FrancophonIA/ELRC3.0 huggingface dataset:
English: Powder 3 ml vial (glass) with rubber stopper (bromobutyl) containing 5 mg teduglutide.
Slovenian: 3-mililitrska viala (steklena) z gumijastim zamaškom (bromobutil), ki vsebuje 5 mg teduglutida.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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.
English: 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
Slovenian: 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
English: 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.
Slovenian: 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.
English: Any volume exceeding the prescribed dose in ml must be expelled and discarded.
Slovenian: Iztisnite in zavrzite volumen, ki presega predpisani odmerek v ml.
English: - if you have had cancer in the gastrointestinal tract, including liver, gallbladder or bile ducts, and pancreas within the last five years.
Slovenian: - če ste imeli v zadnjih petih letih raka prebavil, vključno z jetri, žolčnikom ali žolčevodi in trebušno slinavko.
English: 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.
Slovenian: 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.
English: Fluid overload
Slovenian: Preobremenitev s tekočino
English: In case of a significant deterioration of the cardiovascular disease, the need for continued treatment with Revestive should be reassessed.
Slovenian: Če pride do pomembnega poslabšanja bolezni srca in ožilja, je treba ponovno pretehtati potrebo po nadaljevanju zdravljenja z zdravilom Revestive.
English: One subject was weaned off their parenteral support while on teduglutide.
Slovenian: Pri enem preiskovancu je bila parenteralna prehranska podpora med zdravljenjem s teduglutidom ukinjena.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Slovenian: Če metoda rekonstitucije ne izključuje tveganja kontaminacije z mikrobi, je treba z mikrobiološkega stališča zdravilo uporabiti takoj.
English: Gastrointestinal neoplasia including hepatobiliary tract In the rat carcinogenicity study, benign tumours were found in the small bowel and the extrahepatic bile ducts.
Slovenian: Novotvorbe prebavil, vključno z jetri, žolčnikom in žolčevodi V študiji kancerogenosti na podganah so ugotovili pojav benignih tumorjev v tankem črevesu in ekstrahepatičnih žolčevodih.
English: Revestive 1.25 mg powder and solvent for solution for injection Teduglutide For children and adolescents
Slovenian: Revestive 1,25 mg prašek in vehikel za raztopino za injiciranje teduglutid za otroke in mladostnike
English: EU/1/12/787/003 28 vials
Slovenian: EU/1/12/787/001 28 vial
English: The injection can be self-administered or given by another person, for example your doctor, his/her assistant or your home nurse.
Slovenian: 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.
English: Influenza-like illness
Slovenian: Bolezni trebušne slinavke
English: Revestive is used to treat children and adolescents (aged 1 year and above) with Short Bowel Syndrome.
Slovenian: Zdravilo Revestive se uporablja za zdravljenje otrok in mladostnikov (starih 1 leto ali več) s sindromom kratkega črevesa.
English: 2.2 Uncap the reconstitution needle on the assembled pre-filled syringe with solvent without touching the tip of the needle.
Slovenian: 2.2 Odstranite pokrovček rekonstitucijske igle s sestavljene napolnjene injekcijske brizge z vehiklom, ne da bi se dotaknili igelne konice.
English: (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
Slovenian: 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),
English: After reconstitution, each vial contains 1.25 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 2.5 mg/ml.
Slovenian: Po rekonstituciji ena viala vsebuje 1,25 mg teduglutida v 0,5 ml raztopine, kar ustreza koncentraciji 2,5 mg/ml.
English: 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.
Slovenian: 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.
English: Two (2) subjects were weaned off their parenteral support while on teduglutide.
Slovenian: Pri dveh (2) preiskovancih je bila parenteralna prehranska podpora med zdravljenjem s teduglutidom ukinjena.
English: 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
Slovenian: 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.
English: Gallbladder and bile ducts
Slovenian: Žolčnik in žolčevodi
English: Discard the vial and reconstitution needle together into the sharps disposal container.
Slovenian: Vialo in rekonstitucijsko iglo zavrzite skupaj v vsebnik za odlaganje ostrih predmetov.
English: After reconstitution, each vial contains 5 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml.
Slovenian: Po rekonstituciji ena viala vsebuje 5 mg teduglutida v 0,5 ml raztopine, kar ustreza koncentraciji 10 mg/ml.
English: If you inject more Revestive than you are told to by your doctor, you should contact your doctor, pharmacist or nurse.
Slovenian: Če ste si injicirali več zdravila Revestive, kot vam je naročil vaš zdravnik, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: Due to the risk of dehydration, discontinuation of treatment with Revestive should be managed carefully.
Slovenian: Prekinitev zdravljenja Prekinitev zdravljenja z zdravilom Revestive je treba skrbno spremljati zaradi tveganja za dehidracijo.
English: After reconstitution, from a microbiological point of view, the solution should be used immediately.
Slovenian: Po rekonstituciji je treba raztopino z mikrobiološkega vidika uporabiti takoj.
English: Reconstituted product Chemical and physical stability has been demonstrated for 3 hours at 25°C.
Slovenian: Rekonstituirano zdravilo Kemijska in fizikalna stabilnost je bila dokazana za 3 ure pri 25 °C.
English: If polyps are found before treatment with Revestive, the doctor will decide whether your child should use this medicine.
Slovenian: Če najdejo polipe, preden se otrok začne zdraviti z zdravilom Revestive, bo zdravnik odločil, ali naj vaš otrok zdravilo začne jemati.
English: If polyps are found either before or during your treatment with Revestive, your doctor will decide whether you should continue using this medicine.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: All needles and syringes should be disposed of in a sharps disposal container.
Slovenian: Vse igle in injekcijske brizge je treba zavreči v vsebnik za ostre predmete.
English: ), 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.).
Slovenian: 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.).
English: Pack sizes of 1 vial of powder with 1 pre-filled syringe or 28 vials of powder with 28 pre-filled syringes.
Slovenian: Velikosti pakiranja: 1 viala praška z 1 napolnjeno injekcijsko brizgo ali 28 vial praška z 28 napolnjenimi injekcijskimi brizgami.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Zelo priporočljivo je, da vsakokrat, ko vaš otrok prejme zdravilo Revestive, zabeležite ime in številko serije zdravila, s čimer vodite seznam uporabljenih serij.
English: One vial of powder contains 1.25 mg of teduglutide.
Slovenian: Ena viala praška vsebuje 1,25 mg teduglutida.
English: One vial of powder contains 5 mg of teduglutide*.
Slovenian: Ena viala praška vsebuje 5 mg teduglutida*.
English: In case of gallbladder or bile duct-related symptoms, the need for continued Revestive treatment should be reassessed.
Slovenian: Če se pojavijo simptomi v zvezi z žolčnikom ali žolčevodi, je treba ponovno pretehtati potrebo po nadaljevanju zdravljenja z zdravilom Revestive.
English: Adverse reactions were retrieved from 2 placebo-controlled clinical studies with teduglutide in 109 patients with SBS treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day for up to 24 weeks.
Slovenian: Neželene učinke so analizirali v 2 kliničnih s placebom kontroliranih študijah teduglutida pri 109 bolnikih s SKČ, ki so bili zdravljeni z odmerki 0,05 mg/kg/dan in 0,10/mg/kg/dan do 24 tednov.
English: Reconstituted product Chemical and physical in-use stablility has been demonstrated for 24 hours up to 25°C.
Slovenian: Rekonstituirano zdravilo Kemijska in fizikalna stabilnost med uporabo je bila dokazana za 24 ur pri do 25 °C.
English: Colorectal polyp Colonic stenosis Flatulence Intestinal obstruction Pancreatic duct stenosis Pancreatitis Small intestinal stenosis
Slovenian: Bolezni prebavil napetost trebuha bolečine v trebuhu navzea bruhanje kolorektalni polip stenoza debelega črevesa vetrovi zapora črevesa stenoza izvodila trebušne slinavke vnetje trebušne slinavke stenoza tankega črevesa polip dvanajstnika polip želodca
English: Colo-rectal polyps
Slovenian: Kolorektalni polipi
English: If polyps are found before your treatment with Revestive, your doctor will decide whether you should use this medicine.
Slovenian: Če najdejo polipe, preden se začnete zdraviti z zdravilom Revestive, bo vaš zdravnik odločil, ali boste zdravilo začeli jemati.
English: Revestive comes in pack sizes of 1 vial of powder with 1 pre-filled syringe or 28 vials of powder with 28 pre-filled syringes.
Slovenian: Zdravilo Revestive je na voljo v velikostih pakiranja po 1 vialo praška z 1 napolnjeno injekcijsko brizgo ali 28 vial praška z 28 napolnjenimi injekcijskimi brizgami.
English: The doctor will perform further colonoscopies if your child continues treatment with Revestive.
Slovenian: Če bo vaš otrok nadaljeval zdravljenje z zdravilom Revestive, bo zdravnik delal nadaljnje kolonoskopije.
English: If you inject more Revestive than you are told to by your child's doctor, you should contact the doctor, pharmacist or nurse.
Slovenian: Če ste otroku injicirali več zdravila Revestive, kot vam je naročil zdravnik, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Cases of intestinal obstruction have been reported in clinical studies.
Slovenian: V kliničnih študijah so poročali o primerih zapore črevesa.
English: There were no clinically relevant mean increases of C-reactive protein from baseline following long-term treatment with teduglutide for up to 30 months.
Slovenian: Po dolgotrajnem zdravljenju s teduglutidom do največ 30 mesecev niso opazili nobenega klinično relevantnega povprečnega zvišanja koncentracije C-reaktivnega proteina glede na izhodiščno raven.
English: No dose adjustment is necessary for paediatric patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B adult subjects.
Slovenian: Pri pediatričnih bolnikih z blago ali zmerno okvaro jeter na osnovi študije, izvedene na odraslih preiskovancih z jetrno okvaro stopnje B po lestvici Child-Pugh, prilagajanje odmerka ni potrebno.
English: No accumulation of teduglutide was observed following repeated subcutaneous administrations.
Slovenian: Ob ponovljenem vnosu v podkožje niso zabeležili akumulacije teduglutida.
English: 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 large bowel - Passing gas (flatulence) - Narrowing or blockage of your pancreatic duct, which may cause inflammation of the pancreas - Inflammation of the gallbladder
Slovenian: 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, - vetrovi (flatulenca), - zožitev ali zapora izvodila trebušne slinavke, ki lahko povzroči vnetje trebušne slinavke, - vnetje trebušne slinavke.
English: No dose adjustment is necessary for paediatric patients with mild renal impairment.
Slovenian: Pri pediatričnih bolnikih z blago ledvično okvaro odmerka ni treba prilagajati.
English: - The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
Slovenian: - Druge sestavine zdravila so L-histidin, manitol, natrijev fosfat monohidrat, natrijev hidrogenfosfat heptahidrat.
English: One vial of powder contains 5 mg of teduglutide.
Slovenian: Ena viala praška vsebuje 5 mg teduglutida.
English: - Read the Package Leaflet before using Revestive.
Slovenian: - Pred uporabo zdravila Revestive preberite navodilo za uporabo.
English: Powder: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
Slovenian: Prašek: L-histidin, manitol, natrijev fosfat monohidrat, natrijev hidrogenfosfat heptahidrat.
English: If you have any further questions on the use of this medicine, ask your child's doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z otrokovim zdravnikom, farmacevtom ali medicinsko sestro.
English: Powder: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment).
Slovenian: Prašek: L-histidin, manitol, natrijev fosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev hidroksid (uravnavanje pH), klorovodikova kislina (uravnavanje pH).
English: - Dispose of all needles and syringes in a sharps disposal container.
Slovenian: - Vse igle in injekcijske brizge zavrzite v vsebnik za ostre predmete.
English: Cough Dyspnoea
Slovenian: Zapora črevesa
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: Če otrok opazi katerega koli izmed neželenih učinkov, se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: - The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment).
Slovenian: - Druge sestavine zdravila so L-histidin, manitol, natrijev fosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev hidroksid (uravnavanje pH), klorovodikova kislina (uravnavanje pH).
English: - If the child gets any side effects, talk to your child's doctor, pharmacist or nurse.
Slovenian: - Če pri otroku opazite kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom, farmacevtom ali medicinsko sestro.
English: - If you have any further questions, ask your child's doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z otrokovim zdravnikom, farmacevtom ali medicinsko sestro.
English: The recommended dose of Revestive in children and adolescents (aged 1 to 17 years) is 0.05 mg/kg body weight once daily.
Slovenian: Priporočeni odmerek zdravila Revestive za otroke in mladostnike (stare od 1 do 17 let) je 0,05 mg/kg telesne mase enkrat na dan. Injicirani volumen na telesno maso pri uporabi viale z jakostjo 1,25 mg je naveden v preglednici 1 v nadaljevanju.
English: The pre-filled syringe must be assembled with a reconstitution needle.
Slovenian: Napolnjeno injekcijsko brizgo sestavite z rekonstitucijsko iglo.
English: Sodium phosphate monohydrate Disodium phosphate heptahydrate Sodium hydroxide (pH adjustment) Hydrochloric acid (pH adjustment)
Slovenian: L-histidin manitol natrijev fosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev hidroksid (uravnavanje pH) klorovodikova kislina (uravnavanje pH)
English: Revestive 1.25 mg powder and solvent for solution for injection
Slovenian: Revestive 1,25 mg prašek in vehikel za raztopino za injiciranje
English: Patients with a history of malignancies in the gastrointestinal tract, including the hepatobiliary system and pancreas within the last five years.
Slovenian: Bolniki z anamnezo maligne bolezni prebavil, vključno z jetri, žolčnikom, žolčevodi in trebušno slinavko, v zadnjih petih letih.
English: Fluid overload has been observed in clinical trials.
Slovenian: V kliničnih preskušanjih so opažali preobremenitev s tekočino.
English: - Do not use Revestive after the expiry date which is stated on the carton, the vial and the pre-filled syringe.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli,
English: Sodium phosphate monohydrate Disodium phosphate heptahydrate
Slovenian: L-histidin manitol natrijev fosfat monohidrat natrijev hidrogenfosfat heptahidrat
English: Your child will also have a colonoscopy done (a procedure to see inside their colon and rectum to check for the presence of polyps (small abnormal growths) and have them removed) if they have unexplained blood in their bowel movements (stools).
Slovenian: Če ima otrok nepojasnjeno kri v blatu, mu bodo morali narediti tudi kolonoskopijo (postopek, pri katerem si zdravnik ogleda notranjost debelega črevesa in danke, da vidi, ali so prisotni polipi (majhne nenormalne rašče), in jih odstrani).
English: Solvent Pre-filled syringe (glass) with plungers (bromobutyl) containing 0.5 ml of solvent.
Slovenian: Napolnjena injekcijska brizga (steklo) z bati (bromobutil), ki vsebuje 0,5 ml vehikla.
English: However, chemical and physical stability has been demonstrated for 24 hours at 25°C.
Slovenian: Vendar pa je dokazano, da je raztopina kemijsko in fizikalno stabilna 24 ur pri 25 °C.
English: If you are not sure, ask the doctor, pharmacist or nurse.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Solvent for Revestive
Slovenian: Vehikel za Revestive
English: Pack size of 28 vials of powder with 28 pre-filled syringes.
Slovenian: Velikost pakiranja 28 vial praška z 28 napolnjenimi injekcijskimi brizgami.
English: No dose adjustment is necessary for patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B subjects.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter na osnovi študije, izvedene na preiskovancih z jetrno okvaro stopnje B po lestvici Child-Pugh, prilagajanje odmerka ni potrebno.
English: Materials provided in the pack: - 1 or 28 vials with 5 mg teduglutide as a powder - 1 or 28 pre-filled syringes with solvent
Slovenian: - 1 ali 28 vial s po 5 mg teduglutida v obliki praška, - 1 ali 28 napolnjenih injekcijskih brizg z vehiklom.
English: At Week 12, there was a -35.11% (±53.04) mean change from baseline in parenteral nutrition calorie consumption in the ITT population based on physician-prescribed data.
Slovenian: V 12. tednu je bila srednja sprememba od izhodišča porabe kalorij parenteralne prehrane v populaciji ITT na podlagi podatkov o parenteralni prehrani, ki jo je predpisal zdravnik, -35,11 % (±53,04).
English: Revestive comes in pack sizes of 28 vials of powder with 28 pre-filled syringes.
Slovenian: Zdravilo Revestive je na voljo v pakiranju po 28 vial praška z 28 napolnjenimi injekcijskimi brizgami.
English: Driving, cycling and using machines
Slovenian: Vpliv na sposobnost upravljanja vozil, kolesarjenja in upravljanja strojev
English: In case of pancreatic adverse events, the need for continued Revestive treatment should be reassessed.
Slovenian: Če pride do neželenih dogodkov v zvezi s trebušno slinavko, je treba ponovno pretehtati potrebo po nadaljevanju zdravljenja z zdravilom Revestive.
English: However, chemical and physical stability has been demonstrated for 3 hours at 25°C.
Slovenian: Vendar pa je dokazano, da je raztopina kemijsko in fizikalno stabilna 3 ure pri 25 °C.
English: Revestive 5 mg powder and solvent for solution for injection
Slovenian: Revestive 5 mg prašek in vehikel za raztopino za injiciranje
English: Dispose of all needles and syringes in a sharps disposal container.
Slovenian: Odvrzite vse igle in injekcijske brizge v vsebnik za ostre predmete.