natgillin/translations-raw huggingface dataset:
Based on a minimum of 12 months follow-up the most frequently reported adverse reactions in SPRYCEL-treated patients with newly diagnosed chronic phase CML were fluid retention (including pleural effusion) (19%), diarrhoea (17%), headache (12%), rash (11%), musculoskeletal pain (11%), nausea (8%), fatigue (8%), myalgia (6%), vomiting (5%), and muscle inflammation (4%).
Na temelju najmanje 12 mjeseci praćenja, najčešće zabilježene nuspojave u bolesnika s novodijagnosticiranom KML u kroničnoj fazi liječenih lijekom SPRYCEL bile su zadržavanje tekućine (uključujući pleuralni izljev) (19%), proljev (17%), glavobolja (12%), osip (11%), mišićno-koštana bol (11%), mučnina (8%), umor (8%), mialgija (6%), povraćanje (5%) i upala mišića (4%).
Based on a non- compartmental analysis of data from adults (LAL-CL01/LAL-CL-04), the pharmacokinetics of sebelipase alfa appeared to be nonlinear with a greater than dose-proportional increase in exposure observed between the 1 and 3 mg/kg dosages.
Temeljeno na analizi podataka za odrasle (LAL-CL01/LAL-CL-04) bez uključivanja odjeljaka, čini se da je farmakokinetika sebelipaze alfa nelinearna, s porastom izloženosti većim od onog proporcionalnog dozi uočenim za doze između 1 i 3 mg/kg.
Based on a normal approximation of the difference in % response
Na temelju normalne aproksimacije razlike u % odgovora.
Based on a parallel group comparison
Zasnovano na usporedbi paralelnih skupina.
Based on a pharmacokinetic analysis of 44 patients with mild hepatic impairment and 330 patients with normal hepatic function osimertinib exposures were similar.
Na temelju farmakokinetičkih analiza u 44 bolesnika s blagim oštećenjem funkcije jetre i 330 bolesnika s normalnom funkcijom jetre, izloženosti osimertinibu bile su slične.
Based on a pharmacokinetic study with 12 subjects ≥12 years with VWD, the following pharmacokinetic characteristics for VWF:RCo, VWF:Ag, VWF:CB and FVIII:C were observed:
Na temelju farmakokinetičkog ispitivanja s 12 ispitanika ≥12 godina uočene su sljedeće farmakokinetičke karakteristike za VWF:RCo, VWF:Ag, VWF:CB i FVIII:C:
Based on a pharmacokinetic study with 12 subjects ≥12 years with VWD, the following pharmacokinetic characteristics for VWF:RCo, VWF:Ag, VWF:CB and FVIII:C were observed:
Na temelju farmakokinetičkog ispitivanja u 12 ispitanika ≥12 godina s von Willebrandovom bolešću uočene su sljedeće farmakokinetičke karakteristike za VWF:RCo, VWF:Ag, VWF:CB i FVIII:C:
Based on a pharmacokinetic study with 16 subjects with haemophilia A, the following pharmacokinetic characteristics for FVIII:C were observed:
Na temelju farmakokinetičkih ispitivanja u 16 ispitanika s hemofilijom A uočene su sljedeće farmakokinetičke karakteristike:
Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild (calculated creatinine clearance [CLcr] 60-89 mL/min, n = 43), or moderate (CLcr 30-59 mL/min, n = 15) renal impairment compared to patients with normal renal function (CLcr ≥90 mL/min, n = 85).
Prema populacijskoj farmakokinetičkoj analizi nisu primijećene klinički značajne razlike u klirensu olaratumaba između bolesnika s blagim (izračunati klirens kreatinina [CLcr] 60 – 89 ml/min, n = 43) ili umjerenim (CLcr 30 – 59 ml/min, n = 15) oštećenjem funkcije bubrega i bolesnika s normalnom funkcijom bubrega (CLcr ≥ 90 ml/min, n = 85).
Based on a PopPK model, an increase in nintedanib exposure of approximately 20 - 25% was observed in patients ≥ 75 years compared with patients under 65 years.
Na temelju modela PopPK, povećanje izloženosti nintedanibu od približno 20-25% opaženo je u bolesnika u dobi ≥ 75 godina u usporedbi s bolesnicima ispod 65 godina.
Based on a population pharmacokinetic (PK) analysis no dosage adjustment is necessary for patients with renal impairment (see section 5.2).
S obzirom na rezultate populacijske farmakokinetičke analize, nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrežne funkcije (vidjeti dio 5.2).
Based on a population pharmacokinetic analysis in patients 19 – 78 years of age, clearance of TMZ is not affected by age.
Na temelju farmakokinetičke analize populacije bolesnika u dobi od 19 do 78 godina, dob ne utječe na klirens TMZ-a.
Based on a population pharmacokinetic analysis increasing exposure (AUC) in patients with moderate and severe renal impairment at initiation of treatment during studies was observed (see sections 4.2 and 5.2).
Temeljem farmakokinetičke analize populacije, tijekom ispitivanja zapaženo je povećanje izloženosti lijeku (AUC) na početku liječenja bolesnika s umjerenim i teškim oštećenjem funkcije bubrega (vidjeti dijelove 4.2 i 5.2).
Based on a population pharmacokinetic analysis of 48 patients with mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin >1.0 to 1.5 times ULN and any AST) and
Na temelju populacijske farmakokinetičke analize 48 bolesnika s blagim oštećenjem jetre (ukupni bilirubin ≤GGN i AST >GGN ili ukupni bilirubin >1,0 do 1,5 puta GGN i bilo koji AST) te
Based on a population pharmacokinetic analysis of 97 patients with mild renal impairment (CLcr 60 to
Na temelju populacijske farmakokinetičke analize 97 bolesnika s blagim oštećenjem bubrega (CLcr 60 do <90 ml/min), 22 bolesnika s umjerenim oštećenjem bubrega (CLcr 30 do <60 ml/min) te
Based on a population pharmacokinetic analysis of the PEGASUS study the median ticagrelor Cmax was 391 ng/ml and AUC was 3801 ng*h/ml at steady state for ticagrelor 60 mg.
Temeljeno na analizi populacijske farmakokinetike u studiji PEGASUS, medijan tikagrelora Cmax bio je 391 ng/ml, a AUC 3801 ng*h/ml u stanju ravnoteže za tikagrelor od 60 mg.
Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Na temelju populacijske farmakokinetičke analize klirens bortezomiba povećava se s porastom površine tijela (od engl.body surface area, BSA).
Based on a population pharmacokinetic analysis, gender has no impact on alirocumab pharmacokinetics.
Prema populacijskoj farmakokinetičkoj analizi, spol ne utječe na farmakokinetiku alirokumaba.
Based on a population pharmacokinetic analysis, there are no special instructions for use in the older people.
Na temelju populacijske farmakokinetičke analize, nema posebnih uputa za primjenu u starije osoba.
Based on a population pharmacokinetic analysis, there are no special instructions for use in theolder people.
Na temelju populacijske farmakokinetičke analize, nema posebnih uputa za primjenu u starijih osoba.
Based on a population pharmacokinetics (PK) and pharmacokinetic pharmacodynamic (PK/PD) analysis, sunitinib at doses of 25 mg/m2/day on schedule 4/2 in paediatric patients (ages 6-11 and 12-17 years) with GIST is predicted to provide comparable sunitinib plasma exposures, and subsequently safety and efficacy profiles, to those in adult patients with GIST treated at 50 mg/day on schedule 4/2.
Na temelju populacijske farmakokinetike (FK) i farmakokinetičke-farmakodinamičke (FK/FD) analize, predviđa se da će sunitinib pri dozama od 25 mg/m2/dan po shemi 4/2 za pedijatrijske bolesnike (u dobi od 6-11 i 12-17 godina) s GIST-om dati usporedne vrijednosti izloženosti sunitinibu u plazmi, te posljedično i profile sigurnosti i djelotvornosti, s onima kod odraslih bolesnika s GIST-om liječenima dozom od 50 mg/dan po shemi 4/2.
Based on a population PK analysis in patients with mild (BSA-indexed CrCl 50 to 80 mL/min, n=58) and moderate (BSA-indexed CrCl 30 to 50 mL/min, n=16) renal impairment, mild and moderate impaired renal function had no clinically significant effect on the pharmacokinetics of vismodegib (see section 4.2).
Na temelju populacijske farmakokinetičke analize provedene u bolesnika s blagim (klirens kreatinina [ClCr] indeksiran prema površini tijela: 50-80 ml/min, n=58) i umjerenim (ClCr indeksiran prema površini tijela: 30-50 ml/min, n=16) oštećenjem bubrežne funkcije, utvrđeno je da blago i umjereno oštećenje bubrežne funkcije nije imalo klinički značajnog utjecaja na farmakokinetiku vismodegiba (vidjeti dio 4.2).
Based on a population PK analysis using data from 375 patients, the clearance of elotuzumab increased with increasing body weight supporting a weight-based dose.
Prema populacijskoj farmakokinetičkoj analizi podataka prikupljenih u 375 bolesnika, klirens elotuzumaba povećavao se s povećanjem tjelesne težine, što podupire doziranje na temelju tjelesne težine.
Based on a population PK analysis, no dosage adjustments are necessary for patients with mild hepatic impairment (Total Bilirubin [TB] 1.0 x to 1.5 x upper limit of normal [ULN] or aspartate aminotransferase [AST] > ULN).
S obzirom na rezultate populacijske farmakokinetičke analize, nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem jetrene funkcije (ukupni bilirubin 1,0 – 1,5 x iznad gornje granice normale [GGN] ili aspartat aminotransferaza [AST] > GGN).
Based on a reduction in body weight in both genders and a delayed preputial separation in males (which may be associated with the reduction in weight), the No-Observed-Effect- Level in juvenile rats was considered to be 6 mg/kg/day.
Na temelju sniženja tjelesne težine u oba spola i odgođenog odvajanja prepucija u mužjaka (što može biti povezano sa sniženjem tjelesne težine), doza od 6 mg/kg/dan se smatrala dozom bez opaženog učinka (No-Observed-Effect- Level) u mladih štakora.
Based on a retrospective study, a minority of patients (12%) required a re-initiation of systemic treatment.
Na temelju retrospektivne studije, kod manjine bolesnika (12%) bilo je potrebno ponoviti sistemsko liječenje.
Based on a study conducted in healthy volunteers, therapeutic doses of retigabine (600-1,200 mg/day) resulted in a minor (8-18%) increase in digoxin AUC following a single oral dose of digoxin.
Na temelju ispitivanja na zdravim dobrovoljcima, primjena terapijskih doza retigabina (600 – 1200 mg/dan) rezultirala je manjim porastom (8-18%) AUC digoksina nakon jednokratne peroralne doze digoksina.
Based on a whole blood mean Cmax concentration of 2.6 μM for temsirolimus in MCL patients receiving the 175 mg dose there is a potential for interactions with concomitantly administered medicinal products that are substrates of CYP3A4/5 in patients treated with the 175 mg dose of temsirolimus (see section 4.5).
Na temelju srednje vrijednosti Cmax temsirolimusa u punoj krvi od 2,6 μM u bolesnika s limfomom plaštenih stanica koji su primali dozu od 175 mg, u bolesnika liječenih dozom temsirolimusa od 175 mg postoji mogućnost interakcija s istodobno primijenjenim lijekovima koji su supstrati CYP3A4/5 (vidjeti dio 4.5) .
Based on all field studies, the proportion of mastitis prevented due to herd treatment with Imrestor (Prevented Fraction) is 0.25 (with 95% confidence interval 0.14 – 0.35).
Na osnovi svih terenskih ispitivanja omjer mastitisa spriječenog zahvaljujući primjeni Imrestor na stadu (prevenirana frakcija) je 0,25 (uz 95 % intervala pouzdanosti od 0,14 - 0,35).
Based on all field studies, the proportion of mastitis prevented due to herd treatment with Imrestor (Prevented Fraction) is 0.25 (with 95% confidence interval 0.14 – 0.35).
Na osnovi svih terenskih ispitivanja omjer mastitisa spriječenog zahvaljujući primjeni Imrestora na stadu (prevenirana frakcija) je 0,25 (uz 95 % intervala pouzdanosti od 0,14 - 0,35).
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, 4 events of thrombocytopenia after cessation of treatment were reported, n = 271 (see section 4.4).
Analizom svih odraslih bolesnika s ITP-om koji su primali romiplostim u 4 kontrolirana i 5 nekontroliranih kliničkih ispitivanja nakon prekida liječenja nađena su 4 događaja trombocitopenije, n = 271 (vidjeti dio 4.4)
Based on an analysis of all mCRC clinical trial patients receiving Vectibix monotherapy and in combination with chemotherapy (n = 2,588), the most commonly reported adverse reactions are skin reactions occurring in 93% of patients.
Na temelju analize svih bolesnika u kliničkom ispitivanju s mKRK-om koji su primali Vectibix kao monoterapiju i u kombinaciji s kemoterapijom (n = 2588) najčešće prijavljene nuspojave su kožne reakcije koje se pojavljuju u 93% bolesnika.
Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Na temelju rezultata analize populacijske farmakokinetike u fazi II kliničkih ispitivana, istodobna primjena s deksametazonom, proklorperazinom, fenitoinom, karbamazepinom, ondansetronom, antagonistima H2-receptora te fenobarbitalom nije promijenila klirens TMZ-a.
Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Na temelju rezultata analize populacijske farmakokinetike u fazi II kliničkih ispitivanja, istodobna primjena s deksametazonom, proklorperazinom, fenitoinom, karbamazepinom, ondansetronom, antagonistima H2-receptora te fenobarbitalom nije promijenila klirens TMZ-a.
Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Na temelju rezultata analize populacijske farmakokinetike u kliničkim ispitivanjima faze , istodobna primjena s deksametazonom, proklorperazinom, fenitoinom, karbamazepinom, ondansetronom, antagonistima H2-receptora te fenobarbitalom nije promijenila klirens TMZ-a.
Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Na temelju rezultata analize populacijske farmakokinetike u u fazi II kliničkih ispitivanja, istodobna primjena s deksametazonom, proklorperazinom, fenitoinom, karbamazepinom, ondansetronom, antagonistima H2-receptora te fenobarbitalom nije promijenila klirens TMZ-a.
Based on an estimated exposure of 566,923 patient treatment years, this results in a reporting rate of approximately 0.20%.
Na temelju procijenjene izloženosti od 566 923 bolesnik-godina liječenja, ovo dovodi do izvještajne stope od oko 0,20%.
Based on analysis of population pharmacokinetics and disappearance of ranibizumab from serum for patients with neovascular AMD treated with the 0.5 mg dose, the average vitreous elimination half- life of ranibizumab is approximately 9 days.
Na temelju analize populacijske farmakokinetike i uklanjanja ranibizumaba iz seruma bolesnika s neovaskularnim AMD-om liječenih dozom od 0,5 mg, prosječno poluvrijeme eliminacije ranibizumaba iz staklovine iznosi oko 9 dana.
Based on AUC exposure, the NOEL of 30 mg/kg/day for pheochromocytomas and renal tubular tumours is approximately 4.5 times the exposure at the daily clinical dose of 300 mg.
Temeljeno na izloženosti AUC, NOEL od 30 mg/kg/ dan za feokromocitome i bubrežne tubularne tumore je približno 4,5 puta izloženosti pri dnevnoj kliničkoj dozi od 300 mg.
Based on AUC(0 – inf), lenvatinib accounted for 60% and 64% of the total radioactivity in plasma and blood, respectively.
Na temelju vrijednosti AUC(0 – inf), na lenvatinib je otpalo 60% radioaktivnosti u plazmi i 64% radioaktivnosti u krvi.
Based on AUC(0 – inf), lenvatinib accounted for 60% and 64% of the total radioactivity in plasma and blood, respectively.
Na temelju vrijednosti AUC(0 – inf), na lenvatinib je otpalo 60% ukupne radioaktivnosti u plazmi i 64% ukupne radioaktivnosti u krvi.
Based on available data from patients receiving cinacalcet in placebo controlled studies and single-arm studies the most commonly reported adverse reactions were nausea and vomiting.
Na temelju dostupnih podataka od bolesnika koji su primali sinakalcet u placebom kontroliranim ispitivanjima i ispitivanjima na jednoj skupini, najčešće zabilježene nuspojave bile su mučnina i povraćanje.
Based on available data, ceritinib is eliminated primarily via the liver.
Na temelju dostupnih podataka, ceritinib se eliminira prvenstveno putem jetre.
Based on available data, the Committee concluded that PecFent’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Na temelju dostupnih podataka, Povjerenstvo je zaključilo da koristi lijeka PecFent nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
Based on available safety and efficacy data in the elderly, no dose adjustment is required (see section 5.2).
Temeljem dostupnih podataka o sigurnosti i djelotvornosti u starijih bolesnika, dozu nije potrebno prilagođavati (vidjeti dio 5.2).
Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 PI mutations).
Na temelju dostupnih viroloških i kliničkih podataka u odraslih bolesnika, ne očekuje se da će liječenje biti korisno u bolesnika zaraženih sojevima koji su rezistentni na više inhibitora proteaze (≥ 4 mutacije rezistencije na inhibitore proteaze).
Based on average Cmin concentrations, a predicted average concentration (Cav) could be calculated for 186 subjects dosed with 300 mg.
Na temelju prosječnih Cmin koncentracija, predviđena prosječna koncentracija (Cav) mogla se izračunati za 186 ispitanika koji su primali dozu od 300 mg.
Based on between-study comparisons, the absolute bioavailability of cinacalcet in fasted subjects has been estimated to be about 20-25%.
Na osnovi usporedbe između studija, apsolutna bioraspoloživost sinakalceta u osoba koje su na tašte procijenjena je na oko 20 do 25 %.
Based on CHMP approved protocol, the applicant shall conduct a clinical study with adequate surrogate endpoints on vascular outcomes using imaging techniques to monitor vascular function, disease stabilisation and/or regression.
Prema protokolu koji je odobrilo Povjerenstvo za humane lijekove (CHMP), podnositelj zahtjeva za odobrenje provest će kliničko ispitivanje s odgovarajućim surogatnim mjerama vaskularnih ishoda upotrebom tehnika snimanja kojima će se nadzirati funkcija vaskularnog sustava, stabilizacija bolesti i/ili regresija.
Based on clinical (percent predicted FEV1) and pharmacodynamic (sweat chloride) responses to ivacaftor, efficacy in patients with the G970R mutation could not be established.
Na temelju kliničkog (postotak predviđenog FEV1) i farmakodinamičkog (klorid u znoju) odgovora na ivakaftor, u bolesnika s mutacijom G970R nije se mogla ustanoviti djelotvornost.
based on clinical effect.
na temelju kliničkog učinka.
Based on clinical experience, dronedarone has a low pro-arrhythmic effect and has shown a decrease in arrhythmic death in the ATHENA study (see section 5.1).
Kliničko iskustvo pokazalo je da dronedaron ima slab proaritmijski učinak, a u ispitivanju ATHENA doveo je do smanjenja broja smrti uzrokovanih aritmijom (vidjeti dio 5.1).
Based on clinical studies, the rate of localisation (percent of all patients with at least one hot node) and degree of localisation (average number of hot nodes per patient) of Lymphoseek is not dependent on the radiopharmaceutical injection technique.
Na temelju kliničkih ispitivanja, stopa lokalizacije (postotka svih bolesnika s najmanje jednim zahvaćenim čvorom) i stupnja lokalizacije (prosječan broj zahvaćenih čvorova po bolesniku) lijeka Lymphoseek ne ovise o radiofarmaceutskoj tehnici ubrizgavanja.
Based on clinical study experience with Viramune immediate-release tablets and oral suspension of 361 paediatric patients the majority of which received combination treatment with ZDV or/and ddI, the most frequently reported adverse events related to nevirapine were similar to those observed in adults.
Na temelju iskustva iz kliničkog ispitivanja s Viramune tabletama s trenutnim oslobađanjem i oralnom suspenzijom na 361 pedijatrijskom bolesniku, od kojih je većina primala kombinirano liječenje sa zidovudinom i/ili didanozinom, najčešće prijavljene nuspojave povezane s nevirapinom bile su slične onima opaženih u odraslih osoba.
Based on clinical trial data the inhalation powder TOBI Podhaler was associated with a higher reported rate of cough compared with tobramycin nebuliser solution (TOBI).
Na temelju podataka iz kliničkih ispitivanja, prašak inhalata TOBI Podhaler bio je povezan s većom prijavljenom stopom kašlja u usporedbi s tobramicin otopinom za nebulizator (TOBI).
Based on clinical trial experience, Ilaris does not appear to increase the incidence of MAS in SJIA patients, but no definitive conclusion can be made.
Na temelju iskustava iz kliničkih ispitivanja, čini se da Ilaris ne povećava incidenciju MAS-a u bolesnika sa SJIA-om, ali ne mogu se donijeti konačni zaključci.
Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with Exelon capsules or oral solution can be switched to Exelon transdermal patches as follows:
Na temelju usporedive izloženosti oralnom i transdermalnom rivastigminu (vidjeti dio 5.2), bolesnici liječeni Exelon kapsulama ili oralnom otopinom mogu prijeći na Exelon transdermalne flastere na sljedeći način:
Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with Prometax capsules or oral solution can be switched to Prometax transdermal patches as follows:
Na temelju usporedive izloženosti oralnom i transdermalnom rivastigminu (vidjeti dio 5.2), bolesnici liječeni Prometax kapsulama ili oralnom otopinom mogu prijeći na Prometax transdermalne flastere na sljedeći način:
Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with rivastigmine capsules or oral solution can be switched to Rivastigmine 3M Health Care Ltd. transdermal patches as follows:
Na temelju usporedive izloženosti oralnom i transdermalnom rivastigminu (vidjeti dio 5.2), bolesnici liječeni kapsulama ili oralnom otopinom s rivastigminom mogu prijeći na Rivastigmin3M Health Care Ltd. transdermalne flastere na sljedeći način:
Based on cross-stud y comparison to 600 mg saquinavir three times daily alone.
Zasniva se na usporedbi među ispitivanjima sa 600 mg sakvinavira triput na dan, u monoterapiji.
Based on cross-stud y comparison to 600 mg saquinavir three times daily alone.
Zasniva se na usporedbi među ispitivanjima sa 600 mg sakvinavira triput na dan, u monoterapiji..
Based on cross-study comparison to 400 mg atazanavir once daily alone.
Zasniva se na usporedbi među ispitivanjima s 400 mg atazanavira jedanput na dan , u monoterapiji.
Based on cross-study comparison to 600 mg saquinavir three times daily alone.
Zasniva se na usporedbi među ispitivanjima sa 600 mg sakvinavira triput na dan, u monoterapiji.
Based on cross-study comparison to 800 mg indinavir three times daily alone.
Zasniva se na usporedbi među ispitivanjima s 800 mg indinavira triput na dan, u monoterapiji..
Based on cumulative reviews a total of 7 cases have been reported demonstrating a likely interaction between orlistat and benzodiazepines.
Na temelju kumulativnih pregleda prijavljeno je ukupno 7 slučajeva koji pokazuju vjerojatnu interakciju između orlistata i benzodiazepina.
Based on dabigatran concentrations and clinical assessment, the dose was subsequently modified to a target dose of 2.14 (± 10 %) mg/kg of dabigatran etexilate (100 % of the adult dose adjusted for the patient’s weight).
Na osnovi koncentracija dabigatrana i kliničke ocjene, doza je naknadno modificirana do ciljne doze od 2,14 (± 10 %) mg/kg dabigatraneteksilata (100 % doze za odrasle prilagođene bolesnikovoj težini).
Based on data collected from secondary contacts in households where there was an index case with typical pertussis
Na temelju podataka prikupljenih od sekundarnih kontakata u domaćinstvima u kojima je bio registriran slučaj s tipičnom kliničkom slikom pertusisa.
Based on data for other CYP3A inhibitors,
Temeljeno na podacima za druge