natgillin/translations-raw huggingface dataset:
No definitive conclusion can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study, but given the lack of binding of vedolizumab to male reproductive tissue in monkey and human, and the intact male fertility observed in β7 integrin-knockout mice, it is not expected that vedolizumab will affect male fertility.
Ne može se donijeti konačan zaključak o reproduktivnim organima mužjaka kod ispitivanja toksičnosti ponovljene doze na makaki majmunima, ali s obzirom da se vedolizumab ne veže na tkivo muških reproduktivnih organa u majmuna i ljudi, te s obzirom na intaktnu plodnost uočenu kod mužjaka miševa s deficitom β7 integrina, utjecaj vedolizumaba na plodnost muškaraca se ne očekuje.
No definitive conclusion on adverse effects can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Iz ispitivanja toksičnosti ponovljenih doza na makaki majmunima ne mogu se izvući konačni zaključci o štetnim učincima na muške reproduktivne organe.
No detrimental effects on such activities are predicted from the pharmacology of Benlysta.
Farmakologija lijeka Benlysta ne predviđa nikakve štetne učinke pri takvim aktivnostima.
No development effects were seen at 3.4-fold human exposure at 400 mg twice daily based on AUC0-24 hr (see section 4.6).
Pri razini izloženosti 3,4 puta većoj od izloženosti u ljudi kod primjene doze od 400 mg dvaput na dan izračunate na temelju AUC0-24h (vidjeti dio 4.6) nisu zapaženi učinci na razvoj.
No development effects were seen at 3.4-fold human exposure at 400 mg twice daily based on AUC0-24 hr (see section 4.6).
Pri razini izloženosti 3,4 puta većoj od izloženosti u ljudi pri primjeni doze od 400 mg dvaput na dan izračunate na temelju AUC0-24h (vidjeti dio 4.6) nisu zapaženi učinci na razvoj.
No development of resistance was observed during treatment with retapamulin in the clinical study programme and all clinical isolates were inhibited by retapamulin concentrations of <2 g/ml.
Tijekom programa kliničkog ispitivanja nije uočen razvoj rezistencije za vrijeme liječenja retapamulinom i svi su klinički izolati bili inhibirani koncentracijama retapamulina od <2 g/ml.
No development toxicity was observed at 1 mg/kg/day (approximate exposure ≥0.9 times the AUC in patients administered the RDD).
Pri dozi od 1 mg/kg na dan nije zabilježena toksičnost za razvoj (približna ekspozicija ≥ 0,9 puta od AUC-a u bolesnika koji su dobivali preporučenu dnevnu dozu).
No difference was evident between the two arms as regards the proportion of patients who discontinued because of ADRs (2.5% on everolimus versus 2.6% on placebo).
Nije bilo uočene razlike između dvije skupine s obzirom na udio bolesnika koji su prekinuli terapiju zbog nuspojava na lijek (2,5% na everolimusu u usporedbi s 2,6% na placebu).
No differences in FORSTEO pharmacokinetics were detected with regard to age (range 31 to 85 years).
Nisu otkrivene razlike u farmakokinetici lijeka FORSTEO s obzirom na dob (u rasponu od 31 do 85 godina).
No differences in Preotact pharmacokinetics were detected with regard to age (range 47-88 years).
Nije zabilježena razlika u farmakokinetici Preotacta s obzirom na dob pacijenata (raspon od 47-88 godina).
No differences in the metabolic profiles of granisetron were observed between the oral and transdermal uses.
Nisu opažene razlike u metaboličkim profilima granisetrona pri peroralnoj i transdermalnoj primjeni.
No differences were seen in the pharmacodynamic properties between adult and elderly study patients.
Nisu uočene razlike u farmakodinamičkim svojstvima između studija za odrasle osobe i za starije bolesnike.
No differences were seen in the pharmacodynamic properties between adult and paediatric study patients.
Nisu uočene razlike u farmakodinamičkim svojstvima između studija za odrasle osobe i za djecu.
No differences were seen in the pharmacokinetic parameters between adult and elderly study patients.
Nisu uočene razlike u farmakokinetičkim parametrima u odraslih i starijih bolesnika.
No differences were seen in the pharmacokinetic parameters between adult and paediatric study patients.
Nisu uočene razlike u farmakokinetičkim parametrima u odraslih i pedijatrijskih pacijenata.
No direct comparison of follitropin alfa/LH versus human menopausal gonadotropin (hMG) has been performed.
Dosad nisu izravno uspoređene terapija lijekom folitropin alfa/LH i terapija humanim menopauzalnim gonadotropinom (hMG).
No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio = 1.16, 95 % CI [0.73, 1.83] for DCarbH (TCH) versus ACD (ACT); hazard ratio 0.97, 95 % CI [0.60, 1.55] for ACDH (ACTH) versus ACD).
Nije primijećena prednost u pogledu preživljenja bez bolesti u toj podskupini bolesnica (omjer hazarda = 1,16; 95% CI [0,73; 1,83] za skupinu DCarbH (TCH), naspram AC→D (AC→T); omjer hazarda od 0,97; 95% CI [0,60; 1,55] za AC→DH (AC→TH) naspram AC→D).
No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio = 1.16, 95 % CI [0.73, 1.83] for DCarbH (TCH) versus ACD (ACT); hazard ratio 0.97, 95 % CI [0.60, 1.55] for ACDH (ACTH) versus ACD).
Nije primijećena prednost u pogledu preživljenja bez bolesti u toj podskupini bolesnica (omjer hazarda = 1,16; 95% CI [0,73; 1,83] za skupinu DCarbH (TCH), naspram AC→D (AC→T); omjer hazarda od 0,97; 95% CI [0,60; 1,55] za AC→DH (AC→TH) naspram AC→D.
No disinfectants or other substances impairing the performance of the live vaccine should be used in the sprayer.
Dezinfekcijska sredstva ili druge tvari koje mogu umanjiti učinkovitost žive vakcine ne smiju se upotrijebiti u uređaju za raspršivanje.
No display
Nema prikaza
No distinct correlation between the maintenance opioid dose and Instanyl doses have been established, however in the second pivotal study patients with low maintenance opioid dose tended to achieve effective pain relief with a correspondingly lower strength of Instanyl compared to patients taking higher levels of maintenance opioid dose.
Nije ustanovljena direktna povezanost između doze opijata u terapiji održavanja kronične boli i doze Instanyla, međutim u drugom pivotalnom ispitivanju su bolesnici na nižim dozama opioida u terapiji održavanja u pravilu postizali adekvatno ublažavanje bola s odgovarajuće nižom dozom Instanyla u usporedbi s pacijentima koji su u terapiji održavanja koristili više doze opioida.
No dosage adjustment
S antacidima, inhibitorima
No dosage adjustment in elderly patients is necessary.
U starijih bolesnika dozu ne treba prilagođavati.
No dosage adjustment is considered necessary in patients with hepatic impairment (see section 5.2).
Ne smatra se potrebnim prilagođavati dozu u bolesnika s oštećenjem jetrene funkcije (vidjeti dio 5.2).
No dosage adjustment is considered necessary.
Nije potrebna prilagodba doze.
No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh score 5-6).
Općenito nije potrebna prilagodba doziranja u bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh rezultat 5-6).
No dosage adjustment is necessary for HIV-infected patients with mild hepatic impairment.
Nije potrebna prilagodba doze u bolesnika zaraženih HIV-om s blagim oštećenjem jetre.
No dosage adjustment is necessary for patients with hepatic impairment (see section 5.2).
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem jetrene funkcije (vidjeti dio 5.2).
No dosage adjustment is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score 5-8).
Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (Child Pugh rezultat 5-8).
No dosage adjustment is necessary for patients with mild to moderate renal impairment.
Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem bubrega.
No dosage adjustment is necessary for patients with mild, moderate or severe renal impairment not undergoing dialysis.
Nije potrebno prilagođavati dozu u bolesnika s blagim, umjerenim ili teškim oštećenjem bubrežne funkcije koji se ne liječe dijalizom.
No dosage adjustment is necessary if methadone is co- administered with REYATAZ and ritonavir.
Nije potrebna prilagodba doze ako se metadon primjenjuje istovremeno s lijekom REYATAZ i ritonavirom.
No dosage adjustment is necessary if methadone is co- administered with REYATAZ.
Nije potrebna prilagodba doze ako se metadon primjenjuje istovremeno s lijekom REYATAZ.
No dosage adjustment is necessary if you have a mildly impaired liver function.
Ako imate blago oštećenu funkciju jetre, nije potrebna prilagodba doze.
No dosage adjustment is necessary if you have a mildly or moderately impaired kidney function.
Ako imate blago ili umjereno oštećenu funkciju bubrega, nije potrebna prilagodba doze.
No dosage adjustment is necessary in elderly patients (see section 5.2).
Nije potrebna prilagodba doze u starijih bolesnika (vidjeti dio 5.2).
No dosage adjustment is necessary in patients with hepatic impairment (see section 5.2).
U bolesnika s oštećenjem jetrene funkcije nije potrebno prilagođavati dozu (vidjeti dio 5.2).
No dosage adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 – 80 ml/min).
Nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem bubrežne funkcije (klirens kreatinina 50-80 ml/min).
No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Nije potrebna prilagodba doze u bolesnika s oštećenom funkcijom bubrega čiji je klirens kreatinina ≥ 30 ml/min (vidjeti dijelove 4.3. i 4.4.).
No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Nije potrebna prilagodba doze u bolesnika s oštećenom funkcijom bubrega čiji je klirens kreatinina ≥ 30 ml/min (vidjeti odjeljke 4.3. i 4.4.).
No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Nije potrebna prilagodba doze u bolesnika s oštećenom funkcijom bubrega čiji je klirens kreatinina ≥ ml/min (vidjeti dijelove 4.3 i 4.4).
No dosage adjustment is necessary in patients with renal insufficiency.
Prilagođavanje doze za bolesnike s bubrežnom insuficijencijom nije potrebno.
No dosage adjustment is needed in patients with mild or moderate renal impairment (see section 5.2).
U bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega nije potrebno prilagođavati dozu (vidjeti dio 5.2.).
No dosage adjustment is recommended in patients with impaired hepatic function (see section 5.2).
Ne preporučuje se prilagodba doze u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
No dosage adjustment is required based on age (see section 5.2).
Nije potrebna prilagodba doze na temelju dobi (vidjeti dio 5.2.).
No dosage adjustment is required for female patients as compared to male patients (see section 5.2).
Nije potrebno prilagođivati dozu u žena u usporedbi s muškarcima (vidjeti dio 5.2).
No dosage adjustment is required for patients with mild renal impairment.
Nije potrebno prilagodba doziranja u bolesnika s blagim oštećenjem bubrežne funkcije.
No dosage adjustment is required for patients with renal impairment (see section 5.2).
Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
No dosage adjustment is required for patients with renal impairment (see section 5.2).
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
No dosage adjustment is required for patients with renal or mild and moderate hepatic impairment.
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije bubrega ili blagim i umjerenim oštećenjem funkcije jetre.
No dosage adjustment is required for patients ≥ 65 years of age (see section 5.2).
Nije potrebno prilagođavati dozu u bolesnika u dobi od ≥65 godina (vidjeti dio 5.2.).
No dosage adjustment is required for the elderly with creatinine clearance values > 50 ml/min (see section 5.2).
Nije potrebna prilagodba doziranja u starijih bolesnika s vrijednostima klirensa kreatinina > 50 ml/min (vidjeti dio 5.2).
No dosage adjustment is required in elderly patients (see section 5.2).
Nije potrebno prilagođavati dozu kod starijih bolesnika (vidjeti dio 5.2).
No dosage adjustment is required in patients over 65 years.
Nije potrebno prilagođavati dozu u bolesnika starijih od 65 godina.
No dosage adjustment is required in patients with hepatic impairment (see section 5.2).
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
No dosage adjustment is required in patients with hepatic impairment.
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije jetre.
No dosage adjustment is required in patients with mild or moderate renal impairment.
Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije.
No dosage adjustment is required in patients with mild renal impairment (estimated CrCL ≥ 51 -
Nije potrebno prilagođavati dozu kod bolesnika s blagim oštećenjem funkcije bubrega (procijenjeni CrCL
No dosage adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
Nije potrebno podešavanje doze u bolesnika s oštećenjem bubrega (vidjeti dijelove 4.4 i 5.2).
No dosage adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
Nije potrebno prilagođavanje doze u bolesnika s oštećenjem bubrežne funkcije (vidjeti dijelove 4.4 i 5.2).
No dosage adjustment is required in patients with renal impairment.
Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega.
No dosage adjustment is required in patients with renal impairment.
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrežne funkcije.
No dosage adjustment necessary.
Bez potrebe za prilagodbom doze.
No dosage adjustment necessary.
Nije potrebna prilagodba doza.
No dosage adjustment necessary.
Nije potrebno prilagođavanje
No dosage adjustment necessary.
Nije potrebno prilagođavanje doze
No dosage adjustment of
Na temelju opaženih odnosa
no dosage adjustment of abacavir
lučaju ne treba prilagođavati dozu
no dosage adjustment of abacavir
lučaju, ne treba prilagođavati dozu
No dosage adjustment of CoAprovel is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Za bolesnike s blagim ili umjerenim oštećenjem funkcije jetre nije potrebna prilagodba doze lijeka CoAprovel (vidjeti dio 4.3).
No dosage adjustment of CoAprovel is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Za bolesnike s s blagim ili umjerenim oštećenjem funkcijejetre nije potrebna prilagodba doze lijeka CoAprovel (vidjeti dio 4.3).
No dosage adjustment of DUTREBIS or trimethoprim
Nije potrebno prilagođavati dozu lijeka DUTREBIS ili trimetoprima/sulfametoksazola,
No dosage adjustment of entacapone is required for elderly patients.
Starijim bolesnicima nije potrebno posebno prilagođavati doziranje entakapona.
No dosage adjustment of entacapone is required for older people.
Starijim osobama nije potrebno posebno prilagođavati doziranje entakapona.
No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR >30 ml/min/1,73 m2) doziranje Exforgea nije potrebno prilagođavati.
No dosage adjustment of Galafold is required in patients with hepatic impairment (see section 5.2).
U bolesnika s oštećenjem jetre nije potrebna prilagodba doze lijeka Galafold (vidjeti dio 5.2.).
No dosage adjustment of Irbesartan Hydrochlorothiazide Zentiva is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Za bolesnike s blagim ili umjerenim oštećenjem funkcije jetre nije potrebna prilagodba doze lijeka Irbesartan Hydrochlorothiazide Zentiva (vidjeti dio 4.3).
No dosage adjustment of Irbesartan Hydrochlorothiazide Zentiva is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Za bolesnike s blagim ili umjerenim oštećenjem funkcije nije potrebna prilagodba doze lijeka Irbesartan Hydrochlorothiazide Zentiva (vidjeti dio 4.3).
No dosage adjustment of Karvezide is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Za bolesnike s blagim ili umjerenim oštećenjem funkcije jetre nije potrebna prilagodba doze lijeka Karvezide (vidjeti dio 4.3).
No dosage adjustment of Karvezide is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Za bolesnike s s blagim ili umjerenim oštećenjem funkcijejetre nije potrebna prilagodba doze lijeka Karvezide (vidjeti dio 4.3).
No dosage adjustment required for ISENTRESS or hormonal contraceptives (estrogen- and/or progesterone-based).
Nije potrebno prilagođavati dozu lijeka ISENTRESS ili hormonskih kontraceptiva (na bazi estrogena i/ili progesterona).
No dosage adjustment required for ISENTRESS or midazolam.
Nije potrebno prilagođavati dozu lijeka ISENTRESS ili midazolama.
No dosage adjustment seems warranted for patients with moderate hepatic impairment based on limited data.
Na temelju ograničenih podataka čini se da nije opravdana prilagodba doze u bolesnika s umjerenim oštećenjem jetre.
No dosage adjustments are
Nije potrebna prilagodba doza.
No dosage adjustments are necessary in patients with renal impairment based on study data in mild, moderate, and severe renal impairment and end stage renal disease (see sections 4.4 and 5.2).
Na temelju podataka iz ispitivanja za bolesnike s blagim, umjerenim i teškim oštećenjem bubrega te terminalnim bubrežnim zatajenjem nije potrebna prilagodba doze u bolesnika s oštećenjem bubrega. (vidjeti dijelove 4.4 i 5.2).
No dosage reduction is considered necessary but patients with hepatic impairment should initiate treatment with the lower starting dose, 3 g (3 tablets) per day (see section 5.1).
Smatra se da nije nužno smanjenje doze, no bolesnici s oštećenjem jetre trebaju započeti liječenje s nižom početnom dozom od 3 g dnevno (3 tablete) (vidjeti dio 5.1).
No dosage tapering is needed on treatment discontinuation.
Nije potrebno postepeno smanjivati dozu pri prekidu liječenja.
No dose
Nije predviđeno
No dose adjustment
agranulocitoza1,
No dose adjustment
inusitis
No dose adjustment
Istodobna primjena je
No dose adjustment
Nadzor kliničkih učinaka
No dose adjustment
Nije potrebna prilagodba
No dose adjustment
Nije potrebno
No dose adjustment
Nije potrebno nikakvo
No dose adjustment
Nije potrebno prilagođavati
No dose adjustment
Nije potrebno prilagođavati dozu
No dose adjustment
Plodnost
No dose adjustment
preosjetljivost
No dose adjustment
prilagođavati dozu za
No dose adjustment (see section 5.2).
Dozu ne treba prilagođavati (vidjeti dio 5.2).
No dose adjustment (see sections 4.4 and 5.2).
Dozu ne treba prilagođavati (vidjeti dijelove 4.4 i 5.2).
No dose adjustment for apixaban is required during concomitant therapy with such medicinal products, however in patients receiving concomitant systemic treatment with strong inducers of both CYP3A4 and P-gp apixaban should be used with caution for the prevention of stroke and systemic embolism in patients with NVAF and for the prevention of recurrent DVT and PE.
Kod istodobne primjene s takvim lijekovima nije potrebno prilagođavati dozu apiksabana, ali u bolesnika koji istodobno primaju sistemsku terapiju snažnim induktorima CYP3A4 i P-gp apiksaban treba primjenjivati uz oprez u prevenciji moždanog udara i sistemske embolije u bolesnika s nevalvularnom fibrilacijom atrija i u prevenciji ponavljajućih DVT i PE.
No dose adjustment for apixaban is required when coadministered with less potent inhibitors of CYP3A4 and/or P-gp.
Kod istodobne primjene s manje snažnim inhibitorima CYP3A4 i/ili P-gp-a nije potrebno prilagođavati dozu apiksabana.
No dose adjustment for concomitant use of paracetamol is required.
Nije potrebno prilagođavanje doze za istodobnu primjenu paracetamola.
No dose adjustment for cyclobenzaprine required; increase dose if clinically indicated.
prilagođavati dozu za karisoprodol; primijeniti veću dozu ako je to
No dose adjustment for EMEND is necessary for patients with renal impairment or for patients with ESRD undergoing haemodialysis.
U bolesnika s oštećenjem funkcije bubrega i u bolesnika s ESRD-om koji su na hemodijalizi nije potrebno prilagođavati dozu lijeka EMEND.
No dose adjustment for INVEGA is recommended based on gender, race, or smoking status.
Nema posebnih preporuka o prilagodbi doze lijeka INVEGA vezano uz spol, rasu ili pušački status.
No dose adjustment for PREZISTA/ritonavir is recommended.
za kombinacijom PREZISTA/ritonavir i
No dose adjustment for sitagliptin is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Nije potrebna prilagodba doze sitagliptina za bolesnike s blagim ili umjerenim oštećenjem funkcije jetre (Child Pugh rezultat ≤ 9).
No dose adjustment for Viekirax with and without dasabuvir is recommended in HCV-infected patients with mild, moderate or severe renal impairment (see section 4.2).
Ne preporučuje se prilagođavati dozu lijeka Viekirax u kombinaciji s dasabuvirom ili bez njega u bolesnika s infekcijom HCV-om i blagim, umjerenim ili teškim oštećenjem bubrežne funkcije (vidjeti dio 4.2).
No dose adjustment is
bolesnika bez poznatog
No dose adjustment is
Nije potrebna prilagodba
No dose adjustment is
Nije potrebna prilagodba doze.
No dose adjustment is
Nije potrebno prilagođavati
No dose adjustment is
potrebna prilagodba doze lijeka
No dose adjustment is considered necessary for patients with mild hepatic impairment.
Prilagodba doze nije potrebna u bolesnika s blagim oštećenjem funkcije jetre.
No dose adjustment is considered necessary in patients with hepatic impairment.
Smatra se da nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije jetre.
No dose adjustment is considered necessary in patients with renal impairment.
Smatra se da nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega.
No dose adjustment is generally necessary in elderly patients (≥ 65 years).
U starijih bolesnika (≥ 65 godina) općenito nije potrebna prilagodba doze.
No dose adjustment is necessary
Nije potrebno prilagođavati dozu niti jednog lijeka.
No dose adjustment is necessary
Nije potrebno prilagođavati dozu niti jednog od navedenih lijekova.
No dose adjustment is necessary
simeprevira s efavirenzom se ne
No dose adjustment is necessary (see section 5.2).
Nije potrebna prilagodba doze. (vidjeti dio 5.2).
No dose adjustment is necessary (see section 5.2).
Nije potrebno prilagođavanje doze (vidjeti dio 5.2).
No dose adjustment is necessary (see section 5.2).
Prilagođavanje doze nije potrebno (vidjeti dio 5.2).
No dose adjustment is necessary according to gender.
Dozu nije potrebno prilagoĎavati prema spolu bolesnika.
No dose adjustment is necessary based on age (see section 5.2).
Nije potrebno prilagođavati dozu s obzirom na dob (vidjeti dio 5.2).
No dose adjustment is necessary based on age.
Nije potrebno prilagođavanje doze prema dobi.
No dose adjustment is necessary based on gender or race (see section 5.2).
Nije potrebna prilagodba doze prema spolu ili rasi (vidjeti dio 5.2).
No dose adjustment is necessary based on gender.
Nije potrebno prilagođavanje doze u odnosu na spol.
No dose adjustment is necessary based on race (see section 5.2).
Prilagodba doze, na temelju rase, nije potrebna (vidjeti dio 5.2).
No dose adjustment is necessary for any of these medicinal products.
Nije potrebno prilagođavati dozu ni jednog lijeka.
No dose adjustment is necessary for any of these medicinal products.
Nije potrebno prilagođavati dozu niti jednog od navedenih lijekova.
No dose adjustment is necessary for children 8-16 years.
U djece u dobi od 8 do 16 godina nije potrebno prilagođavati dozu.
No dose adjustment is necessary for concomitant use of amiodarone or quinidine (see sections 4.4, 4.5 and 5.2).
Nije potrebno prilagođavanje doze u slučaju istodobne primjene Pradaxe i amiodarona ili kinidina (vidjeti dijelove 4.4, 4.5 i 5.2).
No dose adjustment is necessary for efavirenz.
imvastatinom nije utjecala na
No dose adjustment is necessary for efavirenz.
Nije potrebno prilagoditi dozu efavirenza.
No dose adjustment is necessary for efavirenz.
Nije potrebno prilagođavati dozu