients with diabetic macular oedema was assessed in two phase 3 randomized, double-masked, sham-controlled studies.
Klinička sigurnost lijeka OZURDEX u bolesnika s dijabetičkim makularnim edemom utvrđena je u dvama randomiziranima, dvostruko slijepima, placebom kontroliranim ispitivanjima faze 3.
The clinical significance
Nije izravno ispitan klinički
The clinical significance of
ANTIDEPRESIVI
The clinical significance of
Klinički značaj
The clinical significance of
Klinički značaj redukcije
The clinical significance of anti-trastuzumab emtansine antibodies is not yet known.
Klinički značaj protutijela na trastuzumab emtanzin još nije poznat.
The clinical significance of these
Klinički značaj opaženih
The clinical significance of these findings is unknown.
Klinički značaj ovih nalaza nije poznat.
The clinical significance of these reductions in serum testosterone is unknown.
Klinički značaj smanjenja serumskog testosterona nije poznat.
The clinical significance of this observation is unknown.
Klinički značaj ovog zapažanja nije poznat
The clinical status of the patient and the ADR profile of Zalmoxis should be born in mind when considering the patient’s ability to perform tasks that require judgement, motor or cognitive skills.
Potrebno je imati u vidu klinički status bolesnika te profil nuspojava Zalmoxisa prilikom razmatranja sposobnosti bolesnika da obavlja radnje koje zahtijevaju prosuđivanje te korištenje motoričkih ili kognitivnih vještina.
The clinical status of the patient and the adverse event profile of lapatinib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Kada se razmatra bolesnikova sposobnost izvođenja zadataka koji zahtijevaju prosudbene, motoričke i kognitivne vještine, potrebno je imati u vidu klinički status bolesnika i profil nuspojava lapatiniba.
The clinical status of the patient and the adverse event profile of Trizivir should be borne in mind when considering the patient’s ability to drive or operate machinery.
Kada se razmatra sposobnost bolesnika da vozi ili upravlja strojem, treba imati na umu njegov klinički status i profil nuspojava lijeka Trizivir.
The clinical status of the patient and the adverse reaction profile of eltrombopag, including dizziness and lack of alertness, should be borne in mind when considering the patient’s ability to perform tasks that require judgement, motor and cognitive skills.
Kada se razmatra sposobnost bolesnika da izvodi zadatke koji zahtijevaju prosudbu, motoričke i kognitivne sposobnosti treba imati na umu klinički status bolesnika i profil nuspojava eltrombopaga, uključujući omaglicu i smanjenu budnost.
The clinical status of the patient and the adverse reaction profile of Kivexa should be borne in mind when considering the patient’s ability to drive or operate machinery.
Kad se razmatra sposobnost bolesnika da vozi ili upravlja strojem, treba imati na umu njegov klinički status i profil nuspojava lijeka Kivexa.
The clinical status of the patient and the adverse reaction profile of macitentan (such as headache, hypotension) should be kept in mind when considering the patient’s ability to drive and use machines.
Klinički status bolesnika i profil nuspojava macitentana (poput glavobolje, hipotenzije) treba imati na umu kad se razmatra bolesnikova sposobnost upravljanja vozilima i rada sa strojevima.
The clinical status of the patient and the adverse reaction profile of selexipag (such as headache or hypotension) should be kept in mind when considering the patient’s ability to drive and use machines.
Klinički status bolesnika i profil nuspojava seleksipaga (poput glavobolje ili hipotenzije) treba imati na umu kad se razmatra bolesnikova sposobnost upravljanja vozilima i rada sa strojevima.
The clinical status of the patient and the adverse reaction profile of Triumeq should be borne in mind when considering the patient’s ability to drive or operate machinery.
Kada se razmatra bolesnikova sposobnost upravljanja vozilima ili rada sa strojevima, na umu treba imati kliničko stanje bolesnika i profil nuspojava lijeka Triumeq.
The clinical status of the patient and the adverse reaction profile should be borne in mind when considering the patient’s ability to perform tasks that require judgement, motor and cognitive skills.
Pri razmatranju bolesnikove sposobnosti izvođenja zadataka koji zahtijevaju rasuđivanje te motoričke ili kognitivne vještine, treba imati na umu klinički status bolesnika i profil nuspojava.
The clinical studies have been conducted in a patient population with a mean age > 65 years.
Klinička ispitivanja provedena su na populaciji bolesnika prosječne dobi ≥ 65 godina.
The clinical studies of Effentora were designed to evaluate safety and efficacy in treating BTP and all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
Klinička ispitivanja Effentore osmišljena su kako bi se procijenila sigurnost i djelotvornost u liječenju probijajuće boli, a svi su bolesnici istovremeno uzimali i opioide poput morfija s odgođenim otpuštanjem ili transdermalni fentanil za perzistentnu bol.
The clinical studies of PecFent were designed to evaluate safety and efficacy in treating BTP and all patients were also on background opioid therapies, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
Klinička ispitivanja PecFenta bila su osmišljena kako bi se procijenila njegova sigurnost i djelotvornost u liječenju probijajuće boli, a svi su bolesnici protiv uporne boli primali i osnovne opioidne terapije kao što su morfin s produženim otpuštanjem ili transdermalni fentanil.
The clinical study protocol provided for all patients to receive aspirin and a daily maintenance dose of prasugrel. bAny intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Protokolom kliničkog ispitivanja bilo je predviđeno da svi bolesnici primaju aspirin i dnevnu dozu održavanja prasugrela. b Svako intrakranijalno krvarenje ili svako klinički zamjetno krvarenje udruženo s padom vrijednosti
The clinical study report (70 patients) should include the following data: Demographic and baseline characteristics, Disease characteristics, Prior anti-cancer therapies, Overall Response Rate (ORR), Clinical Benefit Rate (CBR), Serious Adverse Experiences (SAE)s
Izvještaj o kliničkom ispitivanju (70 bolesnika) mora obuhvaćati sljedeće podatke: Demografske i polazišne karakteristike, karakteristike bolesti, prethodne terapije protiv karcinoma, ukupna stopa odgovora (ORR), stopa kliničke koristi, ozbiljne nuspojave (SAE)
The clinical study report should be submitted by
Završno izvješće o ispitivanju se treba predati do
The clinical trial data currently available in paediatric patients is too limited to characterise the safety profile of mepolizumab in this population (see section 5.1).
Trenutno dostupni podaci iz kliničkih ispitivanja u pedijatrijskih bolesnika previše su oskudni da bi se mogao ocijeniti sigurnosni profil mepolizumaba u ovoj populaciji (vidjeti dio 5.1).
The clinical trial included 29 adult and juvenile patients in a 12-month controlled period, followed by extension therapy for an average total duration of 3.9 years and up to 5.6 years.
U kliničko ispitivanje bilo je uključeno 29 odraslih i mlađih bolesnika u 12-mjesečnom kontroliranom razdoblju, nakon čega je slijedilo produljeno liječenje u prosječnom trajanju od 3,9 godina pa do 5,6 godina.
The clinical trials before marketing authorisation have been performed up to a BMI equal to 40 kg/m2.
Provedena su klinička ispitivanja prije odobrenja za stavljanje lijeka u promet do ITM-a koji odgovara 40 kg/m2.
The clinical trials before marketing authorization have been performed up to a BMI equal to 40 kg/m2.
Provedena su klinička ispitivanja prije odobrenja za stavljanje lijeka u promet do BMI koji odgovara 40 kg/m2.
The clinical trials of Instanyl were designed to evaluate safety and efficacy in treating breakthrough pain.
Klinička ispitivanja Instanyla dizajnirana su da se ocijeni sigurnost i djelotvornost u liječenju probojne boli.
The clinically important adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone or dexamethasone include: deep vein thrombosis and pulmonary embolism, peripheral neuropathy, severe skin reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis, syncope, bradycardia, and dizziness (see sections 4.2, 4.4 and 4.5).
Klinički važne nuspojave povezane s uporabom talidomida u kombinaciji s melfalanom i prednizonom ili deksametazonom uključuju: duboku vensku trombozu i plućnu emboliju, perifernu neuropatiju, teške kožne reakcije uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, sinkopu, bradikardiju i omaglicu (vidjeti dijelove 4.2, 4.4 i 4.5).
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY and COMMIT studies are discussed below.
Klinički značajne nuspojave opažene u studijama CAPRIE, CURE, CLARITY i COMMIT opisane su u daljnjem tekstu.
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and
Klinički značajne nuspojave opažene u studijama CAPRIE, CURE, CLARITY i COMMIT i ACTIVE-A opisane su u daljnjem tekstu.
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT studies are discussed below.
Klinički značajne nuspojave opažene u studijama CAPRIE, CURE, CLARITY i COMMIT opisane su u daljnjem tekstu.
The clock should start from the first Monday after shipment of the first batch of vaccine.
Vrijeme počinje teći od prvog ponedjeljka nakon otpreme prve serije cjepiva.
The clock should start from the first Monday after shipment of the first batch of vaccine.
Vrijeme se počinje računati prvog ponedjeljka nakon isporuke prve serije cjepiva.
The clock will start from the first Monday after shipment of the first batch of vaccine.
Vrijeme se počinje računati prvog ponedjeljka nakon isporuke prve serije cjepiva.
The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap.
Zatvarač se sastoji od silikoniziranog butilnog čepa sa "flip-off" zatvaračem s evidencijom otvaranja.
The Cmax and area under the plasma concentration-time curve (AUC) increase with dose increase from 0.15 mg/kg to 0.5 mg/kg in a dose- proportional manner.
Cmax i površina ispod krivulje odnosa između koncentracije u plazmi i vremena (AUC) povećavaju se s povećavanjem doze od 0,15 mg/kg na 0,50 mg/kg.
The Cmax and area under the plasma concentration-time curve (AUC) were increased by approximately 30% and 45%, respectively.
Cmax se povećao za približno 30%, a područje ispod krivulje 'koncentracija u plazmi-vrijeme' (AUC) za približno 45%.
The Cmax and AUC following a 2- to 10-minute intravenous infusion of 27 mg/m2 was 4,232 ng/mL and 379 ng•hr/mL, respectively.
Vrijednosti Cmax odnosno AUC su, nakon 2- do 10-minutne intravenske infuzije doze od 27 mg/m2 iznosile 4232 ng/ml odnosno 379 ng•hr/ml.
The Cmax and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to 1000 mg.
Cmax i AUC ceftarolina povećavaju se približno u proporciji s dozom unutar raspona jedne doze od 50 do 1000 mg.
The Cmax and AUC of ceftolozane/tazobactam increase approximately in proportion to dose within ceftolozane single-dose range of 250 mg to 3 g and tazobactam single-dose range of 500 mg to 1.5 g.
Cmax i AUC ceftolozana/tazobaktama povećavaju se približno proporcionalno dozi nakon primjene jednokratne doze ceftolozana u rasponu od 250 mg do 3 g i nakon primjene jednokratne doze tazobaktama u rasponu od 500 mg do 1,5 g.
The Cmax and AUC of mirabegron and its metabolites following multiple oral doses in elderly volunteers (≥ 65 years) were similar to those in younger volunteers (18–45 years).
Nakon višekratnih oralnih doza u starijih dobrovoljaca (≥65 godina) Cmax i AUC mirabegrona i njegovih metabolita bili su slični onima u mlaĎih dobrovoljaca (18–45 godina).
The Cmax and AUC of tedizolid increased approximately dose proportionally within the single oral dose range of 200 mg to 1,200 mg and across the intravenous dose range of 100 mg to 400 mg.
Cmax i AUC tedizolida rasli su približno proporcionalno dozi unutar raspona jednokratne peroralne doze od 200 mg do 1200 mg i u rasponu jednokratne intravenske doze od 100 mg do 400 mg.
The Cmax and AUC values of saxagliptin and its major metabolite increased proportionally with the increment in the saxagliptin dose, and this dose-proportionality was observed in doses up to 400 mg.
Vrijednosti Cmax i AUC-a saksagliptina i njegova glavnog metabolita povećavale su se proporcionalno povećanju doze saksagliptina. a ta je proporcionalnost doza opažena za doze do 400 mg.
The Cmax and AUC(0–∞) were slightly decreased for ethinyl estradiol (8% and 4%, respectively), and slightly increased for norethindrone (13% and 14 %, respectively).
Uočeno je blago smanjenje Cmax za 8 % te AUC(0-∞) za 4 % kod etinilestradiola i povećanje Cmax za 13% te AUC(0-∞) za 14% kod noretindrona.
The Cmax was 10 % higher on Day 1 and 24 % higher on Day 5 in elderly relative to younger adults.
Osim toga je u starijih osoba Cmax bio 10% viši 1. dan, odnosno 24% viši 5. dan, u usporedbi s mlađim odraslim osobama.
The Cmax was 10 % higher on Day 1 and 24 % higher on Day 5 in elderly relative to younger adults.
Osim toga je u starijih osoba Cmax bio 10% viši 1. dana, odnosno 24% viši 5. dan, u usporedbi s mlađim odraslim osobama.
The Cmax, AUC(0- 24), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng h/ml, and 0.28 ng/ml, respectively.
U tih je ispitanika Cmax iznosio 6,31 ng/ml, AUC(0-24) 18,33 ng·h/ml, a Cmin 0,28 ng/ml.
The Cmax, AUC(0- 24), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng·h/ml, and 0.28 ng/ml, respectively.
U tih je ispitanika Cmax iznosio 6,31 ng/ml, AUC(0-24) 18,33 ng·h/ml, a Cmin 0,28 ng/ml.
The Cmax, AUC(0-24), and Cmin for these subjects was 14.48 ng/ml,
U tih je ispitanika Cmax iznosio 14,48 ng/ml, AUC(0-24)
The co-administration of 600 mg ciclosporin decreased the Cmax and the AUCinf of eltrombopag by 39% and 24%, respectively.
Istodobna primjena ciklosporina u dozi od 600 mg snizila je Cmax eltrombopaga za 39% i AUCinf eltrombopaga za 24%.
The co-administration of beta-blockers or calcium antagonists with depressant effect on sinus and atrio-ventricular node should be undertaken with caution.
Potreban je oprez prilikom istodobne primjene beta-blokatora ili antagonista kalcija s depresorskim učincima na sinusni i atrioventrikularni čvor.
The co-administration of Descovy is not recommended with certain anticonvulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (e.g., rifampicin, rifabutin, rifapentine), boceprevir, telaprevir, St. John’s wort and HIV protease inhibitors (PIs) other than atazanavir, lopinavir and darunavir (see section 4.5).
Ne preporučuje se istodobna primjena lijeka Descovy s odreĎenim antikonvulzivima (npr., karbamazepinom, okskarbazepinom, fenobarbitalom i fenitoinom), antimikobakterijskim lijekovima (npr. rifampicinom, rifabutinom, rifapentinom), boceprevirom, telaprevirom, gospinom travom i inhibitorima proteaze HIV-a osim atazanavirom, lopinavirom i darunavirom (vidjeti dio 4.5).
The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
Istodobna primjena doksazosina (4 i 8 mg na dan) i tadalafila (dnevna doza od 5 mg i 20 mg u jednoj dozi) značajno pojačava učinak ovog alfa-blokatora na sniženje krvnog tlaka.
The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
Istodobna primjena doksazosina (4 mg i 8 mg na dan) i tadalafila (dnevna doza od 5 mg i 20 mg u jednoj dozi) značajno pojačava učinak ovog alfa-blokatora na sniženje krvnog tlaka.
The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does not affect the pharmacokinetics of its active 5- hydroxyl metabolite and no dosage adjustment is recommended.
Istodobna primjena duloksetina (40 mg dvaput dnevno) povećava AUC tolterodina (2 mg dvaput dnevno) u stanju dinamičke ravnoteže za 71%, ali ne utječe na farmakokinetiku njegova aktivnog 5-hidroksil metabolita pa se prilagodba doze ne preporučuje.
The co-administration of Emtricitabine/Tenofovir disoproxil Zentiva and didanosine is not recommended (see section 4.4 and Table 2).
Istodobna primjena lijeka Emtricitabine/Tenofovir disoproxil Zentiva i didanozina se ne preporučuje (vidjeti dio 4.4 i Tablicu 2).
The co-administration of Eviplera and didanosine is not recommended (see section 4.4 and Table 1).
Ne preporučuje se istovremena primjena lijeka Eviplera i didanozina (vidjeti dio 4.4 i tablicu 1).
The co-administration of Pandemic influenza vaccine H5N1 MedImmune with inactivated vaccines or with the seasonal vaccine Fluenz Tetra has not been studied.
Nije ispitana istodobna primjena Pandemijskog cjepiva protiv influence H5N1 MedImmune s inaktiviranim cjepivima ili sa sezonskim cjepivom Fluenz Tetra.
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 inhibitorima PDE5, uključujući sildenafil, zajedno sa stimulatorima gvanilat ciklaze, kao što je riociguat, je kontrainidicirana i može potencijalno dovesti do simptomatske hipotenzije (vidjeti dio 4.5).
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, uključujnući sildenafil, zajedno sa stimulatorima gvanilat ciklaze, kao što je riociguat, je kontrainidicirana i može potencijalno dovesti do simptomatske hipotenzije (vidjeti dio 4.5).
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, uključujnući sildenafil, zajedno sa stimulatorima gvanilat ciklaze, kao što je riociguat, je kontrainidicirana i može potencijalno dovesti do simtomatske hipotenzije (vidjeti dio 4.5).
The co-administration of PDE5 inhibitors, including vardenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Kontraindicirana je istodobna primjena inhibitora PDE5, uključujući vardenafil, sa stimulatorima gvanilat ciklaze kao što je riocigvat, jer može dovesti do simptomatske hipotenzije (vidjeti dio 4.5).