natgillin/translations-raw huggingface dataset:
These observations were potentially associated with the expected intended pharmacology of teduglutide and were to a varying degree reversible within an 8-13 week recovery period following chronic administration.
Ta opažanja so bila potencialno povezana s pričakovano želeno farmakologijo teduglutida in so bila po kronični uporabi do različne stopnje reverzibilna v obdobju okrevanja 8-13 tednov.
Management of fluids during treatment with Revestive In patients receiving Revestive, parenteral support should be reduced carefully and should not be discontinued abruptly.
Uravnavanje tekočin med zdravljenjem z zdravilom Revestive Pri bolnikih, ki prejemajo zdravilo Revestive, je treba parenteralno podporo zmanjševati previdno in je ne smemo nenadoma prekiniti.
In a phase 1 study no difference in pharmacokinetics of teduglutide could be detected between healthy subjects younger than 65 years versus older than 65 years.
V študiji 1. faze niso ugotovili nobene razlike v farmakokinetiki teduglutida med zdravimi preiskovanci do 65 let starosti v primerjavi s starejšimi od 65 let.
Approximately 38% of the treated patients with a stoma experienced gastrointestinal stoma complications.
Približno 38 % zdravljenih bolnikov s stomo je imelo zaplete v zvezi z gastrointestinalno stomo.
There are no data available in paediatric patients after 6 months (see section 5.1).
Za pediatrične bolnike po 6 mesecih podatkov ni na voljo (glejte poglavje 5.1).
Now you are ready to dissolve the powder with the solvent.
Zdaj ste pripravljeni na raztapljanje praška v vehiklu.
Treatment resulted in enhanced gastrointestinal fluid absorption of approximately 750-1000 ml/day with improvements in the absorption of macronutrients and electrolytes, decreased stomal or faecal fluid and macronutrients excretion, and enhanced key structural and functional adaptations in the intestinal mucosa.
Zdravljenje je povzročilo povečano absorpcijo tekočine iz prebavil za približno 750-1.000 ml/dan z izboljšanjem absorpcije makrohranil in elektrolitov, zmanjšalo se je izločanje stomalne ali fekalne tekočine ter makrohranil, močneje so se izrazile ključne strukturne in funkcionalne prilagoditve črevesne sluznice.
Based on the findings derived from pre-clinical studies (see sections 4.4 and 5.3) and the proposed mechanism of action with the trophic effects on intestinal mucosa, there appears to be a risk for the promotion of small intestinal and/or colonic neoplasia.
Zaradi ugotovitev, ki izhajajo iz predkliničnih študij (glejte poglavji 4.4 in 5.3), in zaradi predlaganega mehanizma delovanja s trofičnim učinkom na črevesno sluznico obstaja tveganje za pospeševanje novotvorb v tankem črevesu in/ali kolonu.
Sixty-five (65) patients entered a follow-up SBS study for up to an additional 28 weeks of treatment.
Petinšestdeset (65) bolnikov se je vključilo v spremljevalno študijo SKČ, ki je obsegala do 28 dodatnih tednov zdravljenja.
Allow the area to air-dry.
Pustite, da se področje posuši na zraku.
Do not touch the top of the vial.
Ne dotikajte se vrhnje površine viale.
NOTE: The final solution should be clear.
OPOZORILO: Končna raztopina mora biti bistra.
The European Medicines Agency has deferred the obligation to submit the results of studies with Revestive in one or more subsets of the paediatric population in the treatment of SBS (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Revestive za eno ali več podskupin pediatrične populacije pri zdravljenju SKČ (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Overall, the safety profile of teduglutide (including type and frequency of adverse reactions, and immunogenicity) in children and adolescents (ages 1-17 years) was similar to that in adults.
V celoti gledano je bil varnostni profil teduglutida (vključno z vrsto in pogostnostjo neželenih učinkov in imunogenostjo) pri otrocih in mladostnikih (starih 1-17 let) podoben kot pri odraslih.
If the solution is cloudy or contains particulate matter, do not inject it.
Če je raztopina motna ali če vsebuje delce, je ne smete injicirati.
In total 88 patients participated in this extension study, thereof 39 treated with placebo and 12 enrolled, but not randomised, in the previous study; 65 of 88 patients completed the extension study.
V tej podaljšani študiji je sodelovalo skupno 88 bolnikov, od tega še 39 predhodno zdravljenih s placebom in 12 vključenih v predhodno študijo brez randomizacije, 65 od 88 bolnikov pa je zaključilo podaljšano študijo.
Four interim reports will be provided within six months after the data lock points (i.e., Q4 2016, Q4 2018, Q4 2020, and Q4 2022).
Q4 2016, Q4 2018, Q4 2020 in Q4 2022).
However, lower exposure (AUC) and shorter half-life were seen in paediatric patients 1 to 17 years of age, as compared with adults.
Ugotovili pa so manjšo izpostavljenost (AUC) in krajši razpolovni čas pri pediatričnih bolnikih, starih 1 leto do 17 let, v primerjavi z odraslimi.
If you see any blood in the syringe, withdraw the needle and replace the needle on the injection syringe with a clean one of the same size.
Če opazite kri v injekcijski brizgi, izvlecite iglo in iglo na injekcijski brizgi nadomestite s čisto iglo enake velikosti.
Revestive may affect how other medicines are absorbed from the gut and therefore how well they work.
Zdravilo Revestive lahko vpliva na absorpcijo drugih zdravil iz črevesa in s tem na učinkovitost njihovega delovanja.
Prepare the injection syringe
Pripravite injekcijsko brizgo
What you need to know before you use Revestive
Kaj morate vedeti, preden boste uporabili zdravilo Revestive
For reconstitution
za rekonstitucijo
Approximately 52% of the patients treated with teduglutide experienced adverse reactions (versus 36% of the patients given placebo).
Pri približno 52 % bolnikov, zdravljenih s teduglutidom, so se pojavile neželeni učinki (v primerjavi s 36 % bolnikov s placebom).
Gender No clinically relevant gender differences were observed in clinical studies.
Spol V kliničnih študijah niso opazili klinično pomembnih razlik med spoloma.
A colonoscopy with removal of polyps should be performed at the time of starting treatment with Revestive.
Kolonoskopijo z odstranitvijo polipov je treba opraviti ob začetku zdravljenja z zdravilom Revestive.
Do not stop using this medicine without consulting your doctor, as a sudden stop can cause changes in your fluid balance.
Ne prenehajte uporabljati tega zdravila, ne da bi se posvetovali s svojim zdravnikom, saj nenadna prekinitev lahko povzroči spremembe v ravnotežju telesnih tekočin.
Other medicines and Revestive
Druga zdravila in zdravilo Revestive
3.6 Check for air bubbles.
3.6 Preverite morebitno prisotnost zračnih mehurčkov.
The doctor will consider this when prescribing this medicine.
Zdravnik bo to upošteval pri predpisovanju tega zdravila.
Patients should be advised to contact their physician in case of sudden weight gain, swollen ankles and/or dyspnoea.
Bolnikom je treba svetovati, naj se posvetujejo s svojim zdravnikom v primeru nenadnega povečanja telesne mase, otekanja gležnjev in/ali dispneje.
Experience in subjects 75 years and above is limited.
Izkušenj pri preiskovancih, starih 75 let ali več je malo.
The corresponding change in the standard of care cohort was 4.31% (±5.36).
Ustrezna sprememba v kohorti s standardnim zdravljenjem je bila 4,31 % (±5,36).
Patients receiving oral concomitant medicinal products requiring titration or with a narrow therapeutic index should be monitored closely due to potential increased absorption (see section 4.5).
Bolnike, ki sočasno prejemajo peroralna zdravila, ki zahtevajo titracijo ali imajo ozek terapevtski indeks, je treba skrbno nadzorovati zaradi možnosti povečane absorpcije (glejte poglavje 4.5).
Of the patients who achieved at least a 20% reduction of parenteral nutrition at Weeks 20 and 24 in the initial study, 75% sustained this response on teduglutide after up to 1 year of continuous treatment.
Od bolnikov, ki so dosegli vsaj 20 % zmanjšanje parenteralne prehrane po 20 in 24 tednih začetne študije, jih je 75 % vzdrževalo takšen odziv ob neprekinjenem zdravljenju s teduglutidom do 1 leto.
The mean reduction in parenteral nutrition was 3.11 l/week (an additional 28.3% reduction).
Povprečno znižanje parenteralne prehrane je bilo 3,11 l/teden (dodatno 28,3-odstotno zmanjšanje).
Revestive should not be administered intravenously or intramuscularly.
Zdravila Revestive se ne sme dati intravensko ali intramuskularno.
With progressive renal impairment up to and including end-stage renal disease the primary pharmacokinetic parameters of teduglutide increased up to a factor of 2.6 (AUCinf) and 2.1 (Cmax) compared to healthy subjects.
Ob naraščajoči stopnji ledvične okvare do vključno končne faze ledvične bolezni sta se primarna parametra farmakokinetike teduglutida povečala za količnik 2,6 (AUCinf) in 2,1 (Cmax) v primerjavi z zdravimi preiskovanci.
In phase 3 studies with SBS patients who received teduglutide for ≥2 years, 28% of patients developed antibodies against E. coli protein (residual host cell protein from the manufacture).
V študijah 3. faze z bolniki z SKČ, ki so prejemali teduglutid ≥2 leti, so se pri 28 % bolnikov razvila protitelesa proti beljakovini E. coli (rezidualna beljakovina gostiteljske celice iz izdelave).
Following intravenous administration teduglutide plasma clearance was approximately 127 ml/hr/kg which is equivalent to the glomerular filtration rate (GFR).
Po intravenski uporabi teduglutida je plazemski očistek znašal približno 127 ml/hr/kg, kar ustreza hitrosti glomerulne filtracije (GFR).
If you use more Revestive than you should
Če ste uporabili večji odmerek zdravila Revestive, kot bi smeli
If air bubbles are present, gently tap the syringe until they rise to the top.
Če so zračni mehurčki prisotni, nežno potrkajte na injekcijsko brizgo, dokler se ne dvignejo na površje.
However, cases of syncope have been reported in clinical studies (see section 4.8).
V kliničnih študijah so poročali o primerih sinkope (glejte poglavje 4.8).
The powder is white and the solvent is clear and colourless.
Prašek je bel, vehikel pa je bister in brezbarven.
2.5 Gently roll the vial between your palms for about 15 seconds.
2.5 Nežno valjajte vialo med dlanmi približno 15 sekund.
In case the injection into the abdomen is hampered by pain, scarring or hardening of the tissue, the thigh can also be used.
Če injekcija v trebuh ni izvedljiva zaradi bolečine, brazgotin ali zatrdlin tkiva, se lahko uporabi tudi stegno.
If a neoplasia is detected, it should be removed.
Če odkrijemo novotvorbe, jih je treba odstraniti.
This usually includes the monitoring of small bowel function, gallbladder and bile ducts, and pancreas for signs and symptoms, and, if indicated, additional laboratory investigations and appropriate imaging techniques.
To običajno vključuje nadzorovanje delovanja tankega črevesa, žolčnika in žolčevodov ter trebušne slinavke glede znakov in simptomov ter po potrebi izvajanje dodatnih laboratorijskih preiskav in ustreznih slikovnih preiskav.
Do not stop using this medicine without consulting the doctor, as a sudden stop can cause changes in your child's fluid balance.
Ne prenehajte uporabljati tega zdravila, ne da bi se posvetovali z zdravnikom, saj nenadna prekinitev lahko povzroči spremembe v otrokovem ravnotežju telesnih tekočin.
Modest increases of C-reactive protein of approximately 25 mg/l have been observed within the first seven days of teduglutide treatment, which decreased continuously under ongoing daily injections.
Zmerno zvišanje koncentracije C-reaktivnega proteina za približno 25 mg/l so opazili v prvih sedmih dneh zdravljenja s teduglutidom, nato se je koncentracija ob vsakodnevnih injekcijah postopoma nižala.
With the other hand, hold the syringe as you would with a pencil.
Z drugo roko držite injekcijsko brizgo, kot bi držali svinčnik.
Thirty (30) of the 43 teduglutide-treated patients from the pivotal study who entered the extension study completed a total of 30 months of treatment.
Trideset (30) od 43 bolnikov, ki so bili zdravljeni s teduglutidom iz ključne študije,ki so bili vključeni v podaljšano študijo, je zaključilo skupno 30 mesecev zdravljenja.
Revestive has not been studied in patients with severe, clinically unstable concomitant diseases, (e.g., cardiovascular, respiratory, renal, infectious, endocrine, hepatic, or CNS), or in patients with malignancies within the last five years (see section 4.3).
Zdravila Revestive niso raziskovali na bolnikih s težkimi klinično nestabilnimi pridruženimi boleznimi (npr. bolezni srca in ožilja, respiratorne, ledvične, infekcijske, endokrine, jetrne bolezni ali bolezni centralnega živčevja) ali na bolnikih z malignimi boleznimi v zadnjih petih letih (glejte poglavje 4.3).
If there is still some undissolved powder, discard the vial and start the preparation again from the beginning with a new vial.
Če v viali še vedno ostane neraztopljen prašek, zavrzite vialo in z novo vialo znova začnite s pripravo od začetka.
D. CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX08.
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove, razna zdravila za bolezni prebavil in presnove, oznaka ATC: A16AX08.
Optimisation and stabilisation of intravenous fluid and nutrition support should be performed before initiation of treatment.
Pred začetkom zdravljenja je treba optimizirati in stabilizirati vnos intravenskih tekočin in prehransko podporo.
Renal elimination was confirmed in a study investigating pharmacokinetics in subjects with renal impairment.
Izločanje skozi ledvice je bilo potrjeno v študiji, kjer so preučevali farmakokinetiko pri preiskovancih z okvaro ledvic.
If a polyp is found, adherence to current polyp follow-up guidelines is recommended.
Če se ugotovi prisotnost polipa, je treba upoštevati veljavne smernice za spremljanje polipov.
- Revestive is for injection under the skin (subcutaneous injection).
- Zdravilo Revestive je namenjeno injiciranju pod kožo (subkutana injekcija).
The change from baseline in the SOC cohort was -0.21 (±0.69) hours/day (-1.75% [±5.89]).
Sprememba od izhodišča v kohorti s SOC je bila -0,21 (±0,69) ure/dan (-1,75 % [±5,89]).
Reduction in parenteral nutrition calories
Zmanjšanje kalorij parenteralne prehrane
The vial should not be shaken, but can be rolled between the palms and gently turned upside-down once.
Viale ne smete stresati, lahko pa jo zavrtite med dlanmi in jo enkrat nežno obrnete navzdol.
Determination of the number of vials needed for administration of one dose must be based on the individual patient's weight and the recommended dose of 0.05 mg/kg/day.
Določitev števila vial, potrebnih za aplikacijo enega odmerka, mora temeljiti na telesni masi posameznega bolnika in na priporočenem odmerku 0,05 mg/kg/dan.
In two completed clinical trials, there were 87 paediatric subjects (aged 1 to 17 years) enrolled and exposed to teduglutide for a duration of up to 6 months.
V dve dokončani klinični študiji so vključili 87 pediatričnih preiskovancev (starih od 1 do 17 let) in jih za obdobje do 6 mesecev izpostavili teduglutidu.
Based upon the pharmacodynamic effect of teduglutide, there is a potential for increased absorption of concomitant medicinal products (see section 4.4).
Na podlagi farmakodinamičnega učinka teduglutida obstaja možnost povečane absorpcije sočasno uporabljenih zdravil (glejte poglavje 4.4).
It is often caused by surgical removal of all or part of the small intestine.
Pogosto jo povzroči popolna ali delna kirurška odstranitev tankega črevesa.
Includes the following preferred terms: Pancreatitis, Pancreatitis acute, and Pancreatitis chronic.
Vključuje naslednje prednostne izraze: pankreatitis, akutni pankreatitis in kronični pankreatitis.
Ninety-seven percent (97%) of patients (37 out of 39 patients treated with teduglutide) that completed the placebo-controlled study entered a long-term extension study where all patients received 0.05 mg/kg of Revestive daily for up to an additional 2 years.
Sedemindevetdeset odstotkov (97 %) bolnikov (37 od 39 bolnikov, zdravljenih s teduglutidom), ki so zaključili s placebom kontrolirano študijo, je vstopilo v dolgoročno podaljšano študijo, v kateri so vsi bolniki prejemali 0,05 mg/kg zdravila Revestive dnevno do 2 dodatni leti.
Dissolve the powder
Raztopite prašek
It should be kept below 25°C and maximum storage time is three hours.
Shraniti jo je treba pri temperaturi do 25 °C, najdaljši dopustni čas shranjevanja je tri ure.
There are no data on the effects of teduglutide on human fertility.
Podatkov o vplivu teduglutida na plodnost pri človeku ni.
The single amino acid substitution relative to naturally occurring GLP-2 results in resistance to in vivo degradation by the enzyme dipeptidyl peptidase-IV (DPP-IV), resulting in an extended half-life.
Zamenjava ene aminokisline v primerjavi z naravno prisotnim GLP-2 ima za posledico odpornost na razgradnjo z encimom dipeptidil peptidaza-IV (DPP-IV) in vivo in zato podaljšan razpolovni čas.
Your doctor may have to change your dose of other medicines.
Vaš zdravnik utegne spremeniti odmerke vaših drugih zdravil.
Do not inject a double dose to make up for a forgotten dose.
Ne injicirajte dvojnega odmerka, če ste pozabili prejšnji odmerek.
Revestive has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Zdravilo Revestive ni bilo raziskano na bolnikih s težko okvaro jeter (glejte poglavji 4.4 in 5.2).
A small amount of bleeding may occur.
Na mestu injiciranja lahko pride do manjše krvavitve.
If you forget to inject this medicine (or cannot inject it at the usual time), use it as soon as possible on that day.
Če ste pozabili injicirati to zdravilo (ali ga ne morete injicirati ob običajnem času), ga uporabite takoj, ko je to mogoče v istem dnevu.
The metabolism of teduglutide is not fully known.
Presnova teduglutida ni popolnoma poznana.
Four subjects (26.7%) on the recommended teduglutide dose achieved at least a three-day reduction in parenteral nutrition needs.
Štirje preiskovanci (26,7 %) na priporočenem odmerku teduglutida so dosegli vsaj tridnevno zmanjšanje potreb po parenteralni prehrani.
This medicine may cause you to feel dizzy.
To zdravilo lahko povzroči občutek vrtoglavice.
In addition, a jejunal adenocarcinoma was observed in a male rat administered the lowest dose tested (animal:human plasma exposure margin of approximately 10-fold).
Poleg tega so opazili adenokarcinom jejunuma pri podganjem samcu, ki je prejemal najnižji testirani odmerek (približno 10-kratni varnostni količnik izpostavljenosti glede na razmerje živalska:človeška plazma).
The most commonly reported adverse reactions were abdominal pain and distension (45%), respiratory tract infections (28%) (including nasopharyngitis, influenza, upper respiratory tract infection, and lower respiratory tract infection), nausea (26%), injection site reactions (26%), headache (16%), and vomiting (14%).
Najpogosteje poročani neželeni učinki so bili bolečine v trebuhu in napetost (45 %), okužbe dihal (28 %) (vključno z nazofaringitisom, gripo, okužbami zgornjih dihal in okužbami spodnjih dihal), navzea (26 %), reakcije na mestu injiciranja (26 %), glavobol (16 %) in bruhanje (14 %).
NOTE: Do not shake the vial.
OPOZORILO: Ne stresajte viale.
Monitoring of small bowel, gallbladder and bile ducts, and pancreas SBS patients are to be kept under close surveillance according to clinical treatment guidelines.
Spremljanje tankega črevesa, žolčnika in žolčevodov ter trebušne slinavke Bolnike s SKČ je treba skrbno spremljati v skladu s smernicami kliničnega zdravljenja.
Results below correspond to the ITT population at the recommended dose of 0.05 mg/kg/day.
Rezultati v nadaljevanju ustrezajo populaciji ITT pri priporočenem odmerku 0,05 mg/kg/dan.
Then gently push up the plunger to expel the air.
Potem nežno pritisnite na bat in iztisnite zrak.
If you forget to inject this medicine (or cannot inject it at your usual time), use it as soon as possible on that day.
Če ste si pozabili injicirati to zdravilo (ali si ga ne morete injicirati ob običajnem času), ga uporabite takoj, ko je to mogoče v istem dnevu.
Your doctor will consider this when prescribing this medicine.
Vaš zdravnik bo to upošteval pri predpisovanju tega zdravila.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or trace residues of tetracycline.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na sledi ostankov tetraciklina.
Active or suspected malignancy.
Aktivna maligna bolezen ali sum na maligno bolezen.
- if your child has or is suspected to have cancer.
- če ima vaš otrok raka ali če obstaja sum, da ima raka.
After 24 weeks of teduglutide treatment, patients showed small overall increase in C-reactive protein of approximately 1.5 mg/l on average.
Po 24 tednih zdravljenja s teduglutidom so pri bolnikih ugotovili blago zvišano koncentracijo C-reaktivnega proteina, v povprečju za približno 1,5 mg/l.
Adverse reactions are listed below by MedDRA system organ class and by frequency.
Spodaj so navedeni neželeni učinki po klasifikaciji organskih sistemov MedDRA in po pogostnosti.
In several nonclinical studies, teduglutide has been shown to preserve mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth.
V številnih predkliničnih raziskavah je bilo ugotovljeno, da teduglutid ohrani celovitost sluznice s pospeševanjem popravljanja in normalne rasti črevesa preko zvečanja višine resic in globine kript.
If heart rate and breathing is normal and you awaken fast, speak to your doctor.
Če imate normalen srčni utrip, normalno hitro dihate in se hitro zbudite, se posvetujte s svojim zdravnikom.
Revestive has not been studied in patients with severe hepatic impairment.
Zdravila Revestive niso raziskovali na bolnikih s težko okvaro jeter.
Five (5) subjects were enrolled in a standard of care cohort.
Pet (5) preiskovancev so vključili v kohorto s standardnim zdravljenjem.
Prior to initiating treatment with Revestive, faecal occult blood testing should be done for all children and adolescents.
Pred začetkom zdravljenja z zdravilom Revestive je treba pri vseh otrocih in mladostnikih opraviti test okultne krvi v blatu.
Instructions for preparing and injecting Revestive
Navodilo za pripravo in injiciranje zdravila Revestive
4.7 Dispose all needles and syringes in a sharps disposal container or hard-walled container (for example, a detergent bottle with a lid).
4.7 Odvrzite vse igle in injekcijske brizge v vsebnik za ostre predmete ali v vsebnik s trdim ohišjem (npr. plastenka od detergenta s pokrovom).
Tell the doctor, pharmacist or nurse if your child is using, has recently used or might use any other medicines.
Obvestite zdravnika, farmacevta ali medicinsko sestro, če vaš otrok uporablja, je pred kratkim uporabljal ali pa bo morda začel uporabljati katero koli drugo zdravilo.
If you forget to use Revestive
Če ste pozabili uporabiti zdravilo Revestive
It is unknown whether teduglutide is excreted in human milk.
Ni znano, ali se teduglutid izloča v materino mleko.
Colo-rectal polyps/Neoplasia
Kolorektalni polipi/novotvorbe
If two vials are needed, the procedure for the second vial must be repeated and the additional solution sucked up into the injection syringe containing the solution from the first vial.
Če sta potrebni dve viali, ponovite postopek z drugo vialo in dodatno raztopino povlecite v injekcijsko brizgo, ki že vsebuje raztopino iz prve viale.
These observations were not confirmed in clinical studies of more than one year duration.
Klinične študije, ki so trajale več kot eno leto, niso potrdile teh opažanj.
The symptoms include sudden weight gain, swollen ankles and/or shortness of breath.
Simptomi vključujejo nenadno povečanje telesne mase, otekanje gležnjev in/ali kratko sapo.