natgillin/translations-raw huggingface dataset:
The frequencies for postmarketing reports were calculated from placebo-controlled clinical trials (comprising a total of 15,234 patients, 7,601 on raloxifene 60 mg and 7,633 on placebo) in postmenopausal women with osteoporosis, or established coronary heart disease (CHD) or increased risk for CHD, without comparison to the frequencies of adverse events in the placebo assignment groups.
Učestalosti za postmarketinška izvješća izračunate su iz placebom kontroliranih kliničkih ispitivanja (koja uključuju ukupno 15 234 bolesnice, 7601 koje su uzimale raloksifen od 60 mg i 7633 koje su uzimale placebo) u žena u postmenopauzi s osteoporozom, ili dokazanom koronarnom bolesti srca (KBS) ili povećanim rizikom za KBS, bez usporedbe s učestalostima štetnih događaja u skupinama kojima je dodijeljen placebo.
The frequencies given below are based on crude incidence rates of adverse reactions observed in the Viramune immediate-release (lead-in phase, table
Dolje navedene učestalosti temelje se na neobrađenim stopama incidencije nuspojava opaženih u skupinama na Viramuneu s trenutnim oslobađanjem (uvodno razdoblje, tablica
The frequencies have not been corrected for placebo.
Za navedene nuspojave nije rađena korekcija prema placebu.
The frequencies in Table 2 below were observed in a total of 233 patients with severe haemophilia A in phase III clinical studies and an extension study.
Učestalosti u tablici 2 niže bile su opažene u ukupno 233 bolesnika s teškom hemofilijom A u kliničkim ispitivanjima faze III i jednom produžetku ispitivanja.
The frequencies in the table below were observed in a total of 153 patients with severe haemophilia B in phase III clinical studies and an extension study.
Učestalosti u tablici niže bile su opažene u ukupno 153 bolesnika s teškom hemofilijom B u kliničkim ispitivanjima faze III i jednom produžetku ispitivanja.
The frequencies of ADRs reported with MabThera alone or in combination with chemotherapy are summarised in Table 1.
Učestalost nuspojava prijavljenih pri primjeni lijeka MabThera u monoterapiji ili u kombinaciji s kemoterapijom sažeta je u Tablici 1.
The frequencies of adverse drug reactions are those reported in the apremilast arms of the four Phase III studies in PsA (n = 1945) or the two Phase III studies in PSOR (n=1184) (highest frequency from either data pool is represented in Table 2).
Učestalosti nuspojava na lijek odnose se na nuspojave koje su prijavljene u skupini koja je primala apremilast u četiri ispitivanja faze III psorijatičnog artritisa (n = 1945) ili dva ispitivanja faze III psorijaze (n=1184) (najveća učestalost iz jednog ili drugog skupa objedinjenih podataka prikazana je u tablici 2).
The frequencies of adverse reactions are defined as follows:
Prikaz učestalosti nuspojava definirana je na sljedeći način:
The frequencies of adverse reactions are expressed in patient-years, according to the following categories:
Učestalosti nuspojava izražene su u bolesnik-godinama prema sljedećim kategorijama: vrlo često (≥1/10 bolesnik-godina);
The frequencies of adverse reactions are ranked according to the following: Very common ( ≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000).
Učestalosti nuspojava navedene su kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000).
The frequencies of adverse reactions are ranked according to the following: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Učestalosti nuspojava izražene su kako slijedi: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100); rijetko (>1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
The frequencies of adverse reactions are those reported in the pomalidomide plus dexamethasone arm of study CC-4047-MM-003 (n = 302) and from post marketing data.
Zabilježene učestalosti nuspojava su one u skupini ispitivanja CC-4047-MM-003 koja je primala pomalidomid s deksametazonom (n=302) te iz podataka prikupljenih nakon stavljanja lijeka na tržište.
The frequencies of adverse reactions reported with Xarelto are summarised in table 2 below by system organ class (in MedDRA) and by frequency.
Nuspojave prijavljene uz Xarelto navedene su niže u tablici 2, prema klasifikaciji organskih sustava (prema MedDRA-i) i prema učestalosti.
The frequencies of both serious and non-serious adverse drug reactions are listed by system organ classes in the table below.
Učestalost nuspojava, uključujući ozbiljne i ne-ozbiljne nuspojave, navedena je prema klasifikaciji organskih sustava dolje u tablici.
The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control, please see Description of selected adverse reactions below.
Učestalost hipoglikemija varira ovisno o populaciji bolesnika, shemi doziranja i stupnju regulacije glikemije, molimo vidjeti Opis odabranih nuspojava u nastavku.
The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control, please see section c below.
Učestalost hipoglikemije varira ovisno o populaciji bolesnika, shemi doziranja i stupnju regulacije glikemije; molimo vidjeti odjeljak c u nastavku.
The frequencies of the adverse reactions are classified as follows: Very common (≥ 1/10)
Učestalosti nuspojava klasificirane su kako slijedi: Vrlo često (≥ 1/10)
The frequencies of the adverse reactions correspond with very common (1/10), common (1/100 to
Učestalost nuspojava može biti vrlo često (1/10), često (1/100 do <1/10), manje često (1/1000 do
The frequencies of the adverse reactions in Table 1 were calculated based on three randomised, double-blind, placebo-controlled studies in patients with alcohol dependence (1,144 patients exposed to Selincro as-needed and 797 exposed to placebo as-needed).
Učestalosti nuspojava u Tablici 1 izračunate su na temelju tri randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja u bolesnika s ovisnošću o alkoholu (1144 bolesnika izloženih Selincru prema potrebi i 797 izloženih placebu prema potrebi).
The frequencies of the adverse reactions reported below are classified as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Učestalost navedenih nuspojava u nastavku određuje se kao vrlo česta (≥ 1/10), česta (≥ 1/100 i < 1/10) i manje česta (≥ 1/1000 i < 1/100).
The frequencies were derived from Phase 3 E/C/F/TAF clinical studies in 866 treatment-naïve adult patients through 96 weeks of treatment (GS-US-292-0104 and GS-US-292-0111).
Učestalosti su izvedene iz podataka faze 3 kliničkih ispitivanja E/C/F/TAF-a tijekom 96 tjedana liječenja 866 odraslih bolesnika koji prethodno nisu bili liječeni (GS-US-292-0104 i GS-US-292-0111).
The frequency and severity of the most commonly reported adverse reactions with Pegasys are similar to those reported with interferon alfa-2a (see Table 9).
Učestalost i intenzitet najčešće prijavljenih nuspojava sličan je u bolesnika liječenih lijekom Pegasys i onih liječenih interferonom alfa-2a (vidjeti Tablicu 9).
The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Kategorije učestalosti definirane su prema sljedećoj konvenciji: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
The frequency categories assigned to the adverse reactions are mainly based on experience from clinical trials including a total of 1,171 patients with chronic hepatitis B receiving lamivudine at 100mg.
Kategorije učestalosti dodijeljene nuspojavama uglavnom se temelje na iskustvu iz kliničkih ispitivanja u kojima je sudjelovao ukupno 1171 bolesnik s kroničnim hepatitisom B na terapiji lamivudinom u dozi od 100mg.
The frequency categories used are:
Koristile su se sljedeće kategorije učestalosti:
The frequency categories used are:
Korištene kategorije učestalosti su:
The frequency category includes all reported events of moderate to severe intensity, regardless of the individual causality assessment.
Kategorija učestalosti uključuje sve sve zabilježene događaje, po težini umjerene do teške, nevezano za individualnu procjenu povezanosti.
The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev.
Kategorija učestalosti "rijetko" određena je prema smjernicama za Sažetak opisa svojstava lijeka (A Guideline on Summary of Product Characteristics, SmPC; rev.
The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev.
Kategorija učestalosti „rijetko“ određena je prema smjernicama za Sažetak opisa svojstava lijeka (rev.
The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1,563).
Kategorija učestalosti manje često procijenjena je na temelju statističkog izračuna na osnovi ukupnog broja bolesnika izloženih emtricitabinu u ovim kliničkim ispitivanjima (n = 1563).
The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1,563).
Kategorija učestalosti „manje često“ procijenjena je iz statističkog izračuna na temelju ukupnog broja bolesnika izloţenih emtricitabinu u ovim kliničkim ispitivanjima (n = 1563).
The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1,563).
Kategorija učestalosti „manje često“ procijenjena je iz statističkog izračuna na temelju ukupnog broja bolesnika izloženih emtricitabinu u ovim kliničkim ispitivanjima (n = 1563).
The frequency category was based on an estimated exposure of approximately 10, 000 patients to fingolimod in all clinical trials.
Kategorija učestalosti temeljila se na procijenjenoj izloženosti otprilike 10 000 bolesnika fingolimodu u svim kliničkim ispitivanjima.
The frequency category was estimated based on relevant clinical trials. α The frequency category was estimated based on observational study data.
Skupina učestalosti procijenila se na temelju odgovarajućih kliničkih ispitivanja. α Kategorija učestalosti procijenjena je na temelju podataka iz opservacijskih ispitivanja.
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in randomised controlled clinical studies (n = 1,563) or tenofovir disoproxil fumarate in randomised controlled clinical studies and the expanded access program (n = 7,319).
Kategorija učestalosti procijenjena je iz statističkog izračuna na temelju ukupnog broja pacijenata izloženih emtricitabinu u randomiziranim kontroliranim kliničkim ispitivanjima (n = 1563) ili tenofovirdizoproksilfumaratu u randomiziranim kontroliranim kliničkim ispitivanjima i programu proširenog pristupa liječenju (n = 7319).
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in randomised controlled clinical studies (n = 1,563) or tenofovir disoproxil fumarate in randomised controlled clinical studies and the expanded access program (n = 7,319).
Kategorija učestalosti procijenjena je pomoću statističkog proračuna na temelju ukupnog broja pacijenata izloženih emtricitabinu u randomiziranim kontroliranim kliničkim ispitivanjima (n = 1563) ili tenofovirdizoproksilfumaratu u randomiziranim kontroliranim kliničkim ispitivanjima i programu proširenog pristupa liječenju (n = 7319).
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in randomised controlled clinical studies (n = 1,563) or tenofovir disoproxil in randomised controlled clinical studies and the expanded access program (n = 7,319).
Kategorija učestalosti procijenjena statističkim izračunom na temelju ukupnog broja bolesnika izloženih emtricitabinu u randomiziranim kontroliranim kliničkim ispitivanjima (n = 1563) ili tenofovirdizoproksilu u randomiziranim kontroliranim kliničkim ispitivanjima i programu proširenog pristupa liječenju (n = 7319).
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to Eviplera or all of its components in randomised controlled clinical studies (n = 1,261).
Kategorija učestalosti procijenjena je na temelju statističkog izračuna na osnovi ukupnog broja bolesnika izloženih lijeku Eviplera ili svim njegovim djelatnim tvarima u randomiziranim kontroliranim kliničkim ispitivanjima (n = 1261).
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to nevirapine in randomised controlled clinical studies (n=2,718).
Učestalost je procijenjena iz statističkih proračuna baziranih na ukupnom broju bolesnika izloženih nevirapinu u randomiziranim, kontroliranim kliničkim ispitivanjima (n=2718).
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil fumarate in randomised controlled clinical studies and the expanded access program (n = 7,319).
Kategorija učestalosti procijenjena je na temelju statističkog izračuna na osnovi ukupnog broja bolesnika izloženih tenofovirdizoproksilfumaratu u randomiziranim kontroliranim kliničkim ispitivanjima i programu proširenog pristupa (n = 7319).
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil fumarate in randomised controlled clinical trials and the expanded access program (n = 7,319).
Kategorija učestalosti procijenjena je pomoću statističkog proračuna na temelju ukupnog broja pacijenata izloženih tenofovirdizoproksilfumaratu u randomiziranim kontroliranim kliničkim ispitivanjima i programu proširenog pristupa liječenju (n = 7319).
The frequency category was estimated from a statistical calculation based on the total number of patients treated with efavirenz in clinical trials (n = 3,969) or exposed to emtricitabine in randomised controlled clinical trials (n = 1,563) or exposed to tenofovir disoproxil fumarate in randomised controlled clinical trials and the expanded access programme (n = 7,319).
Kategorija učestalosti procijenjena je na osnovi statističkog izračuna temeljenog na ukupnom broju pacijenata liječenih efavirenzom u kliničkim ispitivanjima (n = 3969) ili izloženih emtricitabinu u randomiziranim kontroliranim kliničkim ispitivanjima (n = 1563) ili tenofovirdizoproksil fumaratu u randomiziranim kontroliranim kliničkim ispitivanjima i programu proširenog pristupa liječenju (n = 7319).
The frequency category was estimated from a statistical calculation based upon 1576 patients receiving Neulasta in nine randomized clinical trials.
Kategorija učestalosti je procijenjena statističkim izračunom na temelju 1576 bolesnika koji su Neulastu primali u devet randomiziranih kliničkih ispitivanja.
The frequency is based on the program-wide exposure. f Musculoskeletal pain is a composite term which includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, and spinal pain. g Frequencies of laboratory terms reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements.
Učestalost se temelji na izloženosti u širini programa ispitivanja.. f Mišićno-koštana bol je kompozitni pojam koji uključuje bol u leđima, bol u kostima, bol u mišićima i kostima prsišta, nelagodu u mišićima i kostima, mialgiju, bol u vratu, bol u ekstremitetima i bol u kralježnici. g Učestalosti laboratorijskih pojmova odražavaju udio bolesnika u kojih je došlo do pogoršanja laboratorijskih parametara u odnosu na početne vrijednosti.
The frequency is defined as follows: Very common ( 1/10)
Učestalost se definira na sljedeći način: Vrlo često (  1/10)
The frequency is defined as follows: Very common(  1/10)
Učestalost se definira na sljedeći način: Vrlo često (  1/10)
The frequency is estimated as 'common' from clinical trial data.
Prema podacima iz kliničkih ispitivanja učestalost je procijenjena kao „česta“.
The frequency is estimated as 'common' from clinical trial data.
Učestalost je procijenjena kao 'česta' na temelju podataka iz kliničkih ispitivanja.
The frequency is estimated as uncommon from clinical trial data.
Iz podataka dobivenih kliničkim ispitivanjem učestalost se procjenjuje kao manje česta.
The frequency is estimated as uncommon from clinical trial data.
Na temelju podataka iz kliničkih ispitivnaja, učestalost se procjenjuje kao manje česta.
The frequency is estimated as uncommon from clinical trial data.
Prema podacima iz kliničkih ispitivanja, učestalost je procijenjena kao manje česta.
The frequency is estimated as uncommon from clinical trial data.
Učestalost je procijenjena kao manje česta iz podataka iz kliničkog ispitivanja.
The frequency is estimated as uncommon from clinical trial data.
Učestalost je procijenjena kao manje česta iz podataka kliničkih ispitivanja.
The frequency is estimated as uncommon from clinical trial data.
Učestalost se procjenjuje kao manje česta iz podataka o kliničkim ispitivanjima.
The frequency is unknown, but you may be more likely to get this condition if you:
Učestalost nije poznata, ali veća je vjerojatnost da se ovo stanje javi ako:
The frequency listed below is defined using the following convention: common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Učestalost nuspojava navedena u sljedećim tablicama definira se prema sljedećoj konvenciji: često (≥ 1/100 i < 1/10) i manje često (≥ 1/1 000 i < 1/100).
The frequency listed below is defined using the following convention: very common (> 1/10), common (≥ 1/100 to < 1/10), not known (frequency cannot be estimated from available data).
Kategorije učestalosti navedene u nastavku definirane su na sljedeći način: vrlo često (≥1/10), često (≥ 1/100 i < 1/10), nepoznato (ne može se procijeniti iz dostupnih podataka).
The frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Učestalost primjene treba uvijek određivati prema kliničkoj djelotvornosti u pojedinom slučaju.
The frequency of ADRs in pJIA patients can be found in Table 2.
Učestalost nuspojava na lijek kod bolesnika s pJIA prikazana je u tablici 2.
The frequency of adverse events are classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), and very rare (<1/10,000).
Nuspojave se po učestalosti klasificiraju kao vrlo česte (≥1/10), česte (≥1/100 i <1/10), manje česte (≥1/1000 i <1/100), rijetke (≥1/10 000 i <1/1000) i vrlo rijetke (<1/10 000).
The frequency of adverse reactions identified from placebo-controlled clinical studies of sitagliptin and metformin alone, and post-marketing experience
Učestalost nuspojava utvrđenih iz placebom kontroliranih kliničkih ispitivanja samih sitagliptina i metformina i iskustva nakon stavljanja lijeka u promet
The frequency of adverse reactions is classified as follows: Common: ≥ 1/100 to < 1/10
Učestalost nuspojava klasificirana je na sljedeći način: Često: ≥ 1/100 i < 1/10
The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to
Učestalost nuspojava definira se na sljedeći način: vrlo često ≥(
The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Učestalost nuspojava određuje se kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i
The frequency of adverse reactions is defined using the following convention:
Učestalost javljanja nuspojava izražava se kao:
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava definira se prema sljedećem pravilu:
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava definira se s pomoću sljedeće konvencije:
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava definirana je kako slijedi:
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava definirana je primjenom sljedeće konvencije :
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava definirana je primjenom sljedeće konvencije:
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava definirana je upotrebom sljedećih konvencija:
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava je odreĎena sukladno sljedećim pravilima:
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava je određena prema sljedećem pravilu:
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava je određena sukladno sljedećim pravilima;
The frequency of adverse reactions is defined using the following convention:
Učestalost nuspojava određena je sukladno sljedećim pravilima:
The frequency of adverse reactions is defined using the following convention:
Učestalost pojave nuspojava definirana je na slijedeći način:
The frequency of adverse reactions is defined using the following convention:
Učestalost štetnih nuspojava je definirana sljedećim pravilom:
The frequency of adverse reactions is defined using the following convention: very common ( ≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Učestalost nuspojava definirana je kao: vrlo često ( ≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Učestalost nuspojava definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from available data).
Učestalost nuspojava definirana je na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Učestalost niže navedenih nuspojava je definirana na sljedeći način: vrlo često (≥1/10), često (≥1/100 i
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Učestalost nuspojava definira se prema slijedećem prikazu učestalosti nuspojava: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10000 i