natgillin/translations-raw huggingface dataset:
Mode of action Methylnaltrexone bromide is a selective antagonist of opioid binding at the mu-receptor.
Mehanizem delovanja Metilnaltreksonijev bromid je selektiven antagonist vezave opioidov na mu- receptor.
In vitro studies have shown methylnaltrexone 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 metilnaltreksonij antagonist mu- opioidnih receptorjev (inhibicijska konstanta [Ki] = 28 nM), z osemkrat manjšo učinkovitostjo za opioidne receptorje kappa (Ki = 230 nM) in zelo zmanjšano afiniteto za opioidne receptorje delta.
As a quaternary amine, the ability of methylnaltrexone to cross the blood-brain barrier is restricted.
Ker je metilnaltreksonij kvarterni amin, je njegova sposobnost prehajanja krvno- možganske pregrade omejena.
This allows methylnaltrexone to function as a peripherally acting mu-opioid antagonist in tissues such as the gastrointestinal tract, without impacting opioid-mediated analgesic effects on the central nervous system.
To metilnaltreksoniju omogoča, da deluje kot periferno delujoč mu- opioidni antagonist v tkivih, na primer v prebavilih, ne da bi vplival na analgetične učinke opioida na centralno živčevje.
Clinical efficacy and safety 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, placebo-controlled studies.
Klinična učinkovitost in varnost Učinkovitost in varnost metilnatreksonijevega bromida v zdravljenju konstipacije, povzročene z opioidom, pri bolnikih, ki prejemajo paliativno zdravljenje, so dokazali v dveh randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
In these studies, the median age was 68 years (range 21-100); 51% were females.
V teh študijah je bila mediana starost 68 let (razpon 21- 100); 51% je bilo žensk.
In both studies, patients had advanced terminal illness and limited life expectancy, with the majority having a primary diagnosis of incurable cancer; other primary diagnoses included end-stage COPD/ emphysema, cardiovascular disease/ heart failure, Alzheimer’ s disease/ dementia, HIV/ AIDS, or other advanced illnesses.
V obeh študijah so imeli bolniki napredovalo terminalno bolezen in krajšo pričakovano življenjsko dobo, večina jih je imela primarno diagnozo neozdravljivega raka; med drugimi primarnimi diagnozami so bili še končni stadij KOPB/ emfizema, kardiovaskularne bolezni/ popuščanja srca, Alzheimerjeve bolezni/ demence, HIV/ AIDS in drugih napredovalih bolezni.
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 iztrebljanja v predhodnem tednu bodisi nobenega iztrebljanja > 2 dni.
Study 301 compared methylnaltrexone bromide given as a single, double-blind, subcutaneous dose of 0.15 mg/ kg, or 0.3 mg/ kg versus placebo.
V študiji 301 so primerjali metilnatreksonijev bromid, dan kot enkraten, dvojno slep subkutan odmerek 0, 15 mg/ kg, ali 0, 3 mg/ kg s placebom.
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 5 odmerjanja, med katerim se je metilnatreksonijev bromid lahko uporabljal po potrebi, a največ 1 odmerek na 24 ur.
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 0, 3 mg/ kg, n=55, placebo, n=22).
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 metilnatreksonijev 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 (slika 1).
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 metilnatreksonijevega bromida, ki so ga dajali subkutano 2 tedna vsak drugi dan, s placebom.
5 methylnaltrexone bromide 0.15 mg/ kg or placebo.
V prvem tednu (1., 3., 5. in 7. dne) so bolniki prejemali bodisi po 0, 15 mg/ kg metilnatreksonijevega bromida bodisi placebo.
In the second week, a patient’ s assigned dose could be increased to 0.30 mg/ kg if the patient had 2 or fewer rescue-free laxations up to day 8.
V drugem tednu se je lahko bolniku dodeljeni odmerek zvečal na 0, 30 mg/ kg, če je bolnik imel do 8. dneva največ 2 odvajanji brez rešilnega odvajala.
At any time, the patient’ s assigned dose could be reduced based on tolerability.
Bolniku dodeljeni odmerek se je lahko kadarkoli zmanjšal na podlagi slabega prenašanja zdravila.
Data from 133 (62 methylnaltrexone bromide, 71 placebo) patients were analysed.
Analizirali so podatke 133 bolnikov (62 z metilnatreksonijevim bromidom, 71 s placebom).
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 metilnatreksonijevim bromidom, so pogosteje odvajali v 4 urah po prvem odmerku (48%) kot bolniki, ki so prejemali placebo (16%); p < 0, 0001 (slika 1).
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 metilnatreksonijevim 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.
The effect on race could not be analysed because the study population was predominantly Caucasian (88%)
Vpliva rase ni bilo mogoče analizirati, ker so v populaciji študije prevladovali pripadniki bele rase (88%).
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.
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).
Učinkovitost in varnost metilnaltreksonijevega bromida so dokazali tudi pri odprtem zdravljenju od 2. dne do konca 4. tedna v študiji 301 in v dveh odprtih podaljšanih raziskavah (301EXT in 302EXT), v katerih so dajali metilnatreksonijev bromid po potrebi do 4 mesece dolgo.
RELISTOR was administered every 3.2 days (median dosing interval, with a range of 1-39 days).
Zdravilo RELISTOR so dajali na 3, 2 dneva (mediani interval odmerjanja, z razponom 1- 39 dni).
In addition, median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebo-treated patients.
Poleg tega mediani dnevni odmerek opioida ni pomembno odstopal od izhodišča niti pri bolnikih, zdravljenih z metilnatreksonijevim bromidom, niti pri tistih, ki so prejemali placebo.
Effect on cardiac repolarisation 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).
Vpliv na repolarizacijo srca 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 metilnaltreksonij vplival na sekundarne parametre EKG ali morfologijo elektrokardiografskega signala, in to v primerjavi s placebom in pozitivno kontrolo (peroralnim moksifloksacinom v odmerku 400 mg).
Absorption Methylnaltrexone bromide is absorbed rapidly, with peak concentrations (Cmax) achieved at approximately 0.5 hours following subcutaneous administration.
Absorpcija Metilnaltreksonijev bromid se absorbira hitro, maksimalna koncentracija (Cmax) se doseže približno pol ure po subkutanem odmerku zdravila.
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 dose- proportional 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 0, 5 mg/ kg.
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%.
Distribution Methylnaltrexone undergoes moderate tissue distribution.
Porazdelitev Metilnaltreksonij se zmerno porazdeljuje po tkivih.
The steady-state volume of distribution (Vss) is approximately 1.1 l/ kg.
Volumen porazdelitve v stanju ravnovesja (Vss) je približno 1, 1 l/ kg.
Methylnaltrexone is minimally bound to human plasma proteins (11.0% to 15.3%) as determined by equilibrium dialysis.
Kot so ugotovili z ravnovesno dializo, se metilnaltreksonij minimalno veže na beljakovine človeške plazme (11, 0% do 15, 3%).
6 Metabolism Methylnaltrexone is metabolised to a modest extent in humans based on the amount of methylnaltrexone metabolites recovered from excreta.
Presnova Sodeč po količini metilnaltreksonijevih presnovkov, prestreženih iz blata in urina, se metilnaltreksonij pri ljudeh presnavlja v zmernem obsegu.
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.
Each of the methyl-6- naltrexol isomers has somewhat less antagonist activity than parent compound, and a low exposure in plasma of approximately 8% of the drug-related materials.
Vsaka od izomer metil- 6- naltreksola ima nekoliko manjšo antagonistično aktivnost od izhodne spojine in majhno izpostavljenost v plazmi, ki je približno 8% snovi, povezanih z zdravilom.
Methylnaltrexone sulphate is an inactive metabolite and present in plasma at a level of approximately 25% of drug related materials.
Metilnaltreksonijev sulfat je neaktiven presnovek in je prisoten v plazmi na ravni približno 25% snovi, povezanih z zdravilom.
N- demethylation of methylnaltrexone to produce naltrexone is not significant, accounting for 0.06% of the administered dose.
N- demetilacija metilnaltreksonija v naltreksonij ni pomembna, saj predstavlja samo 0, 06% danega odmerka.
Excretion Methylnaltrexone is eliminated primarily as the unchanged active substance.
Izločanje Metilnaltreksonij se odstranjuje iz telesa predvsem kot nespremenjena zdravilna učinkovina.
The terminal disposition half-life (t1/ 2) is approximately 8 hours.
Končni razpolovni čas odstranjevanja (t1/ 2) je približno 8 ur.
Hepatic insufficiency The effect of mild and moderate hepatic impairment on the systemic exposure to methylnaltrexone has been studied in 8 subjects each, with Child-Pugh Class A and B, compared to healthy subjects.
Insuficienca jeter Vpliv blage in zmerne okvare jeter na sistemsko izpostavljenost metilnaltreksoniju so proučevali na po 8 bolnikih razreda A oziroma B po Child- Pughovi lestvici v primerjavi z zdravimi preiskovanci.
Results showed no meaningful effect of hepatic impairment on the AUC or Cmax of methylnaltrexone.
Rezultati niso pokazali pomembnega učinka okvare jeter na AUC ali Cmax metilnaltreksonija.
The effect of severe hepatic impairment on the pharmacokinetics of methylnaltrexone has not been studied.
Učinka težke okvare jeter na farmakokinetiko metilnaltreksonija niso proučevali.
Renal insufficiency 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.
Insuficienca ledvic V študiji prostovoljcev z različnimi stopnjami ledvičnih okvar, ki so prejeli enkraten odmerek 0, 30 mg/ kg metilnaltreksonija, je ledvična okvara izrazito vplivala na izločanje metilnaltreksonijevega bromida skozi ledvici.
The renal clearance of methylnaltrexone decreased with increasing severity of renal impairment.
Ledvični očistek metilnaltreksonija je bil toliko manjši, kolikor večja je bila stopnja ledvične okvare.
Severe renal impairment decreased the renal clearance of methylnaltrexone by 8- to 9-fold; however, this resulted in only a 2-fold increase in total methylnaltrexone exposure (AUC).
Težka ledvična okvara je zmanjšala ledvični očistek metilnaltreksonija za 8 - do 9- krat; vendar se je pri tem celotna izpostavljenost metilnaltreksoniju (AUC) samo podvojila.
Paediatric patients No studies have been performed in the paediatric population (see section 4.2).
Pediatrični bolniki Pri otrocih študij niso opravili (glejte poglavje 4. 2).
Elderly patients In a study comparing single and multiple-dose pharmacokinetic profiles of intravenous methylnaltrexone at a dose of 24 mg between healthy, young (18 to 45 years of age n=10) and elderly (65 years of age and over n=10) subjects, the effect of age on exposure to methylnaltrexone was found to be minor.
Starejši bolniki V študiji, v kateri so primerjali farmakokinetične profile enkratnih in večkratnih 24- miligramskih intravenskih odmerkov metilnaltreksonija pri zdravih mladih (starost 18 do 45 let, n=10) in starejših (starost 65 let in več, n=10) preiskovancih, so ugotovili, da je vpliv starosti na izpostavljenost metilnaltreksoniju manj pomemben.
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
Therefore, no dose adjustment is recommended based on age.
7 približno za 8, 1% oziroma 20% več kot pri mladih preiskovancih.
Gender No meaningful gender differences have been observed.
Spol Pomembnih razlik zaradi spola niso opazili.
Weight An integrated analysis of pharmacokinetic data from healthy subjects indicated that methylnaltrexone mg/ kg dose-adjusted exposure increased as body weight increased.
Telesna teža Celovita analiza farmakokinetičnih podatkov, pridobljenih pri zdravih preiskovancih, je pokazala, da se izpostavljenost, popravljena za odmerek, z naraščanjem telesne teže zvečuje.
The mean methylnaltrexone exposure at 0.15 mg/ kg over a weight range of 38 to 114 kg was 179 (range=139-240) ng. h/ ml.
Povprečna izpostavljenost metilnaltreksoniju pri odmerku 0, 15 mg/ kg pri telesni teži med 38 do 114 kg je bila 179 (razpon=139- 240) ng. h/ ml.
This exposure for the 0.15 mg/ kg dose can be achieved with a weight-band-based 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 teže, tako da pri telesni teži od 38 do manj kot 62 kg uporabimo odmerek 8 mg, pri telesni teži od 62 do 114 kg pa odmerek 12 mg, s čimer dobimo povprečno izpostavljenost 187 (razpon=148- 220) ng. h/ ml.
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 teži med 38 in manj kot 62 kg in 12- miligramski odmerek pri telesni teži med 62 in 114 kg, na podlagi porazdelitve telesne teže bolnikov, ki so sodelovali v študijah 301 in 302, ustreza povprečnemu odmerku 0, 16 (razpon= 0, 21- 0, 13) mg/ kg oziroma 0, 16 (razpon=0, 19- 0, 11) mg/ kg.
Cardiac effects were observed in some non- clinical studies in canines (prolongation of action potentials in Purkinje fibers or prolongation of the QTc interval).
V nekaterih predkliničnih raziskavah na psih so ugotavljali učinke na srce (podaljšanje akcijskih potencialov v Purkynjevih vlaknih ali podaljšanje intervala QTc).
Subcutaneous injections of RELISTOR at 150 mg/ kg/ day decreased fertility in rats.
Subkutane injekcije zdravila RELISTOR v odmerku 150 mg/ kg/ dan so pri podganah zmanjšale plodnost.
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 (izpostavljenost [AUC], 18- krat večja od izpostavljenosti pri ljudeh po subkutanem odmerku 0, 3 mg/ kg), ni vplivala na plodnost ali splošno reproduktivno storilnost.
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.
Carcinogenicity studies have not been conducted with RELISTOR.
Raziskav kancerogenosti z zdravilom RELISTOR niso opravili.
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 injekcije solna kislina (za popravek pH) natrijev hidroksid (za popravek pH)
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
8 Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
After withdrawl in the injection syringe:
Po potegu v injekcijsko brizgo:
Keep the vial in the outer carton in order to protect from light.
Shranjujte vialo v škatli za zagotovitev zaščite pred svetlobo.
For storage of the medicinal product in the syringe, see section 6.3.
Za shranjevanje zdravila v injekcijski brizgi glejte poglavje 6. 3.
Clear, Type I, flint glass, single-use vial, grey butyl rubber stopper, and aluminium overseal with flip-off-cap.
Viala za enkratno uporabo iz prozornega kristalnega stekla vrste I z zamaškom iz sive butilne gume in aluminijasto zapiralno obrobo z zaporko.
8 Each vial contains 0.6 ml of solution for injection.
Ena viala vsebuje 0, 6 ml raztopine za injiciranje.
The presentations of RELISTOR are:
Zdravilo RELISTOR je na voljo v naslednjih oblikah:
1 vial of solution for injection
1 viala raztopine za injiciranje
2 vials of solution for injection 2 sterile 1 ml injection syringes with retractable injection needle 4 alcohol swabs
2 viali raztopine za injiciranje 2 sterilni 1- mililitrski injekcijski brizgi z vskočno injekcijsko iglo 4 alkoholni zloženci
7 vials of solution for injection 7 sterile 1 ml injection syringes with retractable injection needle 14 alcohol swabs
7 vial raztopine za injiciranje 7 sterilnih 1- mililitrskih injekcijskih brizg z vskočno injekcijsko iglo 14 alkoholnih zložencev
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 OPH United Kingdom Tel:
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 OPH Velika Britanija Tel:
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DATUM ZADNJE REVIZIJE BESEDILA
CONDITIONS OF THE MARKETING AUTHORISATION
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Via Franco Gorgone Zona Industriale IT-95030 Catania Italy
Via Franco Gorgone Zona Industriale IT- 95030 Catania Italija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo sistem farmakovigilance, opisan v verziji 1. 2 in predstavljen v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in bo deloval, preden bo dal zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne dejavnosti, ki so opisane v načrtu farmakovigilance, dogovorjene v verziji 1. 2 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitev RMP, s katerimi soglaša CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami CHMP za sisteme obladovanja tveganja za zdravila za uporabo v humani medicini mora biti posodobljeni RMP predložen sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba predložiti posodobljen RMP: • ob prejemu novih podatkov, ki bi lahko vplivali na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja; • v 60 dneh po tistem, ko je dosežen pomemben mejnik (pri farmakovigilanci ali zmanjševanju tveganja); • na zahtevo EMEA.
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OZNAČEVANJE
RELISTOR 12 mg/ 0.6 ml solution for injection.
RELISTOR 12 mg/ 0, 6 ml raztopine za injiciranje.
Methylnaltrexone bromide.
Metilnaltreksonijev bromid.
One ml of solution contains 20 mg methylnaltrexone bromide.
En mililiter raztopine vsebuje 20 mg metilnaltreksonijevega bromida.
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 injekcije, klorovodikova kislina (za popravek pH), natrijev hidroksid (za popravek pH).
1 vial of 0.6 ml
1 viala po 0, 6 ml