FrancophonIA/ELRC3.0 huggingface dataset:
English: 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
Slovenian: 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
English: The doctor may have to change your child's dose of other medicines.
Slovenian: Zdravnik utegne spremeniti odmerke drugih zdravil, ki jih jemlje vaš otrok.
English: Decreased appetite Fluid overload
Slovenian: Presnovne in prehranske motnje zmanjšan apetit preobremenitev s tekočino
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Revestive may potentially trigger the development of antibodies.
Slovenian: Uporaba zdravila Revestive lahko potencialno sproži razvoj protiteles, kar je skladno s potencialnimi imunogenimi lastnostmi zdravil, ki vsebujejo peptide.
English: One additional patient in the follow-up study was weaned off parenteral nutrition.
Slovenian: V okviru spremljevalne študije so parenteralno prehrano ukinili še enemu dodatnemu bolniku.
English: 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.
Slovenian: 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.
English: Revestive should not be used if a cancer is detected during your colonoscopy.
Slovenian: Zdravila Revestive ne smete jemati, če pri kolonoskopiji odkrijejo, da imate raka.
English: 1.25 mg strength Volume to be injected
Slovenian: Jakost 1,25 mg Volumen, ki ga je treba injicirati
English: Once yearly follow-up colonoscopies (or alternate imaging) are recommended during the first 2 years of Revestive treatment.
Slovenian: Prvi dve leti zdravljenja z zdravilom Revestive je priporočljiva kontrolna kolonoskopija (ali druga vrsta slikovne preiskave) enkrat na leto.
English: 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).
Slovenian: 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).
English: Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS).
Slovenian: Zdravilo Revestive je indicirano za zdravljenje bolnikov, starih 1 leto ali več, s sindromom kratkega črevesa (SKČ).
English: 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).
Slovenian: 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).
English: 2.1 Remove the blue flip-off button from the powder vial, wipe the top with an alcohol wipe and allow to dry.
Slovenian: 2.1 Odstranite modri pokrovček z viale s praškom, obrišite vrhnjo površino z alkoholno krpico in pustite, da se posuši.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 1.1 Vzemite napolnjeno injekcijsko brizgo z vehiklom in odstranite zgornji del bele plastične zaporke, tako da je pripravljena za pritrditev rekonstitucijske igle.
English: Uncommon (may affect up to 1 in 100 people) - Polyps (small abnormal growths) in your child's small bowel
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): - polipi (majhne nenormalne tvorbe) v otrokovem tankem črevesu.
English: 2.1 Remove the green flip-off button from the powder vial, wipe the top with an alcohol wipe and allow to dry.
Slovenian: 2.1 Odstranite zeleni pokrovček z viale s praškom, obrišite vrhnjo površino z alkoholno krpico in pustite, da se posuši.
English: 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.
Slovenian: 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.
English: The doctor will choose the dose that is right for your child, depending on their body weight.
Slovenian: Zdravnik bo glede na otrokovo telesno maso izbral odmerek, ki je primeren za vašega otroka.
English: Do not use this medicine after the expiry date which is stated on the carton, the vial and the pre-filled syringe after EXP.
Slovenian: 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.
English: 2.4 Leave the reconstitution needle and empty syringe in the vial.
Slovenian: 2.4 Rekonstitucijsko iglo in prazno injekcijsko brizgo pustite v viali.
English: Caution should be exercised when prescribing Revestive.
Slovenian: Ob predpisovanju zdravila Revestive je potrebna previdnost.
English: Caution is needed if you are hypersensitive to tetracycline (see “Do not use Revestive” section).
Slovenian: Previdnost je potrebna, če ste alergični na tetracikline (glejte poglavje »Ne uporabljajte zdravila Revestive«).
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih zapleti v zvezi z gastrointestinalno stomo
English: 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.
Slovenian: 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).
English: - if you have decreased kidney function.
Slovenian: - če imate okvarjeno delovanje ledvic.
English: 2.7 Observe the vial for any undissolved powder.
Slovenian: 2.7 Poglejte, ali je v viali še kaj neraztopljenega praška.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni 'brez natrija'.
English: 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).
Slovenian: 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).
English: Your doctor will choose the dose that is right for you depending on your body weight.
Slovenian: Vaš zdravnik bo glede na vašo telesno maso izbral odmerek, ki je primeren za vas.
English: Includes the following preferred terms: Injection site haematoma, Injection site erythema, Injection site pain, Injection site swelling and Injection site haemorrhage.
Slovenian: 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.
English: 3.1 Remove the reconstitution syringe from the reconstitution needle which is still in the vial and discard the reconstitution syringe.
Slovenian: 3.1 Odstranite rekonstitucijsko brizgo z rekonstitucijske igle, ki je še vedno v viali, in rekonstitucijsko brizgo zavrzite.
English: 3.4 Remove the injection syringe from reconstitution needle leaving the needle in the vial.
Slovenian: 3.4 Odstranite injekcijsko brizgo z rekonstitucijske igle in pustite iglo v viali.
English: 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.
Slovenian: 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.
English: If you need a sharps disposal container, please contact your child's doctor.
Slovenian: Če potrebujete vsebnik za ostre predmete, se posvetujte z otrokovim zdravnikom.
English: As a precautionary measure, it is preferable to avoid the use of Revestive during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Revestive bolje izogibati.
English: Treatment with teduglutide resulted in a 2.5 l/week reduction in parenteral nutrition requirements (from a pre-treatment baseline of 9.6 litres) versus 0.9 l/week (from a pre-treatment baseline of 10.7 litres) for placebo at 24 weeks.
Slovenian: Zdravljenje s teduglutidom je imelo po 24 tednih za posledico zmanjšanje potrebe po parenteralni prehrani za 2,5 l/teden (glede na izhodiščno vrednost 9,6 litrov pred zdravljenjem) v primerjavi z 0,9 l/teden (glede na izhodiščno vrednost 10,7 litrov pred zdravljenjem) za placebo skupino.
English: If you, or your carer, are injecting the medicine, you or your carer must receive adequate training by your doctor or nurse.
Slovenian: Če si zdravilo injicirate sami ali vam ga injicira negovalec, morate vi ali vaš negovalec opraviti ustrezno usposabljanje pod nadzorstvom svojega zdravnika ali medicinske sestre.
English: The mean change in parenteral nutrition volume from baseline at Week 24, based on subject diary data, was -23.30 (±17.50) mL/kg/day, corresponding to -41.57% (±28.90); the mean change in the SOC arm was -6.03 (±4.5) mL/kg/day (corresponding to a -10.21% [±13.59]).
Slovenian: Povprečna sprememba volumna parenteralne prehrane od izhodišča do 24. tedna na podlagi podatkov v dnevnikih bolnikov je bila -23,30 (±17,50) ml/kg/dan, kar ustreza -41,57 % (±28,90); povprečna sprememba v skupini s SOC je bila -6,03 (±4,5) ml/kg/dan (kar ustreza -10,21 % [±13,59]).
English: Pancreatic adverse events such as chronic and acute pancreatitis, pancreatic duct stenosis, pancreas infection and increased blood amylase and lipase have been reported in clinical studies.
Slovenian: V kliničnih študijah so poročali o neželenih dogodkih v zvezi s trebušno slinavko, na primer kronični ali akutni pankreatitis, stenozo voda trebušne slinavke, okužbo trebušne slinavke ter zvišane koncentracije amilaze in lipaze v krvi.
English: In rats, mean teduglutide concentration in milk was less than 3% of the maternal plasma concentration following a single subcutaneous injection of 25 mg/kg.
Slovenian: Pri podganah je po enkratni podkožni injekciji 25 mg/kg teduglutida povprečna koncentracija teduglutida v mleku znašala manj kot 3 % koncentracije v materini plazmi.
English: If you need a sharps disposal container, please contact your doctor.
Slovenian: Če potrebujete vsebnik za ostre predmete, se posvetujte s svojim zdravnikom.
English: Expel any excessive volume from the syringe with the needle cap still on until your dose is reached.
Slovenian: Iztisnite odvečni volumen iz injekcijske brizge, dokler ne dosežete svojega odmerka, igla pa naj bo še pokrita s pokrovčkom.
English: At the end of study, 14 (48.3%), 7 (24.1%) and 5 (17.2%) patients achieved a reduction of 1, 2, or 3 days per week in parenteral nutrition, respectively.
Slovenian: Ob koncu študije je 14 (48,3 %) bolnikov doseglo skrajšanje prejemanja parenteralne prehranske podpore za 1 dan na teden, 7 (24,1 %) za 2 dni na teden in 5 (17,2 %) za 3 dni na teden.
English: It is strongly recommended that every time Revestive is administered to a patient, the name and lot number of the product are recorded in order to maintain a link between the patient and the lot of the product.
Slovenian: Zelo priporočljivo je, da vsakokrat, ko bolniku date zdravilo Revestive, zabeležite ime in številko serije zdravila, s čimer ohranjate povezavo med bolnikom in serijo zdravila.
English: Of responders in the pivotal study who completed the extension study, 21 out of 22 (96%) sustained their response to teduglutide after an additional 2 years of continuous treatment.
Slovenian: Pri 21 bolnikih od 22 (96 %) odzivnih bolnikov v ključni študiji, ki so zaključili podaljšano študijo, je bil ohranjen odziv na teduglutid po dodatnih dveh letih neprekinjenega zdravljenja.
English: 1.1 Take the pre-filled syringe with the solvent and flip off the top part of the white plastic cap on the pre-filled syringe so that it is ready for the reconstitution needle to be attached.
Slovenian: 1.1 Vzemite napolnjeno injekcijsko brizgo z vehiklom in odstranite zgornji del belega plastičnega pokrovčka na napolnjeni injekcijski brizgi, tako da je pripravljena za pritrditev rekonstitucijske igle.
English: If you, or the carer, are injecting the medicine, you or the carer must receive adequate training by the doctor or nurse.
Slovenian: Če zdravilo injicirate sami ali ga otroku injicira negovalec, morate vi ali negovalec opraviti ustrezno usposabljanje pod nadzorstvom zdravnika ali medicinske sestre.
English: At the end of study, 3 (50%), 2 (33%) and 2 (33%) achieved a reduction of 1, 2, or 3 days per week in parenteral nutrition, respectively.
Slovenian: Po koncu študije so 3 (50 %) bolniki dosegli skrajšanje prejemanja parenteralne prehrane za 1 dan na teden, 2 (33 %) za 2 dni na teden in 2 (33 %) za 3 dni na teden.
English: Revestive is a powder and solvent for solution for injection (5 mg teduglutide in vial, 0.5 ml solvent in pre-filled syringe).
Slovenian: Zdravilo Revestive je prašek in vehikel za raztopino za injiciranje (5 mg teduglutida v viali, 0,5 ml vehikla v napolnjeni injekcijski brizgi).
English: - if you are allergic to teduglutide or any of the other ingredients of this medicine (listed in section 6) or trace residues of tetracycline.
Slovenian: - če ste alergični na teduglutid ali na katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: The solution must not be used if it is cloudy or contains particulate matter.
Slovenian: Raztopine ne smete uporabiti, če je motna ali če vsebuje delce.
English: The mean decrease from baseline at Week 24 in the number of days/week on parenteral nutrition, based on subject diary data, was -1.34 (±2.24) days/week corresponding to a percentage decrease of -21.33% (±34.09).
Slovenian: Povprečno zmanjšanje števila dni/teden na parenteralni prehrani od izhodišča do 24. tedna na podlagi podatkov v dnevnikih bolnikov je bilo -1,34 (±2,24) dni/teden, kar ustreza odstotnemu zmanjšanju -21,33 % (±34,09).
English: 4.2 Clean the intended site of injection on your child's skin with an alcohol swab, using a circular motion, working outwards.
Slovenian: 4.2 Očistite izbrano mesto injiciranja na otrokovi koži z alkoholno blazinico, to naredite s krožnimi gibi v smeri navzven.
English: Congestive heart failure has been observed in clinical trials.
Slovenian: V kliničnih preskušanjih so opažali kongestivno srčno popuščanje.
English: The mean change in parenteral nutrition volume from baseline at Week 12 in the ITT population, based on physician-prescribed data, was -2.57 (±3.56) l/week, correlating to a -39.11% (±40.79) mean decrease, compared to 0.43 (±0.75) l/week, correlating to a 7.38% (±12.76) increase in the standard of care cohort.
Slovenian: Srednja sprememba volumna parenteralne prehrane od izhodišča v 12. tednu v populaciji ITT (Intention to treat - populacija z namenom zdravljenja) na podlagi podatkov o parenteralni prehrani, ki jo je predpisal zdravnik, je bila -2,57 (±3,56) l/teden, kar je bilo 39,11-odstotno (±40,79) povprečno zmanjšanje, v primerjavi z 0,43 (±0,75) l/teden, kar je bilo 7,38-odstotno (±12,76) zvečanje, v kohorti s standardnim zdravljenjem.
English: Medical check-ups before and during treatment with Revestive Before starting treatment with this medicine, your child will 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 vaš otrok začne zdraviti s tem zdravilom, mu bo zdravnik moral narediti preiskavo, s katero bo ugotovil, ali je v njegovem blatu kri.
English: The powder in the vial must then be dissolved by adding all the solvent from the pre-filled syringe.
Slovenian: Nato raztopite prašek v viali tako, da mu dodate celotno količino vehikla iz napolnjene injekcijske brizge.
English: Colonoscopy/sigmoidoscopy is required if there is evidence of unexplained blood in the stool.
Slovenian: Če je v blatu prisotna nepojasnjena kri, je potrebna kolonoskopija/ sigmoidoskopija.
English: - if your child has had cancer in the gastrointestinal tract, including liver, gallbladder or bile ducts, and pancreas within the last five years.
Slovenian: - če je vaš otrok imel v zadnjih petih letih raka prebavil, vključno z jetri, žolčnikom ali žolčevodi in trebušno slinavko.
English: Revestive is a powder and solvent for solution for injection (1.25 mg teduglutide in vial, 0.5 ml solvent in pre-filled syringe).
Slovenian: Zdravilo Revestive je prašek in vehikel za raztopino za injiciranje (1,25 mg teduglutida v viali, 0,5 ml vehikla v napolnjeni injekcijski brizgi).
English: Uncommon (may affect up to 1 in 100 people) - Polyps (small abnormal growths) in your small bowel
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): - polipi (majhne nenormalne tvorbe) v tankem črevesu.
English: Inject the solution
Slovenian: Injicirajte raztopino
English: Revestive should not be used if a cancer is detected during colonoscopy.
Slovenian: Zdravila Revestive otrok ne sme jemati, če pri kolonoskopiji odkrijejo, da ima raka.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj dispnea
English: Ten (10) subjects were weaned off their parenteral support while on teduglutide treatment for 30 months.
Slovenian: Pri desetih (10) preiskovancih je bila parenteralna prehrana med 30-mesečnim zdravljenjem s teduglutidom ukinjena.
English: Revestive is used to treat adults, children and adolescents (aged 1 year and above) with Short Bowel Syndrome.
Slovenian: Zdravilo Revestive se uporablja za zdravljenje odraslih, otrok in mladostnikov (starih 1 leto ali več) s sindromom kratkega črevesa.
English: Continued treatment is recommended for patients who have weaned off parenteral nutrition.
Slovenian: Pri bolnikih, pri katerih je bila prekinjena parenteralna prehrana, je priporočljivo nadaljnje zdravljenje.
English: Powder 3 ml vial (glass) with rubber stopper (bromobutyl) containing 1.25 mg teduglutide.
Slovenian: 3-mililitrska viala (steklena) z gumijastim zamaškom (bromobutil), ki vsebuje 1,25 mg teduglutida.
English: 4.2 Clean the intended site of injection on your skin with an alcohol swab, using a circular motion, working outwards.
Slovenian: 4.2 Očistite izbrano mesto injiciranja na svoji koži z alkoholno blazinico, to naredite s krožnimi gibi v smeri navzven.
English: This is because there is no experience with Revestive in this age group.
Slovenian: Otroci, mlajši od 1 leta, tega zdravila ne smejo uporabljati, ker v tej starostni skupini z zdravilom Revestive nimamo nikakršnih izkušenj.
English: A 1.25 mg strength vial is also available for paediatric use (patients with a body weight <20 kg).
Slovenian: Za uporabo pri otrocih (bolniki s telesno maso <20 kg) so na voljo tudi viale z jakostjo 1,25 mg.
English: Animal data do not indicate any impairment of fertility.
Slovenian: Študije na živalih ne kažejo na vpliv na sposobnost razmnoževanja.
English: Cases of cholecystitis, cholangitis, and cholelithiasis have been reported in clinical studies.
Slovenian: V kliničnih študijah so zabeležili primere holecistitisa, holangitisa in žolčnih kamnov.
English: In the pivotal phase 3 double-blind, placebo-controlled study in patients with SBS, who required parenteral nutrition, 43 patients were randomised to a 0.05 mg/kg/day dose of teduglutide and 43 patients to placebo for up to 24 weeks.
Slovenian: V ključni dvojno-slepi, s placebom kontrolirani študiji 3. faze pri bolnikih s SKČ, ki so potrebovali parenteralno prehrano, je bilo 43 bolnikov randomiziranih v skupino z 0,05 mg/kg/dan teduglutida, in 43 bolnikov v skupino s placebom za čas zdravljenja do 24 tednov.
English: Revestive contains less than 1 mmol sodium (23 mg) per dose.
Slovenian: Zdravilo Revestive vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
English: As a precautionary measure it is preferable to avoid the use of Revestive during breast-feeding.
Slovenian: Iz previdnostnih razlogov se je v času dojenja uporabi zdravila Revestive bolje izogibati.
English: Revestive has minor influence on the ability to drive, ride a bicycle, and use machines.
Slovenian: Zdravilo Revestive ima blag vpliv na sposobnost vožnje, kolesarjenja in upravljanja strojev.
English: There was no change from baseline in the standard of care cohort.
Slovenian: V kohorti s standardnim zdravljenjem ni bilo sprememb od izhodišča.
English: Contact the doctor or the emergency unit if your child experiences yellowing of the skin and the whites in the eyes, itching, dark urine and light-coloured stools or pain in the upper right side or middle of the stomach area
Slovenian: Posvetujte se z zdravnikom ali z urgentno enoto, če ima otrok porumenelo kožo in beločnici, ga srbi, ima temen urin in svetlo obarvano blato ali bolečino v desnem zgornjem delu trebuha ali na sredini trebuha.
English: No dose adjustment is necessary for adult or paediatric patients with mild renal impairment.
Slovenian: Pri odraslih in pediatričnih bolnikih z blago ledvično okvaro odmerka ni treba prilagajati.
English: Treatment should be stopped if no overall improvement of the patient condition is achieved.
Slovenian: Če ne pride do splošnega izboljšanja bolnikovega stanja, je treba zdravljenje prekiniti.
English: Materials provided in the pack: - 28 vials with 1.25 mg teduglutide as a powder - 28 pre-filled syringes with solvent
Slovenian: Pripomočki, ki so na voljo v pakiranju: - 28 vial s po 1,25 mg teduglutida v obliki praška, - 28 napolnjenih injekcijskih brizg z vehiklom.