natgillin/translations-raw huggingface dataset:
Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance &lt; 30 ml/min).
Za bolesnike s teškom insuficijencijom bubrega dostupni su samo ograničeni farmakokinetički podaci (klirens kreatinina manji od 30 ml/min).
Only patients with histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma that had recurred &gt; 6 months after platinum-based chemotherapy and who had not received chemotherapy in the recurrent setting and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents were included in the study.
U ispitivanje su uključene samo bolesnice s histološki potvrđenim karcinomom jajnika, primarnim peritonealnim karcinomom ili karcinomom jajovoda koji je recidivirao nakon &gt; 6 mjeseci od kemoterapije utemeljene na platini, a koje nisu primale kemoterapiju za liječenje recidiva i nisu prethodno bile liječene bevacizumabom, drugim VEGF inhibitorima niti lijekovima koji djeluju na VEGF receptore.
Only PSR patients with partially platinum-sensitive disease (platinum-free interval of 6 to 12 months) and patients with platinum-sensitive disease (platinum-free interval of &gt; 12 months) who were in response following completion of last platinum-based chemotherapy were enrolled.
U ispitivanje su bile uključene samo bolesnice s recidivom karcinoma djelomično osjetljivog na platinu ( interval bez platine od 6 do 12 mjeseci) i bolesnice s recidivom karcinoma osjetljivog na platinu (interval bez platine &gt; 12 mjeseci) koje su ostvarile odgovor nakon završetka posljednje kemoterapije utemeljene na platini.
Only trace amounts of unchanged rilpivirine ( &lt; 1% of dose) were detected in urine.
U mokraći je neizmijenjeni rilpivirin otkriven samo u tragovima ( &lt; 1% doze).
Only trace amounts of unchanged rilpivirine ( &lt; 1% of dose) were detected in urine.
U mokraći su otkrivene samo količine rilpivirina u tragovima ( &lt; 1% doze).
Only trace amounts of unchanged rilpivirine ( &lt; 1% of dose) were detected in urine.
U mokraći su otkriveni samo tragovi nepromijenjenog rilpivirina ( &lt; 1% doze).
Opadry green (containing lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD &amp; C Blue (E132), iron oxide yellow (E172))
Opadry green (sadrži laktozu hidrat, hipromelozu, titanijev dioksid (E171), gliceroltriacetat, FD &amp; C Blue (E132), željezov oksid, žuti (E172))
Opadry II green: (Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD &amp; C Blue (E132), iron oxide yellow (E172))
Opadry II green: (laktoza hidrat, hipromeloza, titanijev dioksid (E171), gliceroltriacetat, FD &amp; C Blue (E132), željezov oksid, žuti (E172)
OPDIVO must be administered with caution in patients with moderate (total bilirubin &gt; 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin &gt; 3 × ULN and any AST) hepatic impairment.
OPDIVO se mora primjenjivati uz oprez u bolesnika s umjerenim (ukupan bilirubin &gt; 1,5 × do 3 × gornja granica normale [GGN] i bilo koja vrijednost AST-a) ili teškim (ukupan bilirubin &gt; 3 × GGN i bilo koja vrijednost AST-a) oštećenjem jetrene funkcije.
Opgenra is contraindicated in children ( &lt; 12 years old), adolescents (12-18 years old) and the skeletally immature (see section 4.3).
Opgenra je kontraindicirana u djece (u dobi &lt; 12 godina), adolescenata (u dobi 12-18 godina) i osoba s nerazvijenim kosturom (vidjeti dio 4.3).
Opicapone is a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor endowed with a high binding affinity (sub-picomolar) that translates into a slow complex dissociation rate constant and a long duration of action ( &gt; 24 hours) in vivo.
Opikapon je periferni, selektivni i reverzibilni inhibitor katekol-O-metiltransferaze (COMT) karakteriziran visokim afinitetom vezivanja (subpikomolarno), što in vivo znači nisku konstantu brzine disocijacije kompleksa i dugo trajanje djelovanja ( &gt; 24 h).
Opicapone showed a marked ( &gt; 90%) and long-lasting ( &gt; 24 hours) COMT inhibition in healthy subjects after administration of 50 mg opicapone.
Nakon primjene 50 mg opikapona u zdravih ispitanika, opikapon je pokazao izrazitu ( &gt; 90%) i dugotrajnu inhibiciju COMT-a ( &gt; 24 h).
Opsumit is not to be initiated in patients with severe hepatic impairment or elevated aminotransferases ( &gt; 3 × ULN) (see sections 4.2 and 4.3), and is not recommended in patients with moderate hepatic impairment.
Terapiju lijekom Opsumit ne smije se započinjati u bolesnika s teškim oštećenjem jetre ili povišenim aminotransferazama ( &gt; 3 × GGN) (vidjeti dijelove 4.2 i 4.3) te se ne preporučuje u bolesnika s umjerenim oštećenjem jetre.
Opsumit must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal ( &gt; 3 × ULN); see sections 4.3 and 4.4).
Terapija Opsumitom se ne smije započinjati u bolesnika s teškim oštećenjem funkcije jetre ili klinički značajno povišenim jetrenim aminotransferazama (više od 3 puta od gornje granice normale ( &gt; 3 × GGN); vidjeti dijelove .3 i 4.4).
Optimark is contraindicated in patients with severe renal impairment (GFR &lt; 30 ml/min/1.73 m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period.
Optimark je kontraindiciran kod bolesnika s teškim oštećenjem funkcije bubrega (GFR &lt; 30 ml/min/1,73m²) i/ili akutnom ozljedom bubrega, bolesnika kojima je transplantirana jetra i bolesnika koji će biti podvrgnuti transplantaciji jetre.
Optimark is contraindicated in patients with severe renal impairment (GFR &lt; 30 ml/min/1.73 m²) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period.
Optimark je kontraindiciran kod bolesnika s teškim oštećenjem funkcije bubrega (GFR &lt; 30 ml/min/1,73m²) i/ili akutnom ozljedom bubrega, bolesnika kojima je transplantirana jetra i bolesnika koji će biti podvrgnuti transplantaciji jetre.
Optimark is contraindicated in patients with severe renal impairment (GFR &lt; 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3).
Optimark je kontraindiciran kod bolesnika s teškim oštećenjem funkcije bubrega (GFR &lt; 30 ml/min/1,73m²) i/ili akutnom ozljedom bubrega, bolesnika kojima je transplantirana jetra i bolesnika koji će biti podvrgnuti transplantaciji jetre (vidjeti dio 4.3).
Optimark is contraindicated in patients with severe renal impairment (GFR &lt; 30ml/min/1.73m2) and/or acute kidney injury,
Optimark je kontraindiciran: kod bolesnika s teškim oštećenjem funkcije bubrega (GFR &lt; 30ml/min/1,73m²) i/ili akutnom ozljedom bubrega,
Oral bioavailability may be limited in paediatric patients aged 2 to &lt; 12 years with malabsorption and very low body weight for age.
Bioraspoloživost nakon peroralne primjene može biti ograničena u djece u dobi od 2 do &lt; 12 godina ako imaju malapsorpciju ili premalu tjelesnu težinu za dob.
Oral bioavailability may be limited in paediatric patients aged 2 to &lt; 12 years with malabsorption and very low body weight for age.
Bioraspoloživost nakon peroralne primjene može biti ograničena u pedijatrijskih bolesnika u dobi od 2 do &lt; 12 godina ako imaju malapsorpciju ili premalu tjelesnu težinu za dob.
Oral bioavailability may be limited in paediatric patients aged 2 to &lt; 12 years with malabsorption and very low body weight for age.
Bioraspoloživost nakon peroralne primjene može biti ograničena u pedijatrijskih bolesnika u dobi od 2 do &lt; 12 godina ako imaju malu apsorpciju ili premalu tjelesnu težinu za dob.
Oral bioavailability may be limited in paediatric patients aged 2- &lt; 12 years with malabsorption and very low body weight for age.
Bioraspoloživost nakon peroralne primjene može biti ograničena u djece u dobi od 2 do &lt; 12 godina ako imaju lošu apsorpciju ili premalu tjelesnu težinu za dob.
Oral candidiasis (G3/4: &lt; 1%)
oralna kandidijaza (G3/4: &lt; 1%)
ORRs were 29% (95% CI: 21, 39) for pemetrexed (p-value &lt; 0.0001 compared with crizotinib) and 7% (95% CI: 2, 16) for docetaxel (p-value &lt; 0.0001 compared with crizotinib).
Stope objektivnog odgovora (ORR) bile su 29% (95% CI: 21, 39) za pemetreksed (p-vrijednost &lt; 0,0001 u usporedbi s krizotinibom) i 7% (95% CI: 2, 16) za docetaksel (p-vrijednost &lt; 0,0001 u usporedbi s krizotinibom). g.
Ospemifene is highly ( &gt; 99%) bound to serum proteins.
Ospemifen se u velikoj mjeri ( &gt; 99%) veže na proteine seruma.
Other common adverse reactions ( &gt; 1%) were abdominal pain, abdominal distension and flatulence.
Ostale česte nuspojave ( &gt; 1%) su bol u abdomenu, distenzija abdomena i flatulencija.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET &gt;
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION &gt;
&lt; D. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET &gt;
Other less frequently ( &lt; 5%) observed undesirable effects included hypersensitivity reactions including anaphylactic reactions.
Druge manje česte ( &lt; 5%) nuspojave bile su reakcije preosjetljivosti uključujući anafilaktičku reakciju.
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias ( &lt; 2 % of overdose cases) and cardiopulmonary arrest.
Druge medicinski značajne posljedice predoziranja obuhvaćaju delirij, konvulzije, komu, mogući neuroleptički maligni sindrom, respiratornu depresiju, aspiraciju, hipertenziju ili hipotenziju, srčane aritmije ( &lt; 2 % slučajeva predoziranja) i kardiopulmonalni arest.
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias ( &lt; 2 % of overdose cases) and cardiopulmonary arrest.
Druge medicinski značajne posljedice predoziranja obuhvaćaju delirij, konvulzije, komu, mogući neuroleptički maligni sindrom, respiratornu depresiju, aspiraciju, hipertenziju ili hipotenziju, srčane aritmije ( &lt; 2% slučajeva predoziranja) i kardiopulmonalni arest.
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias ( &lt; 2% of overdose cases) and cardiopulmonary arrest.
Druge medicinski značajne posljedice predoziranja obuhvaćaju delirij, konvulzije, komu, mogući neuroleptički maligni sindrom, respiratornu depresiju, aspiraciju, hipertenziju ili hipotenziju, srčane aritmije ( &lt; 2 % slučajeva predoziranja) i kardiopulmonalni arest.
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias ( &lt; 2% of overdose cases) and cardiopulmonary arrest.
Druge medicinski značajne posljedice predoziranja obuhvaćaju delirij, konvulzije, komu, mogući neuroleptički maligni sindrom, respiratornu depresiju, aspiraciju, hipertenziju ili hipotenziju, srčane aritmije ( &lt; 2% slučajeva predoziranja) i kardiopulmonalni arest.
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias ( &lt; 2% of overdose cases) and cardiopulmonary arrest.
Druge medicinski značajne posljedice predoziranja uključuju delirij, konvulzije, komu, mogući neuroleptički maligni sindrom, respiratornu depresiju, aspiraciju, hipertenziju ili hipotenziju, srčane aritmije ( &lt; 2% slučajeva predoziranja) i kardiopulmonalni arest.
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias ( &lt; 2% of overdose cases) and cardiopulmonary arrest.
Ostale medicinski značajne posljedice predoziranja su delirij, konvulzije, koma, mogući maligni neuroleptički sindrom, depresija disanja, aspiracija, hipertenzija ili hipotenzija, srčane aritmije ( &lt; 2% slučajeva predoziranja) i kardiopulmonalni arest.
Other negative prognostic factors (age &gt; 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.
Kod odluke o produljenju liječenja na 12 mjeseci moraju se uzeti u obzir drugi negativni prognostički faktori (dob iznad 40 godina, muški spol, premoštavajuća fibroza).
Other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to &lt; 1/10) (see section 4.4).
Često se mogu javiti druge reakcije kao što su prijelom kosti, povećanje tjelesne težine i edemi (≥ 1/100 i &lt; 1/10) (vidjeti dio 4.4).
Other side effects have been reported with the use of at least one of the following: ProQuad, previous formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured by Merck &amp; Co., Inc., or varicella vaccine live (Oka/Merck).
Ostale nuspojave prijavljene su uz primjenu najmanje jednog od sljedećih cjepiva: ProQuad, prethodni pripravci monovalentnih i kombiniranih cjepiva protiv morbila, parotitisa i rubele proizvođača Merck &amp; Co., Inc., ili živog cjepiva protiv varičele (Oka/Merck).
Other signs and symptoms of IBS-C including bloating, complete spontaneous bowel movement (CSBM) frequency, straining, stool consistency, were improved in linaclotide treated patients vs. placebo (p &lt; 0.0001) as shown in the following table.
Ostali znakovi i simptomi IBS-C-a uključujući nadutost, učestalost potpunog spontanog pražnjenja crijeva, naprezanje i konzistenciju stolice su se poboljšali u bolesnika liječenih linaklotidom u usporedbi s placebom (p &lt; 0,0001) kao što je prikazano u sljedećoj tablici.
Out of the 59 patients who responded with complete viral suppression ( &lt; 50 copies/ml) at week 48, 47 patients (80% of the responders at week 48) remained responders at week 96.
Od 59 bolesnika koji su odgovorili potpunom virusnom supresijom ( &lt; 50 kopija/ml) u 48. tjednu, 47 bolesnika (80% odgovora u 48. tjednu) pokazalo je odgovor i u 96. tjednu.
Outcome: Four of the 15 subjects had full recovery (within 5 % of baseline) and 5 had partial recovery (within the normal range, but &gt; 5 % below baseline).
Ishod: Potpuni opravak imalo je četiri od 15 ispitanika (5% unutar početnih vrijednosti), 5 ispitanika imalo je djelomični oporavak (unutar normalnog raspona, ali &gt; 5% ispod početne vrijednosti).
OUTER CARTON &amp; BOTTLE LABEL/ BOTTLES
KUTIJA I NALJEPNICA BOCE/BOCE
Outer carton: 2D barcode carrying the unique identifier included.
Kurija:Sadrži 2D barkod s jedinstvenim identifikatorom. &gt;
Outer carton: 2D barcode carrying the unique identifier included.
Kutija: Sadrži 2D barkod s jedinstvenim identifikatorom. &gt;
Outer carton: 2D barcode carrying the unique identifier included.
Kutija:Sadrži 2D barkod s jedinstvenim identifikatorom. &gt;
Oval, biconvex, brick red coloured, 19.3 x 9.3 mm film-coated tablet with bevelled edges and the inscription 145/40 on one side and the Abbott logo on the other side.
Ovalna, bikonveksna, ciglasto crvena, filmom obložena tableta veličine 19,3 x 9,3 mm s kosim rubovima i oznakom 145/40 na jednoj strani i logotipom Abbott na drugoj strani.
Oval, biconvex, tan coloured, 19.3 x 9.3 mm film-coated tablet with bevelled edges and the inscription 145/20 on one side and the Abbott logo on the other side.
Ovalna, bikonveksna, žućkastosmeđa, filmom obložena tableta veličine 19,3 x 9,3 mm s kosim rubovima i oznakom 145/20 na jednoj strani i logotipom Abbott na drugoj strani.
Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p &lt; 0,001), similar to that observed in the pivotal anti- fracture phase III studies carried-out inpostmenopausal women, was observed.
Tijekom 12 mjeseci uočeno je statistički značajno povećanje srednje vrijednosti BMD-a lumbalne kralježnice, glavnog kriterija djelotvornosti (E (SE)=5,32% (0,75); 95%CI [3,86; 6,79]; p=0,001) slično rezultatima pivotalnih ispitivanja III. faze sprječavanja nastanka prijeloma u žena u poslijemenopauzi.
Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p &lt; 0,001), similar to that observed in the pivotal anti-fracture phase III studies carried-out in postmenopausal women, was observed.
Tijekom 12 mjeseci uočeno je statistički značajno povećanje srednje vrijednosti BMD-a lumbalne kralježnice, glavnog kriterija djelotvornosti (E (SE)=5,32% (0,75); 95%CI [3,86; 6,79]; p=0,001) slično rezultatima pivotalnih ispitivanja III. faze sprječavanja nastanka prijeloma u žena u poslijemenopauzi.
Over 64 weeks, this reduction was 0.76 puffs per day (p &lt; 0.001) compared to tiotropium.
Tijekom 64 tjedna to je smanjenje bilo 0,76 udisaja dnevno (p &lt; 0,001) u usporedbi s tiotropijem.
Over the 6-month (acute and chronic) follow-up period, there was a 22% reduction (p =0.008) in the severity-by-duration score and a 52% (95% CI: [7 to 74%]) reduction (from 6.2% to 3.5%) in the risk of having zoster with severe and long-lasting pain (severity-by-duration score of &gt; 600).
Tijekom 6 mjeseci praćenja (akutne i kronične boli), bodovni rezultat jačine po trajanju boli smanjio se za 22% (p=0,008), a rizik od dobivanja herpes zostera praćenog jakom i dugotrajnom boli smanjio se za 52% (95% CI: [7% do 74%]) (sa 6,2% na 3,5%) (bodovni rezultat jačine po trajanju boli &gt; 600).
Over the course of the study, the overall estimated mean (SD) difference in HbA1c between the sitagliptin and placebo groups was 0.29 % (0.01), 95 % CI (-0.32, -0.27); p &lt; 0.001.
Tijekom ispitivanja, ukupna procijenjena srednja vrijednost (SD) razlike u vrijednostima HbA1c između skupine liječene sitagliptinom i one koja je primala placebo iznosila je 0,29% (0,01), 95% CI (-0,32; -0,27); p &lt; 0,001.
Overall adverse events and adverse reactions for avanafil-treated subjects were more frequent in subjects with a Body Mass Index (BMI) &lt; 25 (normal BMI subjects).
Sveukupni štetni događaji i nuspojave u ispitanika liječenih avanafilom bile su učestalije u ispitanika s indeksom tjelesne mase (BMI) &lt; 25 (normalan BMI ispitanika).
Overall treatment for 16 weeks resulted in lower sustained viral response (65%) than treatment for 24 weeks (76%) (p &lt; 0.0001).
Ukupno liječenje od 16 tjedana rezultiralo je slabijim trajnim virološkim odgovorom (65%) nego liječenje od 24 tjedna (76%) (p &lt; 0,0001).
Overall, 22% had baseline plasma HIV-1 RNA &gt; 100,000 copies/mL.
Sveukupno, 22% bolesnika imalo je početnu razinu HIV-1 RNK u plazmi &gt; 100 000 kopija/ml.
Overall, 54% of subjects had &lt; 3 disease sites at baseline.
Ukupno je 54% ispitanika imalo &lt; 3 mjesta bolesti na početku.
Overall, a significantly greater proportion of eltrombopag subjects (40%) compared with placebo subjects (3%) achieved the primary endpoint (Odds Ratio: 18.0 [95% CI: 2.3, 140.9] p &lt; 0.001) which was similar across the three age cohorts (Table 6).
Ukupno je značajno veći udio ispitanika na eltrombopagu (40%) u usporedbi s onima na placebu (3%) postigao mjeru primarnog ishoda (omjer izgleda: 18,0 [95% CI: 2,3; 140,9] p &lt; 0,001), što je bilo slično u sve tri dobne kohorte (tablica 6).
Overall, no major clinical differences in safety or efficacy were reported between patients ≥ 65 years and patients &lt; 65 years, although a higher frequency of discontinuation (14.8% vs 7.9%) was noted in the former group treated with ONIVYDE+5-FU/LV in the NAPOLI-1 study and in some cases the adverse reactions did not resolve.
Sveukupno, nisu prijavljene velike kliničke razlike u sigurnosti i djelotvornosti lijeka između bolesnika ≥ 65 godina i bolesnika &lt; 65 godina, iako je veća učestalost prekida liječenja (14,8% naspram 7,9%) zabilježena u prvoj skupini liječenoj lijekom ONIVYDE+5-FU/LV u ispitivanju NAPOLI-1, a u nekim slučajevima nuspojave se nisu povukle.
Overall, the frequency categories were similar for all age groups, with the exception of vomiting which was very common ( 1/10) in adults aged 18 to 49 years and common ( 1/100 to &lt; 1/10) in all other age groups, and pyrexia was very common in adults aged 18 to 29 years and common in all other age groups.
Općenito, kategorije učestalosti bile su slične u svim dobnim skupinama, s iznimkom povraćanja koje je bilo vrlo često ( 1/10) u odraslih u dobi od 18 do 49 godina i često ( 1/100 i &lt; 1/10) u svim ostalim dobnim skupinama, a vrućica je bila vrlo česta u odraslih u dobi od 18 do 29 godina i česta u svim ostalim dobnim skupinama.
Overall, the subject incidence of certain adverse events (including cardiac failure) in clinical trials was higher for patients who were ≥ 75 years of age compared to patients who were &lt; 75 years of age (see section 4.4).
Sveukupno, u kliničkim ispitivanjima je incidencija pojedinih štetnih događaja po ispitaniku (uključujući zatajenje srca) bila viša u bolesnika u dobi od ≥ 75 godina u usporedbi s bolesnicima u dobi od &lt; 75 godina (vidjeti dio 4.4).
Overall, these effects on hypoglycaemia risk were consistently observed whatever the age, gender, BMI and duration of diabetes ( &lt; 10 years and ≥10 years) in Toujeo-treated patients compared to insulin glargine 100 units/ml-treated patients.
U usporedbi s bolesnicima liječenima inzulinom glarginom jačine 100 jedinica/ml, navedeni učinci na rizik od hipoglikemije općenito su se dosljedno primjećivali u bolesnika koji su primjenjivali Toujeo, neovisno o dobi, spolu, ITM-u i trajanju šećerne bolesti ( &lt; 10 godina ili ≥10 godina).
Overdosage or an excessive rate of administration (i.e., &gt; 10 ml/kg/h) could result in immediate cardiopulmonary effects, in which case infusion of Oxyglobin should be discontinued immediately until signs abate.
Predoziranje ili prebrz ritam primjene (tj. &gt; 10 ml/kg/h) mogu rezultirati neposrednim kardiopulmonarnim učincima, u kojim slučajevima je potrebno obustaviti infuziju proizvoda Oxyglobin do smanjenja simptoma.
Overdose in 2 healthy adolescents involving the ingestion of 360 mg each of afatinib (as part of a mixed drug ingestion) was associated with adverse events of nausea, vomiting, asthenia, dizziness, headache, abdominal pain and elevated amylase ( &lt; 1.5 times ULN).
Predoziranje 2 zdrava adolescenta koje je uključivalo unos 360 mg afatiniba za svakoga (kao dio unosa više vrsta lijekova) bilo je povezano s razvojem nuspojava u smislu mučnine, povraćanja, astenije, omaglice, glavobolje, abdominalne boli i povišene amilaze ( &lt; 1,5 puta GGN).
P &lt; .0001
P &lt; 0,0001
p &lt; 0.0001
14,7
p &lt; 0.001 compared to historical control of peginterferon alfa and ribavirin.
p &lt; 0,001 u usporedbi s povijesnom kontrolom s peginterferonom alfa i ribavirinom.
p &lt; 0.001 for ustekinumab 45 mg or 90 mg in comparison with etanercept. p = 0.012 for ustekinumab 45 mg in comparison with etanercept.
p &lt; 0,001 za ustekinumab 45 mg ili 90 mg u usporedbi s etanerceptom. p = 0,012 za ustekinumab 45 mg u usporedbi s etanerceptom.
p &lt; 0.001 for ustekinumab 45 mg or 90 mg in comparison with placebo (PBO).
p &lt; 0,001 za ustekinumab 45 mg ili 90 mg u usporedbi s placebom (PBO).
p &lt; 0.001, for each infliximab treatment group vs. control greater values indicate more joint damage.
p &lt; 0,001 za svaku skupinu liječenu infliksimabom u usporedbi s kontrolnom skupinom veće vrijednosti znače jače oštećenje zgloba
p = 0.0640
p &lt; 0,0640
P values: 1 = &lt; 0.001, 2 = 0.037, 3= &lt; 0.002, 4 = &lt; 0.006.
P vrijednosti: 1 = &lt; 0,001, 2 = 0,037, 3= &lt; 0,002, 4 = &lt; 0,006.