natgillin/translations-raw huggingface dataset:
As the dose is given by body weight and adjusted to the clinical outcome of the above mentioned conditions, the dose in the elderly population is not considered to be different from that of adults.
Ker je odmerjanje podano glede na telesno maso in prilagojeno kliničnemu izidu zgoraj navedenih stanj, odmerjanje pri starejši populaciji ni drugačno od odmerjanja pri odraslih.
As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance.
Te ugotovitve nimajo večjega kliničnega pomena, ker je treba odmerek vedno prilagoditi glede na urejenost glikemije pri posameznemu bolniku.
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation
Ker trajanje imunosti še ni natančno določeno, morata shemo revakcinacije odobriti pristojni organ ali odgovorni veterinar ob upoštevanju lokalne epidemiološke situacije.
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Ker trajanje imunosti še ni natančno določeno, morata shemo revakcinacije odobriti pristojen organ ali odgovorni veterinar ob upoštevanju lokalne epidemiološke situacije.
As the effect of the product on egg fertility, hatchability and chick viability has not been investigated, use in breeding birds producing eggs for broiler stock or as replacement layers is not recommended.
Ker učinka zdravila na oplojenost in valilnost jajc ter sposobnost preživetja piščancev niso preučevali, uporaba zdravila pri plemenski perutnini, katerih jajca se uporabljajo za pitovne piščance ali za nadomestne kokoši nesnice, ni priporočljiva .
As the effect of the product on egg fertility, hatchability and chick viability has not been investigated, use in breeding birds producing eggs for broiler stock or as replacement layers is not recommended.
Ker učinka zdravila na oplojenost in valilnost jajc ter sposobnost preživetja piščancev niso preučevali, uporaba zdravila pri plemenski perutnini, katerih jajca se uporabljajo za pitovne piščance ali za nadomestne kokoši nesnice, ni priporočljiva.
As the effective dose is 4.35 mSv when the maximal recommended activity of 185 MBq is administered these adverse events are expected to occur with a low probability.
Ker je učinkovit odmerek pri uporabi odmerka, ki ima največjo priporočeno aktivnostjo 185 MBq, enak 4,35 mSv, je možnost pojava teh neželenih učinkov majhna.
As the effective dose to an adult (70 kg) is 0.69 mSv when the maximal recommended activity of 74 MBq is administered adverse events are expected to occur with a low probability.
Ker je učinkoviti odmerek za odrasle (70 kg) 0,69 mSv, kadar je največja priporočena aktivnost 74 MBq, je verjetnost pojava teh neželenih dogodkov majhna.
As the effects of a possible hyperresponsive reaction on the mother and/or foetus are unknown, caution should be exercised when prescribing bronchitol to pregnant women.
Učinki možne hiperodzivne reakcije na bolnico in/ali plod niso znani, zato je potrebna previdnost pri predpisovanju zdravila Bronchitol nosečnicam.
As the effects of Edistride are dependent on kidney function, the effectiveness of the medicine is reduced in patients with reduced kidney function.
Učinkovitost zdravila Edistride je odvisna od delovanja
As the effects of P-gp inhibitors on the PK of naloxegol were small relative to the effects CYP3A4 inhibitors, the dosing recommendations for Moventig when co-administered with medicinal products causing both P-gp and CYP3A4 inhibition should be based on CYP3A4 inhibitor status - strong, moderate or weak (see sections 4.2, 4.3 and 4.5).
Ker je bil vpliv zaviralcev P-gp na farmakokinetiko naloksegola majhen glede na vpliv zaviralcev CYP3A4, morajo priporočila za sočasno uporabo zdravila Moventig z zdravili, ki zavrejo tako P-gp kot CYP3A4, temeljiti na inhibicijskem stanju CYP3A4 - močno, zmerno ali šibko zavrtje (glejte poglavja 4.2, 4.3 in 4.5).
As the effects of Thymanax have not been established in patients aged 75 years or above, Thymanax is not recommended in this age group.
Ker učinki zdravila Thymanax niso bili preverjeni za bolnike, starejše od 75 let, se to zdravilo za to starostno skupino ne priporoča.
As the effects of Valdoxan have not been established in patients aged 75 years or above, Valdoxan is not recommended in this age group.
Ker učinki zdravila Valdoxan niso bili preverjeni za bolnike, starejše od 75 let, se to zdravilo za to starostno skupino ne priporoča.
As the efficacy and safety of Livensa have not been evaluated in studies of longer duration than 1 year, it is recommended that an appraisal of the treatment is undertaken every 6 months.
Ker učinkovitost in varnost zdravila Livensa nista bili ocenjeni v študijah, ki bi trajale dlje kot 1 leto, se priporoča ocenjevanje zdravljenja vsakih 6 mesecev.
As the embryo- foetal development investigations were performed in healthy pregnant animals and disease (such as diabetes) may modify the permeability of the placenta towards a Fab fragment, the study should be interpreted with caution.
Ker so raziskave razvoja zarodka oziroma plodu izvajali na zdravih brejih živalih, bolezen (kot je sladkorna bolezen) pa lahko spremeni permeabilnost posteljice za Fab fragment, je pri interpretaciji rezultatov te študije potrebna previdnost.
as the frequency in PAH patients cannot be estimated from the available data or assigned a frequency based on the clinical study data from the pivotal placebo-controlled study of ADCIRCA.
»neznana«, saj se pogostnosti pri bolnikih s PAH ne more oceniti na osnovi podatkov, ki so na voljo, ali kot pogostnost na osnovi podatkov kliničnih študij iz ključne, s placebom kontrolirane študije zdravila ADCIRCA.
As the half-life of alfentanil is prolonged in a 4-fold manner when alfentanil is co- administered with voriconazole and in an independent published study, concomitant use of voriconazole with fentanyl resulted in an increase in the mean AUC 0-∞ of fentanyl, frequent monitoring for opiate-associated adverse reactions (including a longer respiratory monitoring period) may be necessary.
Razpolovni čas alfentanila se ob sočasni uporabi z vorikonazolom 4-krat podaljša, v objavljeni neodvisni študiji pa je imela sočasna uporaba vorikonazola skupaj s fentanilom za posledico povečanje povprečne vrednosti AUC 0-∞ fentanila, zato utegne biti potreben pogostejši nadzor z opiati povezanih neželenih učinkov (vključno z daljšim obdobjem respiratornega nadzora).
As the half-life of alfentanil is prolonged in a 4-fold manner when alfentanil is coadministered with voriconazole, and in an independent published study concomitant use of voriconazole with fentanyl resulted in an increase in the mean AUC0-∞ of fentanyl, frequent monitoring for opiate- associated adverse reactions (including a longer respiratory monitoring period) may be necessary.
Razpolovni čas alfentanila se ob sočasni uporabi z vorikonazolom 4-krat podaljša, v objavljeni neodvisni študiji pa je imela sočasna uporaba vorikonazola skupaj s fentanilom za posledico povečanje povprečne vrednosti AUC0-∞ fentanila, zato utegne biti potreben pogostejši nadzor z opiati povezanih neželenih učinkov (vključno z daljšim obdobjem respiratornega nadzora).
As the half-life of alfentanil is prolonged in a 4-fold manner when alfentanil is coadministered with voriconazole, and in an independent published study concomitant use of voriconazole with fentanyl resulted in an increase in the mean AUC0-∞ of fentanyl, frequent monitoring for opiate-associated adverse reactions (including a longer respiratory monitoring period) may be necessary.
Razpolovni čas alfentanila se ob sočasni uporabi z vorikonazolom 4-krat podaljša, v objavljeni neodvisni študiji pa je imela sočasna uporaba vorikonazola skupaj s fentanilom za posledico povečanje povprečne vrednosti AUC0-∞ fentanila, zato utegne biti potreben pogostejši nadzor z opiati povezanih neželenih učinkov (vključno z daljšim obdobjem respiratornega nadzora).
As the in vitro mutagenic activity of lamivudine could not be confirmed by in vivo tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing treatment.
Ker mutagene aktivnosti lamivudina in vitro niso mogli potrditi s testi in vivo, sklepajo, da lamivudin med zdravljenjem bolnikov ne bi smel predstavljati genotoksičnega tveganja.
As the in vitro mutagenic activity of lamivudine could not be confirmed in in vivo tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing treatment.
Ker testi in vivo niso potrdili mutagenega delovanja lamivudina, ugotovljenega in vitro, sklepajo, da lamivudin ne pomeni genotoksične nevarnosti za bolnike, zdravljene z njim.
As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely.
Ker je pojav hemoragične purpure zelo redek, je ni mogoče popolnoma izključiti.
As the incidence of such elevations was 26% among women taking a concomitant ethinylestradiol-containing medicine, such medicinal products are contraindicated with Exviera and ombitasvir/paritaprevir/ritonavir.
Ker je bila incidenca takšnih zvišanj med ženskami, ki so sočasno jemale zdravilo z etinilestradiolom, 26 %, so takšna zdravila med uporabo zdravila Exviera in ombitasvirja/paritaprevirja/ritonavirja kontraindicirana.
As the medicine can be found in semen, the medicine must also not be used in male patients who are unable to comply with the required contraceptive measures.
Ker je zdravilo lahko prisotno v spermi, se ne sme uporabljati niti pri moških bolnikih, ki niso zmožni ravnati v skladu z zahtevanimi kontracepcijskimi ukrepi.
As the minimum dose is 20 mg the syringe is not suitable for paediatric patients with a body weight below 10 kg.
Ker je najmanjši odmerek 20 mg, injekcijska brizga ni primerna za pediatrične bolnike s telesno maso pod 10 kg.
As the MULTAQ Information Card and the Prescriber check list do not include all warnings or contraindications, the SmPC should be referred to prior to prescribing MULTAQ and also prior to prescribing additional medicinal products to a patient already taking MULTAQ.
Informativna kartica o zdravilu MULTAQ in kontrolni seznam za predpisovalca ne vključujeta vseh opozoril ali kontraindikacij, zato je treba pred predpisovanjem zdravila MULTAQ prebrati njegov povzetek glavnih značilnosti; enako velja pred predpisovanjem dodatnih zdravil bolnikom, ki že jemljejo zdravilo MULTAQ.
As the Ovaleap multidose cartridge is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the multidose presentation.
Ker je zdravilo Ovaleap z večodmernim vložkom namenjeno dajanju več injekcij, mora dobiti bolnik jasna navodila za uporabo, v izogib napačni uporabi večodmerne oblike zdravila.
As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose.
Zaradi velikega farmakokinetičnega razpona in akumulacije maropitanta v telesu po enkratnem dnevnem dajanju, so lahko, pri določenih živalih ob ponovitvi odmerka, zadostni tudi nižji odmerki od priporočenih.
As the pharmacological activity of pasireotide mimics that of somatostatin, inhibition of pituitary hormones other than GH and/or IGF-1 cannot be ruled out.
Farmakološko delovanje pasireotida posnema delovanje somatostatina, zato poleg zaviranja rastnega hormona in/ali insulinu podobnega rastnega faktorja-1 (IGF-1) ni mogoče izključiti zaviranja drugih hormonov hipofize.
As the posology is given by body weight and adjusted to the clinical outcome of the above mentioned conditions, the posology in the paediatric population is not considered to be different to that of adults.
Ker je odmerjanje podano glede na telesno maso in prilagojeno kliničnemu izidu zgoraj navedenih stanj, odmerjanje pri pediatričnih bolnikih ni drugačno od odmerjanja pri odraslih.
As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential.
Ker možno tveganje za ljudi ni znano, je pri ženskah v rodnem obdobju potrebna uporaba učinkovite kontracepcije.
As the precise pathogenesis is unknown, only supportive measures can be recommended.
Ker natančna patogeneza ni znana, lahko priporočamo le podporne ukrepe.
As the regimen of nevirapine plus efavirenz did not have additional efficacy and caused more adverse events than each medicinal product separately, this regimen is not recommended.
Ker režim z nevirapinom in efavirenzem ni imel dodatnega učinka in je povzročal več neželenih učinkov kot posamezni zdravili, ga ne priporočajo.
As the renal clearance of gadofosveset may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Ker je lahko pri starejših bolnikih ledvični očistek gadofosveseta slabši, še treba še zlasti pri starejših od 65 let opraviti presejalni test za okvarjeno delovanje ledvic.
As the safety of duloxetine in infants is not known, the use of ARICLAIM while breast-feeding is not recommended.
Ker varnost uporabe duloksetina pri dojenčkih ni znana, odsvetujemo uporabo zdravila ARICLAIM med dojenjem.
As the safety of duloxetine in infants is not known, the use of Duloxetine Lilly while breast-feeding is not recommended.
Ker varnost uporabe duloksetina pri dojenčkih ni znana, odsvetujemo uporabo zdravila Duloxetine Lilly med dojenjem.
As the safety of duloxetine in infants is not known, the use of Xeristar while breast-feeding is not recommended.
Ker varnost uporabe duloksetina pri dojenčkih ni znana, odsvetujemo uporabo zdravila Xeristar med dojenjem.
As the safety of duloxetine in infants is not known, the use of YENTREVE while breast-feeding is not recommended.
Ker varnost uporabe duloksetina pri dojenčkih ni znana, odsvetujemo uporabo zdravila YENTREVE med dojenjem.
As the safety of this for suckling puppies and kittens has not been established, the product should only be used during pregnancy and lactation according to the benefit-risk assessment by the responsible veterinarian.
Ker ni dokazov o varnosti za pasje in mačje mladiče, ki se dojijo, se lahko to zdravilo med brejostjo ali laktacijo uporablja le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
As the safety of this veterinary medicinal product in male dogs used for breeding has not been determined, it should only be used according to the benefit-risk assessment by the responsible veterinarian
Ker varnost zdravila pri pasjih samcih za razplod še ni ugotovljena, se sme to zdravilo uporabljati samo skladno z oceno razmerja med koristmi in tveganji, ki jo opravi odgovorni veterinar.
As the side effects of Holoclar treatment are generally manageable, the CHMP concluded that Holoclar’s benefits outweigh its risks and recommended that it be approved for use in the EU.
Ker so neželeni učinki zdravila Holoclar na splošno obvladljivi, je CHMP zaključil, da so koristi zdravila Holoclar večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and spironolactone.
Ker je terapevtski indeks digoksina zelo ozek,je priporočljivo spremljati stanje živali, ki je zdravljena z digoksinom in spironolaktonom.
As the total number of studied patients is 135, the frequency cannot be less than “uncommon” if an ADR occurs once.
Ker skupno število preiskovanih bolnikov znaša 135, frekvenca ne more biti manj kot "občasna", če se neželeni učinek pojavi enkrat.
As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
Ker je zdravljenje angine pektoris ali kroničnega srčnega popuščanja običajno doživljenjsko, se pred prenehanjem jemanja tega zdravila posvetujte z zdravnikom.
As the updated analysis is provided for descriptive purposes only, a p-value is not provided. b Hazard ratio (Xofigo over placebo) < 1 favours Xofigo.
Ker je posodobljena analiza navedena samo zaradi opisa, vrednost p ni navedena. b razmerje ogroženosti (zdravilo Xofigo v primerjavi s placebom) < 1 je v korist zdravila Xofigo
As the veterinary medicinal product may cause moderate eye irritation, avoid contact with eyes.
Ker zdravilo za uporabo v veterinarski medicini lahko povzroči draženje oči, pazite, da ne pride v stik z očmi.
As the veterinary medicinal product may cause moderate eye irritation, avoid contact with eyes.
Ker zdravilo za uporabo v veterinarski medicini lahko povzroči zmerno draženje oči, se izogibajte stiku z očmi.
As there are many co-morbid conditions that may affect laboratory values in sJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.
Pri bolnikih s sJIA lahko veliko sočasnih bolezni vpliva na laboratorijske vrednosti, zato moramo pri vsakem bolniku posebej presoditi, ali je zdravljenje s tocilizumabom treba prekiniti.
As there are no adequate and well controlled studies of para- aminosalicylic acid in humans, GRANUPAS should be given to a pregnant woman only if clearly needed.
Ker ni bila izvedena nobena zadovoljiva in dobro kontrolirana študija uporabe para-aminosalicilne kisline pri ljudeh, se lahko zdravilo GRANUPAS uporablja pri nosečnicah samo, če je to nujno potrebno.
As there are no adequately powered and well-controlled studies in pregnant women and because animal studies are not always predictive of human response, this medicinal product should be used during pregnancy only if the physician has established a clear need.
Ker pri nosečnicah ni ustreznih in dobro nadzorovanih študij in ker študije na živalih nimajo vedno napovedne vrednosti za odziv pri človeku, tega zdravila pri nosečnicah ne smete uporabljati, razen če zdravnik presodi, da je to nujno potrebno.
As there has been some data showing an increased risk of heart attack with Osseor, the decision to prescribe Osseor should take into account the patient’s individual heart risk.
Ker nekateri podatki kažejo na povečano tveganje za srčni napad v povezavi z zdravilom Osseor, je treba pri predpisovanju zdravila upoštevati posameznikovo tveganje za srčni napad.
As there has been some data showing an increased risk of heart attack with Protelos, the decision to prescribe Protelos should take into account the patient’s individual heart risk.
Ker nekateri podatki kažejo na povečano tveganje za srčni napad v povezavi z zdravilom Protelos, je treba pri predpisovanju zdravila upoštevati posameznikovo tveganje za srčni napad.
As there is a possibility that NSF may occur with Ablavar, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI.
Ker obstaja možnost, da se NSF pojavi pri uporabi Ablavar, se mu je treba izogniti pri bolnikih s hudo ledvično okvaro in pri bolnikih v obdobju pred presaditvijo jeter, razen če je diagnostična informacija bistvenega pomena in je ni mogoče pridobiti z nekontrastnim magnetnoresonančnim slikanjem..
As there is in vitro evidence that aminosalicylate derivatives (eg. olsalazine, mesalazine or sulfazalazine) inhibit the TPMT enzyme, which metabolises 6–mercaptopurine, they should be administered with caution to patients receiving concurrent Xaluprine therapy (see section 4.4).
Ker obstajajo dokazi in vitro, da derivati aminosalicilatov (npr. olsalazin, mesalazin ali sulfalazin) zavirajo encim TPMT, ki presnavlja 6-merkaptopurin, je potrebna posebna previdnosti pri njihovi sočasni uporabi pri bolnikih, ki prejemajo tudi zdravilo Xaluprine (glejte poglavje 4.4).
As there is no experience with Caelyx in patients who have had splenectomy, treatment with Caelyx is not recommended.
Izkušenj z zdravilom Caelyx pri splenektomiranih bolnikih ni, zato zdravljenje teh bolnikov z njim ni priporočljivo.
As these events were added to the CCDS in the post-marketing setting from a review of all reports, they are applicable to all indications, including medically ill patients.
Ker so bili ti dogodki v CCDS vključeni šele po začetku trženja, ko je bil opravljen pregled vseh poročil, se nanašajo na vse indikacije, vključno pri bolnih osebah.
As this event was commonly reported in non-0 blood group patients receiving high doses for non-PID indications, increased vigilance is recommended.
Ker o tem učinku pogosto poročajo pri bolnikih, ki nimajo krvne skupine 0 in prejemajo visoke odmerke za indikacije, ki niso PID, se priporoča povečano nadziranje.
As this may be a class-effect, the concomitant administration of Xadago and pethidine is contraindicated (see section 4.3).
Ker gre morda za razredni učinek, je sočasno dajanje zdravila Xadago in petidina kontraindicirano (glejte poglavje 4.3).
As this medicinal product contains metformin, the treatment should be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia.
To zdravilo vsebuje metformin, zato je zdravljenje z njim treba prekiniti 48 ur pred elektivno operacijo v splošni, spinalni ali epiduralni anesteziji.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
To zdravilo injiciral vaš zdravnik ali medicinska sestra zato ni verjetno, da bi ga lahko prejeli preveč.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
To zdravilo vam bo injiciral vaš zdravnik ali medicinska sestra zato ni verjetno, da bi ga lahko prejeli preveč.
As this medicine is given to you by a doctor, it is unlikely that you will be given too much.
Ker vam bo to zdravilo injiciral zdravnik, ni verjetno, da boste prejeli prevelik odmerek.
As this medicine is prescribed by a doctor, each dose is prepared for you only and each preparation consists of a single dose.
Ker to zdravilo predpiše zdravnik, se vsak odmerek pripravi samo za vas; vsakič se pripravi le en odmerek.
As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too much or too little, however, tell your doctor if you notice one of the following adverse reactions:
Ker boste to zdravilo prejeli v bolnišnici, ni verjetno, da ga boste prejeli preveč ali premalo, vendar pa obvestite svojega zdravnika, če opazite enega od naslednjih neželenih učinkov:
As this patient alert card contains important information about your treatment, please carry this card with you at all times to inform healthcare professionals about your intake of Pradaxa®.
Kontrolna kartica za bolnika vsebuje pomembne podatke o vašem zdravljenju, zato jo imejte vedno pri sebi, tako boste lahko zdravstvenim delavcem pokazali, da jemljete zdravilo Pradaxa®.
As this product is given by a doctor or other healthcare professional, it is very unlikely that you will be given too much Zerbaxa.
Zdravilo Zerbaxa vam bo dal zdravnik ali drug zdravstveni delavec, zato je zelo malo verjetno, da bi ga prejeli preveč.
As this vaccine presentation contains traces of gentamicin and contains tetracycline as biomarker, occasional hypersensitivity reactions may be observed in domestic animals that have accidentally ingested the bait.
Ker ta oblika cepiva vsebuje gentamicin v sledovih in tetraciklin kot biomarker, se lahko pri domačih živalih, ki so ponesreči požrle vabo, občasno pojavijo preobčutljivostne reakcije.
As this vaccine presentation contains traces of gentamicin and contains tetracycline as biomarker, occasional hypersensitivity reactions may be observed in domestic animals that have accidentally ingested the bait.
Ker ta oblika cepiva vsebuje sledove gentamicina in tetraciklin kot biomarker, se pri domačih živalih, ki so vabo pomotoma zaužile, lahko pojavi preobčutljivost.