FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: Ovaj lijek se daje injekcijom pod kožu (supkutanom injekcijom) ili u (1) natkoljenice (bedra), (2) abdomen (trbuh) ili (3) nadlakticu (ako ne injicirate sami). (Pogledajte UPUTE ZA PRIPREMU I PRIMJENU INJEKCIJE RELISTOR-a na kraju ove upute).
English: Do not use this medicine after the expiry date which is stated on the carton, tray lid and syringe label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake „EXP“.
English: Relistor contains an active substance called methylnaltrexone bromide which acts by blocking the side effects of opioid pain medicines that affect the bowel.
Croatian: Relistor sadrži djelatnu tvar pod nazivom metilnaltreksonbromid koja sprječava nuspojave koje opioidni lijekovi za ublažavanje bolova imaju na probavni sustav.
English: In order to get the air out of the syringe, gently push the plunger down to inject the air into the vial.
Croatian: Da biste iz štrcaljke izbacili zrak, lagano gurajte klip prema dolje, kako biste injicirali zrak u bočicu.
English: Make sure you have set aside a proper amount of time to complete the injection.
Croatian: Odvojite dovoljno vremena za davanje injekcije.
English: Opioid-induced constipation in adult patients with chronic pain (except palliative care patients with advanced illness)
Croatian: Konstipacija uzrokovana opioidima u odraslih bolesnika s kroničnom boli (osim bolesnika s uznapredovalom bolešću koji primaju palijativnu skrb)
English: Methylnaltrexone bromide is metabolised to a modest extent in humans based on the amount of methylnaltrexone bromide metabolites recovered from excreta.
Croatian: Metilnaltreksonbromid se kod ljudi metabolizira u umjerenom opsegu, kako je utvrđeno na temelju metabolita metilnaltreksonbromida koji su nađeni u izlučevinama.
English: Therefore, Relistor should only be administered with caution in these patients.
Croatian: Stoga se kod ovih bolesnika Relistor smije primjenjivati samo uz povećani oprez.
English: The following instructions explain how to inject Relistor.
Croatian: Uvod Sljedeće upute opisuju kako dati injekciju Relistora.
English: The effect of severe hepatic impairment on the pharmacokinetics of methylnaltrexone bromide has not been studied.
Croatian: Učinak teškog oštećenja jetre na farmakokinetiku metilnaltreksonbromida nije ispitan.
English: Ask your doctor, nurse or pharmacist for instructions on the right way to throw away (dispose of) the container.
Croatian: Obratite se Vašem liječniku, medicinskoj sestri ili ljekarniku glede uputa kako da na pravi način bacite
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodiumfree.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. praktički ne sadrži natrij.
English: Study 302 compared double-blind, subcutaneous doses of methylnaltrexone bromide given every other day for 2 weeks versus placebo.
Croatian: U ispitivanju 302 uspoređene su dvostruko slijepe supkutane doze metilnaltreksonbromida koji je davan svaki drugi dan tijekom 2 tjedna, s placebom.
English: The mean methylnaltrexone bromide exposure at 0.15 mg/kg over a weight range of 38 to 114 kg was 179 (range = 139-240) ng•h/mL.
Croatian: Srednja vrijednost izloženosti metilnaltreksonbromidu u dozi od 0,15 mg/kg, pri rasponu tjelesne težine od 38 do 114 kg, iznosila je 179 ng•h/ml (raspon= 139 - 240).
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.
Croatian: Cmax i površina ispod krivulje odnosa između koncentracije u plazmi i vremena (AUC) povećavaju se s povećavanjem doze od 0,15 mg/kg na 0,50 mg/kg.
English: Wipe the vial's rubber stopper with an alcohol swab and place it on your flat work surface.
Croatian: Jastučićem natopljenim alkoholom obrišite gumeni čep na bočici i postavite ju na ravnu radnu plohu.
English: Methylnaltrexone bromide is excreted via the milk of lactating rats.
Croatian: Metilnaltreksonbromid se izlučuje u mlijeku štakora.
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.
Croatian: Kada je štrcaljka prazna, brzim pokretom izvucite iglu iz kože pazeći pri tom da je držite pod istim kutom pod kojim ste je umetnuli.
English: It is unknown whether methylnaltrexone bromide is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se metilnaltreksonbromid u majčino mlijeko u ljudi.
English: Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, vomiting, abdominal pain, palpitations, and blushing have occurred in patients treated with methylnaltrexone bromide.
Croatian: Simptomi povezani s ustezanjem od opioida, uključujući hiperhidrozu, zimicu, povraćanje, bol u abdomenu, palpitacije, i crvenilo pojavili su se kod bolesnika koji su liječeni metilnaltreksonbromidom.
English: The double-blind dose was followed by an open-label, 4-week dosing period, where methylnaltrexone bromide could be used as needed, no more frequently than 1 dose in a 24-hour period.
Croatian: Nakon dvostruko slijepe doze slijedilo je otvoreno razdoblje doziranja od 4 tjedna u kojem je metilnaltreksonbromid primjenjivan po potrebi, ne češće od jedne doze tijekom 24 sata.
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.
Croatian: Bolesnici liječeni metilnaltreksonbromidom imali su značajno veću stopu laksacije unutar 4 sata nakon dvostruko slijepe doze (62% za 0,15 mg/kg i 58% za 0,3 mg/kg) od bolesnika koji su primili placebo (14%); p<0,0001 za svaku dozu u odnosu na placebo.
English: Relistor can be injected without regard to food.
Croatian: Relistor se može injicirati neovisno o obrocima.
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).
Croatian: Kod mladih štakora kojima je metilnaltreksonbromid davan intravenski tijekom 13 tjedana, nastupili su štetni klinički znakovi (pojave konvulzija i teškog disanja) i to pri dozama (≥ 3 mg/kg/dan) i izloženostima (5,4 puta veća izloženost {AUC} nego kod odraslih ljudi pri supkutanoj dozi od 0,15 mg/kg) koje su bile niže od onih koje su prouzrokovale sličnu toksičnost kod odraslih štakora (20 mg/kg/dan).
English: • 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.
Croatian: • Važno je biti u blizini zahoda, po potrebi uz pomoć, budući da se stolica može pojaviti kroz 30
English: INFORMATION IN BRAILLE RELISTOR 12 mg/0.6 mL
Croatian: PODACI NA BRAILLEOVOM PISMU Relistor 12 mg/0,6 ml
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30° C.
English: Hydrochloric acid (to adjust pH)
Croatian: Kloridna kiselina (za podešavanje pH)
English: To prepare the area of skin where Relistor is to be injected, wipe the injection site with an alcohol swab.
Croatian: 3. Da biste pripremili mjesto injiciranja Relistora, očistite ubodno mjesto jastučićem natopljenim alkoholom.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Nuspojave su unutar svake skupine učestalosti prikazane redosljedom u padajućem nizu prema ozbiljnosti:
English: The effect of mild and moderate hepatic impairment on the systemic exposure to methylnaltrexone bromide has been studied in 8 subjects each, with Child-Pugh Class A and B, compared to healthy subjects.
Croatian: Učinak blagog i umjerenog oštećenja jetre na sistemsku izloženost metilnaltreksonbromidu ispitan je na po 8 ispitanika (8 za blago i 8 za umjereno oštećenje), s Child-Pugh stadijem A i B, u usporedbi sa zdravim ispitanicima.
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.
Croatian: 150/100 mg/kg/dan kod štakora dovele su do smanjene težine potomstva; doze do 25 mg/kg/dan (18 puta veća izloženost [AUC] nego kod ljudi pri supkutanoj dozi od 0,3 mg/kg) nisu utjecale na trudove, porod ili preživljavanje i rast potomstva.
English: Methylnaltrexone bromide is minimally metabolised by CYP isozymes.
Croatian: Metilnaltreksonbromid se u vrlo maloj mjeri metabolizira djelovanjem CYP izoenzima.
English: Step 4a: Injecting Relistor using a pack containing injection syringe with retractable injection needle
Croatian: Korak 4a: Injiciranje Relistora kod upotrebe pakiranja koje sadrži štrcaljku za injekciju s iglom za injekciju na uvlačenje
English: Conversion to methyl-6-naltrexol isomers and methylnaltrexone sulphate appears to be the primary pathway to metabolism.
Croatian: Čini se da je glavni metabolički put konverzija u izomere metil-6-naltreksola i metilnaltrekson sulfat.
English: Dispose of the pre-filled syringe as instructed by your doctor, nurse or pharmacist.
Croatian: Zbrinite napunjenu štrcaljku prema uputama svojeg liječnika, medicinske sestre ili ljekarnika.
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.
Croatian: Bolesnici liječeni metilnaltreksonbromidom također su imali značajno veću stopu laksacije unutar 4 sata nakon davanja najmanje 2 od prve 4 doze lijeka (52%) od bolesnika koji su primili placebo (9%); p=0,0001.
English: Step 4b: Injecting Relistor using a standard injection syringe and injection needle
Croatian: Korak 4b: Injiciranje Relistora kod upotrebe standardne injekcijske štrcaljke i injekcijske igle
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.
Croatian: (metilnaltreksonbromid 0,15 mg/kg, n = 47; metilnaltreksonbromid 0,3 mg/kg, n = 55; placebo, n = 52).
English: sweating, hair standing on end, blushing, fast heart beat)
Croatian: drhtanje, curenje iz nosa, znojenje, naježena koža, crvenilo, ubrzani otkucaji srca)
English: Make sure that the dose prescribed by your doctor matches the dose on the pre-filled syringe label.
Croatian: Provjerite odgovara li doza na naljepnici napunjene štrcaljke dozi koju je propisao Vaš liječnik
English: Do not touch the needle or allow the needle to touch any surface.
Croatian: NEMOJTE dodirivati iglu i pazite da igla ne dotakne bilo koju drugu površinu.
English: Tel. +36 1 998 99 47 e-mail: mail.hu@sobi.com
Croatian: +36 1 998 99 47 e-mail: mail.hu@sobi.com
English: Clear solution, colourless to pale-yellow, essentially free from visible particulates.
Croatian: Bistra, bezbojna do blijedo žuta otopina, uglavnom bez vidljivih čestica.
English: The activity of methylnaltrexone bromide has been studied in patients with constipation induced by opioids.
Croatian: Aktivnost metilnaltreksonbromida ispitivana je kod bolesnika s konstipacijom uzrokovanom opioidima.
English: • Diarrhoea (passing of frequent watery stools)
Croatian: Mučnina Proljev (česte vodenaste stolice)
English: Sodium hydroxide (to adjust pH)
Croatian: Natrijev hidroksid (za podešavanje 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).
Croatian: Niti kod mladih niti kod odraslih pasa nisu nastupili štetni učinci pri dozi od 5 mg/kg/dan (44 puta veća izloženost {AUC} nego kod odraslih ljudi pri supkutanoj dozi od 0,15 mg/kg).
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.
Croatian: Vaš liječnik, medicinska sestra ili ljekarnik će Vam reći koju su Vam dozu propisali i kako često je trebate uzimati.
English: Common: Vomiting
Croatian: Često: povraćanje
English: Swedish Orphan Biovitrum s.r.o.
Croatian: Swedish Orphan Biovitrum s.r.o. Magyarországi Fióktelepe
English: Use of methylnaltrexone bromide in patients with colostomy, peritoneal catheter, active diverticular disease or fecal impaction has not been studied.
Croatian: Primjena metilnaltreksonbromida nije ispitivana kod bolesnika s kolostomijom, peritonejskim kateterom, aktivnom divertikulskom bolešću ili impakcijom fecesa.
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.
Croatian: 25 mg/kg/dan (18 puta veće doze od izloženosti [AUC] kod ljudi pri supkutanoj dozi od 0,3 mg/kg) nisu utjecale na plodnost ili opću reproduktivnu sposobnost.
English: Ensure you have the correct dose level in the syringe (e.g. 0.4 mL if you have been prescribed 8 mg)
Croatian: Uvjerite se da imate odgovarajuću dozu lijeka u štrcaljki (npr. 0,4 ml ukoliko
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.
Croatian: Metilnaltreksonbromid mora se koristiti oprezno u bolesnika s poznatim ili suspektnim lezijama GI trakta.
English: Methylnaltrexone bromide is not recommended in patients with severe hepatic impairment or with end-stage renal impairment requiring dialysis (see section 4.2).
Croatian: Oštećenje jetre i bubrega Metilnaltreksonbromid se ne preporučuje bolesnicima s teškim oštećenjem jetre ili onima s oštećenjem bubrega u završnoj fazi koji su na dijalizi (vidjeti dio 4.2).
English: Generally, these reactions were mild or moderate.
Croatian: Općenito su te nuspojave bile blage do umjerene težine.
English: • If you develop severe or persistent diarrhoea (passing of frequent watery stools), discontinue therapy and contact your doctor immediately.
Croatian: • Ako dođe do teškog ili dugotrajnog proljeva (česte vodenaste stolice), odmah prekinite terapiju i javite se svom liječniku.
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.
Croatian: Ovo je postignuto u 28,7% bolesnika u skupini koja je svakodnevno primala metilnaltrekson u dozi od 12 mg (p<0,001 naspram placeba), u 14,9% bolesnika u skupini koja je primala metilnaltrekson svaki drugi dan (p<0,012 naspram placeba) i u 6,2% bolesnika koji su primali placebo.
English: 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.
Croatian: metilnaltreksonbromid u dozi od 12 mg svaki drugi dan, n=148, placebo, n=162) je liječeno u dvostruko slijepom razdoblju.
English: Clear, Type I, flint glass, single-use vial, grey butyl rubber stopper, and aluminium overseal with flipoff-cap.
Croatian: Prozirno silikatno staklo tipa I, bočica za jednokratnu primjenu, sivi čep od butil gume i aluminijski prsten s „flip-off“ kapicom.
English: INFORMATION IN BRAILLE RELISTOR 12 mg
Croatian: PODACI NA BRAILLEOVOM PISMU Relistor 12 mg
English: Dizziness may occur, and this may have an effect on the ability to drive and use machines (see section 4.8).
Croatian: Može se javiti omaglica, koja može utjecati na sposobnost upravljanja vozilima i rada na strojevima (vidjeti dio
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LABEL TEXT FOR TRAY LIDDING (PRE-FILLED SYRINGE PRESENTATION)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP TEKST NALJEPNICE ZA POKLOPAC SPREMNIKA (NAPUNJENA ŠTRCALJKA)
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).
Croatian: Nakon stavljanja lijeka u promet, prijavljeni su slučajevi gastrointestinalne (GI) perforacije nakon primjene metilnaltreksonbromidakod bolesnika sa stanjima koja se mogu povezati s lokaliziranim ili difuznim smanjenjem strukturalnog integriteta u zidu gastrointestinalnog trakta (npr.bolest peptičkog ulkusa, pseudoopstrukcija (Ogilviev sindrom), divertikularna bolest, infiltrativne zloćudne bolesti gastrointestinalnog trakta ili peritonealne metastaze).
English: Study 3356 compared 4-week treatment regimens of methylnaltrexone bromide 12 mg once daily and methylnaltrexone bromide 12 mg every other day with placebo.
Croatian: U ispitivanju 3356 uspoređeni su 4-tjedni režimi liječenja metilnaltreksonbromidom u dozi od 12 mg jedanput dnevno i metilnaltreksonbromidom u dozi od 12 mg svaki drugi dan s placebom.
English: 7 vials of 0.6 mL
Croatian: 7 bočica od 0,6 ml
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.
Croatian: Držite klip štrcaljke jednom rukom i ravnim pokretom skinite pokrov igle.
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.
Croatian: Ovo je postignuto u 59% bolesnika u skupini koja je svakodnevno primala metilnaltrekson u dozi od 12 mg (p<0,001 naspram placeba), u 61% bolesnika u skupini koja je primala metilnaltrekson svaki drugi dan (p<0,001 naspram placeba) i u 38% bolesnika koji su primali placebo.
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.
Croatian: Postavljena su dva primarna ishoda: udio bolesnika s laksacijom bez primjene dodatnog laksativa unutar 4 sata nakon davanja prve doze ispitivanog lijeka i udio bolesnika s laksacijom bez primjene dodatnog laksativa unutar 4 sata nakon davanja najmanje 2 od prve 4 doze lijeka.
English: 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.
Croatian: 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: 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.
Croatian: Bolesnici liječeni metilnaltreksonbromidom imali su veću stopu laksacije unutar 4 sata nakon davanja prve doze lijeka (48%) od bolesnika koji su primili placebo (16%); p<0,0001.
English: If you stop using Relistor You should talk to a doctor or pharmacist if you want to stop using this medicine.
Croatian: Ukoliko želite prestati uzimati Relistor, morate se obratiti svom liječniku ili ljekarniku.
English: How to use Relistor
Croatian: Kako uzimati Relistor
English: Pack containing 7 vials, 7 injection syringes with retractable injection needle, and 14 alcohol swabs (i.e. 7 inner cartons).
Croatian: Pakiranje koje sadrži 7 bočica, 7 štrcaljki za injekciju s iglom za injekciju na uvlačenje i 14 alkoholom natopljenih jastučića (tj. 7 unutarnjih kutija).
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).
Croatian: Kod mladih štakora nisu nastupile negativne nuspojave pri dozi od 1 mg/kg/dan, kao niti kod odraslih štakora pri dozi od 5 mg/kg/dan (1,6 puta više odnosno 7,8 puta više od izloženosti {AUC} kod odraslih ljudi pri supkutanoj dozi od 0,15 mg/kg).
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).
Croatian: Nema podataka o bolesnicima koji su na dijalizi s bolešću bubrega u završnom stadiju te se stoga metilnaltreksonbromid ne preporučuje kod ovih bolesnika (vidjeti dio 4.4).
English: 8 pre-filled syringes
Croatian: 8 napunjenih štrcaljki
English: Avoid repeated injections at the exact same spot previously used.
Croatian: Izbjegavajte dati injekciju uvijek na istom mjestu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.6 mL of solution (12 mg methylnaltrexone bromide)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,6 ml otopine (12 mg metilnaltreksonbromida)
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.
Croatian: mg/kg moguće je postići prilagodbom doze ovisno o tjelesnoj težini, tako što se koristi doza od 8 mg za tjelesnu težinu od 38 do manje od 62 kg, odnosno doza od 12 mg za tjelesnu težinu od 62 do 114 kg, čime se postiže srednja vrijednost izloženosti od 187 ng•h/ml (raspon= 148 - 220).
English: Cardiac effects were observed in some non-clinical studies in canines (prolongation of action potentials in Purkinje fibers or prolongation of the QTc interval).
Croatian: (produženo trajanje akcijskog potencijala u Purkinjeovim vlaknima ili produženo trajanje QTc intervala).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NALJEPNICE ZA ŠTRCALJKU
English: • If you have Crohn´s disease or gastrointestinal ulcers
Croatian: Ako imate Chronovu bolest ili čireve u probavnom sustavu
English: There are no data available from patients with severe hepatic impairment (Child-Pugh Class C), and methylnaltrexone bromide is not recommended in these patients (see section 4.4).
Croatian: Nema dostupnih podataka za bolesnike s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) te se stoga metilnaltreksonbromid ne preporučuje kod ovih bolesnika (vidjeti dio 4.4).
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).
Croatian: Ukupni omjer koristi i rizika treba uzeti u obzir prilikom primjene metilnaltreksonbromida kod bolesnika s ovim ili drugim stanjima koja mogu dovesti do oštećenja integriteta zida gastrointestinalnog trakta (npr. Chronova bolest).
English: Sodium calcium edetate
Croatian: Natrijev kalcijev edetat Glicinklorid
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.
Croatian: Nakon umetanja igle otpustite kožu i polagano pritisnite klip do kraja sve dok se napunjena štrcaljka ne isprazni.