FrancophonIA/ELRC3.0 huggingface dataset:
English: Xelevia 100 mg film-coated tablets
Slovenian: Xelevia 100 mg filmsko obložene tablete
English: Xelevia 100 mg film-coated tablets Sitagliptin
Slovenian: Xelevia 100 mg filmsko obložene tablete sitagliptin
English: Xelevia 25 mg film-coated tablets
Slovenian: Xelevia 25 mg filmsko obložene tablete
English: Xelevia 50 mg film-coated tablets Sitagliptin
Slovenian: Xelevia 50 mg filmsko obložene tablete sitagliptin
English: Xelevia 50 mg film-coated tablets
Slovenian: Xelevia 50 mg filmsko obložene tablete
English: If bullous pemphigoid is suspected, Xelevia should be discontinued.
Slovenian: Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom Xelevia prekiniti.
English: Paediatric No studies with Xelevia have been performed in paediatric patients.
Slovenian: Otroci Pri otrocih študij z zdravilom Xelevia niso izvedli.
English: Chimeric yellow fever dengue virus serotype 1* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 2* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 3* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 4* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** * Produced in Vero cells by recombinant DNA technology.
Slovenian: Himerni virus rumene mrzlice denga - serotip 1 (živ, oslabljen)*..................................................................... 4.5 - 6.0 log10 CCID50/odmerek** Himerni virus rumene mrzlice denga - serotip 2 (živ, oslabljen)*..................................................................... 4.5 - 6.0 log10 CCID50/odmerek** Himerni virus rumene mrzlice denga - serotip 3 (živ, oslabljen)*..................................................................... 4.5 - 6.0 log10 CCID50/odmerek** Himerni virus rumene mrzlice denga - serotip 4 (živ, oslabljen)*..................................................................... 4.5 - 6.0 log10 CCID50/odmerek**
English: This product contains genetically modified organisms (GMOs).
Slovenian: To cepivo vsebuje genetsko spremenjene organizme.
English: ** CCID50: 50% Cell Culture Infectious Dose.
Slovenian: **CCID50: 50 % infekcijski odmerek v celični kulturi (CCID - Cell Culture Infectious Dose).
English: --¹ After reconstitution, one dose (0.5 mL) contains:
Slovenian: Po rekonstituciji en odmerek (0,5 ml) vsebuje:
English: Powder: 5 doses; solvent: 2.5 ml
Slovenian: Prašek: 5 odmerkov; vehikel: 2,5 ml
English: 5 sets of 2 vials (1 with powder + 1 with solvent, 5 doses each)
Slovenian: 5 kompletov z 2 vialama (1 s praškom + 1 z vehiklom, 5 odmerkov vsakega)
English: 1 vial + 1 pre-filled syringe
Slovenian: 1 viala + 1 napolnjena injekcijska brizga
English: 10 vials + 10 pre-filled syringes
Slovenian: 10 vial + 10 napolnjenih injekcijskih brizg
English: 1 vial + 1 pre-filled syringe + 2 needles
Slovenian: 1 viala + 1 napolnjena injekcijska brizga + 2 igli
English: Some patients have actually committed suicide.
Slovenian: Nekaj bolnikov je dejansko naredilo samomor.
English: This is to be expected and is not a cause for concern.
Slovenian: To je pričakovano in ni razlog za skrb.
English: • Look in the window.
Slovenian: • Poglejte v okence.
English: - thoughts about threatening the life of others.
Slovenian: - misli, kako ogroziti življenja drugih.
English: Some bubbles may be present, but this is normal.
Slovenian: Prisotnih je lahko nekaj mehurčkov, vendar je to normalno.
English: Date of first authorisation: 29 May 2000 Date of latest renewal: 29 May 2010
Slovenian: Datum prve odobritve: 29. maj 2000 Datum zadnjega podaljšanja: 29. maj 2010
English: The frequency of such re-activation appears to be low.
Slovenian: Pogostnost takšne reaktivacije se zdi majhna.
English: - The contents should now be completely dissolved.
Slovenian: Vsebina naj bi bila zdaj popolnoma raztopljena.
English: Before reconstitution 3 years.
Slovenian: Pred rekonstitucijo 3 leta
English: If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Slovenian: Če pride do te reakcije, jim je treba svetovati, naj si potem temeljito sperejo usta.
English: From a microbiological point of view, the product is to be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
English: You will need the following supplies that are included in the package:
Slovenian: Potrebovali boste naslednji pribor, ki je priložen v pakiranju:
English: - have heart disease that has not been well controlled during the past 6 months.
Slovenian: - imate srčno bolezen, ki v zadnjih 6 mesecih ni bila dobro nadzorovana.
English: • Wash your hands well with soap and warm water.
Slovenian: • Dobro si umijte roke z milom in toplo vodo.
English: In those patients the SVR was 12 %.
Slovenian: Pri teh bolnikih je bil SVR 12 %.
English: The study results are summarized in Table 15.
Slovenian: Rezultati študije so povzeti v preglednici 15.
English: Please read the instructions carefully and follow them step by step.
Slovenian: Prosimo, natančno preberite navodila in sledite vsakemu koraku posebej.
English: Elderly ( 65 years of age)
Slovenian: Starostniki (starost  65 let)
English: % (number) of patients
Slovenian: % (število) bolnikov
English: Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Slovenian: Zato boste redno napoteni na krvne preiskave, da se zdravnik prepriča, da se okužba z virusom HIV ne slabša.
English: - have had any serious illness affecting breathing or blood.
Slovenian: - ste imeli kakršno koli resno bolezen, ki je vplivala na dihanje ali kri.
English: Number of capsules (200 mg)
Slovenian: Število kapsul (200 mg)
English: Take/administer the dose of this medicine as soon as you remember, but only if within 1-2 days after the forgotten dose.
Slovenian: Uporabite odmerek tega zdravila takoj, ko se spomnite, vendar le v času 1-2 dni po pozabljenem odmerku.
English: Some children did not reach their projected height within 1-5.5 years after completing treatment.
Slovenian: Nekateri otroci tudi niso dosegli pričakovane telesne višine v obdobju 1 do 5,5 let po zaključku zdravljenja.
English: A patient may be missing or have had a different result for week 4 or week 12.
Slovenian: Možno je, da manjka en bolnik oziroma da je imel v 4. tednu ali v 12. tednu različna rezultata.
English: Use this solution immediately.
Slovenian: To raztopino uporabite takoj.
English: Of these, sixty-three were sustained responders.
Slovenian: Triinšestdeset od teh je imelo trajen odziv.
English: It is considered that graft rejection reactions may be induced.
Slovenian: Smatra se, da lahko pride do reakcij zavrnitve presadka.
English: • Find a well-lit, clean flat work surface such as a table.
Slovenian: • Izberite dobro osvetljeno, čisto in ravno delovno površino, na primer mizo.
English: If necessary, the dose may be changed during treatment.
Slovenian: Če bo potrebno, bo morda odmerek spremenil med zdravljenjem.
English: You may hear a "click" sound.
Slovenian: Morda boste zaslišali "klik".
English: Bilirubin - direct
Slovenian: Bilirubin - direktni
English: Your doctor will monitor you for signs and symptoms of these conditions.
Slovenian: Zdravnik vas bo spremljal glede znakov in simptomov teh bolezni.
English: Response at end of treatment 49 % 41 % 33 % 24 % 65 % 56 % 54 % Sustained response
Slovenian: Odziv na koncu zdravljenja 49 % 41 % 33 % 24 % 65 % 56 % 54 % Trajni odziv
English: Let the skin air dry.
Slovenian: Pustite, da se koža na zraku posuši.
English: Pull the needle straight out of the skin.
Slovenian: Izvlecite iglo naravnost ven iz kože.
English: Bilirubin - indirect
Slovenian: Bilirubin - indirektni
English: Ask a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Slovenian: Prosite družinskega člana ali dobrega prijatelja, naj vam pomaga biti pozoren na znake depresije ali spremembe vedenja.
English: Any or all of these activities may contribute to interferon's therapeutic effects.
Slovenian: Kateri koli od teh učinkov ali vsi skupaj lahko prispevajo k terapevtskemu delovanju interferona.
English: - are taking telbivudine.
Slovenian: - jemljete telbivudin.
English: Children and adolescents This medicine is not recommended for use in patients under the age of 3 years.
Slovenian: Otroci in mladostniki To zdravilo ni priporočljivo za uporabo pri bolnikih, mlajših od 3 let.
English: Your doctor will determine the correct dose for you.
Slovenian: Zdravnik bo določil pravi odmerek za vas.
English: Be sure the solution is at room temperature up to 25°C.
Slovenian: Prepričajte se, da je raztopina pri sobni temperaturi do 25 °C.
English: - are allergic to any interferon.
Slovenian: - ste alergični na kateri koli interferon.
English: Standard methods to increase elimination of the medicinal product, e.g., dialysis, have not been shown to be useful.
Slovenian: Običajne metode za povečanje izločanja zdravila, na primer dializa, se niso izkazale za koristne.
English: In terms of activity, about one-third of sustained responders showed improvement and none showed worsening.
Slovenian: Kar zadeva učinkovitost, se je pri približno eni tretjini bolnikov s trajnim odzivom pokazalo izboljšanje bolezni, pri nobenem od bolnikov pa ni prišlo do poslabšanja.
English: This medicine is intended for subcutaneous use.
Slovenian: To zdravilo je namenjeno subkutani uporabi.
English: If it is very close to your next injection, do not double the dose to make up for the forgotten dose, but continue your treatment as usual.
Slovenian: Če je čas za vašo naslednjo injekcijo zelo blizu, ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, ampak zdravljenje nadaljujte kot ponavadi.
English: Other side effects that have been reported in adults include:
Slovenian: Ostali neželeni učinki, o katerih so poročali pri odraslih, so:
English: Fluid replacement may be necessary.
Slovenian: Lahko je potrebno tudi nadomeščati tekočino.
English: When this medicine is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Slovenian: Ko se to zdravilo uporablja samostojno, je manj verjetno, da se pojavijo nekateri od teh učinkov, nekateri učinki pa se sploh ne pojavijo.
English: In all three treatment groups, sustained virologic response rates were similar.
Slovenian: V vseh treh terapevtskih skupinah so bili deleži trajnega virološkega odziva podobni.
English: The mechanisms involved in clearance of interferons in man have not yet been fully elucidated.
Slovenian: Mehanizmi, ki sodelujejo pri očistku interferonov pri človeku, še niso popolnoma pojasnjeni.
English: Ask your healthcare provider or pharmacist for an appropriate container.
Slovenian: Zdravstvenega delavca ali farmacevta prosite za ustrezen vsebnik.
English: During treatment, some patients may experience eye problems, or loss of vision in rare instances.
Slovenian: Med zdravljenjem imajo lahko nekateri bolniki težave z očmi ali v redkih primerih izgubijo vid.
English: The effect of this medicine on human pregnancy is not known.
Slovenian: Učinek tega zdravila na nosečnost pri človeku ni znan.
English: The decision to extend therapy to one year of treatment should be based on prognostic factors (e.g., genotype, age > 40 years, male gender, bridging fibrosis).
Slovenian: Odločitev za podaljšanje terapije na eno leto mora temeljiti na prognostičnih dejavnikih (npr. genotip, starost > 40 let, moški spol, premostitvena fibroza).
English: Unknown frequency side effects (frequency cannot be estimated from the available data): - Wanting to harm others.
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): želja škodovati drugim.
English: Another approximately 2 % had a transient decrease below the lower limit of normal.
Slovenian: Pri drugih približno 2 % bolnikov je prišlo do prehodnega zmanjšanja vrednosti pod spodnjo mejo normale.
English: < 12 g/dl after four weeks of dose reduction
Slovenian: < 12 g/dl po štirih tednih zmanjševanja odmerka
English: Additional 5 seconds ensures complete dose delivery.
Slovenian: Dodatnih 5 sekund zagotavlja, da je injiciran celotni odmerek.
English: Children and adolescents are particularly prone to develop depression when being treated with this medicine and ribavirin.
Slovenian: Otroci in mladostniki so še posebej nagnjeni k depresiji, kadar so zdravljeni s tem zdravilom in ribavirinom.
English: Dose reduction of boceprevir is not recommended.
Slovenian: Zmanjšanja odmerka boceprevirja ne priporočamo.
English: These events included suicidal ideation and attempted suicide (see section 4.4).
Slovenian: Med temi pojavi so bile samomorilne misli in poskusi samomora (glejte poglavje 4.4).
English: Your doctor should carry out an eye examination before starting your treatment.
Slovenian: Zdravnik naj vam pred začetkom zdravljenja opravi pregled oči.
English: These studies were limited to four weeks due to the appearance of anti-interferon antibodies in most monkeys.
Slovenian: Trajanje teh študij je bilo omejeno na štiri tedne zaradi pojava protiteles proti interferonu pri večini opic.
English: You are now ready to inject the dose.
Slovenian: Zdaj ste pripravljeni na injiciranje odmerka.
English: If it gets worse, your doctor will decide whether or not your ribavirin treatment needs to be changed.
Slovenian: Če se poslabša, se bo zdravnik odločil, ali je pri vas potrebna sprememba zdravljenja z ribavirinom ali ne.
English: Transient rashes do not necessitate interruption of treatment.
Slovenian: Prehodni izpuščaji pa ne zahtevajo prekinitve zdravljenja.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8ºC.
Slovenian: Kemično in fizikalno stabilnost med uporabo so dokazali za čas 24 ur pri temperaturi med 2 °C in 8 ºC.
English: With your other hand, hold the syringe as you would a pencil.
Slovenian: Z drugo roko primite brizgo tako, kot bi držali svinčnik.
English: Alopecia, dry skin
Slovenian: alopecija, suha koža
English: In case of any changes in vision, you must tell your doctor and have a prompt and complete eye examination.
Slovenian: V primeru kakršne koli spremembe vida, morate to povedati zdravniku in imeti takoj natančen pregled oči.
English: Detailed information on this medicinal product is available on the web-site of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: (%)) in previously untreated children and adolescents by genotype and treatment duration - All subjects n = 107 24 weeks
Slovenian: (%)) pri predhodno nezdravljenih otrocih in mladostnikih glede na genotip in trajanje zdravljenja - vsi preiskovanci n = 107 24 tednov
English: - have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Slovenian: - imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda želel bolj skrbno spremljati.
English: Positive predictive value
Slovenian: Pozitivna napovedna vrednost
English: Anorexia, decreased appetite
Slovenian: anoreksija, zmanjšan apetit
English: Pen (CLEARCLICK)
Slovenian: peresnik (CLEARCLICK)
English: If the solution is cold, warm the syringe between your palms.
Slovenian: Če je raztopina hladna, brizgo ogrejte med dlanmi.
English: Effects on fertility have not been determined.
Slovenian: Učinka na plodnost niso določali.
English: Keep your work area, your hands, and the injection site clean to decrease the risk of infection.
Slovenian: Pazite, da bodo delovna površina, vaše roke in mesto injiciranja ostali čisti, da boste zmanjšali tveganje za okužbo.
English: It is not known whether the components of this medicinal product are excreted into experimental animal or human milk (see section 4.6 for relevant human data on pregnancy and lactation).
Slovenian: Ni znano, ali se sestavine tega zdravila izločajo v materino mleko pri preskušanih živalih in pri človeku (glejte poglavje 4.6 za ustrezne podatke o nosečnosti in dojenju pri človeku).
English: - have ever had a heart attack or a heart problem.
Slovenian: - ste kdaj imeli srčni infarkt ali težave s srcem.
English: This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
Slovenian: To povzroči hudo anemijo, med njene simptome pa sodita neobičajna utrujenost in pomanjkanje energije.
English: Ninety-four of 107 subjects enrolled in the 5 year long-term follow-up trial.
Slovenian: Štiriindevetdeset od 107 preiskovancev je bilo vključenih v 5-letno dolgoročno spremljevalno preskušanje.
English: Alopecia, pruritus
Slovenian: alopecija, pruritus
English: Before reconstitution, this medicine may appear either as a white tablet-shaped solid that is whole or in pieces, or as a white powder.
Slovenian: Pred rekonstitucijo je to zdravilo videti bodisi kot bela trdna snov v obliki tablete, ki je cela ali v koščkih, ali kot bel prašek.
English: Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
Slovenian: Zlasti pri bolnikih na velikih odmerkih metadona je treba upoštevati tveganje podaljšanja intervala QTc.
English: Monitoring of lipid levels is, therefore, recommended.
Slovenian: Priporočljivo je torej spremljanje koncentracije lipidov.
English: • TSH level must be within normal limits
Slovenian: mora biti v okviru normalnih meja
English: Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.
Slovenian: Takoj se posvetujte z zdravnikom ali poiščite nujno medicinsko pomoč, če kažejo neobičajne simptome vedenja, se počutijo depresivno ali če želijo škodovati sebi ali drugim.
English: This medicine is injected into your body to work with your immune system.
Slovenian: To zdravilo se injicira v vaše telo in nato deluje na vaš imunski sistem.
English: - are taking medicine that suppresses (weakens) your immune system.
Slovenian: - jemljete zdravila, ki zavirajo (slabijo) imunski sistem.
English: Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of selfinjection.
Slovenian: Ne skušajte si injicirati zdravila, če niste prepričani, da razumete postopek in vse zahteve za samoinjiciranje.
English: 327 patients completed at least 5 years of long-term follow-up and only 3 out of 366 sustained responders relapsed during the study.
Slovenian: 327 bolnikov je zaključilo najmanj 5-letno dolgoročno spremljanje in le 3 od 366 bolnikov s trajnim virološkim odzivom so imeli ponoven izbruh bolezni v času te študije.
English: - have autoimmune hepatitis or any other problem with your immune system.
Slovenian: - imate avtoimunski hepatitis ali kakršne koli druge težave z imunskim sistemom.
English: • DO NOT SHAKE TO MIX.
Slovenian: • NE STRESAJTE, DA BI PREMEŠALI.
English: Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Slovenian: Kadar je le mogoče, je treba zdravljenje pri otroku uvesti po obdobju intenzivne rasti v puberteti, da bi zmanjšali tveganje za zastoj rasti.
English: Dyspepsia, gingivitis
Slovenian: dispepsija, gingivitis
English: The clinical significance of this finding is unknown; however, patients should be monitored for signs and symptoms of increased sedative effect, as well as respiratory depression.
Slovenian: Klinični pomen tega izsledka ni znan, vendar je treba bolnike spremljati glede znakov in simptomov okrepljenega sedativnega učinka, kot tudi morebitnega pojava depresije dihanja.
English: Do not use this medicine if you notice discolouration of the powder, which should be white.
Slovenian: Ne uporabljajte tega zdravila, če opazite spremembo barve praška, ki mora biti bele barve.
English: - have had severe heart problems.
Slovenian: - ste kdaj imeli hude težave s srcem.
English: You are ready to inject
Slovenian: Pripravljeni ste za injiciranje
English: Growth and development (children and adolescents):
Slovenian: Rast in razvoj (otroci in mladostniki):
English: Patients with severe renal impairment, including those on hemodialysis, should be closely monitored.
Slovenian: Bolnike s hudo ledvično okvaro, vključno s tistimi na hemodializi, morate natančno spremljati.
English: No sustained response
Slovenian: Ni trajnega odziva
English: Interferons are made by your body's immune system to help fight infections and severe diseases.
Slovenian: Interferone izdeluje vaš telesni imunski sistem za pomoč pri premagovanju okužb in hudih bolezni.
English: You may develop a dry mouth or vomiting, both of which can damage your teeth.
Slovenian: Pojavijo se lahko suha usta ali bruhanje, kar lahko poškoduje vaše zobe.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of ViraferonPeg therapy are:
Slovenian: Sprejemljive začetne vrednosti, ki vam lahko služijo kot smernica pred uvedbo terapije z zdravilom ViraferonPeg, so naslednje:
English: The decision to treat should be made on a case by case basis (see section 4.4).
Slovenian: Odločitev za zdravljenje mora biti sprejeta za vsak primer posebej (glejte poglavja 4.4).
English: - pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Slovenian: - pljučna arterijska hipertenzija - bolezen, ki povzroči hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerih kri teče iz srca v pljuča.
English: Contact your doctor immediately if you notice any of the following serious side effects occurring during treatment:
Slovenian: Takoj se posvetujte z zdravnikom, če med zdravljenjem opazite katerega od naslednjih resnih neželenih učinkov:
English: This includes adults also infected with clinically stable HIV (Human Immunodeficiency Virus).
Slovenian: To vključuje odrasle osebe, ki imajo sočasno klinično stabilno okužbo z virusom HIV (virus humane imunske pomanjkljivosti).
English: The average molecular mass is approximately 31,300 daltons of which the protein moiety constitutes approximately 19,300.
Slovenian: Povprečna molekulska masa je približno 31.300 daltonov, od tega je 19.300 daltonov za beljakovinski del.
English: There was no improvement in terms of fibrosis observed in this study.
Slovenian: V tej študiji niso opazili izboljšanja fibroze.
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm
Slovenian: V študiji 1 (glejte poglavje 5.1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm
English: Pharmacotherapeutic group: Immunostimulants, Interferons, ATC code: L03AB10.
Slovenian: Farmakoterapevtska skupina: Imunostimulansi, Interferoni, oznaka ATC: L03AB10.
English: The potency of this product should not be compared to that of another pegylated or non-pegylated protein of the same therapeutic class (see section 5.1).
Slovenian: Jakosti tega zdravila se ne sme primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin iz istega terapevtskega razreda (glejte poglavje 5.1).
English: # Calculated from urine data collected over an interval of 48-hours ## Calculated from urine data collected over an interval of 24-hours
Slovenian: # izračunano iz podatkov analize urina, zbranega v obdobju 48 ur ## izračunano iz podatkov analize urina, zbranega v obdobju 24 ur
English: Do not massage the injection site.
Slovenian: Injekcijskega mesta ne masirajte.
English: In this subgroup, there was a 56 % (463/823) sustained virological response rate.
Slovenian: V tej podskupini je bil delež trajnega virološkega odziva 56 % (463/823).
English: Moreover, the safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.
Slovenian: Poleg tega varnost in učinkovitost uporabe telbivudina v kombinaciji z interferoni za zdravljenje kroničnega hepatitisa B nista bili dokazani.