natgillin/translations-raw huggingface dataset:
REPLACE-2 major bleeding was defined as the occurrence of any of the following: intracranial haemorrhage, retroperitoneal haemorrhage, blood loss leading to a transfusion of at least two units of whole blood or packed red blood cells, or bleeding resulting in a haemoglobin drop of more than g/dl, or a fall in haemoglobin greater than 4 g/dl (or 12% of haematocrit) with no bleeding site identified.
Veliko krvarenje ispitivanja REPLACE-2 definirano je kao pojava bilo kojeg od sljedećeg: intrakranijalno krvarenje, retroperitonealno krvarenje, gubitak krvi za koje je potrebna transfuzija od najmanje dvije jedinice pune krvi ili koncentrata eritrocita, ili krvarenje koje je uzrokovalo pad hemoglobina za više od 3 g/dl, ili pad hemoglobina za više od 4 g/dl (ili hematokrit od 12%) bez identificiranja mjesta krvarenja.
REPLACE-2 study results: 30-day endpoints (intent-to-treat and per-protocol populations
Rezultati ispitivanja REPLACE-2: 30-dnevni ishodi (populacija s namjerom liječenja (ITT) i populacija prema planu ispitivanja)
Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology.
Nadoknada endogenog hormona rasta u odraslih s nedostatkom hormona rasta bilo dječje bilo odrasle etiologije.
Replacement therapy in adults with growth hormone deficiency
Nadomjesna terapija u odraslih s deficitom hormona rasta
Replacement therapy in adults with pronounced growth hormone deficiency.
Nadomjesna terapija za odrasle s izraženim deficitom hormona rasta.
Replacement therapy in adults, and children and adolescents (0-18 years) in:
Nadomjesno liječenje odraslih, djece i adolescenata (0-18 godina) kod:
Replacement therapy in adults, children and adolescents (0-18 years) in primary immunodeficiency syndromes such as:
Nadomjesna terapija u odraslih, djece i adolescenata (0-18 godina) s primarnim sindromima imunodeficijencije kao što su:
Replacement therapy in adults, children and adolescents (2-18 years) in:
Nadomjesna terapija u odraslih, djece i adolescenata (2 - 18 godina starosti) kod:
Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Nadomjesna terapija kod mijeloma ili kronične limfocitne leukemije s teškom sekundarnom hipogamaglobulinemijom i rekurentnim infekcijama.
Replacement therapy in primary immunodeficiency
Nadomjesna terapija kod primarne
Replacement therapy in primary immunodeficiency
Nadomjesna terapija u primarnoj imunodeficijenciji
Replacement therapy in primary immunodeficiency (PID)
Nadomjesno liječenje kod primarne imunodeficijencije (PID)
Replacement therapy in primary immunodeficiency (PID)
Nadomjesno liječenje kod primarrne imunodeficijencije (PID)
Replacement therapy in primary immunodeficiency (PID) syndromes
Nadomjesna terapija kod sindroma primarne imunodeficijencije (PID)
Replacement therapy in primary immunodeficiency syndromes
Nadomjesna terapija kod sindroma primarnih imunodeficijencija
Replacement therapy in secondary immunodeficiency
imunodeficijencije
Replacement therapy in secondary immunodeficiency
Nadomjesno liječenje sekundarnih imunodeficijencija
replacement therapy should be clinically
nadomjesnu hormonsku terapiju treba klinički
Replagal 1 mg/ml concentrate for solution for infusion agalsidase alfa
Replagal 1 mg/ml koncentrat za otopinu za infuziju agalzidaza alfa
Replagal 1 mg/ml concentrate for solution for infusion.
Replagal 1 mg/ml koncentrat za otopinu za infuziju.
Replagal 1 mg/ml sterile concentrate agalsidase alfa
Replagal 1 mg/ml sterilni koncentrat agalzidaza alfa
Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g.
Replagal je smanjio masu lijevog ventrikula prosječno za 11,5 g dok su bolesnici koji su primali placebo imali povećanje u masi lijevog ventrikula od 21,8 g.
Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases.
Liječenje Replagalom mora nadzirati liječnik s iskustvom u liječenju Fabryjeve bolesti ili drugih nasljednih metaboličkih bolesti.
Replagal was also associated with improved myocardial contractility, a decrease in mean QRS duration and a concomitant decrease in septal thickness on echocardiography.
Replagal je također povezan s poboljšanjem kontraktilnosti miokarda, smanjenjem srednjeg trajanja QRS kompleksa i istodobnim smanjenjem debljine septuma na ehokardiografiji.
Replagal was originally authorised under ‘exceptional circumstances’, because as the disease is rare, limited information was available at the time of approval.
Replagal je prvobitno odobren u „iznimnim okolnostima” zbog toga što su, iz znanstvenih razloga, u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije.
replication and the assembly of HCV virions.
RNK, tako i za sklapanje viriona HCV-a.
Replication of the parasite damages the dog’s intestinal mucosa, which may cause enteritis.
Umnažanje parazita oštećuje sluznicu crijeva psa, što može uzrokovati enteritis.
Replicon genotype
Genotip replikona
Report any (intended or unintended) pregnancy during and two months following discontinuation of treatment with GILENYA immediately to the prescriber.
Odmah prijaviti svaku (namjernu ili slučajnu) trudnoću tijekom te dva mjeseca nakon prekida liječenja GILENYOM liječniku koji je propisao lijek.
report by 31
31. ožujka
Report immediately to your doctor any symptoms of infection such as fever, sore throat or flu-like symptoms. if you are HIV positive or if your kidney or liver function is impaired, your doctor may recommend additional tests.
Odmah prijavite svom liječniku bilo koje simptome infekcije, poput vrućice, grlobolje ili simptoma nalik gripi. ako ste HIV pozitivni ili Vam je funkcija bubrega ili jetre oštećena, liječnik može preporučiti dodatne pretrage.
report of the
konačnog
Report submission is no later than day 22 (i.e. the following Monday).
Podnošenje izvješća ne smije biti nakon 22. dana (tj. sljedećeg ponedjeljka).
report:
izvješća:
reported 11
napadaja11
Reported adverse reactions are listed below, by system organ class and by frequency.
U nastavku su navedene prijavljene nuspojave prema razredu organskog sustava i učestalosti.
Reported adverse reactions listed in Table 5 are based on experience from the two multicentre children and adolescents clinical trials using ribavirin with interferon alfa-2b or peginterferon alfa-2b.
Prijavljene nuspojave navedene u Tablici 5 temelje se na iskustvu iz dva multicentrična klinička ispitivanja u djece i adolescenata koji su uzimali ribavirin s interferonom alfa-2b ili peginterferonom alfa-2b.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with impaired renal failure or acute worsening of renal function.
Prijavljeni slučajevi laktacidoze u bolesnika na metforminu prvenstveno su se pojavili u dijabetičara sa zatajenjem bubrega ili akutnim pogoršanjem funkcije bubrega.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Prijavljeni slučajevi laktacidoze u bolesnika koji uzimaju metformin prvenstveno su se pojavili u dijabetičkih bolesnika sa značajnim zatajivanjem bubrega.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Prijavljeni slučajevi laktacidoze u bolesnika liječenih metforminom, pojavili su se primarno u dijabetičara sa značajnim zatajenjem bubrega.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Prijavljeni slučajevi laktacidoze u bolesnika na metforminu pojavili su se prvenstveno u bolesnika sa šećernom bolešću i značajnim zatajenjem bubrega.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Zabilježeni slučajevi laktacidoze javili su se uglavnom u dijabetičara sa značajnim bubrežnim zatajenjem liječenih metforminom.
Reported commonly in placebo
Često zabilježene uz placebo
Reported diagnoses in patients suspected of having ILD-like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome (ARDS), alveolitis, and lung infiltration.
U bolesnika za koje se sumnjalo da imaju simptome nalik intersticijskoj bolesti pluća prijavljeni su pneumonitis, radijacijski pneumonitis, hipersenzitivni pneumonitis, intersticijska upala pluća, intersticijska bolest pluća, obliterirajući bronhiolitis, plućna fibroza, akutni respiratorni distres sindrom (ARDS), alveolitis i plućni infiltrat.
Reported over 3 years in a COPD study
Zabilježene tijekom 3 godine u ispitivanju KOPB-a
Reported rates of recurrent rash following a switch from nevirapine to efavirenz therapy, primarily based on retrospective cohort data from published literature, range from 13 to 18 %, comparable to the rate observed in patients treated with efavirenz in clinical studies. (See section 4.4.)
Prijavljene stope rekurentnog osipa nakon prelaska s liječenja nevirapinom na liječenje efavirenzom, prvenstveno na temelju podataka iz retrospektivnih kohortnih ispitivanja iz objavljene literature, kreću se od 13 do 18%, što je usporedivo sa stopama opaženim u bolesnika liječenih efavirenzom u kliničkim ispitivanjima (vidjeti dio 4.4).
Reported rates of recurrent rash following a switch from nevirapine to efavirenz therapy, primarily based on retrospective cohort data from published literature, range from 13 to 18%, comparable to the rate observed in patients treated with efavirenz in clinical studies. (See section 4.4.)
Prijavljene stope rekurentnog osipa nakon prelaska s liječenja nevirapinom na liječenje efavirenzom, prvenstveno na temelju podataka iz retrospektivnih kohortnih ispitivanja iz objavljene literature, kreću se od 13 do 18%, što je usporedivo sa stopama opaženim u bolesnika liječenih efavirenzom u kliničkim ispitivanjima (vidjeti dio 4.4).
Reported serious infections, some with fatal outcome, included active tuberculosis, which may present with intrapulmonary or extrapulmonary disease, invasive pulmonary infections, including candidiasis, aspergillosis, coccidioidomycosis and pneumocystis jirovecii, pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis.
Prijavljene ozbiljne infekcije, neke sa smrtnim ishodom, uključivale su aktivnu tuberkulozu, koja se manifestirala u plućnom i izvanplućnom obliku, invazivne plućne infekcije, uključujući kandidijazu, aspergilozu, kokcidiomikozu i pneumocistis jirovecii, pneumoniju, celulitis, herpes zoster, gastroenteritis, divertikulitis, sepsu i bakterijski artritis.
Reported very commonly in placebo
Vrlo često zabilježene uz placebo
reported with a higher incidence (very common) in patients who received two concurrent injections of Xiapex in the same hand compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren’s contracture.
Zabilježeno s većom incidencijom (vrlo često) u bolesnika koji su istovremeno primili dvije injekcije Xiapexa u istu šaku u usporedbi s ispitanicima koji su primili do tri jednokratne injekcije u placebom kontroliranim ključnim ispitivanjima faze III kod Dupuytrenove kontrakture.
Reporting of adverse effects
Prijavljivanje nuspojava
Reporting of medication errors or any side effects.
Prijavljivanje medikacijskih pogrešaka ili bilo kakvih nuspojava.
Reporting of medication errors or any side effects.
Prijavljivanje medikacijskih pogrešaka ili bilo kojih nuspojava.
Reporting of serious adverse drug reactions
izvješće o ozbiljnim nuspojavama
Reporting of side effe cts
Prijavljivanje nuspojava
Reporting of side effect
Prijavljivanje nuspojava
Reporting of side effects
Prijava nuspojava
Reporting of side effects
Prijavljivanje nuspojava:
Reporting of side effects
Prijavljivanje sumnji na nuspojave
Reporting of side effects.
Prijavljivanje nuspojava
Reporting of suspected adverse reactions
Prijavljivanj sumnji na nuspojavu
Reporting of suspected adverse reactions
Prijavljivanje nuspojava
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Prijavljivanje sumnji na nuspojavu: Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
Reporting suspected adverse reactions after authorisation of the medical product is important.
Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
Reporting suspected adverse reactions after authorisation of the medicial product is important.
Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Nakon dobivanja odobrenja lijeka vaţno je prijavljivanje sumnji na njegove nuspojave.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Nakon dobivanja odobrenja za lijek, važno je prijavljivanje sumnji na njegove nuspojave.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Nakon dobivanja odobrenja za stavljanje lijeka u promet važno je prijavljivanje sumnji na nuspojave.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Reporting suspected adverse reactions after authorization of the medicinal product is important.
Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
Reporting suspected adverse reactions afterauthorisation of themedicinal product is important.
Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
Reporting to be fortnightly for the first 3 months of the pandemic.
Podnošenje izvješća vrši se svakih četrnaest dana tijekom prva 3 mjeseca pandemije.
Reporting to be monthly for the first 6 months.
Izvještavanje će biti mjesečno prvih 6 mjeseci.
Reporting to be monthly for the first 6 months.
Mjesečno izvještavanje prvih 6 mjeseci.
Reporting to be monthly for the first 6 months.
Prvih 6 mjeseci je izvještavanje mjesečno.
Reportng suspected adverse reactions after authorisation of the medicinal product is important.
Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
Reports - with each
izvješća
Reports from published literature confirmed that methylthioninium chloride is effective in treating methaemoglobinaemia that has been caused by exposure to a medicine or chemical in adults and children.
Prijave iz objavljene literature potvrđuju da je metiltioninijev klorid djelotvoran u liječenju methemoglobinemije koja je uzrokovana izlaganjem lijekovima ili kemikalijama u odraslih i djece.
Reports from the sub-
Izvješća iz pod
Reports have been received from post-approval marketing experience in association with the use of Enurev Breezhaler.
Dobivena su izvješća iz iskustva nakon stavljanja lijeka u promet, povezana s primjenom Enurev Breezhalera.
Reports have been received from post-approval marketing experience in association with the use of Seebri Breezhaler.
Dobivena su izvješća iz iskustva nakon stavljanja lijeka u promet, povezana s primjenom Seebri Breezhalera.
Reports have been received from post-approval marketing experience in association with the use of Tovanor Breezhaler.
Dobivena su izvješća iz iskustva nakon stavljanja lijeka u promet, povezana s primjenom Tovanor Breezhalera.
Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod 5 % cream use.
Primljene su prijave lokalizirane hipopigmentacije i hiperpigmentacije nakon primjene imikvimod 5 % kreme.
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Podaci u literaturi ukazuju da liječenje druge indikacije dopaminergičkim lijekovima može rezultirati augmentacijom.
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Podaci u literaturi ukazuju na to da liječenje drugih indikacija dopaminergičkim lijekovima može rezultirati augmentacijom.
reports of abnormal liver tests values,
abnormalne vrijednosti jetrenih pretraga,
Reports of extravasation with subsequent infusion site reactions including e.g. infusion site dermatitis, infusion site desquamation, and infusion site ulcer have been received.
Primljena su izvješća o ekstravazacijama s posljedičnim reakcijama na mjestu infuzije, uključujući, primjerice, dermatitis na mjestu infuzije, deskvamaciju na mjestu infuzije i vrijed na mjestu infuzije.
Reports of gastrointestinal perforation on tocilizumab were primarily reported as complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess.
Slučajevi perforacije u probavnom sustavu pri liječenju tocilizumabom bili su u prvom redu prijavljeni kao komplikacije divertikulitisa, uključujući generalizirani purulentni peritonitis, perforacije donjeg dijela gastrointestinalnog sustava, fistule i apsces.
Reports of overdoses with oseltamivir have been received from clinical trials and during post- marketing experience.
Zaprimljene su prijave o predoziranju oseltamivirom iz kliničkih ispitivanja i nakon stavljanja lijeka u promet.
Reports of serious allergic reactions including anaphylaxis have been received following Humira administration.
Ozbiljne alergijske reakcije, uključujući anafilaksu, prijavljivane su nakon primjene lijeka Humira.
Reports of serious infection have been received in post-marketing surveillance including device- related infection, device-related sepsis, pneumonia, sepsis, bacteraemia, and urinary tract infection.
Unutar razdoblja postmarketinškog praćenja zaprimljene su prijave ozbiljnih infekcija, uključujući infekcije povezane s uređajem, sepse povezane s uređajem, upalu pluća, sepsu, bakterijemiju i infekciju mokraćnog sustava.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the postmarketing period (see section 4.8).
Nakon stavljanja u promet zabilježeni su slučajevi raznih zloćudnih bolesti (uključujući karcinome dojke i pluća te limfome) (vidjeti dio 4.8).
Reports on recruitment progress of the patient surveillance database will be analysed and reported to the CHMP at the time of PSURs (for safety) and of the Annual Re- assessments (for efficacy and safety).
Izvješća o napretku popunjavanja baze podataka za nadzor bolesnika analizirat će se i podnositi CHMP-u istovremeno sa PSUR-evima (za sigurnost) i Godišnjim ponovnim izvješćem o lijeku (za djelotvornost i sigurnost).
Reproducti ve system and breast disorders
Poremećaji reproduktivnog sustava i dojki
Reproduction and development studies have demonstrated a potent effect on foetal loss with a high rate observed in rats and mice (180 pg/ml and 30 pg/ml plasma, respectively) at exposures 1.2 to 6 times the clinical exposure (up to 25 pg/ml).
Reprodukcijske i razvojne studije pokazale su snažan učinak na gubitak ploda s visokom stopom zabilježenom u štakora i miševa (180 pg/ml, odnosno 30pg/ml plazme) pri izloženostima 1,2 do 6 puta većima od kliničke izloženosti (do 25 pg/ml)
Reproduction is authorised provided the source is acknowledged.
Dozvoljava se reproduciranje uz uvjet navođenja izvora.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. dvostruko veće doze sve dok se ne dosegne najdjelotvornija doza.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. hematopoetskih matičnih stanica.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. i smrću.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. liječenje KOPB-a.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. na koje standardni antibiotici ne djeluju.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. na spavanje.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. naslijeđenom od oba roditelja).
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. nazivom Abilify.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. odlaska na spavanje.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. optičkog živca (živca koji šalje signale iz oka u mozak).
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. pacijenta.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. protiv virusa.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. protok urina.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. svaki mjesec.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. tablete od 20 mg.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. tjelesnoj težini.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. toksemije (sindrom mastitis-metritis-agalakcija) uz odgovarajuću antibiotsku terapiju.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. ublažavanje boli.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. uključujući zračne putove u plućima.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. vanjskog dijela tijela).
Reproduction is authorised provided the source is acknowledged.
Umnažanje je dopušteno samo uz citiranje izvora.
Reproduction is authorised provided the source is acknowledged.
Umnažanje je dozvoljeno pod uvjetom da je izvor naveden, osim u komercijalne svrhe.
Reproduction is authorised provided the source is acknowledged.
Umnažanje je dozvoljeno pod uvjetom da se potvrdi izvor.
Reproduction is authorised provided the source is acknowledged.
Umnožavanje je dopušteno uz uvjet da se navede izvor.
Reproduction is authorised provided the source is acknowledged.
Umnožavanje je dopušteno uz uvjet navođenja izvora.
Reproduction is authorised provided the source is acknowledged.
Umnožavanje je dozvoljeno pod uvjetom da se navede izvor.
Reproduction is authorised provided the source is acknowledged.
Za dodatne informacije vidjeti uputu o lijeku.
Reproduction is authorised provided the source is acknowledged. after the end of the operation.
Reproduction is authorised provided the source is acknowledged. četiri sata nakon završetka kirurškog zahvata.
Reproduction is authorised provided the source is acknowledged. already taking, together with the lowest dose (5 mg) of empagliflozin.
Reproduction is authorised provided the source is acknowledged.