FrancophonIA/ELRC3.0 huggingface dataset:
English: With the needle still inserted in the upside down vial, check for air bubbles in the syringe.
Slovenian: Ko je igla še zabodena v na glavo zasukani viali, se prepričajte, ali je v brizgi kaj zračnih mehurčkov.
English: In patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 mL of solution) for those weighing 62 to 114 kg.
Slovenian: Pri bolnikih s težkimi ledvičnimi okvarami (očistek kreatinina manjši od 30 ml/min) moramo odmerek metilnaltreksonijevega bromida zmanjšati z 12 mg na 8 mg (0,4 ml raztopine) pri bolnikih, ki tehtajo
English: Methylnaltrexone bromide undergoes moderate tissue distribution.
Slovenian: Metilnaltreksonijev bromid se zmerno porazdeljuje po tkivih.
English: Use of methylnaltrexone bromide in patients with colostomy, peritoneal catheter, active diverticular disease or fecal impaction has not been studied.
Slovenian: Pri bolnikih s kolostomo, peritonealnim katetrom, aktivno divertikulozo ali fekalno impakcijo uporabe metilnaltreksonijevega bromida niso proučevali.
English: A total of 154 patients (methylnaltrexone bromide 0.15 mg/kg, n = 47; methylnaltrexone bromide 0.3 mg/kg, n = 55, placebo, n = 52) were treated in the double-blind period.
Slovenian: Vključenih in zdravljenih v dvojno slepem obdobju je bilo skupaj 154 bolnikov (metilnaltreksonijev bromid 0,15 mg/kg, n = 47, metilnaltreksonijev bromid
English: After the needle is inserted, let go of the skin and slowly push the plunger all the way down until the pre-filled syringe is empty.
Slovenian: Potem ko ste iglo zabodli, kožo spustite in počasi potiskajte bat navzdol, dokler ne izpraznite napolnjene injekcijske brizge.
English: A supplementary analysis evaluated the percentage of patients achieving ≥3 complete RFBMs per week and an increase of ≥1 complete
Slovenian: V dopolnilni analizi so ocenili odstotek bolnikov, ki so dosegli ≥ 3 celovita iztrebljanji brez rešilnega odvajala na teden, in povečanje za ≥ 1 celovito iztrebljanje brez rešilnega odvajala na teden v vsaj 3 ali 4 tednih zdravljenja.
English: Patients should be monitored for severe, persistent, or worsening abdominal pain; methylnaltrexone bromide should be discontinued if this symptom occurs.
Slovenian: Bolnike je treba spremljati, če bi se pojavila huda, trdovratna bolečina v trebuhu ali bi se le-ta poslabšala.
English: The mean percentage of methylnaltrexone bromide resulting in any RFBM within 4 hours were 28.9% and 30.2% respectively for the once daily and every other day dose groups compared with 9.4% and 9.3% respectively for the corresponding placebo regimen (p < 0.001).
Slovenian: Povprečni odstotek metilnaltreksonijevega bromida, ki je povzročil iztrebljanje brez rešilnega odvajala v 4 urah, je bil 28,9 % pri skupini z enim odmerkom na dan oz. 30,2 % pri skupini z odmerkom vsak drugi dan, v primerjavi z 9,4 % oz. 9,3 % za ustrezni režim s placebom (p < 0,001).
English: Median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebo-treated patients.
Slovenian: Mediani dnevni odmerek opioida se ni značilno razlikoval od izhodišča niti v skupini, zdravljeni z metilnaltreksonijevim bromidom, niti v skupini, ki je dobivala placebo.
English: Place used pre-filled syringe in a closable, puncture-resistant container.
Slovenian: Uporabljeno napolnjeno injekcijsko brizgo dajte v zaprt vsebnik za ostre odpadke.
English: Store below 30ºC.
Slovenian: Shranjujte pri temperaturi do 30 ºC.
English: No adverse effects occurred in juvenile rats at 1 mg/kg/day or in adult rats at 5 mg/kg/day (1.6 times and 7.8 times, respectively, the exposure {AUC} in adult humans at a subcutaneous dose of 0.15 mg/kg).
Slovenian: Pri mladičih podgan, ki so prejemali odmerke po 1 mg/kg/dan, oziroma pri odraslih podganah pri odmerkih po 5 mg/kg/dan (izpostavljenost [AUC], 1,6-krat oziroma 7,8-krat večja od izpostavljenosti pri odraslih ljudeh po subkutanem odmerku 0,15 mg/kg) se neželeni učinki niso pojavili.
English: Methylnaltrexone bromide is minimally metabolised by CYP isozymes.
Slovenian: Izocimi s CYP minimalno presnavljajo metilnaltreksonijev bromid.
English: The overall risk-benefit profile should be taken into account when using methylnaltrexone bromide in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn's disease).
Slovenian: Pri uporabi metilnaltreksonijevega bromida pri bolnikih s temi ali drugimi stanji, ki bi lahko povzročila okvaro integritete stene prebavil (npr. Crohnovo boleznijo), je treba upoštevati celoten profil glede tveganja in koristi.
English: sweating, hair standing on end, blushing, fast heart beat)
Slovenian: tresenje, nahod, znojenje, kurja polt, vročinski oblivi, hitro utripanje srca),
English: Each vial contains 0.6 mL of solution for injection.
Slovenian: Ena viala vsebuje 0,6 ml raztopine za injiciranje.
English: Hepatic impairment
Slovenian: Okvare jeter
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Slovenian: Napolnjeno injekcijsko brizgo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
English: NAME OF THE MEDICINAL PRODUCT Relistor 12 mg/0.6 mL solution for injection
Slovenian: IME ZDRAVILA Relistor 12 mg/0,6 ml raztopina za injiciranje
English: Common: Injection site reactions (e.g. stinging, burning, pain , redness, oedema) Reporting of suspected adverse reactions
Slovenian: Bolezni kože in podkožja pogosti: reakcije na mestu injiciranja (npr. zbadanje, pekoč občutek, bolečina, rdečica, edem) Poročanje o domnevnih neželenih učinkih
English: The first co-primary endpoint was the proportion of patients having a rescue free bowel movements (RFBMs) within 4 hours of the first dose administration and the second the percentage of active injections resulting in any RFBM within 4 hours during the double-blind phase.
Slovenian: Prvi sočasni primarni cilj študije je bil delež bolnikov z iztrebljanjem brez rešilnega odvajala v 4 urah po prvem odmerku in drugi odstotek aktivnih injiciranj, ki so povzročili iztrebljanje brez rešilnega odvajala v 4 urah med dvojno slepo fazo.
English: Carefully pull back the plunger on the syringe to either the 0.4 mL mark for 8 mg of Relistor or the 0.6 mL mark for 12 mg Relistor.
Slovenian: Če vam je predpisan 8-mg odmerek zdravila Relistor, bat injekcijske brizge previdno izvlecite do oznake 0,4 ml oziroma do oznake 0,6 ml, če vam je predpisan 12-mg odmerek zdravila Relistor.
English: You will be instructed by your doctor, nurse or pharmacist on the techniques of self-injection.
Slovenian: medicinska sestra ali farmacevt vas bo naučil metode samoinjiciranja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT (PRE-FILLED SYRINGE PRESENTATION)
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI (NAPOLNJENA INJEKCIJSKA BRIZGA)
English: 7 vials of 0.6 mL
Slovenian: 7 vial po 0,6 ml
English: Dizziness is a common side effect of this medicine.
Slovenian: Pogost neželeni učinek tega zdravila je vrtoglavost.
English: Sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH).
Slovenian: Natrijev klorid, natrijev kalcijev edetat, glicin klorid, voda za injekcije, klorovodikova kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH).
English: No adverse effects occurred in either juvenile or adult dogs at a dose of 5 mg/kg/day (44 times the exposure {AUC} in adult humans at a subcutaneous dose of 0.15 mg/kg).
Slovenian: Tako pri mladičih kot pri odraslih psih, ki so prejemali odmerke po 5 mg/kg/dan (izpostavljenost [AUC], 44-krat večja od izpostavljenosti pri odraslih ljudeh po subkutanem odmerku 0,15 mg/kg) se neželeni učinki niso pojavili.
English: 0.6 mL (12 mg) More than 114 kg 0.15 mg/kg
Slovenian: 0,13) mg/kg oziroma 0,16 (razpon = 0,19-0,11) mg/kg.
English: Patients may receive two consecutive doses 24 hours apart, only when there has been no response (bowel movement) to the dose on the preceding day.
Slovenian: Le če predhodnega dne ni odziva (iztrebljanja) na odmerek, lahko bolnik vzame dva zaporedna odmerka v presledku 24 ur.
English: Gastrointestinal (GI) conditions and GI perforation Methylnaltrexone bromide should be used with caution in patients with known or suspected lesions of the GI tract.
Slovenian: Metilnaltreksonijev bromid je treba pri bolnikih z znano lezijo prebavil ali sumom nanjo uporabljati previdno.
English: Relistor 8 mg solution for injection in pre-filled syringe Relistor 12 mg solution for injection in pre-filled syringe Methylnaltrexone bromide
Slovenian: Navodilo za uporabo Relistor 8 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Relistor 12 mg raztopina za injiciranje v napolnjeni injekcijski brizgi metilnaltreksonijev bromid
English: - The other ingredients are sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH) and sodium hydroxide (to adjust pH).
Slovenian: - Pomožne snovi so natrijev klorid, natrijev kalcijev edetat, glicin klorid, voda za injekcije, klorovodikova kislina (za uravnavanje pH) in natrijev hidroksid (za uravnavanje pH).
English: Hold the vial on the work surface with the other hand so that it can not slip off. You will feel a slight resistance as the needle passes through the stopper.
Slovenian: Vialo med tem z drugo roko držite na delovni površini tako, da ne more zdrsniti.
English: Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide
Slovenian: Relistor 12 mg/0,6 ml raztopina za injiciranje metilnaltreksonijev bromid
English: Methylnaltrexone bromide is metabolised to a modest extent in humans based on the amount of methylnaltrexone bromide metabolites recovered from excreta.
Slovenian: Sodeč po količini presnovkov metilnaltreksonijevega bromida, prestreženih iz blata in urina, se metilnaltreksonijev bromid pri ljudeh presnavlja v zmernem obsegu.
English: Dispose of the capped syringe or needle and syringe in a closable puncture-resistant container as instructed by your doctor, nurse or pharmacist.
Slovenian: Pokrito iglo ali iglo in brizgo po navodilih svojega zdravnika, medicinske sestre ali farmacevta zavrzite v zabojnik, ki je namenjen za odstranjevanje ostrih predmetov.
English: Each vial contains 0.6 mL of solution.
Slovenian: Ena viala vsebuje 0,6 ml raztopine.
English: The 8 mg pre-filled syringe presentation of Relistor should only be used to treat these patients when existing medical conditions require the dose to be decreased to 8 mg (0.4 mL of solution), see Special Populations.
Slovenian: če je treba zaradi obstoječih zdravstvenih težav odmerek zmanjšati na 8 mg (0,4 ml raztopine), glejte
English: How to store Relistor
Slovenian: Shranjevanje zdravila Relistor
English: - If you get any side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: If you have suffered from constipation before you had to take opioids (for pain), please talk to your doctor.
Slovenian: Pogovorite se s svojim zdravnikom, če ste bili zaprti, še preden ste morali začeti jemati opioide (zaradi bolečine).
English: Talk to your doctor or pharmacist before using Relistor.
Slovenian: Pred začetkom uporabe zdravila Relistor se posvetujte z zdravnikom ali farmacevtom.
English: Tap the upside down syringe and push out any air bubbles with the plunger
Slovenian: Rahlo potrkajte po obrnjeni injekcijski brizgi in in zračne mehurčke iztisnite z batom
English: Stool consistency was not meaningfully improved in patients who had soft stool at baseline.
Slovenian: Pri bolnikih, ki so imeli v izhodišču mehko blato, se konzistenca blata ni pomembno izboljšala.
English: One mL of solution contains 20 mg methylnaltrexone bromide.
Slovenian: 1 mililiter raztopine vsebuje 20 mg metilnaltreksonijevega bromida.
English: NAME OF THE MEDICINAL PRODUCT Relistor 8 mg solution for injection in pre-filled syringe
Slovenian: IME ZDRAVILA Relistor 8 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: NAME OF THE MEDICINAL PRODUCT Relistor 12 mg solution for injection in pre-filled syringe
Slovenian: IME ZDRAVILA Relistor 12 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LABEL TEXT FOR TRAY LIDDING (PRE-FILLED SYRINGE PRESENTATION)
Slovenian: BESEDILO NA NALEPKI PREKRIVNE FOLIJE LEŽIŠČA (NAPOLNJENA INJEKCIJSKA
English: Step 4a: Injecting Relistor using a pack containing injection syringe with retractable injection needle Step 4b: Injecting Relistor using a standard injection syringe and injection needle Step 5 Disposing of supplies
Slovenian: Korak 4b: Injiciranje zdravila Relistor s standardno injekcijsko brizgo in injekcijsko iglo Korak 5: Odstranjevanje
English: (See INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR at the end of this leaflet.)
Slovenian: INJEKCIJE ZDRAVILA RELISTOR na koncu tega navodila za uporabo zdravila).
English: Opioid-withdrawal-like symptoms (any of the following: feeling cold, shivering, runny nose,
Slovenian: simptomi, podobni odtegnitvenim pri opioidih (kar koli od naslednjega: občutek mrazenja,
English: Consequently, no meaningful change in AUC of methylnaltrexone bromide, in addition to Cmax, was observed before and after multiple-dose administration of cimetidine.
Slovenian: Zato niso pred uporabo večkratnih odmerkov cimetidina in po njej opazili nobene pomembne spremembe AUC metilnaltreksonijevega bromida, prav tako ne Cmax.
English: The recommended dose for patients receiving supportive care for advanced illness is 8 mg methylnaltrexone bromide (0.4 mL of solution) for patients weighing 38-61 kg or 12 mg (0.6 mL of solution) for patients weighing 62-114 kg.
Slovenian: Priporočeni odmerek za bolnike, ki prejemajo podporno nego za napredovalo bolezen, je 8 mg metilnaltreksonijevega bromida (0,4 ml raztopine) za bolnike, ki tehtajo 38-61 kg, ali 12 mg (0,6 ml raztopine) za bolnike, ki tehtajo 62-114 kg. Odmerek se daje vsakih 48 ur (na 2 dni) v obliki podkožne injekcije.
English: 2 vials with 2 sterile 1 mL injection syringes with retractable injection needle and 4 alcohol swabs; or 7 vials with 7 sterile 1 mL injection syringes with retractable injection needle and 14 alcohol swabs.
Slovenian: 2 viali z 2 sterilnima 1-mililitrskima injekcijskima brizgama z vskočno injekcijsko iglo in 4 alkoholnimi zloženci; ali
English: After the needle is inserted, let go of the skin and slowly push the plunger all the way down to inject Relistor.
Slovenian: Potem ko ste iglo zabodli, kožo spustite in injicirajte zdravilo Relistor tako, da bat previdno potisnete do konca navzdol.
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: Konstipacija, povzročena z opioidi, pri odraslih bolnikih s kronično bolečino (razen pri bolnikih z napredovalo boleznijo, ki prejemajo paliativno nego) Priporočeni odmerek metilnaltreksonijevega bromida je 12 mg (0,6 ml raztopine) subkutano, po potrebi, v vsaj 4 odmerkih na teden, do enkrat na dan (7 odmerkov tedensko).
English: Rapid onset of bowel movements
Slovenian: Hiter začetek odvajanja blata
English: OTHER Keep the vial in the outer carton in order to protect from light.
Slovenian: DRUGI PODATKI Vialo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
English: The recommended dose for patients receiving supportive care in advanced illness is 8 mg methylnaltrexone bromide (0.4 mL of solution) for patients weighing 38-61 kg or 12 mg (0.6 mL of solution) for patients weighing 62-114 kg.
Slovenian: Priporočeni odmerek metilnaltreksonijevega bromida je 8 mg (0,4 ml raztopine) (za bolnike, ki tehtajo 38-61 kg) ali 12 mg (0,6 ml raztopine) (za bolnike, ki tehtajo 62-114 kg).
English: Methylnaltrexone bromide
Slovenian: - Učinkovina je metilnaltreksonijev bromid.
English: Each syringe of 0.4 mL contains 8 mg methylnaltrexone bromide.
Slovenian: Ena napolnjena injekcijska brizga z 0,4 ml vsebuje 8 mg metilnaltreksonijevega bromida.
English: You may see some fluid or bubbles inside the vial when the syringe is properly filled.
Slovenian: Ko bo brizga pravilno napolnjena, boste v viali mogoče videli nekaj tekočine ali mehurčkov.
English: Make sure the solution in the vial is clear and colourless to pale yellow, and does not contain flakes or particles.
Slovenian: Prepričajte se, da je raztopina v viali bistra in brezbarvna do svetlo rumena in brez kosmičev ali vidnih delcev.
English: • To avoid needle-stick injuries, do not recap used needles.
Slovenian: • Ne nataknite pokrovčka na uporabljeno iglo, da se ne bi zbodli.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Relistor 12 mg/0,6 ml raztopina za injiciranje metilnaltreksonijev bromid subkutana uporaba
English: NAME OF THE MEDICINAL PRODUCT Relistor 8 mg solution for injection in pre-filled syringe Methylnaltrexone bromide
Slovenian: IME ZDRAVILA Relistor 8 mg raztopina za injiciranje v napolnjeni injekcijski brizgi metilnaltreksonijev bromid
English: If you stop using Relistor You should talk to a doctor or pharmacist if you want to stop using this medicine.
Slovenian: Če želite prenehati uporabljati to zdravilo, se posvetujte z zdravnikom ali farmacevtom.
English: Opioid-induced constipation in adult patients with chronic non-cancer pain The efficacy and safety of methylnaltrexone bromide in the treatment of opioid-induced constipation in patients with chronic non-cancer pain were demonstrated in a randomized, double-blind, placebo-controlled study (Study 3356).
Slovenian: Konstipacija, povzročena z opioidi, pri odraslih bolnikih s kronično bolečino, ki ni posledica raka Učinkovitost in varnost metilnaltreksonijevega bromida pri zdravljenju konstipacije, povzročene z opioidi, pri bolnikih s kronično bolečino, ki ni posledica raka, je bila dokazana v randomizirani,
English: DO NOT touch the needle or allow it to come into contact with any other surface.
Slovenian: Ne dotikajte se igle in pazite, da se z njo česa ne dotaknete.
English: There was no significant relationship between baseline opioid dose and laxation response in methylnaltrexone bromide-treated patients in these studies.
Slovenian: V teh študijah pri bolnikih, zdravljenih z metilnaltreksonijevim bromidom, ni bilo signifikantne povezave med izhodiščnim odmerkom opioida in laksacijskim odzivom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR VIAL LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: The pre-filled syringe should NEVER be reused.
Slovenian: Korak 4: Odstranjevanje Napolnjene injekcijske brizge ne smete NIKOLI uporabiti še enkrat.
English: Each vial of 0.6 mL contains 12 mg methylnaltrexone bromide.
Slovenian: Ena 0,6-mililitrska viala vsebuje 12 mg metilnaltreksonijevega bromida.
English: Step 2: Choosing and preparing an injection site 1.
Slovenian: Korak 2: Izbira in priprava mesta injiciranja
English: Each syringe of 0.6 mL contains 12 mg methylnaltrexone bromide.
Slovenian: Ena napolnjena injekcijska brizga z 0,6 ml vsebuje 12 mg metilnaltreksonijevega bromida.
English: Common: opioid-withdrawal-like symptoms (like chills, tremor, rhinorrhea, piloerection, hot flush, palpitation, hyperhidrosis, vomiting, abdominal pain)
Slovenian: Bolezni živčevja pogosti: vrtoglavost pogosti: simptomi, podobni odtegnitvenim pri opioidih (kot so mrzlica, tremor, rinoreja, piloerekcija,
English: B. PACKAGE LEAFLET
Slovenian: BESEDILO NA NALEPKI VIALE
English: Clear, Type I, flint glass, single-use vial, grey butyl rubber stopper, and aluminium overseal with flipoff-cap.
Slovenian: Viala za enkratno uporabo iz prozornega kristalnega stekla vrste I z zamaškom iz sive butilne gume in aluminijasto zapiralno obrobo z zaporko.
English: Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, vomiting, abdominal pain, palpitations, and blushing have occurred in patients treated with methylnaltrexone bromide.
Slovenian: Pri bolnikih, ki so prejemali metilnaltreksonijev bromid, so se pojavili simptomi, ki so podobni odtegnitvenim simptomom pri opioidih in vključujejo hiperhidrozo, mrzlico, bruhanje, bolečino v trebuhu, palpitacije in vročinske oblive.
English: Hepatic and renal impairment
Slovenian: Bolezni prebavil in perforacija prebavil
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: KLINIČNI PODATKI 4.1 Terapevtske indikacije
English: Patients with severe renal impairment whose weight falls outside the 62 to 114 kg range (see section 5.2) need to reduce their mg/kg dose by 50 %.
Slovenian: Pri bolnikih s težkimi ledvičnimi okvarami (očistek kreatinina manjši od 30 ml/min) moramo odmerek metilnaltreksonijevega bromida zmanjšati z 12 mg na 8 mg (0,4 ml raztopine) pri bolnikih, ki tehtajo 62 do 114 kg. Bolniki s težkimi ledvičnimi okvarami, katerih telesna teža je zunaj meja 62 do 114 kg (glejte poglavje 5.2), morajo prejemati 50 % manjši odmerek v mg/kg.
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/011
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/463/011
English: Ensure you have the correct dose level in the syringe (e.g. 0.4 mL if you have been prescribed 8 mg)
Slovenian: 0,4 ml, če vam je bil predpisan odmerek 8 mg)
English: 2 sterile 1 mL injection syringes with retractable injection needle 4 alcohol swabs
Slovenian: 2 sterilni 1-mililitrski injekcijski brizgi z vskočno injekcijsko iglo
English: • Diarrhoea (passing of frequent watery stools)
Slovenian: navzea (siljenje na bruhanje), driska (pogosto odvajanje vodenega blata), vetrovi (flatulenca).
English: Each pre-filled syringe contains 0.4 mL of solution for injection.
Slovenian: 6.5 Vrsta ovojnine in vsebina Ena napolnjena injekcijska brizga vsebuje 0,4 ml raztopine za injiciranje.
English: Pick up the syringe from your work surface.
Slovenian: Odložite pokrovček igle nazaj na delovno površino.
English: What Relistor looks like and contents of the pack Relistor is a solution for injection.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Relistor
English: Common: Dizziness
Slovenian: Ledvične okvare
English: Weight
Slovenian: BRIZGA)
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/010
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/463/010
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije Przedsiębiorstwo Farmaceutyczne Jelfa SA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/463/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/463/008
English: Each pre-filled syringe contains 0.6 mL of solution for injection.
Slovenian: 6.5 Vrsta ovojnine in vsebina Ena napolnjena injekcijska brizga vsebuje 0,6 ml raztopine za injiciranje.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/463/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/463/004
English: Solution for injection.
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/463/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/463/001
English: There were no clinically relevant changes from baseline in pain scores in either the methylnaltrexone bromide or placebo-treated patients.
Slovenian: Niti pri bolnikih, ki so prejemali metilnaltreksonijev bromid, niti pri tistih, ki so jemali placebo, ni bilo klinično pomembnih sprememb v lestvicah za ocenjevanje intenzivnosti bolečine.
English: Firmly hold the barrel of the pre-filled syringe and pull the needle cap straight off. Do not touch the needle or allow it to touch any surface.
Slovenian: Čvrsto držite valj napolnjene brizge in potegnite pokrovček igle naravnost proč.