natgillin/translations-raw huggingface dataset:
The following adverse reactions have been identified based on evaluation of the full duration of the phase II and phase III clinical studies and are listed in Table 1 as MedDRA preferred term by system organ class and in order of decreasing incidence (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).
Naslednje neželene učinke so odkrili na podlagi evalvacije skupnega trajanja kliničnih študij 2. in 3. faze in so navedeni v Preglednici 1 po organskih sistemih, kot je priporočeno po MedDRA, in razvrščeni po padajoči incidenci (zelo pogosti: ≥ 1/10; pogosti: ≥ 1/100 do < 1/10; občasni: ≥ 1/1.000 do < 1/100; redki: ≥ 1/10.000 do < 1/1.000; zelo redki: < 1/10.000 in neznano: pogostnosti ni mogoče oceniti na podlagi razpoložljivih podatkov).
The following adverse reactions have been identified during postmarketing use of Nespo:
Med pomarketinško uporabo Nespa so ugotovili naslednje neželene učinke:
The following adverse reactions have been identified following studies with Possia (Table 1).
Po študijah z zdravilom Possia so ugotovili naslednje neželene učinke (preglednica 1).
The following adverse reactions have been identified for agalsidase alfa:
Pri agalzidazi alfa so ugotovili naslednje neželene reakcije:
The following adverse reactions have been identified in clinical studies with patients receiving Lynparza monotherapy.
Pri bolnicah, ki so v kliničnih študijah prejemale monoterapijo z zdravilom Lynparza, so zabeležili naslednje neželene učinke.
The following adverse reactions have been identified in clinical studies with patients receiving vandetanib as treatment for MTC.
V kliničnih študijah pri bolnikih, ki so prejemali vandetanib za zdravljenje MTC, so ugotovili naslednje neželene učinke.
The following adverse reactions have been identified in Phase 2/3 clinical trials with dalbavancin.
Naslednji neželeni učinki so bili zabeleženi v fazi 2/3 kliničnih preskušanj z dalbavancinom.
The following adverse reactions have been identified or suspected in the clinical trials programme for esomeprazole and post-marketing.
V programu kliničnih preskušanj esomeprazola in med uporabo zdravila po prihodu na trg so bili ugotovljeni ali domnevni naslednji neželeni učinki zdravila.
The following adverse reactions have been observed in a field study in dogs: Very common (more than 1 in 10 animals)
V študijah pri psih na terenu so opazili naslednje neželene učinke: Zelo pogosti (pojavijo se pri 1 od 10 živali)
The following adverse reactions have been observed in laboratory studies in dogs:
V laboratorijskih študijah pri psih so opazili naslednje neželene učinke:
The following adverse reactions have been observed in patients who received Tarceva administered as single agent and patients who received Tarceva concurrently with chemotherapy.
Naslednje neželene učinke so opazili pri bolnikih, ki so prejemali zdravilo Tarceva kot samostojno zdravilo, in bolnikih, ki so prejemali zdravilo Tarceva skupaj s kemoterapijo.
The following adverse reactions have been observed under treatment with Somatropin Biopartners in a 6-month controlled clinical study with 151 adult patients with GHD of adult- or childhood-onset and in a 6-month extension study.
Naslednje neželene učinke so opazili pri zdravljenju z zdravilom Somatropin Biopartners v 6-mesečni kontrolirani klinični študiji s 151 odraslimi bolniki s pomanjkanjem rastnega hormona z začetkom v odrasli dobi ali v otroštvu, in v 6-mesečnem podaljšku študije.
The following adverse reactions have been observed:
Opazili so naslednje neželene učinke:
The following adverse reactions have been reported during clinical studies and/or post-marketing use with alendronate.
Iz kliničnih študij in/ali v obdobju trženja alendronata so poročali o naslednjih neželenih učinkih.
The following adverse reactions have been reported during clinical studies in adults and/or post- marketing use for CRIXIVAN monotherapy and/or CRIXIVAN with combination antiretroviral therapy (CART).
Med kliničnimi študijami pri odraslih in/ali pri uporabi v obdobju trženja so pri zdravilu CRIXIVAN samem in/ali zdravilu CRIXIVAN ob kombiniranem protiretrovirusnem zdravljenju (CART) poročali o naslednjih neželenih učinkih.
The following adverse reactions have been reported during clinical studies with SIMBRINZA twice-daily dosing and during clinical studies and post-marketing surveillance with the individual components brinzolamide and brimonidine.
O naslednjih neželenih učinkih so poročali v kliničnih študijah z zdravilom SIMBRINZA v odmerkih dvakrat na dan ter v kliničnih študijah in spremljanju v obdobju trženja posameznih učinkovin, brinzolamida in brimonidina.
The following adverse reactions have been reported during post-marketing experience: Skin and subcutaneous tissue disorders: Rosacea
Med postmarketinškimi izkušnjami so bili poročani naslednji neželeni učinki: Bolezni kože in podkožja: Rozacea
The following adverse reactions have been reported during post-marketing surveillance of tolvaptan approved for other indications.
V spremljanju tolvaptan, odobrenega za druge indikacije, so v obdobju trženja poročali o naslednjih neželenih učinkih.
The following adverse reactions have been reported during post-marketing surveillance.
Med nadzor om v obdobju trženja so bili opisani naslednji neželeni učinki.
The following adverse reactions have been reported in clinical studies involving 18 patients treated with Coagadex.
V kliničnih študijah, ki so vključevale 18 bolnikov, zdravljenih z zdravilom Coagadex, so poročali o naslednjih neželenih učinkih.
The following adverse reactions have been reported post-marketing in temporal association with the use of Xarelto.
V obdobju trženja so poročali o naslednjih neželenih učinkih, ki so bili v časovni povezavi z uporabo zdravila Xarelto.
The following adverse reactions have been reported to have a causal association with lapatinib alone or lapatinib in combination with capecitabine, trastuzumab or letrozole.
O naslednjih neželenih učinkih so poročali kot vzročno povezane z lapatinibom samim ali lapatinibom v kombinaciji s kapecitabinom, trastuzumabom ali z letrozolom.
The following adverse reactions have been reported with ceftazidime alone and/or identified during the Phase 2 and Phase 3 trials with Zavicefta.
Naslednji neželeni učinki so bili poročani s ceftazidimom samim in/ali ugotovljeni v kliničnih preskušanjih 2. in 3. faze z zdravilom Zavicefta.
The following adverse reactions have been reported with Effentora and/or other fentanyl-containing compounds during clinical studies and post marketing experience.
Z uporabo zdravila Effentora in/ali drugih zdravil, ki vsebujejo fentanil, so poročali o naslednjih neželeni učinkih iz kliničnih študij in obdobja po začetku trženja.
The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines:
Poročali so o naslednjih neželenih reakcijah po cepljenju s cepivom Twinrix ali z monovalentnima cepivoma proti hepatitisu A ali hepatitisu B izdelovalca GlaxoSmithKline:
The following adverse reactions have been reported with Myocet during clinical studies and post marketing experience.
O naslednjih neželenih učinkih so poročali pri uporabi zdravila Myocet med kliničnimi študijami in pri izkušnjah po trženju.
The following adverse reactions have been reported with PecFent and/or other fentanyl-containing compounds during clinical studies and post marketing experience (frequencies defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Z uporabo zdravila PecFent in/ali drugih zdravil, ki vsebujejo fentanil, so poročali o naslednjih neželenih učinkih iz kliničnih študij in obdobja po začetku trženja (pogostnost je opredeljena kot zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do
The following adverse reactions have only been observed with rivastigmine capsules and oral solution and not in clinical studies with rivastigmine transdermal patches: somnolence, malaise, tremor, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).
Naslednje neželene učinke so opažali samo pri uporabi kapsul in peroralne raztopine z rivastigminom, ne pa v kliničnih študijah s transdermalnimi obliži z rivastigminom: somnolenco, splošno slabo počutje, tremor, zmedenost, povečano potenje (pogosto); razjede dvanajstnika, angino pektoris (redko); krvavitev v prebavila (zelo redko); in nekaj primerov hudega bruhanja, ki je bilo povezano z rupturo požiralnika (pogostnost neznana).
The following adverse reactions in retroperitoneal or intra-abdominal surgery and in neurosurgery was common (defined as ≥ 1/100, < 1/10).
Sledeči našteti neželeni učinki pri retroperitonealnih in intraabdominalnih kirurških posegih ter v nevrokirurgiji so bili pogosti (definirano kot ≥1/100 do <1/10).
The following adverse reactions listed below have been accumulated from all clinical trials in patients treated with telmisartan for hypertension or in patients 50 years or older at high risk of cardiovascular events.
Našteti neželeni učinki zdravila so zbrani iz vseh kliničnih preskušanj pri bolnikih, ki so se s telmisartanom zdravili zaradi hipertenzije, ali pri bolnikih starih 50°let ali starejših, z velikim tveganjem za srčnožilne dogodke.
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with Ebixa and since its introduction in the market.
V spodnji preglednici so navedeni podatki o neželenih učinkih, zbrani v kliničnih študijah zdravila Ebixa in od začetka trženja dalje.
The following adverse reactions listed in the Table below have been accumulated in clinical studies with memantine and since its introduction in the market.
V preglednici so navedeni podatki o neželenih učinkih memantina, zbrani v kliničnih študijah in v obdobju trženja zdravila.
The following adverse reactions listed in the table below were observed in clinical studies or with post-marketing experience.
Naslednje neželene učinke, ki so našteti v spodnji preglednici, so opazili v kliničnih študijah ali med spremljanjem zdravila na trgu.
The following adverse reactions occurred more often (≥ 1/100) than placebo, or were identified as possibly medically relevant adverse reactions (*).
Naslednji neželeni učinki so se pojavili pogosteje (≥ 1/100) kot pri placebu, ali pa je bilo ugotovljeno, da pomenijo morebiti medicinsko pomembne neželene reakcije na zdravilo (*).
The following adverse reactions occurred more often (≥ 1/100) than placebo, or were identified as possibly medically relevant adverse reactions in clinical trials with aripiprazole (see section 5.1).
Pri kliničnih preskušanjih aripiprazola v obliki raztopine za injiciranje so se naslednji neželeni učinki pojavili pogosteje (≥ 1/100) kot pri placebu, ali pa je bilo ugotovljeno, da pomenijo morebiti medicinsko pomembne neželene reakcije na zdravilo (glejte poglavje 5.1).
The following adverse reactions relate to 166 MBC and 120 MOC patients treated with 175 mg/m2 Paxene administered as a 3-hour infusion as second-line chemotherapy in two clinical studies and were considered possibly or probably related to Paxene.
Navedeni neželeni učinki se nanašajo na 166 bolnic z MBC in 120 bolnic z MOC, pri katerih so v dveh kliničnih študijah kot zdravljenje drugega izbora uporabili 175 mg/m2 zdravila Paxene v obliki 3- urne infuzije, in za katere menijo, da so morebiti ali verjetno povezani z zdravilom Paxene.
The following adverse reactions were assessed to be related with Travoprost 40 µg/mL eye drops, solution (either BAK or Polyquad- preserved) and are classified according to 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).
Naslednji neželeni učinki so bili ocenjeni kot povezani z zdravljenjem s kapljicami za oko s travoprostom v odmerku 40 µg/ml (konzerviranimi bodisi z BAK ali s Polyquadom) in so razvrščeni v skladu z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov).
The following adverse reactions were identified prior to registration of LEMTRADA during use of alemtuzumab for the treatment of B-cell chronic lymphocytic leukaemia (B-CLL), as well as for the treatment of other disorders, generally at higher and more frequent doses (e.g.
Naslednji neželeni dogodki so bili ugotovljeni pred pridobitvijo dovoljenja za promet z zdravilom LEMTRADA med uporabo alemtuzumaba za zdravljenje B-celične kronične limfocitne levkemije (B-KLL) ter za zdravljenje drugih bolezni, običajno z večjimi in pogostejšimi odmerki (npr.
The following adverse reactions were identified through post-marketing surveillance but not reported as drug-related in randomised controlled Phase III clinical trials (Protocols 018, 019, and 021): thrombocytopenia, suicidal ideation, suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness), hepatic failure, Stevens Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis.
Naslednje neželene učinke so odkrili med spremljanjem zdravila po prihodu na trg, medtem ko o njih v randomiziranih nadzorovanih kliničnih preskušanjih faze III (Protokoli 018, 019 in 021) niso poročali kot o z zdravilom povezanimi neželenimi učinki: trombocitopenija, samomorilne misli, samomorilno vedenje (predvsem pri bolnikih, ki so v preteklosti že kdaj imeli psihiatrične motnje), odpoved jeter, Stevens-Johnsonov sindrom, izpuščaj z eozinofilijo in s sistemskimi simptomi kot posledica zdravljenja z zdravilom (DRESS – Drug Rash with Eosinophilia and Systemic Symptoms), rabdomioliza.
The following adverse reactions were observed during clinical studies conducted with Toujeo (see section 5.1) and during clinical experience with insulin glargine 100 units/ml.
Med kliničnimi študijami, izvedenimi z zdravilom Toujeo (glejte poglavje 5.1), in med klinično uporabo insulina glargina 100 enot/ml so opažali naslednje neželene reakcije.
The following adverse reactions were observed in a pooled analysis of the HEC and MEC studies at a greater incidence with oral aprepitant than with standard therapy or in postmarketing use:
V nadaljevanju so navedeni neželeni učinki iz združene analize HEC in MEC študij, ki so jih pri peroralnemu aprepitantu opazili pogosteje kot pri standardni obliki zdravljenja, ali iz obdobja trženja zdravila:
The following adverse reactions were observed in the NAPOLI-1 clinical study:
Naslednje neželene učinke so opazili v klinični študiji NAPOLI-1:
The following adverse reactions were reported at a higher frequency category than in the other clinical studies:
Naslednji neželeni učinki so bili opaženi z večjo pogostnostjo kot v drugih kliničnih študijah:
The following adverse reactions were reported during clinical studies and/or post-marketing use:
V kliničnih študijah in/ali v obdobju trženja so poročali o naslednjih neželenih učinkih:
The following adverse reactions were reported during clinical trials with Ambirix.
V kliničnih preskušanjih cepiva Ambirix so ugotovili naslednje neželene učinke.
The following adverse reactions were reported during clinical trials with LUMIGAN 0.3 mg/mL single-dose or in the post-marketing period.
V kliničnih preskušanjih z zdravilom LUMIGAN 0,3 mg/ml (enoodmerna oblika) ali po prihodu zdravila na trg so poročali o naslednjih neželenih učinkih.
The following adverse reactions were reported during post-marketing surveillance following vaccination with Ambirix.
Naslednje neželene učinke so zabeležili med postmarketinškim spremljanjem po cepljenju s cepivom Ambirix.
The following adverse reactions were reported in clinical trials and from post-marketing spontaneous reporting.
V kliničnih preskušanjih in spontanih poročilih iz obdobja trženja so poročali o naslednjih neželenih učinkih..
The following adverse reactions were reported in controlled clinical studies at the recommended dose of 2 mg with frequencies corresponding to 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) and not known (cannot be estimated from available data).
V nadzorovanih kliničnih študijah pri priporočenem odmerku 2 mg so poročali o naslednjih neželenih učinkih po pogostnosti, ki je definirana kot zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1.000 do < 1/100), redko (≥ 1/10.000 do < 1/1.000), zelo redko (< 1/10.000) in neznano (ni mogoče oceniti iz razpoložljivih podatkov).
The following adverse reactions were reported in controlled clinical studies at the recommended dose of 2 mg with frequencies corresponding to 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) and not known (cannot be estimated from the available data).
V nadzorovanih kliničnih študijah pri priporočenem odmerku 2 mg so poročali o naslednjih neželenih učinkih po pogostnosti, ki je definirana kot zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1.000 do < 1/100), redko (≥ 1/10.000 do < 1/1.000), zelo redko (< 1/10.000) in neznano (ni mogoče oceniti iz razpoložljivih podatkov).
The following adverse reactions were reported in patients in the Tasigna clinical studies at a frequency of less than 5%.
O naslednjih neželenih učinkih so poročali pri bolnikih iz kliničnih študij z zdravilom Tasigna z manj kot 5-odstotno pogostnostjo.
The following adverse reactions were reported in patients treated with alirocumab in pooled controlled studies:
Kumulativno so bili v kontroliranih študijah pri bolnikih, zdravljenih z alirokumabom, opisani naslednji neželeni učinki:
The following adverse reactions were reported in placebo controlled trials where subjects received anaesthesia and/or neuromuscular blocking agents (1,078 subject exposures to sugammadex versus 544 to placebo):
V s placebom nadzorovanih kliničnih preskušanjih, kjer so osebe prejele anestezijo in/ali živčnomišične relaksante (1.078 oseb je prejelo sugamadeks, 544 pa placebo) so poročali o naslednjih neželenih učinkih:
The following adverse reactions were reported with Opgenra.
O naslednjih neželenih učinkih po poročali kot o učinkih, ki bi lahko bili vzročno-posledično povezani z uporabo zdravila Opgenra.
The following adverse reactions were reportedduring clinical studies and/or post-marketing use:
V kliničnih študijah in/ali v obdobju trženja so poročali o naslednjih neželenih učinkih:
The following adverse reactions which may be causally related to the administration of Viramune prolonged-release tablets have been reported.
Poročila navajajo naslednje neželene reakcije, ki so lahko vzročno povezani z dajanjem zdravila Viramune s podaljšanim sproščanjem.
The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer’s dementia treated with Exelon.
Neželene učinke, navedene v spodnji preglednici 1, so zbrali pri bolnikih z Alzheimerjevo demenco, zdravljenih z zdravilom Exelon.
The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer’s dementia treated with Prometax.
Neželene učinke, navedene v spodnji preglednici 1, so zbrali pri bolnikih z Alzheimerjevo demenco, zdravljenih z zdravilom Prometax.
The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer’s dementia treated with rivastigmine.
Neželene učinke, navedene v spodnji preglednici 1, so zbrali pri bolnikih z Alzheimerjevo demenco, zdravljenih z rivastigminom.
The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer’s dementia treated with rivastigmine.
Neželene učinke, navedene v spodnji preglednici 1, so zbrali pri bolnikih z Alzheimerjevo demenco, zdravljenih z zdravilom rivastigmin.
The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Corbilta or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the post- marketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
Neželeni učinki v nadaljevanju, našteti v preglednici 1, so bili zbrani iz združenih podatkov enajstih dvojno slepih kliničnih preskušanj, ki so zajela 3.230 bolnikov (1.810 zdravljenih z zdravilom Corbilta ali entakaponom v kombinaciji z levodopo/zaviralcem dekarboksilaze, in 1.420 zdravljenih s placebom v kombinaciji z levodopo/zaviralcem dekarboksilaze ali kabergolinom v kombinaciji z levodopo/zaviralcem dekarboksilaze), in iz podatkov v obdobju trženja, od uvedbe entekapona za kombinirano uporabo z levodopo/zaviralcem dekarboksilaze.
The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Corbilta or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the post- marketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
Neželeni učinki v nadaljevanju, našteti v preglednici 1, so bili zbrani iz združenih podatkov iz enajstih dvojno slepih kliničnih preskušanj, ki so zajela 3.230 bolnikov (1.810 zdravljenih z zdravilom Corbilta ali entakaponom v kombinaciji z levodopo/zaviralcem dekarboksilaze, in 1.420 zdravljenih s placebom v kombinaciji z levodopo/zaviralcem dekarboksilaze ali kabergolinom v kombinaciji z levodopo/zaviralcem dekarboksilaze), in iz podatkov v obdobju trženja, od uvedbe entekapona za kombinirano uporabo z levodopo/zaviralcem dekarboksilaze.
The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Levodopa/Carbidopa/Entacapone Orion or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the post-marketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
Neželeni učinki v nadaljevanju, našteti v preglednici 1, so bili zbrani iz združenih podatkov iz enajstih dvojno slepih kliničnih preskušanj, ki so zajela 3.230 bolnikov (1.810 zdravljenih z zdravilom Levodopa/Carbidopa/Entacapone Orion ali entakaponom v kombinaciji z levodopo/zaviralcem dekarboksilaze, in 1.420 zdravljenih s placebom v kombinaciji z levodopo/zaviralcem dekarboksilaze ali kabergolinom v kombinaciji z levodopo/zaviralcem dekarboksilaze), in iz podatkov v obdobju trženja, od uvedbe entekapona za kombinirano uporabo z levodopo/zaviralcem dekarboksilaze.