natgillin/translations-raw huggingface dataset:
In addition, palivizumab inhibits virus replication in cell culture and, therefore, may also interfere with viral culture assays.
Poleg tega palivizumab zavira replikacijo virusov v celičnih kulturah in zato lahko vpliva na nekatere teste na virusnih kulturah.
In addition, patients should also refrain from taking St. John’s Wort.
Poleg tega naj bolniki ne uporabljajo šentjanževke.
In addition, patients taking other medications associated with nephrolithiasis may be at increased risk.
Povečano nevarnost za nastanek ledvičnih kamnov imajo tudi bolniki, ki jemljejo druga zdravila. povezana z nefrolitiazo.
In addition, patients treated with MACI had fewer side effects compared with microfracture- treated patients.
Poleg tega so imeli bolniki, zdravljeni z zdravilom MACI, manj neželenih učinkov v primerjavi z bolniki, zdravljenimi s postopkom mikrofrakture.
In addition, patients were instructed to perform penile modeling at home for six weeks after each treatment cycle.
Poleg tega so bolnikom naročili, naj šest tednov po vsakem ciklu zdravljenja doma izvajajo modeliranje penisa.
In addition, patients’ self-reported quality of sleep, number of awakenings and morning alertness significantly improved with Circadin compared to placebo.
Poleg tega poročila bolnikov kažejo na pomembno izboljšavo kakovosti spanja in jutranje budnosti v skupini z zdravilom Circadin v primerjavi s tisto s placebom.
In addition, Perjeta mediates antibody-dependent cell-mediated cytotoxicity (ADCC).
Poleg tega zdravilo Perjeta posreduje od protiteles odvisno, celično posredovano citotoksičnost (ADCC – antibody-dependent cell-mediated cytotoxicity).
In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck’s recombinant hepatitis B vaccine in healthy adults.
Poleg tega so pri zdravih odraslih dokazali obstoj s cepivom sproženega imunskega spomina za površinski antigen virusa hepatitisa B (HBsAg) z anamnestičnim odzivom protiteles na obnovitveni odmerek prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B.
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.
Kemična in fizikalna stabilnost med uporabo sta dokazani za 48 ur pri temperaturi 2 do 8°C, če je bila raztopina pripravljena v vrečki, ki ne vsebuje PVC.
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to
Kemična in fizikalna stabilnost med uporabo sta dokazani za 48 ur pri temperaturi 2 do 8°C, če je bila raztopina pripravljena v vrečki, ki ne vsebuje PVC.
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Kemična in fizikalna stabilnost med uporabo sta dokazani za 48 ur pri temperaturi 2 do 8°C, če je bila raztopina pripravljena v vrečki, ki ne vsebuje PVC.
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Kemična in fizikalna stabilnost po navodilih pripravljene raztopine za infundiranje, med uporabo, sta dokazani za 48 ur pri temperaturi 2 do 8°C, če je bila raztopina pripravljena v vrečki, ki ne vsebuje PVC.
In addition, physical and chemical in-use stability of the infusion solution prepared with sodium chloride 9 mg/ml (0.9%) or 5% glucose infused solution in non-PVC bags or with 5% glucose in glass bottles has been demonstrated for up to 48 hours when stored between 2°C to 8°C and for up to 6 hours when stored below 25°C.
Poleg tega je bilo dokazano, da je infuzijska raztopina med uporabo, če je pripravljena z raztopino natrijevega klorida 9 mg/ml (0,9 %) ali s 5% raztopino glukoze v vrečah, ki ne vsebujejo PVC ali s 5% raztopino glukoze v steklenih steklenicah, kemijsko in fizikalno stabilna 48 ur pri temperaturi od 2-8 °C in do 6 ur, če je shranjena pri temperaturi do 25 °C.
In addition, posaconazole oral suspension (200 mg or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to 8- 10 hours during co-administration.
Poleg tega je peroralna suspenzija posakonazola (200 mg ali 400 mg) med sočasno uporabo podaljšala povprečni terminalni razpolovni čas midazolama s približno 3 do 4 ure na 8 do 10 ur.
In addition, preclicinal juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3).
Pri novorojenih podganjih mladičih, ki so jim dajali odmerke ribavirina, so ugotovili manjše, od odmerka odvisno splošno zmanjšanje rasti, ki se je kasneje pokazalo kot rahlo zmanjšanje telesne mase, razdalje od temena do trtice
In addition, pregabalin is effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment plasma pregabalin concentrations are reduced by approximately 50%).
Poleg tega hemodializa učinkovito odstrani pregabalin iz plazme (po 4-urni hemodializi se koncentracija pregabalina v plazmi zmanjša za približno 50%).
In addition, Pregabalin Pfizer is available in an HDPE bottle containing 200 capsules for the 75 mg, 150 mg and 300 mg strengths.
Poleg tega je zdravilo Pregabalin Pfizer v jakostih 75 mg, 150 mg in 300 mg na voljo v plastenki iz polietilena visoke gostote z 200 kapsulami.
In addition, prior to use, surgeons intending to use Opgenra should receive a Training DVD containing animated images of an operation on a patient and including the following information:
Poleg tega morajo kirurgi, ki bodo uporabljali zdravilo Opgenra, pred uporabo prejeti DVD za usposabljanje, ki vključuje animirane slike kirurškega posega na bolniku, in naslednje informacije:
In addition, rare and sometimes serious allergic reactions such as hypersensitivity, nummular eczema, urticaria, and hypersensitivity vasculitis have been reported in controlled clinical studies. (See section 4.4)
Poleg tega so bile v kontroliranih kliničnih študijah opisane redke in včasih resne alergijske reakcije, na primer preobčutljivost, numularni ekcem, urtikarija in preobčutljivostni vaskulitis. (Glejte poglavje 4.4)
In addition, re-transplant recipients whose previous grafts survived for at least 6 months after transplantation were included.
V te študije so bili vključeni tudi bolniki po ponovni presaditvi, pri katerih se je prejšnja presajena ledvica ohranila vsaj 6 mesecev.
In addition, reactions at the site of injection (itching and redness), low blood sugar levels (when used with a sulphonylurea) and headache occurred.
Pojavile so se tudi reakcije na mestu injiciranja (srbečica in pordelost), nizke ravni sladkorja v krvi (pri uporabi s sulfonilsečnino) in glavoboli.
In addition, reactivation of herpes simplex and herpes zoster has been observed in clinical studies with Aptivus, co-administered with low dose ritonavir.
Poleg tega so v kliničnih preskušanjih zdravila Aptivus, ob hkratnem jemanju majhnih odmerkov ritonavirja, zasledili reaktivacijo herpesa simpleksa in herpesa zosterja.
In addition, reactivation of herpes simplex and herpes zoster has been observed in clinical studies with PREZISTA co-administered with low dose ritonavir.
V kliničnih preskušanjih z zdravilom PREZISTA in z majhnim odmerkom ritonavirja so opazili tudi reaktivacijo virusov herpes simplex in herpes zoster.
In addition, regorafenib has shown anti-metastatic effects in vivo.
Poleg tega je regorafenib in vivo pokazal tudi učinke proti metastazam.
In addition, regular monitoring of renal function is advised during concomitant administration of potentially nephrotoxic agents, regardless of the patient’s pre-existing renal function (see also section 4.5).
Poleg tega se pri sočasnem dajanju potencialno nefrotoksičnih sredstev svetuje redno kontroliranje ledvične funkcije, ne glede na bolnikovo obstoječo ledvično funkcijo (glejte tudi poglavje 4.5).
In addition, renal function should be closely monitored with a frequency tailored to the individual patient’s medical condition.
Poleg tega je treba ledvično funkcijo skrbno nadzorovati in prilagoditi pogostnost nadzora zdravstvenemu stanju posameznega bolnika.
In addition, results of the post-authorisation studies to investigate the long term safety and efficacy of Opgenra and also investigate the actual drug utilisation in ‘real life’ are needed to further characterise the safety and efficacy profile.
Poleg tega je treba dopolniti profil varnosti in učinkovitosti z rezultati študij, opravljenih po pridobitvi dovoljenja, namenjenih raziskavi dolgoročne varnosti in učinkovitosti ter dejanske uporabe zdravila Opgenra v praksi.
In addition, RET mutation negative patients who do not receive vandetanib due to RET status or contraindication will be allowed to enrol and followed.
Poleg tega bodo lahko vključeni in spremljani bolniki z negativnim statusom RET, ki ne prejemajo vandetaniba zaradi statusa RET ali kontraindikacije.
In addition, Reyataz must not be given to patients taking rifampicin (used to treat tuberculosis), sildenafil (when this medicine is used to treat pulmonary arterial hypertension), St John’s wort (a herbal medicine used to treat depression) or medicines that are broken down in the body in the same way as Reyataz and are harmful at high levels in the blood.
Prav tako se ga ne sme dajati bolnikom, ki jemljejo rifampicin (zdravilo za zdravljenje tuberkoloze), sildenafil (kadar se uporablja za zdravljenje pljučne arterijske hipertenzije), šentjanževko (zeliščni pripravek za zdravljenje depresije) ali zdravila, ki se v telesu presnavljajo enako kot zdravilo Reyataz in so v velikih količinah v krvi škodljiva.
In addition, rosiglitazone was not genotoxic in a battery of in vivo and in vitro genotoxicity studies and there was no evidence of colon tumours in lifetime studies of rosiglitazone in two rodent species.
Poleg tega rosiglitazon ni bil genotoksičen v skupini študij genotoksičnosti in vivo in in vitro; v vseživljenjskih študijah rosiglitazona pri dveh vrstah glodalcev niso ugotovili znakov tumorjev kolona.
In addition, saxagliptin did not meaningfully alter the pharmacokinetics of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, the active components of a combined oral contraceptive (ethinyl estradiol and norgestimate), diltiazem or ketoconazole.
Poleg tega saksagliptin ni pomembno spremenil farmakokinetike metformina, glibenklamida, pioglitazona, digoksina, simvastatina, zdravilnih učinkovin v kombiniranih peroralnih kontraceptivih (etinilestradiol in norgestimat), diltiazema ali ketokonazola.
In addition, section 4.8 of the SmPC is to be updated to include preferred terms that reflect bronchoconstriction i.e. “bronchospasm” with a frequency of “not known”, “wheezing with a frequency of “uncommon”.
Poleg tega je treba posodobiti poglavje 4.8 povzetka glavnih značilnosti zdravila, da bo vključevalo priporočene izraze, ki izražajo bronhokonstrikcijo, tj. »bronhospazem« s pogostostjo »ni znano« in »sopenje« s pogostostjo »občasna«.
In addition, side effects are reported which are known to occur with controlled ovarian hyperstimulation treatment (e.g. abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when the embryo develops outside the womb) and miscarriage (see the patient information leaflet of the FSH-containing preparation you are treated with)).
Poleg tega so poročali tudi o drugih neželenih učinkih, za katere je znano, da se pojavljajo pri kontrolirani hiperstimulaciji jajčnikov (npr. trebušne bolečine, sindrom hiperstimulacije jajčnikov (OHSS), zunajmaternična nosečnost (kadar se zarodek razvija zunaj maternice) in splav (glejte navodilo za uporabo za FSH vsebujoče zdravilo, s katerim vas zdravijo)).
In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery.
Poleg tega so pri novorojencih opazili znake in simptome antagonističnega učinka na adrenergične receptorje beta (npr. bradikardija, hipotenzija, dihalna stiska in hipoglikemija), če so antagoniste adrenergičnih receptorjev beta uporabljali pred porodom.
In addition, signs of neurological disorders may be more severe (e.g. convulsion) in mdr1 mutant (-/-) Collies, Shelties and Australian Shepherds.
Poleg tega so nevrološke motnje lahko resnejše (n.pr. mišični krč), pri kolijih, šetlandskih ovčarjih ali avstralskih ovčarjih z mutacijo gena MDR1.
In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials.
Prav tako so, pri približno 1 % bolnikov v s placebom nadzorovanih kliničnih študijah, poročali o kožnem karcinomu.
In addition, some previous infections may reappear.
Poleg tega se vam lahko ponovno pojavijo nekatere prejšnje okužbe.
In addition, some previous infections may reappear.
Poleg tega se vam lahko povrnejo nekatere prejšnje okužbe.
In addition, special precaution should be taken in patients with predisposition for development of DVTs.
Poleg tega je pri bolnikih s predispozicijo za nastanek globoke venske tromboze (DVT – deep vein thrombosis) potrebna posebna previdnost.
In addition, statistically significant vaccine efficacy against CIN2+ associated with HPV-16 and HPV-18 individually was demonstrated.
Poleg tega je bila dokazana statistično značilna učinkovitost cepiva proti CIN2+, povezanemu s HPV-16 in HPV-18 posamezno.
In addition, studies conducted with MedImmune’s 2009 H1N1 pandemic LAIV and seasonal T/LAIV vaccine are also considered supportive because all these vaccines are manufactured using the same process, administered through the same route, and studied primarily in naïve individuals.
Poleg tega veljajo kot podpora tudi študije z MedImmune cepivoma (pandemskim cepivom LAIV 2009 H1N1 in sezonskim cepivom T/LAIV), ker so vsa tri cepiva izdelana po enakem postopku, je pot uporabe enaka in so v prvi vrsti raziskana pri predhodno neizpostavljenih osebah.
In addition, studies from the published literature in patients with thalassaemia major were provided to support use of Ferriprox in combination with another iron chelator.
Poleg tega so bile v podporo uporabi zdravila Ferriprox v kombinaciji z drugim kelatorjem železa predložene študije iz objavljene literature pri bolnikih s talasemijo.
In addition, Studies RA-I and RA-II had a mandatory withdrawal for non-responders at Week 16, the majority of whom were on placebo.
Poleg tega je bila v okviru raziskav RA-I in RA-II za bolnike, ki se na zdravljenje niso odzivali in katerih večina je prejemala placebo, obvezna prekinitev zdravljenja po 16 tednih.
In addition, study I evaluated haemostatic efficacy in the treatment of bleeding episodes; and determined haemostatic efficacy during perioperative management in subjects undergoing major surgical procedures.
V študiji I so dodatno ocenili hemostatsko učinkovitost pri zdravljenju epizod krvavitve in določili hemostatsko učinkovitost v predoperativni obravnavi oseb pred večjimi kirurškimi posegi.
In addition, Study V investigated the safety and efficacy of abatacept or infliximab relative to placebo.
V študiji V so raziskovali tudi varnost in učinkovitost abatacepta ali infliksimaba v primerjavi s placebom.
In addition, surgeons and healthcare professionals who will be involved in treating patients with MACI will receive educational materials providing detailed guidance on how to use MACI as well as information on its risks and the need to follow-up patients treated with MACI.
Poleg tega bodo kirurgi in zdravstveni delavci, ki bodo vključeni v zdravljenje bolnikov z zdravilom MACI, prejeli izobraževalno gradivo s podrobnimi napotki glede uporabe zdravila MACI ter informacijami o z njim povezanih tveganjih in potrebi po spremljanju bolnikov, zdravljenih z zdravilom MACI.
In addition, systemic signs, such as lethargy and a reduction in appetite may also commonly occur, sometimes accompanied by pyrexia and a stiff gait.
Pogosti so lahko tudi sistemski znaki, kot sta letargija in zmanjšan apetit, ki jih včasih spremljata pireksija in toga hoja.
In addition, T-cell receptor DNA sequencing verified that T-cell clonality was increased with daratumumab treatment, indicating immune modulatory effects that may contribute to clinical response.
Poleg tega so s sekvenciranjem DNA za T-celični receptor potrdili, da zdravljenje z daratumumabom poveča klonalnost limfocitov T, kar kaže na imunomodulatorno delovanje, ki lahko prispeva h kliničnemu odzivu.
In addition, tell your doctor or pharmacist if you are using any of the following medicines, as the dose of Plenadren may need to be changed:
Poleg tega zdravnika ali farmacevta obvestite, če uporabljate katero od spodaj navedenih zdravil, saj bo morda treba spremeniti vaš odmerek zdravila Plenadren:fenitoin, karbamazepin in barbiturate
In addition, tenofovir may increase plasma levels of raltegravir, however, the mechanism for this effect is unknown (see Table 1).
Tudi tenofovir lahko poveča plazemske koncentracije raltegravirja, vendar pa mehanizem tega učinka ni znan (glejte preglednico 1).
In addition, tenofovir may increase plasma levels of raltegravir, however, the mechanism for this effect is unknown (see Table 2).
Tudi tenofovir lahko poveča plazemske koncentracije raltegravirja, vendar pa mehanizem tega učinka ni znan (glejte preglednico 2).
In addition, tenofovir may increase plasma levels of raltegravir, however, the mechanism for this effect is unknown (see Table 3).
Tudi tenofovir lahko poveča plazemske koncentracije raltegravirja, vendar pa mehanizem tega učinka ni znan (glejte preglednico 3).
In addition, the 15 mg strength contains indigo carmine (E132) and the 20 mg strength contains iron oxide red (E172)
15 mg oblika zdravila poleg tega vsebuje še indigo karmin (E132), 20 mg oblika pa rdeč železov oksid (E172)
In addition, the allergy related adverse reactions in the table were reported mostly during the 3 month to 3 year follow-up period.
Poleg tega so poročali o alergijskih neželenih učinkih, navedenih v preglednici, večinoma v obdobju od 3 mesecev do 3 let spremljanja.
In addition, the applicant conducted a ‘bioequivalence’ study in 58 patients with cystic fibrosis aged 6 years and above to determine whether Vantobra produces similar levels of the active substance in the body as the reference medicine, Tobi.
Poleg tega je izvedel tudi študijo „biološke enakovrednosti“, v katero je bilo vključenih 58 bolnikov s cistično fibrozo, starih šest let in več, da bi ugotovil, ali zdravilo Vantobra vzpostavi podobno raven zdravilne učinkovine v telesu kot referenčno zdravilo Tobi.
In addition, the benefits of treatment in terms of the proportion achieving sustained virological response (SVR) compared with placebo were modest in these patients (especially for those with baseline albumin ≤ 35g/L) compared with the group overall.
Poleg tega je korist zdravljenja glede na razmerje doseganja trajnega virološkega odziva (SVR- sustained virological response) v primerjavi s placebom skromna pri teh bolnikih (še posebej pri tistih z izhodiščno vrednostjo albuminov ≤ 35 g/L) v primerjavi s celotno skupino.
In addition, the benefits of treatment in terms of the proportion achieving SVR compared with placebo were modest in these patients (especially for those with baseline albumin ≤ 35 g/L) compared with the group overall.
Poleg tega je korist zdravljenja glede na razmerje doseganja SVR v primerjavi s placebom skromna pri teh bolnikih (še posebej pri tistih z izhodiščno vrednostjo albuminov ≤ 35 g/L) v primerjavi s celotno skupino.
In addition, the CHMP noted that the overall benefit of Pradaxa in the treatment and prevention of DVT and PE is comparable to that of warfarin.
CHMP je poleg tega izpostavil, da so skupne koristi zdravila Pradaxa pri zdravljenju in preprečevanju globoke venske tromboze in pljučne embolije primerljive koristim varfarina.
In addition, the CHMP recognised that pharmacy preparations of amifampridine are still being used, which further limits the numbers of patients treated with Firdapse.
Odbor CHMP ugotavlja, da so farmacevtski pripravki amifampridina še vedno v uporabi, kar nadalje omejuje število bolnikov, ki prejemajo zdravilo Firdapse.
In addition, the CHMP required that an additional study should be carried out to confirm that the current recommended dose is the most appropriate dose.
Poleg tega je zahteval, da se opravi dodatna študija, s katero bi potrdili, da je trenutno priporočeni odmerek najprimernejši odmerek.
In addition, the Committee concluded that all patients should have their heart closely monitored after the first dose.
Poleg tega je sklenil, da je treba pri vseh bolnikih po prvem odmerku natančno spremljati srčni utrip.
In addition, the company is conducting a five-year observational study to assess the longer-term effects of the medicine as well as a six-year observational study in children who were aged 2 to 5 years at the time of treatment start to assess long-term effects of early treatment.
Poleg tega družba izvaja petletno opazovalno študijo za oceno dolgoročnejših učinkov zdravila in šestletno opazovalno študijo pri otrocih, ki so bili ob začetku zdravljenja stari dve do pet let, za oceno dolgoročnih učinkov zgodnjega začetka zdravljenja.
In addition, the company presented extensive supportive data from large studies and from clinical practice on how well other similar pandemic and seasonal live attenuated influenza A vaccines work in children.
Poleg tega je družba predložila obsežne podporne podatke iz velikih študij in klinične prakse o učinkovitosti drugih podobnih pandemskih in sezonskih živih oslabljenih cepiv proti gripi A pri otrocih.
In addition, the company presented the results of studies looking at the level of protection in adults and in children for up to three years after vaccination with Ixiaro, and at the response to booster doses.
Poleg tega je družba predstavila rezultate študij, v katerih so proučevali raven zaščite pri odraslih in otrocih do tri leta po cepljenju s cepivom Ixiaro in odziv na obnovitvene odmerke.
In addition, the company provided data from several studies comparing the overall survival of patients who had or who had not been previously treated and were given Yervoy at 3 mg per kg bodyweight.
Družba je poleg tega zagotovila podatke iz številnih drugih študij za primerjavo celokupnega preživetja pri predhodno zdravljenih in nezdravljenih bolnikih, ki so prejemali zdravilo Yervoy v odmerku 3 mg na kg telesne mase.
In addition, the company provided data on 40 patients with CD30- positive HL, whose cancer had come back or had not responded to at least two prior therapies and who are not eligible for autologous stem cell transplant or multi-agent chemotherapy.
Poleg tega je podjetje zagotovilo podatke raziskav pri 40 bolnikih s Hodgkinovim limfomom, pozitivnih na CD30, pri katerih se je rak ponovil ali se niso odzvali na vsaj dve predhodni zdravljenji oziroma niso bili primerni za avtologno presaditev matičnih celic ali kemoterapijo z več zdravili.
In addition, the company that makes Daliresp will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine’s side effects and how it should be used.
Poleg tega bo družba, ki izdeluje zdravilo Daliresp, zagotovila, da bodo v vseh državah članicah Evropske unije (EU) zdravstveni delavci, ki bodo predpisovali zdravilo, prejeli izobraževalno gradivo o neželenih učinkih zdravila in njegovi uporabi.
In addition, the company that makes Daxas will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine’s side effects and how it should be used.
Poleg tega bo družba, ki izdeluje zdravilo Daxas, zagotovila, da bodo v vseh državah članicah Evropske unije (EU) zdravstveni delavci, ki bodo predpisovali zdravilo, prejeli izobraževalno gradivo o neželenih učinkih zdravila in njegovi uporabi.