natgillin/translations-raw huggingface dataset:
Mode of action Doripenem is a synthetic carbapenem antibacterial agent.
5 Mehanizem delovanja Doripenem je sintetična karbapenemska protimikrobna učinkovina.
In vitro doripenem showed little potential to antagonize or be antagonized by other antibacterial agents.
In vitro ima doripenem le majhno antagonistično delovanje na druge protimikrobne učinkovine oziroma imajo le- te majhno antagonistično delovanje nanj.
Additive activity or weak synergy with amikacin and levofloxacin has been seen for Pseudomonas aeruginosa and for gram-positive bacteria with daptomycin, linezolid, levofloxacin, and vancomycin.
Pri Pseudomonas aeruginosa so opazili aditivno delovanje ali šibko sinergistično delovanje z amikacinom in levofloksacinom, pri gram - pozitivnih bakterijah pa z daptomicinom, linezolidom, levofloksacinom in vankomicinom.
5 Pharmacokinetic/pharmacodynamic relationship Similar to other beta-lactam antimicrobial agents, the time that the plasma concentration of doripenem exceeds the MIC (%T > MIC) of the infecting organism has been shown to best correlate with efficacy in pre-clinical pharmacokinetic/pharmacodynamic (PK/PD) studies.
Razmerje med farmakokinetiko in farmakodinamiko Podobno kot pri drugih betalaktamskih antibiotikih so predklinične študije farmakokinetike in farmakodinamike (PK/ PD) pokazale, da je učinkovitosti zdravila najbolj odvisna od časa, ko plazemska koncentracija doripenema preseže vrednost MIC (% T > MIC) za zadevnega povzročitelja okužbe.
Monte Carlo simulations using pathogen susceptibility results from completed phase 3 trials and population PK data indicated that the %T > MIC target of 35% was achieved in greater than 90% of patients with nosocomial pneumonia, complicated urinary tract infections and complicated intra-abdominal infections, for all degrees of renal function.
Simulacije Monte Carlo, opravljene na podlagi izvidov občutljivosti posameznih patogenov iz zaključenih preskušanj 3. faze in populacijski farmakokinetični podatki kažejo, da je bila tarčna vrednost% T > MIC 35% dosežena pri več kot 90% bolnikov z bolnišnično pljučnico, okužbami sečil z zapleti in intraabdominalnimi okužbami z zapleti za vse stopnje delovanja ledvic.
Extending the infusion time of Doribax to 4 hours maximizes the %T > MIC for a given dose and is the basis for the option to administer 4-hour infusions in patients with nosocomial pneumonia including ventilator-associated pneumonia.
Ta ugotovitev je služila kot osnova za možnost dajanja 4- urnih infuzij bolnikom z bolnišnično pljučnico, vključno s pljučnico, povezano z uporabo respiratorja.
In seriously ill patients or those with an impaired immune response, a 4-hour infusion time may be more suitable when the MIC of doripenem for the known or suspected pathogen(s) has been shown or is expected to be > 0.5 mg/l, in order to reach a target attainment of 50% T > MIC in at least 95% of the patients (see section 4.2).
Za doseganje ciljne vrednosti 50% T > MIC pri najmanj 95% bolnikov je pri resno bolnih ali bolnikih z oslabljenim imunskim odzivom dajanje 4- urnih infuzij lahko primernejše, kadar je, oziroma je pričakovano, da je, MIC doripenema za znanega ali domnevnega patogena/ patogenov > 0, 5 mg/ l (glejte poglavje 4. 2).
Monte Carlo simulations supported the use of 500 mg 4-hour infusions every 8 hours in subjects with normal renal function for target pathogens with doripenem MICs ≤ 4 mg/l.
Simulacije Monte Carlo govorijo v prid uporabi 500 mg odmerka doripenema v 4- urni infuziji na 8 ur pri preiskovancih z normalnim delovanjem ledvic za ciljne patogene z vrednostmi MIC doripenema ≤ 4 mg/ l.
Mechanisms of resistance Bacterial resistance mechanisms that effect doripenem include active substance inactivation by carbapenem-hydrolyzing enzymes, mutant or acquired PBP’s, decreased outer membrane permeability and active efflux.
Mehanizmi rezistence na antibiotike Med mehanizme bakterijske rezistence na doripenem sodijo inaktivacija zdravilne učinkovine z encimi, ki povzročajo hidrolizo karbapenemov, mutirani ali pridobljeni vezavni proteini za peniciline (PBP), zmanjšanje prepustnosti zunanje membrane in izločanje z aktivnim transportom.
Doripenem is stable to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by gram-positive and gram-negative bacteria, with the exception of relatively rare carbapenem hydrolyzing beta-lactamases.
Doripenem je odporen na hidrolizo z večino betalaktamaz, vključno s penicilinazami in cefalosporinazami, ki jih izdelujejo gram- pozitivne in gram- negativne bakterije, z izjemo razmeroma redkih betalaktamaz, ki hidrolizirajo karbapeneme.
Breakpoints Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Mejne vrednosti Mejne vrednosti minimalne inhibitorne koncentracije (MIC), ki jih je določil Evropski odbor za testiranje občutljivosti na antibiotike (European Committee on Antimicrobial Susceptibility Testing - EUCAST), so naslednje:
S ≤1 mg/l and R > 4 mg/l inferred from the methicillin breakpoint
S ≤ 1 mg/ l in R > 4 mg/ l Neodvisne od vrste Stafilokoki Enterobacteriaceae Acinetobacter spp.
Streptococcus spp. other than S. pneumoniae S. pneumoniae Enterococci Haemophilus spp.
Streptococcus spp. z izjemo S. pneumoniae S. pneumoniae
S ≤1 mg/l and R > 4 mg/l S ≤1 mg/l and R > 4 mg/l S ≤1 mg/l and R > 4 mg/l S ≤1 mg/l and R > 1 mg/l S ≤ 1 mg/l and R > 1 mg/l “inappropriate target” S ≤ 1 mg/l and R > 1 mg/l IE (insufficient evidence) S ≤1 mg/l and R > 1 mg/l
na osnovi mejne vrednosti meticilina S ≤ 1 mg/ l in R > 4 mg/ l S ≤ 1 mg/ l in R > 4 mg/ l S ≤ 1 mg/ l in R > 4 mg/ l S ≤ 1 mg/ l in R > 1 mg/ l S ≤ 1 mg/ l in R > 1 mg/ l
with time for selected species and
Enterokoki Haemophilus spp.
local information on resistance is desirable, particularly when treating severe infections.
“ neobčutljivi ” S ≤ 1 mg/ l and R > 1 mg/ l
6 Commonly Susceptible Species:
6
Gram Positive Aerobes Enterococcus faecalis*$ Staphylococcus aureus (methicillin susceptible strains only)*^ Staphylococcus spp.
Gram- pozitivni aerobi Enterococcus faecalis* $Staphylococcus aureus (samo za meticilin občutljivi sevi) * ^ Staphylococcus spp.
(methicillin susceptible strains only)^ Streptococcus pneumoniae* Streptococcus spp.
(samo za meticilin občutljivi sevi) ^ Streptococcus pneumoniae * Streptococcus spp.
Gram Negative Aerobes Citrobacter diversus Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae* Haemophilus influenzae* Escherichia coli Klebsiella pneumoniae* Klebsiella oxytoca Morganella morganii Proteus mirabilis* Proteus vulgaris Providencia rettgeri Providencia stuartii Salmonella species Serratia marcescens Shigella species
Serratia marcescens Shigella spp.
Anaerobes Bacteroides fragilis* Bacteroides caccae* Bacteroides ovatus Bacteroides uniformis* Bacteroides thetaiotaomicron* Bacteroides vulgatus* Bilophila wadsworthia Peptostreptococcus magnus Peptostreptococcus micros* Porphyromonas spp.
Anaerobi Bacteroides fragilis * Bacteroides caccae * Bacteroides ovatus Bacteroides uniformis * Bacteroides thetaiotaomicron * Bacteroides vulgatus * Bilophilora wadsworthia Peptostreptococcus magnus Peptostreptococcus micros * Porphyromonas spp.
Acinetobacter baumannii* Acinetobacter spp.
Acinetobacter baumannii *
7 5.2 Pharmacokinetic properties
7 Acinetobacter spp.
The mean Cmax and AUC0-∞ of doripenem in healthy subjects across studies following administration of 500 mg over 1 hour are approximately 23 µg/ml and 36 µg.h/ml, respectively.
Srednje vrednosti Cmax in AUC0- ∞ za doripenem pri zdravih preiskovancih v različnih študijah po dajanju 500 mg odmerka v času 1 ure so bile približno 23 µg/ ml in 36 µgh/ ml.
The mean Cmax and AUC0-∞ of doripenem in healthy subjects across studies following administration of 500 mg and 1 g over 4 hours are approximately 8 µg/ml and 17 µg/ml, and 34 µg.h/ml and 68 µg.h/ml, respectively.
Srednje vrednosti Cmax in AUC0- ∞ za doripenem pri zdravih preiskovancih v različnih študijah po dajanju odmerka 500 mg oziroma 1 g v času 4 ur znašajo približno 8 µg/ ml in 17 µg/ ml oziroma 34 µgh/ ml in 68 µgh/ ml.
There is no accumulation of doripenem following multiple intravenous infusions of either 500 mg or 1 g administered every 8 hours for 7 to 10 days in patients with normal renal function.
Po večkratnih intravenskih infuzijah doripenema v odmerku bodisi 500 mg ali 1 g na 8 ur v času 7 do 10 dni pri bolnikih z normalnim delovanjem ledvic ni prišlo do kopičenja zdravila v telesu.
Distribution The average binding of doripenem to plasma proteins was approximately 8.1% and is independent of plasma concentrations.
Porazdelitev Povprečna stopnja vezave doripenema na plazemske beljakovine znaša približno 8, 1% in ni odvisna od njegove plazemske koncentracije.
The volume of distribution at steady state is approximately 16.8 L, similar to extracellular fluid volume in man.
Porazdelitveni volumen zdravila v stanju dinamičnega ravnovesja je približno 16, 8 l, kar je podobno volumnu zunajcelične tekočine pri človeku.
Metabolism Metabolism of doripenem to a microbiologically inactive ring-opened metabolite occurs primarily via dehydropeptidase-I.
Presnova Presnova doripenema do mikrobiološko neaktivnega presnovka z odprtim obročem poteka predvsem s pomočjo encima dehidropeptidaze- I.
Elimination Doripenem is primarily eliminated unchanged by the kidneys.
Izločanje Doripenem se izloča predvsem v nespremenjeni obliki preko ledvic.
Mean plasma terminal elimination half- life of doripenem in healthy young adults is approximately 1-hour and plasma clearance is approximately 15.9 l/hour.
Srednja končna plazemska razpolovna doba izločanja doripenema pri zdravih mladih odraslih znaša približno 1 uro, njegov plazemski očistek pa je približno 15, 9 l/ uro.
Mean renal clearance is 10.3 l/hour.
Srednji ledvični očistek doripenema znaša 10, 3 l/ uro.
The magnitude of this value, coupled with the significant decrease in the elimination of doripenem seen with concomitant probenecid administration, suggests that doripenem undergoes glomerular filtration, tubular secretion and re- absorption.
Velikost te vrednosti ter pomembno zmanjšanje izločanja doripenema, ki so ga opazili pri sočasni uporabi probenecida, kažeta, da se doripenem izloča z glomerulno filtracijo, s tubulno sekrecijo in se tudi reabsorbira.
In healthy young adults given a single 500 mg dose of Doribax, 71% and 15% of the dose was recovered in urine as unchanged active substance and ring-opened metabolite, respectively.
Pri zdravih mladih odraslih, ki so prejeli enkraten 500 mg odmerek zdravila Doribax, so v seču izmerili 71% odmerka v obliki nespremenjene učinkovine in 15% odmerka v obliki presnovka z odprtim obročem.
Following the administration of a single 500 mg dose of radiolabeled doripenem to healthy young adults, less than 1% of the total radioactivity was recovered in faeces.
Po aplikaciji enkratnega 500 mg odmerka radioaktivno označenega doripenema zdravim mladim odraslim so v blatu našli manj kot 1% skupne radioaktivnosti.
The pharmacokinetics of doripenem are linear over a dose range of 500 mg to 1 g when intravenously infused over either 1 or 4 hours.
Farmakokinetika doripenema po intravenskem infundiranju odmerkov od 500 mg do 1 g v obdobju 1 ali 4 ur je linearna.
Renal Insufficiency Following a single 500 mg dose of Doribax, doripenem AUC increased 1.6-fold, 2.8-fold, and 5.1-fold in subjects with mild (CrCl 51-79 ml/min), moderate (CrCl 31-50 ml/min), and severe renal impairment (CrCl ≤ 30 ml/min), respectively, compared to age-matched healthy subjects with normal renal function (CrCl > 80 ml/min).
Ledvična insuficienca Po enkratnem odmerku 500 mg zdravila Doribax se je pri preiskovancih z blago ledvično okvaro (CrCl 51- 79 ml/ min) vrednost AUC doripenema povečala za 1, 6- krat, pri tistih z zmerno ledvično okvaro (CrCl 31- 50 ml/ min) za 2, 8- krat in pri tistih s hudo ledvično okvaro (CrCl ≤ 30 ml/ min) za 5, 1- krat v primerjavi z enako starimi zdravimi preiskovanci, ki so imeli normalno delovanje ledvic (CrCl > 80 ml/ min).
AUC of the microbiologically inactive ring-opened metabolite is expected to be considerably increased in patients with severe renal impairment compared with healthy subjects.
V primerjavi z zdravimi preiskovanci je pri bolnikih s hudo ledvično okvaro 8 pričakovano znatno zvišanje AUC mikrobiološko neaktivnega presnovka z odprtim obročem.
Dosage adjustment is necessary in patients with moderate and severe renal impairment (see section 4.2).
Pri bolnikih z zmerno in hudo ledvično okvaro je potrebna prilagoditev odmerjanja (glejte poglavje 4. 2).
AUCs of doripenem and of the microbiologically inactive ring-opened metabolite are substantially increased in patients who require haemodialysis compared with healthy subjects.
Vrednost AUC za doripenem in njegov mikrobiološko neaktiven presnovek z odprtim obročem je zelo povečana pri bolnikih, ki potrebujejo hemodializo, glede na zdrave preiskovance.
In a study where six subjects with end stage renal disease on haemodialysis received a single dose of 500 mg doripenem by i.v. infusion, the amount of doripenem removed during the four-hour haemodialysis session was 231 mg (46% of the dose).
V študiji, v kateri je šest preiskovancev v zadnjem stadiju ledvične bolezni na hemodializi prejelo en 500 mg odmerek doripenema z intravensko infuzijo, je količina doripenema, odstranjena med štiriurno hemodializo, znašala 231 mg (46% odmerka).
Hepatic Impairment The pharmacokinetics of doripenem in patients with hepatic impairment have not been established.
Jetrna okvara Pri bolnikih z jetrno okvaro niso preučili farmakokinetike doripenema.
As doripenem does not appear to undergo hepatic metabolism, the pharmacokinetics of Doribax are not expected to be affected by hepatic impairment.
Ker je videti, da se doripenem ne presnavlja v jetrih, ni pričakovati, da bi jetrna okvara vplivala na farmakokinetiko zdravila Doribax.
8 Elderly The impact of age on the pharmacokinetics of doripenem was evaluated in healthy elderly male and female subjects (66-84 years of age).
Starostniki Vpliv starosti na farmakokinetiko doripenema so ocenili pri zdravih starejših moških in ženskah (starih od 66 do 84 let).
Doripenem AUC increased 49% in elderly adults relative to young adults.
Vrednost AUC za doripenem pri starejših odraslih je bila za 49% višja kot pri mlajših odraslih.
No dosage adjustment is necessary in elderly patients, except in cases of moderate to severe renal insufficiency (see section 4.2).
Pri starostnikih prilagoditev odmerka ni potrebna, razen v primeru zmerne do hude ledvične insuficience (glejte poglavje 4. 2).
Gender The effect of gender on the pharmacokinetics of doripenem was evaluated in healthy male and female subjects.
Spol Vpliv spola na farmakokinetiko doripenema so ocenili pri zdravih moških in ženskah.
No dose adjustment is recommended based on gender.
Vrednost AUC za doripenem je bila za 15% višja pri ženskah kot pri moških, vendar prilagoditev odmerka zdravila glede na spol ni priporočena.
Race The effect of race on doripenem pharmacokinetics was examined through a population pharmacokinetic analysis.
Rasa Vpliv rase na farmakokinetiko doripenema so proučevali z analizo populacijske farmakokinetike.
No significant difference in mean doripenem clearance was observed across race groups and therefore, no dosage adjustment is recommended for race.
Med posameznimi rasnimi skupinami niso opazili značilnih razlik v srednjem očistku doripenema, zato prilagoditev odmerka zdravila glede na raso ni priporočena.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakologije varnosti in genotoksičnosti ne kažejo posebnega tveganja za človeka.
However, these studies are of limited relevance because studies were performed with single daily dosing resulting in less than one tenth of daily doripenem exposure duration in animals.
Vendar je pomen teh šudij omejen, ker so bile izvedene z enkrat dnevnim odmerjanjem, zaradi česar je bilo trajanje dnevne izpostavljenosti doripenemu pri živalih manjše kot ena desetina.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3.
Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6. 3.
Storage of reconstituted solutions:
9 Shranjevanje rekonstituiranih raztopin:
Upon reconstitution with sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, Doribax suspension in the vial may be held for up to 1 hour below 30°C prior to transfer and dilution in the infusion bag.
Po rekonstituciji zdravila s sterilno vodo za injekcije ali 9 mg/ ml (0, 9%) raztopino natrijevega klorida za injiciranje lahko suspenzijo zdravila Doribax pustite stati v viali do 1 uro pri temperaturi do 30°C, preden jo prenesete v infuzijsko vrečko in jo s tem razredčite.
Following dilution in the infusion bag with sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection, Doribax infusions stored at controlled room temperature or under refrigeration should be completed according to the times in the following table:
Po redčenju v infuzijski vrečki z 9 mg/ ml (0, 9%) raztopino natrijevega klorida za injiciranje ali s 50 mg/ ml (5%) raztopino dekstroze za injiciranje je treba infuzije zdravila Doribax, ki so bile hranjene pri nadzorovani sobni temperaturi ali v hladilniku, uporabiti z upoštevanjem časov iz spodnje preglednice:
9 Time by which reconstitution, dilution and infusion must complete for Doribax infusion solutions
Čas, v katerem je treba končati rekonstitucijo, redčenje in infundiranje infuzijskih raztopin zdravila Doribax
Solution stored at
Raztopina, shranjena pri sobni temperaturi
Solution stored in a
Raztopina, shranjena v hladilniku (2°C- 8°C)
sodium chloride 9 mg/ml (0.9%) solution for injection +
9 mg/ ml (0, 9%) raztopina natrijevega klorida za injiciranje +
temperature 12 hours
12 ur
refrigerator (2°C-8°C) 72 hours*
72 ur *
dextrose 50 mg/ml (5%) solution for injection
50 mg/ ml (5%) raztopina dekstroze za injiciranje
24 hours *
24 ur *
* Once removed from the refrigerator, infusions should be completed within the room temperature stability time, provided the total refrigeration time, time to reach room temperature and infusion time does not exceed refrigeration stability time. + Dextrose 50 mg/ml (5%) solution for injection should not be used for infusion durations greater than 1 hour.
* Ko jih enkrat vzamete iz hladilnika, je treba infuzijske raztopine uporabiti v času stabilnosti pri sobni temperaturi, tako da seštevek časa shranjevanja v hladilniku, časa do doseganja sobne temperature in časa infundiranja zdravila ne bo presegel časa stabilnosti zdravila v hladilniku. + Če infundiranje traja dlje kot 1 uro, se 50 mg/ ml (5%) raztopine dekstroze za injiciranje ne sme uporabljati.
Chemical and physical in-use stability has been demonstrated for the times and solutions shown in the above Table.
Kemična in fizikalna stabilnost zdravila med uporabo je bila dokazana za čas in vrste raztopin, ki so navedene v zgornji preglednici.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, je za čas shranjevanja med uporabo in pogoje shranjevanja pred uporabo odgovoren uporabnik in običajno ne bi smeli preseči 24 ur pri temperaturi med 2°C in 8°C, razen če sta rekonstitucija oz. redčenje potekala v nadzorovanih in validiranih aseptičnih pogojih.
For storage conditions of the reconstituted medicinal product, and infusion solutions see section 6.3.
Za pogoje shranjevanja rekonstituiranega zdravila in infuzijskih raztopin glejte poglavje 6. 3.
Clear 20 ml Type I glass vial.
20 ml viale iz prozornega stekla tipa I.
Preparation of 500 mg dose of solution for infusion 1.
Priprava 500 mg odmerka raztopine za infundiranje 1.
Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to the vial and shake it to form a suspension.
Dodajte 10 ml sterilne vode za injekcije ali 10 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje v vialo in jo stresite, da bo nastala suspenzija.
Note: the suspension is not for direct infusion.
Suspenzija ni namenjena 10 neposrednemu infundiranju.
Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 100 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection and mix to complete dissolution.
Suspenzijo potegnite v brizgo z iglo in jo injicirajte v infuzijsko vrečko, ki vsebuje bodisi 100 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali 100 ml 50 mg/ ml (5%) raztopine dekstroze za injiciranje in zmešajte, da se zaključi proces raztapljanja.
Inspect the suspension visually for foreign matter.
Opomba:
Note: the suspension is not for direct infusion.
Suspenzija ni namenjena neposrednemu infundiranju.
Remove 55 ml of this solution from the
Suspenzijo posesajte v brizgo z iglo in jo injicirajte v infuzijsko vrečko, ki vsebuje bodisi 100 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali pa 100 ml 50 mg/ ml (5%) raztopine dekstroze za injiciranje in zmešajte, da se zaključi proces raztapljanja.
Infuse all of the remaining solution to administer a 250 mg dose of doripenem.
Vzemite 55 ml te raztopine iz infuzijske vrečke in jo zavržite, vso preostalo raztopino pa infundirajte bolniku, da bo dobil 250 mg odmerek doripenema.
Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg, 30 B- 2340 Beerse Belgija
{MM/YYYY}
{MM/ LLLL}
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
Turnhoutseweg 30 B-2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg, 30 B- 2340 Beerse Belgija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in the version dated 10 May 2007 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 je sistem farmakovigilance kot je opisan v različici z dne 10. maja 2007, predstavljeni v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da 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 3 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 obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v 3. različici načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (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 CHMP smernicami za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini je treba posodobljen RMP predložiti skupaj z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).