natgillin/translations-raw huggingface dataset:
In addition, an increased incidence of significant elevations of ALT was observed in patients treated with tolvaptan [4.4% (42/958)] compared to those receiving placebo [1.0% (5/484)].
Uz to, kod bolesnika liječenih tolvaptanom zapažena je povećana incidencija značajno povišenih ALT [4,4% (42/958)] u usporedbi s onima koji su primali placebo [1,0% (5/484)].
In addition, an updated RMP should be submitted
Nadalje, nadopunjen RMP treba biti dostavljen
In addition, an updated RMP should be submitted
Nadalje, nadopunjeni RMP treba dostaviti
In addition, an updated RMP should be submitted
Nadalje, nadopunjeni RMP treba dostaviti:
In addition, an updated RMP should be submitted
Nadopunjeni RMP treba biti dostavljen:
In addition, an updated RMP should be submitted:
Nadalje, nadopunjen RMP treba dostaviti:
In addition, any prescriber of Uptravi will also have to register first with the company that markets Uptravi before being able to prescribe it.
Osim toga, svi oni koji propisuju lijek Uptravi također će se prvo morati registrirati u tvrtki koja lijek Uptravi stavlja u promet prije nego što ga budu mogli propisivati.
In addition, any signs or symptoms of immune-related adverse reactions, including diarrhoea and colitis, must be assessed during treatment with YERVOY (see Tables 1A, 1B, and section 4.4).
Uz to, mora se ispitati svaki znak ili simptom imunološki uzrokovanih nuspojava za vrijeme liječenja lijekom YERVOY, uključujući proljev i kolitis (vidjeti tablice 1A, 1B i dio 4.4).
In addition, around 65% of patients given Feraccru achieved normal levels of haemoglobin compared with 10% of those on placebo.
Nadalje, u otprilike 65 % bolesnika koji su uzimali Feraccru dosegnuta je normalna razina hemoglobina u usporedbi s 10 % bolesnika koji su dobivali placebo.
In addition, at Week 32, subjects who did not achieve a PASI-75 response in ESTEEM 1, or a PASI- 50 response in ESTEEM 2, were permitted to use topical psoriasis therapies and/or phototherapy in addition to apremilast 30 mg BID treatment.
Nadalje, u 32. tjednu, ispitanicima koji nisu postigli odgovor PASI-75 u ispitivanju ESTEEM 1 ili odgovor PASI-50 u ESTEEM 2, bila je dopuštena primjena topikalnih terapija za psorijazu i/ili fototerapija uz terapiju apremilastom od 30 mg BID.
In addition, ATryn was used in five patients who received the medicine during surgery in a ‘compassionate-use programme’ (a programme through which doctors can request a medicine for one of their patients before it is authorised).
Nadalje, lijek ATryn primijenjen je u petero bolesnika koji su primili lijek tijekom operacije u okviru
In addition, based on surface area (mg/m2) dose ratios resulted in approximately 0.6 to 22 times and 1.0 to 29 times in males and females, respectively, the clinical dose of 20 mg.
Pored toga, prema tjelesnoj površini (mg/m2) omjer doza bio je otprilike 0,6 do 22 puta i 1,0 do 29 puta u mužjaka odnosno ženki veći nego kod primjene kliničke doze od 20 mg.
In addition, before starting to use this medicine, tell your doctor if you:
Dodatno, prije nego počnete primjenjivati ovaj lijek, obavijestite svog liječnika ako:
In addition, before starting to use this medicine, tell your doctor if you: have been told by a doctor that pregnancy would be dangerous for you.
Dodatno, prije nego počnete primjenjivati ovaj lijek, obavijestite svog liječnika: ako Vam je liječnik rekao da trudnoća za Vas može biti opasna.
In addition, beneficial reductions in weight and blood pressure were seen in patients treated with Jardiance.
Pored toga, kod bolesnika liječenih lijekom Jardiance uočena su korisna smanjenja tjelesne težine i krvnog tlaka.
In addition, beneficial reductions in weight and blood pressure were seen.
Nadalje, također je uočeno korisno smanjivanje tjelesne težine i krvnoga tlaka.
In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
Također je prijavljeno da su beta- adrenergički agonisti uzrokovali promjene na elektrokardiogramu (EKG), kao što su izravnati T val, produljenje QT intervala i depresija ST segmenta, iako nije poznata klinička važnost tih pojava.
In addition, between one and two thirds of the patients in the five main trials showed a reduction in the number of white blood cells containing the Philadelphia chromosome.
Nadalje, između jedne i dvije trećine bolesnika u pet glavnih ispitivanja utvrđeno je smanjenje u broju bijelih j+krvnih stanica koje su sadržavale Philadelphia kromosom.
In addition, by inhibiting protein synthesis and cell division, Oncaspar can disturb the mechanism of action of other substances which require cell division for their effect, e.g. methotrexate.
Osim toga, inhibicijom sinteze proteina i diobe stanica, Oncaspar može ometati mehanizam djelovanja drugih tvari kojima je potrebna dioba stanica da bi bile učinkovite, npr. metotreksat.
In addition, cabozantinib inhibits other tyrosine kinases including RET, the GAS6 receptor (AXL), the stem cell factor receptor (KIT), and Fms-like tyrosine kinase-3 (FLT3).
Pored toga, kabozantinib inhibira druge tirozin kinaze, uključujući RET, receptor GAS6 (AXL), receptor faktora matičnih stanica (KIT) te Fms-sličnu tirozinsku kinazu 3 (FLT3).
In addition, cases of interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency have been reported.
Također su prijavljeni slučajevi intersticijske bolesti pluća, uključujući plućne infiltrate, sindroma akutnog respiratornog distresa, upale pluća, pneumonitisa, pleuralnog izljeva, respiratornog distresa, akutnog plućnog edema i respiratorne insuficijencije.
In addition, caution is warranted when using telavancin to treat patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.
Osim toga oprez je potreban kada se telavancin upotrebljava za liječenje bolesnika s urođenim sindromom produljenog QT intervala, poznatim produljenim QTc intervalom, nekompenziranim zatajenjem srca ili teškom hipertrofijom lijeve klijetke.
In addition, caution should be taken when pixantrone is continuously co-administered with efflux transport inducers such as rifampicin, carbamazepin and glucocorticoids, as pixantrone excretion might be increased with a consequent decrease of systemic exposure.
Nadalje, oprez je potreban i kad se piksantron kontinuirano primjenjuje zajedno s induktorima efluksa, kao što su rifampicin, karbamazepin i glukokortikoidi, budući da izlučivanje piksantrona može biti povećano s posljedičnim smanjenjem sistemske ekspozicije.
In addition, central volume was slightly (9%) lower in females compared to males.
Osim toga, središnji volumen bio je nešto manji (9%) u žena nego u muškaraca.
In addition, children and adolescents have been treated in two phase I studies (in patients with CML or Ph+ acute leukaemia) and one phase II study.
Osim toga, djeca i adolescenti su liječeni u dva ispitivanja faze I (bolesnici s KML ili Ph+ akutnom leukemijom) i jednom ispitivanju faze II.
In addition, children have been treated in two phase I studies (in patients with CML or Ph+ acute leukaemia) and one phase II study.
Osim toga, djeca su liječena u dva ispitivanja faze I (u bolesnika s KML ili Ph+ akutnom leukemijom) i jednom ispitivanju faze II.
In addition, consideration should be given to referring the patient to a paediatric specialist (see section 5.1).
Nadalje, potrebno je razmotriti upućivanje bolesnika specijalisti pedijatru (vidjeti dio 5.1).
In addition, constipation, dyspepsia, gastritis, abdominal pain, gastroesophageal reflux disease, abdominal distension, eructation, flatulence and decreased appetite have been reported in up to 3.6% of patients treated with Xultophy.
Nadalje, konstipacija, dispepsija, gastritis, bol u abdomenu, gastroezofagealna refluksna bolest, distenzija abdomena, podrigivanje, flatulencija i smanjen apetit prijavljeni su u do 3,6% bolesnika liječenih lijekom Xultophy.
In addition, dabigatran AUCτ,ss and Cmax,ss and the coagulation measures for dabigatran effect or the inhibition of platelet aggregation as measure of clopidogrel effect remained essentially unchanged comparing combined treatment and the respective mono-treatments.
Nadalje, AUCτ,ss i Cmax,ss dabigatrana te koagulacijski testovi kao mjera učinka dabigatrana ili testovi inhibicije agregacije trombocita kao mjere učinka klopidogrela ostali su u osnovi nepromijenjeni uz kombinirano liječenje u odnosu na monoterapiju.
In addition, Day+100 survival rate was improved in the Defitelio group with 38.2% (39/102) of the patients surviving versus 25.0% (8/32) in the historical control group (p=0.034).
Osim toga, stopa preživljenja na dan+100 poboljšala se u skupini koja je primala Defitelio s 38,2% (39/102) bolesnika s preživljenjem naspram 25,0% (8/32) u povijesnoj kontrolnoj skupini (p=0,034).
In addition, decreased number of implantation sites per litter and a prolongation of gestation were seen when pups were mated after reaching maturity.
Nadalje, pri parenju mladunčadi nakon dosezanja odrasle dobi, zamijećen je smanjeni broj mjesta implantacije po leglu te produljenje gestacije.
In addition, doctors may perform ECG continuously during
Osim toga, liječnici mogu raditi EKG kontinuirano tijekom šest sati ili po potrebi produljiti vrijeme nadzora.
In addition, doses of 240 mg tid have been administered to obese patients for 6 months.
Uz to, pretilim bolesnicima primjenjivane su doze od 240 mg tri puta dnevno u trajanju od 6 mjeseci.
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of IntronA with ribavirin.
I suhoća usta može imati štetan učinak na zube i sluznicu usta tijekom dugotrajnog liječenja kombinacijom lijeka IntronA i ribavirina.
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of Pegasys with ribavirin.
K tome, suhoća usta može imati štetne posljedice na zube i membrane usta tijekom dugotrajnog liječenja kombinacijom lijeka Pegasys i ribavirina.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of IntronA and ribavirin.
Uz to, i suhoća usta može štetno djelovati na zube i sluznicu usta tijekom dugotrajne kombinirane terapije lijekom IntronA i ribavirinom.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Ribavirin and peginterferon alfa-2b or interferon alfa-2b.
Uz to, i suha usta mogu imati štetan učinak na zube i sluznicu usta tijekom dugotrajnog liječenja kombinacijom lijeka Ribavirin Mylan s peginterferonom alfa-2b ili interferonom alfa•2b.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of ribavirin and peginterferon alfa-2b or interferon alfa-2b.
Uz to, i suhoća usta može štetno djelovati na zube i sluznicu usta tijekom dugotrajnog liječenja kombinacijom ribavirina s peginterferonom alfa-2b ili interferonom alfa-2b.
In addition, dry mouth that could have a damaging effect on teeth and membranes of the mouth has been reported during long-term treatment with this medicine in combination therapy with an alpha interferon.
Nadalje, tijekom dugotrajne kombinirane terapije ovim lijekom. i alfa interferonom prijavljena je i suhoća usta koja može štetno djelovati na zube i sluznicu usta.
In addition, due to an increased risk of venous thromboembolic events associated with carfilzomib, females should avoid the use of hormonal contraceptives that are associated with a risk of thrombosis during treatment with carfilzomib (see section 4.4 and 4.8).
Dodatno, zbog povećanog rizika od venskih tromboemboličkih događaja povezanih s primjenom karfilzomiba, žene bi trebale izbjegavati primjenu hormonskih kontraceptiva povezanih s rizikom od tromboze tijekom liječenja karfilzomibom (vidjeti dijelove 4.4 i 4.8).
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Nadalje, tijekom pandemije, resursi potrebni za dubinsku procjenu Periodičkih izvješća o neekodljivosti lijeka u formatu definiranom u Svesku 9a Pravilnika koji uređuje lijekove u Europskoj Uniji možoijneće biti primjereni za brzu identifikaciju novog sigurnosnog pitanja.
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Nadalje, tijekom trajanja pandemije, resursi potrebni za detaljnu analizu periodičkih izvješća o neškodljivosti lijeka, u formatu koji je zadan u Volumenu 9a Propisa o lijekovima u Europskoj Uniji, možda neće biti dostatni za brzo otkrivanje novih sigurnosnih problema.
In addition, duration a pandemic, resources needed for an in-depth evaluation of PSURs in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Nadalje, tijekom pandemije, resursi potrebni za dubinsku procjenu PSUR-eva u formatu definiranom u Svesku 9a Pravilnika koji uređuje lijekove u Europskoj Uniji možda neće biti primjereni za brzu identifikaciju novog sigurnosnog pitanja.
In addition, during a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Nadalje, tijekom pandemije, resursi potrebni za dubinsku procjenu Periodičkih izvješća o neškodljivosti lijeka u formatu definiranom u Volumenu 9a Pravilnika koji uređuje lijekove u Europskoj Uniji možda neće biti primjereni za brzu identifikaciju novog sigurnosnog pitanja.
In addition, during each 28-day cycle, the patient also receives cancer treatment with lenalidomide and dexamethasone.
Osim toga, bolesnik se tijekom svakog ciklusa od 28 dana liječi i lenalidomidom i deksametazonom, drugim lijekovima za liječenje raka.
In addition, efficacy against uncommon rotavirus genotypes G8P[4](severe gastro-enteritis) and G12P[6] (any gastro-enteritis) has been demonstrated.
Dodatno, pokazana je i djelotvornost prema manje čestim rotavirusnim genotipovima G8P[4](teški gastroenteritis) i G12P[6] (bilo koji oblik gastroenteritisa).
In addition, endomyocardial biopsies were performed in 8 solid tumour patients with cumulative anthracycline doses of 509 mg/m2–1,680 mg/m2.
Dodatno su učinjene biopsije endomiokarda u 8 bolesnika sa solidnim tumorima koji su primili kumulativne doze antraciklina od 509 mg/m2 – 1,680 mg/m2.
In addition, female partners of male patients treated with CellCept are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of CellCept.
Osim toga, partnericama bolesnika muškoga spola koji se liječe lijekom CellCept preporučuje se korištenje visoko učinkovite kontracepcije tijekom liječenja i još ukupno 90 dana nakon posljednje doze lijeka CellCept.
In addition, female partners of male patients treated with mycophenolate are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of mycophenolate.
Osim toga, partnericama bolesnika muškoga spola koji se liječe mikofenolatom preporučuje se korištenje visoko učinkovite kontracepcije tijekom liječenja i još ukupno 90 dana nakon posljednje doze mikofenolata.
In addition, female partners of male patients treated with mycophenolate mofetil are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of Myclausen.
Osim toga, partnericama bolesnika muškoga spola koji se liječe lijekom Myclausen preporučuje se korištenje visoko učinkovite kontracepcije tijekom liječenja i još ukupno 90 dana nakon posljednje doze lijeka Myclausen.
In addition, for the overall population, Mirvaso demonstrated statistical superiority (p<0.001) over vehicle gel with respect to rapid initial onset of a clinically meaningful effect (1-Grade Composite Success for CEA and PSA) after the first application at 30 minutes on Day 1(secondary endpoint 27.9% vs.
Osim toga, za ukupnu populaciju, Mirvaso se pokazao statistički superiorniji (p<0,001) od podloge gela u pogledu brzog nastupanja klinički značajnog učinka (kompozitna 1-stupanjska uspješnost za CEA i PSA) nakon prve primjene u 30 minuta na
In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Uz to, u postmarketinškom praćenju trovalentnih cjepiva između pandemija prijavljene su sljedeće nuspojave:
In addition, from Post-marketing surveillance with seasonal trivalent vaccines in all age groups and with the MF59 adjuvanted seasonal trivalent vaccine with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), licensed for use in elderly subjects above 65 years of age, the following adverse events have been reported:
Osim toga, iz postmarketinškog praćenja sezonskog trovalentnih cjepiva u svim dobnim skupinama i sezonskog adjuvantiranog trovalentnog cjepiva MF59 sastava sličnog Focetriji (površinski antigen, inaktivirano, adjuvantirano s MF59C.1), odobreno za primjenu na starijim ispitanicima u dobi iznad 65 godina, prijavljeni su sljedeći štetni događaji:
In addition, further to a signal work-up for diabetes insipidus, four out of five literature reports lead to a possible association with temozolomide therapy, therefore the product information should be updated accordingly.
Dodatno, nastavno na signal zbog diabetes insipidusa, četiri od pet izvješća iz literature dovode do zaključka o mogućoj povezanosti s liječenjem temozolomidom, stoga je potrebno ažurirati informacije o lijeku.
In addition, Gaucher disease has been associated with an increased risk of immunoglobulin abnormalities such as hyperimmunoglobulinemia, polyclonal gammopathy, monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma.
Nadalje, Gaucherova je bolest povezana s povećanim rizikom od poremećaja imunoglobulina, poput hiperimunoglobulinemije, poliklonske gamopatije, monoklonske gamopatije neodređenog značaja (engl. monoclonal gammopathy of undetermined significance, MGUS) i multiplog mijeloma.
In addition, giving Adcetris to patients who have had a stem cell transplant and are considered at risk of the cancer progressing or coming back, resulted in a clear clinical benefit.
Osim toga, kod primjene lijeka Adcetris u bolesnika koji su bili podvrgnuti transplantaciji matičnih stanica i za koje se smatra da su izloženi riziku od progresije ili ponovnog javljanja raka zabilježena je očita klinička korist.
In addition, GMCs were lower for antibodies to most serotypes after a two- dose infant series than after a three-dose infant series.
Osim toga, geometrijski prosjek vrijednosti koncentracije protutijela na većinu serotipova nakon serije od dvije doze u dojenačkoj dobi bili su niži nego nakon serije od tri doze u dojenačkoj dobi.
In addition, hypothyroidism (an underactive thyroid gland), vomiting, colitis (inflammation of the gut), abdominal pain, arthralgia (joint pain) and headache were seen.
Osim toga, uočeni su hipotiroidizam (smanjena funkcija štitnjače), povraćanje, kolitis (upala crijeva), abdominalna bol, artralgija (bol u zglobovima) i glavobolja.
In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Osim toga, ibandronatna kiselina ne inhibira glavne jetrene izoenzime P450 u ljudi i ne inducira jetreni P450 citokromski sustav u štakora.
In addition, if you experience or are diagnosed with any of the following conditions you should talk to your doctor, pharmacist or nurse as they may advise you to stop taking Aerinaze:
Osim toga, morate reći svom liječniku, ljekarniku ili medicinskoj sestri ako imate ili Vam je dijagnosticirano neko od sljedećih stanja jer će Vam možda savjetovati da prestanete uzimati Aerinaze:
In addition, if you suddenly stop taking Aerivio Spiromax or reduce your dose of Aerivio Spiromax this may (very rarely) cause you to have problems with your adrenal glands (adrenal insufficiency) which sometimes causes side effects.
Uz to, ako naglo prestanete uzimati Aerivio Spiromax ili smanjite dozu Aerivio Spiromaxa, to može (vrlo rijetko) prouzročiti probleme s nadbubrežnim žlijezdama (insuficijenciju nadbubrežnih žlijezda), što ponekad uzrokuje nuspojave.
In addition, if you suddenly stop taking Aerivio Spiromax or reduce your dose of Aerivio Spiromax this may (very rarely) cause you to have problems with your adrenal glands (adrenal insufficiency) which sometimes causes side effects.
Uz to, ako naglo prestanete uzimati Airexar Spiromax ili smanjite dozu Airexar Spiromaxa, to može (vrlo rijetko) prouzročiti probleme s nadbubrežnim žlijezdama (insuficijenciju nadbubrežnih žlijezda), što ponekad uzrokuje nuspojave.
In addition, imepitoin has a weak calcium channel blocking effect which may contribute to its anticonvulsive properties.
Osim toga, imepitoin ima slabi učinak blokiranja kalcijevih kanala što može pridonijeti njegovim svojstvima djelovanja protiv konvulzija.
In addition, Imlygic makes the infected melanoma cells produce a protein called GM-CSF.
Osim toga, Imlygic djeluje tako da inficirane stanice melanoma proizvode protein koji se naziva GM- CSF.
In addition, in a clinical trial 6% of paediatric patients tested seropositive at least once during the study for antibodies capable of neutralising the biologic effects of anakinra.
Dodatno, u kliničkom se ispitivanju 6% pedijatrijskih bolesnika pokazalo seropozitivno najmanje jednom tijekom ispitivanja na protutijela sposobna za neutralizaciju bioloških učinaka anakinre.
In addition, in a double-blind placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
Osim toga, u dvostruko slijepom, placebom kontroliranom ispitivanju kod odraslih bolesnika koji su primali osnovnu terapiju metotreksatom, opaženo je da bolesnici koji su liječeni Enbrelom i anakinrom imaju povećanu stopu ozbiljnih infekcija (7%) i neutropenije u odnosu na bolesnike liječene samo Enbrelom (vidjeti dijelove 4.4 i 4.8).
In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
Osim toga, u dvostruko slijepom, placebom kontroliranom ispitivanju kod odraslih bolesnika koji su primali osnovnu terapiju metotreksatom, opaženo je da bolesnici koji su liječeni Enbrelom i anakinrom imaju povećanu stopu ozbiljnih infekcija (7%) i neutropenije u odnosu na bolesnike liječene samo Enbrelom (vidjeti dijelove 4.4 i 4.8).