natgillin/translations-raw huggingface dataset:
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.
Vaš liječnik, medicinska sestra ili ljekarnik će Vam reći koju su Vam dozu propisali i kako često je trebate uzimati.
Common: Vomiting
Često: povraćanje
Swedish Orphan Biovitrum s.r.o.
Swedish Orphan Biovitrum s.r.o. Magyarországi Fióktelepe
Use of methylnaltrexone bromide in patients with colostomy, peritoneal catheter, active diverticular disease or fecal impaction has not been studied.
Primjena metilnaltreksonbromida nije ispitivana kod bolesnika s kolostomijom, peritonejskim kateterom, aktivnom divertikulskom bolešću ili impakcijom fecesa.
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.
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.
Ensure you have the correct dose level in the syringe (e.g. 0.4 mL if you have been prescribed 8 mg)
Uvjerite se da imate odgovarajuću dozu lijeka u štrcaljki (npr. 0,4 ml ukoliko
Gastrointestinal (GI) conditions and GI perforation Methylnaltrexone bromide should be used with caution in patients with known or suspected lesions of the GI tract.
Metilnaltreksonbromid mora se koristiti oprezno u bolesnika s poznatim ili suspektnim lezijama GI trakta.
Methylnaltrexone bromide is not recommended in patients with severe hepatic impairment or with end-stage renal impairment requiring dialysis (see section 4.2).
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).
Generally, these reactions were mild or moderate.
Općenito su te nuspojave bile blage do umjerene težine.
• If you develop severe or persistent diarrhoea (passing of frequent watery stools), discontinue therapy and contact your doctor immediately.
• Ako dođe do teškog ili dugotrajnog proljeva (česte vodenaste stolice), odmah prekinite terapiju i javite se svom liječniku.
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.
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.
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.
metilnaltreksonbromid u dozi od 12 mg svaki drugi dan, n=148, placebo, n=162) je liječeno u dvostruko slijepom razdoblju.
Clear, Type I, flint glass, single-use vial, grey butyl rubber stopper, and aluminium overseal with flipoff-cap.
Prozirno silikatno staklo tipa I, bočica za jednokratnu primjenu, sivi čep od butil gume i aluminijski prsten s „flip-off“ kapicom.
INFORMATION IN BRAILLE RELISTOR 12 mg
PODACI NA BRAILLEOVOM PISMU Relistor 12 mg
Dizziness may occur, and this may have an effect on the ability to drive and use machines (see section 4.8).
Može se javiti omaglica, koja može utjecati na sposobnost upravljanja vozilima i rada na strojevima (vidjeti dio
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LABEL TEXT FOR TRAY LIDDING (PRE-FILLED SYRINGE PRESENTATION)
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP TEKST NALJEPNICE ZA POKLOPAC SPREMNIKA (NAPUNJENA ŠTRCALJKA)
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).
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).
Study 3356 compared 4-week treatment regimens of methylnaltrexone bromide 12 mg once daily and methylnaltrexone bromide 12 mg every other day with placebo.
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.
7 vials of 0.6 mL
7 bočica od 0,6 ml
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.
Držite klip štrcaljke jednom rukom i ravnim pokretom skinite pokrov igle.
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.
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.
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.
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.
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.
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.
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.
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.
If you stop using Relistor You should talk to a doctor or pharmacist if you want to stop using this medicine.
Ukoliko želite prestati uzimati Relistor, morate se obratiti svom liječniku ili ljekarniku.
How to use Relistor
Kako uzimati Relistor
Pack containing 7 vials, 7 injection syringes with retractable injection needle, and 14 alcohol swabs (i.e. 7 inner cartons).
Pakiranje koje sadrži 7 bočica, 7 štrcaljki za injekciju s iglom za injekciju na uvlačenje i 14 alkoholom natopljenih jastučića (tj. 7 unutarnjih kutija).
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).
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).
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).
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).
8 pre-filled syringes
8 napunjenih štrcaljki
Avoid repeated injections at the exact same spot previously used.
Izbjegavajte dati injekciju uvijek na istom mjestu.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.6 mL of solution (12 mg methylnaltrexone bromide)
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,6 ml otopine (12 mg metilnaltreksonbromida)
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.
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).
Cardiac effects were observed in some non-clinical studies in canines (prolongation of action potentials in Purkinje fibers or prolongation of the QTc interval).
(produženo trajanje akcijskog potencijala u Purkinjeovim vlaknima ili produženo trajanje QTc intervala).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NALJEPNICE ZA ŠTRCALJKU
• If you have Crohn´s disease or gastrointestinal ulcers
Ako imate Chronovu bolest ili čireve u probavnom sustavu
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).
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).
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).
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).
Sodium calcium edetate
Natrijev kalcijev edetat Glicinklorid
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.
Nakon umetanja igle otpustite kožu i polagano pritisnite klip do kraja sve dok se napunjena štrcaljka ne isprazni.
There was no significant relationship between baseline opioid dose and laxation response in methylnaltrexone bromide-treated patients in these studies.
U navedenim ispitivanjima nije opažena značajna povezanost između ishodišne doze opioida i odgovora s laksacijom kod bolesnika koji su liječeni metilnaltreksonbromidom.
The primary endpoint was the proportion of patients with a rescue-free laxation within 4 hours of the double-blind dose of study medicinal product.
Primarni ishod ispitivanja bio je udio bolesnika s laksacijom bez primjene dodatnog laksativa unutar 4 sata nakon primjene dvostruko slijepe doze ispitivanog lijeka.
1 vial of 0.6 mL
1 bočica od 0,6 ml
The effect on race could not be analysed because the study population was predominantly Caucasian (88 %).
Budući da su bolesnici bijele rase činili najveći dio ispitivane populacije (88%), nije se mogao analizirati učinak rase.
Common: Injection site reactions (e.g. stinging, burning, pain , redness, oedema) Reporting of suspected adverse reactions
Često: reakcije na mjestu injekcije (npr. probadanje, žarenje, bol, crvenilo, edem) Prijavljivanje sumnji na nuspojavu
You can press a cotton ball or gauze over the injection site.
Pritisnite ubodno mjesto pamučnim tupferom ili gazom.
Methylnaltrexone bromide undergoes moderate tissue distribution.
Distribucija Metilnaltreksonbromid podliježe umjerenoj distribuciji u tkiva.
Carefully pull back the plunger to correct level on syringe (e.g. 0.4 mL if you have been prescribed 8 mg)
Oprezno povucite klip kako biste podesili nivo u štrcaljki (npr. 0,4 ml ukoliko
Use of methylnaltrexone bromide in patients with known or suspected mechanical gastrointestinal obstruction, patients at increased risk for recurrent obstruction or in patients with acute surgical abdomen is contraindicated due to the potential for gastrointestinal perforation.
Kontraindicirana je primjena metilnaltreksonbromida kod bolesnika s poznatom ili suspektnom mehaničkom gastrointestinalnom opstrukcijom, bolesnika s povećanim rizikom za rekurentnu opstrukciju ili bolesnika s akutnim kirurškim abdomenom zbog moguće gastrointestinalne perforacije.
7 pre-filled syringes
7 napunjenih štrcaljki
Each pre-filled syringe contains 0.4 mL of solution for injection.
Svaka napunjena štrcaljka sadrži 0,4 ml otopine za injekciju.
The effect on race could not be analysed because the study population was predominantly Caucasian (90 %).
Budući da su bolesnici bijele rase činili najveći dio ispitivane populacije (90%), nije se mogao analizirati učinak rase.
Pack containing 2 vials, 2 injection syringes with retractable injection needle, and 4 alcohol swabs (i.e. 2 inner cartons).
Pakiranje koje sadrži 2 bočice, 2 štrcaljke za injekciju s iglom za injekciju na uvlačenje i 4 alkoholom natopljena jastučića (tj. 2 unutarnje kutije).
Another secondary endpoint evaluated the proportion of patients with ≥3 RFBMs per week during the 4-week double-blind phase.
Drugim sekundarnim ishodom ispitivan je udio bolesnika s ≥3 pražnjenja crijeva bez primjene dodatnog laksativa tjedno tijekom 4-tjedne dvostruko slijepe faze.
After the needle is inserted, let go of the skin and slowly push the plunger all the way down to inject Relistor.
Nakon umetanje igle otpustite kožu i polagano pritisnite klip do kraja, kako biste injicirali Relistor.
Slowly push the plunger up to force the air bubbles out of the syringe.
Polagano gurnite klip prema gore kako biste izbacili mjehuriće zraka iz štrcaljke.
Absolute bioavailability of a 0.30 mg/kg subcutaneous dose versus a 0.30 mg/kg intravenous dose is 82 %.
Apsolutna bioraspoloživost supkutane doze od 0,30 mg/kg u odnosu na intravensku dozu od 0,30 mg/kg iznosi
Doses may also be given with longer intervals, as per clinical need.
Ovisno o kliničkoj procjeni, doze se mogu davati i u većim razmacima.
In a double-blind, randomised, parallel-group ECG study of single, subcutaneous doses of methylnaltrexone bromide (0.15, 0.30 and 0.50 mg/kg), in 207 healthy volunteers, no signal of QT/QTc prolongation or any evidence of an effect on secondary ECG parameters or waveform morphology was detected as compared to placebo and a positive control (orally administered 400 mg moxifloxacin).
U dvostruko slijepom, randomiziranom ispitivanju s paralelnim skupinama ispitivan je EKG nakon jednokratnih supkutanih doza metilnaltreksonbromida (0,15, 0,30 i 0,50 mg/kg) kod 207 zdravih dobrovoljaca, pri čemu nisu nađeni znakovi prolongacije QT/QTc intervala niti učinci na sekundarne
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