natgillin/translations-raw huggingface dataset:
You will be instructed by your doctor, nurse or pharmacist on the techniques of self-administration.
Vaš zdravnik, medicinska sestra ali farmacevt vas bo naučil metode samoinjiciranja.
0.6 mL of solution (12 mg methylnaltrexone bromide) Read the package leaflet before use.
0,6 ml raztopine (12 mg metilnaltreksonijevega bromida) Pred uporabo preberite priloženo navodilo!
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 zdravnik, medicinska sestra ali farmacevt vam bo tudi povedal, kakšen odmerek vam je bil predpisan, in kako pogosto ga morate uporabljati.
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.
Doseglo ga je 59 % bolnikov v skupini, ki je dnevno prejemala metilnaltrekson 12 mg (p < 0,001 v primerjavi s placebom), 61 % bolnikov, ki so ga prejemali vsak drugi dan (p < 0,001 v primerjavi s placebom) in 38 % bolnikov, ki so dobivali placebo.
These include the Relistor vial, a 1 mL injection syringe (with or without retractable needle), 2 alcohol swabs, and a cotton ball or gauze.
1-mililitrska injekcijska brizga (z vskočno iglo ali brez nje), 2 alkoholna zloženca in kosem vate ali gaza.
Quickly pull the needle out of the skin, being careful to keep it at the same angle as it was inserted.
Iglo hitro potegnite iz kože in pazite, da jo potegnete ven pod istim kotom, pod katerim ste jo zapičili v kožo.
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).
Pri mladičih podgan, ki so 13 tednov intravensko prejemali metilnaltreksonijev bromid, so se neželeni klinični znaki (pojavi konvulzij in oteženo dihanje) pojavili pri nižjih odmerkih (≥ 3 mg/kg/dan) in izpostavljenostih (izpostavljenost [AUC], 5,4-krat večja od izpostavljenosti pri odraslih ljudeh po subkutanem odmerku 0,15 mg/kg) od tistih, ki so sprožili podobno toksične učinke pri odraslih podganah (20 mg/kg/dan).
Step 4a: Injecting Relistor using a pack containing injection syringe with retractable injection needle
Korak 4a: Injiciranje zdravila Relistor s pakiranjem, ki vsebuje injekcijsko brizgo z vskočno injekcijsko iglo
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.
Poleg tega je analiza pokazala, da 8-miligramski odmerek pri telesni masi med 38 in manj kot 62 kg in 12-miligramski odmerek pri telesni masi med 62 in 114 kg, na podlagi porazdelitve telesne mase bolnikov, ki so sodelovali v študijah 301 in 302, ustreza povprečnemu odmerku 0,16 (razpon = 0,21
Doses may also be given with longer intervals, as per clinical need.
Običajna terapevtska shema je en sam odmerek vsak drugi dan. Odmerki se lahko dajejo tudi v daljših presledkih, glede na klinične potrebe.
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.
Če na katero koli vprašanje (na tej kartici) v času svojega zdravljenja ne morete odgovoriti z DA, se posvetujte s svojim zdravnikom, medicinsko sestro ali farmacevtom.
What you need to know before you use Relistor
Kaj morate vedeti, preden boste uporabili zdravilo Relistor Ne uporabljajte zdravila Relistor
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 valj brizge z eno roko in potegnite pokrovček igle naravnost proč.
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.
Bolniki, zdravljeni z metilnaltreksonijevim bromidom, so pogosteje odvajali v 4 urah po prvem odmerku (48 %) kot bolniki, ki so prejemali placebo (16 %); p<0,0001.
The following instructions explain how to inject Relistor.
V teh navodilih boste našli razlago, kako si vbrizgavajte zdravilo Relistor.
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
Korak 2: Izbira in priprava mesta injiciranja Korak 3: Injiciranje zdravila Relistor v napolnjeni injekcijski brizgi Korak 4: Odstranjevanje
Step 3: Injecting Relistor pre-filled syringe
Korak 3: Injiciranje zdravila Relistor v napolnjeni injekcijski brizgi
Step 4b: Injecting Relistor using a standard injection syringe and injection needle
Korak 4b: Injiciranje zdravila Relistor s standardno injekcijsko brizgo in injekcijsko iglo
8 pre-filled syringes
8 napolnjenih injekcijskih brizg
Clear solution, colourless to pale-yellow, essentially free from visible particulates.
Bistra raztopina, brezbarvna do svetlo rumena, praktično brez vidnih delcev
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).
To zdravilo se daje kot podkožna injekcija (s subkutano injekcijo) v (1) stegno ali (2) trebuh ali (3)
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).
Priporočeni odmerek za bolnike z dolgotrajno bolečino (razen za bolnike, ki prejemajo podporno nego zaradi napredovale bolezni) je 12 mg metilnaltreksonijevega bromida (0,6 ml raztopine), danega v obliki podkožne injekcije po potrebi, vendar vsaj 4-krat na teden in največ enkrat na dan (7-krat na teden).
Cases of a hole developing in the bowel wall (gastrointestinal perforation) have been reported in patients using Relistor.
Pri bolnikih, ki so uporabljali zdravilo Relistor, so poročali o predrtju stene črevesja (gastrointestinalna perforacija).
It is clear, colourless to pale yellow, and does not contain flakes or particles.
To je bistra, brezbarvna do svetlo rumena raztopina in ne vsebuje kosmičev ali delcev.
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 cilj študije, prilagojen za povprečno spremembo od izhodišča, tedensko iztrebljanje brez rešilnega odvajala, je bil 3,1 v skupini, zdravljeni z metilnaltreksonijevim bromidom 12 mg enkrat na dan, 2,1 v skupini, zdravljeni z metilnaltreksonijevim bromidom 12 mg vsak drugi dan, in 1,5 v skupini, ki je dobivala placebo v 4-tedenskem dvojno slepem obdobju.
2 vials of 0.6 mL
2 viali po 0,6 ml
Not known: Gastrointestinal perforation (see section 4.4), Common: Vomiting
Bolezni prebavil neznana: gastrointestinalna perforacija (glejte poglavje 4.4) pogosti: bruhanje zelo pogosti: bolečine v trebuhu, navzea, driska, vetrovi
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, povzročena z opioidi, pri odraslih bolnikih z napredovalo boleznijo Učinkovitost in varnost metilnaltreksonijevega bromida v zdravljenju konstipacije, povzročene z opioidom, pri bolnikih, ki prejemajo paliativno zdravljenje, so dokazali v dveh randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
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.
4 urah po prvem odmerku preiskovanega zdravila in delež bolnikov z iztrebljanjem brez rešilnega odvajala v 4 urah po vsaj 2 od prvih 4 odmerkov zdravila.
Pack containing 2 vials, 2 injection syringes with retractable injection needle, and 4 alcohol swabs (i.e. 2 inner cartons).
Škatla, ki vsebuje 2 viali, 2 injekcijski brizgi z vskočno injekcijsko iglo in 4 alkoholne zložence (t.j.
The renal clearance of methylnaltrexone bromide decreased with increasing severity of renal impairment.
Ledvični očistek metilnaltreksonijevega bromida je bil toliko manjši, kolikor večja je bila stopnja ledvične okvare.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.6 mL of solution (12 mg methylnaltrexone bromide)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,6 ml raztopine (12 mg metilnaltreksonijevega bromida)
In addition, median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebotreated patients.
Poleg tega mediani dnevni odmerek opioida ni pomembno odstopal od izhodišča niti pri bolnikih, zdravljenih z metilnaltreksonijevim bromidom, niti pri tistih, ki so prejemali placebo.
Patients had opioid-induced constipation (< 3 rescue medication-free bowel movements per week during the screening period).
(< 3 iztrebljanja brez rešilnega odvajala na teden v obdobju presejanja).
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.
Bolniki so pred presejanjem imeli z opioidom povzročeno konstipacijo, opredeljeno bodisi kot <3
Pack containing 7 vials, 7 injection syringes with retractable injection needle, and 14 alcohol swabs (i.e. 7 inner cartons).
Škatla, ki vsebuje 7 vial, 7 injekcijskih brizg z vskočno injekcijsko iglo in 14 alkoholnih zložencev (t.j.
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.
Kožno gubo spustite in bat injekcijske brizge počasi potisnite navzdol, dokler ni brizga prazna in zaslišite klik.
1 vial of 0.6 mL
1 viala po 0,6 ml
Allow the injection site to air-dry before injecting.
Pred injiciranjem naj se mesto injiciranja posuši na zraku.
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).
Delež bolnikov z iztrebljanjem brez rešilnega odvajala v 4 urah po prvem odmerku je bil 34,2 % v kombinirani skupini z metilnaltreksonijevim bromidom v primerjavi z 9,9 % v skupini s placebom
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C.
• Reaction at the site of injection (e.g., stinging, burning, pain, redness, oedema)
reakcija na mestu injiciranja (npr. zbadanje, pekoč občutek, bolečina, rdečica, oteklina),
Make sure the liquid in the pre-filled syringe is clear and colourless to pale yellow, and does not have any particles in it.
Prepričajte se, da je tekočina v napolnjeni brizgi bistra in brezbarvna do svetlo rumena in brez vidnih delcev.
7 pre-filled syringes
7 napolnjenih injekcijskih brizg
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.
4-tedenskemu, dvojno slepemu obdobju je sledilo 8-tedensko odprto obdobje, v katerem so metilnaltreksonijev bromid uporabljali po potrebi, a ne pogosteje kot enkrat na dan. Skupaj 460 bolnikov (metilnaltreksonijev bromid 12 mg enkrat na dan, n = 150, metilnaltreksonijev bromid 12 mg vsak drugi dan, n = 148, placebo, n = 162) je bilo zdravljenih v dvojno slepem obdobju.
Step 3: Choosing and preparing an injection site
Korak 3: Izbira in priprava mesta injiciranja
7 sterile 1 mL injection syringes with retractable injection needle 14 alcohol swabs
7 sterilnih 1-mililitrskih injekcijskih brizg z vskočno injekcijsko iglo 14 alkoholnih zložencev
Contents of the pack and other information
Shranjevanje zdravila Relistor Vsebina pakiranja in dodatne informacije
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LABEL TEXT FOR INTERMEDIATE CARTON (VIAL PRESENTATION)
BESEDILO NA NALEPKI NA VMESNI ŠKATLI (VIALA)
The needle will automatically retract from the skin and be capped.
Sedaj se igla sama od sebe potegne iz kože in pokrije s pokrovčkom.
Look for the needle tip inside the vial.
Bodite pozorni na konico igle v viali.
With the needle still inserted in the upside down vial, check for air bubbles in the syringe.
Ko je igla še zabodena v na glavo zasukani viali, se prepričajte, ali je v brizgi kaj zračnih mehurčkov.
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.
Pri bolnikih s težkimi ledvičnimi okvarami (očistek kreatinina manjši od 30 ml/min) moramo odmerek metilnaltreksonijevega bromida zmanjšati z 12 mg na 8 mg (0,4 ml raztopine) pri bolnikih, ki tehtajo
Methylnaltrexone bromide undergoes moderate tissue distribution.
Metilnaltreksonijev bromid se zmerno porazdeljuje po tkivih.
Use of methylnaltrexone bromide in patients with colostomy, peritoneal catheter, active diverticular disease or fecal impaction has not been studied.
Pri bolnikih s kolostomo, peritonealnim katetrom, aktivno divertikulozo ali fekalno impakcijo uporabe metilnaltreksonijevega bromida niso proučevali.
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.
Vključenih in zdravljenih v dvojno slepem obdobju je bilo skupaj 154 bolnikov (metilnaltreksonijev bromid 0,15 mg/kg, n = 47, metilnaltreksonijev bromid
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.
Potem ko ste iglo zabodli, kožo spustite in počasi potiskajte bat navzdol, dokler ne izpraznite napolnjene injekcijske brizge.
A supplementary analysis evaluated the percentage of patients achieving ≥3 complete RFBMs per week and an increase of ≥1 complete
V dopolnilni analizi so ocenili odstotek bolnikov, ki so dosegli ≥ 3 celovita iztrebljanji brez rešilnega odvajala na teden, in povečanje za ≥ 1 celovito iztrebljanje brez rešilnega odvajala na teden v vsaj 3 ali 4 tednih zdravljenja.
Patients should be monitored for severe, persistent, or worsening abdominal pain; methylnaltrexone bromide should be discontinued if this symptom occurs.
Bolnike je treba spremljati, če bi se pojavila huda, trdovratna bolečina v trebuhu ali bi se le-ta poslabšala.
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).
Povprečni odstotek metilnaltreksonijevega bromida, ki je povzročil iztrebljanje brez rešilnega odvajala v 4 urah, je bil 28,9 % pri skupini z enim odmerkom na dan oz. 30,2 % pri skupini z odmerkom vsak drugi dan, v primerjavi z 9,4 % oz. 9,3 % za ustrezni režim s placebom (p < 0,001).
Median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebo-treated patients.
Mediani dnevni odmerek opioida se ni značilno razlikoval od izhodišča niti v skupini, zdravljeni z metilnaltreksonijevim bromidom, niti v skupini, ki je dobivala placebo.
Place used pre-filled syringe in a closable, puncture-resistant container.
Uporabljeno napolnjeno injekcijsko brizgo dajte v zaprt vsebnik za ostre odpadke.
Store below 30ºC.
Shranjujte pri temperaturi do 30 ºC.
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).
Pri mladičih podgan, ki so prejemali odmerke po 1 mg/kg/dan, oziroma pri odraslih podganah pri odmerkih po 5 mg/kg/dan (izpostavljenost [AUC], 1,6-krat oziroma 7,8-krat večja od izpostavljenosti pri odraslih ljudeh po subkutanem odmerku 0,15 mg/kg) se neželeni učinki niso pojavili.
Methylnaltrexone bromide is minimally metabolised by CYP isozymes.
Izocimi s CYP minimalno presnavljajo metilnaltreksonijev bromid.
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).
Pri uporabi metilnaltreksonijevega bromida pri bolnikih s temi ali drugimi stanji, ki bi lahko povzročila okvaro integritete stene prebavil (npr. Crohnovo boleznijo), je treba upoštevati celoten profil glede tveganja in koristi.
sweating, hair standing on end, blushing, fast heart beat)
tresenje, nahod, znojenje, kurja polt, vročinski oblivi, hitro utripanje srca),
Each vial contains 0.6 mL of solution for injection.
Ena viala vsebuje 0,6 ml raztopine za injiciranje.
Hepatic impairment
Okvare jeter
Keep the pre-filled syringe in the outer carton in order to protect from light.
Napolnjeno injekcijsko brizgo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
NAME OF THE MEDICINAL PRODUCT Relistor 12 mg/0.6 mL solution for injection
IME ZDRAVILA Relistor 12 mg/0,6 ml raztopina za injiciranje
Common: Injection site reactions (e.g. stinging, burning, pain , redness, oedema) Reporting of suspected adverse reactions
Bolezni kože in podkožja pogosti: reakcije na mestu injiciranja (npr. zbadanje, pekoč občutek, bolečina, rdečica, edem) Poročanje o domnevnih neželenih učinkih
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 sočasni primarni cilj študije je bil delež bolnikov z iztrebljanjem brez rešilnega odvajala v 4 urah po prvem odmerku in drugi odstotek aktivnih injiciranj, ki so povzročili iztrebljanje brez rešilnega odvajala v 4 urah med dvojno slepo fazo.
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.
Če vam je predpisan 8-mg odmerek zdravila Relistor, bat injekcijske brizge previdno izvlecite do oznake 0,4 ml oziroma do oznake 0,6 ml, če vam je predpisan 12-mg odmerek zdravila Relistor.
You will be instructed by your doctor, nurse or pharmacist on the techniques of self-injection.
medicinska sestra ali farmacevt vas bo naučil metode samoinjiciranja.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT (PRE-FILLED SYRINGE PRESENTATION)
PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI (NAPOLNJENA INJEKCIJSKA BRIZGA)
7 vials of 0.6 mL
7 vial po 0,6 ml
Dizziness is a common side effect of this medicine.
Pogost neželeni učinek tega zdravila je vrtoglavost.
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, glicin klorid, voda za injekcije, klorovodikova kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH).
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).
Tako pri mladičih kot pri odraslih psih, ki so prejemali odmerke po 5 mg/kg/dan (izpostavljenost [AUC], 44-krat večja od izpostavljenosti pri odraslih ljudeh po subkutanem odmerku 0,15 mg/kg) se neželeni učinki niso pojavili.
0.6 mL (12 mg) More than 114 kg 0.15 mg/kg
0,13) mg/kg oziroma 0,16 (razpon = 0,19-0,11) mg/kg.
Patients may receive two consecutive doses 24 hours apart, only when there has been no response (bowel movement) to the dose on the preceding day.
Le če predhodnega dne ni odziva (iztrebljanja) na odmerek, lahko bolnik vzame dva zaporedna odmerka v presledku 24 ur.
Gastrointestinal (GI) conditions and GI perforation Methylnaltrexone bromide should be used with caution in patients with known or suspected lesions of the GI tract.
Metilnaltreksonijev bromid je treba pri bolnikih z znano lezijo prebavil ali sumom nanjo uporabljati previdno.
Relistor 8 mg solution for injection in pre-filled syringe Relistor 12 mg solution for injection in pre-filled syringe Methylnaltrexone bromide
Navodilo za uporabo Relistor 8 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Relistor 12 mg raztopina za injiciranje v napolnjeni injekcijski brizgi metilnaltreksonijev bromid
- 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).
- Pomožne snovi so natrijev klorid, natrijev kalcijev edetat, glicin klorid, voda za injekcije, klorovodikova kislina (za uravnavanje pH) in natrijev hidroksid (za uravnavanje pH).
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.
Vialo med tem z drugo roko držite na delovni površini tako, da ne more zdrsniti.
Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide
Relistor 12 mg/0,6 ml raztopina za injiciranje metilnaltreksonijev bromid
Methylnaltrexone bromide is metabolised to a modest extent in humans based on the amount of methylnaltrexone bromide metabolites recovered from excreta.
Sodeč po količini presnovkov metilnaltreksonijevega bromida, prestreženih iz blata in urina, se metilnaltreksonijev bromid pri ljudeh presnavlja v zmernem obsegu.
Dispose of the capped syringe or needle and syringe in a closable puncture-resistant container as instructed by your doctor, nurse or pharmacist.
Pokrito iglo ali iglo in brizgo po navodilih svojega zdravnika, medicinske sestre ali farmacevta zavrzite v zabojnik, ki je namenjen za odstranjevanje ostrih predmetov.
Each vial contains 0.6 mL of solution.
Ena viala vsebuje 0,6 ml raztopine.
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.
če je treba zaradi obstoječih zdravstvenih težav odmerek zmanjšati na 8 mg (0,4 ml raztopine), glejte
How to store Relistor
Shranjevanje zdravila Relistor
- If you get any side effects, talk to your doctor or pharmacist.
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
If you have suffered from constipation before you had to take opioids (for pain), please talk to your doctor.
Pogovorite se s svojim zdravnikom, če ste bili zaprti, še preden ste morali začeti jemati opioide (zaradi bolečine).
Talk to your doctor or pharmacist before using Relistor.
Pred začetkom uporabe zdravila Relistor se posvetujte z zdravnikom ali farmacevtom.
Tap the upside down syringe and push out any air bubbles with the plunger
Rahlo potrkajte po obrnjeni injekcijski brizgi in in zračne mehurčke iztisnite z batom
Stool consistency was not meaningfully improved in patients who had soft stool at baseline.
Pri bolnikih, ki so imeli v izhodišču mehko blato, se konzistenca blata ni pomembno izboljšala.
One mL of solution contains 20 mg methylnaltrexone bromide.
1 mililiter raztopine vsebuje 20 mg metilnaltreksonijevega bromida.
NAME OF THE MEDICINAL PRODUCT Relistor 8 mg solution for injection in pre-filled syringe
IME ZDRAVILA Relistor 8 mg raztopina za injiciranje v napolnjeni injekcijski brizgi