natgillin/translations-raw huggingface dataset:
In order to further investigate the safety and reactogenicity of Pandemic influenza vaccine H5N1 MedImmune, the MAH should conduct an open-label single arm interventional study to evaluate the safety and immunogenicity of P/LAIV in children and adolescents from 12 months to less than 18 years of age during the next declared pandemic.
Za dodatno proučitev varnosti in reaktogenosti Cepiva proti pandemski gripi H5N1 MedImmune mora imetnik dovoljenja za promet z zdravilom med naslednjo razglašeno pandemijo opraviti odprto intervencijsko študijo z eno skupino (enim krakom) za oceno varnosti in imunogenosti P/LAIV pri otrocih in mladostnikih, starih od 12 mesecev do manj kot 18 let.
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil je treba zaščiteno ime in številko serije uporabljenega zdravila jasno zabeležiti (ali navesti) v bolnikovi dokumentaciji.
In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil mora biti v kartoteki bolnika, ki zdravilo prejema, jasno dokumentirano (ali navedeno) ime in številka serije zdravila.
In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil morata biti v kartoteki bolnika, ki zdravilo prejema, jasno dokumentirana (ali navedena) ime in številka serije zdravila.
In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil, mora biti v kartoteki bolnika, ki zdravilo prejema, jasno dokumentirano (ali navedeno), zaščiteno ime in številka serije zdravila.
In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Zaradi izboljšanja sledljivosti bioloških zdravil je treba v bolnikovi kartoteki jasno zabeležiti (ali navesti) lastniško (zaščiteno) ime zdravila in številko serije uporabljenega zdravila.
In order to improve the traceability of biological medicinal products, the tradename of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil je treba zaščiteno ime uporabljenega zdravila jasno zabeležiti (navesti) v bolnikovi dokumentaciji.
In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti zdravil za stimulacijo eritropoeze (ESA) je treba v bolnikovi dokumentaciji jasno zabeležiti (ali navesti) trgovsko ime uporabljenega ESA.
In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file.
Zaradi izboljšanja sledljivosti zdravil za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent) je treba ime apliciranega ESA jasno zapisati (ali navesti) v bolnikovi kartoteki.
In order to improve the traceability, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file.
Za izboljšanje sledljivosti je treba tržno ime in številko serije uporabljenega zdravila jasno zabeležiti v bolniško kartoteko.
In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil je treba zaščiteno ime in številko serije uporabljenega zdravila jasno zabeležiti (navesti) v bolnikovi dokumentaciji.
In order to improve traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil je treba lastniško ime uporabljenega zdravila in številko serije jasno zabeležiti (navesti) v bolnikovo kartoteko.
In order to improve traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil je treba zaščiteno ime in številko serije danega zdravila jasno zabeležiti v bolnikovi dokumentaciji.
In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil je treba zaščiteno ime in številko serije uporabljenega zdravila jasno zabeležiti v bolnikovi dokumentaciji.
In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Z namenom, da bi izboljšali sledljivost bioloških zdravil, morata biti zaščiteno ime in številka serije uporabljenega zdravila jasno zabeležena.
In order to improve traceability of granulocyte-colony stimulating factors, the product name (Accofil) and batch number of the administered product should be clearly recorded in the patient file
Za izboljšanje sledljivosti granulocitne kolonije spodbujajočih faktorjev je treba ime zdravila (Accofil) in številko serije uporabljenega zdravila jasno zapisati v bolniško kartoteko.
In order to improve traceability of granulocyte-colony stimulating factors, the product name (Grastofil) and batch number of the administered product should be clearly recorded in the patient file
Za izboljšanje sledljivosti granulocitne kolonije spodbujajočih faktorjev je treba ime zdravila (Grastofil) in številko serije uporabljenega zdravila jasno zapisati v bolniško kartoteko.
In order to increase haemoglobin levels to greater than 10 g/dl (6.21 mmol/l), the recommended starting dose in patients not on dialysis is 1.2 microgram/kg body weight, administered once every month as a single subcutaneous injection.
Da bi povečali koncentracijo hemoglobina nad 10 g/dl (6,21 mmol/l), se pri nedializnih bolnikih priporoča začetni odmerek 1,2 mikrograma/kg telesne mase enkrat na mesec v obliki ene subkutane injekcije.
In order to increase haemoglobin levels to greater than 10 g/dl (6.21 mmol/l), the recommended starting dose in patients not on dialysis is 1.2 microgram/kg body weight, administered once every month as a single subcutaneous injection.
Da bi povečali koncentracijo hemoglobina nad 10 g/dl (6,21 mmol/l), se pri nedializnih bolnikih priporočeni začetni odmerek 1,2 mikrograma/kg telesne mase enkrat na mesec v obliki ene subkutane injekcije.
In order to investigate suitable bio-/tumour markers (including VEGF) to allow
Da bi raziskali ustrezne bio-/tumorske markerje (vključno z VEGF), ki bi omogočili
In order to investigate the long-term safety of eliglustat in patients prescribed eliglustat, the
Za proučitev dolgoročne varnosti eliglustata pri bolnikih, ki jim je predpisan eliglustat, bo
In order to maintain renal blood flow, prolonged episodes of hypotension (mean arterial pressure below 60 mmHg) should be avoided in dogs during sevoflurane anaesthesia.
Zaradi vzdrževanja krvnega pretoka skozi ledvice se moramo pri psih pod sevofluransko anestezijo izogibati dolgotrajnim epizodam hipotenzije (srednji arterijski tlak pod 60 mmHg).
In order to minimise exposure to sevoflurane vapour, the following recommendations are made:
Da bi kar najbolj zmanjšali izpostavitev hlapom sevoflurana, priporočamo naslednje:
In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha- blocker therapy prior to initiating sildenafil treatment.
Da bo možnost za pojav posturalne hipotenzije čim manjša, je treba pri bolnikih pred začetkom zdravljenja s sildenafilom doseči hemodinamično stabilnost v zdravljenju z antagonisti adrenergičnih receptorjev alfa.
In order to minimise the risk of too rapid correction of hyponatraemia the increase of serum sodium should be less than 10-12 mmol/l/24 hours and less than 18 mmol/l/48 hours.
Za zmanjšanje tveganja prehitrega popravka hiponatriemije mora biti povečanje natrija v serumu manj kot 10 – 12 mmol/l/24 ur in manj kot 18 mmol/l/48 ur.
In order to obtain the correct dosage the concentration of Econor has to be adjusted.
Da zagotovimo pravilen odmerek, moramo prilagoditi koncentracijo zdravila.
In order to obtain the correct dose the concentration of Aivlosin has to be adjusted accordingly.
Da dosežete pravilni odmerek, morate ustrezno prilagoditi koncentracijo zdravila Aivlosin.
In order to preserve renal blood flow, prolonged episodes of hypotension (mean arterial pressure below 60 mmHg) should be avoided in dogs during sevoflurane anaesthesia.
Zaradi vzdrževanja krvnega pretoka skozi ledvice se moramo pri psih pod sevofluransko anestezijo izogibati dolgotrajnim epizodam hipotenzije (srednji arterijski tlak pod 60 mmHg).
In order to prevent blood clots forming in the tubes of your dialysis machine, this medicine will be given by an injection into the tube leaving the body (arterial line).
Da preprečite nastajanje krvnih strdkov v cevju naprave za dializo, je treba zdravilo injicirati v cevko, ki vodi iz telesa (arterijska linija).
In order to prevent constipation, laxatives and dietary measures including oral hydration are recommended from day 1 to day 5 or 7 after each vinflunine administration (see section 4.4).
Za preprečevanje zaprtja se od 1. do 5. oz. do 7. dne po vsakem odmerku vinflunina priporoča jemanje odvajal in dietno prehrano, vključno s peroralno rehidracijo (glejte poglavje 4.4).
In order to prevent dust formation, do not shake the veterinary medicinal product.
Ne stresajte zdravila, da ne bi nastal prah.
In order to prevent extracorporeal clot formation during haemodialysis, enoxaparin sodium is given by injection into the arterial line of the extracorporeal circulation.
Za preprečevanje nastanka krvnih strdkov v zunajtelesnem krvnem obtoku med hemodializo se skozi arterijsko linijo v zunajtelesni obtok injicira natrijev enoksaparinat.
In order to prevent medication errors it is also important to check the vial labels to ensure that the medicine being prepared and given is Herceptin (trastuzumab) and not trastuzumab emtansine.
Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo Herceptin (trastuzumab) in ne trastuzumab emtanzin.
In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is Herceptin (trastuzumab) and not Kadcyla (trastuzumab emtansine).
Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo Herceptin (trastuzumab) in ne zdravilo Kadcyla (trastuzumab emtanzin).
In order to prevent medication errors it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Kadcyla (trastuzumab emtansine) and not Herceptin (trastuzumab).
Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo res zdravilo Kadcyla (trastuzumab emtanzin) in ne zdravilo Herceptin (trastuzumab).
In order to prevent medication errors it is important to check the vial labels to ensure that the medicinal product being prepared is Kadcyla (trastuzumab emtansine) and not Herceptin (trastuzumab).
Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo res zdravilo Kadcyla (trastuzumab emtanzin) in ne zdravilo Herceptin (trastuzumab).
In order to prevent medication errors it is important to review the Summary of Product Characteristics and to check the outer carton and vial labels to ensure that the medicinal product being prepared and administered is Kadcyla and not Herceptin.
Za preprečitev napak je pomembno pregledati Povzetek glavnih značilnosti zdravila in preveriti škatlo in nalepko na viali, da se zagotovi, da je pripravljeno in aplicirano zdravilo Kadcyla in ne Herceptin.
In order to properly adjust the dose of the anticoagulant and to avoid excessive hypocoagulability, controls of the extent of anticoagulation (APTT, and where appropriate anti-Factor Xa activity) should be performed regularly, at close intervals and in particular in the first minutes/hours following the start of antithrombin use.
Da bi ustrezno prilagodili odmerek antikoagulanta in se izognili prekomerni hipokoagulabilnosti, je treba redno in dovolj pogosto, še posebej v prvih minutah/urah po začetku uporabe antitrombina, preverjati stopnjo antikoagulacije (aktivirani parcialni tromboplastinski čas in kjer je primerno, aktivnost antifaktorja Xa).
In order to provide long-term efficacy data in terms of DFS and OS, the MAH should submit the results of study BO25126 (APHINITY), a randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer
Za zagotovitev podatkov o dolgoročni učinkovitosti v smislu DFS in OS mora imetnik dovoljenja za promet predložiti rezultate študije BO25126 (APHINITY), randomizirane, multicentrične, dvojno slepe, s placebom kontrolirane primerjave kemoterapije v kombinaciji s trastuzumabom in placebom ter kemoterapije v kombinaciji s trastuzumabom in pertuzumabom kot adjuvantnega zdravljenja pri bolnikih z operabilnim HER2-pozitivnim primarnim rakom dojk.
In order to qualify for enrolment, patients were required to have a platelet count < lower limit of normal range (LLN), evidence of haemolysis such as an elevation in serum LDH, and serum creatinine above the upper limits of normal, without the need for chronic dialysis.
Da so bolniki izpolnili pogoje za vključitev, so morali imeti število trombocitov manjše od spodnje meje normalnega razpona (LLN - lower limit of normal range), znake hemolize, npr. zvišanje serumske LDH, in serumski kreatinin nad zgornjo mejo normalne vrednosti, brez potrebe po kronični dializi.
In order to reduce the potential risk of bleeding into the spinal canal associated with the concurrent use of enoxaparin sodium and anaesthesia or analgesia using the subarachnoid or epidural routes of administration, the pharmacokinetic profile of the medicinal product should be considered (see section 5.2).
Da bi zmanjšali tveganje za krvavitev v hrbtenični kanal, ki je povezano s sočasno uporabo natrijevega enoksaparinata in epiduralne ali subarahnoidne anestezije/analgezije, je treba upoštevati farmakokinetične značilnosti zdravila (glejte poglavje 5.2).
In order to reduce the potential risk of bleeding into the spinal canal associated with the concurrent use of enoxaparin sodium and anaesthesia or analgesia using the subarachnoid or epidural routes of administration, the pharmacokinetic profile of the medicinal product should be considered (see section 5.2).
Da bi zmanjšali tveganje za krvavitev v hrbtenični kanal, ki je povezano s sočasno uporabo natrijevega enoksaparinata in epiduralne ali subarahnoidne anestezije/analgezije, morate upoštevati farmakokinetične značilnosti zdravila (glejte poglavje 5.2).
In order to reduce the risk of resistance in patients receiving lamivudine monotherapy, a modification of treatment should be considered if serum HBV DNA remains detectable at or beyond 24 weeks of treatment.
Da bi zmanjšali tveganje odpornosti pri bolnikih, ki prejemajo monoterapijo z lamivudinom, je treba razmisliti o prilagoditvi zdravljenja, če je HBV DNA v serumu zaznana po 24 ali več tednih zdravljenja.
In order to reduce the risk of resistance in patients receiving lamivudine monotherapy, a switch to or addition of an alternative agent without cross-resistance to lamivudine based on therapeutic guidelines should be considered if serum HBV DNA remains detectable at or beyond 24 weeks of treatment (see section 5.1).
Da bi zmanjšali tveganje odpornosti pri bolnikih, ki prejemajo monoterapijo z lamivudinom, je treba skladno s smernicami za zdravljenje razmisliti o zamenjavi ali dodatku drugega zdravila, ki nima navzkrižne odpornosti proti lamivudinu, če je HBV DNA v serumu zaznana po 24 ali več tednih zdravljenja (glejte poglavje 5.1).
In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme.
Da bi zmanjšali nevarnost pojava neželenih učinkov, odmerek dosegate postopoma, po priporočilu spodnje sheme dnevnega odmerjanja:
In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:
Da bi zmanjšali nevarnost pojava neželenih učinkov, odmerek dosegate postopoma, po priporočilu spodnje sheme dnevnega odmerjanja.
In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows.
Da bi zmanjšali pojavnost neželenih učinkov, je potrebno postopno zviševanje odmerka po 5 mg na teden v prvih treh tednih zdravljenja, dokler ni dosežen vzdrževalni odmerek, kot je navedeno.
In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:
Da bi zmanjšali pojavnost neželenih učinkov, je potrebno postopno zviševanje odmerka po 5 mg na teden v prvih treh tednih zdravljenja, dokler ni dosežen vzdrževalni odmerek, in sicer:
In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:
Da bi zmanjšali pojavnost neželenih učinkov, je potrebno postopno zviševanje odmerka po 5 mg na teden v prvih treh tednih zdravljenja, dokler ni dosežen vzdrževalni odmerek, kot je navedeno.
In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows.
Da bi zmanjšali pojavnost neželenih učinkov, je potrebno postopno zviševanje odmerka po 5 mg na teden v prvih treh tednih zdravljenja, kot sledi.
In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows.
Da bi zmanjšali pojavnost neželenih učinkov, je potrebno postopno zviševanje odmerka po 5 mg na teden v prvih treh tednih zdravljenja, kot sledi:
In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows.
Da bi zmanjšali pojavnost neželenih učinkov, je v prvih treh tednih zdravljenja potrebno postopno povečevanje odmerka po 5 mg na teden, dokler ni dosežen vzdrževalni odmerek.
In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:
Da bi zmanjšali pojavnost neželenih učinkov, je v prvih treh tednih zdravljenja potrebno postopno povečevanje odmerka po 5 mg na teden, dokler ni dosežen vzdrževalni odmerek, in sicer:
In order to rule out bias in the investigator-based assessment of PFS, a blinded independent central review of scans was performed; this review supported the investigator assessment, as shown in Table 4.
Da bi izključili pristranskost pri ocenjevanju PFS, ki so ga izvajali raziskovalci, so opravili slepo neodvisno centralno preverjanje pregledov; to preverjanje je podprlo ocene raziskovalcev, kot je prikazano v Preglednici 4.
In order to support its recommendations for Combivir doses in children, the company presented information from studies of the levels of lamivudine and zidovudine in the blood of children taking the medicines separately.
V podporo svojim priporočilom za odmerjanje zdravila Combivir pri otrocih je družba predstavila podatke iz študij o ravneh lamivudina in zidovudina v krvi otrok, ki so zdravili jemali ločeno.
In order to use Pradaxa® safely, please consider the important information inside.
Prosimo, da zaradi varne uporabe zdravila Pradaxa® upoštevate pomembne informacije v tej kartici.
In other cases, rivastigmine has been discontinued (see section 4.8).
V drugih primerih so zdravilo rivastigmin ukinili (glejte poglavje 4.8).
In other cases, seek help as soon as possible
V vseh ostalih primerih poiščite pomoč v najkrajšem možnem času.
In other clinical studies where children 6 months to 17 years received a similar vaccine containing A/Indonesia/05/2005, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
V drugih kliničnih študijah, v katerih so otroci v starosti od 6 mesecev do 17 let dobili podobno cepivo, ki je vsebovalo A/Indonesia/05/2005, so pri otrocih, mlajših od 6 let, po drugem odmerku opažali večjo pogostnost nekaterih neželenih učinkov (vključno z bolečino na mestu injiciranja, pordelostjo in zvišano telesno temperaturo).
In other clinical studies where children 6 months to 17 years received another pandemic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
V drugih kliničnih študijah, v katerih so otroci v starosti od 6 mesecev do 17 let dobili drugo cepivo proti pandemski gripi (H5N1 A/Indonesia/05/2005, izdelano v Dresdnu v Nemčiji), so pri otrocih, mlajših od 6 let, po drugem odmerku opažali večjo pogostnost nekaterih neželenih učinkov (vključno z bolečino na mestu injiciranja, pordelostjo in zvišano telesno temperaturo).
In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
V drugih študijah (prospektivne in presečne) so najbolj izrazito zmanjšanje MKG opazili pri bolnikih, zdravljenih z dizoproksiltenofovirijevim fumaratom z okrepljenim zaviralcem proteaze.
In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil fumarate as part of a regimen containing a boosted protease inhibitor.
V drugih študijah (prospektivne in presečne) so najbolj izrazito zmanjšanje MGK opazili pri bolnikih, zdravljenih z dizoproksiltenofovirijevim fumaratom kot del režima, ki je vseboval okrepljenega zaviralca proteaze.
In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil fumarate as part of a regimen containing a boosted protease inhibitor.
V drugih študijah (prospektivne in presečne) so najbolj izrazito zmanjšanje MKG opazili pri bolnikih, zdravljenih z dizoproksiltenofovirijevim fumaratom z okrepljenim zaviralcem proteaze.
In other studies, PRES was reported in patients treated with monotherapy ZALTRAP (0.5%) and in combination with other chemotherapies (see section 4.4).
PRES je bil opisan pri bolnikih, ki so prejemali monoterapijo z zdravilom ZALTRAP (0,5 %) in v kombinaciji z drugimi kemoterapijami (glejte poglavje 4.4).
In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Clopidogrel BMS instead of aspirin.
To pomeni, da se bo približno 10 bolnikov od 1 000 izognilo novemu ishemičnemu napadu v dveh letih po pričetku prejemanja zdravila Clopidogrel BMS namesto aspirina.