natgillin/translations-raw huggingface dataset:
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).
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).
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).
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).
- The active substance is teduglutide.
- Učinkovina je teduglutid.
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).
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).
Three subjects (3/15, 20%) on the recommended teduglutide dose were weaned off parenteral nutrition by Week 12.
Trem preiskovancem (3/15, 20 %) na priporočenem odmerku teduglutida so do 12. tedna popolnoma ukinili parenteralno prehrano.
If a dose is missed, that dose should be injected as soon as possible on that day.
Če bolnik odmerek izpusti, mora prejeti injekcijo takoj, ko je to mogoče, v istem dnevu.
Treatment should be initiated under the supervision of a medical professional with experience in the treatment of SBS.
Zdravljenje se mora začeti pod nadzorom zdravstvenega delavca, ki ima izkušnje z zdravljenjem SKČ.
Avoid areas that are inflamed, swollen, scarred or covered by a mole, birthmark or other lesion.
Izogibajte se področjem, ki so vneta, otekla, prekrita z brazgotino, pegami, kožnimi znamenji ali drugimi spremembami.
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.
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.
Reduction in parenteral nutrition volume
Zmanjšanje volumna parenteralne prehrane
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).
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).
The recommended daily dose for your child is 0.05 mg per kg body weight.
Priporočeni dnevni odmerek za vašega otroka je 0,05 mg na kg telesne mase.
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.
Preglednici z injiciranimi volumni na podlagi priporočenega odmerka na telesno maso tako za odrasle kot pediatrične bolnike sta navedeni v poglavju 4.2.
The corresponding increase in enteral calories was 58.80% (±64.20), compared to 57.02% (±55.25) in the standard of care cohort.
Ustrezno zvečanje enteralnih kalorij je bilo 58,80 % (±64,20), v primerjavi s 57,02 % (±55,25) v kohorti s standardnim zdravljenjem.
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.
1.2 Pritrdite rekonstitucijsko iglo (22G, 1½" (0,7 x 40 mm)) na sestavljeno napolnjeno injekcijsko brizgo s privijanjem v smeri urinega kazalca.
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.
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.
Following subcutaneous administration, similar Cmax of teduglutide across age groups was demonstrated by population pharmacokinetics modelling.
Po subkutanem dajanju so s populacijskim farmakokinetičnim moduliranjem dokazali podobno Cmax teduglutida po starostnih skupinah.
Solvent: Water for injections.
Vehikel: voda za injekcije.
5 mg strength Volume to be injected
Jakost 5 mg Volumen, ki ga je treba injicirati
In a phase 1 study the effect of hepatic impairment on the pharmacokinetics of teduglutide following subcutaneous administration of 20 mg teduglutide was investigated.
V študiji 1. faze so preučevali učinek okvare jeter na farmakokinetiko teduglutida po subkutani uporabi 20 mg teduglutida.
Do not use Revestive
Ne uporabljajte zdravila Revestive:
Uncommon (may affect up to 1 in 100 people): - Fainting.
Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): - Omedlevica.
Attach the needle to the injection syringe containing the medicine.
Iglo pritrdite na injekcijsko brizgo z zdravilom.
Common (may affect up to 1 in 10 people): - Congestive heart failure.
Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): - Kongestivno srčno popuščanje.
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).
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).
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.
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.
Caution is needed if your child is hypersensitive to tetracycline (see “Do not use Revestive” section).
Previdnost je potrebna, če je vaš otrok alergičen na tetracikline (glejte poglavje »Ne uporabljajte zdravila Revestive«.
The injection volume per body weight when using the 5 mg strength vial is provided in Table 2 below.
Injicirani volumen na telesno maso pri uporabi viale z jakostjo 5 mg je naveden v preglednici 2 v nadaljevanju.
In case of malignancy, Revestive therapy must be discontinued (see section 4.3).
V primeru maligne bolezni se mora zdravljenje z zdravilom Revestive prekiniti (glejte poglavje 4.3).
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.
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.
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.
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.
In a phase 1 study, the effect of renal impairment on the pharmacokinetics of teduglutide following subcutaneous administration of 10 mg teduglutide was investigated.
V študiji 1. faze so preučevali učinek okvare ledvic na farmakokinetiko teduglutida po subkutani uporabi 10 mg teduglutida.
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.
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
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.
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.
Talk to your doctor before using Revestive: - if you have severely decreased liver function.
Pred začetkom uporabe zdravila Revestive se posvetujte z zdravnikom: - če imate močno okvarjeno delovanje jeter.
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.
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.
Revestive contains the active substance teduglutide.
Zdravilo Revestive vsebuje učinkovino teduglutid.
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.
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.
If your child is pregnant or breast-feeding, the use of Revestive is not recommended.
Če je vaša hči noseča ali doji, uporaba zdravila Revestive ni priporočljiva.
After reconstitution, the solution should be used immediately.
Po rekonstituciji je treba raztopino uporabiti takoj.
How to use Revestive
Kako uporabljati zdravilo Revestive
The reactions included injection site haematoma, injection site erythema, injection site pain, injection site swelling and injection site haemorrhage (see also section 5.3).
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).
All adverse reactions identified in post-marketing experience are italicised.
Vsi neželeni učinki, ki so jih ugotovili po prihodu zdravila na trg, so napisani v poševnem tisku.
Congestive heart failure
Srčne bolezni kongestivno srčno popuščanje
What Revestive contains
Kaj vsebuje zdravilo Revestive
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.
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).
There is no experience in children under 1 year of age.
Pri otrocih, mlajših od 1 leta, nimamo izkušenj.
Revestive has minor influence on the ability to drive and use machines.
Zdravilo Revestive ima blag vpliv na sposobnost vožnje in upravljanja strojev.
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.
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.
Concomitant medicinal products
Sočasna zdravila
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
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.
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).
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.
Following subcutaneous administration, teduglutide has an apparent volume of distribution of 26 litres in patients with SBS.
Porazdelitev Po subkutani uporabi ima teduglutid pri bolnikih s SKČ navidezni volumen porazdelitve 26 litrov.
The recommended daily dose is 0.05 mg per kg body weight.
Priporočeni dnevni odmerek je 0,05 mg na kg telesne mase.
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.
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.
Powder and solvent for solution for injection 1 vial of powder containing 5 mg teduglutide 1 pre-filled syringe containing 0.5 ml of solvent 28 vials of powder containing 5 mg teduglutide 28 pre-filled syringes containing 0.5 ml of solvent
prašek in vehikel za raztopino za injiciranje 1 viala praška, ki vsebuje 5 mg teduglutida 1 napolnjena injekcijska brizga, ki vsebuje 0,5 ml vehikla 28 vial praška, ki vsebujejo po 5 mg teduglutida 28 napolnjenih injekcijskih brizg, ki vsebujejo po 0,5 ml vehikla
The doctor may have to change your child's dose of other medicines.
Zdravnik utegne spremeniti odmerke drugih zdravil, ki jih jemlje vaš otrok.
Decreased appetite Fluid overload
Presnovne in prehranske motnje zmanjšan apetit preobremenitev s tekočino
Teduglutide was studied in a 12-week, open-label, clinical study in 42 paediatric subjects aged 1 year through 14 years with SBS who were dependent on parenteral nutrition.
Teduglutid so proučevali v 12-tedenski odprti klinični študiji pri 42 pediatričnih preiskovancih s SKČ, starih od 1 do 14 let, ki so bili odvisni od parenteralne prehrane.
The doctor will take special care and monitor your child's small bowel function and monitor for signs and symptoms indicating problems with the gallbladder, bile ducts and pancreas.
Zdravnik bo posebno skrbno spremljal delovanje otrokovega tankega črevesa in bo pozoren na znake in simptome, ki bi kazali na težave z žolčnikom, žolčevodi in trebušno slinavko.
Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Revestive may potentially trigger the development of antibodies.
Uporaba zdravila Revestive lahko potencialno sproži razvoj protiteles, kar je skladno s potencialnimi imunogenimi lastnostmi zdravil, ki vsebujejo peptide.
One additional patient in the follow-up study was weaned off parenteral nutrition.
V okviru spremljevalne študije so parenteralno prehrano ukinili še enemu dodatnemu bolniku.
Your doctor will take special care and monitor your small bowel function and monitor for signs and symptoms indicating problems with your gallbladder, bile ducts and pancreas.
Vaš zdravnik bo še posebej skrben in bo spremljal delovanje vašega tankega črevesa ter bo pozoren na znake in simptome, ki kažejo na težave vašega žolčnika, žolčevodov in trebušne slinavke.
Revestive should not be used if a cancer is detected during your colonoscopy.
Zdravila Revestive ne smete jemati, če pri kolonoskopiji odkrijejo, da imate raka.
1.25 mg strength Volume to be injected
Jakost 1,25 mg Volumen, ki ga je treba injicirati
Once yearly follow-up colonoscopies (or alternate imaging) are recommended during the first 2 years of Revestive treatment.
Prvi dve leti zdravljenja z zdravilom Revestive je priporočljiva kontrolna kolonoskopija (ali druga vrsta slikovne preiskave) enkrat na leto.
4.1 Find an area on your belly, or if you have pain or hardening of the tissue on your belly, on your thigh where it is easy for you to give the injection (see the diagram).
4.1 Izberite si predel na svojem trebuhu ali, v primeru bolečin ali zatrdlin tkiva na vašem trebuhu, predel na svojem stegnu, kamor boste lahko injicirali zdravilo (glejte sliko).
Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS).
Zdravilo Revestive je indicirano za zdravljenje bolnikov, starih 1 leto ali več, s sindromom kratkega črevesa (SKČ).
4.1 Find an area on your child's belly, or if they have pain or hardening of the tissue on their belly, on your child's thigh where it is easy for you to give the injection (see the diagram).
4.1 Izberite predel na otrokovem trebuhu ali, v primeru bolečin ali zatrdlin tkiva na otrokovem trebuhu, predel na otrokovem stegnu, kamor boste lahko injicirali zdravilo (glejte sliko).
2.1 Remove the blue flip-off button from the powder vial, wipe the top with an alcohol wipe and allow to dry.
2.1 Odstranite modri pokrovček z viale s praškom, obrišite vrhnjo površino z alkoholno krpico in pustite, da se posuši.
In another phase 3 double-blind, placebo-controlled study in patients with SBS, who required parenteral nutrition, patients received a 0.05 mg/kg/day dose (n=35), a 0.10 mg/kg/day dose (n=32) of teduglutide or placebo (n=16) for up to 24 weeks.
V drugi dvojno slepi, s placebom kontrolirani študiji 3. faze pri bolnikih s SKČ, ki so potrebovali parenteralno prehrano, so bolniki prejemali odmerek teduglutida 0,05 mg/kg/dan (n=35), odmerek teduglutida 0,10 mg/kg/dan (n=32) ali placebo (n=16) do 24 tednov.
1.1 Take the pre-filled syringe with solvent and flip off the top part of the white plastic cap so that it is ready for the reconstitution needle to be attached.
1.1 Vzemite napolnjeno injekcijsko brizgo z vehiklom in odstranite zgornji del bele plastične zaporke, tako da je pripravljena za pritrditev rekonstitucijske igle.
Uncommon (may affect up to 1 in 100 people) - Polyps (small abnormal growths) in your child's small bowel
Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): - polipi (majhne nenormalne tvorbe) v otrokovem tankem črevesu.
2.1 Remove the green flip-off button from the powder vial, wipe the top with an alcohol wipe and allow to dry.
2.1 Odstranite zeleni pokrovček z viale s praškom, obrišite vrhnjo površino z alkoholno krpico in pustite, da se posuši.
Based on subject diary data, 18 (69.2%) subjects in the 0.05 mg/kg/day group achieved the primary endpoint of ≥20% reduction in PN/IV volume at end of treatment, compared to baseline; in the SOC arm, 1 (11.1%) subject achieved this endpoint.
Na podlagi podatkov v dnevnikih bolnikov je 18 (69,2%) bolnikov v skupini z odmerkom 0,05 mg/kg/dan doseglo glavni cilj, ki je bil ≥20-odstotno zmanjšanje volumna parenteralne/intravenske (PN/IV) prehrane ob koncu zdravljenja v primerjavi z izhodiščem; v skupini s SOC je dosegel ta cilj 1 (11,1 %) bolnik.
The doctor will choose the dose that is right for your child, depending on their body weight.
Zdravnik bo glede na otrokovo telesno maso izbral odmerek, ki je primeren za vašega otroka.
Do not use this medicine after the expiry date which is stated on the carton, the vial and the pre-filled syringe after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, viali in napolnjeni injekcijski brizgi poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
2.4 Leave the reconstitution needle and empty syringe in the vial.
2.4 Rekonstitucijsko iglo in prazno injekcijsko brizgo pustite v viali.
Caution should be exercised when prescribing Revestive.
Ob predpisovanju zdravila Revestive je potrebna previdnost.
Caution is needed if you are hypersensitive to tetracycline (see “Do not use Revestive” section).
Previdnost je potrebna, če ste alergični na tetracikline (glejte poglavje »Ne uporabljajte zdravila Revestive«).
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih zapleti v zvezi z gastrointestinalno stomo
Three (3) doses of teduglutide, 0.0125 mg/kg/day (n=8), 0.025 mg/kg/day (n=14), and 0.05 mg/kg/day (n=15), were investigated for 12 weeks.
Dvanajst tednov so raziskovali tri (3) odmerke teduglutida, 0,0125 mg/kg/dan (n=8), 0,025 mg/kg/dan (n=14) in 0,05 mg/kg/dan (n=15).
- if you have decreased kidney function.
- če imate okvarjeno delovanje ledvic.
2.7 Observe the vial for any undissolved powder.
2.7 Poglejte, ali je v viali še kaj neraztopljenega praška.
This medicine contains less than 1 mmol sodium (23 mg) per dose.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni 'brez natrija'.
The mean decrease from baseline at Week 12 in the number of days/week on parenteral nutrition, in the ITT population based on physician-prescribed data, was -1.36 (±2.37) days/week corresponding to a percentage decrease of -24.49% (±42.46).
Srednje zmanjšanje števila dni/tednov na parenteralni prehrani od izhodišča v 12. tednu v populaciji ITT na podlagi podatkov o parenteralni prehrani, ki jo je predpisal zdravnik, je bilo -1,36 (±2,37) dni/teden, kar je ustrezalo odstotnemu zmanjšanju -24,49 % (±42,46).
Your doctor will choose the dose that is right for you depending on your body weight.
Vaš zdravnik bo glede na vašo telesno maso izbral odmerek, ki je primeren za vas.
Includes the following preferred terms: Injection site haematoma, Injection site erythema, Injection site pain, Injection site swelling and Injection site haemorrhage.
Vključuje naslednje prednostne izraze: hematom na mestu injiciranja, eritem na mestu injiciranja, bolečina na mestu injiciranja, oteklina na mestu injiciranja in krvavitev na mestu injiciranja.
3.1 Remove the reconstitution syringe from the reconstitution needle which is still in the vial and discard the reconstitution syringe.
3.1 Odstranite rekonstitucijsko brizgo z rekonstitucijske igle, ki je še vedno v viali, in rekonstitucijsko brizgo zavrzite.
3.4 Remove the injection syringe from reconstitution needle leaving the needle in the vial.
3.4 Odstranite injekcijsko brizgo z rekonstitucijske igle in pustite iglo v viali.
Treatment with teduglutide resulted in a 4.4 l/week reduction in parenteral nutrition requirements (from a pre-treatment baseline of 12.9 litres) versus 2.3 l/week (from a pre-treatment baseline of 13.2 litres) for placebo at 24 weeks.
Zdravljenje s teduglutidom je imelo po 24 tednih za posledico zmanjšanje potrebe po parenteralni prehrani za 4,4 l/teden (glede na izhodiščno vrednost 12,9 litrov pred zdravljenjem) v primerjavi z 2,3 l/teden (glede na izhodiščno vrednost 13,2 litrov pred zdravljenjem) za placebo skupino.