FrancophonIA/ELRC3.0 huggingface dataset:
English: If unsure, please contact your doctor, nurse or pharmacist.
Slovenian: Če ste glede tega negotovi, se posvetujte s svojim zdravnikom, medicinsko sestro ali farmacevtom.
English: If you get a stomach ache that is either severe or will not go away, stop taking this medicine and call your doctor straight away.
Slovenian: Če imate hude bolečine v trebuhu, ki ne minejo, prenehajte uporabljati to zdravilo in nemudoma obvestite svojega zdravnika.
English: Methylnaltrexone bromide-treated patients also had significantly higher rates of laxation within 4 hours after at least 2 of the first 4 doses (52 %) than did placebo-treated patients (9 %); p<0.0001.
Slovenian: Bolniki, zdravljeni z metilnaltreksonijevim bromidom, so tudi signifikantno pogosteje iztrebljali v 4 urah po vsaj 2 od prvih 4 odmerkov (52 %) kot bolniki, ki so prejemali placebo (9 %); p<0,0001.
English: Pack containing 4, 7, 8 or 10 pre-filled syringes with a needle shield.
Slovenian: Škatla, ki vsebuje 4, 7, 8 ali 10 napolnjenih injekcijskih brizg z varnostnim pokrovčkom.
English: This exposure for the 0.15 mg/kg dose can be achieved with a weight-bandbased dose adjustment using an 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg, yielding a mean exposure of 187 (range = 148-220) ng•h/mL.
Slovenian: To izpostavljenost lahko za odmerek 0,15 mg/kg dosežemo s prilagoditvijo odmerka na podlagi razponov telesne mase, tako da pri telesni masi od 38 do manj kot 62 kg uporabimo odmerek 8 mg, pri telesni masi od 62 do 114 kg pa odmerek 12 mg, s čimer dobimo povprečno izpostavljenost 187 (razpon = 148-220) ng•h/ml.
English: Patients with hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section
Slovenian: Bolniki z okvaro jeter Pri bolnikih z blagimi do zmernimi okvarami jeter ni potrebno prilagajanje odmerka (glejte poglavje
English: There are no data available from patients with end-stage renal impairment on dialysis, and methylnaltrexone bromide is not recommended in these patients (see section 4.4).
Slovenian: Podatkov o bolnikih z ledvično okvaro v končnem stadiju na dializi ni na voljo in uporaba metilnaltreksonijevega bromida pri teh bolnikih ni priporočljiva (glejte poglavje 4.4).
English: Pre-filled syringe of clear type I glass with stainless-steel needle, plastic plunger, and polypropylene rigid needle cover.
Slovenian: Napolnjena injekcijska brizga iz prozornega stekla tipa I z iglo in nerjavečega stekla, plastičnim batom in togim pokrovčkom igle iz polipropilena.
English: You can press a cotton ball or gauze over the injection site.
Slovenian: Na mesto injiciranja lahko pritisnete kosem vate ali zloženec iz gaze.
English: Opioid withdrawal
Slovenian: Odtegnitev opioidov
English: • Please talk to your doctor if you experience stomach ache which continues, nausea (feeling sick) or vomiting (being sick) that is new or becomes worse.
Slovenian: • Pogovorite se s svojim zdravnikom, če se vam na novo pojavijo bolečine v trebuhu, ki ne prenehajo, navzea (slabost) ali bruhanje, ali če se slednji poslabšajo.
English: The following instructions explain how to prepare and give an injection of Relistor when using a prefilled syringe.
Slovenian: V teh navodilih boste našli razlago, kako pripravite in jemljete zdravilo Relistor, če uporabljate napolnjeno injekcijsko brizgo.
English: Do not attempt to administer an injection until you are sure that you understand how to give the injection.
Slovenian: Ne poskušajte si dati injekcije, dokler niste prepričani, da veste,
English: When the syringe is empty, quickly pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Slovenian: Ko je brizga prazna, iglo hitro potegnite iz kože in pazite, da jo potegnete ven pod istim kotom, pod katerim ste jo zapičili v kožo.
English: Conversion to methyl-6-naltrexol isomers and methylnaltrexone sulphate appears to be the primary pathway to metabolism.
Slovenian: Zdi se, da je poglavitna presnovna pot pretvorba v izomere metil-6-naltreksola in metilnaltreksonijev sulfat.
English: INFORMATION IN BRAILLE RELISTOR 12 mg
Slovenian: PODATKI V BRAILLOVI PISAVI RELISTOR 12 mg
English: This was achieved in 28.7% of the patients in the group receiving daily methylnaltrexone 12 mg (p<0.001 vs. placebo), in 14.9% of those receiving it every other day (p=0.012 vs. placebo), and in 6.2% of the placebo treated patients.
Slovenian: Doseglo ga je 28,7% bolnikov v skupini, ki je dnevno prejemala metilnaltrekson 12 mg (p < 0,001 v primerjavi s placebom), 14,9% bolnikov, ki so ga prejemali vsak drugi dan (p = 0,012 v primerjavi s placebom) in 6,2% bolnikov, ki so dobivali placebo.
English: Relistor is given as a subcutaneous injection.
Slovenian: Zdravilo Relistor dajemo v obliki subkutane injekcije.
English: The Cmax and area under the plasma concentration-time curve (AUC) increase with dose increase from 0.15 mg/kg to 0.5 mg/kg in a doseproportional manner.
Slovenian: Cmax in površina pod krivuljo koncentracije v plazmi v odvisnosti od časa (AUC) se z zvečanjem odmerka zvečata sorazmerno odmerku od 0,15 mg/kg do
English: Methylnaltrexone bromide-treated patients had a significantly higher rate of laxation within 4 hours of the double-blind dose (62 % for 0.15 mg/kg and 58 % for 0.3 mg/kg) than placebo-treated patients (14 %); p<0.0001 for each dose versus placebo.
Slovenian: Bolniki, ki so prejemali metilnaltreksonijev bromid, so signifikantno pogosteje iztrebljali v 4 urah po dvojno slepem odmerku (62 % pri 0,15 mg/kg in 58 % pri 0,3 mg/kg) kot bolniki, ki so prejemali placebo (14 %); p<0,0001 za vsakega od odmerkov proti placebu.
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Slovenian: POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodiumfree.
Slovenian: Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) did not affect fertility or general reproductive performance.
Slovenian: Odmerki do 25 mg/kg/dan (18-kratna izpostavljenost [AUC] pri ljudeh po subkutanem odmerku 0,3 mg/kg) niso vplivali na plodnost ali splošno reproduktivno sposobnost.
English: • If you have Crohn´s disease or gastrointestinal ulcers
Slovenian: • Če imate Crohnovo bolezen ali razjedo v prebavilih.
English: A RFBM was defined as a bowel movement that occurred without laxative use during the previous 24 hours.
Slovenian: Iztrebljanje brez rešilnega odvajala je bilo opredeljeno kot iztrebljanje, do katerega je prišlo brez uporabe odvajala v predhodnih 24 urah.
English: Czech republic
Slovenian: Češka
English: Paediatric population No studies have been performed in the paediatric population (see section 4.2).
Slovenian: Pri otrocih študij niso opravili (glejte poglavje 4.2).
English: Do not touch the needle or allow the needle to touch any surface.
Slovenian: Ne dotikajte se igle in pazite, da se ne bo igla česa dotaknila.
English: Step 1: Preparing for an injection
Slovenian: Korak 1: Priprava na injiciranje
English: Cases of GI perforation have been reported in the postauthorisation period after use of methylnaltrexone bromide in patientswith conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, pseudo obstruction (Ogilvie's syndrome), diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases).
Slovenian: V obdobju po izdaji dovoljenja za promet so po uporabi metilnaltreksonijevega bromida pri bolnikih s stanji, ki jih lahko povezujemo z lokalno ali sistemsko oslabitvijo strukturne integritete stene prebavne cevi (npr. peptično razjedo, psevdoobstrukcijo (Ogilviejev sindrom), divertikulozo, infiltracijske maligne bolezni prebavil ali peritonealne metastaze), poročali o primerih gastrointestinalne perforacije.
English: Subcutaneous injections of Relistor at 150/100 mg/kg/day to rats resulted in decreased offspring weights; doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) had no effect on labour, delivery, or offspring survival and growth.
Slovenian: Subkutane injekcije zdravila Relistor podganam v odmerkih 150/100 mg/kg/dan so povzročile zmanjšanje telesne teže mladičev; odmerki do 25 mg/kg/dan (izpostavljenost [AUC], 18-krat večja od izpostavljenosti pri ljudeh po subkutanem odmerku 0,3 mg/kg) niso vplivali na popadke, kotitev ali preživetje in rast mladičev.
English: 0.4 mL of solution (8 mg methylnaltrexone bromide) Read the package leaflet before use.
Slovenian: 0,4 ml raztopine (8 mg metilnaltreksonijevega bromida) Pred uporabo preberite priloženo navodilo!
English: Solution for injection (injection).
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje (injiciranje)
English: Relistor pre-filled syringe Alcohol swab Cotton ball or gauze Adhesive plaster
Slovenian: napolnjeno injekcijsko brizgo zdravila Relistor alkoholni zloženec kosem vate ali gazo samolepilni obliž
English: The organic cation transporter (OCT)-related drug-drug interaction potential between methylnaltrexone bromide and an OCT inhibitor was studied in 18 healthy subjects by comparing the single-dose pharmacokinetic profiles of methylnaltrexone bromide before and after multiple 400 mg doses of cimetidine.
Slovenian: povezanega s prenašalcem organskih kationov (OCT), med metilnaltreksonijevim bromidom in zaviralcem OCT, tako da so primerjali farmakokinetični profil enkratnega odmerka metilnaltreksonijevega bromida pred več zaporednimi 400-miligramskimi odmerki cimetidina in po njih.
English: Another secondary endpoint evaluated the proportion of patients with ≥3 RFBMs per week during the 4-week double-blind phase.
Slovenian: Drugi ocenjeni sekundarni cilj študije je bil delež bolnikov z ≥ 3 iztrebljanji brez rešilnega odvajala na teden v 4-tedenski dvojno slepi fazi.
English: You will be instructed by your doctor, nurse or pharmacist on the techniques of self-administration.
Slovenian: Vaš zdravnik, medicinska sestra ali farmacevt vas bo naučil metode samoinjiciranja.
English: 0.6 mL of solution (12 mg methylnaltrexone bromide) Read the package leaflet before use.
Slovenian: 0,6 ml raztopine (12 mg metilnaltreksonijevega bromida) Pred uporabo preberite priloženo navodilo!
English: Your doctor, nurse or pharmacist will have advised you which dose they have prescribed for you and how often you need to take it. For patients receiving supportive care for advanced illness, the usual doses are given in the table below.
Slovenian: Vaš zdravnik, medicinska sestra ali farmacevt vam bo tudi povedal, kakšen odmerek vam je bil predpisan, in kako pogosto ga morate uporabljati.
English: This was achieved in 59% of the patients in the group receiving daily methylnaltrexone 12 mg (p<0.001 vs. placebo), in 61% of those receiving it every other day (p<0.001 vs. placebo), and in 38% of the placebo treated patients.
Slovenian: Doseglo ga je 59 % bolnikov v skupini, ki je dnevno prejemala metilnaltrekson 12 mg (p < 0,001 v primerjavi s placebom), 61 % bolnikov, ki so ga prejemali vsak drugi dan (p < 0,001 v primerjavi s placebom) in 38 % bolnikov, ki so dobivali placebo.
English: These include the Relistor vial, a 1 mL injection syringe (with or without retractable needle), 2 alcohol swabs, and a cotton ball or gauze.
Slovenian: 1-mililitrska injekcijska brizga (z vskočno iglo ali brez nje), 2 alkoholna zloženca in kosem vate ali gaza.
English: Quickly pull the needle out of the skin, being careful to keep it at the same angle as it was inserted.
Slovenian: Iglo hitro potegnite iz kože in pazite, da jo potegnete ven pod istim kotom, pod katerim ste jo zapičili v kožo.
English: In juvenile rats administered intravenous methylnaltrexone bromide for 13 weeks, adverse clinical signs (incidences of convulsions and labored breathing) occurred at dosages (≥ 3 mg/kg/day) and exposures (5.4 times the exposure {AUC} in adult humans at a subcutaneous dose of 0.15 mg/kg) that were lower than those that caused similar toxicity in adult rats (20 mg/kg/day).
Slovenian: Pri mladičih podgan, ki so 13 tednov intravensko prejemali metilnaltreksonijev bromid, so se neželeni klinični znaki (pojavi konvulzij in oteženo dihanje) pojavili pri nižjih odmerkih (≥ 3 mg/kg/dan) in izpostavljenostih (izpostavljenost [AUC], 5,4-krat večja od izpostavljenosti pri odraslih ljudeh po subkutanem odmerku 0,15 mg/kg) od tistih, ki so sprožili podobno toksične učinke pri odraslih podganah (20 mg/kg/dan).
English: Step 4a: Injecting Relistor using a pack containing injection syringe with retractable injection needle
Slovenian: Korak 4a: Injiciranje zdravila Relistor s pakiranjem, ki vsebuje injekcijsko brizgo z vskočno injekcijsko iglo
English: In addition, the analysis showed that 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg correspond to mean doses of 0.16 (range = 0.21-0.13) mg/kg and 0.16 (range = 0.19-0.11) mg/kg, respectively, based on the body weight distribution of patients participating in studies 301 and 302.
Slovenian: Poleg tega je analiza pokazala, da 8-miligramski odmerek pri telesni masi med 38 in manj kot 62 kg in 12-miligramski odmerek pri telesni masi med 62 in 114 kg, na podlagi porazdelitve telesne mase bolnikov, ki so sodelovali v študijah 301 in 302, ustreza povprečnemu odmerku 0,16 (razpon = 0,21
English: Doses may also be given with longer intervals, as per clinical need.
Slovenian: Običajna terapevtska shema je en sam odmerek vsak drugi dan. Odmerki se lahko dajejo tudi v daljših presledkih, glede na klinične potrebe.
English: If you answer No to any of the following questions during the course of treatment with your medicine please contact your doctor, nurse or pharmacist.
Slovenian: Če na katero koli vprašanje (na tej kartici) v času svojega zdravljenja ne morete odgovoriti z DA, se posvetujte s svojim zdravnikom, medicinsko sestro ali farmacevtom.
English: What you need to know before you use Relistor
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Relistor Ne uporabljajte zdravila Relistor
English: Hold the barrel of the syringe with one hand and pull the needle cover straight off. Place the needle cover back on the work surface.
Slovenian: Držite valj brizge z eno roko in potegnite pokrovček igle naravnost proč.
English: Methylnaltrexone bromide-treated patients had a higher rate of laxation within 4 hours of the first dose (48 %) than placebo-treated patients (16 %); p<0.0001.
Slovenian: Bolniki, zdravljeni z metilnaltreksonijevim bromidom, so pogosteje odvajali v 4 urah po prvem odmerku (48 %) kot bolniki, ki so prejemali placebo (16 %); p<0,0001.
English: The following instructions explain how to inject Relistor.
Slovenian: V teh navodilih boste našli razlago, kako si vbrizgavajte zdravilo Relistor.
English: Step 1: Preparing for an injection Step 2: Choosing and preparing an injection site Step 3: Injecting Relistor pre-filled syringe Step 4: Disposing of supplies
Slovenian: Korak 2: Izbira in priprava mesta injiciranja Korak 3: Injiciranje zdravila Relistor v napolnjeni injekcijski brizgi Korak 4: Odstranjevanje
English: Step 3: Injecting Relistor pre-filled syringe
Slovenian: Korak 3: Injiciranje zdravila Relistor v napolnjeni injekcijski brizgi
English: Step 4b: Injecting Relistor using a standard injection syringe and injection needle
Slovenian: Korak 4b: Injiciranje zdravila Relistor s standardno injekcijsko brizgo in injekcijsko iglo
English: 8 pre-filled syringes
Slovenian: 8 napolnjenih injekcijskih brizg
English: Clear solution, colourless to pale-yellow, essentially free from visible particulates.
Slovenian: Bistra raztopina, brezbarvna do svetlo rumena, praktično brez vidnih delcev
English: This medicine is given by an injection under the skin (by subcutaneous injection) in either (1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (if not self-injecting).
Slovenian: To zdravilo se daje kot podkožna injekcija (s subkutano injekcijo) v (1) stegno ali (2) trebuh ali (3)
English: The recommended dose for patients with long-term pain (except patients receiving supportive care for advanced illness) is 12 mg methylnalrexone bromide (0.6 mL of solution) given as an injection under the skin , as needed, but at least given 4 times a week and up to once a day (7 times a week).
Slovenian: Priporočeni odmerek za bolnike z dolgotrajno bolečino (razen za bolnike, ki prejemajo podporno nego zaradi napredovale bolezni) je 12 mg metilnaltreksonijevega bromida (0,6 ml raztopine), danega v obliki podkožne injekcije po potrebi, vendar vsaj 4-krat na teden in največ enkrat na dan (7-krat na teden).
English: Cases of a hole developing in the bowel wall (gastrointestinal perforation) have been reported in patients using Relistor.
Slovenian: Pri bolnikih, ki so uporabljali zdravilo Relistor, so poročali o predrtju stene črevesja (gastrointestinalna perforacija).
English: It is clear, colourless to pale yellow, and does not contain flakes or particles.
Slovenian: To je bistra, brezbarvna do svetlo rumena raztopina in ne vsebuje kosmičev ali delcev.
English: The key secondary endpoint of adjusted mean change from baseline in weekly RFBMs was 3.1 in the methylnaltrexone bromide 12 mg once daily treatment group, 2.1 in the methylnaltrexone bromide 12 mg every other day treatment group, and 1.5 in the placebo treatment group during the 4-week doubleblind period.
Slovenian: Ključni sekundarni cilj študije, prilagojen za povprečno spremembo od izhodišča, tedensko iztrebljanje brez rešilnega odvajala, je bil 3,1 v skupini, zdravljeni z metilnaltreksonijevim bromidom 12 mg enkrat na dan, 2,1 v skupini, zdravljeni z metilnaltreksonijevim bromidom 12 mg vsak drugi dan, in 1,5 v skupini, ki je dobivala placebo v 4-tedenskem dvojno slepem obdobju.
English: 2 vials of 0.6 mL
Slovenian: 2 viali po 0,6 ml
English: Not known: Gastrointestinal perforation (see section 4.4), Common: Vomiting
Slovenian: Bolezni prebavil neznana: gastrointestinalna perforacija (glejte poglavje 4.4) pogosti: bruhanje zelo pogosti: bolečine v trebuhu, navzea, driska, vetrovi
English: Opioid-induced constipation in adult patients with advanced illness The efficacy and safety of methylnaltrexone bromide in the treatment of opioid-induced constipation in patients receiving palliative care was demonstrated in two randomised, double-blind, placebocontrolled studies.
Slovenian: Konstipacija, povzročena z opioidi, pri odraslih bolnikih z napredovalo boleznijo Učinkovitost in varnost metilnaltreksonijevega bromida v zdravljenju konstipacije, povzročene z opioidom, pri bolnikih, ki prejemajo paliativno zdravljenje, so dokazali v dveh randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
English: There were 2 primary endpoints: proportion of patients with a rescue-free laxation within 4 hours of the first dose of study medicinal product and proportion of patients with a rescue-free laxation within 4 hours after at least 2 of the first 4 doses of medicinal product.
Slovenian: 4 urah po prvem odmerku preiskovanega zdravila in delež bolnikov z iztrebljanjem brez rešilnega odvajala v 4 urah po vsaj 2 od prvih 4 odmerkov zdravila.
English: Pack containing 2 vials, 2 injection syringes with retractable injection needle, and 4 alcohol swabs (i.e. 2 inner cartons).
Slovenian: Škatla, ki vsebuje 2 viali, 2 injekcijski brizgi z vskočno injekcijsko iglo in 4 alkoholne zložence (t.j.
English: The renal clearance of methylnaltrexone bromide decreased with increasing severity of renal impairment.
Slovenian: Ledvični očistek metilnaltreksonijevega bromida je bil toliko manjši, kolikor večja je bila stopnja ledvične okvare.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.6 mL of solution (12 mg methylnaltrexone bromide)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,6 ml raztopine (12 mg metilnaltreksonijevega bromida)
English: In addition, median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebotreated patients.
Slovenian: Poleg tega mediani dnevni odmerek opioida ni pomembno odstopal od izhodišča niti pri bolnikih, zdravljenih z metilnaltreksonijevim bromidom, niti pri tistih, ki so prejemali placebo.
English: Patients had opioid-induced constipation (< 3 rescue medication-free bowel movements per week during the screening period).
Slovenian: (< 3 iztrebljanja brez rešilnega odvajala na teden v obdobju presejanja).
English: Prior to screening, patients had opioid-induced constipation defined as either <3 bowel movements in the preceding week or no bowel movement for >2 days.
Slovenian: Bolniki so pred presejanjem imeli z opioidom povzročeno konstipacijo, opredeljeno bodisi kot <3
English: Pack containing 7 vials, 7 injection syringes with retractable injection needle, and 14 alcohol swabs (i.e. 7 inner cartons).
Slovenian: Škatla, ki vsebuje 7 vial, 7 injekcijskih brizg z vskočno injekcijsko iglo in 14 alkoholnih zložencev (t.j.
English: After the needle is inserted, let go of the skin and slowly push the plunger all the way down until the syringe is empty and you hear a click to inject Relistor.
Slovenian: Kožno gubo spustite in bat injekcijske brizge počasi potisnite navzdol, dokler ni brizga prazna in zaslišite klik.
English: 1 vial of 0.6 mL
Slovenian: 1 viala po 0,6 ml
English: Allow the injection site to air-dry before injecting.
Slovenian: Pred injiciranjem naj se mesto injiciranja posuši na zraku.
English: The proportion of patients having an RFBM within 4 hours of the first dose was 34.2% in the combined methylnaltrexone bromide group versus 9.9% in the placebo group (p<0.001).
Slovenian: Delež bolnikov z iztrebljanjem brez rešilnega odvajala v 4 urah po prvem odmerku je bil 34,2 % v kombinirani skupini z metilnaltreksonijevim bromidom v primerjavi z 9,9 % v skupini s placebom
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C.
English: • Reaction at the site of injection (e.g., stinging, burning, pain, redness, oedema)
Slovenian: reakcija na mestu injiciranja (npr. zbadanje, pekoč občutek, bolečina, rdečica, oteklina),
English: Make sure the liquid in the pre-filled syringe is clear and colourless to pale yellow, and does not have any particles in it.
Slovenian: Prepričajte se, da je tekočina v napolnjeni brizgi bistra in brezbarvna do svetlo rumena in brez vidnih delcev.
English: 7 pre-filled syringes
Slovenian: 7 napolnjenih injekcijskih brizg
English: A total of 460 patients (methylnaltrexone bromide 12 mg once daily, n=150, methylnaltrexone bromide 12 mg every other day, n=148, placebo, n=162) were treated in the double-blind period.
Slovenian: 4-tedenskemu, dvojno slepemu obdobju je sledilo 8-tedensko odprto obdobje, v katerem so metilnaltreksonijev bromid uporabljali po potrebi, a ne pogosteje kot enkrat na dan. Skupaj 460 bolnikov (metilnaltreksonijev bromid 12 mg enkrat na dan, n = 150, metilnaltreksonijev bromid 12 mg vsak drugi dan, n = 148, placebo, n = 162) je bilo zdravljenih v dvojno slepem obdobju.
English: Step 3: Choosing and preparing an injection site
Slovenian: Korak 3: Izbira in priprava mesta injiciranja
English: 7 sterile 1 mL injection syringes with retractable injection needle 14 alcohol swabs
Slovenian: 7 sterilnih 1-mililitrskih injekcijskih brizg z vskočno injekcijsko iglo 14 alkoholnih zložencev
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Relistor Vsebina pakiranja in dodatne informacije
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LABEL TEXT FOR INTERMEDIATE CARTON (VIAL PRESENTATION)
Slovenian: BESEDILO NA NALEPKI NA VMESNI ŠKATLI (VIALA)
English: The needle will automatically retract from the skin and be capped.
Slovenian: Sedaj se igla sama od sebe potegne iz kože in pokrije s pokrovčkom.
English: Look for the needle tip inside the vial.
Slovenian: Bodite pozorni na konico igle v viali.