natgillin/translations-raw huggingface dataset:
There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers (ARBs) or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Obstajajo dokazi, da sočasna uporaba zaviralcev ACE, antagonistov angiotenzinskih receptorjev II (ARB) ali aliskirena poveča tveganje za hipotenzijo, hiperkaliemijo in zmanjšano delovanje ledvic (vključno z akutno odpovedjo ledvic).
There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Obstajajo dokazi, da sočasna uporaba zaviralcev ACE, blokatorjev receptorjev angiotenzina II ali aliskirena poveča tveganje za hipotenzijo, hiperkaliemijo in zmanjšano delovanje ledvic (vključno z akutno odpovedjo ledvic).
There is experience with twice daily infusions of Vimpat up to 5 days.
Glede na izkušnje priporočajo dvakrat dnevno infundiranje zdravila Vimpat za zdravljenje do 5 dni.
There is increased potential for PDE5 inhibitor- associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).
Povečana je možnost neželenih učinkov zaviralca PDE5 (pojav motenj vida, hipotenzije, podaljšane erekcije in sinkope).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic impairment due to the metformin active substance (see section 4.4).
Nevarnost laktacidoze je povečana pri akutni zastrupitvi z alkoholom (zlasti ob postu, pomanjkljivem prehranjevanju ali jetrni odpovedi) zaradi zdravilne učinkovine metformina (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic impairment) due to the metformin active substance of Komboglyze (see section 4.4).
Zaradi vsebnosti učinkovine metformina v zdravilu Komboglyze obstaja večje tveganje za laktacidozo v primeru akutne zastrupitve z alkoholom (zlasti v primeru stradanja, podhranjenosti ali okvare jeter) (glejte poglavji 4.3 in 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic impairment) due to the metformin active substance of this medicinal product (see section 4.4).
Zaradi vsebnosti metformina v tem zdravilu obstaja večje tveganje za laktacidozo v primeru akutne intoksikacije z alkoholom (zlasti v primeru postenja, podhranjenosti ali okvare jeter) (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic impairment) due to the metformin component (see section 4.4).
Pri akutni zastrupitvi z alkoholom zaradi metformina obstaja večje tveganje za razvoj laktacidoze (še posebej v primeru omejenega uživanja hrane, podhranjenosti ali okvare jeter) (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Competact (see section 4.4).
Ker je v zdravilu Competact zdravilna učinkovina metformin, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience) povečana nevarnost laktacidoze (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Efficib (see section 4.4).
Ker je v zdravilu Efficib zdravilna učinkovina metformin, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience) povečana nevarnost laktacidoze (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Eucreas (see section 4.4).
Zaradi metformina, zdravilne učinkovine v zdravilu Eucreas, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience), povečano tveganje za laktacidozo (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Glubrava (see section 4.4).
Ker je v zdravilu Glubrava zdravilna učinkovina metformin, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience) povečana nevarnost laktacidoze (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Icandra (see section 4.4).
Zaradi metformina, zdravilne učinkovine v zdravilu Icandra, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience), povečano tveganje za laktacidozo (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Janumet (see section 4.4).
Ker je v zdravilu Janumet zdravilna učinkovina metformin, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience) povečana nevarnost laktacidoze (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Ristfor (see section 4.4).
Ker je v zdravilu Ristfor zdravilna učinkovina metformin, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience) povečana nevarnost laktacidoze (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Velmetia (see section 4.4).
Ker je v zdravilu Velmetia zdravilna učinkovina metformin, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience) povečana nevarnost laktacidoze (glejte poglavje 4.4).
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Zomarist (see section 4.4).
Zaradi metformina, zdravilne učinkovine v zdravilu Zomarist, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience), povečano tveganje za laktacidozo (glejte poglavje 4.4).
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression inneurodegenerative dementia.
Vse več je dokazov, da motnje v delovanju glutamatnega živčnega prenosa, še posebej preko receptorjev NMDA, prispevajo tako k izraženosti simptomov kot napredovanju bolezni pri nevrodegenerativni demenci.
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular atNMDA- receptors, contributes to both expression of symptoms and disease progression inneurodegenerative dementia.
Vse več je dokazov, da motnje v delovanju glutamatnega živčnega prenosa, še posebej preko receptorjev NMDA, prispevajo tako k izraženosti simptomov kot napredovanju bolezni pri nevrodegenerativni demenci.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Ni zadostnih kliničnih podatkov o uporabi zdravila Apidra pri otrocih in mladostnikih.
There is insufficient data among different races with posaconazole concentrate for solution for infusion.
O uporabi posakonazola v koncentratu za raztopino za infundiranje pri različnih rasah ni dovolj podatkov.
There is insufficient data available to draw any definite conclusions regarding intrinsic pharmaco- kinetic factors such as age, gender, race and weight.
Zaradi pomanjkljivih podatkov ni mogoče postaviti dokončnih zaključkov o intrinzičnih farmako- kinetičnih dejavnikih, kot so starost, spol, rasa in telesna masa.
There is insufficient data available to make formal recommendations on dose reduction (in the absence of an adverse event) in patients with chronic phase (CP) CML who have achieved Major Cytogenetic Response.
Pri bolnikih s KML v kronični fazi (KF), ki so dosegli bistven citogenetski odgovor, ni dovolj podatkov za formalna priporočila o zmanjšanju odmerka (v odsotnosti neželenega učinka).
There is insufficient data on the diagnostic liability of the Helicobacter Test INFAI for children of the age 3-11 to recommend its use in patients with gastrectomy and in patients younger than 3 years of age.
O diagnostični zanesljivosti zdravila Test Helicobacter INFAI za otroke stare 3 – 11 let ni dovolj podatkov, da bi lahko priporočili njegovo uporabo pri bolnikih z gastrektomijo in pri otrocih mlajših od treh let.
There is insufficient data on the diagnostic liability of the Helicobacter Test INFAI to recommend its use in patients with gastrectomy.
O diagnostični zanesljivosti zdravila Test Helicobacter INFAI ni dovolj podatkov, da bi lahko priporočili njegovo uporabo pri bolnikih z gastrektomijo in bolnikih.
There is insufficient data on the diagnostic liability of the Helicobacter Test INFAI to recommend its use in patients with gastrectomy.
O diagnostični zanesljivosti zdravila Test Helicobacter INFAI ni dovolj podatkov, da bi lahko priporočili njegovo uporabo pri bolnikih z gastrektomijo.
There is insufficient data on the reliability of the Helicobacter Test INFAI for children of the age 3-11 for recommending its use in patients with removal of parts of the stomach.
Ni zadostnih podatkov o zanesljivosti zdravila Test Helicobacter INFAI za otroke od 3 do 11 let, da bi lahko priporočali njegovo uporabo pri bolnikih, ki so jim odstranili dele želodca.
There is insufficient data on the reliability of the Helicobacter Test INFAI for recommending its use in patients with removal of parts of the stomach.
Ni zadostnih podatkov o zanesljivosti zdravila Test Helicobacter INFAI, da bi lahko priporočali njegovo uporabo pri bolnikih, ki so jim odstranili dele želodca.
There is insufficient evidence that Synflorix provides protection against pneumococcal serotypes not contained in the vaccine except the cross-reactive serotype 19A (see section 5.1) or against non- typeable Haemophilus influenzae.
Na voljo ni zadostnih dokazov, da cepivo Synflorix nudi zaščito pred pnevmokoknimi serotipi, ki jih cepivo ne vsebuje, razen pred navzkrižno reaktivnim serotipom 19A (glejte poglavje 5.1) ali proti netipiziranemu Haemophilus influenzae.
There is insufficient evidence to assess the safety and efficacy of ORENCIA in combination with anakinra or rituximab (see section 4.4).
Varnosti in učinkovitosti zdravila ORENCIA v kombinaciji z anakinro ali rituksimabom zaradi nezadostnih podatkov ni bilo možno ovrednotiti (glejte poglavje 4.4).
There is insufficient evidence to determine whether re-initiation of emtricitabine alters the course of post-treatment exacerbations of hepatitis.
Ni dovolj dokazov, s katerimi bi določili, ali ponoven začetek zdravljenja z emtricitabinom spremeni potek poslabšanja hepatitisa po zdravljenju.
There is insufficient experience of the use of topotecan in patients with severely impaired hepatic function (serum bilirubin  10 mg/dl).
Z uporabo topotekana ni dovolj izkušenj pri bolnikih s hudo okvarjenim delovanjem jeter (bilirubin v serumu ≥ 10 mg/dl).
There is insufficient experience of the use of topotecan in patients with severely impaired hepatic function (serum bilirubin  10 mg/dl).
Z uporabo topotekana ni dovolj izkušenj pri bolnikih s hudo okvarjenim delovanjem jeter (bilirubin v serumu  10 mg/dl).
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Z uporabo topotekana za zdravljenje bolnikov s hudimi motnjami delovanja ledvic (očistek kreatinina < 20 ml/min) ali s hudo okvaro jetrne funkcije, ki je posledica ciroze (serumski bilirubin ≥ 10 mg/dl), ni dovolj izkušenj.
There is insufficient experience to recommend the use of Rapamune in children and adolescents (see section 4.2).
Zaradi nezadostnih izkušenj pri tej starostni skupini uporabe zdravila Rapamune ni mogoče priporočiti pri otrocih in mladostnikih (glejte poglavje 4.2).
There is insufficient information on the effects of desloratadine and pseudoephedrine sulphate in newborns/infants..
Podatki o učinku desloratadina in psevdoefedrinijevega sulfata na dojene novorojence/otroke so nezadostni.
There is insufficient information on the effects of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate in newborns/infants.
Podatki o učinku elvitegravirja, kobicistata, emtricitabina in dizoproksiltenofovirijevega fumarata na dojene novorojence/otroke so nezadostni.
There is insufficient information on the excretion of asfotase alfa in human milk.
Ni dovolj podatkov o izločanju asfotaze alfa v materino mleko.
There is insufficient information on the excretion of certolizumab pegol in human or animal breast milk.
O izločanju certolizumab pegola v mleko pri ljudeh ali živalih ni na voljo dovolj podatkov.
There is insufficient information on the excretion of fluticasone furoate or vilanterol trifenatate and/or metabolites in human milk.
Podatkov o izločanju flutikazonfuroata oziroma vilanterolijevega trifenatata in/ali njunih presnovkov v materinem mleku pri človeku ni dovolj.
There is insufficient information on the excretion of gadoversetamide in animal milk.
Ni dovolj podatkov o izločanju gadoversetamida v mleko pri živalih.
There is insufficient information regarding the concomitant use of Simponi with other biological therapeutics used to treat the same conditions as Simponi.
Na voljo ni zadostnih podatkov o sočasni uporabi zdravila Simponi z drugimi biološkimi zdravili, ki se uporabljajo za enako zdravljenje kot zdravilo Simponi.
There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly- diagnosed high-grade glioma.
Na voljo ni dovolj podatkov, da bi določili varnost in učinkovitost bevacizumaba pri otrocih z novo diagnosticiranim gliomom visoke stopnje malignosti.
There is insufficient information to make dose adjustment recommendations for patients on other forms of dialysis (see section 5.2).
Za priporočila za odmerjanje pri bolnikih na drugih oblikah dialize ni zadostnih podatkov (glejte poglavje 5.2).
There is insufficient information to recommend dosage adjustments in adolescents aged from 12 to < 18 years with bodyweight < 33 kg and in children aged from 2 to 12 years with ESRD.
Pri mladostnikih, starih od 12 do < 18 let s telesno maso < 33 kg, in otrocih, starih od 2 do 12 let, s končno odpovedjo ledvic (ESRD – end-stage renal disease) ni na voljo dovolj podatkov za priporočilo o prilagoditvi odmerka.
There is limited amount of data from the use of pertuzumab in pregnant women.
Podatki o uporabi pertuzumaba pri nosečnicah so omejeni.
There is limited clinical data (n = 2) on the use of SIRTURO in elderly patients.
Kliničnih podatkov o uporabi zdravila SIRTURO pri starejših bolnikih je zelo malo (n = 2).
There is limited clinical data in patients aged 75 or over.
Kliničnih podatkov o bolnicah, starih 75 let ali več, je malo.
There is limited clinical data on the safety of CIALIS in patients with severe hepatic insufficiency (Child- Pugh Class C).
O varnosti zdravila CIALIS pri bolnikih s hudo insuficienco jeter (razred C po Child-Pughu) obstajajo le omejeni klinični podatki.
There is limited clinical data on the safety of CIALIS in patients with severe hepatic insufficiency (Child- Pugh Class C).
O varnosti zdravila CIALIS pri bolnikih s hudo insufienco jeter (razred C po Child-Pughu) obstajajo le omejeni klinični podatki.
There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C).
Pri bolnikih s hudo jetrno insufienco (razred C po Child-Pughu) je na voljo le malo kliničnih podatkov o varnosti zdravila CIALIS pri enkratnem odmerjanju.
There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Pri bolnikih s hudo jetrno insuficienco (razred C po Child-Pughu) je na voljo le malo kliničnih podatkov o varnosti zdravila Tadalafil Mylan pri enkratnem odmerjanju.
There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Pri bolnikih s hudo jetrno insufienco (razred C po Child-Pughu) je na voljo le malo kliničnih podatkov o varnosti tadalafila pri enkratnem odmerjanju.
There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) so na voljo le omejeni klinični podatki o varnosti tadalafila Mylan; v kolikor ga predpišemo, naj zdravnik, ki zdravilo predpiše, skrbno ovrednoti razmerje med koristmi in tveganjem pri posamezniku.
There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) so na voljo le omejeni klinični podatki o varnosti zdravila Tadalafil Mylan; v kolikor ga predpišemo, naj zdravnik, ki zdravilo predpiše, skrbno ovrednoti razmerje med koristmi in tveganjem pri posamezniku.
There is limited clinical data on the safety of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
O varnosti zdravila Tadalafil Mylan pri bolnikih s hudo insufienco jeter (razred C po Child-Pughu) obstajajo le omejeni klinični podatki.
There is limited clinical experience with NovoMix 30 in children aged 6–9 years (see section 5.1).
Za uporabo zdravila NovoMix 30 pri otrocih od 6. do 9. leta starosti je kliničnih izkušenj malo (glejte poglavje 5.1).
There is limited clinical experience with selexipag in patients over the age of 75 years, therefore Uptravi should be used with caution in this population (see section 4.2).
Klinične izkušnje s seleksipagom pri bolnikih, starih več kot 75 let, so omejene, zato je treba zdravilo Uptravi pri tej populaciji uporabljati previdno (glejte poglavje 4.2).
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Izkušenj iz kliničnih preskušanj učinkovitosti desloratadina pri mladostnikih, starih od 12 do 17 let, je malo (glejte poglavji 4.8 in 5.1).
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents12 through 17 years of age (see sections 4.8 and 5.1).
Izkušenj iz kliničnih preskušanj glede učinkovitosti uporabe desloratadina pri mladostnikih, starih od 12 do 17 let, je malo (glejte poglavji 4.8 in 5.1).
There is limited data available for patients older than 65 years.
Podatkov pri bolnikih, starejših od 65 let, je malo.
There is limited data in patients between 75-84 years old (N=60).
Podatkov o bolnikih, starih med 75 in 84 let, je malo (N = 60).
There is limited data in patients with cardiac impairment.
Podatki pri bolnikih s srčno okvaro je malo.
There is limited data in patients with cardiac impairment.
Podatkov pri bolnikih s srčno okvaro je malo.
There is limited experience in children and adolescents with Ph+ ALL and very limited experience in children and adolescents with MDS/MPD, DFSP, and HES/CEL.
Izkušenj pri otrocih in mladostnikih z Ph+ ALL je malo in zelo malo pri otrocih in mladostnikih z MDS/MPD, DFSP in s HES/CEL.
There is limited experience in children between 6 months and 17 years of age.
Pri otrocih, starih med 6 meseci in 17 leti, so izkušnje omejene.
There is limited experience in children with Ph+ ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Izkušenj pri otrocih s Ph+ ALL je malo, pri otrocih z MDS/MPD, DFSP ali s HES/CEL pa zelo malo.
There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Izkušnje so pri otrocih s Ph pozitivno ALL omejene, pri otrocih z MDS/MPD, DFSP in HES/CEL pa zelo omejene.
There is limited experience in non-Caucasian patients and patients at elevated immunological risk (e.g. retransplantation, evidence of panel reactive antibodies, PRA).
Pri bolnikih, ki niso bele rase in bolnikih z večjim imunološkim tveganjem (npr. retransplantacija, dokaz panelnih reaktivnih protiteles (PRA)) je izkušenj malo.
There is limited experience in paediatric patients, see section 4.8.
Izkušenj pri pediatričnih bolnikih je malo, glejte poglavje 4.8.
There is limited experience in paediatric patients.
Izkušenj pri pediatričnih bolnikih je malo.
There is limited experience in patients with a history or presence of clinically relevant central nervous system (CNS) pathology (e.g. epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis) as they were excluded from clinical trials.
Malo izkušenj je pri bolnikih z anamnestično ali trenutno klinično pomembno patologijo osrednjega živčevja (npr. z epilepsijo, konvulzijami, parezo, afazijo, možgansko kapjo, hudimi poškodbami možganov, demenco, Parkinsonovo boleznijo, cerebelarno boleznijo, psihoorganskim sindromom, psihozo), ker ti bolniki niso bili vključeni v klinična preskušanja.
There is limited experience in patients with congestive heart failure New York Heart Association (NYHA) class I-II and Xultophy should therefore be used with caution in these patients.
Izkušanje z zdravljenjem bolnikov s kongestivnim srčnim popuščanjem razreda I–II po razvrstitvi ameriškega združenja New York Heart Association (NYHA) so omejene, zato je pri njih treba zdravilo Xultophy uporabljati previdno.
There is limited experience in patients with congestive heart failure New York Heart Association (NYHA) class I­II and liraglutide should therefore be used with caution.
Izkušenj pri zdravljenju bolnikov s srčnim popuščanjem razreda I–II po razvrstitvi NYHA (New York Heart Association) je malo, zato je treba liraglutid uporabljati previdno.
There is limited experience in patients with congestive heart failure.
Izkušnje pri bolnikih s kongestivnim srčnim popuščanjem so omejene.
There is limited experience in patients with congestive heart failure.
Povečanje hitrosti srčnega utripa
There is limited experience in patients ≥ 65 years.
Izkušnje pri bolnikih, starih ≥ 65 let, so omejene.
There is limited experience in patients ≥65 years.
Izkušnje pri bolnikih, starih ≥ 65 let, so omejene.
There is limited experience in the use of imiquimod cream in the treatment of men with foreskin- associated warts.
Izkušnje z zdravljenjem bradavic na kožici penisa z imikvimod kremo so omejene.
There is limited experience in treating elderly CAPS patients.
Izkušnje pri zdravljenju starejših bolnikov s CAPS so omejene.
There is limited experience of overdosage with Combivir.
Izkušnje s prevelikim odmerjanjem zdravila Combivir so omejene.
There is limited experience of the booster dose in the elderly population.
Izkušnje za obnovitveni odmerek pri starejši populaciji so omejene.