natgillin/translations-raw huggingface dataset:
Slowly push the plunger up until all air bubbles are removed. 
Polagano pritisnite klip prema gore da izbacite sve mjehuriće zraka.
The renal clearance of methylnaltrexone bromide decreased with increasing severity of renal impairment. 
Bubrežni klirens metilnaltreksonbromida smanjivao se proporcionalno rastućem stupnju oštećenja bubrega.
Relistor pre-filled syringe Alcohol swab Cotton ball or gauze Adhesive plaster 
Jastučić natopljen alkoholom Pamučni tupfer ili gazu
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. 
Preporučena doza za bolesnike koji primaju suportivnu skrb za uznapredovalu bolest je 8 mg metilnaltreksonbromida (0,4 ml otopine) za bolesnike koji teže 38-61 kg, ili 12 mg (0,6 ml otopine) za bolesnike koji teže 62-114 kg.
If you answer No to any of the following questions during the course of treatment with your medicine please contact your doctor, nurse or pharmacist. 
Ako tijekom uzimanja lijeka na bilo koje od sljedećih pitanja odgovorite s NE, molimo obratite se svojem liječniku, medicinskoj sestri ili ljekarniku.
No studies were performed in patients with end-stage renal impairment requiring dialysis. 
Na bolesnicima s terminalnim stadijem bubrežne bolesti koja zahtijeva dijalizu, ispitivanja nisu provedena.
- 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. 
(peritonejski kateter), ili patite od divertikulske bolesti ili impakcije fecesa (uklještenje i zastoj stolice u crijevima), jer u takvim slučajevima ovaj lijek treba koristiti s oprezom.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LABEL TEXT FOR INTERMEDIATE CARTON (VIAL PRESENTATION) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP TEKST NALJEPNICE ZA UNUTARNJU KUTIJU (BOČICA)
Opioid-induced constipation in adult patients with advanced illness The efficacy and safety of methylnaltrexone bromide in the treatment of opioid-induced constipation in patients receiving palliative care was demonstrated in two randomised, double-blind, placebocontrolled studies. 
Konstipacija uzrokovana opioidima u odraslih bolesnika s uznapredovalom bolešću Djelotvornost i sigurnost metilnaltreksonbromida u liječenju konstipacije uzrokovane opioidima kod bolesnika koji primaju palijativnu skrb pokazana je u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja.
The efficacy and safety of methylnaltrexone bromide were also demonstrated in open-label treatment administered from Day 2 through Week 4 in Study 301, and in two open-label extension studies (301EXT and 302EXT) in which methylnaltrexone bromide was given as needed for up to 4 months (only 8 patients up to this point). 
Djelotvornost i sigurnost metilnaltreksonbromida također su dokazane u otvorenoj fazi istraživanja liječenjem od 2. dana do 4. tjedna u ispitivanju 301, kao i u dva otvorena, produžena ispitivanja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT (PRE-FILLED SYRINGE PRESENTATION) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TEKST KUTIJE (NAPUNJENA ŠTRCALJKA)
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). 
Preporučena doza za bolesnike s dugoročnom boli (osim bolesnika koji primaju suportivnu skrb za uznapredovalu bolest) iznosi 12 mg metilnaltreksonbromida (0,6 ml otopine) koja se primjenjuje injekcijom pod kožu, po potrebi, ali najmanje 4 puta tjedno i najviše jedanput dnevno (7 doza tjedno).
With the needle still inserted in the upside down vial, check for air bubbles in the syringe. 
Dok je igla još uronjena u naglavce okrenutoj bočici, provjerite ima li u štrcaljki mjehurića zraka.
In addition, the analysis showed that 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg correspond to mean doses of 0.16 (range = 0.21-0.13) mg/kg and 0.16 (range = 0.19-0.11) mg/kg, respectively, based on the body weight distribution of patients participating in studies 301 and 302. 
Nadalje, na temelju distribucije tjelesne težine bolesnika koji su sudjelovali u ispitivanjima 301 i 302, analiza je pokazala da doza od 8 mg kod tjelesne težine od 38 do manje od 62 kg te doza od 12 mg za tjelesnu težinu od 62 do 114 kg odgovara srednjim dozama od 0,16 mg/kg (raspon= 0,21 - 0,13), odnosno 0,16 mg/kg (raspon= 0,19 - 0,11).
The recommended dose of methylnaltrexone bromide is 12 mg (0.6 mL of solution) subcutaneously, as needed, given as at least 4 doses weekly, up to once daily (7 doses weekly). 
Preporučena doza metilnaltreksonbromida iznosi 12 mg (0,6 ml otopine) supkutano, po potrebi, i primjenjuje se u najmanje 4 doze tjedno, najviše jedanput dnevno (7 doza tjedno).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT (VIAL PRESENTATION) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TEKST VANJSKE KUTIJE (BOČICA)
How to store Relistor 
Kako čuvati Relistor
It is recommended to rotate injection sites. 
Preporučuje se stalna promjena mjesta injekcije.
Do not rub the injection site. 
Nemojte trljati ubodno mjesto.
- 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). 
- Ostali sastojci su natrijev klorid, natrijev kalcijev edetat, glicinklorid, voda za injekcije, kloridna kiselina (za podešavanje pH) i natrijev hidroksid (za podešavanje pH).
A RFBM was defined as a bowel movement that occurred without laxative use during the previous 24 hours. 
Pražnjenje crijeva bez dodatnog laksativa definirano je kao pražnjenje crijeva do kojeg je došlo bez primjene laksativa u prethodna 24 sata.
Gastrointestinal disorders 
Gastrointestinalna (GI) stanja i GI perforacija
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). 
Konstipacija uzrokovana opioidima u odraslih bolesnika s kroničnom nemalignom boli Djelotvornost i sigurnost metilnaltreksonbromida u liječenju konstipacije uzrokovane opioidima u bolesnika s kroničnom nemalignom boli dokazane su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju (ispitivanje 3356).
• Nausea (feeling sick) 
Omaglica (ošamućenost)
In addition, median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebotreated patients. 
Nadalje, medijan dnevne doze opioida nije se značajno razlikovao od ishodišne vrijednosti bilo kod bolesnika liječenih metilnaltreksonbromidom, ili kod bolesnika koji su primili placebo.
7 sterile 1 mL injection syringes with retractable injection needle 14 alcohol swabs 
7 sterilnih štrcaljki za injekciju od 1 ml s iglom za injekciju na uvlačenje 14 alkoholom natopljenih jastučića
Step 5: Disposing of supplies 
Korak 5: Zbrinjavanje neupotrijebljenog lijeka
Common: opioid-withdrawal-like symptoms (like chills, tremor, rhinorrhea, piloerection, hot flush, palpitation, hyperhidrosis, vomiting, abdominal pain) 
Često: simptomi slični ustezanju od opioida (kao zimica, tremor, rinoreja, piloerekcija, navale vrućine, palpitacija, hiperhidroza, povraćanje, bol u abdomenu)
Talk to your doctor or pharmacist before using 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). 
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).
PATIENT CHECKLIST 
BOLESNIKOVA KONTROLNA LISTA
• To avoid needle-stick injuries, do not recap used needles. 
Da se ne biste uboli, nemojte vraćati pokrov na upotrijebljenu iglu.
Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide 
Relistor 12 mg/0,6 ml otopina za injekciju metilnaltreksonbromid
Tap the upside down syringe and push out any air bubbles with the plunger 
Lupkajte po naglavce okrenutoj štrcaljki i klipom izbacite mjehuriće zraka
The proportion of patients having an RFBM within 4 hours of the first dose was 34.2% in the combined methylnaltrexone bromide group versus 9.9% in the placebo group (p<0.001). 
Udio bolesnika s pražnjenjem crijeva bez primjene dodatnog laksativa, unutar 4 sata od prve doze iznosio je 34,2% u kombiniranoj skupini s metilnaltreksonbromidom naspram 9,9% u placebo skupini
Opioid-withdrawal-like symptoms (any of the following: feeling cold, shivering, runny nose, 
Simptomi slični ustezanju od opioida (bilo koji od sljedećih simptoma: osjećaj hladnoće,
NAME OF THE MEDICINAL PRODUCT Relistor 12 mg/0.6 mL solution for injection 
NAZIV LIJEKA Relistor 12 mg/0,6 ml otopina za injekciju
NAME OF THE MEDICINAL PRODUCT Relistor 8 mg solution for injection in pre-filled syringe 
NAZIV LIJEKA Relistor 8 mg otopina za injekciju u napunjenoj štrcaljki
Holding the filled syringe with the needle pointing up, recheck the syringe for air bubbles. 
Držeći napunjenu štrcaljku s iglom usmjerenom gore, provjerite ima li u štrcaljki mjehurića zraka.
The three areas of the body recommended for injection of Relistor are: (1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (only if injecting another person). 
(2) abdomen (trbuh) i (3) nadlaktica (samo ako dajete injekciju drugoj osobi).
Make sure the liquid in the pre-filled syringe is clear and colourless to pale yellow, and does not have any particles in it. 
Provjerite da je otopina u bočici bistra, bezbojna do blijedožuta te da u njoj nema pahuljica ili čestica.
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 
Korak 4b: Injiciranje Relistora kod upotrebe standardne injekcijske štrcaljke i injekcijske igle Korak 5: Zbrinjavanje neupotrijebljenog lijeka
One mL of solution contains 20 mg methylnaltrexone bromide. 
Jedan ml otopine sadrži 20 mg metilnaltreksonbromida.
After the needle is inserted, let go of the skin and slowly push the plunger all the way down until the syringe is empty and you hear a click to inject Relistor. 
Kako biste u injicirali Relistor Nakon umetanja igle otpustite kožu i polako pritisnite klip do kraja dok ne čujete “klik”, što znači da je štrcaljka prazna.
The rate of laxation response was maintained throughout the extension studies for those patients who continued treatment. 
Kod bolesnika koji su nastavili s liječenjem, stopa odgovora s laksacijom bila je održana tijekom produžetka ispitivanja.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe of 0.4 mL contains 8 mg of methylnaltrexone bromide. 
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka napunjena štrcaljka od 0,4 ml sadrži 8 mg metilnaltreksonbromida.
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. 
Prvi koprimarni ishod ispitivanja bio je udio bolesnika s pražnjenjem crijeva bez primjene dodatnog laksativa (engl. (engl. rescue free bowel movements), unutar 4 sata od primjene prve doze, a drugi koprimarni ishod bio je postotak aktivnih injekcija koje su uzrokovale pražnjenje crijeva bez primjene dodatnog laksativa, unutar 4 sata tijekom dvostruko slijepe faze.
Each syringe of 0.4 mL contains 8 mg methylnaltrexone bromide. 
Svaka štrcaljka od 0,4 ml sadrži 8 mg metilnaltreksonbromida.
Median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebo-treated patients. 
Medijan dnevne doze opioida nije značajno varirao od početne doze ni kod bolesnika koji su liječeni metilnaltreksonbromidom ni kod bolesnika koji su primali placebo.
Patients with hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 
Nije potrebna prilagodba doze kod bolesnika s blagim do umjerenim oštećenjem jetre (vidjeti dio 5.2).
NAME OF THE MEDICINAL PRODUCT Relistor 12 mg solution for injection in pre-filled syringe 
NAZIV LIJEKA Relistor 12 mg otopina za injekciju u napunjenoj štrcaljki
• Reaction at the site of injection (e.g., stinging, burning, pain, redness, oedema) 
Često: reakcije na mjestu injekcije (npr. probadanje, žarenje, bol, crvenilo, edem)
Each vial contains 0.6 mL of solution for injection. 
Svaka bočica sadrži 0,6 ml otopine za injekciju.
In these patients, the treatment with usual laxatives should be stopped when commencing treatment with Relistor (see section 5.1). 
U ovih bolesnika, liječenje uobičajenim laksativima treba prekinuti prilikom početka liječenja lijekom
Patients weighing less than 38 kg or greater than 114 kg should use Relistor vials because the recommended mg/kg dose cannot be accurately delivered with the pre-filled syringe. 
Relistora jer se preporučena doza u mg/kg ne može precizno primijeniti korištenjem napunjenih štrcaljki.
Place used pre-filled syringe in a closable, puncture-resistant container. 
Iskorištenu napunjenu štrcaljku stavite u neprobojni spremnik koji možete zatvoriti.
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. 
Ako je Vaša tjelesna težina manja od 38 kg ili veća od 114 kg, morate koristiti bočice
Step 3: Choosing and preparing an injection site 
Korak 3: Odabir i priprema ubodnog mjesta
Relistor 8 mg solution for injection in pre-filled syringe Relistor 12 mg solution for injection in pre-filled syringe Methylnaltrexone bromide 
Uputa o lijeku: Informacija za korisnika Relistor 8 mg otopina za injekciju u napunjenoj štrcaljki Relistor 12 mg otopina za injekciju u napunjenoj štrcaljki metilnaltreksonbromid
Opioid withdrawal 
Ustezanje od opioda
A supplementary analysis evaluated the percentage of patients achieving ≥3 complete RFBMs per week and an increase of ≥1 complete 
Dopunskom analizom ispitivan je postotak bolesnika koji su postigli ≥3 pražnjenja crijeva bez primjene dodatnog laksativa tjedno i povećanje od ≥1 potpunog pražnjenja crijeva bez primjene dodatnog laksativa tjedno tijekom najmanje 3 od 4 tjedna u kojima su primali lijek.
The key secondary endpoint of adjusted mean change from baseline in weekly RFBMs was 3.1 in the methylnaltrexone bromide 12 mg once daily treatment group, 2.1 in the methylnaltrexone bromide 12 mg every other day treatment group, and 1.5 in the placebo treatment group during the 4-week doubleblind period. 
Ključni sekundarni ishod ispitivanja tj. prilagođena srednja promjena od početka u pražnjenju crijeva bez primjene dodatnog laksativa iznosila je 3,1 u skupini koja je liječena metilnaltreksonbromidom u dozi od 12 mg jedanput dnevno, 2,1 u skupini koja je liječena metilnaltreksonbromidom u dozi od
Sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH). 
Natrijev klorid, natrijev kalcijev edetat, glicinklorid, voda za injekciju, kloridna kiselina (za podešavanje pH), natrijev hidroksid (za podešavanje pH).
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide 
NAZIV LIJEKA I PUT(EVI) PRIMIJENE LIJEKA Relistor 12 mg/0,6 ml otopina za injekciju metilnaltreksonbromid
Following intravenous injection of methylnaltrexone bromide for 13 weeks, similar methylnaltrexone related toxicity was observed in both juvenile and adult dogs. 
Slična toksičnost povezana s metilnaltreksonbromidom opažena je kako kod mladih, tako i kod odraslih pasa nakon što su 13 tjedana dobivali intravensku injekciju metilnaltreksonbromida.
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. 
2 bočice s 2 sterilne štrcaljke za injekciju od 1 ml s iglom za injekciju na uvlačenje i 4 alkoholom natopljena jastučića; ili
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe of 0.6 mL contains 12 mg of methylnaltrexone bromide. 
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka napunjena štrcaljka od 0,6 ml sadrži 12 mg metilnaltreksonbromida.
A total of 460 patients (methylnaltrexone bromide 12 mg once daily, n=150, methylnaltrexone bromide 12 mg every other day, n=148, placebo, n=162) were treated in the double-blind period. 
460 bolesnika (metilnaltreksonbromid u dozi od 12 mg jedanput dnevno, n=150,
Step 2: Choosing and preparing an injection site 1. 
Korak 2: Odabir i priprema ubodnog mjesta
There were no clinically relevant changes in pain scores from baseline in either the methylnaltrexone bromide or placebo-treated patients. 
Nisu opažene klinički značajne promjene stupnjevanja boli, bilo kod bolesnika liječenih metilnaltreksonbromidom, ili kod bolesnika koji su primili placebo.
With the needle still in the vial, turn the vial upside-down. 
Držeći iglu u bočici, okrenite bočicu naglavce.
Each syringe of 0.6 mL contains 12 mg methylnaltrexone bromide. 
Svaka štrcaljka od 0,6 ml sadrži 12 mg metilnaltreksonbromida.
Step 4: Disposing of supplies 
Korak 4: Zbrinjavanje neupotrijebljenog lijeka
OTHER Keep the vial in the outer carton in order to protect from light. 
DRUGO Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
Posology 
Flaster
There were no clinically relevant changes from baseline in pain scores in either the methylnaltrexone bromide or placebo-treated patients. 
Nisu opažene klinički značajne promjene od početnih vrijednosti stupnjevanja boli ni kod bolesnika liječenih metilnaltreksonbromidom ni kod bolesnika koji su primali placebo.
Each vial contains 0.6 mL of solution. 
Svaka bočica sadrži 0,6 ml otopine.
Consequently, no meaningful change in AUC of methylnaltrexone bromide, in addition to Cmax, was observed before and after multiple-dose administration of cimetidine. 
U skladu s tim, nije opažena značajna promjena niti AUC metilnaltreksonbromida niti Cmax,
The dose is normally given every 48 hours (every two days) as an injection under the skin. 
Doza se obično daje svakih 48 sati
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. 
do 114 kg, doza metilnaltreksonbromida mora se smanjiti s 12 mg na 8 mg (0,4 ml otopine).
MARKETING AUTHORISATION NUMBER EU/1/08/463/011 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/011
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). 
Prosječni postotak metilnaltreksonbromida koji je doveo do pražnjenja crijeva bez primjene dodatnog laksativa, unutar 4 sata iznosio je 28,9% za skupinu koja je uzimala lijek jedanput dnevno, odnosno 30,2% za kupinu koja je uzimala lijek svaki drugi dan u usporedbi s 9,4%, odnosno
Do not use Relistor 
Ako prestanete uzimati Relistor
Cases of a hole developing in the bowel wall (gastrointestinal perforation) have been reported in patients using Relistor. 
U bolesnika koji su uzimali ovaj lijek opisani su slučajevi gastrointestinalne perforacije, tj. puknuća crijeva.
0.6 mL (12 mg) More than 114 kg 0.15 mg/kg 
kg) ili 12 mg (0,6 ml otopine) (za bolesnike koji teže 62 - 114 kg).
It is used for patients when other medicines for constipation, called laxatives, have not worked well enough. 
(zatvor), tzv. laksativi, nisu imali dovoljno dobar učinak.
4.4 Special warnings and precautions for use 
4.4 Posebna upozorenja ili mjere opreza pri uporabi Teški simptomi i simptomi koji se pogoršavaju
NAME OF THE MEDICINAL PRODUCT Relistor 8 mg solution for injection in pre-filled syringe Methylnaltrexone bromide 
Relistor 8 mg otopina za injekciju u napunjenoj štrcaljki metilnaltreksonbromid
Look for the needle tip inside the vial. 
Provjerite da li je vrh igle u bočici.
NAME OF THE MEDICINAL PRODUCT Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide 
Relistor 12 mg/0,6 ml otopina za injekciju Metilnaltreksonbromid
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR VIAL LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Relistor 8 mg injection 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Relistor 8 mg injekcija metilnaltreksonbromid s.c.
NAME OF THE MEDICINAL PRODUCT Relistor 12 mg solution for injection in pre-filled syringe Methylnaltrexone bromide 
Relistor 12 mg otopina za injekciju u napunjenoj štrcaljki metilnaltreksonbromid
MARKETING AUTHORISATION NUMBER EU/1/08/463/007 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/007
MARKETING AUTHORISATION NUMBER EU/1/08/463/009 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/009
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. 
Prilikom prolaska igle kroz čep osjetit ćete blagi otpor.
MARKETING AUTHORISATION NUMBER EU/1/08/463/005 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/005
MARKETING AUTHORISATION NUMBER EU/1/08/463/002 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/002
MARKETING AUTHORISATION NUMBER EU/1/08/463/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/001
Gather the supplies you will need for your injection: 
Složite sve predmete koji su Vam potrebni za injekciju: Napunjenu štrcaljku Relistora
Dizziness may occur and this may have an effect on the ability to drive and use machines (see section 4.8). 
Metilnaltreksonbromid malo utječe na sposobnost upravljanja vozilima i rada na strojevima.Može se javiti omaglica, koja može utjecati na sposobnost upravljanja vozilima i rada na strojevima (vidjeti dio
MARKETING AUTHORISATION NUMBER EU/1/08/463/006 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/006
• 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. 
• Molimo također se savjetujte sa svojim liječnikom ukoliko imate kolostomiju, cjevčicu u trbuhu
MARKETING AUTHORISATION NUMBER EU/1/08/463/008 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/008
Τηλ: +39 02 828 77 050 e-mail: mail.it@sobi.com 
Swedish Orphan Biovitrum S.r.l. Τηλ: +39 02 828 77 050 e-mail: mail.it@sobi.com
A total of 460 patients (methylnaltrexone bromide 
0,4 ml otopine (8 mg metilnaltreksonbromida)
MARKETING AUTHORISATION NUMBER EU/1/08/463/004 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/004
2 sterile 1 mL injection syringes with retractable injection needle 4 alcohol swabs 
2 bočice od 0,6 ml 2 sterilne štrcaljke za injekciju od 1 ml s iglom za injekciju na uvlačenje
- Please talk to your doctor if you experience stomach ache which continues, nausea, (feeling sick) or vomiting (being sick) that is new or becomes worse. 
(ukoliko Vam je “zlo”) ili povraćanje, novonastalo ili pogoršano.
MARKETING AUTHORISATION NUMBER EU/1/08/463/003 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/003
10 March 2014 
10. ožujka 2014.