FrancophonIA/ELRC3.0 huggingface dataset:
English: If severe or persistent diarrhoea occurs during treatment, patients should be advised not to continue therapy with methylnaltrexone bromide and consult their physician.
Croatian: Pojavi li se tijekom liječenja težak ili trajan proljev, bolesnicima treba savjetovati da ne nastavljaju liječenje metilnaltreksonbromidom te da se posavjetuju sa svojim liječnikom.
English: Do not attempt to administer an injection until you are sure that you understand how to give the injection.
Croatian: Nemojte pokušavati dati injekciju dok niste sigurni da razumijete kako dati injekciju.
English: In palliative care patients, Relistor is added to usual laxative treatment (see section 5.1).
Croatian: U bolesnika koji primaju palijativnu skrb, Relistor se dodaje liječenju uobičajenim laksativima (vidjeti dio 5.1).
English: For patients with long-term pain (except patients receiving supportive care for advanced illness), fill the syringe to the 0.6 mL mark for 12 mg of Relistor.
Croatian: Za bolesnike s dugoročnom boli (osim bolesnika koji primaju suportivnu skrb za uznapredovalu bolest) napunite štrcaljku do oznake od 0,6 ml za 12 mg lijeka Relistor.
English: The most common adverse reactions in all patients exposed to methylnaltrexone bromide during all phases of placebo-controlled studies were abdominal pain, nausea, diarrhoea and flatulence.
Croatian: Najčešće nuspojave kod svih bolesnika koji su primali metilnaltreksonbromid tijekom svih faza placebom kontroliranih ispitivanja bile su abdominalna bol, mučnina, proljev i flatulencija.
English: The following instructions explain how to prepare and give an injection of Relistor when using a prefilled syringe.
Croatian: Slijedeće upute opisuju kako pripremiti i dati injekciju Relistora kada se koristi napunjena štrcaljka.
English: If you forget to use Relistor
Croatian: Ako ste zaboravili uzeti Relistor
English: A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus.
Croatian: U ispitivanju na zdravim dragovoljcima opažena je ortostatska hipotenzija povezana s dozom od 0,64 mg/kg, koja je davana kao intravenski bolus.
English: Do not insert it at an angle as the needle may bend or break.
Croatian: Nemojte umetati iglu pod kutom jer bi se mogla savinuti ili slomiti.
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Croatian: Nemojte injicirati na mjestu gdje je kože osjetljiva, oštećena, crvena ili tvrda.
English: Subcutaneous injections of Relistor at 150 mg/kg/day decreased fertility in rats.
Croatian: Supkutane injekcije Relistora u dozi od 150 mg/kg/dan smanjile su plodnost kod štakora.
English: Subcutaneous use (SC)
Croatian: Potkožna primjena (s.c.)
English: If you have used more 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.
Croatian: Ako uzmete više ovog lijeka nego što ste trebali (bilo da ste injicirali preveliku količinu odjednom, bilo da ste koristili više od jedne injekcije tijekom 24 sata), može se dogoditi da osjećate omaglicu pri ustajanju pa se odmah se obratite liječniku ili ljekarniku.
English: This section contains important questions that you will need to answer before you take Relistor, and during treatment with Relistor.
Croatian: U ovom odlomku navedena su važna pitanja na koja morate odgovoriti prije i tijekom liječenja
English: Methylnaltrexone bromide is absorbed rapidly, with peak concentrations (Cmax) achieved at approximately 0.5 hours following subcutaneous administration.
Croatian: Metilnaltreksonbromid se brzo apsorbira, pri čemu se vršne koncentracije (Cmax) postižu otprilike 0,5 sati nakon supkutane primjene.
English: What Relistor contains - The active substance is methylnaltrexone bromide.
Croatian: Što Relistor sadrži - Djelatna tvar je metilnaltreksonbromid.
English: 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.
Croatian: Kod odraslih i mladih pasa koji su dobivali dozu metilnaltreksonbromida od 20 mg/kg/dan, opaženi su klinički znaci koji ukazuju na toksičnost na CNS i produljenje QTc intervala.
English: Methylnaltrexone bromide does not affect the pharmacokinetics of medicinal products metabolised by cytochrome P450 (CYP) isozymes.
Croatian: Metilnaltreksonbromid ne utječe na farmakokinetiku lijekova koji se metaboliziraju putem izoenzima citokroma P450 (CYP).
English: Therefore, Relistor should not be used for treatment of patients with constipation not related to opioid use.
Croatian: Stoga se Relistor ne smije koristiti za liječenje bolesnika s konstipacijom koja nije povezana s primjenom opioida.
English: It treats constipation that is caused by medicines for moderate to severe pain called opioids (for example morphine or codeine).
Croatian: Ovaj lijek služi za liječenje zatvora koji uzrokuju lijekovi za umjerenu i jaku bol koji se nazivaju opioidi (na primjer morfin ili kodein).
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.
Croatian: Napunjenu štrcaljku s 8 mg lijeka Relistor treba koristiti isključivo za liječenje ovih bolesnika kada postojeća medicinska stanja zahtijevaju smanjenje doze na 8 mg (0,4 ml otopine), vidjeti dio Posebne populacije.
English: • If you have severe liver or kidney disease.
Croatian: ● Ako imate tešku bolest jetre ili bubrega.
English: N-demethylation of methylnaltrexone bromide to produce naltrexone is not significant, accounting for 0.06 % of the administered dose.
Croatian: N-demetilacija metilnaltreksonbromida kojom nastaje naltrekson nije značajna, a odgovara za 0,06% primijenjene doze.
English: 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.
Croatian: Svaki od izomera metil-6-naltreksola posjeduje nešto slabiju antagonističku aktivnost od ishodišnog lijeka te nisku izloženost u plazmi od oko 8% od tvari povezanih s lijekom.
English: In a clinical drug interaction study in healthy adult male subjects, a subcutaneous dose of 0.3 mg/kg of methylnaltrexone bromide did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate.
Croatian: U kliničkom ispitivanju interakcije lijekova na odraslim zdravim muškim ispitanicima, supkutana doza od 0,3 mg/kg metilnaltreksonbromida nije značajno utjecala na metabolizam dekstrometorfana, supstrata CYP2D6.
English: Keep the needle attached to the syringe.
Croatian: Ostavite iglu pričvršćenu na štrcaljku.
English: • 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
Croatian: ● Ako osjećate mučninu, povraćate, drhtite, znojite se, imate bol u trbuhu i/ili osjećate ubrzane otkucaje srca kratko nakon uzimanja Relistora obratite se svom liječniku
English: Do not touch this area again before giving the injection.
Croatian: Nemojte ponovno dodirivati ovo mjesto prije davanja injekcije.
English: • Safely throw away the Relistor pre-filled syringe after use (Step 4).
Croatian: Nakon upotrebe bacite napunjenu štrcaljku Relistora na sigurno mjesto (Korak 4).
English: There are no adequate data with the use of methylnaltrexone bromide in pregnant women.
Croatian: Ne postoje adekvatni podaci o primjeni metilnaltreksonbromida kod trudnica.
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
Croatian: Korak 1: Priprema za injekciju Korak 2: Odabir i priprema ubodnog mjesta Korak 3: Injiciranje Relistora napunjenom štrcaljkom Korak 4: Zbrinjavanje neupotrijebljenog lijeka
English: In vitro studies have shown methylnaltrexone bromide to be a mu-opioid receptor antagonist (inhibition constant [Ki] = 28 nM), with 8-fold less potency for kappa opioid receptors (Ki = 230 nM) and much reduced affinity for delta opioid receptors.
Croatian: In vitro ispitivanja su pokazala da je metilnaltreksonbromid antagonist mu-opioidnog receptora (konstanta inhibicije [Ki] = 28 nM), s 8 puta slabijim afinitetom za kappa opioidne receptore (Ki = 230 nM) i značajno smanjenim afinitetom za delta opioidne receptore.
English: Allow the injection site to air-dry before injecting.
Croatian: Ostavite ubodno mjesto da se osuši na zraku prije davanja injekcije.
English: Clean the injection site with an alcohol swab and let it dry.
Croatian: 3. Očistite ubodno mjesto jastučićem natopljenim alkoholom i pustite da se osuši.
English: Methylnaltrexone bromide has minor influence on the ability to drive and use machines.
Croatian: Metilnaltreksonbromid malo utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: Patients should be monitored for severe, persistent, or worsening abdominal pain; methylnaltrexone bromide should be discontinued if this symptom occurs.
Croatian: Bolesnici trebaju biti nadzirani zbog moguće pojave teške, perzistirajuće boli ili pogoršanja boli u abdomenu; treba obustaviti primjenu metilnaltreksonbromida pri pojavi ovih simptoma.
English: The mean steady-state Cmax and AUC for the elderly were 545 ng/mL and 412 ng•h/mL, approximately 8.1 % and 20 %, respectively, greater than those for young subjects.
Croatian: Srednje vrijednosti Cmax i AUC u stanju dinamičke ravnoteže kod starijih osoba bile su 545 ng/ml i 412 ng•h/ml, odnosno oko 8,1% i 20% veće od istih vrijednosti kod mlađih ispitanika.
English: Elderly population No dose adjustment is recommended based on age (see section 5.2).
Croatian: Ne preporučuje se prilagodba doze u skladu s dobi (vidjeti dio 5.2).
English: Durability of response was demonstrated in Study 302, in which the laxation response rate was consistent from dose 1 through dose 7 over the course of the 2-week, double-blind period.
Croatian: Trajanje učinaka pokazano je u ispitivanju 302, u kojem je stopa odgovora s laksacijom bila stalno prisutna od 1. do 7. doze lijeka tijekom dvostruko slijepog razdoblja od 2 tjedna.
English: Only use this medicine if the solution is clear, colourless to pale yellow, and does not contain flakes or particles.
Croatian: Ovaj lijek koristite jedino ako je otopina bistra, bezbojna do blijedožuta i ne sadrži pahuljice ili čestice.
English: The renal clearance of methylnaltrexone bromide was reduced following multiple-dose administration of cimetidine (from 31 L/h to 18 L/h).
Croatian: Bubrežni klirens metilnaltreksonbromida bio je smanjen nakon višestrukog doziranja cimetidina (s 31 l/h na 18 l/h).
English: INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR
Croatian: UPUTE ZA PRIPREMU I PRIMIJENU INJEKCIJE RELISTORA
English: If unsure, please contact your doctor, nurse or pharmacist.
Croatian: Ako niste sigurni, molimo obratite se Vašem liječniku, medicinskoj sestri ili ljekarniku.
English: Dizziness is a common side effect of this medicine.
Croatian: Omaglica je česta nuspojava ovog lijeka.
English: Patients had opioid-induced constipation (< 3 rescue medication-free bowel movements per week during the screening period).
Croatian: Bolesnici su imali konstipaciju uzrokovanu opioidima (< 3 pražnjenja crijeva tjedno tijekom razdoblja probira bez primjene dodatnog laksativa).
English: Pick up the syringe from your work surface.
Croatian: Podignite štrcaljku s radne površine.
English: Insert the needle straight down into the centre of the vial stopper.
Croatian: Uvedite iglu ravno nadolje u središte čepa bočice.
English: Areas with scars or stretch marks should be avoided.
Croatian: Treba izbjegavati mjesta s ožiljcima ili strijama.
English: 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.
Croatian: Polako vucite klip prema dolje do oznake na štrcaljki od 0,4 ml ili 0,6 ml ili do oznake doze koja Vam je propisana od Vašeg liječnika, medicinske sestre ili ljekarnika.
English: The 4-week, double-blind period was followed by an 8-week, open-label period during which methylnaltrexone bromide was to be used as needed, but no more frequently than once daily.
Croatian: Nakon 4tjednog, dvostruko slijepog razdoblja slijedilo je 8-tjedno, otvoreno razdoblje tijekom kojeg je metilnaltreksonbromid primjenjivan po potrebi, ali ne češće od jedanput dnevno.
English: Remove the syringe and needle from the vial.
Croatian: Izvadite štrcaljku i iglu iz bočice.
English: NEVER recap the needle.
Croatian: NIKADA nemojte vraćati pokrov na iglu.
English: Step 1: Preparing for an injection
Croatian: Korak 1: Priprema za injekciju
English: Animal studies have shown excretion of methylnaltrexone bromide in breast milk.
Croatian: Ispitivanja na životinjama pokazala su izlučivanje metilnaltreksonbromida u mlijeko životinja.
English: Severity and worsening symptoms Patients should be advised to promptly report severe, persistent, and/or worsening symptoms.
Croatian: Bolesnike se mora uputiti da bez odlaganja prijave teške simptome, simptome koji traju i/ili se pogoršavaju.
English: In a study comparing single and multiple-dose pharmacokinetic profiles of intravenous methylnaltrexone bromide at a dose of 24 mg between healthy, young (18 to 45 years of age n = 10) and elderly (65 years of age and over n = 10) subjects, the effect of age on exposure to methylnaltrexone bromide was found to be minor.
Croatian: U ispitivanju u kojemu je uspoređen farmakokinetički profil metilnaltreksonbromida nakon jednokratne i višekratne intravenske doze od 24 mg kod zdravih, mladih (18 do 45 godina, n=10) i starijih ispitanika (u dobi od 65 godina i stariji n=10), bilo je utvrđeno da je učinak dobi na izloženost metilnaltreksonbromidu zanemariv.
English: Your doctor will decide if you can use Relistor if you are pregnant.
Croatian: Relistor ukoliko ste trudni.
English: 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).
Croatian: Učestalost nuspojava je klasificirana kao: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In a study of volunteers with varying degrees of renal impairment receiving a single dose of 0.30 mg/kg methylnaltrexone bromide, renal impairment had a marked effect on the renal excretion of methylnaltrexone bromide.
Croatian: U ispitivanju na dobrovoljcima s različitim stupnjevima oštećenja bubrega koji su primili jednokratnu dozu od 0,30 mg/kg metilnaltreksonbromida, oštećenje bubrega imalo je značajan učinak na izlučivanje metilnaltreksonbromida bubrezima.
English: An integrated analysis of pharmacokinetic data from healthy subjects indicated that methylnaltrexone bromide mg/kg dose-adjusted exposure increased as body weight increased.
Croatian: Integrirana analiza farmakokinetičkih podataka kod zdravih ispitanika upućuje na to da se s povećanjem tjelesne težine povećava izloženost metilnaltreksonbromidu s rastućom dozom mg/kg.
English: • Flatulence (passing wind)
Croatian: Nadutost (vjetrovi)
English: Results showed no meaningful effect of hepatic impairment on the AUC or Cmax of methylnaltrexone bromide.
Croatian: Rezultati nisu pokazali značajni učinak oštećenja jetre na AUC ili Cmax metilnaltreksonbromida.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 July 2008
Croatian: Datum prvog odobrenja: 02. srpnja 2008.
English: Very common: Abdominal pain, nausea, diarrhoea, flatulence Skin and subcutaneous tissue disorders
Croatian: Vrlo često: abdominalna bol, mučnina, proljev, flatulencija Poremećaji kože i potkožnog tkiva
English: Step 2: Preparing the injection syringe
Croatian: Korak 2: Priprema injekcijske štrcaljke
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.
Croatian: Oprezno izvucite klip štrcaljke ili do oznake za 0,4 ml za dozu od 8 mg Relistora, ili do oznake za 0,6
English: Methylnaltrexone bromide is eliminated primarily as the unchanged active substance.
Croatian: Metilnaltreksonbromid se u prvom redu eliminira kao nepromijenjena djelatna tvar.
English: Packs of more than one vial contain inner cartons consisting of: one vial, one 1 mL injection syringe with retractable injection needle, and two alcohol swabs.
Croatian: Pakiranja s više od jedne bočice sadrže unutarnje kutije u kojima su: jedna bočica, jedna štrcaljka za injekciju od 1 ml s iglom za injekciju na uvlačenje i dva alkoholom natopljena jastučića.
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.
Croatian: Prije probira kod bolesnika je inducirana konstipacija opioidima, definirana ili kao < 3 stolice tijekom proteklog tjedna ili kao izostanak stolice tijekom > 2 dana.
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.
Croatian: Ukoliko osjetite bol u trbuhu koja je ili teška ili ne prolazi, prestanite uzimati ovaj lijek i odmah se obratite liječniku.
English: Pre-filled syringe of clear type I glass with stainless-steel needle, plastic plunger, and polypropylene rigid needle cover.
Croatian: Napunjena štrcaljka od prozirnog stakla tip I s iglom od nehrđajućeg čelika, plastičnim klipom i krutim polipropilenskim pokrovom za iglu.
English: 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.
Croatian: Lagano lupkajte po štrcaljki kako bi se mjehurići zraka podigli do vrha štrcaljke; svakako čvrsto držite bočicu i štrcaljku.
English: If needed, you may cover the injection site with a plaster.
Croatian: Po potrebi, pokrijte ubodno mjesto flasterom.
English: Contact your pharmacist, nurse or doctor for assistance.
Croatian: Obratite se za pomoć Vašem ljekarniku, medicinskoj sestri ili liječniku.
English: If you are using the supplied injection syringe with retractable injection needle, DO NOT PUSH THE PLUNGER DOWN COMPLETELY.
Croatian: Koristite li isporučenu injekcijsku štrcaljku s iglom za injekciju na uvlačenje, NEMOJTE
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.
Croatian: To uključuje bočicu Relistora, injekcijsku štrcaljku od 1 ml (s ili bez igle za injekciju na uvlačenje), 2 alkoholom natopljena jastučića i pamučni tupfer ili gazu.
English: The effects of methylnaltrexone bromide in pregnant women are not known.
Croatian: Učinci metilnaltreksonbromida kod trudnica nisu poznati.
English: Relistor is a solution for injection.
Croatian: Relistor je otopina za injekciju.
English: • Do not use a Relistor pre-filled syringe more than one time, even if there is medicine in the syringe.
Croatian: Uvijek upotrijebite napunjenu štrcaljku Relistora samo jedan put, čak i kad u štrcaljki ostane lijeka.
English: As a quaternary amine, the ability of methylnaltrexone bromide to cross the blood-brain barrier is restricted.
Croatian: Sposobnost prolaska metilnaltreksonbromida, kao kvarternog amina, kroz krvno-moždanu barijeru je ograničena.
English: Czech republic
Croatian: Češka Republika
English: The three areas of the body recommended for injection of Relistor are upper legs, abdomen, and upper arms.
Croatian: Tri tjelesne regije koje se preporučuju za davanje injekcije Relistora su natkoljenice, trbuh i nadlaktice.
English: • 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).
Croatian: ● Ako imate teške simptome u području trbuha koji ne prestaju ili se pogoršavaju, odmah se javite liječniku, jer bi to mogli biti simptomi puknuća crijeva (intestinalne perforacije).
English: Quickly pull the needle out of the skin, being careful to keep it at the same angle as it was inserted.
Croatian: Brzim pokretom izvucite iglu iz kože i pri tom pazite da ju držite pod istim kutom pod kojim ste ju umetnuli.
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.
Croatian: Mogućnost interakcija lijek-lijek povezana s organskim kationskim transporterom (OTC) između metilnaltreksonbromida i OCT inhibitora ispitivana je kod 18 zdravih ispitanika uspoređivanjem farmakokinetskih profila pojedinačne doze metilnaltreksonbromida prije i poslije višekratnih doza 400 mg cimetidina.
English: Important information about some of the ingredients of Relistor This medicine contains less than 1 mmol sodium (23 mg) per dose i.e., essentially “sodium free.”
Croatian: Važne informacije o nekim sastojcima Relistora Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. u osnovi je "bez natrija”
English: Dispose of the capped syringe or needle and syringe in a closable puncture-resistant container as instructed by your doctor, nurse or pharmacist.
Croatian: Štrcaljku s pokrovom ili štrcaljku s iglom odbacite u neprobojni spremnik koji možete zatvoriti, u skladu s uputama Vašeg liječnika, medicinske sestre ili ljekarnika.
English: Stool consistency was not meaningfully improved in patients who had soft stool at baseline.
Croatian: Konzistencija stolice nije značajno poboljšana kod bolesnika koji su na početku imali mekanu stolicu.
English: 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.
Croatian: Razlika između metilnaltreksonbromida u dozi od 12 mg jedanput dnevno i placeba u iznosu od 1,6 pražnjenja crijeva bez primjene dodatnog laksativa tjedno statistički je značajna (p<0,001) i klinički bitna.
English: • This medicine should not be used for treatment of patients with constipation which is not related to opioid use.
Croatian: • Ovaj lijek se ne smije koristiti za liječenje zatvora kod bolesnika kod kojih zatvor nije povezan s primjenom opioida.
English: The adverse reactions are classified as: very common (≥1/10); common (≥1/100 to <1/10); uncommon
Croatian: Učestalost nuspojava je klasificirana kao: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često
English: INFORMATION IN BRAILLE RELISTOR 8 mg
Croatian: PODACI NA BRAILLEOVOM PISMU Relistor 8 mg
English: You will be instructed by your doctor, nurse or pharmacist on the techniques of self-injection.
Croatian: Vaš liječnik, medicinska sestra ili ljekarnik objasnit će Vam tehniku samoinjiciranja.
English: If you push solution back into the vial, slowly pull back the plunger to draw the correct amount of solution back into the syringe.
Croatian: Ako istisnete otopinu natrag u bočicu, polagano povucite klip natrag, kako biste uvukli ispravnu količinu tekućine u štrcaljku.
English: Study 301 compared methylnaltrexone bromide given as a single, double-blind, subcutaneous dose of 0.15 mg/kg, or 0.3 mg/kg versus placebo.
Croatian: U ispitivanju 301 uspoređen je metilnaltreksonbromid, davan kao jednokratna, dvostruko slijepa supkutana doza od 0,15 mg/kg ili 0,3 mg/kg, s placebom.
English: If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe.
Croatian: Ako ima mjehurića, lagano lupkajte prstom po štrcaljki kako bi se mjehurići zraka podigli do vrha štrcaljke.
English: Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/kg.
Croatian: Bolesnici čija je težina izvan navedenog raspona trebaju primiti dozu od 0,15 mg/kg.