natgillin/translations-raw huggingface dataset:
If you need a sharps disposal container, please contact your child's doctor.
Če potrebujete vsebnik za ostre predmete, se posvetujte z otrokovim zdravnikom.
As a precautionary measure, it is preferable to avoid the use of Revestive during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Revestive bolje izogibati.
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.
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.
If you, or your carer, are injecting the medicine, you or your carer must receive adequate training by your doctor or nurse.
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.
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]).
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]).
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.
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.
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.
Pri podganah je po enkratni podkožni injekciji 25 mg/kg teduglutida povprečna koncentracija teduglutida v mleku znašala manj kot 3 % koncentracije v materini plazmi.
If you need a sharps disposal container, please contact your doctor.
Če potrebujete vsebnik za ostre predmete, se posvetujte s svojim zdravnikom.
Expel any excessive volume from the syringe with the needle cap still on until your dose is reached.
Iztisnite odvečni volumen iz injekcijske brizge, dokler ne dosežete svojega odmerka, igla pa naj bo še pokrita s pokrovčkom.
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.
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.
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.
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.
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.
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.
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.
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.
If you, or the carer, are injecting the medicine, you or the carer must receive adequate training by the doctor or nurse.
Če zdravilo injicirate sami ali ga otroku injicira negovalec, morate vi ali negovalec opraviti ustrezno usposabljanje pod nadzorstvom zdravnika ali medicinske sestre.
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.
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.
Revestive is a powder and solvent for solution for injection (5 mg teduglutide in vial, 0.5 ml solvent in pre-filled syringe).
Zdravilo Revestive je prašek in vehikel za raztopino za injiciranje (5 mg teduglutida v viali, 0,5 ml vehikla v napolnjeni injekcijski brizgi).
- if you are allergic to teduglutide or any of the other ingredients of this medicine (listed in section 6) or trace residues of tetracycline.
- če ste alergični na teduglutid ali na katero koli sestavino tega zdravila (navedeno v poglavju 6)
The solution must not be used if it is cloudy or contains particulate matter.
Raztopine ne smete uporabiti, če je motna ali če vsebuje delce.
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).
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).
4.2 Clean the intended site of injection on your child's skin with an alcohol swab, using a circular motion, working outwards.
4.2 Očistite izbrano mesto injiciranja na otrokovi koži z alkoholno blazinico, to naredite s krožnimi gibi v smeri navzven.
Congestive heart failure has been observed in clinical trials.
V kliničnih preskušanjih so opažali kongestivno srčno popuščanje.
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.
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.
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.
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.
The powder in the vial must then be dissolved by adding all the solvent from the pre-filled syringe.
Nato raztopite prašek v viali tako, da mu dodate celotno količino vehikla iz napolnjene injekcijske brizge.
Colonoscopy/sigmoidoscopy is required if there is evidence of unexplained blood in the stool.
Če je v blatu prisotna nepojasnjena kri, je potrebna kolonoskopija/ sigmoidoskopija.
- if your child has had cancer in the gastrointestinal tract, including liver, gallbladder or bile ducts, and pancreas within the last five years.
- če je vaš otrok imel v zadnjih petih letih raka prebavil, vključno z jetri, žolčnikom ali žolčevodi in trebušno slinavko.
Revestive is a powder and solvent for solution for injection (1.25 mg teduglutide in vial, 0.5 ml solvent in pre-filled syringe).
Zdravilo Revestive je prašek in vehikel za raztopino za injiciranje (1,25 mg teduglutida v viali, 0,5 ml vehikla v napolnjeni injekcijski brizgi).
Uncommon (may affect up to 1 in 100 people) - Polyps (small abnormal growths) in your small bowel
Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): - polipi (majhne nenormalne tvorbe) v tankem črevesu.
Inject the solution
Injicirajte raztopino
Revestive should not be used if a cancer is detected during colonoscopy.
Zdravila Revestive otrok ne sme jemati, če pri kolonoskopiji odkrijejo, da ima raka.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj dispnea
Ten (10) subjects were weaned off their parenteral support while on teduglutide treatment for 30 months.
Pri desetih (10) preiskovancih je bila parenteralna prehrana med 30-mesečnim zdravljenjem s teduglutidom ukinjena.
Revestive is used to treat adults, children and adolescents (aged 1 year and above) with Short Bowel Syndrome.
Zdravilo Revestive se uporablja za zdravljenje odraslih, otrok in mladostnikov (starih 1 leto ali več) s sindromom kratkega črevesa.
Continued treatment is recommended for patients who have weaned off parenteral nutrition.
Pri bolnikih, pri katerih je bila prekinjena parenteralna prehrana, je priporočljivo nadaljnje zdravljenje.
Powder 3 ml vial (glass) with rubber stopper (bromobutyl) containing 1.25 mg teduglutide.
3-mililitrska viala (steklena) z gumijastim zamaškom (bromobutil), ki vsebuje 1,25 mg teduglutida.
4.2 Clean the intended site of injection on your skin with an alcohol swab, using a circular motion, working outwards.
4.2 Očistite izbrano mesto injiciranja na svoji koži z alkoholno blazinico, to naredite s krožnimi gibi v smeri navzven.
This is because there is no experience with Revestive in this age group.
Otroci, mlajši od 1 leta, tega zdravila ne smejo uporabljati, ker v tej starostni skupini z zdravilom Revestive nimamo nikakršnih izkušenj.
A 1.25 mg strength vial is also available for paediatric use (patients with a body weight <20 kg).
Za uporabo pri otrocih (bolniki s telesno maso <20 kg) so na voljo tudi viale z jakostjo 1,25 mg.
Animal data do not indicate any impairment of fertility.
Študije na živalih ne kažejo na vpliv na sposobnost razmnoževanja.
Cases of cholecystitis, cholangitis, and cholelithiasis have been reported in clinical studies.
V kliničnih študijah so zabeležili primere holecistitisa, holangitisa in žolčnih kamnov.
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.
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.
Revestive contains less than 1 mmol sodium (23 mg) per dose.
Zdravilo Revestive vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
As a precautionary measure it is preferable to avoid the use of Revestive during breast-feeding.
Iz previdnostnih razlogov se je v času dojenja uporabi zdravila Revestive bolje izogibati.
Revestive has minor influence on the ability to drive, ride a bicycle, and use machines.
Zdravilo Revestive ima blag vpliv na sposobnost vožnje, kolesarjenja in upravljanja strojev.
There was no change from baseline in the standard of care cohort.
V kohorti s standardnim zdravljenjem ni bilo sprememb od izhodišča.
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
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.
No dose adjustment is necessary for adult or paediatric patients with mild renal impairment.
Pri odraslih in pediatričnih bolnikih z blago ledvično okvaro odmerka ni treba prilagajati.
Treatment should be stopped if no overall improvement of the patient condition is achieved.
Če ne pride do splošnega izboljšanja bolnikovega stanja, je treba zdravljenje prekiniti.
Materials provided in the pack: - 28 vials with 1.25 mg teduglutide as a powder - 28 pre-filled syringes with solvent
Pripomočki, ki so na voljo v pakiranju: - 28 vial s po 1,25 mg teduglutida v obliki praška, - 28 napolnjenih injekcijskih brizg z vehiklom.
Powder 3 ml vial (glass) with rubber stopper (bromobutyl) containing 5 mg teduglutide.
3-mililitrska viala (steklena) z gumijastim zamaškom (bromobutil), ki vsebuje 5 mg teduglutida.
It is strongly recommended that every time you or your child receive a dose of Revestive, the name and lot number of the product are recorded in order to maintain a record of the lots used.
Zelo priporočljivo je, da vsakokrat, ko vi ali vaš otrok prejmete zdravilo Revestive, zabeležite ime in številko serije zdravila, s čimer vodite seznam uporabljenih serij.
Contact your doctor or the emergency unit if you experience 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
Posvetujte se s svojim zdravnikom ali z urgentno enoto, če imate porumenelo kožo in beločnici, vas srbi, imate temen urin in svetlo obarvano blato ali bolečino v desnjem zgornjem delu trebuha ali na sredini trebuha.
Powder and solvent for solution for injection 28 vials of powder containing 1,25 mg teduglutide 28 pre-filled syringes containing 0.5 ml of solvent
prašek in vehikel za raztopino za injiciranje 28 vial praška, ki vsebujejo po 1,25 mg teduglutida 28 napolnjenih injekcijskih brizg, ki vsebujejo po 0,5 ml vehikla
Increases in enteral nutrition volume and enteral calories Based on prescribed data, the mean percentage change from baseline at Week 12 in enteral volume, in the ITT population, was 25.82% (±41.59) compared to 53.65% (±57.01) in the standard of care cohort.
Zvečanja volumna enteralne prehrane in enteralnih kalorij Na podlagi podatkov o predpisovanju je bila srednja sprememba enteralnega volumna v odstotkih od izhodišča v 12. tednu v populaciji ITT 25,82 % (±41,59), v primerjavi s 53,65 % (±57,01) v kohorti s standardnim zdravljenjem.
Any volume exceeding the prescribed dose in ml must be expelled and discarded.
Iztisnite in zavrzite volumen, ki presega predpisani odmerek v ml.
- if you have had cancer in the gastrointestinal tract, including liver, gallbladder or bile ducts, and pancreas within the last five years.
- če ste imeli v zadnjih petih letih raka prebavil, vključno z jetri, žolčnikom ali žolčevodi in trebušno slinavko.
No new safety signals have been identified in patients exposed to 0.05 mg/kg/day of teduglutide for up to 30 months in a long-term open-label extension study.
Pri bolnikih, ki so bili do 30 mesecev vključeni v dolgoročno odprto podaljšano študijo in so prejemali odmerek 0,05 mg/kg/dan teduglutida, niso opazili nobenih novih varnostnih signalov.
Fluid overload
Preobremenitev s tekočino
In case of a significant deterioration of the cardiovascular disease, the need for continued treatment with Revestive should be reassessed.
Če pride do pomembnega poslabšanja bolezni srca in ožilja, je treba ponovno pretehtati potrebo po nadaljevanju zdravljenja z zdravilom Revestive.
One subject was weaned off their parenteral support while on teduglutide.
Pri enem preiskovancu je bila parenteralna prehranska podpora med zdravljenjem s teduglutidom ukinjena.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Če metoda rekonstitucije ne izključuje tveganja kontaminacije z mikrobi, je treba z mikrobiološkega stališča zdravilo uporabiti takoj.
Gastrointestinal neoplasia including hepatobiliary tract In the rat carcinogenicity study, benign tumours were found in the small bowel and the extrahepatic bile ducts.
Novotvorbe prebavil, vključno z jetri, žolčnikom in žolčevodi V študiji kancerogenosti na podganah so ugotovili pojav benignih tumorjev v tankem črevesu in ekstrahepatičnih žolčevodih.
Revestive 1.25 mg powder and solvent for solution for injection Teduglutide For children and adolescents
Revestive 1,25 mg prašek in vehikel za raztopino za injiciranje teduglutid za otroke in mladostnike
EU/1/12/787/003 28 vials
EU/1/12/787/001 28 vial
The injection can be self-administered or given by another person, for example your doctor, his/her assistant or your home nurse.
Zdravilo Revestive se injicira pod kožo (subkutano) enkrat na dan. Injekcijo si lahko vbrizgate sami ali pa vam jo vbrizga druga oseba, na primer vaš zdravnik, njegov/a pomočnik/ca ali vaša patronažna medicinska sestra.
Influenza-like illness
Bolezni trebušne slinavke
Revestive is used to treat children and adolescents (aged 1 year and above) with Short Bowel Syndrome.
Zdravilo Revestive se uporablja za zdravljenje otrok in mladostnikov (starih 1 leto ali več) s sindromom kratkega črevesa.
2.2 Uncap the reconstitution needle on the assembled pre-filled syringe with solvent without touching the tip of the needle.
2.2 Odstranite pokrovček rekonstitucijske igle s sestavljene napolnjene injekcijske brizge z vehiklom, ne da bi se dotaknili igelne konice.
(or smaller) injection syringe may be used - Thin injection needles for subcutaneous injection (e.g., size 26G, length 5/8" (0.45 x 16 mm), or smaller needles for children, as appropriate) - Alcohol wipes - Alcohol swabs - A puncture-proof container for safe disposal of the used syringes and needles
Za otroke lahko uporabimo 0,5-mililitrsko (ali manjšo) injekcijsko brizgo, - tanke injekcijske igle za injiciranje v podkožje (npr. velikost 26G, dolžina 5/8" (0,45 x 16 mm),
After reconstitution, each vial contains 1.25 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 2.5 mg/ml.
Po rekonstituciji ena viala vsebuje 1,25 mg teduglutida v 0,5 ml raztopine, kar ustreza koncentraciji 2,5 mg/ml.
At the end of study, 21 (70%), 18 (60%) and 18 (60%) of the 30 completers achieved a reduction of 1, 2, or 3 days per week in parenteral support, respectively.
Po koncu študije je 21 (70 %) bolnikov od 30 bolnikov, ki je zaključilo študijo, doseglo skrajšanje prejemanja parenteralne prehranske podpore za 1 dan na teden, 18 (60 %) za 2 dni na teden in 18 (60 %) za 3 dni na teden.
Two (2) subjects were weaned off their parenteral support while on teduglutide.
Pri dveh (2) preiskovancih je bila parenteralna prehranska podpora med zdravljenjem s teduglutidom ukinjena.
Common (may affect up to 1 in 10 people): - Flu (influenza) or flu-like symptoms - Decreased appetite - Swelling of hands and/or feet - Problems sleeping, anxiety - Cough, shortness of breath - Polyps (small abnormal growths) in your child's large bowel - Passing gas (flatulence) - Narrowing or blockage of your child's pancreatic duct, which may cause inflammation of the pancreas - Inflammation of the gallbladder
Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): - gripa (influenca) ali gripi podobni simptomi, - zmanjšan apetit, - otekanje rok in/ali nog, - nespečnost, tesnoba, - kašelj, kratka sapa, - polipi (majhne nenormalne tvorbe) v debelem črevesu vašega otroka, - vetrovi (flatulenca), - zožitev ali zapora otrokovega izvodila trebušne slinavke, ki lahko povzroči vnetje trebušne slinavke, - vnetje trebušne slinavke.
Gallbladder and bile ducts
Žolčnik in žolčevodi
Discard the vial and reconstitution needle together into the sharps disposal container.
Vialo in rekonstitucijsko iglo zavrzite skupaj v vsebnik za odlaganje ostrih predmetov.
After reconstitution, each vial contains 5 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml.
Po rekonstituciji ena viala vsebuje 5 mg teduglutida v 0,5 ml raztopine, kar ustreza koncentraciji 10 mg/ml.
If you inject more Revestive than you are told to by your doctor, you should contact your doctor, pharmacist or nurse.
Če ste si injicirali več zdravila Revestive, kot vam je naročil vaš zdravnik, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
Due to the risk of dehydration, discontinuation of treatment with Revestive should be managed carefully.
Prekinitev zdravljenja Prekinitev zdravljenja z zdravilom Revestive je treba skrbno spremljati zaradi tveganja za dehidracijo.
After reconstitution, from a microbiological point of view, the solution should be used immediately.
Po rekonstituciji je treba raztopino z mikrobiološkega vidika uporabiti takoj.
Reconstituted product Chemical and physical stability has been demonstrated for 3 hours at 25°C.
Rekonstituirano zdravilo Kemijska in fizikalna stabilnost je bila dokazana za 3 ure pri 25 °C.
If polyps are found before treatment with Revestive, the doctor will decide whether your child should use this medicine.
Če najdejo polipe, preden se otrok začne zdraviti z zdravilom Revestive, bo zdravnik odločil, ali naj vaš otrok zdravilo začne jemati.
If polyps are found either before or during your treatment with Revestive, your doctor will decide whether you should continue using this medicine.
Če najdejo polipe, preden se začnete zdraviti z zdravilom Revestive ali med zdravjenjem z zdravilom Revestive, bo vaš zdravnik odločil, ali še lahko nadaljujete z uporabo tega zdravila.
The injection can be self-administered or given by another person, for example your child's doctor, his/her assistant or your child's home nurse.
Zdravilo Revestive se injicira pod kožo (subkutano) enkrat na dan. Injekcijo si lahko otrok vbrizga sam ali pa mu jo vbrizga druga oseba, na primer otrokov zdravnik, njegov/a pomočnik/ca ali otrokova patronažna medicinska sestra.
All needles and syringes should be disposed of in a sharps disposal container.
Vse igle in injekcijske brizge je treba zavreči v vsebnik za ostre predmete.
), every patient should be assessed for the need of an enhanced surveillance schedule based on the patient characteristics (e.g., age and underlying disease, previous occurrence of polyps etc.).
Poleg potrebe po kolonoskopiji z odstranitvijo polipov ob začetku zdravljenja (glejte poglavje 4.4) je treba pri vsakem bolniku pretehtati potrebo po poostrenem nadzoru, odvisno od bolnikovih značilnosti (npr. starost in osnovna bolezen, predhodno pojavljanje polipov itd.).
Pack sizes of 1 vial of powder with 1 pre-filled syringe or 28 vials of powder with 28 pre-filled syringes.
Velikosti pakiranja: 1 viala praška z 1 napolnjeno injekcijsko brizgo ali 28 vial praška z 28 napolnjenimi injekcijskimi brizgami.
Adverse reactions were retrieved from 2 placebo-controlled clinical studies with teduglutide in 109 adult patients with SBS treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day for up to 24 weeks.
Neželene učinke so analizirali v 2 kliničnih s placebom kontroliranih študijah teduglutida pri 109 odraslih bolnikih s SKČ, ki so bili zdravljeni z odmerki 0,05 mg/kg/dan in 0,10/mg/kg/dan do 24 tednov.
It is strongly recommended that every time your child receives a dose of Revestive, the name and lot number of the product are recorded in order to maintain a record of the lots used.
Zelo priporočljivo je, da vsakokrat, ko vaš otrok prejme zdravilo Revestive, zabeležite ime in številko serije zdravila, s čimer vodite seznam uporabljenih serij.
One vial of powder contains 1.25 mg of teduglutide.
Ena viala praška vsebuje 1,25 mg teduglutida.
One vial of powder contains 5 mg of teduglutide*.
Ena viala praška vsebuje 5 mg teduglutida*.
In case of gallbladder or bile duct-related symptoms, the need for continued Revestive treatment should be reassessed.
Če se pojavijo simptomi v zvezi z žolčnikom ali žolčevodi, je treba ponovno pretehtati potrebo po nadaljevanju zdravljenja z zdravilom Revestive.