natgillin/translations-raw huggingface dataset:
Durability of response was demonstrated in Study 302, in which the laxation response rate was consistent from dose 1 through dose 7 over the course of the 2-week, double-blind period.
Trajnost odziva so dokazali v študiji 302, v kateri je bila pogostnost odvajalnega odziva v 2-tedenskem dvojno slepem obdobju nespremenjena od 1. do 7. odmerka.
Following intravenous injection of methylnaltrexone bromide for 13 weeks, similar methylnaltrexone related toxicity was observed in both juvenile and adult dogs.
Po 13-tedenskem intravenskem injiciranju metilnaltreksonijevega bromida so podobno z metilnaltreksonom povezano toksičnost opazili tako pri mladičih kot pri odraslih psih.
In a study of volunteers with varying degrees of renal impairment receiving a single dose of 0.30 mg/kg methylnaltrexone bromide, renal impairment had a marked effect on the renal excretion of methylnaltrexone bromide.
V študiji prostovoljcev z različnimi stopnjami ledvičnih okvar, ki so prejeli enkraten odmerek 0,30 mg/kg metilnaltreksonijevega bromida, je ledvična okvara izrazito vplivala na izločanje metilnaltreksonijevega bromida skozi ledvici.
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.
Vpliv blage in zmerne okvare jeter na sistemsko izpostavljenost metilnaltreksonijevemu bromidu so proučevali na po 8 bolnikih razreda A oziroma B po Child-Pughovi lestvici v primerjavi z zdravimi preiskovanci.
If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe.
Če vidite mehurčke, rahlo potrkajte s prstom po brizgi, da se zračni mehurčki dvignejo na vrh brizge.
The capped syringe or syringe and needle should NEVER be reused.
Pokrite brizge ali brizge s pokrovčkom ne smete NIKOLI uporabiti še enkrat.
Are you receiving opioid therapy (for example morphine or codeine) for your illness?
Se zdravite z opioidi (na primer z morfijem ali kodeinom)?
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).
V dvojno slepi randomizirani študiji EKG s paralelnima skupinama, v kateri so proučevali enkratne subkutane odmerke metilnaltreksonijevega bromida (0,15, 0,30 in 0,50 mg/kg) na 207 zdravih prostovoljcih, niso odkrili nobenega znaka podaljšanja intervala QT/QTc in nobenega dokaza, da bi metilnaltrekson vplival na sekundarne parametre EKG ali morfologijo elektrokardiografskega signala, in to v primerjavi s placebom in pozitivno kontrolo (peroralnim moksifloksacinom v odmerku 400 mg).
The most common adverse reactions in all patients exposed to methylnaltrexone bromide during all phases of placebo-controlled studies were abdominal pain, nausea, diarrhoea and flatulence.
Najpogostejše neželene reakcije pri vseh bolnikih, ki so bili izpostavljeni metilnaltreksonijevemu bromidu med vsemi fazami s placebom kontroliranih študij, so bile bolečine v trebuhu, navzea, driska in vetrovi.
Relistor contains an active substance called methylnaltrexone bromide which acts by blocking the side effects of opioid pain medicines that affect the bowel.
Zdravilo Relistor vsebuje učinkovino, imenovano metilnaltreksonijev bromid, ki deluje tako, da zavira neželene učinke opioidnih zdravil na črevesju.
• If you or your doctor know that your bowels were or are obstructed or your bowels are in a state where there is an immediate need for surgical intervention (which has to be diagnosed by your doctor).
• če vi sami veste ali če vaš zdravnik ve, da imate ali ste imeli zaporo črevesa, ali če je vaše črevo v takšnem stanju, da je potreben takojšen kirurški poseg (diagnozo takega stanja pa mora postaviti vaš zdravnik).
• If you have severe liver or kidney disease.
• Če imate težko bolezen jeter ali ledvic.
The effects of methylnaltrexone bromide in pregnant women are not known.
Učinki metilnaltreksonijevega bromida pri nosečnicah niso znani.
If you push the plunger completely, you will hear a ‘click' sound.
Če boste potisnili bat do konca navzdol, boste zaslišali klik.
There may be local laws about how you should throw away used needles and syringes.
Morda za odstranjevanje uporabljenih igel in injekcijskih brizg veljajo lokalni predpisi.
INFORMATION IN BRAILLE RELISTOR 8 mg
PODATKI V BRAILLOVI PISAVI RELISTOR 8 mg
Absolute bioavailability of a 0.30 mg/kg subcutaneous dose versus a 0.30 mg/kg intravenous dose is 82 %.
Absolutna biološka uporabnost subkutanega odmerka 0,30 mg/kg v primerjavi z intravenskim odmerkom 0,30 mg/kg je 82 %.
Study 3356 compared 4-week treatment regimens of methylnaltrexone bromide 12 mg once daily and methylnaltrexone bromide 12 mg every other day with placebo.
V študiji 3356 so primerjali 4-tedenski režim zdravljenja z metilnaltreksonijevim bromidom 12 mg enkrat na dan in metilnaltreksonijevim bromidom 12 mg vsak drugi dan s placebom.
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).
Za injiciranje zdravila Relistor so priporočljiva tri mesta: (1) stegno, (2) trebuh in (3) nadlaket (samo če zdravilo injicira nekdo drug).
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.
Dvojno slepemu odmerku je sledilo 4-tedensko obdobje odprtega odmerjanja, med katerim se je metilnaltreksonijev bromid lahko uporabljal po potrebi, a največ 1 odmerek na 24 ur.
Methylnaltrexone bromide is excreted via the milk of lactating rats.
Metilnaltreksonijev bromid se izloča z mlekom doječih podgan.
How to use Relistor
Kako uporabljati zdravilo Relistor
The mean steady-state Cmax and AUC for the elderly were 545 ng/mL and 412 ng•h/mL, approximately 8.1 % and 20 %, respectively, greater than those for young subjects.
Povprečni Cmax in AUC v stanju ravnovesja pri starejših preiskovancih sta bili 545 ng/ml in 412 ng·h/ml, kar je približno za 8,1 %
If you forget a dose, talk to your doctor or pharmacist as soon as possible.
Če ste pozabili uporabiti odmerek, se čimprej posvetujte z zdravnikom ali farmacevtom.
Results showed no meaningful effect of hepatic impairment on the AUC or Cmax of methylnaltrexone bromide.
Rezultati niso pokazali pomembnega učinka okvare jeter na AUC ali Cmax metilnaltreksonijevega bromida.
The three areas of the body recommended for injection of Relistor are upper legs, abdomen, and upper arms.
Trije predeli telesa, ki jih priporočamo za injiciranje zdravila Relistor, so stegno, trebuh in nadlaket.
Elderly population No dose adjustment is recommended based on age (see section 5.2).
Na podlagi starosti ne priporočajo nikakršnega prilagajanja odmerjanja (glejte poglavje 5.2).
In palliative care patients, Relistor is added to usual laxative treatment (see section 5.1).
Pri bolnikih, ki prejemajo paliativno nego, se zdravilo Relistor doda običajnemu odvajalnemu zdravljenju (glejte poglavje 5.1).
The effect of severe hepatic impairment on the pharmacokinetics of methylnaltrexone bromide has not been studied.
Učinka težke okvare jeter na farmakokinetiko metilnaltreksonijevega bromida niso proučevali.
Methylnaltrexone bromide is not recommended in patients with severe hepatic impairment or with end-stage renal impairment requiring dialysis (see section 4.2).
Metilnaltreksonijev bromid ni priporočljiv za bolnike s težkimi okvarami jeter ali z okvarami ledvic v končnem stadiju, pri katerih je potrebna dializa (glejte poglavje 4.2).
Study 302 compared double-blind, subcutaneous doses of methylnaltrexone bromide given every other day for 2 weeks versus placebo.
V študiji 302 so primerjali dvojno slepe odmerke metilnaltreksonijevega bromida, ki so ga dajali subkutano 2 tedna vsak drugi dan, s placebom.
If not, do not use the pre-filled syringe and call your nurse, doctor or pharmacist.
Če ni taka, napolnjene injekcijske brizge ne uporabite in pokličite svojega zdravnika ali farmacevta.
Methylnaltrexone bromide is minimally bound to human plasma proteins (11.0 % to 15.3 %) as determined by equilibrium dialysis.
Kot so ugotovili z ravnovesno dializo, se metilnaltrekson minimalno veže na beljakovine človeške plazme (11,0 % do 15,3 %).
• If you develop severe or persistent diarrhoea (passing of frequent watery stools), discontinue therapy and contact your doctor immediately.
• Če se pri vas razvije težka ali trdovratna driska (pogosto odvajanje vodenega blata), prenehajte jemati zdravilo Relistor in se takoj obrnite na svojega zdravnika.
It is unknown whether methylnaltrexone bromide is excreted in human breast milk.
Ni znano, ali se metilnaltreksonijev bromid izloča v materino mleko.
Step 2: Preparing the injection syringe
Korak 2: Priprava injekcijske brizge
Only use this medicine if the solution is clear, colourless to pale yellow, and does not contain flakes or particles.
To zdravilo uporabljajte le, če je raztopina bistra, brezbarvna do svetlo rumena in ne vsebuje kosmičev ali delcev.
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.
Primarna končna točka je bila delež bolnikov z iztrebljanjem brez rešilnega odvajala v 4 urah po dvojno slepem odmerku preiskovanega zdravila.
It is recommended to move to a different site each time an injection is given.
Priporočljivo je, da za vsako novo injekcijo izberete drugo mesto injiciranja.
In vitro studies have shown methylnaltrexone bromide to be a mu-opioid receptor antagonist (inhibition constant [Ki] = 28 nM), with 8-fold less potency for kappa opioid receptors (Ki = 230 nM) and much reduced affinity for delta opioid receptors.
Študije in vitro so pokazale, da je metilnaltreksonijev bromid antagonist mu-opioidnih receptorjev (inhibicijska konstanta [Ki] = 28 nM), z osemkrat manjšo učinkovitostjo za opioidne receptorje kappa
In order to get the air out of the syringe, gently push the plunger down to inject the air into the vial.
Da boste odstranili zrak iz injekcijske brizge, previdno potisnite bat navzdol, da boste v vialo vbrizgnili zrak.
Relistor is a solution for injection.
Zdravilo Relistor je raztopina za injiciranje.
The activity of methylnaltrexone bromide has been studied in patients with constipation induced by opioids.
Aktivnost metilnaltreksonijevega bromida so proučevali pri bolnikih s konstipacijo zaradi jemanja opioidov.
With the needle still in the vial, turn the vial upside-down.
Ko bo igla še v viali, zasukajte vialo na glavo.
The dose is normally given every 48 hours (every two days) as an injection under the skin.
Odmerek zdravila se vbrizga pod kožo običajno enkrat na 48 ur (vsak drugi dan).
Opioid-induced constipation in adult patients with chronic pain (except palliative care patients with advanced illness)
Konstipacija, povzročena z opioidi, pri odraslih bolnikih z napredovalo boleznijo (pri bolnikih, ki prejemajo paliativno nego)
NEVER recap the needle.
NIKOLI ne smete še enkrat natakniti pokrovčka na iglo.
(≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Neželeni učinki so razvrščeni kot: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000)in ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Important information about some of the ingredients of Relistor This medicine contains less than 1 mmol sodium (23 mg) per dose i.e., essentially “sodium free.”
Pomembne informacije o nekaterih sestavinah zdravila Relistor To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
What Relistor looks like and contents of the pack
Izgled zdravila Relistor in vsebina pakiranja
Slowly push the plunger up to force the air bubbles out of the syringe.
Počasi pritisnite na bat, da iztisnete zračne mehurčke iz brizge.
Other common side effects that may affect up to 1 in 10 people are:
Drugi pogosti neželeni učinki, ki lahko prizadenejo največ 1 od 10 bolnikov, so: vrtoglavica (omotičnost),
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).
dne do konca 4. tedna v študiji 301 in v dveh odprtih podaljšanih raziskavah (301EXT in 302EXT), v katerih so dajali metilnaltreksonijev bromid po potrebi do 4 mesece dolgo (samo 8 bolnikov).
Assemble the supplies you will need for your injection.
Pripravite si vse, kar boste potrebovali za injiciranje.
Wipe the vial's rubber stopper with an alcohol swab and place it on your flat work surface.
Obrišite gumijasti zamašek viale z alkoholnim zložencem in položite vialo na ravno delovno površino.
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).
Podatkov o bolnikih s težkimi okvarami jeter (razred C po Child-Pughovi lestvici) ni na voljo in uporaba metilnaltreksonijevega bromida pri teh bolnikih ni priporočljivo (glejte poglavje 4.4).
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.
Pri bolnikih, za katere vemo ali sumimo, da imajo mehansko obstrukcijo v prebavilih, bolnikih s povečanim tveganjem za ponavljajočo se obstrukcijo ali pri bolnikih, ki imajo akutni abdomen po kirurškem posegu, je uporaba metilnaltreksonijevega bromida kontraindicirana zaradi možnosti perforacije prebavil.
Single vial
1 viala
Dispose of the pre-filled syringe as instructed by your doctor, nurse or pharmacist.
Zavrzite napolnjeno brizgo po navodilih svojega zdravnika, medicinske sestre ali farmacevta.
INFORMATION IN BRAILLE RELISTOR 12 mg/0.6 mL
PODATKI V BRAILLOVI PISAVI RELISTOR 12 mg/0,6 ml
Remove the syringe and needle from the vial.
Potegnite iglo z brizgo iz viale.
An integrated analysis of pharmacokinetic data from healthy subjects indicated that methylnaltrexone bromide mg/kg dose-adjusted exposure increased as body weight increased.
Celovita analiza farmakokinetičnih podatkov, pridobljenih pri zdravih preiskovancih, je pokazala, da se izpostavljenost metilnaltreksonijevemu bromidu, popravljena za odmerek, z naraščanjem telesne mase zvečuje.
If unsure, please contact your doctor, nurse or pharmacist.
Če ste glede tega negotovi, se posvetujte s svojim zdravnikom, medicinsko sestro ali farmacevtom.
If you get a stomach ache that is either severe or will not go away, stop taking this medicine and call your doctor straight away.
Če imate hude bolečine v trebuhu, ki ne minejo, prenehajte uporabljati to zdravilo in nemudoma obvestite svojega zdravnika.
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.
Bolniki, zdravljeni z metilnaltreksonijevim bromidom, so tudi signifikantno pogosteje iztrebljali v 4 urah po vsaj 2 od prvih 4 odmerkov (52 %) kot bolniki, ki so prejemali placebo (9 %); p<0,0001.
Pack containing 4, 7, 8 or 10 pre-filled syringes with a needle shield.
Škatla, ki vsebuje 4, 7, 8 ali 10 napolnjenih injekcijskih brizg z varnostnim pokrovčkom.
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.
To izpostavljenost lahko za odmerek 0,15 mg/kg dosežemo s prilagoditvijo odmerka na podlagi razponov telesne mase, tako da pri telesni masi od 38 do manj kot 62 kg uporabimo odmerek 8 mg, pri telesni masi od 62 do 114 kg pa odmerek 12 mg, s čimer dobimo povprečno izpostavljenost 187 (razpon = 148-220) ng•h/ml.
Patients with hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section
Bolniki z okvaro jeter Pri bolnikih z blagimi do zmernimi okvarami jeter ni potrebno prilagajanje odmerka (glejte poglavje
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).
Podatkov o bolnikih z ledvično okvaro v končnem stadiju na dializi ni na voljo in uporaba metilnaltreksonijevega bromida pri teh bolnikih ni priporočljiva (glejte poglavje 4.4).
Pre-filled syringe of clear type I glass with stainless-steel needle, plastic plunger, and polypropylene rigid needle cover.
Napolnjena injekcijska brizga iz prozornega stekla tipa I z iglo in nerjavečega stekla, plastičnim batom in togim pokrovčkom igle iz polipropilena.
You can press a cotton ball or gauze over the injection site.
Na mesto injiciranja lahko pritisnete kosem vate ali zloženec iz gaze.
Opioid withdrawal
Odtegnitev opioidov
• 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.
• Pogovorite se s svojim zdravnikom, če se vam na novo pojavijo bolečine v trebuhu, ki ne prenehajo, navzea (slabost) ali bruhanje, ali če se slednji poslabšajo.
The following instructions explain how to prepare and give an injection of Relistor when using a prefilled syringe.
V teh navodilih boste našli razlago, kako pripravite in jemljete zdravilo Relistor, če uporabljate napolnjeno injekcijsko brizgo.
Do not attempt to administer an injection until you are sure that you understand how to give the injection.
Ne poskušajte si dati injekcije, dokler niste prepričani, da veste,
When the syringe is empty, quickly pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Ko je brizga prazna, iglo hitro potegnite iz kože in pazite, da jo potegnete ven pod istim kotom, pod katerim ste jo zapičili v kožo.
Conversion to methyl-6-naltrexol isomers and methylnaltrexone sulphate appears to be the primary pathway to metabolism.
Zdi se, da je poglavitna presnovna pot pretvorba v izomere metil-6-naltreksola in metilnaltreksonijev sulfat.
INFORMATION IN BRAILLE RELISTOR 12 mg
PODATKI V BRAILLOVI PISAVI RELISTOR 12 mg
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.
Doseglo ga je 28,7% bolnikov v skupini, ki je dnevno prejemala metilnaltrekson 12 mg (p < 0,001 v primerjavi s placebom), 14,9% bolnikov, ki so ga prejemali vsak drugi dan (p = 0,012 v primerjavi s placebom) in 6,2% bolnikov, ki so dobivali placebo.
Relistor is given as a subcutaneous injection.
Zdravilo Relistor dajemo v obliki subkutane injekcije.
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.
Cmax in površina pod krivuljo koncentracije v plazmi v odvisnosti od časa (AUC) se z zvečanjem odmerka zvečata sorazmerno odmerku od 0,15 mg/kg do
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.
Bolniki, ki so prejemali metilnaltreksonijev bromid, so signifikantno pogosteje iztrebljali v 4 urah po dvojno slepem odmerku (62 % pri 0,15 mg/kg in 58 % pri 0,3 mg/kg) kot bolniki, ki so prejemali placebo (14 %); p<0,0001 za vsakega od odmerkov proti placebu.
METHOD OF ADMINISTRATION Read the package leaflet before use
POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodiumfree.
Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
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.
Odmerki do 25 mg/kg/dan (18-kratna izpostavljenost [AUC] pri ljudeh po subkutanem odmerku 0,3 mg/kg) niso vplivali na plodnost ali splošno reproduktivno sposobnost.
• If you have Crohn´s disease or gastrointestinal ulcers
• Če imate Crohnovo bolezen ali razjedo v prebavilih.
A RFBM was defined as a bowel movement that occurred without laxative use during the previous 24 hours.
Iztrebljanje brez rešilnega odvajala je bilo opredeljeno kot iztrebljanje, do katerega je prišlo brez uporabe odvajala v predhodnih 24 urah.
Paediatric population No studies have been performed in the paediatric population (see section 4.2).
Pri otrocih študij niso opravili (glejte poglavje 4.2).
Do not touch the needle or allow the needle to touch any surface.
Ne dotikajte se igle in pazite, da se ne bo igla česa dotaknila.
Step 1: Preparing for an injection
Korak 1: Priprava na injiciranje
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).
V obdobju po izdaji dovoljenja za promet so po uporabi metilnaltreksonijevega bromida pri bolnikih s stanji, ki jih lahko povezujemo z lokalno ali sistemsko oslabitvijo strukturne integritete stene prebavne cevi (npr. peptično razjedo, psevdoobstrukcijo (Ogilviejev sindrom), divertikulozo, infiltracijske maligne bolezni prebavil ali peritonealne metastaze), poročali o primerih gastrointestinalne perforacije.
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.
Subkutane injekcije zdravila Relistor podganam v odmerkih 150/100 mg/kg/dan so povzročile zmanjšanje telesne teže mladičev; odmerki do 25 mg/kg/dan (izpostavljenost [AUC], 18-krat večja od izpostavljenosti pri ljudeh po subkutanem odmerku 0,3 mg/kg) niso vplivali na popadke, kotitev ali preživetje in rast mladičev.
0.4 mL of solution (8 mg methylnaltrexone bromide) Read the package leaflet before use.
0,4 ml raztopine (8 mg metilnaltreksonijevega bromida) Pred uporabo preberite priloženo navodilo!
Solution for injection (injection).
FARMACEVTSKA OBLIKA raztopina za injiciranje (injiciranje)
Relistor pre-filled syringe Alcohol swab Cotton ball or gauze Adhesive plaster
napolnjeno injekcijsko brizgo zdravila Relistor alkoholni zloženec kosem vate ali gazo samolepilni obliž
The organic cation transporter (OCT)-related drug-drug interaction potential between methylnaltrexone bromide and an OCT inhibitor was studied in 18 healthy subjects by comparing the single-dose pharmacokinetic profiles of methylnaltrexone bromide before and after multiple 400 mg doses of cimetidine.
povezanega s prenašalcem organskih kationov (OCT), med metilnaltreksonijevim bromidom in zaviralcem OCT, tako da so primerjali farmakokinetični profil enkratnega odmerka metilnaltreksonijevega bromida pred več zaporednimi 400-miligramskimi odmerki cimetidina in po njih.
Another secondary endpoint evaluated the proportion of patients with ≥3 RFBMs per week during the 4-week double-blind phase.
Drugi ocenjeni sekundarni cilj študije je bil delež bolnikov z ≥ 3 iztrebljanji brez rešilnega odvajala na teden v 4-tedenski dvojno slepi fazi.