natgillin/translations-raw huggingface dataset:
Pharmacotherapeutic group: Laxatives, Peripheral opioid receptor antagonists, ATC code: A06AH01 
Farmakoterapevtska skupina: Odvajala, antagonisti perifernih opioidnih receptorjev, oznaka ATC: A06AH01
Throughout both study periods, patients maintained their usual laxative regimen. 
Med obema obdobjema študije so se bolniki držali svojega običajnega predpisanega programa odvajanja.
• If you are receiving supportive care for your advanced illness, this medicine will only be used for a limited period of time, which will usually be less than 4 months. 
• Če prejemate podporno nego zaradi napredovale bolezni, se lahko to zdravilo uporablja le v omejenem časovnem obdobju, ki običajno ni daljše od 4 mesecev.
This may have an effect on your ability to drive and use machines. 
To lahko vpliva na vašo sposobnost vožnje in upravljanja strojev.
Dose (mL) = patient weight (kg) x 0.0075 
odmerek (ml) = bolnikova telesna teža (kg) x 0,0075
A total of 136, 21, and 82 patients received at least one open-label dose in studies 301, 301EXT, and 302EXT, respectively. 
Vsega skupaj 136, 21 in 82 bolnikov je v študijah 301, 301EXT oziroma 302EXT prejelo vsaj po en odprt odmerek.
This should be taken into account when prescribing methylnaltrexone bromide for such patients. 
To je treba upoštevati pri predpisovanju metilnaltreksonijevega bromida takšnim bolnikom.
You may use a sharps container (such as a yellow biohazard container). 
Uporabite lahko vsebnik za ostre odpadke (na primer rumeni vsebnik za biološko nevarne odpadke).
Effect on cardiac repolarisation 
Vpliv na repolarizacijo srca
Remove the protective plastic cap from the vial. 
Odstranite plastično zaščitno zaporko z viale.
Relistor was administered every 3.2 days (median dosing interval, with a range of 1-39 days). 
Zdravilo Relistor so dajali na 3,2 dneva (mediani interval odmerjanja, z razponom 1-39 dni).
In both studies, patients had advanced terminal illness and limited life expectancy, with the majority having a primary diagnosis of incurable cancer; other primary diagnoses included end-stage COPD/emphysema, cardiovascular disease/heart failure, Alzheimer's disease/dementia, HIV/AIDS, or other advanced illnesses. 
V obeh študijah so imeli bolniki napredovalo terminalno bolezen in krajšo pričakovano življenjsko dobo, večina jih je imela primarno diagnozo neozdravljivega raka; med drugimi primarnimi diagnozami so bili še končni stadij KOPB/emfizema, kardiovaskularne bolezni/popuščanja srca, Alzheimerjeve bolezni/demence, HIV/AIDS in drugih napredovalih bolezni.
In this study, the median patient age was 49 years (range 23-83); 60% were females. 
V tej študiji je bila mediana starost bolnikov 49 let (razpon 23-83); 60 % je bilo žensk.
Your doctor will tell you whether you should stop or continue taking your usual laxatives when you start using this medicine. 
Zdravnik vam bo povedal, ali naj z običajnim laksativnim zdravljenjem prenehate ali nadaljujete, ko začnete uporabljati to zdravilo.
This section contains important questions that you will need to answer before you take Relistor, and during treatment with Relistor. 
To poglavje vsebuje pomembna vprašanja, na katera boste morali odgovoriti, preden vzamete zdravilo Relistor ali med zdravljenjem z zdravilom Relistor.
It is used for patients when other medicines for constipation, called laxatives, have not worked well enough. 
Uporablja se pri bolnikih, če druga zdravila proti zaprtju, imenovana laksativi, niso bila dovolj učinkovita.
The mechanism of this effect is unknown; however, the human cardiac potassium ion channel (hERG) appears not to be involved. 
Mehanizem tega učinka ni znan; zdi pa se, da kalijevi kanalčki (hERG) v človeškem srcu niso vpleteni.
Approximately half of the dose is excreted in the urine and somewhat less in faeces. 
Približno pol odmerka se izloči z urinom in nekaj manj z blatom.
Select a flat, clean, well-lit working surface where you can lay out the contents of your Relistor carton. 
Pripravite si ravno, čisto in dobro osvetljeno delovno površino, kamor boste zložili vsebino škatle zdravila Relistor.
Patients were required to discontinue all previous laxative therapy. 
Od bolnikov se je zahtevalo, da so se prenehali zdraviti z vsemi predhodnimi odvajalnimi zdravili.
Gender No meaningful gender differences have been observed. 
Pomembnih razlik zaradi spola niso opazili.
Dizziness may occur, and this may have an effect on the ability to drive and use machines (see section 4.8). 
Lahko se pojavi vrtoglavost, ki lahko vpliva na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
Your doctor will decide if you can use Relistor if you are pregnant. 
Vaš zdravnik se bo odločil, ali lahko med nosečnostjo uporabljate zdravilo Relistor.
This injection should not be mixed in the same syringe with any other medicine. 
Te raztopine za injiciranje ne smete zmešati v isti brizgi z nobenim drugim zdravilom.
Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia. 
Pri bolnikih, ki imajo motnje hematoencefalne bariere, se lahko poveča tveganje za opioidni odtegnitveni sindrom in/ali zmanjšano analgezijo.
Due to light sensitivity, the solution for injection should be used within 24 hours. 
Zaradi občutljivosti za svetlobo morate raztopino za injiciranje uporabiti v 24 urah.
• If you are allergic to methylnaltrexone bromide or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na metilnaltreksonijev bromid ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Constipation not related to opioid use 
Konstipacija, ki ni povezana z uporabo opioidov
• This medicine should not be used for treatment of patients with constipation which is not related to opioid use. 
• Tega zdravila se ne sme uporabljati za zdravljenje bolnikov s konstipacijo, ki ni povezana z uporabo opioidov.
The effect on race could not be analysed because the study population was predominantly Caucasian (88 %). 
Vpliva rase ni bilo mogoče analizirati, ker so v populaciji študije prevladovali pripadniki bele rase (88 %).
Do you have a contact number for your community nurse or the health centre? 
Imate telefonsko številko medicinske sestre vašega zdravnika ali zdravstvenega doma?
If severe or persistent diarrhoea occurs during treatment, patients should be advised not to continue therapy with methylnaltrexone bromide and consult their physician. 
Če se med zdravljenjem pojavi huda ali trdovratna driska, moramo bolnikom svetovati, naj ne nadaljujejo zdravljenja z metilnaltreksonijevim bromidom in naj se posvetujejo s svojim zdravnikom.
If this happens, discard the product and start again using another vial and syringe. 
Če se to zgodi, zdravilo zavrzite in začnite znova z drugo vialo in injekcijsko brizgo.
Methylnaltrexone sulphate is an inactive metabolite and present in plasma at a level of approximately 25 % of drug related materials. 
Metilnaltreksonijev sulfat je neaktiven presnovek in je prisoten v plazmi na ravni približno 25 % snovi, povezanih z zdravilom.
For storage conditions of the medicinal product in the syringe, see section 6.3. 
Za pogoje shranjevanje zdravila v injekcijski brizgi glejte poglavje 6.3.
The 8 mg pre-filled syringe will only be used to treat these patients if the dose needs to be decreased because of another medical problem. 
8-mg napolnjena injekcijska igla se za te bolnike uporablja samo, če je treba zaradi druge zdravstvene težave odmerek zmanjšati.
PATIENT CHECKLIST 
KONTROLNA KARTICA ZA BOLNIKA
Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/kg. 
Bolniki, katerih telesna teža je zunaj navedenih meja, naj prejmejo po 0,15 mg/kg.
The safety and efficacy of methylnaltrexone bromide in children less than 18 years has not been established. 
Varnosti in učinkovitost metilnaltreksonijevega bromida pri otrocih, mlajših od 18 let, nista bili dokazani.
At any time, the patient's assigned dose could be reduced based on tolerability. 
Bolniku dodeljeni odmerek se je lahko kadarkoli zmanjšal na podlagi slabega prenašanja zdravila.
Women using this medicine should not breast-feed, since it is not known if methylnaltrexone bromide passes into human breast milk. 
Ženske, ki uporabljajo to zdravilo, ne smejo dojiti, saj ni znano, ali se metilnaltreksonijev bromid izloča v materino mleko.
• It is important to be near a toilet with assistance available if necessary, since bowel movement may happen within 30 minutes after injection of the medicine. 
• Pomembno je, da ste blizu stranišča in da je na voljo pomoč, če je to potrebno, ker lahko pride do iztrebljanja že v 30 minutah po vbrizganju zdravila.
• Safely throw away the Relistor pre-filled syringe after use (Step 4). 
• Napolnjeno injekcijsko brizgo zdravila Relistor po uporabi varno odstranite (korak 4).
It treats constipation that is caused by medicines for moderate to severe pain called opioids (for example morphine or codeine). 
Uporablja se za zdravljenje zaprtja, ki ga povzročajo zdravila za lajšanje zmernih do hudih bolečin, imenovana opioidi (na primer morfin ali kodein).
Relistor is indicated for the treatment of opioid-induced constipation when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older. 
Zdravilo Relistor je indicirano za zdravljenje konstipacije, povzročene z opioidi, kadar je odziv na odvajalno zdravljenje nezadosten, pri odraslih bolnikih, starih 18 let ali več.
What Relistor is and what it is used for 
Kaj je zdravilo Relistor in za kaj ga uporabljamo
The effect on race could not be analysed because the study population was predominantly Caucasian (90 %). 
Učinka na raso ni bilo mogoče analizirati, saj je bila večina študijske populacije belcev (90 %).
Data from clinical trials suggest treatment with methylnaltrexone bromide can result in the rapid onset (within 30 to 60 minutes on average) of a bowel movement. 
Podatki iz kliničnih preskušanj kažejo, da zdravljenje z metilnaltreksonijevim bromidom lahko povzroči hiter začetek odvajanja blata (povprečno v 30 do 60 minutah).
Once you have drawn the medicine into the syringe, it must be used within 24 hours because Relistor is affected by light and may not work properly if it is left in the syringe for longer than 24 hours. 
Ko izvlečete zdravilo v injekcijsko brizgo, ga morate porabiti v roku 24 ur, saj svetloba vpliva na zdravilo Relistor, ki morda ne bo pravilno učinkovalo, če ga boste v injekcijski brizgi pustili dlje kot 24 ur.
Do not insert it at an angle as the needle may bend or break. 
Ne zabodite je pod kotom, ker bi se v tem primeru igla lahko zvila ali zlomila.
In the second week, a patient's assigned dose could be increased to 0.30 mg/kg if the patient had 2 or fewer rescue-free laxations up to day 8. 
V drugem tednu se je lahko bolniku dodeljeni odmerek zvečal na 0,30 mg/kg, če je bolnik imel do 8. dneva največ 2 odvajanji brez rešilnega odvajala.
Do not inject into areas where the skin is tender, bruised, red, or hard. 
Ne injicirajte si v predele, kjer je koža občutljiva, podpluta, pordela ali trda.
Hold the syringe at eye level so that you can see the dosing marks and make sure the tip of the needle is in the fluid all of the time. 
Držite brizgo v višini oči, da boste lahko videli oznake za odmerjanje, in se prepričajte, da je konica igle povsem potopljena v tekočini.
Each of the methyl-6-naltrexol isomers has somewhat less antagonist activity than parent compound, and a low exposure in plasma of approximately 8 % of the drug-related materials. 
Vsaka od izomer metil-6-naltreksola ima nekoliko manjšo antagonistično aktivnost od izhodne spojine in majhno izpostavljenost v plazmi, ki je približno 8 % snovi, povezanih z zdravilom.
This allows methylnaltrexone bromide to function as a peripherally acting mu-opioid antagonist in tissues such as the gastrointestinal tract, without impacting opioid-mediated analgesic effects on the central nervous system. 
To metilnaltreksonijevemu bromidu omogoča, da deluje kot periferno delujoč mu-opioidni antagonist v tkivih, na primer v prebavilih, ne da bi vplival na analgetične učinke opioida na centralno živčevje.
Make sure not to touch the rubber stopper again. 
Pazite, da se gumijastega zamaška ne dotaknete več.
Other medicines and Relistor 
Druga zdravila in zdravilo Relistor
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti:
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with methylnaltrexone bromide should be made, taking into account the benefit of breast-feeding to the child and the benefit of methylnaltrexone bromide therapy to the woman. 
Odločiti se je treba med nadaljevanjem/prenehanjem dojenja in nadaljevanjem/prekinitvijo zdravljenja z metilnaltreksonijevim bromidom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
There was no evidence of a differential effect of gender on safety or efficacy. 
Dokazov o učinku zdravila glede na spol na varnost in učinkovitost ni bilo.
The use of methylnaltrexone bromide for treating opioid-induced constipation beyond 48 weeks has not been evaluated in clinical trials. 
Uporabe metilnaltreksonijevega bromida za zdravljenje konstipacije, povzročene z opioidi, ki bi trajala dlje od 48 tednov, v kliničnih preskušanjih niso ocenili.
During the first week (days 1, 3, 5, 7), patients received either methylnaltrexone bromide 0.15 mg/kg or placebo. 
V prvem tednu (1., 3., 5. in 7. dne) so bolniki prejemali bodisi po 0,15 mg/kg metilnaltreksonijevega bromida bodisi placebo.
Step 5: Disposing of supplies 
Korak 5: Odstranjevanje
Opioid-induced constipation in adult patients with advanced illness Methylnaltrexone bromide treatment has not been studied in adult patients with advanced illness in clinical trials for longer than 4 months, and should therefore only be used for a limited period (see section 5.1). 
Z opioidi povzročena konstipacija pri odraslih bolnikih z napredovalo boleznijo Zdravljenja z metilnaltreksonijevim bromidom niso preučili pri odraslih bolnikih v kliničnih preskušanjih, daljših od 4 mesecev, zato ga je treba uporabljati le za omejeno obdobje (glejte poglavje 5.1).
If you weigh less than 38 kg or more than 114 kg you should use Relistor vials because the correct dose cannot be accurately delivered with these pre-filled syringes. 
Če tehtate manj kot 38 ali več kot 114 kg, uporabljajte viale zdravila Relistor, saj natančno dajanje ustreznega odmerka z napolnjenimi injekcijskimi brizgami ni mogoče.
Make sure that the dose prescribed by your doctor matches the dose on the pre-filled syringe label. 
Prepričajte se, da je odmerek, ki vam ga je predpisal zdravnik, enak kot odmerek, naveden na nalepki napolnjene injekcijske brizge.
Methylnaltrexone bromide has minor influence on the ability to drive and use machines. 
Metilnaltreksonijev bromid ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
If you are using the supplied injection syringe with retractable injection needle, DO NOT PUSH THE PLUNGER DOWN COMPLETELY. 
Če uporabljate priloženo injekcijsko brizgo z vskočno injekcijsko iglo, NE POTISNITE BATA DO KONCA NAVZDOL.
What Relistor is and what it is used for What you need to know before you use Relistor How to use Relistor 
Kaj je zdravilo Relistor in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Relistor Kako uporabljati zdravilo Relistor
INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR 
NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA RELISTOR
Your doctor will determine your dose. 
Odmerek vam bo določil zdravnik.
A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus. 
V študiji na zdravih prostovoljcih so ugotovili ortostatsko hipotenzijo, povezano z odmerkom 0,64 mg/kg, danim v obliki intravenskega bolusa.
Slowly pull the plunger down to the 0.4 mL or 0.6 mL mark on the syringe or as advised, depending on the dose prescribed by your doctor, nurse or pharmacist. 
Počasi izvlecite bat do oznake, ki označuje 0,4 ml, 0,6 ml ali drugo količino, odvisno od odmerka, ki vam ga je predpisal vaš zdravnik, medicinska sestra ali farmacevt.
Methylnaltrexone should not be used during pregnancy unless clearly necessary. 
Metilnaltreksonijevega bromida ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Methylnaltrexone bromide is a selective antagonist of opioid binding at the mu-receptor. 
Metilnaltreksonijev bromid je selektiven antagonist vezave opioidov na mu-receptor.
Use the other hand to gently pinch the cleaned area of skin and hold it firmly. 
Z drugo roko na očiščenem predelu kože nežno naredite kožno gubo in jo čvrsto držite.
Gently tap the syringe to make any air bubbles rise to the top of the syringe; be sure that you still hold onto the vial and syringe. 
Rahlo potrkajte po brizgi, da se bodo morebitni zračni mehurčki dvignili do vrha brizge; pazite, da boste še vedno držali vialo in brizgo.
Data from 133 (62 methylnaltrexone bromide, 71 placebo) patients were analysed. 
Analizirali so podatke 133 bolnikov (62 z metilnaltreksonijevim bromidom, 71 s placebom).
Do not attempt to administer an injection until you are sure that you understand how to prepare and give an injection. 
Ne poskušajte si dati injekcije, dokler niste prepričani, da veste, kako se zdravilo pripravi in injicira.
Studies in animals have shown reproductive toxicity at high doses (see section 5.3). 
Študije na živalih so pri visokih odmerkih pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Cardiac effects were observed in some non-clinical studies in canines (prolongation of action potentials in Purkinje fibers or prolongation of the QTc interval). 
V nekaterih predkliničnih raziskavah na psih so ugotavljali učinke na srce (podaljšanje akcijskih potencialov v Purkynjevih vlaknih ali podaljšanje intervala QTc).
NN: 
NN: {številka}
Severe renal impairment decreased the renal clearance of methylnaltrexone bromide by 8- to 9-fold; however, this resulted in only a 2-fold increase in total methylnaltrexone bromide exposure (AUC). 
Težka ledvična okvara je zmanjšala ledvični očistek metilnaltreksonijevega bromida za 8- do 9-krat; vendar se je pri tem celotna izpostavljenost metilnaltreksonijevemu bromidu (AUC) samo podvojila.
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: 
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC: {številka}
Gather the supplies you will need for your injection: 
Pripravite si vse, kar boste potrebovali za injiciranje:
Pack sizes of 4, 7, 8 and 10 pre-filled syringes. 
Pakiranja po 4, 7, 8 in 10 napolnjenih injekcijskih brizg.
If you forget to use Relistor 
Če ste pozabili uporabiti zdravilo Relistor
• If you have severe stomach symptoms which continue or get worse, contact your doctor immediately because these could be symptoms of a hole developing in the bowel wall (intestinal perforation). 
• Če se pri vas pojavijo hude trebušne težave, ki se nadaljujejo ali se slabšajo, se takoj posvetujte s svojim zdravnikom, saj bi lahko ti znaki kazali na predrtje stene črevesja (perforacijo črevesja).
After withdrawal in the injection syringe: 
Po potegu v injekcijsko brizgo:
Therefore, Relistor should only be administered with caution in these patients. 
Zato moramo zdravilo Relistor pri teh bolnikih uporabljati zelo previdno.
If you have used more of this medicine than you should (either by injecting too much on a single occasion or by using more than one injection in 24 hours), you may feel dizzy when standing up, so talk to a doctor or pharmacist immediately. 
Če ste uporabili večji odmerek zdravila Relistor, kot bi smeli Če ste uporabili več tega zdravila, kot bi smeli (bodisi z enkratnim vbrizganjem prevelikega odmerka bodisi tako, da ste si dali več kot eno injekcijo v 24 urah), ste lahko med vstajanjem omotični, zato se takoj posvetujte s svojim zdravnikom ali farmacevtom.
Due to the safety design of the syringe, a small air bubble may be resistant to removal. 
Zaradi varnostne zasnove injekcijske brizge majhnih zračnih mehurčkov morda ne boste mogli povsem odstraniti.
Look at the pre-filled syringe. 
Oglejte si napolnjeno injekcijsko brizgo.
• Please also talk to your doctor if you have a colostomy, a tube in your abdomen (peritoneal catheter), or suffer from diverticular disease or faecal impaction as this medicine should be used carefully in these circumstances. 
• Pogovorite se s svojim zdravnikom tudi, če imate kolostomijo, cevko v trebuhu (peritonealni kateter) ali če trpite za divertikularno boleznijo ali impaktacijo blata, saj je treba to zdravilo v teh primerih uporabljati previdno.
It is recommended to rotate injection sites. 
Priporočljivo je menjavati mesta injiciranja.
In vitro metabolism studies suggest that methylnaltrexone bromide does not inhibit the activity of CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 or CYP3A4, while it is a weak inhibitor of the metabolism of a model CYP2D6 substrate. 
Študije presnove in vitro kažejo, da metilnaltreksonijev bromid ne inhibira aktivnosti CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 in CYP3A4, je pa šibak inhibitor presnove modelnega substrata CYP2D6.
• If you feel sick, vomit, shiver, sweat, have belly pain and/or feel a fast heart beat shortly after taking Relistor talk to your doctor 
• Če vam je slabo, bruhate, imate mrzlico, se znojite, vas boli trebuh in/ali občutite hiter srčni utrip kmalu po tem, ko ste vzeli zdravilo Relistor, se posvetujte z zdravnikom.
The adverse reactions are classified as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data). 
Neželeni učinki so razvrščeni kot: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000) in neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Do not touch this area again before giving the injection. 
Nato se ne dotikajte več tega predela, dokler ne boste dali injekcije.
These patients should use Relistor vials and not the pre-filled syringe. 
Ti bolniki morajo uporabljati viale zdravila Relistor, ne napolnjenih injekcijskih brizg.
Always make sure you have the correct dose in the syringe. 
Vedno se prepričajte, da ste v injekcijsko brizgo izvlekli pravilen odmerek zdravila.
The rate of laxation response was maintained throughout the extension studies for those patients who continued treatment. 
Odzivnost na odvajalo je pri bolnikih, ki so nadaljevali zdravljenje, vztrajala ves čas podaljšanih študij.
In adult and juvenile dogs given methylnaltrexone bromide at 20 mg/kg/day, clinical signs indicative of CNS toxicity and prolongation of QTc interval were observed. 
Pri odraslih psih in mladičih, ko so prejemali metilnaltreksonijev bromid v odmerkih 20 mg/kg/dan, so opazili klinične znake, značilne za toksičnost za osrednji živčni sistem, in podaljšanje intervala QTc.
Slowly push the plunger up until all air bubbles are removed. 
Počasi potisnite bat navzgor, dokler ne boste odstranili vseh zračnih mehurčkov.
SN: 
SN: {številka}
In these patients, the treatment with usual laxatives should be stopped when commencing treatment with Relistor (see section 5.1). 
Pri teh bolnikih je treba zdravljenje z običajnimi odvajalnimi zdravili pri uvedbi zdravljenja z zdravilom Relistor ustaviti (glejte poglavje 5.1).
The difference between methylnaltrexone bromide 12 mg once daily and placebo of 1.6 RFBMs per week is statistically significant (p < 0.001) and clinically meaningful. 
Razlika med metilnaltreksonijevim bromidom 12 mg enkrat na dan in placebom, ki je 1,6 iztrebljanja brez rešilnega odvajala na teden, je statistično značilna (p < 0,001) in klinično pomembna.
Therefore, Relistor should not be used for treatment of patients with constipation not related to opioid use. 
Zato zdravila Relistor ne bi smeli uporabljati za zdravljenje bolnikov s konstipacijo, ki ni povezana z uporabo opioidov.
Keep the needle attached to the syringe. 
Igla naj ostane pritrjena na brizgo.
There may be a little bleeding at the injection site. 
Na mestu injiciranja se lahko pojavi par kapljic krvi.