FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, a jejunal adenocarcinoma was observed in a male rat administered the lowest dose tested (animal:human plasma exposure margin of approximately 10-fold).
Slovenian: Poleg tega so opazili adenokarcinom jejunuma pri podganjem samcu, ki je prejemal najnižji testirani odmerek (približno 10-kratni varnostni količnik izpostavljenosti glede na razmerje živalska:človeška plazma).
English: The most commonly reported adverse reactions were abdominal pain and distension (45%), respiratory tract infections (28%) (including nasopharyngitis, influenza, upper respiratory tract infection, and lower respiratory tract infection), nausea (26%), injection site reactions (26%), headache (16%), and vomiting (14%).
Slovenian: Najpogosteje poročani neželeni učinki so bili bolečine v trebuhu in napetost (45 %), okužbe dihal (28 %) (vključno z nazofaringitisom, gripo, okužbami zgornjih dihal in okužbami spodnjih dihal), navzea (26 %), reakcije na mestu injiciranja (26 %), glavobol (16 %) in bruhanje (14 %).
English: NOTE: Do not shake the vial.
Slovenian: OPOZORILO: Ne stresajte viale.
English: Monitoring of small bowel, gallbladder and bile ducts, and pancreas SBS patients are to be kept under close surveillance according to clinical treatment guidelines.
Slovenian: Spremljanje tankega črevesa, žolčnika in žolčevodov ter trebušne slinavke Bolnike s SKČ je treba skrbno spremljati v skladu s smernicami kliničnega zdravljenja.
English: Results below correspond to the ITT population at the recommended dose of 0.05 mg/kg/day.
Slovenian: Rezultati v nadaljevanju ustrezajo populaciji ITT pri priporočenem odmerku 0,05 mg/kg/dan.
English: Then gently push up the plunger to expel the air.
Slovenian: Potem nežno pritisnite na bat in iztisnite zrak.
English: If you forget to inject this medicine (or cannot inject it at your usual time), use it as soon as possible on that day.
Slovenian: Če ste si pozabili injicirati to zdravilo (ali si ga ne morete injicirati ob običajnem času), ga uporabite takoj, ko je to mogoče v istem dnevu.
English: Your doctor will consider this when prescribing this medicine.
Slovenian: Vaš zdravnik bo to upošteval pri predpisovanju tega zdravila.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or trace residues of tetracycline.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na sledi ostankov tetraciklina.
English: Active or suspected malignancy.
Slovenian: Aktivna maligna bolezen ali sum na maligno bolezen.
English: - if your child has or is suspected to have cancer.
Slovenian: - če ima vaš otrok raka ali če obstaja sum, da ima raka.
English: After 24 weeks of teduglutide treatment, patients showed small overall increase in C-reactive protein of approximately 1.5 mg/l on average.
Slovenian: Po 24 tednih zdravljenja s teduglutidom so pri bolnikih ugotovili blago zvišano koncentracijo C-reaktivnega proteina, v povprečju za približno 1,5 mg/l.
English: Adverse reactions are listed below by MedDRA system organ class and by frequency.
Slovenian: Spodaj so navedeni neželeni učinki po klasifikaciji organskih sistemov MedDRA in po pogostnosti.
English: In several nonclinical studies, teduglutide has been shown to preserve mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth.
Slovenian: V številnih predkliničnih raziskavah je bilo ugotovljeno, da teduglutid ohrani celovitost sluznice s pospeševanjem popravljanja in normalne rasti črevesa preko zvečanja višine resic in globine kript.
English: If heart rate and breathing is normal and you awaken fast, speak to your doctor.
Slovenian: Če imate normalen srčni utrip, normalno hitro dihate in se hitro zbudite, se posvetujte s svojim zdravnikom.
English: Revestive has not been studied in patients with severe hepatic impairment.
Slovenian: Zdravila Revestive niso raziskovali na bolnikih s težko okvaro jeter.
English: Five (5) subjects were enrolled in a standard of care cohort.
Slovenian: Pet (5) preiskovancev so vključili v kohorto s standardnim zdravljenjem.
English: Prior to initiating treatment with Revestive, faecal occult blood testing should be done for all children and adolescents.
Slovenian: Pred začetkom zdravljenja z zdravilom Revestive je treba pri vseh otrocih in mladostnikih opraviti test okultne krvi v blatu.
English: Instructions for preparing and injecting Revestive
Slovenian: Navodilo za pripravo in injiciranje zdravila Revestive
English: 4.7 Dispose all needles and syringes in a sharps disposal container or hard-walled container (for example, a detergent bottle with a lid).
Slovenian: 4.7 Odvrzite vse igle in injekcijske brizge v vsebnik za ostre predmete ali v vsebnik s trdim ohišjem (npr. plastenka od detergenta s pokrovom).
English: Tell the doctor, pharmacist or nurse if your child is using, has recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če vaš otrok uporablja, je pred kratkim uporabljal ali pa bo morda začel uporabljati katero koli drugo zdravilo.
English: If you forget to use Revestive
Slovenian: Če ste pozabili uporabiti zdravilo Revestive
English: It is unknown whether teduglutide is excreted in human milk.
Slovenian: Ni znano, ali se teduglutid izloča v materino mleko.
English: Colo-rectal polyps/Neoplasia
Slovenian: Kolorektalni polipi/novotvorbe
English: If two vials are needed, the procedure for the second vial must be repeated and the additional solution sucked up into the injection syringe containing the solution from the first vial.
Slovenian: Če sta potrebni dve viali, ponovite postopek z drugo vialo in dodatno raztopino povlecite v injekcijsko brizgo, ki že vsebuje raztopino iz prve viale.
English: These observations were not confirmed in clinical studies of more than one year duration.
Slovenian: Klinične študije, ki so trajale več kot eno leto, niso potrdile teh opažanj.
English: The symptoms include sudden weight gain, swollen ankles and/or shortness of breath.
Slovenian: Simptomi vključujejo nenadno povečanje telesne mase, otekanje gležnjev in/ali kratko sapo.
English: A treatment period of 6 months is recommended after which treatment effect should be evaluated.
Slovenian: Priporočajo obdobje zdravljenja je 6 mesecev, po katerem je treba oceniti učinek zdravljenja.
English: What Revestive is and what it is used for What you need to know before you use Revestive How to use Revestive
Slovenian: Kaj je zdravilo Revestive in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Revestive Kako uporabljati zdravilo Revestive Možni neželeni učinki
English: The maximum exposure and the overall extent of exposure to teduglutide following single 20 mg subcutaneous doses were lower (10-15%) in subjects with moderate hepatic impairment relative to those in healthy matched controls.
Slovenian: Največja izpostavljenost in skupen obseg izpostavljenosti teduglutidu po enkratnem subkutanem odmerku 20 mg sta bila pri preiskovancih z zmerno okvaro jeter nižja (10 %-15 %) v primerjavi s primerljivimi zdravimi kontrolnimi preiskovanci.
English: Once you have all the materials ready, you need to assemble the pre-filled syringe.
Slovenian: Ko imate pripravljene vse potrebne pripomočke, sestavite napolnjeno injekcijsko brizgo.
English: NOTE: Once prepared, the solution should be used immediately.
Slovenian: OPOZORILO: Po pripravi je treba raztopino takoj uporabiti.
English: This medicine may cause your child to feel dizzy.
Slovenian: To zdravilo lahko pri vašem otroku povzroči občutek vrtoglavice.
English: The doctor may need to give your child a lower dose of this medicine.
Slovenian: Zdravnik utegne vašemu otroku predpisati nižji odmerek tega zdravila.
English: Injection site reactions occurred in 26% of SBS patients treated with teduglutide, compared to 5% of patients in the placebo arm.
Slovenian: Reakcije na mestu injiciranja so se pojavile pri 26 % bolnikov s SKČ, zdravljenih s teduglutidom, pri bolnikih v skupini s placebom pa pri 5 %.
English: The recommended dose of Revestive in children and adolescents (aged 1 to 17 years) is the same as for adults (0.05 mg/kg body weight once daily).
Slovenian: Priporočeni odmerek zdravila Revestive za otroke in mladostnike (stare od 1 do 17 let) je enak kot za odrasle (0,05 mg/kg telesne mase enkrat na dan).
English: Teduglutide was rapidly absorbed from subcutaneous injection sites with maximum plasma levels occurring approximately 3-5 hours after dose administration at all dose levels.
Slovenian: Teduglutid se je hitro absorbiral iz podkožnih vbodnih mest in najvišje plazemske vrednosti so bile dosežene približno 3-5 ur po dajanju odmerka pri vseh velikostih odmerkov.
English: 3.7 Your child's dose in ml has been calculated by the doctor.
Slovenian: 3.7 Odmerek v ml za vašega otroka je izračunal otrokov zdravnik.
English: Treatment effect should be evaluated after 6 months.
Slovenian: Po šestih mesecih je treba oceniti učinek zdravljenja.
English: No data are available for paediatric patients with moderate to severe renal impairment and end-stage renal disease (ESRD).
Slovenian: Podatki za pediatrične bolnike z zmerno do težko okvaro ledvic in boleznijo ledvic v končnem stadiju (ESRD-end stage renal disease) niso na voljo.
English: - The solvent contains water for injections.
Slovenian: - Vehikel vsebuje vodo za injekcije.
English: It improves the absorption of nutrients and fluid from your remaining gastrointestinal tract (gut).
Slovenian: Izboljša absorpcijo hranil in tekočine iz preostanka vaših prebavil (črevesa).
English: Pharmacokinetic data demonstrated that the teduglutide exposure of foetal rabbits and suckling rat pups was very low.
Slovenian: Farmakokinetični podatki so pokazali, da je bila izpostavljenost teduglutidu pri kunčjih zarodkih in podganjih dojenih mladičih zelo majhna.
English: 4.5 Inject the medicine slowly by pushing steadily on the plunger until all the medicine is injected and the syringe is empty.
Slovenian: 4.5 Zdravilo injicirajte počasi z enakomernim pritiskanjem na bat, dokler ne injicirate celotne količine zdravila in izpraznite injekcijsko brizgo.
English: The rate and extent of absorption of teduglutide is dose-proportional at single and repeated subcutaneous doses up to 20 mg.
Slovenian: Hitrost in stopnja absorpcije teduglutida sta sorazmerni z velikostjo odmerka pri enkratnem odmerku in pri ponovljenih subkutanih odmerkih do 20 mg.
English: The objectives of the study were to evaluate safety, tolerability, and efficacy of teduglutide compared to standard of care.
Slovenian: Cilji študije so bili oceniti varnost, prenašanje in učinkovitost teduglutida v primerjavi s standardnim zdravljenjem.
English: Such events might impact the ability to drive and use machines.
Slovenian: Takšni dogodki bi lahko vplivali na sposobnost vožnje in upravljanja strojev.
English: It should be kept below 25°C and maximum storage time is twenty-four hours.
Slovenian: Shraniti jo je treba pri temperaturi do 25 °C, najdaljši dopustni čas shranjevanja je štiriindvajset ur.
English: - if your child is allergic to teduglutide or any of the other ingredients of this medicine (listed in section 6) or trace residues of tetracycline.
Slovenian: - če je vaš otrok alergičen na teduglutid ali na katero koli sestavino tega zdravila (navedeno v poglavju 6) ali na sledi ostankov tetraciklina.
English: These 10 subjects had required parenteral nutrition support for 1.2 to 15.5 years, and prior to treatment with teduglutide had required between 3.5 l/week and 13.4 l/week of parenteral nutrition support.
Slovenian: Teh 10 preiskovancev je parenteralno prehransko podporo potrebovalo od 1,2 do 15,5 let, pred zdravljenjem s teduglutidom so potrebovali parenteralno prehransko podporo med 3,5 l/teden in 13,4 l/teden.
English: Your doctor may need to give you a lower dose of this medicine.
Slovenian: Vaš zdravnik vam utegne predpisati nižji odmerek tega zdravila.
English: - if you suffer from certain cardiovascular diseases (affecting the heart and/or blood vessels) such as high blood pressure (hypertension) or have a weak heart (cardiac insufficiency).
Slovenian: - če imate določene kardiovaskularne bolezni (prizadenejo srce in/ali krvne žile), na primer visok krvni tlak (hipertenzija) ali šibko srce (srčno popuščanje).
English: Patients should be stable following a period of intestinal adaptation after surgery.
Slovenian: Bolniki morajo biti stabilni, obdobje prilagajanja črevesa po operaciji mora biti končano.
English: No clinical drug-drug interaction studies have been performed.
Slovenian: Študij medsebojnega delovanja niso izvedli.
English: Caution is needed when administering Revestive to persons with a known hypersensitivity to tetracycline (see section 4.3).
Slovenian: Previdnost je potrebna pri dajanju zdravila Revestive osebam z znano preobčutljivostjo na tetracikline (glejte poglavje 4.3).
English: Of the 39 placebo subjects, 29 completed 24 months of treatment with teduglutide.
Slovenian: Od 39 preiskovancev, ki so prejemali placebo, jih je 29 zaključilo 24-mesečno zdravljenje s teduglutidom.
English: Sixteen (16, 55.2%) of the 29 completers achieved a 20% or greater reduction of parenteral nutrition.
Slovenian: Šestnajst (16, 55,2 %) od 29 preiskovancev, ki je zaključilo študijo, je doseglo 20- ali večodstotno znižanje parenteralne prehrane.
English: The dose will be given in millilitres (ml) of solution.
Slovenian: Odmerek se odmerja v mililitrih (ml) raztopine.
English: If you stop using Revestive
Slovenian: Če ste prenehali uporabljati zdravilo Revestive
English: No dose adjustment is necessary in patients above the age of 65 years.
Slovenian: Pri bolnikih, starejših od 65 let, prilagajanje odmerka ni potrebno.
English: If this happens to your child, they should not drive, ride a bicycle or use machines until they feel better.
Slovenian: Če se mu to zgodi, ne sme upravljati vozil, kolesariti ali upravljati strojev, dokler se njegovo počutje ne izboljša.
English: Teduglutide has a terminal elimination half-life of approximately 2 hours.
Slovenian: Končni razpolovni čas izločanja teduglutida je približno 2 uri.
English: Reproductive and developmental toxicity studies evaluating teduglutide have been carried out in rats and rabbits at doses of 0, 2, 10 and 50 mg/kg/day subcutaneously.
Slovenian: Študije reproduktivne in razvojne toksičnosti teduglutida so bile opravljene na podganah in kuncih s subkutanimi odmerki po 0, 2, 10 in 50 mg/kg/dan.
English: Of these, 28 patients (93%) achieved a 20% or greater reduction of parenteral support.
Slovenian: Od teh jih je 28 (93 %) doseglo 20ali več-odstotno znižanje parenteralne prehranske podpore.
English: Then gently turn the vial upside-down once with the reconstitution needle and empty syringe still in the vial.
Slovenian: Nato enkrat nežno obrnite vialo navzdol, medtem ko sta rekonstitucijska igla in prazna injekcijska brizga še vedno v viali.
English: The mean reduction in parenteral nutrition was 4.0 l/week (39.4% reduction from baseline - the start of the extension study) and 4 of the 6 completers (66.7%) achieved a 20% or greater reduction in parenteral support.
Slovenian: Povprečno znižanje parenteralne prehrane je bilo 4,01 l/teden (39,4-odstotno zmanjšanje glede na izhodiščno raven - začetek podaljšane študije), 4 od 6 preiskovancev (66,7 %), ki so zaključili študijo, so dosegli 20- ali večodstotno znižanje parenteralne prehrane.
English: Similar to GLP-2, teduglutide is 33 amino acids in length with an amino acid substitution of alanine by glycine at the second position of the N-terminus.
Slovenian: Teduglutid je sestavljen iz 33 aminokislin, podobno kot GLP-2, le da ima substitucijo alanina z glicinom na drugem mestu glede na N-konec.
English: An individual assessment whether increased frequency of surveillance is necessary should be performed based on the patient characteristics (e.g., age, underlying disease).
Slovenian: Potrebo po povečani pogostnosti preiskav je treba presoditi pri vsakem bolniku posebej glede na njegove značilnosti (npr. starost, osnovna bolezen).
English: No data are available for children under 1 year of age.
Slovenian: Za otroke, mlajše od 1 leta, podatkov ni na voljo.
English: *Includes the following preferred terms: Nasopharyngitis, Influenza, Upper respiratory tract infection, and Lower respiratory tract infection.
Slovenian: *Vključuje naslednje prednostne izraze: nazofaringitis, gripa, okužba zgornjih dihal in okužba spodnjih dihal.
English: 4.6 Pull the needle straight out of the skin and discard the needle and syringe together into the sharps disposal container.
Slovenian: 4.6 Izvlecite iglo naravnost ven iz kože in jo zavrzite skupaj z brizgo v vsebnik za odlaganje ostrih predmetov.
English: An additional 24-week, randomised, double-blind, multicentre study was conducted in 59 paediatric patients aged 1 year through 17 years who were dependent on parenteral support.
Slovenian: Dodatno 24-tedensko randomizirano, dvojno slepo multicentrično študijo so opravili pri 59 pediatričnih bolnikih, starih od 1 do 17 let, ki so bili odvisni od parenteralne podpore.
English: Subsequent faecal occult blood testing should be done annually in children and adolescents while they are receiving Revestive.
Slovenian: Poznejše testiranje na okultno kri v blatu pri otrocih in mladostnikih med prejemanjem zdravila Revestive moramo opravljati enkrat na leto.
English: Subjects were maintained on teduglutide even if no longer requiring parenteral nutrition.
Slovenian: Preiskovanci so teduglutid prejemali še naprej, tudi če pri njih parenteralna prehrana ni bila več potrebna.
English: In pre-clinical studies, severe granulomatous inflammations were found associated with the injection sites.
Slovenian: V predkliničnih študijah so ugotovili primere hudega granulomatoznega vnetja v povezavi z mestom injiciranja.
English: The mean reduction of weekly parenteral nutrition volume was 4.9 l/week (52% reduction from baseline) after one year of continuous teduglutide treatment.
Slovenian: Povprečno zmanjšanje tedenskega volumna parenteralne prehrane je znašalo 4,9 l/teden (52 % zmanjšanje glede na izhodiščno vrednost) po enem letu neprekinjenega zdravljenja s teduglutidom.
English: Once a clear colourless solution is formed in the vial, the solution should be sucked up into a 1 ml injection syringe (or 0.5 ml or smaller injection syringe for paediatric use) with scale intervals of 0.02 ml or smaller (not included in the pack).
Slovenian: Ko v viali nastane bistra brezbarvna raztopina, povlecite raztopino v 1 ml injekcijsko brizgo (ali 0,5 ml ali manjšo injekcijsko brizgo za pediatrično uporabo) z merilno lestvico v razmikih po 0,02 ml ali manj (ni vključena v pakiranju).
English: 3.2 Take the injection syringe and attach it to the reconstitution needle which is still in the vial.
Slovenian: 3.2 Vzemite injekcijsko brizgo in jo pritrdite na rekonstitucijsko iglo, ki je še vedno v viali.
English: - if your child suffers from certain cardiovascular diseases (affecting the heart and/or blood vessels) such as high blood pressure (hypertension) or has a weak heart (cardiac insufficiency).
Slovenian: - če ima vaš otrok določene kardiovaskularne bolezni (prizadenejo srce in/ali krvne žile), na primer visok krvni tlak (hipertenzija) ali šibko srce (srčno popuščanje).
English: The mean reduction in parenteral nutrition (n=30) was 7.55 l/week (a 65.6% reduction from baseline).
Slovenian: Povprečno zmanjšanje parenteralne prehrane (n = 30) je bilo 7,55 l/teden (65,6-odstotno zmanjšanje glede na izhodiščno raven).
English: When starting and while getting treated with Revestive, the doctor may adjust the amount of intravenous fluids or nutrition your child receives.
Slovenian: Ob začetku zdravljenja in med zdravljenjem z zdravilom Revestive bo zdravnik mogoče prilagodil količino intravenskih tekočin ali prehrane, ki jih prejema vaš otrok.
English: If heart rate and breathing is normal and your child awakens fast, speak to the doctor.
Slovenian: Če ima vaš otrok normalen srčni utrip, normalno hitro diha in se hitro zbudi, se posvetujte z zdravnikom.
English: There continued to be evidence of increased response to treatment for up 2.5 years in all groups exposed to teduglutide in terms of parenteral nutrition volume reduction, gaining additional days off parenteral nutrition per week, and achieving weaning of parenteral support.
Slovenian: V vseh skupinah bolnikov, ki so prejemali teduglutid, se je do 2,5 let dolgo kazal večji odziv na zdravljenje v smislu znižanja volumna parenteralne prehrane, povečanja števila dni na teden brez parenteralne prehrane in prenehanja parenteralne prehrane.
English: Not known (frequency cannot be estimated from the available data): - Allergic reaction (hypersensitivity) - Fluid retention - Polyps (small abnormal growths) in your stomach
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): - alergijska reakcija (preobčutljivost), - zastajanje tekočine,
English: Of the 12 subjects not randomised in the pivotal study, 6 completed 24 months of treatment with teduglutide.
Slovenian: Od 12 preiskovancev, ki v ključni študiji niso bili randomizirani, jih je 6 zaključilo 24-mesečno zdravljenje s teduglutidom.
English: Due to the heterogeneity of the SBS population, a carefully monitored down-titration of the daily dose may be considered for some patients to optimise tolerability of the treatment.
Slovenian: Zaradi heterogenosti populacije s SKČ je pri nekaterih bolnikih potrebna skrbno nadzorovana titracija z zniževanjem dnevnega odmerka, da se izboljša prenašanje zdravila.
English: Keep using this medicine for as long as your child's doctor prescribes it for them.
Slovenian: Uporabljajte to zdravilo toliko časa, dokler ga predpisuje otrokov zdravnik.
English: Adenomas of the jejunal mucosa were observed in 1 out of 50 males and 5 out of 50 males exposed to teduglutide plasma levels approximately 10- and 155-fold higher than obtained in patients administered the recommended daily dose.
Slovenian: Adenome sluznice jejunuma so opazili pri 1 od 50 samcev in pri 5 od 50 samcev, ki so bili izpostavljeni približno 10- in 155-krat višjim plazemskim koncentracijam teduglutida v primerjavi z bolniki na priporočenem dnevnem odmerku.
English: NOTE: If your doctor has told you that you need two vials, prepare a second pre-filled syringe with solvent and a second powder vial as shown in the main steps 1 and 2.
Slovenian: OPOZORILO: Če vam je vaš zdravnik predpisal dve viali, pripravite drugo napolnjeno injekcijsko brizgo z vehiklom in drugo vialo s praškom, kot je prikazano v glavnih korakih 1 in 2.
English: For paediatric patients with a body weight >20 kg, the 5 mg strength vial should be used.
Slovenian: Za pediatrične bolnike s telesno maso >20 kg uporabljajte viale z jakostjo 5 mg.
English: Do not use this medicine if you notice that the solution is cloudy or contains particulate matter.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je raztopina motna ali vsebuje delce.
English: What Revestive looks like and contents of the pack
Slovenian: Izgled zdravila Revestive in vsebina pakiranja
English: 5 How to store Revestive Contents of the pack and other information
Slovenian: Shranjevanje zdravila Revestive Vsebina pakiranja in dodatne informacije
English: An in vitro study indicates that teduglutide does not inhibit cytochrome P450 drug metabolising enzymes.
Slovenian: Študija in vitro je pokazala, da teduglutid ne zavira encimov za presnovo zdravil s citokromom P450.
English: 4.3 Remove the plastic cap from the needle of the prepared injection syringe.
Slovenian: 4.3 Odstranite plastični pokrovček z igle na pripravljeni injekcijski brizgi.
English: - if your child has decreased kidney function.
Slovenian: - če ima vaš otrok okvarjeno delovanje ledvic.