natgillin/translations-raw huggingface dataset:
In the case of major surgical interventions in particular, precise monitoring of substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Osobito u slučaju velikih kirurških zahvata, nadomjesno liječenje je neophodno potrebno precizno nadgledati analizom zgrušavanja (aktivnost faktora IX u plazmi).
In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Osobito u slučaju većih kirurških zahvata neizostavno je precizno praćenje nadomjesne terapije pomoću analize koagulacije (određivanja aktivnosti faktora VIII u plazmi).
In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Osobito u slučaju većih kirurških zahvata neophodno je precizno praćenje nadomjesne terapije analizom zgrušavanja krvi (aktivnosti faktora VIII u plazmi).
In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
U slučaju većih kirurških zahvata obavezna je precizna kontrola nadomjesnog liječenja određivanjem i praćenjem aktivnost faktora VIII u plazmi.
In the case of measles, this impairment may persist for up to 1 year.
U slučaju ospica, umanjena učinkovitost može potrajati i do godinu dana.
In the case of overdosage, seek medical advice.
U slučaju predoziranja potražite veterinarski savjet.
In the case of overdosage, symptomatic treatment should be initiated.
U slučaju predoziranja potrebno je provesti simptomatsku terapiju.
In the case of overdosage, symptomatic treatment should be initiated.
U slučaju predoziranja potrebno je započeti simptomatsko liječenje.
In the case of overdose symptomatic treatment should be initiated.
U slučaju predoziranja potrebno je provesti simptomatsku terapiju.
In the case of overdose symptomatic treatment should be initiated.
U slučaju predoziranja, potrebno je započeti simptomatsko liječenje.
In the case of patients experiencing severe visual loss (best corrected visual acuity less than 6/60 in one or both eyes), XALKORI treatment should be discontinued and appropriate evaluation should be performed.
U slučaju kad bolesnik ima teži gubitak vida (najbolja korigirana oštrina vida manja od 6/60 na jednom ili oba oka), liječenje lijekom XALKORI treba prekinuti i potrebno je napraviti odgovarajuću procjenu
In the case of severe neutropenia (<500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
U slučajevima teške neutropenije (< 500 stanica/mm3 u trajanju od sedam dana ili dulje) za vrijeme liječenja docetakselom, preporuča se smanjenje doze u sljedećim ciklusima liječenja ili primjena odgovarajućih simptomatskih mjera (vidjeti dio 4.2).
In the case of severe neutropenia (<500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
U slučajevima teške neutropenije ( 500 stanica/mm3 u trajanju od sedam dana ili dulje) za vrijeme liječenja docetakselom, preporučuje se smanjenje doze u sljedećim ciklusima liječenja ili primjena odgovarajućih simptomatskih mjera (vidjeti dio 4.2).
In the case of signs suggestive of an adrenal insufficiency, in addition to the general measures to eliminate the drug and reduce its absorption, a 100 mg dose of hydrocortisone should be administered at once, together with saline and glucose infusions.
Ako simptomi ukazuju na adrenalnu insuficijenciju, osim općih mjera uklanjanja lijeka i smanjenja njegove apsorpcije, odmah treba primijeniti 100 mg hidrokortizona zajedno s infuzijom fiziološke otopine i glukoze.
In the case of the following haemorrhagic events, factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
U slučaju sljedećih pojava krvarenja, aktivnost faktora VIII ne smije pasti ispod određene razine aktivnosti u plazmi (u % u odnosu na normalnu ili IU/dl) u odgovarajućem razdoblju.
In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
U slučaju niže navedenih krvarenja aktivnost faktora IX ne bi smjela pasti ispod navedene razine aktivnosti u plazmi (u % u odnosu na normalno ili IU/dl) u odgovarajućem vremenskom razdoblju.
In the case of the following haemorrhagic events, the FVIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) within the corresponding period.
U slučaju sljedećih hemoragijskih događaja aktivnost FVIII ne smije pasti ispod navedene razine plazmatske aktivnosti (izraženo kao % u odnosu na normalnu ili u IU/dl) unutar odgovarajućeg razdoblja.
In the case of tipranavir co-administered with low dose ritonavir, concomitant use with rifampicin is expected to result in sub-optimal levels of tipranavir which may lead to loss of virologic response and possible resistance to tipranavir.
U slučaju primjene tipranavira uz nisku dozu ritonavira očekuje se da istodobna primjena rifampicina rezultira sniženom ekspozicijom tipranaviru, što može dovesti do gubitka virusnog
In the case of treatment failure associated with S. aureus, the presence of strains possessing additional virulence factors (such as Panton- Valentine Leukocidin) should be considered.
U slučaju neuspjeha liječenja povezanog sa S. aureus, treba razmotriti prisutnost sojeva koji posjeduju dodatne faktore virulencije (poput Panton- Valentine Leukocidina).
In the case of treatment-related adverse events, discontinuation of voriconazole and use of alternative antifungal agents must be considered (see section 4.4 and 4.8)
U slučaju štetnih događaja povezanih s liječenjem, treba razmisliti o prekidu uzimanja vorikonazola i primjeni alternativnih antimikotika (vidjeti dijelove 4.4 i 4.8).
In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given as in the recommended immunisation schedule.
U osoba koje nisu cijepljene ili nisu dovršile cijepljenje, dodatne doze treba primijeniti prema preporučenom rasporedu imunizacije.
In the case of unvaccinated or incompletely vaccinates individuals, additional doses should be given as in the recommended immunisation schedules.
U osoba koje nisu cijepljene ili nisu dovršile cijepljenje, dodatne doze treba primijeniti prema preporučenom rasporedu imunizacije.
In the case the required concentration is 4 micrograms/ml:
Ako je potrebna koncentracija od 4 mikrograma/ml:
In the case the required concentration is 8 micrograms/ml:
Ako je potrebna koncentracija od 8 mikrograma/ml:
In the cases evaluated close temporal relationship was reported coupled with a possible mode of action which supports a causal relationship between Ganfort and Dysgeusia.
U ocijenjenim slučajevima zabilježena je bliska vremenska povezanost s mogućim načinom djelovanja, što podržava uzročnu povezanost između Ganforta i disgeuzije.
In the catch-up cohorts, children between 7-11 months of age at first vaccine dose received Synflorix or hepatitis B control vaccine according to a 2-dose primary schedule followed by a booster dose and children between 12-18 months of age at first vaccine dose received 2 doses of either Synflorix or hepatitis A control vaccine.
U kohortama s naknadnom provedbom propuštene ili odgođene uobičajene imunizacije, djeca koja su prvu dozu cjepiva primila u dobi od 7-11 mjeseci primila su Synflorix ili cjepivo protiv hepatitisa B kao kontrolu prema rasporedu primarne imunizacije s 2 doze, a nakon toga i dozu docjepljivanja, dok su djeca koja su prvu dozu cjepiva primila u dobi od 12-18 mjeseci primila 2 doze ili cjepiva Synflorix ili cjepiva protiv hepatitisa A kao kontrolu.
In the challenge studies performed by the company, insufficient protection was seen in approximately one quarter of horses vaccinated with the recommended dose.
U ispitivanjima provjere izvršenim od strane kompanije, vidljiva je nedovoljna zaštita u aproksimativno jednom dijelu konja cijepljenih s preporučenom dozom.
In the chronic toxicity studies no tumourigenic or unexpected mitogenic responses were observed in any tissue type.
U studijama kronične toksičnosti nije zapažen tumorogeni ili neočekivan mitogeni odgovor kod bilo kojeg tipa tkiva.
In the CIDP study, a multicentre open label trial (Privigen impact on mobility and autonomy PRIMA study), patients (who have previously either received IVIG or not) were treated with a Privigen starting dose of 2g/kg bw given over 2-5 days followed by 6 maintenance doses of 1g/kg bw over 1-2 days every three weeks.
U ispitivanju KUDP, multicentričnom otvorenom ispitivanju (PRIMA - Privigen impact on mobility and autonomy study), bolesnici (koji su prethodno primali i.v.Ig ili ne) liječeni su početnom dozom Privigena od 2 g/kg TT davanoj tijekom 2-5 dana nakon čega slijedi šest doza održavanja od 1 g/kg TT tijekom 1 do 2 dana svaka tri tjedna.
In the circulation, dexmedetomidine is largely bound to plasma proteins (93%).
Deksmedetomidin je u cirkulaciji uglavnom vezan uz proteine u plazmi (93%).
In the cirrhosis cohort, 4 patients with hepatocellular carcinoma underwent liver transplantation after 1–71 days of treatment; 3 of the
U kohorti s cirozom, 4 bolesnika s hepatocelularnim karcinomom bila su podvrgnuta presađivanju jetre nakon 1 – 71 dana liječenja; u
In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 were evaluated.
U kliničkom razvojnom programu bilo je procijenjeno 1085 bolesnika s početnom vrijednosti eGFR 30 mL/min/1,73 m2 do < 60 mL/min/1,73 m2.
In the clinical program, there were nine cases of accidental extravasation of Myocet, none of which were associated with severe skin damage, ulceration or necrosis.
U kliničkom programu bilo je devet slučajeva slučajne ekstravazacije od kojih nijedan nije bio povezan s teškim oštećenjem kože, ulceracijom ili nekrozom.
In the clinical studies conducted in infants, children and adolescents, the incidence and nature of symptoms after the first and second vaccination were similar to those occurred in adults or older people.
U kliničkim ispitivanjima provedenim na dojenčadi, djeci i adolescentima, učestalost i priroda simptoma nakon prvog i drugog cijepljenja bili su slični onima koji su se pojavili u odraslih osoba i starijih osoba.
In the clinical studies in cancer patients, the most frequent strengths used were 100 and 200 micrograms.
U kliničkim ispitivanjima na bolesnicima s karcinomom najčešće su korištene jačine od 100 i 200 mikrograma.
In the clinical studies in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH).
U kliničkim ispitivanjima u bolesnika na hemodijalizi sevelamer sam nije imao trajan i klinički značajan učinak na intaktni paratiroidni hormon (iPTH) u serumu.
In the clinical studies mucosal bleedings (i.e. epistaxis, gingival, gastrointestinal, genito urinary) and anaemia were seen more frequently during long term rivaroxaban treatment on top of single or dual anti-platelet therapy.
U kliničkim ispitivanjima krvarenja iz sluznice (tj. epistaksa, krvarenja desni, gastrointestinalno te genitourinarno krvarenje) i anemija zabilježeni su češće tijekom dugotrajnog liječenja rivaroksabanom u usporedbi s jednostrukom ili dvojnom antitrombocitnom terapijom.
In the clinical studies of eltrombopag, overall no clinically significant differences in safety of eltrombopag were observed between subjects aged at least 65 years and younger subjects.
U kliničkim ispitivanjima eltrombopaga, sveukupno nisu zamijećene klinički značajne razlike u sigurnosti njegove primjene između osoba od 65 ili više godina i mlađih ispitanika.
In the clinical studies of Stribild over 144 weeks, 13 (1.9%) subjects in the Stribild group (n = 701) and 8 (2.3%) subjects in the ATV/r+FTC/TDF group (n = 355) discontinued study drug due to a renal adverse reaction.
U kliničkim ispitivanjima Stribilda u trajanju od 144 tjedna, 13 ispitanika (1,9%) iz skupine koja je primala Stribild (n = 701) i 8 ispitanika (2,3%) iz skupine koja je primala ATV/r+ FTC/TDF (n = 355) prekinuli su primanje ispitivanog lijeka zbog nuspojava na bubrezima.
In the clinical studies only patients with cutaneous melanoma were studied.
U kliničkim su ispitivanjima ispitivani samo bolesnici s kožnim melanomom.
In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to Aloxi.
U kliničkim ispitivanjima opažene su sljedeće nuspojave koje su možda ili vjerojatno bile povezane s primjenom lijeka Aloxi.
In the clinical studies there was one report of overdose where the subject ingested 5000 mg of eltrombopag.
U kliničkim ispitivanjima prijavljen je jedan slučaj predoziranja u kojem je ispitanik uzeo 5000 mg eltrombopaga.
In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1).
U kliničkim ispitivanjima u kojima su provedene oftalmološke pretrage, smanjenje oštrine vida i promjene vidnog polja javljali su s većom incidencijom u bolesnika liječenih pregabalinom nego u bolesnika koji su primali placebo; incidencija promjena očne pozadine bila je veća u bolesnika koji su primali placebo (vidjeti dio 5.1).
In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1).
U kliničkim ispitivanjima u kojima su provedene oftalmološke pretrage, smanjenje oštrine vida i promjene vidnog polja javljali su se češće u bolesnika liječenih pregabalinom nego u bolesnika koji su primali placebo; incidencija promjena očne pozadine bila je veća u bolesnika koji su primali placebo (vidjeti dio 5.1).
In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1).
U kliničkim ispitivanjima u kojima su provedeni oftalmološke pretrage i testovi, smanjenje oštrine vida i promjene vidnog polja javljali su se s većom incidencijom u bolesnika liječenih pregabalinom nego u bolesnika koji su primali placebo; incidencija promjena očne pozadine bila je veća u bolesnika koji su primali placebo (vidjeti dio 5.1).
In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1).
U kliničkim ispitivanjima u kojima su provedeni oftalmološke pretrage, smanjenje oštrine vida i promjene vidnog polja javljali su s većom incidencijom u bolesnika liječenih pregabalinom nego u bolesnika koji su primali placebo; incidencija promjena očne pozadine bila je veća u bolesnika koji su primali placebo (vidjeti dio 5.1).
In the clinical studies, Comfortis was compared with a veterinary medicine authorised in the EU for the treatment and prevention of flea infestations (selamectin, a ‘spot-on’ applied to the skin of the dog or cat).
U kliničkim ispitivanjima, Comfortis je uspoređen s veterinarsko-medicinskim proizvodom odobrenim u EU za liječenje i prevenciju infestacije buhama (selamektin, otopina za nakapavanje na kožu pasa ili mačaka).
In the clinical studies, patients randomised to simeprevir in combination with peginterferon alfa-2b and ribavirin obtained numerically lower SVR12 rates and also experienced viral breakthrough and viral relapse more frequently than those treated with simeprevir in combination with peginterferon alfa-2a and ribavirin (see section 5.1).
U kliničkim ispitivanjima, bolesnici randomizirani na simeprevir u kombinaciji sa peginterferonom alfa-2b i ribavirinom postigli su brojčano niže stope SVR12, te su također doživjeli su virološki proboj i virološki relaps češće nego oni koji su liječeni simeprevirom u kombinaciji s peginterferonom alfa-2a i ribavirinom (vidjeti dio 5.1).
In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded.
Bolesnici s vrijednostima kreatinina u serumu > 400 μmol/l ili 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 89% of the subjects one month after the first dose and in 100% one month after the third dose (i.e. month 7).
U kliničkim ispitivanjima, specifična humoralna protutijela protiv hepatitisa A utvrđena su u približno 89% ispitanika mjesec dana nakon prve doze, te u 100% njih mjesec dana nakon treće doze (tj. mjesec 7).
In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 94% of the adults one month after the first dose and in 100% one month after the third dose (i.e. month 7).
U kliničkim ispitivanjima, specifična humoralna protutijela protiv hepatitisa A utvrđena su u približno 94% odraslih osoba mjesec dana nakon prve doze, te u 100% njih mjesec dana nakon treće doze (tj. mjesec 7).
In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10 % of the baseline value (see section 4.4).
U kliničkim je ispitivanjima liječenje zoledronatnom kiselinom nastavljeno tek kad se kreatinin vratio na vrijednosti unutar 10% početne vrijednosti (vidjeti dio 4.4).
In the clinical study evaluating ONIVYDE+5-FU/LV, 5 of 8 underweight patients experienced a grade 3 or 4 adverse reaction, mostly myelosuppression, while 7 of the 8 patients required dose modification such as dose delay, dose reduction or dose discontinuation (see section 4.4).
U kliničkom ispitivanju koje je procjenjivalo ONIVYDE+5-FU/LV, 5 od 8 pothranjenih bolesnika imalo je nuspojave stupnja 3 ili 4, uglavnom mijelosupresiju, dok je za 7 od 8 bolesnika bila potrebna modifikacija doze kao što je odgađanje doze, smanjenje doze ili prekid doziranja (vidjeti dio 4.4).
In the clinical study evaluating ONIVYDE+5-FU/LV, 5 of 8 underweight patients experienced a Grade 3 or 4 adverse reactions, mostly myelosuppression, while 7 of the 8 patients required dose modification such as dose delay, dose reduction or dose discontinuation.
U kliničkom ispitivanju koje je procjenjivalo ONIVYDE+5-FU/LV, 5 od 8 pothranjenih bolesnika imalo je nuspojave stupnja 3 ili 4, uglavnom mijelosupresiju, dok je za 7 od 8 bolesnika bila potrebna modifikacija doze kao što je odgađanje doze, smanjenje doze ili prekid doziranja.
In the clinical study Grade 3 or Grade 4 diarrhoea occurred in 15 out of 117 patients (12.8%) receiving ONIVYDE+5-FU/LV.
U kliničkom ispitivanju proljev stupnja 3 ili stupnja 4 javio se u 15 od 117 bolesnika (12,8%) koji su primali ONIVYDE+5-FU/LV.
In the clinical study in women 24 to 45 years, 98.4%, 98.1%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
U kliničkom ispitivanju u žena u dobi od 24 do 45 godina, 98,4%, žena koje su primile Gardasil postalo je seropozitivno na HPV 6, 98,1% na HPV 11, 98,8% na HPV 16 i 97,4% na HPV 18 mjesec dana nakon
In the clinical study program, many patients were on concomitant antihypertensive therapy (mostly agents acting on the renin-angiotensin system, beta-blockers, calcium antagonists and diuretics) without experiencing an increase in the incidence of orthostatic hypotension.
U programu kliničkog ispitivanja mnogi su bolesnici istovremeno primali antihipertenzivnu terapiju (uglavnom lijekove koji djeluju na sustav renin-angiotenzin, beta-blokatore, antagoniste kalcija i diuretike), a da pritom incidencija ortostatske hipotenzije nije bila povećana.
In the clinical study, early diarrhoea onset occurred in 35 patients (29.9%) and cholinergic events occurred in 4 patients (3.4%) receiving ONIVYDE+5-FU/LV.
U kliničkom ispitivanju, rani nastup proljeva javio se u 35 bolesnika (29,9%), a kolinergički događaji javili su se u 4 bolesnika (3,4%) koji su primali ONIVYDE+5-FU/LV.
In the clinical trial demonstrating effectiveness of ONIVYDE, higher plasma exposures of total irinotecan and SN-38 for patients in the ONIVYDE+5-FU/LV treatment arm were associated with longer OS and PFS as well as with higher ORR (objective response rate).
U kliničkom ispitivanju za dokaz učinkovitosti lijeka ONIVYDE, veće izloženosti ukupnom irinotekanu i SN-38 u plazmi za bolesnike u ispitivanoj skupini koja je primala ONIVYDE+5-FU/LV bile su povezane s dužim OS i PFS, kao i s većom ORR (stopom objektivnog odgovora).
In the clinical trial evaluating MabThera maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the MabThera groups.
U kliničkom ispitivanju terapije održavanja lijekom MabThera u relapsirajućem/refraktornom folikularnom limfomu, medijan vrijednosti IgG-a nakon početne terapije bio je ispod donje granice normalnih vrijednosti (< 7 g/l) i u opservacijskoj skupini i u skupini koja je primala lijek MabThera.
In the clinical trial in granulomatosis with polyangiitis and microscopic polyangitis, 99 patients were treated with MabThera (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
U kliničkom ispitivanju kod granulomatoze s poliangitisom i mikroskopskog poliangitisa 99 bolesnika je liječeno lijekom MabThera (375 mg/m2, jedanput tjedno tijekom 4 tjedna) i glukokortikoidima (vidjeti dio 5.1).
In the clinical trial performed with IOA in the European Union the following Pearl Indices for the age class 18-35 years were calculated:
U kliničkom ispitivanju provedenom s lijekom IOA u Europskoj Uniji izračunati su sljedeći Pearlovi indeksi za dobnu skupinu od 18 do 35 godina:
In the clinical trial performed with IOA in the United States the following Pearl Indices for the age class 18-35 years were calculated:
U kliničkom ispitivanju provedenom s lijekom IOA u SAD-u izračunati su sljedeći Pearlovi indeksi za dobnu skupinu od 18 do 35 godina:
In the clinical trial performed with Zoely in the European Union the following Pearl Indices for the age class 18-35 years were calculated:
U kliničkom ispitivanju provedenom s lijekom Zoely u Europskoj Uniji izračunati su sljedeći Pearlovi indeksi za dobnu skupinu od 18 do 35 godina:
In the clinical trial program, atypical femoral fractures were reported rarely in patients treated with denosumab (see section 4.4).
U programu kliničkih ispitivanja atipične femoralne frakture rijetko su zabilježene u bolesnika liječenih denosumabom (vidjeti dio 4.4).
In the clinical trial, the mean final dose of Zycortal was 1.9 mg/kg (range 1.2–2.5 mg/kg) and the mean final dosing interval was 38.7 ± 12.7 days (range 20–99 days) with the majority of dogs having a dosing interval between 20 and 46 days.
U kliničkom ispitivanju, srednja krajnja doza Zycortala bila je 1,9 mg/kg (raspon 1,2–2,5 mg/kg) i srednji krajnji interval doziranja bio je 38,7 ± 12,7 dana (raspon 20–99 dana) s time da je većina pasa imala interval doziranja između 20 i 46 dana.