natgillin/translations-raw huggingface dataset:
The study will look at the effects of Fampyra on other aspects of walking ability besides walking speed and will further investigate ways for the earlier identification of patients who respond to Fampyra earlier in order to guide further treatment.
V študiji bodo proučevali učinke zdravila Fampyra na druge vidike sposobnosti hoje, poleg hitrosti hoje, in dodatno raziskali načine za zgodnje odkrivanje bolnikov, ki se na zdravilo Fampyra prej odzovejo, da bi se omogočilo usmerjanje nadaljnjega zdravljenja.
The study will run for 2 years and at pre-specified times, the data will be collected and analysed (e.g.
Študija bo potekala 2 leti in po predhodno določenih časovnih terminih, podatki bodo zbrani in analizirani (npr.
The study, which lasted 24 months, compared Imlygic with GM-CSF injected under the skin.
V študiji, ki je trajala 24 mesecev, so zdravilo Imlygic primerjali s podkožno injiciranim GM- CSF.
The study, which lasted for 20 weeks, consisted of an initial phase of 8 weeks to establish the dose and an evaluation phase of 12 weeks.
Študija, ki je trajala 20 tednov, je vključevala 8-tedensko začetno fazo za določitev odmerka in 12-tedensko fazo ocenjevanja.
the study.
zgodnje prenehanje študije.
the study.
študije.
The study’s primary endpoint was the composite of cardiovascular death, MI, stroke, and UCR.
Primarni opazovani dogodek študije je bil sestavljeni dogodek srčno-žilne smrti, MI, možganske kapi in UCR.
The subcutaneous injection should always be administered at the same time of the day to increase compliance and the site of injection must be varied to prevent lipoatrophy.
Subkutano injekcijo je zavoljo čim boljšega sodelovanja bolnika vedno treba dati ob istem času dneva, mesto injiciranja pa je treba menjavati, da se prepreči lipoatrofija.
The subgroup of patients 75 years or above did not demonstrate a benefit for PFS or OS, but was too small (n=25) to draw any definitive conclusions.
V podskupini bolnikov, starih 75 let ali več, ni bilo dokazane koristi za PFS ali celokupno preživetje, vendar je bila podskupina premajhna (n = 25), da bi omogočala dokončne sklepe.
The subject incidence of serious adverse reactions at the recommended dose of Kineret (100 mg/day) was comparable with placebo (7.1% compared with 6.5% in the placebo group).
Incidenca resnih neželenih učinkov v študijah RA pri priporočenem odmerku zdravila Kineret (100 mg/dan) je bila primerljiva s placebom (7,1 % v primerjavi s 6,5 % v skupini s placebom).
The subject was initially comatose with AV block and then fully recovered without permanent sequelae.
Bolnik je bil v začetku komatozen z atrioventrikularnim blokom, vendar si je popolnoma opomogel brez trajnih posledic.
The subjects received either a single intravenous dose of 1000 Units or a 1000 Units dose followed by a second dose of 1000 Units 60 minutes later.
Preiskovanci so prejeli bodisi enkraten intravenski odmerek 1000 enot bodisi odmerek 1000 enot, ki mu je čez 60 minut sledil še en odmerek 1000 enot.
The subjects were aged 6 years and above and had an FEV1% predicted of 25-75%.
Osebe so bile stare 6 let in več in so imele napovedano vrednost FEV1 25–75 %.
The subjects were then continued on different regimens based on Treatment Week (TW) 8 response-guided therapy (Victrelis-RGT).
Potem so preiskovanci nadaljevali z različnimi režimi zdravljenja upoštevaje odziv v 8. tednu zdravljenja (TZ) (Victrelis-RTG – Response Guided Therapy).
The subject’s fluid status should be evaluated following parenteral support reduction and corresponding adjustment performed, as needed.
Tekočinsko stanje osebe je treba oceniti po zmanjšanju parenteralne podpore in po potrebi opraviti ustrezno prilagoditev.
The subsequent administration of PROCOMVAX for completion of the hepatitis B vaccination series in infants who were born of HBsAg-positive mothers and received HBIG or infants born of mothers of unknown status has not been studied. as with other similar vaccines, cases of Haemophilus b disease may occur in the week after vaccination prior to the onset of the protective effects of the vaccine. because hepatitis B infection can go undetected for a long period of time, it is possible that an individual may already be infected at the time the vaccine is given.
tako kot pri drugih podobnih cepivih se lahko v tednu po cepljenju, torej še pred začetkom zaščitnih učinkov cepiva, pojavijo primeri bolezni zaradi okužbe s hemofilusom b. ker lahko okužba s hepatitisom B dolgo ostane neopažena, se lahko zgodi, da je oseba v času cepljenja že okužena.
The substance binds with high affinity to the ATP-binding site in such a manner that it is a potent inhibitor of wild-type BCR-ABL and maintains activity against 32/33 imatinib-resistant mutant forms of BCR-ABL.
Učinkovina se z visoko afiniteto veže na ATP vezavno mesto in sicer v taki meri, da močno zavira nemutiran BCR-ABL, poleg tega pa ohranja aktivnost tudi proti 32/33 mutiranim oblikam BCR-ABL, rezistentnim na imatinib.
The substance is also absorbed into the systemic circulation where it binds strongly to carbonic anhydrase in red blood cells (RBCs).
Učinkovina se absorbira tudi v sistemski krvni obtok, kjer se močno veže na karboanhidrazo v eritrocitih.
The success and assessment of treatment may be impaired if the treated area is affected by the presence of skin diseases (skin inflammation, located infection, psoriasis, excema, and benign or malignant skin cancers) as well as tattoos.
Uspešnost in ocena zdravljenja sta lahko zmanjšana, če je zdravljeno območje prizadeto zaradi kožnih bolezni (vnetje kože, lokalne okužbe, psoriaza, ekcem in benigni ali maligni rak kože) ali je tetovirano.
The success and assessment of treatment may be impaired if the treated area of the skin is further affected by
Uspeh in ocena zdravljenja sta lahko manjša, če je zdravljeno območje kože prizadeto zaradi
The success rates in RIE patients are shown in the table below.
Deleži odzivov pri bolnikih z infekcijskim endokarditisom desne strani so prikazani v spodnji preglednici.
The successful engraftment achieved in all patients during phase II trials suggests the appropriateness of the targeted AUCs.
Uspešna presaditev pri vseh bolnikih v preskušanjih II. faze kaže na ustreznost ciljnih vrednosti AUC.
The successful global response rate at the end of intravenous treatment (primary endpoint) and end of all treatment and all-cause mortality up to the 6 week follow-up visit is shown in Table 5.
Delež uspešnega globalnega odziva na koncu intravenskega zdravljenja (primarni opazovani dogodek) in na koncu celotnega zdravljenja ter umrljivost iz vseh vzrokov do kontrolnega obiska v 6. tednu so prikazani v preglednici 5.
The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 18/35 (51.4%) and 16/35 (45.7%) at the End of All Treatment.
Delež uspešnega globalnega odziva na koncu intravenskega zdravljenja (primarni opazovani dogodek) je bil 18/35 (51,4 %), na koncu celotnega zdravljenja pa 16/35 (45,7 %).
The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3); the successful global response rate at the End of All Treatment was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3).
Delež uspešnega globalnega odziva na koncu intravenskega zdravljenja (primarni opazovani dogodek) za anidulafungin je bil 8/11 (72,7 %), za kaspofungin pa 3/3 (100,0 %) (razlika –27,3, 95-% IZ –80,9, 40,3); delež uspešnega globalnega odziva na koncu celotnega zdravljenja za anidulafungin je bil 8/11 (72,7 %), za kaspofungin pa 3/3 (100,0 %) (razlika –27,3, 95-% IZ –80,9, 40,3).
The sugammadex pharmacokinetic parameters were calculated from the total sum of non-complex- bound and complex-bound concentrations of sugammadex.
Farmakokinetični parametri sugamadeksa so bili izračunani iz skupnega seštevka koncentracij sugamadeksa, ki je bil vezan v obliki kompleksov ali nevezan.
The suggested order is as follows, unless otherwise advised by your doctor:
Priporočeni vrstni red je naslednji, razen če vam zdravnik naroči drugače:
The suggested pathophysiologic mechanism includes immune-complex formation and deposition due to development of antibodies against omalizumab.
Domnevajo, da gre za patofiziološki mehanizem, ki vključuje tvorbo in odlaganje imunskih kompleksov, do katerih pride zaradi razvoja protiteles proti omalizumabu.
The summaries of opinion of the Committee for Orphan Medicinal Products for Sprycel can be found on the Agency’s website ema.europa.eu/Find medicine/Human medicines/Rare disease designation:
Povzetka mnenja Odbora za zdravila sirote o zdravilu Sprycel sta na voljo na spletni strani agencije na naslovu: ema.europa.eu/Find medicine/Human medicines/Rare disease designation:
The summaries of the opinion of the Committee for Orphan Medicinal Products for Gazyvaro can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CLL and FL).
Povzetek mnenja Odbora za zdravila sirote za zdravilo Gazyvaro je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:(CLL in FL).
The summaries of the opinion of the Committee for Orphan Medicinal Products for Iclusig can be found on the Agency’s website:
Povzetki mnenja Odbora za zdravila sirote o zdravilu Iclusig so na voljo na spletni strani agencije:
The summaries of the opinion of the Committee for Orphan Medicinal Products for Vidaza can be found on the Agency’s website: here (myelodysplastic syndromes) and here (AML).
Povzetek mnenja Odbora za zdravila sirote o zdravilu Vidaza je na voljo na spletni strani agencije: tukaj (mielodisplastični sindromi) in tukaj (akutna mieloična levkemija).
The summaries of the opinions of the Committee for Orphan Medicinal Products for Ravicti can be found on the Agency’s website:
Povzetki mnenj Odbora za zdravila sirote o zdravilu Ravicti so na voljo na spletni strani agencije:
The summaries of the opinions of the Committee for Orphan Medicinal Products for Revlimid can be found on the Agency’s website ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Povzetki mnenj Odbora za zdravila sirote o zdravilu Revlimid so na voljo na spletni strani agencije na naslovu ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
The summaries of the opinions of the Committee for Orphan Medicinal Products for Signifor can be found on the Agency’s website:
Povzetka mnenj Odbora za zdravila sirote o zdravilu Signifor sta na voljo na spletni strani agencije:
The summaries of the opinions of the Committee for Orphan Medicinal Products for Zavesca on the Agency’s website ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Povzetki mnenj Odbora za zdravila sirote o zdravilu Zavesca so na voljo na spletni strani agencije na naslovu ema.europa.eu/Find medicine/Human medicines/Rare disease designation:
The summary of clinical response in the modified intent-to-treat (mITT) population results is shown in the following table.
Povzetek kliničnega odziva v modificirani populaciji, ki so jo nameravali zdraviti (mITT - modified intent-to- treat), je prikazan v spodnji preglednici.
The summary of opinion of the Committee for Orphan Medicinal Products for Ceplene can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Ceplene je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of opinion of the Committee for Orphan Medicinal Products for Evoltra can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare Disease Designations.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Evoltra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
The summary of opinion of the Committee for Orphan Medicinal Products for Exjade can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Exjade je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
The summary of opinion of the Committee for Orphan Medicinal Products for Inovelon can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Inovelon je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
The summary of opinion of the Committee for Orphan Medicinal Products for Kuvan can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Kuvan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of opinion of the Committee for Orphan Medicinal Products for Lysodren can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Lysodren je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of opinion of the Committee for Orphan Medicinal Products for Mozobil is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Mozobil je na voljo tukaj.
The summary of opinion of the Committee for Orphan Medicinal Products for Peyona can be found on the Agency’s website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Peyona je na voljo na spletni strani agencije na naslovu ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of opinion of the Committee for Orphan Medicinal Products for Tasigna can be found on the Agency’s website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Tasigna je na voljo na spletni strani agencije pod EMA website/Find medicine/Human medicines/Rare disease designations.
The Summary of Product Characteristics
Povzetek glavnih značilnosti zdravila
The Summary of Product Characteristics
povzetek glavnih značilnosti zdravila,
The Summary of Product Characteristics
Povzetek glavnih značilnosti zdravila.
The Summary of Product Characteristics
Povzetek glavnih značilnosti zdravila;
The Summary of Product Characteristics (in full)
Povzetek glavnih značilnosti zdravila (v celoti),
The Summary of Product Characteristics (SmPC)
Povzetek glavnih značilnosti zdravila (SmPC).
The Summary of Product Characteristics (SmPC) of MabThera 100 mg and 500 mg concentrate for solution for infusion should be referred to for information on dosing instructions and method of administration.
Za informacije o odmerjanju in načinu uporabe glejte povzetek glavnih značilnosti zdravila MabThera 100 mg in 500 mg koncentrat za raztopino za infundiranje.
The Summary of Product Characteristics (SmPC) of MabThera100 mg and 500 mg concentrate for solution for infusion should be referred to for information on dosing instructions and method of administration.
Za informacije o odmerjanju in načinu uporabe glejte povzetek glavnih značilnosti zdravila MabThera 100 mg in 500 mg koncentrat za raztopino za infundiranje.
The summary of product characteristics and package leaflet of bimatoprost (formulations 0.01%) should be amended to reflect the following adverse drug reactions: iris hyperpigmentation with a frequency uncommon and macular oedema, blepharal pigmentation, periorbital and lid changes including deepening of the eyelid sulcus and dry eye with a frequency not known.
Povzetek glavnih značilnosti zdravila in navodila za uporabo bimatoprosta (0,01 % formulacije) bi bilo treba spremeniti, da bi bili iz njih razvidni naslednji neželeni učinki: hiperpigmentacija šarenice ki se pojavi občasno, in makularni edem, pigmentacija vek, spremembe kože okrog očesa in vek vključno s poglobitvijo sulkusa v okolici vek in suhe oči z neznano pogostnostjo.
The summary of product characteristics and the patient information leaflet.
tem, kdaj morajo poiskati pomoč zdravstvenega osebja, povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The Summary of Product Characteristics for melphalan should be consulted for information on the interactions of melphalan.
Podatke o medsebojnem delovanju melfalana z drugimi zdravili je treba pregledati v Povzetku glavnih značilnosti melfalana .
The Summary of Product Characteristics for peginterferon alfa and ribavirin must therefore be consulted before starting therapy with INCIVO.
Preden začnete zdravljenje z zdravilom INCIVO, preberite tudi Povzetek glavnih značilnosti zdravil peginterferon alfa in ribavirin.
The Summary of Product Characteristics for the co-administered ritonavir-boosted protease inhibitor should be consulted.
Glejte Povzetek glavnih značilnosti zdravila sočasno danega zaviralca proteaze, ojačanega z ritonavirjem.
The Summary of Product Characteristics of cobicistat or ritonavir as appropriate, must therefore be consulted prior to initiation of therapy with PREZISTA.
Pred uvedbo zdravljenja z zdravilom PREZISTA morate prebrati Povzetek glavnih značilnosti zdravila za kobicistat oziroma ritonavir.
The Summary of Product Characteristics of peginterferon alfa and ribavirin (PR) must be consulted prior to initiation of therapy with Victrelis.
Pred uvedbo zdravljenja z zdravilom Victrelis morate prebrati povzetka glavnih značilnosti zdravila za peginterferon alfa in ribavirin (PR).
The Summary of Product Characteristics of the co-administered protease inhibitor should be consulted for specific recommendations.
Upoštevati je treba specifična priporočila v povzetku glavnih značilnosti sočasno uporabljenega zaviralca proteaz.
The summary of the opinion of the Committee for Orphan Medicinal Products for Adcetris can be found on the Agency’s website:
Povzetek mnenja Odbora za zdravila sirote o zdravilu Adcetris je na voljo na spletni strani agencije:
The summary of the opinion of the Committee for Orphan Medicinal Products for Adempas can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Adempas je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Alprolix can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Alprolix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Arzerra can also be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Arzerra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
The summary of the opinion of the Committee for Orphan Medicinal Products for Atriance can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Atriance je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Blincyto can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Blincyto je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Bosulif can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Bosulif je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Bronchitol can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Povzetek mnenja Odbora za zdravila sirote za zdravilo Bronchitol je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
The summary of the opinion of the Committee for Orphan Medicinal Products for Cayston can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Cayston je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Cerdelga can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Cerdelga je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Coagadex can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Coagadex je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Cometriq can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Cometriq je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Cresemba can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (invasive aspergillosis) ema.europa.eu/Find medicine/Human medicines/Rare disease designation (mucormycosis)
Povzetek mnenja Odbora za zdravila sirote o zdravilu Cresemba je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (invazivna aspergiloza) ema.europa.eu/Find medicine/Human medicines/Rare disease designation (mukormikoza)
The summary of the opinion of the Committee for Orphan Medicinal Products for Dacogen can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote za zdravilo Dacogen je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Darzalex can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Darzalex je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Defitelio can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Defitelio je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Deltyba can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Deltyba je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designationn.