natgillin/translations-raw huggingface dataset:
However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature (15C - 25C).
Vendar pa so kemijsko in fizikalno stabilnost med uporabo dokazali za 3 ure pri sobni temperaturi (15 C – 25 C).
However, chemical and physical in-use stability of unopened product in the original carton protected from light has been demonstrated for up to 8 hours when stored below 25°C. Do not refreeze a vial once it has been thawed.
Kemijska in fizikalna stabilnost neodprtega zdravila med uporabo je dokazana do 8 ur, če je zdravilo shranjeno v originalni škatli, zaščiteno pred svetlobo in pri temperaturi do 25 °C. Že odmrznjene viale ne smete ponovno zamrzniti.
However, chemical and physical stability after reconstitution was demonstrated for 8 hours below 25°C.
Dokazana je bila kemijska in fizikalna stabilnost cepiva po rekonstituciji do 8 ur pri temperaturi do 25 °C.
However, chemical and physical stability has been demonstrated for 24 hours at 2°C – 8°C.
Vendar pa je bila dokazana kemična in fizikalna stabilnost za čas 24 ur pri temperaturi med 2 °C in 8 °C.
However, chemical and physical stability has been demonstrated for 3 hours at 25°C.
Vendar pa je dokazano, da je raztopina kemično in fizikalno stabilna 3 ure pri 25 °C.
However, chemical and physical stability has been demonstrated for 3 hours at 25ºC.
Vendar pa je dokazano, da je raztopina kemijsko in fizikalno stabilna 3 ure pri 25 °C.
However, children who received 7-valent Prevenar for the primary series would not be primed against the additional serotypes contained in Synflorix (1, 5, 7F).
Toda otroci, ki dobijo 7-valentno cepivo Prevenar za primarno zaporedje, ne bodo imeli priprave proti dodatnim serotipom, ki jih vsebuje cepivo Synflorix (1, 5, 7F).
However, children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Vaxelis but the protection may not be as good as in children with a healthy immune system. suffers from any undiagnosed illness of the brain or epilepsy which is not controlled.
Vendar pa se otroke z dolgotrajnimi težavami z imunskim sistemom, kot je okužba s HIV (AIDS), lahko cepi s cepivom Vaxelis, vendar zaščita morda ne bo tako dobra kot pri otrocih z zdravim imunskim sistemom. ima nediagnosticirano bolezen možganov ali nenadzorovano epilepsijo.
However, ChondroCelect has not been evaluated in combination with collagen membranes in clinical studies, although a commercially available collagen membrane has been used in patients treated with ChondroCelect under compassionate use.
Vendar pa zdravilo ChondroCelect ni bilo ocenjeno v kombinaciji s kolagenskimi membranami v kliničnih študijah, čeprav so bile komercialno razpoložljive kolagenske membrane uporabljene pri bolnikih, zdravljenih z zdravilom ChondroCelect v sočutni uporabi.
However, clinical experience in patients > 80 years of age is limited and caution should be exercised when treating this population.
Vendar pa so klinične izkušnje pri bolnikih nad 80 let omejene, zato je pri zdravljenju te populacije potrebna previdnost.
However, clinical monitoring is recommended
Kljub temu pa je priporočljivo klinično
However, clopidogrel and ASA have been administered together for up to one year (see section 5.1).
Vendar pa so klopidogrel in ASA uporabljali sočasno do enega leta (glejte poglavje 5.1).
However, clopidogrel and ASA have been administered together for up to one year (see section 5.1).
Vseeno so klopidogrel in acetilsalicilno kislino sočasno uporabljali do enega leta (glejte poglavje 5.1).
However, Cmax increases by 15-23%.
Vendar pa se Cmax poveča za 15–23 %.
However, co-administration of axitinib with paclitaxel, a known CYP2C8 substrate, did not result in increased plasma concentrations of paclitaxel in patients with advanced cancer, indicating lack of clinical CYP2C8 inhibition.
Vendar pa pri sočasni uporabi aksitiniba skupaj s paklitakselom, znanim substratom CYP2C8, ni prišlo do povečanih plazemskih koncentracij paklitaksela pri bolnikih z napredovalim rakavim obolenjem, kar kaže na odsotnost kliničnega zaviranja CYP2C8.
However, co-administration of maraviroc with tenofovir (substrate for renal elimination) and cotrimoxazole (contains trimethoprim, a renal cation transport inhibitor), showed no effect on the pharmacokinetics of maraviroc.
Vendar sočasna uporaba maraviroka s tenofovirjem (substrat za ledvično izločanje) in kotrimoksazolom (vsebuje trimetoprim, zaviralec ledvičnega transporta kationov) ni vplivala na farmakokinetiko maraviroka.
However, combined hormonal contraceptives are not recommended due to the increased risk of venous thrombo-embolic disease.
Vendar pa kombinirani hormonski kontraceptivi niso priporočljivi zaradi povečanega tveganja za vensko trombembolično bolezen.
However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or S- warfarin.
Pri zdravih prostovoljcih, v okviru klinične farmakološke študije, hkratno dajanje duloksetina v kombinaciji z varfarinom v stanju dinamičnega ravnovesja ni povzročilo klinično značilne spremembe vrednosti INR glede na osnovno vrednost kot tudi ne spremembe v farmakokinetiki R- ali S- varfarina.
However, considering that dizziness and somnolence are common adverse reactions patients should be cautioned about their ability to drive a car or operate machinery.
Ker sta vrtoglavica in somnolenca pogosta neželena učinka, morate bolnike opozoriti, naj bodo pozorni na svojo sposobnost vožnje in upravljanja s stroji.
However, considering that pharmacologically active metabolites are eliminated via urine, it is advised that patients with severe renal impairment should be carefully monitored for any adverse reactions.
Vendar pa moramo, glede na to, da se farmakološko aktivni presnovki odstranjujejo iz telesa z urinom, bolnike s hudo okvaro ledvic skrbno spremljati glede kakršnihkoli neželenih učinkov.
However, considering the circumstances these drugs were considered less likely to have caused the events.
Vendar so menili, da je ob upoštevanju okoliščin manj verjetno, da so dogodke povzročila ta zdravila.
However, crizotinib has not been studied in patients with hepatic impairment.
Vendar pa krizotiniba pri bolnikih z okvaro jeter niso preučevali.
However, CV events were similar between linagliptin and placebo (1.03% with linagliptin vs 1.35% with placebo).
Vendar pa so bili srčno-žilni dogodki med uporabo linagliptina in placeba podobni (1,03 % pri linagliptinu in 1,35 % pri placebu).
However, CYP3A4 inhibitors often also affect P- gp.
Vendar zaviralci CYP3A4 pogosto vplivajo tudi na P-gp.
However, data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced sperm count and reduced libido) including fertility after 6 months, or repeated implantation, are limited.
Vendar so podatki, ki kažejo popolno reverzibilnost kliničnih učinkov (zmanjšana moda, zmanjšana količina ejakulata, zmanjšano število semenčic in zmanjšan libido), s plodnostjo vred, po šestih mesecih ali večkratnih implantacijah, omejeni.
However, data on elderly patients exposed to the maximum dose (120 mg per day) are limited and, thus, caution is recommended when using this dose with the elderly population.
Vendar pa so podatki o starejših bolnikih, ki sobili izpostavljeni največjemu odmerku (120 mg na dan), omejeni, zato je ob uporabi tega odmerka pri starejši populaciji priporočljiva previdnost.
However, data suggested a 20 % higher levetiracetam clearance in children taking enzyme- inducing antiepileptic medicinal products.
Vendar pa podatki nakazujejo, da je pri otrocih, kateri jemljejo protiepileptična zdravila, ki inducirajo encime, povečan očistek levetiracetama za 20 %.
However, data suggested a 20 % higher levetiracetam clearance in children taking enzyme- inducing antiepileptic medicinal products.
Vendar pa podatki nakazujejo, da je pri otrocih, ki jemljejo protiepileptična zdravila, ki inducirajo encime, povečan očistek levetiracetama za 20 %.
However, dialysis can remove both alcohol and propylene glycol in the case of overdose with ritonavir oral solution.
Kljub temu dializa lahko odstrani tako alkohol kot propilenglikol v primeru prevelikega odmerjanja s peroralno raztopino ritonavirja.
However, dilatation of the renal pelvis was noticed with a No Observed Effect Level (NOEL) at exposures 2.4 times and 0.6 times the clinical exposures at 100 mg and 300 mg doses, respectively, and did not fully reverse within the approximately 1-month recovery period.
Pri izpostavljenostih, ki so 2,4-krat in 0,6-krat presegale klinične izpostavljenosti pri odmerkih 100 mg in 300 mg so opazili razširjenje ledvičnega meha, pri čemer niso opazili učinka te spremembe (NOEL- No Observed Effect Level).
However, dizziness has been reported during treatment with efavirenz, emtricitabine and tenofovir disoproxil fumarate.
Vendar so med zdravljenjem z efavirenzom, emtricitabinom in dizoproksiltenofovirijevim fumaratom poročali o omotici.
However, dizziness, fatigue and visual impairment have been reported during treatment with Invirase.
Med zdravljenjem z zdravilom Invirase so poročali o omotici, utrujenosti in okvari vida.
However, do not change the number of inhalations your doctor has prescribed without talking to your doctor first.
Vendar pa števila inhalacij, ki vam ga je predpisal zdravnik, ne spreminjajte brez predhodnega posveta z zdravnikom.
However, do not drive or use any machines if you are feeling unwell.
Vendar ne vozite ali upravljajte s stroji, če se ne počutite dobro.
However, dog owners are advised to consult a veterinary surgeon if they intend to use the product on dogs given other products/medication
Posvetujte se z veterinarjem, če nameravate zdravilo uporabiti na psih, ki jemljejo druge izdelke/zdravila.
However, dogs should not be allowed to swim or be shampooed within 48 hours after treatment.
Vendar pa živalim ne smete dovoliti plavanja ali jih šamponirati 48 ur po zdravljenju.
However, dose adjustment may be required because of age-related decreases in creatinine clearance (see Renal impairment above and section 4.2).
Prilagajanje bo lahko potrebno zaradi zmanjšanja očistka kreatinina, povezanega s starostjo (glejte razdelek Ledvična okvara zgoraj in poglavje 4.2).
However, dose titration may be preferable in paediatric patients.
Pri pediatričnih bolnikih je bolje odmerek titrirati.
However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted post natally and was accompanied by a decrease in IgG level in the newborn animals affected.
Opazili pa so od odmerka odvisen farmakološki upad števila celic B v limfatičnih organih ploda, ki je trajal tudi postnatalno, spremljalo ga je tudi znižanje IgG pri prizadetih mladičih.
However, doxorubicin may potentiate the toxicity of other antineoplastic agents.
Vendar lahko doksorubicin okrepi toksični učinek drugih zdravil z delovanjem na novotvorbe.
However, due to increased exposure in these populations dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose-dependent adverse reactions.
Vendar se je treba zaradi povečane izpostavljenosti zdravilu pri teh populacijah natančno ravnati po priporočilih, naj se odmerjanje titrira glede na individualno prenašanje, saj je pri bolnikih s klinično pomembno okvaro ledvic ali jeter lahko število neželenih učinkov bolj odvisno od odmerka.
However, due to increased exposure in these populations, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose-dependent adverse reactions.
Vendar se je treba zaradi povečane izpostavljenosti zdravilu pri teh populacijah natančno ravnati po priporočilih, naj se odmerjanje titrira glede na individualno prenašanje, saj je pri bolnikih s klinično pomembno okvaro ledvic ali jeter lahko število neželenih učinkov bolj odvisno od odmerka.
However, due to possible additive pharmacodynamic effects (myelotoxicity), caution is advised as co- administration may increase the risk and severity of haematologic toxicity of Teysuno.
Zaradi morebitnih aditivnih farmakodinamskih učinkov (mielotoksičnost) se priporoča previdnost, saj se zaradi sočasne uporabe lahko povečata nevarnost in stopnja resnosti hematološke toksičnosti zdravila Teysuno.
However, due to ritonavir’s metabolic inhibitory properties its use as a pharmacokinetic enhancer of other protease inhibitors is the prevalent use of ritonavir in clinical practice (see section 4.2).
Toda ker ritonavir zavira presnovo, se v klinični praksi pretežno uporablja kot farmakokinetični stopnjevalec drugih zaviralcev proteaz (glejte poglavje 4.2).
However, due to the importance of microbiological infection risk for injectable products, the reconstituted solution should be used immediately unless reconstitution has taken place in controlled and validated aseptic conditions.
Vendar pa je treba zaradi tveganja mikrobiološke okužbe pri zdravilih za injiciranje pripravljeno raztopino uporabiti takoj, razen če je priprava raztopine potekala v nadzorovanih in preverjenih aseptičnih pogojih.
However, due to the low dose of protein administered and the short half-life of 99mTc, dosage adjustment is probably not necessary in such patients.
Vseeno zaradi nizkega odmerka vnešenih beljakovin in kratkega razpolovnega časa 99mTc prilagoditev odmerka pri teh bolnikih verjetno ni potrebna.
However, due to the low pathogenicity of these strains, it is not necessary to keep vaccinated dogs separated from non- vaccinated dogs.
Zaradi nizke patogenosti teh sevov ločevanje cepljenih psov od necepljenih ni potrebno.
However, due to the results of animal studies in breast- feeding females and neonates (see section 5.3), breast-feeding is contra-indicated in women taking PROCYSBI (see section 4.3).
Vendar pa je glede na rezultate študij na živalih pri doječih samicah in novorojenih mladičih (glejte poglavje 5.3) dojenje pri ženskah, ki jemljejo zdravilo PROCYSBI, kontraindicirano (glejte poglavje 4.3).
However, due to the results of animal studies in breast-feeding mothers and neonates (see section 5.3), breast-feeding is contra-indicated in women taking CYSTAGON.
Vendar pa je - glede na rezultate študij na živalih pri doječih materah in novorojenih mladičih (glejte poglavje 5.3) – dojenje pri ženskah, ki jemljejo CYSTAGON, kontraindicirano.
However, due to the results of animal studies in breast-feeding mothers and neonates (see section 5.3), breast-feeding is contraindicated in women taking CYSTAGON.
Vendar pa je - glede na rezultate študij na živalih pri doječih materah in novorojenih mladičih (glejte poglavje 5.3) – dojenje pri ženskah, ki jemljejo CYSTAGON, kontraindicirano.
However, due to the unknown absolute bioavailability, the importance of hepatic and renal excretion for the clearance of parent vemurafenib is uncertain.
Zaradi neznane absolutne biološke uporabnosti, pomembnost izločanja skozi jetra in ledvice za očistek matične spojine vemurafeniba ni jasna.
However, due to their transient nature, the incidence of antibodies detected at each assessment point was typically less than 7% in rheumatoid arthritis subjects and psoriasis subjects.
Vendar je bila incidenca protiteles, odkritih ob vsakem periodičnem določanju, zaradi njihove začasne narave pri bolnikih z revmatoidnim artritisom in bolnikih s psoriazo manjša od 7 %.
However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion".
V in vitro študijah je bilo zdravilo v PVC vrečkah za kontinuirano infuzijo, pri temperaturi 30 °C, kemijsko in fizikalno stabilno 24 ur.
However, during the period of administration of filgrastim for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to
Med dajanjem filgrastima za mobilizacijo krvotvornih matičnih celic v periferno kri pa je treba prenehati z dajanjem filgrastima oziroma zmanjšati njegov odmerek, če se število levkocitov poveča na
However, during the period of administration of filgrastim for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/L.
Če bolniku prejema filgrastim za zbiranje matičnih celic v periferni krvi, je potrebno zdravljenje s filgrastimom prenehati ali pa, v primeru da število levkocitov preseže vrednost 70 x 109/l, zmanjšati odmerek.
However, during the period of administration of filgrastim for PBPC mobilisation, it should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/l.
Vendar pa je pri dajanju filgrastima za izplavljanje matičnih celic v periferno kri, treba z njegovim dajanjem prenehati ali njegov odmerek zmanjšati, če se število levkocitov poveča na > 70 x 109/l.
However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Vendar pa se zdi, da obstaja pri starejših bolnikih (>70 let) povečano tveganje za pojav nevtropenije in trombocitopenije (glejte poglavje 4.4).
However, elderly patients (>70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Vendar pa se zdi, da obstaja pri starejših bolnikih (> 70 let) povečano tveganje za pojav nevtropenije in trombocitopenije (glejte poglavje 4.4).
However, ellaOne does not interrupt an existing pregnancy (see section 4.6).
Vendar zdravilo ellaOne ne prekine obstoječe nosečnosti (glejte poglavje 4.6).
However, even high doses of protamine do not fully neutralise the anti-Xa activity of enoxaparin sodium (maximum 60%).
Vendar pa aktivnosti anti-Xa natrijevega enoksaparinata ni mogoče nikoli povsem nevtralizirati, niti z velikimi odmerki protamina (največ 60 %).
However, fatigue has been reported in patients taking daratumumab and this should be taken into account when driving or using machines.
Pri bolnikih, ki so prejemali daratumumab, so poročali o utrujenosti, kar je treba upoštevati pri vožnji in upravljanju s stroji.
However, fatigue, dizziness and somnolence have been reported in some patients taking EDURANT and should be considered when assessing a patient’s ability to drive or operate machinery.
Pri nekaterih bolnikih, ki so jemali zdravilo EDURANT, so poročali o utrujenosti, omotici in somnolenci, kar je treba upoštevati pri ocenjevanju bolnikovih sposobnosti vožnje ali upravljanja s stroji.
However, fetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 µg/kg.
Vendar se je pojavila resorpcija ploda in zmanjšanje zaroda pri brejih kuncih, ki so prejemali dnevne odmerke od 3 do 100 µg/kg.
However, fewer patients receiving Humira with methotrexate developed antibodies against Humira (which can prevent its action), so the results favoured the use of Humira with methotrexate over Humira used alone.
Vendar pa je bilo v skupini bolnikov, ki so jemali zdravilo Humira v kombinaciji z metotreksatom, manj tistih, pri katerih so se razvila protitelesa (kar lahko prepreči delovanje zdravila), zaradi česar so rezultati govorili v prid jemanju zdravila Humira v kombinaciji z metotreksatom in ne jemanju zdravila Humira kot samostojnega zdravila.
However, following a re-examination of this opinion, the Committee concluded that the medicine’s modest effectiveness could also be of benefit to some of these patients.
Vendar pa je po ponovni presoji svojega mnenja zaključil, da lahko skromna učinkovitost zdravila koristi nekaterim bolnikom.
However, for patients with high risk of bleeding, a dose reduction of Pradaxa to 220 mg taken as one 110 mg capsule twice daily should be considered (see sections 4.4 and 5.2).
Toda pri bolnikih z velikim tveganjem za krvavitve je treba presoditi o zmanjšanju odmerka Pradaxe na 220 mg, po eno kapsulo po 110 mg dvakrat na dan (glejte poglavji 4.4 in 5.2).
However, for patients with high risk of bleeding, a dose reduction of Pradaxa to 220 mg taken as one 110 mg capsule twice daily should be considered (see sections 4.4 and 5.2).
Toda pri bolnikih z velikim tveganjem za krvavitve je treba presoditi o zmanjšanju odmerka zdravila Pradaxa na 220 mg, po eno kapsulo po 110 mg dvakrat na dan (glejte poglavji 4.4 in 5.2).
However, for the treatment of HIV infection only a 300 mg daily dose of lamivudine (in combination with other antiretroviral agents) has been shown to be efficacious.
Vendar pa se je za zdravljenje okužbe z virusom HIV kot učinkovit izkazal le lamivudin v odmerku 300 mg na dan (v kombinaciji z drugimi protiretrovirusnimi zdravili).
However, formal interaction studies have not been performed.
Vendar formalnih študij o interakcijah še niso opravili.
However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.
Vendar pa često šamponiranje ali stik živali z vodo neposredno po nanosu zdravila, zelo zmanjšata njegovo učinkovitost.
However, full induction by bosentan might not have been reached and a further decrease of protease inhibitors cannot be excluded.
Vendar pa popolna indukcija z bosentanom morda ni bila dosežena, zato nadaljnega zmanjševanja zaviralcev proteaze ni mogoče izključiti.
However, given the seriousness of these events and the number of reported cases, the risk of formation of sevelamer crystals associated with serious gastrointestinal disorders was considered relevance to the prescriber.
Toda glede na resnost teh učinkov in število poročanih primerov je bilo ocenjeno, da je tveganje za nastanek kristalov sevelamerja, povezanih z resnimi boleznimi prebavil, pomembno za zdravnike, ki predpisujejo zdravilo.
However, given the side effects, the CHMP considered it important to find ways to identify any subgroups of patients who are more likely to respond to Stivarga.
Obenem je zaradi neželenih učinkov menil, da je nujno treba poiskati načine za opredelitev morebitnih podskupin bolnikov, pri katerih obstaja večja verjetnost, da se bodo odzvali na zdravilo Stivarga.
However, given the small number of subjects 65 years or older, an effect of age cannot be ruled out conclusively.
Toda glede na majhno število preiskovancev, starih 65 let ali več, vpliva starosti ni mogoče dokončno izključiti.
However, Grade 3 hypersensitivity reactions associated with detectable ATAs occurred in 2 of 366 Perjeta-treated patients (0.5%) in phase I and II studies.
Preobčutljivostne reakcije stopnje 3, povezane z merljivimi protitelesi, so se pojavile pri 2 od 366 (0,5 %) bolnikov, ki so se zdravili z zdravilom Perjeta v študijah faze I in II.
However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
Vendar pa, z zdravljenjem povezani neželeni učinki stopnje 3 ali 4 so bili pogostejši pri bolnikih nad 60 let starosti kot pri mlajših bolnikih.
However, HBVAXPRO is expected to have no or negligible influence on the ability to drive and use machines.
Vendar pa se pri cepivu HBVAXPRO pričakuje, da nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
However, hypoglycaemia may develop over sequential stages.
A hipoglikemija se lahko razvije v dveh zaporednih stopnjah.
However, iatrogenic addiction following therapeutic use of opioids is rare in the treatment of cancer related pain.
Iatrogena odvisnost, ki bi jo povzročila uporaba opioidov v okviru zdravljenja bolečine zaradi raka, pa je redka.
However, iatrogenic addiction following therapeutic use of opioids is rare.
Vendar pa je iatrogena zasvojenost po terapevtski uporabi opioidov redka.