natgillin/translations-raw huggingface dataset:
Replace the pen cap with the ‘triangle’ opposite the dosage indicator as seen in Diagram L.
Pokrovček postavite nazaj na peresnik tako, da bo trikotnik postavljen nasproti kazalnika odmerkov, kot je prikazano na sliki L.
Replace the pen cap.
Znova namestite pokrovček peresnika
Replace the pen cap.
Znova namestite pokrovček peresnika.
Replace the Viraferon, solution for injection, multidose pen cap with the ‘triangle’ opposite the dosage indicator as seen in Diagram L.
Postavite pokrovček nazaj na večodmerni peresnik Viraferon raztopina za injiciranje tako, da bo trikotnik postavljen nasproti kazalnika odmerkov, kot je prikazano na sliki L.
Replace with the following volume of sterile sodium chloride 9 mg/ml (0.9%), or 5% glucose solution for injection (ml)
Nadomestite z navedenim volumnom 9 mg/ml (0,9-odstotne) sterilne raztopine natrijevega klorida ali 5-odstotne raztopine glukoze za injiciranje (ml)
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.
Večja krvavitev je bila v študiji REPLACE-2 opredeljena kot: intrakranialna krvavitev, retroperitonealna krvavitev, izguba krvi, ki vodi do transfuzije vsaj dveh enot krvi ali zapakiranih krvnih celic ali krvavitev, ki povzroči zmanjšanje koncentracije hemoglobina za 3 g/dl ali več ali padec hemoglobina za 4 g/dl ali več (ali 12% hematokrita) brez očitnega mesta krvavitve.
Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology.
Nadomeščanje endogenega rastnega hormona pri odraslih s pomanjkanjem rastnega hormona, ki se začne v otroštvu ali odrasli dobi.
Replacement therapy
Nadomeščanje drugega zdravila
Replacement therapy in adults with growth hormone deficiency
Nadomestno zdravljenje odraslih s pomanjkanjem rastnega hormona
Replacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology.
Nadomestno zdravljenje pri odraslih z izrazitim pomanjkanjem rastnega hormona, ki se začne v otroštvu ali odrasli dobi.
Replacement therapy in adults with pronounced growth hormone deficiency.
Nadomestno zdravljenje odraslih z izrazitim pomanjkanjem rastnega hormona
Replacement therapy in adults, and children and adolescents (0-18 years) in:
Nadomestno zdravljenje odraslih, otrok in mladostnikov (0 – 18 let) pri:
Replacement therapy in adults, children and adolescents (2-18 years) in:
Nadomestno zdravljenje pri odraslih, otrocih in mladostnikih (2–18 let) pri:
Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Nadomestno zdravljenje pri mielomu ali kronični limfocitni levkemiji s hudo sekundarno hipogamaglobulinemijo in ponavljajočimi se okužbami.
Replacement therapy in primary immunodeficiency
Nadomestno zdravljenje pri primarni imunski
Replacement therapy in primary immunodeficiency
Nadomestno zdravljenje pri primarni imunski pomanjkljivosti
Replacement therapy in primary immunodeficiency (PID) syndromes
Nadomestno zdravljenje sindromov primarne imunske pomanjkljivosti (PID)
replacement therapy should be clinically
hormonske nadomestne terapije, je treba
Replagal 1 mg/ml concentrate for solution for infusion agalsidase alfa
Replagal 1 mg/ml koncentrat za raztopino za infundiranje agalzidaza alfa
Replagal 1 mg/ml concentrate for solution for infusion.
Replagal 1 mg/ml koncentrat za raztopino za infundiranje
Replagal has no or negligible influence on the ability to drive and use machines.
Zdravilo Replagal nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Replagal is administered at a dose of 0.2 mg/kg body weight every other week by intravenous infusion over 40 minutes.
Zdravilo Replagal dajte v odmerku 0,2 mg/kg telesne mase vsak drugi teden s 40-minutno intravensko infuzijo.
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.
Zdravilo Replagal je maso levega prekata zmanjšalo povprečno za 11,5 g, medtem ko se je masa levega prekata pri bolnikih, ki so prejemali placebo, povečala za 21,8 g.
Replagal was originally authorised under ‘exceptional circumstances’, because as the disease is rare, limited information was available at the time of approval.
Zdravilo Replagal je pridobilo dovoljenje za promet v „izjemnih okoliščinah“, saj so bile zaradi redkosti bolezni ob odobritvi zdravila na voljo le omejene informacije.
replication and the assembly of HCV virions.
in sestavljanje virionov HCV.
Replication of the parasite damages the dog’s intestinal mucosa, which may cause enteritis.
Razmnoževanje parazita poškoduje sluznico prebavnega trakta psa, kar lahko povzroči enteritis.
Replicons with single substitutions at position 155 or 156 and double variants with substitutions at residues 36 and 155 showed cross-resistance to all protease inhibitors tested with a wide range of sensitivities.
Replikoni z eno samo substitucijo na mestu 155 ali 156 in dvojne variante s substitucijami na ostankih 36 in 155 so pokazale navzkrižno rezistenco za vse testirane zaviralce proteaze s širokim razponom občutljivosti.
report by 31
poročila o študiji do 31.
Report immediately to your doctor any symptoms of infection such as: fever, sore throat or flu-like symptoms.
Če se pojavijo simptomi okužbe, kot so: zvišana telesna temperatura, boleče grlo ali gripi podobni simptomi, to takoj sporočite svojemu zdravniku.
report of the
enoskupinsko
Report submission is no later than day 22 (i.e. the following Monday).
Predložitev poročila je najkasneje na 22. dan (npr. naslednji ponedeljek).
Reported adverse reactions are listed below, by system organ class and by frequency.
V nadaljevanju so našteti do sedaj opaženi neželeni učinki, ki so navedeni glede na prizadeti organski sistem in pogostnost.
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.
Prijavljeni neželeni učinki, ki so navedeni v Preglednici 5, temeljijo na izkušnjah dveh multicentričnih študij za otroke in mladostnike, kjer so uporabljali ribavirin z interferonom alfa-2b ali peginterferonom alfa-2b..
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.
Prijavljeni neželeni učinki, ki so navedeni v Preglednici 5, temeljijo na izkušnjah iz dveh multicentričnih študij za otroke in mladostnike, kjer so uporabljali ribavirin z interferonom alfa-2b ali peginterferonom alfa-2b.
Reported adverse reactions listed in Table 6 are based on experience from the two multicentre children and adolescents clinical trials using ribavirin with interferon alfa-2b or peginterferon alfa-2b.
Neželeni učinki, o katerih so poročali in so navedeni v preglednici 6, temeljijo na izkušnjah iz dveh multicentričnih študij pri otrocih in mladostnikih, kjer so uporabljali ribavirin z interferonom alfa-2b ali peginterferonom alfa-2b.
reported by the parents as adversely affecting the child’s daily activities For both vaccination groups, the majority of the reactions were short lasting.
Pri obeh skupinah je bila večina reakcij po cepljenju kratkotrajnih.
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.
Poročila o primerih laktacidoze pri bolnikih, ki so jemali metformin, navajajo, da so jih zasledili zlasti pri bolnikih s sladkorno boleznijo z okvaro ledvic ali akutnim poslabšanjem delovanja ledvic.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Do primerov laktacidoze, o katerih so poročali pri bolnikih, ki so jemali metformin, je prišlo večinoma pri diabetikih s pomembno okvaro ledvic.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
O primerih laktacidoze pri zdravljenju z metforminom so poročali predvsem pri diabetikih s pomembno ledvično odpovedjo.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
O primerih laktacidoze pri zdravljenju z metforminom so poročali predvsem pri diabetikih s pomembno odpovedjo ledvic.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Pri bolnikih, ki so dobivali metformin, so se primeri laktacidoze pojavili predvsem pri sladkornih bolnikih s pomembno odpovedjo ledvic.
Reported commonly in placebo
pogosto poročali pri placebu
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.)
Delež ponovitev izpuščaja po zamenjavi zdravljenja z nevirapinom z zdravljenjem z efavirenzem, o katerem so poročali in ki temelji na podatkih iz retrospektivnih kohortnih študij iz objavljene literature, znaša od 13 do 18 %, kar je primerljivo z deležem, ki so ga opazili pri bolnikih, ki so se z efavirenzem zdravili v kliničnih študijah. (Glejte poglavje 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).
Delež ponovitev izpuščaja po zamenjavi zdravljenja z nevirapinom z zdravljenjem z efavirenzem, o katerem so poročali in ki temelji na podatkih iz retrospektivnih kohortnih študij iz objavljene literature, znaša od 13 do 18 %, kar je primerljivo z deležem, ki so ga opazili pri bolnikih, ki so se z efavirenzem zdravili v kliničnih študijah. (Glejte poglavje 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.)
Delež ponovitev izpuščaja po zamenjavi zdravljenja z nevirapinom z zdravljenjem z efavirenzem, o katerem so poročali in ki temelji na podatkih iz retrospektivnih kohortnih študij iz objavljene literature, znaša od 13 do 18 %, kar je primerljivo z deležem, ki so ga opazili pri bolnikih, ki so se z efavirenzem zdravili v kliničnih študijah. (Glejte poglavje 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.
Med opisanimi resnimi okužbami, od katerih so se nekatere končale tudi s smrtnim izidom, so bile aktivna tuberkuloza, ki se lahko pojavi v intrapulmonalni ali ekstrapulmonalni obliki, invazivne okužbe pljuč, kot so kandidoza, aspergiloza, kokcidioidomikoza in Pneumocystis jiroveci, pljučnica, flegmona, herpes zoster, gastroenteritis, divertikulitis, sepsa in bakterijski artritis.
Reported symptoms have included flushing, dyspnoea, fever, facial swelling, headache, back pain, chills, tightness in the chest and throat, and/or hypotension.
Med simptomi, o katerih so poročali, so bili rdečica, dispneja, povišana telesna temperatura, otekanje obraza, glavobol, bolečine v hrbtu, mrzlica, tiščanje v prsih in grlu in/ali hipotenzija.
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.
poročano z višjo incidenco (zelo pogosti) pri bolnikih, ki so prejeli dve sočasni injekciji zdravila Xiapex,v isto roko v primerjavi z osebami, zdravljenimi z do tremi enkratnimi injekcijami v ključnih študijah 3. faze za Dupuytrenovo kontrakturo, nadzorovanih s placebom.
reported11
epileptične napade11
reported11
z okulogiracijo)
Reporting of medication errors or any side effects
Poročanje o napakah pri zdravljenju in vseh neželenih učinkih.
Reporting of medication errors or any side effects.
Da je treba prijaviti napake z zdravilom in vsak neželen učinek.
Reporting of serious adverse drug reactions
poročanje resnih neželenih učinkov, izobraževalno gradivo za bolnike.
Reporting of side effe cts
Poročanje o ne želenih učinkih
Reporting of side effect
Poročanje o neželenih učinkih
Reporting of side effects
Poročanje o ne želenih učinkih
Reporting of side effects
Poročanje o neželenih učinkih:
Reporting of side effects
Poročanje o neželenih učinkov
Reporting of side effects
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Reporting of side effects
Če se pojavijo neželeni učinki
Reporting of side effects.
Poročanje o neželenih učinkih
Reporting suspected adverse reactions after authorisation of the medicial product is important.
Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
Reporting suspected adverse reactions afterauthorisation of themedicinal product is important.
Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
Reporting to be fortnightly for the first 3 months of the pandemic.
V prvih treh mesecih pandemije naj bo poročanje štirinajstdnevno.
Reporting to be monthly for the first 6 months.
Poročanje je prvih 6 mesecev mesečno.
Reporting to be monthly for the first 6 months.
Poročanje mora biti prvih 6 mesecev vsak mesec.
Reporting to be monthly for the first 6 months.
V prvih 6 mesecih bo poročanje potekalo enkrat na mesec.
Reportng suspected adverse reactions after authorisation of the medicinal product is important.
Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
Reports - with each
študiji - z vsakim
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.
Poročila iz objavljene literature potrjujejo, da je metiltioninijev klorid učinkovit pri zdravljenju methemoglobinemije, ki jo pri odraslih in otrocih povzroča izpostavljenost zdravilom ali kemikalijam.
Reports from the sub-
Poročila tega
Reports have been received from post-approval marketing experience in association with the use of Enurev Breezhaler.
Poročila izhajajo iz izkušenj z uporabo zdravila Enurev Breezhaler po njegovem prihodu na trg.
Reports have been received from post-approval marketing experience in association with the use of Seebri Breezhaler.
Poročila izhajajo iz izkušenj z uporabo zdravila Seebri Breezhaler po njegovem prihodu na trg.
Reports have been received from post-approval marketing experience in association with the use of Tovanor Breezhaler.
Poročila izhajajo iz izkušenj z uporabo zdravila Tovanor Breezhaler po njegovem prihodu na trg.
Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod 5 % cream use.
Poročali so o lokalni hipopigmentaciji in hiperpigmentaciji po uporabi kreme imikvimod 5%.
Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Poročila so vključevala smrtne izide in življenjsko nevarno akutno dihalno odpoved s hitrim nastopom (glejte poglavje 4.8).
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Iz literature je razvidno, da je okrepitev simptomov pri zdravljenju druge indikacije lahko posledica zdravljenja z dopaminergičnimi zdravili.
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Podatki iz literature kažejo, da je poslabšanje pri zdravljenju druge indikacije lahko posledica zdravljenja z dopaminergičnimi zdravili.
reports of abnormal liver tests values,
primeri nenormalnih izvidov laboratorijskih jetrnih preiskav,
Reports of angioedema (some serious) such as swelling of the face, lips and/or tongue which may be associated with difficulty breathing or wheezing have been received in association with use of Esbriet in the post-marketing setting.
V povezavi z uporabo zdravila Esbriet obstajajo v obdobju trženja zdravila poročila o angioedemu (nekatera resna), kot so oteklost obraza, ustnic in/ali jezika, ki so lahko povezana s težkim dihanjem ali sopenjem.
Reports of extravasation with subsequent infusion site reactions including e.g. infusion site dermatitis, infusion site desquamation, and infusion site ulcer have been received.
Poročali so o ekstravazaciji s posledično reakcijo na mestu infundiranja, ki vključujejo npr. dermatitis na mestu infundiranja, luščenje kože na mestu infundiranja in razjede na mestu infundiranja.
Reports of infusion related reactions or anaphylaxis coincident with concomitant use of oral urate lowering agents were submitted in this Periodic Safety Update Report, where infusion reactions in 28 cases and 9 cases with anaphylactic reactions were reported.
V tem redno posodobljenem poročilu o varnosti zdravila so bila predložena poročila o reakcijah, povezanih z infuzijami, ali anafilaksi, ki sovpadajo s sočasno uporaba peroralnega zdravljenja za zniževanje ravni uratov, pri čemer je bilo 28 poročil o primerih reakcij, povezanih z infuzijami, in 9 poročil o primerih anafilaktičnih reakcij.
Reports of overdoses with oseltamivir have been received from clinical trials and during post- marketing experience.
Poročila o prevelikem odmerjanju z zdravilom Ebilfumin so bila prejeta iz kliničnih preskušanj in po prihodu zdravila na trg.
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.
Poročila o resnih okužbah, prejeta v obdobju trženja, so vključevala okužbe, povezane s pripomočkom, sepso, povezano s pripomočkom, pljučnico, sepso, bakteriemijo in okužbo sečil.
Reports of severe abdominal pain and diarrhoea have been observed in clinical trials with the 25 mg dose, typically occurring shortly after initiation of treatment.
V kliničnih preskušanjih z odmerkom 25 mg so zabeležili hude bolečine v trebuhu in drisko; praviloma so se te težave pojavile kmalu po uvedbi zdravila.
Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Poročila o resnih posledicah trombocitopenije, vključno s smrtnimi primeri zaradi krvavitve iz tumorja, pa so bila redka.
Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Redko so poročali o pomembnih posledicah trombocitopenije, vključno s smrtmi zaradi tumorskih krvavitev.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the postmarketing period (see section 4.8).
V obdobju trženja zdravila so prejeli več poročil o raznih malignih boleznih (vključno z rakom dojke in pljuč ter limfomi) (glejte poglavje 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).
Poročila o vključevanju bolnikov v zbirko podatkov spremljanja bolnikov se analizirajo in poročajo CHMP v času priprave PSUR (za varnost) in letnega ponovnega pregleda (za učinkovitost in varnost).
Reports on recruitment progress of the registry will be submitted with PSURs and Annual Re-assessments.
Poročila o napredku vključevanja v register bodo predložena skupaj s poročili PSUR in letnimi ponovnimi ocenami.
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).
Raziskave reprodukcije in razvoja so pokazale močan učinek zdravila na izgubo plodov – pri podganah in miših so ugotavljali veliko pogostnost (180 pg/ml plazme pri podganah in 30 pg/ml plazme pri miših) pri izpostavljenosti zdravilu, ki je bila 1,2 do 6-krat večja od klinične izpostavljenosti (do 25 pg/ml).
Reproduction is authorised provided the source is acknowledged
Reproduction is authorised provided the source is acknowledged kmetijstva.
Reproduction is authorised provided the source is acknowledged monitored included weight gain, mortality as well as faecal and nasal shedding.
Reproduction is authorised provided the source is acknowledged izločanje virusa z iztrebki in skozi nos.
Reproduction is authorised provided the source is acknowledged.
Razmnoževanje je dovoljeno ob navedbi vira.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. beljakovine.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. bolnikovega odziva.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. cepljenih mladičev.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. dvakrat na dan.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. glukoze (sladkorja) v krvi.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. grenivke.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. inaktivirane celice bakterije Bordetella bronchiseptica.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. mišice.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. morajo preteči najmanj štiri ure.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. na dan.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. nadzorujejo izločanje seča.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. nepoškodovano kožo trebuha, nadlakti, rame ali stegna.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. odmerek dati pred začetkom tveganega obdobja.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. odmerek dobro prenaša.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. omogoča deljenje in razmnoževanje.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. oziroma ostaja stabilno in so neželeni učinki znosni.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. podedovana od obeh staršev).