FrancophonIA/ELRC3.0 huggingface dataset:
English: Medical check-ups before and during treatment with Revestive Before you start treatment with this medicine, your doctor will need to perform a colonoscopy (a procedure to see inside your colon and rectum) to check for the presence of polyps (small abnormal growths) and remove them.
Slovenian: Zdravniški pregledi pred in med zdravljenjem z zdravilom Revestive Preden se začnete zdraviti s tem zdravilom, bo vaš zdravnik moral narediti kolonoskopijo (postopek, pri katerem si zdravnik ogleda notranjost vašega debelega črevesa in danke, da vidi, ali so prisotni polipi (majhne nenormalne rašče), in jih odstrani.
English: When starting and while getting treated with Revestive, your doctor may adjust the amount of intravenous fluids or nutrition you receive.
Slovenian: Ob začetku zdravljenja in med zdravljenjem z zdravilom Revestive vam bo zdravnik mogoče prilagodil količino intravenskih tekočin ali prehrane, ki jih prejemate.
English: - Store below 25°C.
Slovenian: - Shranjujte pri temperaturi do 25 °C.
English: 3.5 Take the injection needle, but do not remove the plastic needle cap.
Slovenian: 3.5 Vzemite injekcijsko iglo, vendar z nje ne odstranite pokrovčka.
English: Based on integrated data from two trials in adults with SBS (a 6-month randomised placebo-controlled trial, followed by a 24-month open-label trial), the development of anti-teduglutide antibodies in subjects who received subcutaneous administration of 0.05 mg/kg teduglutide once daily was 3% (2/60) at Month 3, 17% (13/77) at Month 6, 24% (16/67) at Month 12, 33% (11/33) at Month 24, and 48% (14/29) at Month 30.
Slovenian: Na podlagi združenih podatkov iz dveh preskušanj pri odraslih s SKČ (6-mesečno randomizirano preskušanje, kontrolirano s placebom, ki mu je sledilo 24-mesečno odprto preskušanje), je bil razvoj anti-teduglutidnih protiteles pri preiskovancih, ki so prejemali po 0,05 mg/kg teduglutida subkutano enkrat na dan, 3 % (2/60) po 3 mesecih, 17 % (13/77) po 6 mesecih, 24 % (16/67) po 12 mesecih, 33 % (11/33) po 24 mesecih in 48 % (14/29) po 30 mesecih.
English: Revestive can be used in children and adolescents (aged 1 year and above).
Slovenian: Zdravilo Revestive se lahko uporablja pri otrocih in mladostnikih (starih 1 leto ali več).
English: Teduglutide increases villus height and crypt depth of the intestinal epithelium.
Slovenian: Teduglutid zveča višino resic in globino kript v črevesnem epiteliju.
English: Such events might impact the ability to drive, ride a bicycle, or use machines.
Slovenian: Takšni dogodki bi lahko vplivali na sposobnost vožnje, kolesarjenja ali upravljanja strojev.
English: NOTE: Do not use the same area each day for each injection - rotate sites (use upper, lower, and left and right side of your child's belly) to avoid discomfort.
Slovenian: OPOZORILO: Ne uporabljajte istega področja za injekcijo vsak dan - izmenjujte mesta injiciranja (uporabite zgornji, spodnji, levi in desni del otrokovega trebuha) v izogib nelagodju.
English: In case of malignancy, Revestive treatment must be discontinued (see sections 4.3 and 5.3).
Slovenian: V primeru maligne bolezni se mora zdravljenje z zdravilom Revestive prekiniti (glejte poglavji 4.3 in 5.3).
English: At Week 16 (4 weeks following the end of treatment) parenteral nutrition volume reductions were still evident but less than observed at Week 12 when subjects were still on teduglutide (mean decrease of -31.80% (±39.26) compared to a 3.92% (±16.62) increase in the standard of care group).
Slovenian: V 16. tednu (4 tedne po koncu zdravljenja) so bila zmanjšanja volumna parenteralne prehrane še vedno očitna, vendar manjša od tistih v 12. tednu, ko so bili preiskovanci še vedno na teduglutidu (srednje zmanjšanje -31,80 % (±39,26), v primerjavi s 3,92 % (±16,62) zvečanjem v skupini s standardnim zdravljenjem).
English: Keep using this medicine for as long as your doctor prescribes it for you.
Slovenian: Uporabljajte to zdravilo toliko časa, dokler vam ga predpisuje vaš zdravnik.
English: The primary efficacy analysis of the study results showed no statistically significant difference between the group on teduglutide 0.10 mg/kg/day and the placebo group, while the proportion of subjects receiving the recommended teduglutide dose of 0.05 mg/kg/day achieving at least a 20% reduction of parenteral nutrition at Week 20 and 24 was statistically significantly different versus placebo (46% versus 6.3%, p<0.01).
Slovenian: Analiza osnovne učinkovitosti rezultatov študije ni pokazala statistično pomembnih razlik med skupino s teduglutidom 0,10 mg/kg/dan in placebo skupino, medtem ko je bil delež preiskovancev s priporočenim odmerkom teduglutida 0,05 mg/kg/dan, ki so dosegli vsaj 20 % zmanjšanje potrebe po parenteralni prehrani, po 20 in 24 tednih statistično pomembno različen od placeba (46 % v primerjavi s 6,3 %; p < 0,01).
English: Teduglutide treatment induced expansion of the absorptive epithelium by significantly increasing villus height in the small intestine.
Slovenian: Zdravljenje s teduglutidom je povzročilo povečanje absorpcijskega epitelija s pomembnim zvečanjem višine resic v tankem črevesu.
English: The reconstituted solution should be administered by subcutaneous injection once daily, alternating sites between 1 of the 4 quadrants of the abdomen.
Slovenian: Rekonstituirano raztopino je treba dati v obliki subkutane injekcije enkrat na dan, pri čemer je treba menjati mesta injiciranja in injicirati v enega od 4 kvadrantov trebuha.
English: Twenty-one (21) patients treated with teduglutide (48.8%) versus 9 on placebo (20.9%) achieved at least a one day reduction in parenteral nutrition administration (p=0.008).
Slovenian: Enaindvajset (21) bolnikov, zdravljenih s teduglutidom (48,8 %), je doseglo skrajšanje prejemanja parenteralne prehrane za vsaj en dan v primerjavi z 9 bolniki na placebu (20,9 %) (p = 0,008).
English: A table with the injection volumes based on the recommended dose per body weight for paediatric patients is provided in section 4.2.
Slovenian: Preglednica z injiciranimi volumni na podlagi priporočenega odmerka na telesno maso za pediatrične bolnike je navedena v poglavju 4.2.
English: Shaking the vial may produce foam, which makes it difficult to extract the solution from the vial.
Slovenian: Stresanje viale lahko povzroči nastanek pene, ki oteži pretakanje raztopine iz viale.
English: NOTE: If your child's 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 otrokov 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: NOTE: Do not use the same area each day for each injection - rotate sites (use upper, lower, and left and right side of your belly) to avoid discomfort.
Slovenian: OPOZORILO: Ne uporabljajte istega področja za injekcijo vsak dan - izmenjujte mesta injiciranja (uporabite zgornji, spodnji, levi in desni del trebuha) v izogib nelagodju.
English: Detailed instructions on the preparation and injection of Revestive are provided in the package leaflet.
Slovenian: Podrobna navodila za pripravo in injiciranje zdravila Revestive najdete v Navodilu za uporabo.
English: It improves the absorption of nutrients and fluid from your child's remaining gastrointestinal tract (gut).
Slovenian: Izboljša absorpcijo hranil in tekočine iz preostanka prebavil (črevesa) vašega otroka.
English: Final study report
Slovenian: Poročilo o zaključku študije
English: At week 24, there was a decrease in the infusion time of -3.03 (±3.84) hours/day in the 0.05 mg/kg/day arm, corresponding to a percentage change of -26.09% (±36.14).
Slovenian: V 24. tednu se je infuzijski čas skrajšal za -3,03 (±3,84) ure/dan v skupini z odmerkom 0,05 mg/kg/dan, kar ustreza odstotni spremembi -26,09 % (±36,14).
English: If you are pregnant or breast-feeding, the use of Revestive is not recommended.
Slovenian: Če ste noseči ali dojite, uporaba zdravila Revestive ni priporočljiva.
English: Three (3) paediatric subjects in the 0.05 mg/kg group achieved the additional endpoint of enteral autonomy by week 24.
Slovenian: Trije (3) pediatrični bolniki v skupini z 0,05 mg/kg so do 24. tedna dosegli dodatni cilj študije, avtonomnost na enteralni prehrani.
English: Two (2) patients on the recommended teduglutide dose were weaned off parenteral nutrition by Week 24.
Slovenian: Dvema (2) bolnikoma na priporočenem odmerku teduglutida je bilo mogoče ukiniti parenteralno prehrano po 24 tednih.
English: In a rat carcinogenicity study, treatment related benign neoplasms included tumours of the bile duct epithelium in males exposed to teduglutide plasma levels approximately 32- and 155-fold higher than obtained in patients administered the recommended daily dose (incidence of 1 out of 44 and 4 out of 48, respectively).
Slovenian: V študiji kancerogenosti na podganah so v zvezi z zdravljenjem opazili benigne novotvorbe, vključno s tumorji epitelija žolčevodov pri samcih, izpostavljenih približno 32- in 155-krat višjim plazemskim koncentracijam teduglutida v primerjavi z bolniki na priporočenem dnevnem odmerku (pojavnost 1 od 44 in 4 od 48).
English: The proportion of teduglutide-treated subjects achieving a 20% to 100% reduction of parenteral nutrition at Week 20 and 24 was statistically significantly different from placebo (27 out of 43 subjects, 62.8% versus 13 out of 43 patients, 30.2%, p=0.002).
Slovenian: Delež preiskovancev, zdravljenih s teduglutidom, ki so dosegli od 20 % do 100 % zmanjšanje parenteralne prehrane po 20 in 24 tednih, je bil statistično pomembno različen od placeba (27 od 43 preiskovancev, 62,8 %, v primerjavi s 13 od 43 preiskovancev, 30,2 %; p = 0,002).
English: - The active substance is teduglutide.
Slovenian: - Učinkovina je teduglutid.
English: Materials needed but not included in the pack: - Reconstitution needles (size 22G, length 1½" (0.7 x 40 mm)) - 0.5 or 1 ml injection syringes (with scale intervals of 0.02 ml or smaller).
Slovenian: Potrebni pripomočki, ki niso vključeni v pakiranju: - rekonstitucijske igle (velikost 22G, dolžina 1½" (0,7 x 40 mm)), - 0,5 ali 1 ml injekcijske brizge (z merilno lestvico v razmikih po 0,02 ml ali manj).
English: Three subjects (3/15, 20%) on the recommended teduglutide dose were weaned off parenteral nutrition by Week 12.
Slovenian: Trem preiskovancem (3/15, 20 %) na priporočenem odmerku teduglutida so do 12. tedna popolnoma ukinili parenteralno prehrano.
English: If a dose is missed, that dose should be injected as soon as possible on that day.
Slovenian: Če bolnik odmerek izpusti, mora prejeti injekcijo takoj, ko je to mogoče, v istem dnevu.
English: Treatment should be initiated under the supervision of a medical professional with experience in the treatment of SBS.
Slovenian: Zdravljenje se mora začeti pod nadzorom zdravstvenega delavca, ki ima izkušnje z zdravljenjem SKČ.
English: Avoid areas that are inflamed, swollen, scarred or covered by a mole, birthmark or other lesion.
Slovenian: Izogibajte se področjem, ki so vneta, otekla, prekrita z brazgotino, pegami, kožnimi znamenji ali drugimi spremembami.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden uporabite to zdravilo.
English: Reduction in parenteral nutrition volume
Slovenian: Zmanjšanje volumna parenteralne prehrane
English: In adult or paediatric patients with moderate and severe renal impairment (creatinine clearance less than 50 ml/min), and end-stage renal disease, the daily dose should be reduced by 50% (see section 5.2).
Slovenian: Pri odraslih in pediatričnih bolnikih z zmerno ali težko ledvično okvaro (očistek kreatinina manj kot 50 ml/min) ali z ledvično boleznijo v končni fazi je treba zmanjšati dnevni odmerek za 50 % (glejte poglavje 5.2).
English: The recommended daily dose for your child is 0.05 mg per kg body weight.
Slovenian: Priporočeni dnevni odmerek za vašega otroka je 0,05 mg na kg telesne mase.
English: Tables with the injection volumes based on the recommended dose per body weight for both adults and paediatric patients are provided in section 4.2.
Slovenian: Preglednici z injiciranimi volumni na podlagi priporočenega odmerka na telesno maso tako za odrasle kot pediatrične bolnike sta navedeni v poglavju 4.2.
English: The corresponding increase in enteral calories was 58.80% (±64.20), compared to 57.02% (±55.25) in the standard of care cohort.
Slovenian: Ustrezno zvečanje enteralnih kalorij je bilo 58,80 % (±64,20), v primerjavi s 57,02 % (±55,25) v kohorti s standardnim zdravljenjem.
English: 1.2 Attach the reconstitution needle (22G, 1½" (0.7 x 40 mm)) to the assembled pre-filled syringe by screwing it on in a clockwise direction.
Slovenian: 1.2 Pritrdite rekonstitucijsko iglo (22G, 1½" (0,7 x 40 mm)) na sestavljeno napolnjeno injekcijsko brizgo s privijanjem v smeri urinega kazalca.
English: Patients on teduglutide maintained their previous dose assignment throughout the extension phase, while placebo patients were randomised to active treatment, either 0.05 or 0.10 mg/kg/day.
Slovenian: Bolniki na teduglutidu so tudi v podaljšani fazi prejemali svoj prejšnji odmerek, medtem ko so bili bolniki s placebom randomizirani v dve skupini z aktivnim zdravljenjem, bodisi po 0,05 ali po 0,10 mg/kg/dan.
English: Following subcutaneous administration, similar Cmax of teduglutide across age groups was demonstrated by population pharmacokinetics modelling.
Slovenian: Po subkutanem dajanju so s populacijskim farmakokinetičnim moduliranjem dokazali podobno Cmax teduglutida po starostnih skupinah.
English: Solvent: Water for injections.
Slovenian: Vehikel: voda za injekcije.
English: 5 mg strength Volume to be injected
Slovenian: Jakost 5 mg Volumen, ki ga je treba injicirati
English: In a phase 1 study the effect of hepatic impairment on the pharmacokinetics of teduglutide following subcutaneous administration of 20 mg teduglutide was investigated.
Slovenian: V študiji 1. faze so preučevali učinek okvare jeter na farmakokinetiko teduglutida po subkutani uporabi 20 mg teduglutida.
English: Do not use Revestive
Slovenian: Ne uporabljajte zdravila Revestive:
English: Uncommon (may affect up to 1 in 100 people): - Fainting.
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): - Omedlevica.
English: Attach the needle to the injection syringe containing the medicine.
Slovenian: Iglo pritrdite na injekcijsko brizgo z zdravilom.
English: Common (may affect up to 1 in 10 people): - Congestive heart failure.
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): - Kongestivno srčno popuščanje.
English: In paediatric patients with moderate and severe renal impairment (creatinine clearance less than 50 ml/min), and end-stage renal disease, the daily dose should be reduced by 50% (see section 5.2).
Slovenian: Pri pediatričnih bolnikih z zmerno ali težko ledvično okvaro (očistek kreatinina manj kot 50 ml/min) ali z ledvično boleznijo v končni fazi je treba zmanjšati dnevni odmerek za 50 % (glejte poglavje 5.2).
English: At Week 16, the parenteral nutrition calories consumption continued to decrease with percentage mean changes from baseline of -39.15% (±39.08) compared to -0.87% (±9.25) for the standard of care cohort.
Slovenian: V 16. tednu se je poraba kalorij parenteralne prehrane še naprej zmanjševala s srednjimi spremembami v odstotkih od izhodišča -39,15 % (±39,08), v primerjavi z -0,87 % (±9,25) za kohorto s standardnim zdravljenjem.
English: Caution is needed if your child is hypersensitive to tetracycline (see “Do not use Revestive” section).
Slovenian: Previdnost je potrebna, če je vaš otrok alergičen na tetracikline (glejte poglavje »Ne uporabljajte zdravila Revestive«.
English: The injection volume per body weight when using the 5 mg strength vial is provided in Table 2 below.
Slovenian: Injicirani volumen na telesno maso pri uporabi viale z jakostjo 5 mg je naveden v preglednici 2 v nadaljevanju.
English: In case of malignancy, Revestive therapy must be discontinued (see section 4.3).
Slovenian: V primeru maligne bolezni se mora zdravljenje z zdravilom Revestive prekiniti (glejte poglavje 4.3).
English: At Week 12, based on subject diary data, subjects showed mean percentage reductions of 35.55% (±35.23) hours per day compared to baseline, which corresponded to reductions in the hours/day of parenteral nutrition usage of -4.18 (±4.08), while subjects in the standard of care cohort showed minimal change in this parameter at the same time point.
Slovenian: V 12. tednu so preiskovanci na podlagi dnevniških podatkov kazali povprečno zmanjšanje v odstotkih za 35,55 % (±35,23) ur na dan v primerjavi z izhodiščem, kar je ustrezalo zmanjšanju uporabe parenteralne prehrane za -4,18 (±4,08) ur/dan, medtem ko so preiskovanci v kohorti s standardnim zdravljenjem kazali minimalno spremembo tega parametra v isti časovni točki.
English: If your child is pregnant or breast-feeding, may be pregnant or is planning to have a baby, ask the doctor, pharmacist or nurse for advice before using this medicine.
Slovenian: Če je vaša hči noseča ali doji, bi lahko bila noseča ali načrtuje zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden uporabite to zdravilo.
English: In a phase 1 study, the effect of renal impairment on the pharmacokinetics of teduglutide following subcutaneous administration of 10 mg teduglutide was investigated.
Slovenian: V študiji 1. faze so preučevali učinek okvare ledvic na farmakokinetiko teduglutida po subkutani uporabi 10 mg teduglutida.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Slovenian: Trajanje shranjevanja med uporabo naj normalno ne bi presegalo 24 ur pri 2 do 8 °C, razen če je bilo zdravilo rekonstituirano v kontroliranih in validiranih aseptičnih razmerah
English: The solution must be injected subcutaneously into a cleaned area on the abdomen, or if this is not possible, on the thigh (see section 4.2 Method of administration) using a thin needle for subcutaneous injection.
Slovenian: Raztopino injicirajte subkutano v očiščen predel trebuha ali, če to ni mogoče, v stegno (glejte poglavje 4.2 Način uporabe) s pomočjo tanke igle za injiciranje v podkožje.
English: Talk to your doctor before using Revestive: - if you have severely decreased liver function.
Slovenian: Pred začetkom uporabe zdravila Revestive se posvetujte z zdravnikom: - če imate močno okvarjeno delovanje jeter.
English: Medical check-ups before and during treatment with Revestive Before you start treatment with this medicine, you will need to have a test done to see if there is blood in the stool.
Slovenian: Zdravniški pregledi pred in med zdravljenjem z zdravilom Revestive Preden se boste začeli zdraviti s tem zdravilom, vam bodo morali narediti preiskavo, s katero bodo ugotovili, ali je v vašem blatu kri.
English: Revestive contains the active substance teduglutide.
Slovenian: Zdravilo Revestive vsebuje učinkovino teduglutid.
English: The solution must be injected subcutaneously into a cleaned area on the abdomen, or if this is not possible, on the thigh (see section 4.2 Method of administration) using a thin needle for subcutaneous injection suitable for paediatric use.
Slovenian: Raztopino injicirajte subkutano v očiščen predel trebuha ali, če to ni mogoče, v stegno (glejte poglavje 4.2 Način uporabe) s pomočjo tanke igle za injiciranje v podkožje, primerne za pediatrično uporabo.
English: If your child is pregnant or breast-feeding, the use of Revestive is not recommended.
Slovenian: Če je vaša hči noseča ali doji, uporaba zdravila Revestive ni priporočljiva.
English: After reconstitution, the solution should be used immediately.
Slovenian: Po rekonstituciji je treba raztopino uporabiti takoj.
English: How to use Revestive
Slovenian: Kako uporabljati zdravilo Revestive
English: The reactions included injection site haematoma, injection site erythema, injection site pain, injection site swelling and injection site haemorrhage (see also section 5.3).
Slovenian: Reakcije so vključevale hematom na mestu injiciranja, rdečino na mestu injiciranja, bolečino na mestu injiciranja, oteklino na mestu injiciranja in krvavitev na mestu injiciranja (glejte tudi poglavje 5.3).
English: All adverse reactions identified in post-marketing experience are italicised.
Slovenian: Vsi neželeni učinki, ki so jih ugotovili po prihodu zdravila na trg, so napisani v poševnem tisku.
English: Congestive heart failure
Slovenian: Srčne bolezni kongestivno srčno popuščanje
English: What Revestive contains
Slovenian: Kaj vsebuje zdravilo Revestive
English: Two doses of teduglutide were studied: 0.025 mg/kg/day (n=24) and 0.05 mg/kg/day (n=26); 9 subjects were enrolled in a standard of care (SOC) arm. Randomisation was stratified by age across dose groups.
Slovenian: Proučili so dva odmerka teduglutida: 0,025 mg/kg/dan (n=24) in 0,05 mg/kg/dan (n=26); 9 bolnikov so vključili v skupino s standardnim zdravljenjem (standard of care - SOC).
English: There is no experience in children under 1 year of age.
Slovenian: Pri otrocih, mlajših od 1 leta, nimamo izkušenj.
English: Revestive has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Revestive ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: 2.3 Taking the powder vial, insert the reconstitution needle attached to the assembled pre-filled syringe into the centre of the rubber stopper and gently push the plunger all the way down to inject all the solvent into the vial.
Slovenian: 2.3 Vzemite vialo s praškom, z rekonstitucijsko iglo, ki je pritrjena na sestavljeno napolnjeno injekcijsko brizgo, prebodite sredino gumijaste zaporke, nežno pritisnite bat do konca in injicirajte celotno količino vehikla v vialo.
English: Concomitant medicinal products
Slovenian: Sočasna zdravila
English: Very common (may affect more than 1 in 10 people): - Respiratory tract infection (any infection of the sinuses, throat, airways or lungs) - Headache - Stomach pain, bloated stomach, feeling sick (nausea), swelling of stoma (an artificial opening for waste removal), vomiting - Reddening, pain or swelling at the site of the injection
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): - okužba dihal (kakršna koli okužba sinusov, žrela, dihalnih poti ali pljuč); - glavobol, - bolečine v trebuhu, napet trebuh, občutek slabosti (navzea), otekanje stome (umetna odprtina za odvajanje blata), bruhanje; - pordelost, bolečina ali oteklina na mestu injiciranja.
English: You will also have a colonoscopy done (a procedure to see inside your colon and rectum to check for the presence of polyps (small abnormal growths) and have them removed) if you have unexplained blood in your bowel movements (stools).
Slovenian: Naredili vam bodo tudi kolonoskopijo (postopek, pri katerem si zdravnik ogleda notranjost vašega debelega črevesa in danke, da vidi, ali so prisotni polipi (majhne nenormalne tvorbe), in jih odstrani), če imate nepojasnjeno kri v blatu.
English: Following subcutaneous administration, teduglutide has an apparent volume of distribution of 26 litres in patients with SBS.
Slovenian: Porazdelitev Po subkutani uporabi ima teduglutid pri bolnikih s SKČ navidezni volumen porazdelitve 26 litrov.
English: The recommended daily dose is 0.05 mg per kg body weight.
Slovenian: Priporočeni dnevni odmerek je 0,05 mg na kg telesne mase.
English: Teduglutide was studied in 17 patients with SBS allocated to five treatment groups using doses of 0.03, 0.10 or 0.15 mg/kg teduglutide once daily, or 0.05 or 0.075 mg/kg bid in a 21-day open-label, multicenter, dose-ranging study.
Slovenian: Teduglutid so preučevali pri 17 bolnikih s SKČ, ki so bili razporejeni v pet skupin zdravljenja z uporabo odmerkov po 0,03, 0,10 ali 0,15 mg/kg teduglutida enkrat na dan ali 0,05 ali 0,075 mg/kg dvakrat na dan v 21 dni trajajoči odprti multicentrični študiji različnih odmerkov.