natgillin/translations-raw huggingface dataset:
The adverse reaction profile presented below is based on the analysis of pooled placebo- controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Profil štetnog događaja opisan niže temelji se na analizi zbirnih placebom konroliranih kliničkih istraživanja za sve ispitivane indikacije, u kojima je liječeno s levetiracetamom ukupno 3416 bolesnika.
The adverse reaction profile reported in patients >75 years of age treated with thalidomide 100 mg once daily was similar to the adverse reaction profile observed in patients ≤75 years of age treated with thalidomide 200 mg once daily (see Table 3).
Profil nuspojava prijavljenih u bolesnika starijih od 75 godina liječenih talidomidom u dozi od 100 mg jedanput na dan bio je sličan profilu nuspojava opaženih u bolesnika u dobi ≤ 75 godina liječenih talidomidom u dozi od 200 mg jedanput na dan (vidjeti tablicu 3).
The adverse reaction rates reported after either vaccination dose (i.e.
Stope nuspojava prijavljenih nakon bilo koje doze primljenog cjepiva (tj.
The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (≤ 18 years of age) than in adults.
Prijave nuspojava nakon stavljanja lijeka u promet relativno su češće uključivale reakcije na mjestu injiciranja (bol na mjestu injiciranja, reakcija na mjestu injiciranja) i kožne reakcije (osip, urtikarija) u djece i adolescenata (≤ 18 godina) nego u odraslih.
The adverse reactions (all grades) experienced by at least 20% of the patients in renal cell carcinoma and mantle cell lymphoma registration studies include anaemia, nausea, rash (including rash, pruritic rash, maculopapular rash, pustular rash), decreased appetite, oedema asthenia, fatigue, thrombocytopaenia, diarrhoea, pyrexia, epistaxis, mucosal inflammation, stomatitis, vomiting, hyperglycemia, hypercholesterolemia, dysgeusia, pruritus, cough, infection, pneumonia, dyspnoea.
Tijekom ispitivanja, nuspojave (svi stupnjevi), koje je imalo najmanje 20% bolesnika u ispitivanjima primjene kod karcinoma bubrežnih stanica i limfoma plaštenih stanica, uključuju anemiju, mučninu, osip (uključujući osip, osip sa svrbežom, makulopapularni osip), smanjeni apetit, edeme, asteniju, umor, trombocitopeniju, proljev, pireksiju, epistaksu, upalu sluznica, stomatitis, povraćanje, hiperglikemiju, hiperkolesterolemiju, disgeuziju, svrbež, kašalj, infekciju, upalu pluća, dispneju.
The adverse reactions are classified by System Organ Class and frequency, 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), not known (cannot be estimated from the available data) and were reported with Mirvaso in clinical studies (see Table 1).
Nuspojave su popisane prema MedDRA klasifikaciji organskih sustava i prema učestalosti uz sljedeće odrednice: 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), a zabilježene su kod gela Mirvaso u kliničkim ispitivanjima (vidjeti Tablicu 1.).
The adverse reactions are displayed by system organ class and frequency: very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1000 to < 1/100), rare (≥1/10,000 to < 1/1000) and very rare (< 1/10,000).
Nuspojave su navedene po organskim sustavima i učestalosti: vrlo često (≥1/10), često (≥1/100 i < 1/10), manje često (≥1/1000 i < 1/100), rijetko (≥1/10,000 i < 1/1000) i vrlo rijetko (< 1/10 000).
The adverse reactions are listed below, by system organ class and by frequency.
U nastavku su navedene nuspojave prema klasifikaciji organskih sustava i učestalosti.
The adverse reactions are listed by system organ class (SOC) and frequency.
Nuspojave su navedene prema organskim sustavima i učestalosti.
The adverse reactions are listed by system organ class (SOC) and frequency: 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).
Nuspojave su navedene prema klasifikaciji organskih sustava (SOC) i frekvenciji: 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).
The adverse reactions are listed by system organ class and absolute frequency.
Nuspojave su navedene prema organskim sustavima i apsolutnoj učestalosti.
The adverse reactions are listed by system organ class and frequency.
Nuspojave su navedene u skladu s klasifikacijom organskih sustava i učestalosti..
The adverse reactions are listed by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and not known (cannot be estimated from the available data).
prema organskim sustavima i učestalosti pojavljivanja: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100) i nepoznato (ne može se procijeniti iz dostupnih podataka)).
The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Order Class by frequency and incidence.
Nuspojave su prikazane kao MedDRA preporučeni pojmovi prema MedDRA klasifikaciji organskih sustava po učestalosti i incidenciji.
The adverse reactions are reported in this table with the following frequency 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).
Nuspojave su u ovoj tablici zabilježene prema sljedećoj konvenciji prikaza učestalosti: vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000).
The adverse reactions associated with the use of teriparatide in osteoporosis clinical trials and post- marketing exposure are summarised in the table below.
Nuspojave povezane s primjenom teriparatida u kliničkim ispitivanjima liječenja osteoporoze te nakon stavljanja lijeka u promet sažeto su prikazane u sljedećoj tablici.
The adverse reactions considered at least possibly related to conditioning treatment including thiotepa, reported in paediatric patients as more than an isolated case, are listed below by system organ class and by frequency.
Nuspojave za koje se smatra da su barem moguće povezane s pripremnom terapijom s tiotepom, prijavljene u pedijatrijskih bolesnika u više od jednog izoliranog slučaja, su navedene prema klasi organskih sustava i njihovoj učestalosti.
The adverse reactions considered at least possibly related to the treatment are listed below by body system, organ class and absolute frequency.
Nuspojave koje se barem dijelom mogu pripisati liječenju su svrstane prema organskim sustavima i ukupnoj učestalosti.
The adverse reactions considered at least possibly related to treatment from clinical study and post- marketing experience are listed below by body system organ class and frequency.
Nuspojave koje se smatraju barem moguće povezanima s liječenjem u kliničkim ispitivanjima i nakon stavljanja lijeka u promet navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti.
The adverse reactions considered at least possibly related to treatment with NUEDEXTA in the placebo-controlled and the open-label extension phase of the above mentioned clinical study are listed below by body system organ class and frequency. very common (≥1/10)
Nuspojave za koje se smatralo da su barem moguće povezane s terapijom NUEDEXTOM, u placebom kontroliranoj i otvorenoj fazi produžetka gore spomenutog kliničkog ispitivanja, navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti.
The adverse reactions considered at least possibly related to treatment with the components of Triumeq from clinical study and post-marketing experience are listed in Table 2 by body system, organ class and absolute frequency.
Nuspojave prijavljene u kliničkim ispitivanjima i nakon stavljanja lijeka u promet, čija se povezanost sa sastavnicama lijeka Triumeq smatra barem mogućom, navedene su u Tablici 2 prema klasifikaciji organskih sustava i apsolutnoj učestalosti.
The adverse reactions considered at least possibly related to treatment with the components of Truvada from clinical study and post-marketing experience in HIV-1 infected patients are listed in Table 3, below, by body system organ class and frequency.
Nuspojave za koje se na temelju kliničkog ispitivanja i iskustva nakon stavljanja lijeka u promet u pacijenata zaraženih virusom HIV-1 smatra da su barem moguće povezane s liječenjem sastojcima Truvade, navedene su niže u Tablici 3 po organskim sustavima i učestalosti.
The adverse reactions described in this section were identified in the pivotal clinical study (N = 189).
Nuspojave opisane u ovom dijelu identificirane su tijekom pivotalnog kliničkog ispitivanja (N = 189).
The adverse reactions have been included in the table as a result of postmarketing or clinical study data from the use of tadalafil in the treatment of erectile dysfunction; and in addition, the frequency estimates are based on only 1 or 2 patients experiencing the adverse reaction in the pivotal placebo- controlled study of ADCIRCA.
Ove su nuspojave uključene u tablicu na temelju podataka prikupljenih nakon stavljanja lijeka u promet, odnosno u kliničkim ispitivanjima primjene tadalafila u liječenju erektilne disfunkcije, a dodatno se procjena učestalosti temelji na samo jednom ili dva bolesnika koji su dobili tu nuspojavu u pivotalnom placebom kontroliranom ispitivanju lijeka ADCIRCA.
The adverse reactions identified in these clinical trials and from post-marketing experience are presented in table 1.
Nuspojave zabilježene u ovim kliničkim ispitivanjima i nakon stavljanja lijeka u promet su prikazane u tablici 1.
The adverse reactions in Study D2302 (TRANSFORMS), a 1-year study in 849 patients treated with fingolimod which used interferon beta-1a as comparator, were generally similar to placebo-controlled studies, taking into account the differences in study duration.
Nuspojave u ispitivanju D2302 (TRANSFORMS), jednogodišnjem ispitivanju provedenom na 849 bolesnika liječenih fingolimodom, u kojem se interferon beta-1a koristio kao lijek usporedbe, općenito su bile slične kao u placebo kontroliranom ispitivanju, uzimajući u obzir razlike u trajanju ispitivanja.
The adverse reactions in Table 2 are listed by system organ class and highest frequency observed.
Nuspojave u Tablici 2 navedene su prema klasifikaciji organskih sustava i najveće uočene učestalosti.
The adverse reactions in the adult ITP studies (N=550), paediatric ITP studies (N=107), the HCV studies (N=955), the SAA studies (N=43) and post-marketing reports are listed below by MedDRA system organ class and by frequency.
Nuspojave iz ispitivanja odraslih s ITP-om (N=550), pedijatrijskih ispitanika s ITP-om (N=107), ispitivanja HCV-a (N=955), ispitivanja teške aplastične anemije (N=43) te izvješća nakon stavljanja lijeka u promet navedene su niže prema MedDRA klasifikaciji organskih sustava i učestalosti.
The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated with telmisartan for hypertension and from post-marketing reports.
Dolje navedene nuspojave prikupljene su iz kontroliranih kliničkih ispitivanja u bolesnika liječenih zbog hipertenzije telmisartanom i iz podataka prikupljenih nakon stavljanja lijeka u promet.
The adverse reactions listed below in table 1 are classified according to System organ class.
Niže navedene nuspojave u tablici 1 kategorizirane su prema klasifikaciji organskih sustava.
The adverse reactions listed below in table 2 are classified according to System Organ Class.
Nuspojave navedene u nastavku u Tablici 2 kategorizirane su prema organskim sustavima.
The adverse reactions listed in Table 3 are presented by system organ class and frequency categories, 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), not known (cannot be estimated from the available data).
Nuspojave navedene u Tablici 3 prikazane su prema klasifikaciji organskih sustava i kategorijama učestalosti pojavljivanja, a definirane su 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 adverse reactions listed in Table 4 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
U Tablici 4 su navedene nuspojave iz kliničkih ispitivanja provedenih u odraslih bolesnika koji prethodno nisu bili liječeni interferonom u kojih je liječenje trajalo godinu dana, te nuspojave prijavljene nakon stavljanja lijeka u promet.
The adverse reactions listed in Table 5 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
U Tablici 5 navedene su nuspojave iz kliničkih ispitivanja provedenih u odraslih bolesnika koji prethodno nisu bili liječeni interferonom, u kojih je liječenje trajalo godinu dana, te nuspojave prijavljene nakon stavljanja lijeka u promet.
The adverse reactions listed in Table 5 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
U Tablici 5 su navedene nuspojave iz kliničkih ispitivanja provedenih u odraslih bolesnika koji prethodno nisu bili liječeni u kojih je liječenje trajalo godinu dana, te nuspojave prijavljene nakon stavljanja lijeka u promet.
The adverse reactions listed in the table below were reported in at least one of the 321 patients receiving delamanid in the double blind placebo controlled clinical trial mentioned above.
Nuspojave navedene u tablici u nastavku prijavljene su u barem jednog od 321 bolesnika koji su primili delamanid u gore navedenom dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju.
The adverse reactions listed in this section are primarily derived from clinical trials and/or as adverse drug reactions from spontaneous reports when ribavirin was used in combination with interferon alfa- 2b or peginterferon alfa-2b.
Nuspojave navedene u ovom dijelu prije svega su izvedene iz kliničkih ispitivanja i/ili nuspojava iz spontanih prijava kad se ribavirin primjenjivao u kombinaciji s interferonom alfa-2b ili peginterferonom alfa-2b.
The adverse reactions listed in this section fall into the following frequency categories: 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); not known (cannot be estimated from the available data).
Nuspojave navedene u ovom dijelu mogu se svrstati u sljedeće kategorije učestalosti: 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 adverse reactions most commonly (≥1% in the total perampanel group and greater than placebo) leading to discontinuation were dizziness and somnolence.
Nuspojave koje su najčešće (≥1% u cijeloj skupini koja je uzimala perampanel i više nego placebo) dovele do prekida liječenja bile su omaglica i pospanost.
The adverse reactions observed for the combination of dolutegravir + abacavir/lamivudine in an analysis of pooled data from Phase IIb to Phase IIIb clinical trials were generally consistent with the adverse reaction profiles for the individual components dolutegravir, abacavir and lamivudine.
Nuspojave primijećene kod primjene kombinacije dolutegravir + abakavir/lamivudin u analizi objedinjenih podataka iz kliničkih ispitivanja faze IIb do faze IIIb u načelu su bile u skladu s profilima nuspojava pojedinačnih sastavnica dolutegravira, abakavira i lamivudina.
The adverse reactions observed in adolescent patients who received treatment with tenofovir disoproxil fumarate were consistent with those observed in clinical studies of tenofovir disoproxil fumarate in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Nuspojave opažene u adolescentnih pacijenata liječenih tenofovirdizoproksilfumaratom bile su sukladne onima opaženima u kliničkim ispitivanjima tenofovirdizoproksilfumarata u odraslih (vidjeti dio 4.8 Tablični prikaz nuspojava i 5.1).
The adverse reactions observed in adolescents are similar to the ones observed in adults.
Nuspojave primijećene u adolescentica slične su onima primijećenim u odraslih.
The adverse reactions observed in clinical studies and reported in post-marketing experience are detailed below.
Nuspojave primijećene u kliničkim ispitivanjima i prijavljene nakon stavljanja lijeka na tržište detaljno su navedene u nastavku.
The adverse reactions observed in paediatric patients who received treatment with tenofovir disoproxil fumarate were consistent with those observed in clinical studies of tenofovir disoproxil fumarate in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Nuspojave opažene u pedijatrijskih pacijenata koji su primali liječenje tenofovirdizoproksilfumaratom bile su sukladne onima opaženima u kliničkim ispitivanjima tenofovirdizoproksilfumarata u odraslih (vidjeti dio 4.8 Tablični prikaz nuspojava i 5.1).
The adverse reactions observed in patients treated for multiple myeloma are listed below by system organ class and frequency.
Nuspojave primijećene u bolesnika liječenih zbog multiplog mijeloma navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti.
The adverse reactions observed in patients treated for myelodysplastic syndromes and mantle cell lymphoma are listed below by system organ class and frequency.
Nuspojave primijećene u bolesnika liječenih zbog mijelodisplastičnih sindroma i limfoma plaštenih stanica navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti.
The adverse reactions observed in patients treated with pomalidomide plus dexamethasone are listed below by system organ class (SOC) and frequency for all adverse reactions and for Grade 3 or 4 adverse reactions.
Sve nuspojave 3. ili 4. stupnja primijećene kod bolesnika liječenih pomalidomidom s deksametazonom navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti.
The adverse reactions observed more frequently with Rd or Rd18 than MPT were: diarrhoea (45.5%), fatigue (32.8%), back pain (32.0%), asthenia (28.2%), insomnia (27.6%), rash (24.3%), decreased appetite (23.1%), cough (22.7%), pyrexia (21.4%), and muscle spasms (20.5%).
Nuspojave opažene češće uz Rd ili Rd18 nego uz MPT bile su: proljev (45,5%), umor (32,8%), bol u leđima (32,0%), astenija (28,2%), nesanica (27,6%), osip (24,3%), smanjeni apetit (23,1%), kašalj (22,7%), pireksija (21,4%) i mišićni spazam (20,5%).
The adverse reactions observed with continued treatment for 384 weeks were consistent with the safety profile of tenofovir disoproxil fumarate.
Nuspojave primijećene tijekom nastavka liječenja do 384. tjedna bile su u skladu sa sigurnosnim profilom tenofovirdizoproksilfumarata.
The adverse reactions of bleeding in Table 1 are summarized for the TRA 2°P TIMI 50 study.
Nuspojave krvarenja iz ispitivanja TRA 2ºP - TIMI 50 sažeto su prikazane u Tablici 1.
The adverse reactions presented have been identified from clinical studies as well as from post- marketing reports (an asterisk [*] indicates adverse reactions identified during post-marketing surveillance).
Prikazane nuspojave identificirane su u kliničkim ispitivanjima kao i iz izvješća nakon stavljanja lijeka u promet (zvjezdica [*] označava nuspojave identificirane tijekom praćenja lijeka nakon stavljanja lijeka u promet).
The adverse reactions presented have been identified from clinical studies as well as from post- marketing reports (an asterisk [*] indicates adverse reactions identified during post-marketing surveillance).
Prikazane nuspojave identificirane su u kliničkim ispitivanjima kao i iz izvješća nakon stavljanja lijeka u promet (zvjezdica [*]označava nuspojave identificirane tijekom praćenja lijeka nakon stavljanja lijeka u promet).
The adverse reactions previously reported with one of the two active substances (aliskiren and hydrochlorothiazide) of Rasilez HCT and listed below may occur with Rasilez HCT.
Nuspojave već prije prijavljene u bolesnika s jednom od dvije djelatne tvari lijeka Rasilez HCT (aliskiren i hidroklorotiazid) niže su navedene i mogu se pojaviti s uzimanjem Rasilez HCT-a.
The adverse reactions previously reported with one or both of the two active substances (aliskiren and amlodipine) of Rasilamlo and listed below may occur with Rasilamlo.
Nuspojave već prije prijavljene u bolesnika s jednom ili obje od dvije djelatne tvari (aliskiren i amlodipin) lijeka Rasilamlo niže su navedene i mogu se pojaviti s uzimanjem lijeka Rasilamlo.
The adverse reactions profiles in adults in the Multiple-Cycle extension of HEC and MEC studies for up to 6 additional cycles of chemotherapy were generally similar to those observed in Cycle 1.
Profil nuspojava u odraslih u višekratnim ciklusima produžetka HEC i MEC ispitivanja (najviše šest) uglavnom je bio sličan onom zabilježenom u prvom ciklusu kemoterapije.
The adverse reactions profiles in the Multiple-Cycle extension of HEC and MEC studies for up to 6 additional cycles of chemotherapy were generally similar to those observed in Cycle 1.
Profil nuspojava u višekratnim ciklusima produžetka ispitivanja u jako i umjereno emetogenoj kemoterapiji (najviše šest) uglavnom je bio sličan onom zabilježenom u prvom ciklusu kemoterapije.
The adverse reactions ranked under headings of frequency, are presented in Table 6.
Nuspojave navedene prema učestalosti prikazane su u Tablici 6.
The adverse reactions reported below are based on pooled clinical trial data from phase II and III clinical trials involving 131 patients taking the medicinal product and on data from post-marketing surveillance.
Nuspojave navedene u nastavku temelje se na zbirnim podacima iz kliničkih ispitivanja faza II i III provedenim na 131 bolesniku koji je uzimao lijek i na podacima prikupljenim tijekom praćenja nakon stavljanja lijeka u promet.
The adverse reactions reported below are classified according to frequency of occurrence as follows:
Dolje navedene nuspojave klasificirane su prema učestalosti pojavljivanja kako slijedi:
The adverse reactions reported by the highest percentage of patients were haematologic (anaemia, leukopaenia, neutropaenia, and thrombocytopaenia), metabolic (hypercholesterolaemia, hyperlipaemia, hyperglycaemia, increase of serum aspartate amino transferase (AST) and serum alanine aminotransferase (ALT) plasma levels), and digestive (mucositis, stomatitis, nausea, and vomiting).
Nuspojave zabilježene u najvećem postotku bolesnika bile su hematološke (anemija, leukopenija, neutropenija i trombocitopenija), metaboličke (hiperkolesterolemija, hiperlipemija, hiperglikemija, povećanje razine serumske aspartat aminotransferaze (AST) i serumske alanin aminotransferaze (ALT) u plazmi) te probavne (mukozitis, stomatitis, mučnina i povraćanje).
The adverse reactions reported during clinical trials conducted with SCENESSE are listed in the table below by MedDRA system organ class and frequency convention.
Nuspojave prijavljene tijekom kliničkih ispitivanja provedenih s lijekom SCENESSE navedene su u tablici niže u tekstu prema MedDRA klasifikaciji organskih sustava i učestalosti.
The adverse reactions reported in clinical studies using GANFORT were limited to those earlier reported for either of the single active substances bimatoprost and timolol.
Nuspojave prijavljene u kliničkim ispitivanjima s GANFORT-om ograničene su na prethodno navedene nuspojave na obje pojedinačne djelatne tvari bimatoprost i timolol.
The adverse reactions reported in the clinical study using GANFORT single-dose were limited to those earlier reported for either GANFORT (multi-dose formulation) or for the single active substances bimatoprost or timolol.
Nuspojave prijavljene u kliničkom ispitivanju s jednodoznim GANFORT-om ograničene su na prethodno navedene nuspojave na GANFORT (višedozni pripravak) ili na pojedinačne djelatne tvari bimatoprost ili timolol.