natgillin/translations-raw huggingface dataset:
Adverse reactions known to be associated with antipsychotic therapy and also reported during treatment with aripiprazole include neuroleptic malignant syndrome, tardive dyskinesia, seizure, cerebrovascular adverse reactions and increased mortality in elderly demented patients, hyperglycaemia and diabetes mellitus (see section 4.4).
Nuspojave za koje se zna da su povezane s terapijom antipsihoticima i koje su bile prijavljene i tijekom liječenja aripiprazolom uključuju neuroleptički maligni sindrom, tardivnu diskineziju, napadaje, cerebrovaskularne nuspojave i povećan mortalitet u starijih bolesnika s demencijom, hiperglikemiju i šećernu bolest (vidjeti dio 4.4).
Adverse reactions known to occur with each active substance given singly, but which have not been seen in clinical trials with Jentadueto, may occur during treatment with this medicinal product.
Nuspojave za koje je poznato da se javljaju sa svakom djelatnom tvari primijenjenom pojedinačno, ali koje nisu opažene u kliničkim ispitivanjima s Jentaduetom, mogu se pojaviti tijekom liječenja ovim lijekom.
Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Actelsar HCT.
Nuspojave za koje se zna da se pojavljuju sa svakom komponentom zasebno, ali nisu bile primijećene u kliničkim ispitivanjima mogu se pojaviti tijekom liječenja Actelsarom HCT.
Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with PritorPlus.
Nuspojave za koje se zna da se pojavljuju sa svakom komponentom zasebno, ali nisu bile primijećene u kliničkim ispitivanjima mogu se pojaviti tijekom liječenja PritorPlusom.
Adverse reactions leading to dose reduction occurred in approximately 5% of patients.
Nuspojave koje su dovele do smanjenja doze pojavile su se kod oko 5% bolesnika.
Adverse reactions like syncope (frequency: uncommon) and dizziness (frequency: common) have been reported (see section 4.8).
Prijavljene su nuspojave poput sinkope (učestalost: manje često) i omaglice (učestalost: često) (vidjeti dio 4.8.).
Adverse reactions like syncope (frequency: uncommon) and dizziness (frequency: common) have been reported (see section 4.8).
Prijavljene su nuspojave poput sinkope (učestalost: manje često) i omaglice (učestalost: često) vidjeti dio 4.8).
Adverse reactions may be more common during concomitant use of ARICLAIM and herbal preparations containing St John’s wort (Hypericum perforatum).
Pri istodobnom uzimanju lijeka ARICLAIM i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
Adverse reactions may be more common during concomitant use of Cymbalta and herbal preparations containing St John’s wort (Hypericum perforatum).
Pri istodobnom uzimanju lijeka Cymbalta i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
Adverse reactions may be more common during concomitant use of Duloxetine Lilly and herbal preparations containing St John’s wort (Hypericum perforatum).
Pri istodobnom uzimanju lijeka Duloksetin Lilly i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
Adverse reactions may be more common during concomitant use of Duloxetine Mylan and herbal preparations containing St John’s wort (Hypericum perforatum).
Pri istodobnom uzimanju lijeka Duloxetine Mylan i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
Adverse reactions may be more common during concomitant use of Duloxetine Zentiva and herbal preparations containing St. John’s wort (Hypericum perforatum).
Pri istodobnom uzimanju lijeka Duloxetine Zentiva i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
Adverse reactions may be more common during concomitant use of Xeristar and herbal preparations containing St John’s wort (Hypericum perforatum).
Pri istodobnom uzimanju lijeka Xeristar i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
Adverse reactions may be more common during concomitant use of YENTREVE and herbal preparations containing St John’s wort (Hypericum perforatum).
Pri istodobnom uzimanju lijeka YENTREVE i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Nuspojave koje nisu zabilježene u kliničkim ispitivanjima, ali su zapažene u životinja pri razinama ekspozicije sličnima kliničkim razinama i koje bi mogle biti važne za kliničku primjenu, bile su sljedeće:
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: nelarabine caused histopathological changes to the central nervous system (white matter) vacuolation and degenerative changes in cerebrum, cerebellum and spinal cord of monkeys after treatment with nelarabine daily during 23 days, at exposures below the human therapeutic exposure.
Nuspojave koje nisu zabilježene u kliničkim ispitivanjima, ali su zapažene u životinja pri razinama izloženosti sličnim onima u ljudi i s mogućom važnošću za kliničku primjenu bile su sljedeće: u majmuna koji su kroz 23 dana bili svakodnevno tretirani nelarabinom u dozi nižoj od terapijske doze koja se primjenjuje u ljudi, nelarabin je uzrokovao histopatološke promjene u središnjem živčanom sustavu (bijeloj tvari), vakuolizaciju i degenerativne promjene u velikom i malom mozgu, te kralježničnoj moždini.
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: pancreatic islet cell vacuolation, testicular tubular degeneration, gastrointestinal ulceration, bone fractures and calluses, hepatic haematopoiesis, and pulmonary phospholipidosis.
Nuspojave koje nisu opažene u kliničkim ispitivanjima, ali su viđene u životinja izloženih koncentracijama sličnim onima koje se primjenjuju u kliničkoj praksi te mogu biti za kliničku primjenu uključivale su: pojavu vakuola u stanicama otočića gušterače, testikularnu tubularnu degeneraciju, gastrointestinalne ulceracije, prijelome kostiju i kaluse, hepatalnu hematopoezu i pulmonalnu fosfolipidozu.
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use, were as follows: pancreatic islet cell vacuolation, testicular tubular degeneration, gastrointestinal ulceration, bone fractures and calluses, hepatic haematopoiesis, and pulmonary phospholipidosis.
Nuspojave koje nisu opažene u kliničkim ispitivanjima, ali su viđene u životinja izloženih koncentracijama sličnim onima koje se primjenjuju u kliničkoj praksi te mogu biti za kliničku primjenu uključivale su: pojavu vakuola u stanicama otočića gušterače, testikularnu tubularnu degeneraciju, gastrointestinalne ulceracije, prijelome kostiju i kaluse, hepatalnu hematopoezu i pulmonalnu fosfolipidozu.
Adverse reactions not observed in the clinical development of Numient, but reported for other levodopa/carbidopa medicinal products.
Nuspojave nisu opažene u kliničkom razvoju Numienta, ali su prijavljene kod drugih lijekova s levodopom/karbidopom.
Adverse reactions observed are listed below, by system organ class and frequency.
Opažene nuspojave navedene su ispod, po klasi organskih sustava i učestalosti.
Adverse reactions observed during clinical studies and post-marketing experience are listed below by frequency category.
U tablici su nuspojave zabilježene u kliničkim ispitivanjima i nakon stavljanja lijeka u promet popisane prema kategorijama učestalosti, definiranima kao: vrlo često (≥ 1/10); često (≥ 1/100 i
Adverse reactions observed during clinical studies are listed below by frequency category.
Nuspojave primijećene tijekom kliničkih ispitivanja navedene su niže prema kategorijama učestalosti.
Adverse reactions observed in 20 placebo-controlled studies and post-marketing experience with bosentan are ranked according to 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).
Nuspojave uočene u 20 placebom kontroliranih studija s bosentanom i iskustvima nakon stavljanja lijeka na tržište poredane su prema učestalosti koristeći sljedeću konvenciju: 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).
Adverse reactions observed in atopic dermatitis study up to day 16
Nuspojave uočene u studiji atopijskog dermatitisa do 16. dana
Adverse reactions observed in double-blind studies with pioglitazone as monotherapy are listed below (Table 4)
U tablici u nastavku (tablica 4) navedene su nuspojave opažene u dvostruko slijepim ispitivanjima pioglitazona kao monoterapije
Adverse reactions observed in pooled Phase 2 and 3 studies
Nuspojave zabilježene u objedinjenim ispitivanjima faze 2 i 3
Adverse reactions observed with ivacaftor alone are also provided in Table 2.
Nuspojave opažene uz primjenu samo ivakaftora također su prikazane u tablici 2.
Adverse reactions observed with other human immunoglobulin preparations
Nuspojave uočene kod drugih pripravaka ljudskog imunoglobulina
Adverse reactions observed with the co-administration of fenofibrate and simvastatin (Cholib)
Nuspojave opažene kod istodobne primjene fenofibrata i simvastatina (Cholib)
Adverse reactions occurred in 78.4% of the patients over a 36-months postoperative follow-up period..
Tijekom postoperativnog razdoblja praćenja od 36 mjeseci nuspojave su se pojavile u 78,4% bolesnika..
Adverse reactions occurred in 9.6% of male subjects and 6.0% of female partners.
Nuspojave su se javile kod 9,6 % muških ispitanika i kod 6,0 % ženskih partnerica.
Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients.
Nuspojave su se pojavljivale s istom učestalošću kod osoba liječenih placebom i telmisartanom.
Adverse reactions occurred with similar frequency in placebo and telmisartantreated patients.
Nuspojave su se pojavljivale s istom učestalošću kod osoba liječenih placebom i telmisartanom.
Adverse reactions occurring in patients with transitional cell carcinoma of the urothelium and in patients with other disease than this indication and potentially severe or adverse reactions that are a class effect of the vinca alkaloids are described below:
Nuspojave koje se javljaju u bolesnika s karcinomom prijelaznih stanica urotela i u bolesnika s drugim indikacijama te potencijalno teške ili nuspojave koje su posljedica učinaka vinka alkaloida, opisane su u nastavku:
Adverse reactions occurring in the 4 month, lead-in, open-label period of the study were similar in type and frequency to those seen in adults (Table 2) with the following exceptions:
Nuspojave koje su se javile u 4-mjesečnoj otvorenoj fazi ispitivanja bile su vrstom i učestalošću slične onima viđenima u odraslih bolesnika (Tablica 2), uz sljedeće izuzetke:
Adverse reactions occurring in ≥0.5% of patients are listed by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT).
Nuspojave koje su se javile u ≥ 0,5% bolesnika navedene su prema klasifikaciji organskih sustava (engl.
Adverse reactions occurring more frequently (≥3%) in Tarceva-treated patients than in the placebo group in the pivotal study BR.21, and in at least 10% of patients in the Tarceva group, are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 1.
Nuspojave koje su češće primijećene (≥3%) u bolesnika liječenih lijekom Tarceva nego u skupini koja je primala placebo te u najmanje 10% bolesnika u skupini koja je primala lijek Tarceva, opažene tijekom ispitivanja BR.21 navedene su, prema stupnju toksičnosti sukladno općim kriterijima toksičnosti Nacionalnog instituta za rak (National Cancer Institute-Common Toxicity Criteria, NCI- CTC) u tablici 1.
Adverse reactions occurring more frequently (3%) in Tarceva 100 mg plus gemcitabine-treated patients than in the placebo plus gemcitabine group in the pivotal study PA.3, and in at least 10% of patients in the Tarceva 100 mg plus gemcitabine group, are summarised by National Cancer Institute- Common Toxicity Criteria (NCI-CTC) Grade in Table 3.
Nuspojave koje su češće primijećene (3%) u bolesnika liječenih lijekom Tarceva 100 mg i gemcitabinom nego u skupini koja je primala placebo i gemcitabin te u najmanje 10% bolesnika u skupini koja je primala lijek Tarceva 100 mg i gemcitabin, prema rezultatima dobivenima iz osnovnog ispitivanja PA.3. navedene su, prema stupnju toksičnosti sukladno općim kriterijima toksičnosti Nacionalnog instituta za rak (National Cancer Institute-Common Toxicity Criteria, NCI-CTC), u Tablici 3.
Adverse reactions of gout were reported more frequently in tolvaptan-treated patients (28/961, 2.9%) than in patients receiving placebo (7/483, 1.4%).
Nuspojave gihta zabilježene su češće u bolesnika liječenih tolvaptanom (28/961; 2,9%) nego u bolesnika koji su primali placebo (7/483; 1,4%).
Adverse reactions of the digestive tract (such as vomiting) were commonly reported but most cases were mild and recovered without treatment.
Gastrointestinalne nuspojave (poput povraćanja) prijavljivane su često, ali većina slučajeva bila je blaga i prošla je bez liječenja.
Adverse reactions of the digestive tract such as vomiting and diarrhoea were commonly reported, loss of appetite, haemorrhagic diarrhoea and melaena have been reported in uncommon cases.
Češće su prijavljivane nuspojave probavnog trakta, poput povraćanja i dijareje, a rjeđe gubitak apetita, hemoragijska dijareja i melena.
Adverse reactions of the digestive tract were reported very commonly, but most cases were mild and recovered without treatment.
Gastrointestinalne nuspojave prijavljivane su vrlo često, ali većina slučajeva bila je blaga i povukla se bez liječenja.
Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include: Infections and infestations
Nuspojave nepoznate učestalosti prijavljene uz primjenu samog hidroklorotiazida uključuju: Infekcije i infestacije
Adverse reactions only reported during the post marketing period are also included in the table with a frequency “not known” (cannot be estimated from the available data)
Nuspojave prijavljene samo nakon stavljanja lijeka u promet također su obuhvaćene u tablici, a njihova je učestalost označena kao "nepoznato" (ne može se procijeniti iz dostupnih podataka).
Adverse reactions per system organ class
Nuspojave prema klasifikaciji organskih sustava
Adverse reactions previously reported with one of the individual active substances may be potential adverse reactions with Jentadueto, even if not observed in clinical trials with this medicinal product.
Nuspojave prethodno prijavljene s jednom od pojedinačnih djelatnih tvari moguće su nuspojave s Jentaduetom, čak i ako nisu primijećene u kliničkim ispitivanjima s ovim lijekom.
Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with amlodipine/valsartan as well, even if not observed in clinical trials or during the post-marketing period.
Nuspojave koje su ranije prijavljene s jednom od pojedinačnih komponenti (amlodipinom ili valsartanom) mogu biti i moguće nuspojave amlodipina/valsartana, iako nisu uočene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet.
Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Copalia as well, even if not observed in clinical trials or during the post-marketing period.
Nuspojave koje su ranije prijavljene s jednom od pojedinačnih komponenti (amlodipinom ili valsartanom) mogu biti i moguće nuspojave Copalie, iako nisu uočene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet.
Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Dafiro as well, even if not observed in clinical trials or during the post-marketing period.
Nuspojave koje su ranije prijavljene s jednom od pojedinačnih komponenti (amlodipinom ili valsartanom) mogu biti i moguće nuspojave Dafira, iako nisu uočene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet.
Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Exforge as well, even if not observed in clinical trials or during the post-marketing period.
Nuspojave koje su ranije prijavljene s jednom od pojedinačnih komponenti (amlodipinom ili valsartanom) mogu biti i moguće nuspojave Exforgea, iako nisu uočene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet.
Adverse reactions previously reported with one of the individual components (telmisartan or amlodipine) may be potential adverse reactions with Twynsta as well, even if not observed in clinical trials or during the post-marketing period.
Nuspojave koje su prethodno bile prijavljene uz jednu od pojedinih komponenti (telmisartan ili amlodipin) također predstavljaju potencijalne nuspojave uz Twynstu, čak iako nisu primijećene u kliničkim ispitivanjima ili tijekom razdoblja nakon stavljanje lijeka u promet.
Adverse reactions previously reported with one of the individual components may be potential adverse reactions with PritorPlus, even if not observed in clinical trials with this product.
Nuspojave prethodno prijavljene s jednom od individualnih komponenti mogu biti potencijalne nuspojave PritorPlusa, čak iako nisu zabilježene u kliničkim ispitivanjima ovoga lijeka.
Adverse reactions previously reported with one of the individual components may be potential adverse reactions with Tolucombi, even if not observed in clinical trials with this product.
Nuspojave prethodno prijavljene s jednom od individualnih komponenti mogu biti potencijalne nuspojave lijeka Tolucombi, čak iako nisu zabilježene u kliničkim ispitivanjima ovoga lijeka.
Adverse reactions previously reported with one of the individual components may occur with Rasilamlo even if not observed in clinical trials.
Nuspojave ranije prijavljene s nekom od pojedinačnih komponenti mogu se pojaviti s Rasilamlom čak i ako nisu bile opažene u kliničkim ispitivanjima.
Adverse reactions previously reported with one of the individual components may occur with Rasilez HCT even if not observed in clinical trials.
Nuspojave ranije prijavljene s nekom od pojedinačnih komponenti mogu se pojaviti s Rasilez HCT- om čak i ako nisu bile opažene u kliničkim ispitivanjima.
ADVERSE REACTIONS Rabbits:
NUSPOJAVE Kunići:
Adverse reactions reactions that occurred during clinical studies or that were spontaneously reported from post-marketing experience are listed by frequency in the table below.
Nuspojave iz kliničkih ispitivanja ili one koje su spontano prijavljene nakon stavljanja lijeka u promet navedene su prema učestalosti u tablici u nastavku.
Adverse reactions reported are listed according to the following frequency categories:
Prijavljene nuspojave navedene su prema sljedećim kategorijama učestalosti:
Adverse reactions reported are listed according to the following frequency: Very common:  1/10
Nuspojave su prema učestalosti pojavljivanja definirane kao: Vrlo često:  1/10
Adverse reactions reported are listed per dose according to the following frequency:
Prijavljene nuspojave navedene su prema sljedećim učestalostima:
Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Nuspojave zabilježene u više od jednoga izoliranog slučaja navedene su niže u tekstu po klasifikaciji organskih sustava i incidenciji.
Adverse reactions reported at a very common (≥1/10), common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100) frequency with eculizumab are listed by system organ class and preferred term.
Nuspojave zabilježene uz ekulizumab kao vrlo česte (≥1/10), česte (≥1/100 i <1/10) ili manje česte (≥1/1000 i <1/100) navedene su prema klasifikaciji organskih sustava i preporučenim izrazima.
Adverse reactions reported both in adults and paediatric patients as more than an isolated case are listed below, by system organ class and by frequency.
Nuspojave prijavljene u odraslih i pedijatrijskih bolesnika veće brojnosti nego samo u izoliranim slučajevima navedene su u nastavku, klasificirane po sustavu organa i po učestalosti.
Adverse reactions reported during post-marketing with CellCept are similar to those seen in the controlled renal and hepatic transplant studies.
Nuspojave prijavljene tijekom post-marketinškog praćenja sigurnosti primjene lijeka CellCept slične su onima opaženima u kontroliranim ispitivanjima bolesnika s bubrežnim i jetrenim presatkom.
Adverse reactions reported during the first six months of two pooled pivotal Phase III trials of 6 and 12 months duration are listed by MedDRA system organ class (Table 1).
Nuspojave prijavljene tijekom prvih šest mjeseci dvaju objedinjenih ključnih ispitivanja faze III trajanja od 6 odnosno 12 mjeseci navedene su prema organskom sustavu prema MedDRA-i (Tablica 1).
Adverse reactions reported for subjects receiving dinutuximab in combination with GM-CSF, IL-2, and isotretinoin are summarised in Table 5.
Nuspojave prijavljene za ispitanike koji primaju dinutuksimab u kombinaciji s GM-CSF-om, IL-2 i izotretinoinom su prikazane u Tablici 5.
Adverse reactions reported from placebo- and active-controlled phase III studies over the entire treatment period are presented in Table 1.
U Tablici 1 navode se nuspojave prijavljene tijekom cijeloga razdoblja liječenja u ispitivanjima faze III kontroliranim placebom ili aktivnim kontrolnim lijekom.
Adverse reactions reported from the clinical programme are those that occurred in the Phase 3 double blind placebo controlled studies for the treatment of Dupuytren’s contracture in adult patients with a palpable cord (AUX-CC-857, AUX-CC-859) and the post-marketing clinical studies (AUX-CC-864, AUX-CC-867) for two concurrent injections in the same hand.
Nuspojave zabilježene u kliničkom programu su one koje su se pojavile u dvostruko slijepim, placebom kontroliranim ispitivanjima faze III liječenja Dupuytrenove kontrakture u odraslih bolesnika s opipljivim tračkom (AUX-CC-857, AUX-CC-859) i kliničkim ispitivanjima istovremene primjene dvije injekcije u istu šaku (AUX-CC-864, AUX-CC-867) nakon stavljanja lijeka u promet.
Adverse reactions reported from the clinical programme are those that occurred in the Phase 3 double-blind placebo controlled studies.
Nuspojave zabilježene u kliničkom programu su one koje su se javile u dvostruko slijepim, placebom kontroliranim ispitivanjima faze III.
Adverse reactions reported in 2,799 patients treated with pembrolizumab in clinical trials are reported in Table 2.
Nuspojave prijavljene u 2799 bolesnika liječenih pembrolizumabom u kliničkim ispitivanjima prijavljene su u Tablici 2.
Adverse reactions reported in 554 patients with multiple myeloma who were treated with elotuzumab in 6 clinical trials are presented in Table 3.
Nuspojave prijavljene u 554 bolesnika s multiplim mijelomom liječena elotuzumabom u 6 kliničkih ispitivanja prikazane su u Tablici 3.
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being related or possibly related to vaccination have been categorised by frequency.
Nuspojave zabilježene u kliničkom ispitivanju nakon provedenog primarnog cijepljenja cjepivom Fendrix koje se smatraju povezanima ili moguće povezanima s cijepljenjem kategorizirane su prema učestalosti.