natgillin/translations-raw huggingface dataset:
De bivirkninger, som førte til seponering af Doribax, var kvalme (0, 1%), diaré (0, 1%), pruritus (0, 1%), svampeinfektion i vulva (0, 1%), forhøjelse af leverenzymer (0, 2%) og udslæt (0, 2%).
Adverse drug reactions that led to Doribax discontinuation were nausea (0.1%), diarrhoea (0.1%), pruritus (0.1%), vulvomycotic infection (0.1%), hepatic enzyme increased (0.2%) and rash (0.2%).
De mest almindelige bivirkninger var hovedpine (10%), diaré (9%) og kvalme (8%).
The most common adverse reactions were headache (10%), diarrhoea (9%) and nausea (8%).
Bivirkningerne på grund af Doribax 500 mg er anført nedenfor efter frekvenskategori.
Adverse drug reactions due to Doribax 500 mg are listed below by frequency category.
Frekvenskategorierne er defineret som følger: meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100 til < 1/ 10), ikke almindelig (≥ 1/ 1. 000 til < 1/ 100).
Very common (≥ 1/10); Common (≥1/100 to < 1/10); Uncommon (≥1/1,000 to < 1/100).
Inden for hver frekvensgruppe angives bivirkningerne i faldende rækkefølge efter sværhedsgrad.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Bivirkninger identificeret under kliniske forsøg med Doribax Infektioner og parasitære sygdomme
Adverse Drug Reactions Identified During Clinical Trials with Doribax Infections and infestation Immune system disorders Nervous system disorders Vascular disorders Gastrointestinal disorders
Almindelig: candidiasis oris, svampeinfektion i vulva
C. difficile colitis (see section 4.4)
Immunsystemet Nervesystemet Vaskulære sygdomme Mave- tarm- kanalen
Hepato-biliary disorders Skin and subcutaneous tissue disorders
Ikke almindelig: overfølsomhedsreaktioner (se pkt.
Common: hepatic enzyme increased Common: pruritus, rash
Lever og galdeveje Hud og subkutane væv
Adverse Drug Reactions Identified During Post-marketing Experience with Doribax Blood and the lymphatic system disorders
Almindelig: forhøjelse af leverenzymer Almindelig: pruritus, udslæt
Frequency not known: neutropenia
Bivirkninger identificeret efter markedsføring af Doribax Blod og lymfesystem Immunsystemet
Immune system disorders
4. 4)
Frequency not known: anaphylaxis (see section 4.4)
I tilfælde af overdosering skal Doribax seponeres, og generel understøttende behandling bør gives, indtil renal eliminering finder sted.
In the event of overdose, Doribax should be discontinued and general supportive treatment given until renal elimination takes place.
5. 2), men der findes ingen information om brug af hæmodialyse til behandling af overdosering.
Doribax can be removed by haemodialysis (see section 5.2); however, no information is available on the use of haemodialysis to treat overdose.
Farmakoterapeutisk klassifikation: carbapenemer.
Pharmacotherapeutic group:
ATC- kode:
Carbapenems, ATC code:
Virkningsmåde Doripenem er et syntetisk carbapenemantibiotikum.
Mode of action Doripenem is a synthetic carbapenem antibacterial agent.
5 In vitro- forsøg med doripenem viser et ringe potentiale for at antagonisere eller blive antagoniseret af andre antibiotika.
In vitro doripenem showed little potential to antagonize or be antagonized by other antibacterial agents.
Der er set additiv aktivitet over for eller svag synergi med amikacin og levofloxacin for Pseudomonas aeruginosa og for grampositive bakterier med daptomycin, linezolid, levofloxacin og vancomycin.
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.
Sammenhæng mellem farmakokinetik/ farmakodynamik Ligesom for andre betalaktamantibiotika er det påvist, at den tid hvori doripenems plasmakoncentration overskrider infektionsorganismens MIC (% T > MIC), bedst korrelerer med effekten i prækliniske farmakokinetiske/ farmakodynamiske (PK/ PD) forsøg.
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.
For alle grader af nyrefunktion indikerer Monte Carlo- simuleringer med patogenfølsomhedsresultater fra afsluttede fase III- forsøg og farmakokinetiske populationsdata, at% T > MIC- målet på 35% blev nået hos mere end 90% af patienter med nosokomiel pneumoni, komplicerede urinvejsinfektioner og komplicerede intraabdominale infektioner.
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.
Hvis infusionstiden for Doribax forlænges til 4 timer, maksimeres% T > MIC for en given dosis, og dette danner grundlaget for muligheden om at indgive infusioner med en varighed på 4 timer til patienter med nosokomiel pneumoni herunder respiratorassocieret pneumoni.
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.
4. 2).
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).
Monte Carlo- simuleringer understøttede anvendelsen af infusion med 500 mg i 4 timer hver 8. time til patienter med normal nyrefunktion for målpatogener med MIC- værdier for doripenem på ≤ 4 mg/ l.
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.
Resistensmekanismer De bakterielle resistensmekanismer, der påvirker doripenem, omfatter inaktivering af det aktive stof forårsaget af carbapenemhydroliserende enzymer, muterede eller erhvervede PBP' er, reduceret ydre membranpermeabilitet og aktivt effluks.
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.
Doripenem er stabilt over for hydrolyse forårsaget af de fleste betalaktamaser, bl. a. penicillinaser og cefalosporinaser produceret af grampositive og gramnegative bakterier, bortset fra relativt sjældne carbapenemhydrolyserende betalaktamaser.
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.
Som det kendes fra andre antibiotika, bl. a. carbapenem, har doripenem vist sig at selektere for resistente bakteriestammer.
As with other antimicrobial agents, including carbapenems, doripenem has been shown to select for resistant bacterial strains.
Følsomhedsgrænser Følsomhedsgrænserne for minimal inhibitorisk koncentration (MIC) fastsat af Den Europæiske Referencekomité EUCAST (European Committee on Antimicrobial Susceptibility Testing) er følgende:
Breakpoints Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Ikke stammerelaterede Staphylococci methicillin
Non species related Staphylococci
S ≤ 1 mg/ l og R > 4 mg/ l udledt af følsomhedsgrænsen for
S ≤1 mg/l and R > 4 mg/l inferred from the methicillin breakpoint
Streptococcus spp. bortset fra S. pneumoniae S. pneumoniae Enterococci Haemophilus spp.
Streptococcus spp. other than S. pneumoniae S. pneumoniae Enterococci Haemophilus spp.
N. gonorrhoeae Anaerobe
N. gonorrhoeae Anaerobes
S ≤ 1 mg/ l og R > 4 mg/ l S ≤ 1 mg/ l og R > 4 mg/ l S ≤ 1 mg/ l og R > 4 mg/ l S ≤ 1 mg/ l og R > 1 mg/ l S ≤ 1 mg/ l og R > 1 mg/ l ” uegnende målværdier ” S ≤ 1 mg/ l og R > 1 mg/ l Utilstrækkelig evidens S ≤ 1 mg/ l og R > 1 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 > 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
6 Følsomhed Prævalensen af erhvervet resistens kan variere geografisk og med tid for udvalgte arter, og lokal information om resistens anbefales, især i tilfælde af alvorlige infektioner.
local information on resistance is desirable, particularly when treating severe infections.
Ekspertrådgivning bør søges efter behov, når den lokale resistensprævalens er af en sådan karakter, at stoffets nytte ved mindst nogle af infektionstyperne er tvivlsom.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Der er i Den Europæiske Union rapporteret om lokaliserede infektionsophobninger grundet carbapenemresistente organismer.
Localized clusters of infections due to carbapenem-resistant organisms have been reported in the European Union.
Almindeligvis følsomme arter:
6 Commonly Susceptible Species:
Grampositive aerobe Enterococcus faecalis* $Staphylococcus aureus (kun methicillinfølsomme stammer) * ^ Staphylococcus spp.
Gram Positive Aerobes Enterococcus faecalis*$ Staphylococcus aureus (methicillin susceptible strains only)*^ Staphylococcus spp.
(kun methicillinfølsomme stammer) ^ Streptococcus pneumoniae * Streptococcus spp.
(methicillin susceptible strains only)^ Streptococcus pneumoniae* Streptococcus spp.
Gramnegative aerobe 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- arter Serratia marcescens Shigella- arter
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
Anaerobe Bacteroides fragilis * Bacteroides caccae * Bacteroides ovatus Bacteroides uniformis * Bacteroides thetaiotaomicron * Bacteroides vulgatus * Bilophila wadsworthia Peptostreptococcus magnus Peptostreptococcus micros * Porphyromonas spp.
Anaerobes Bacteroides fragilis* Bacteroides caccae* Bacteroides ovatus Bacteroides uniformis* Bacteroides thetaiotaomicron* Bacteroides vulgatus* Bilophila wadsworthia Peptostreptococcus magnus Peptostreptococcus micros* Porphyromonas spp.
7 Naturligt resistente organismer:
7 5.2 Pharmacokinetic properties
23 µg/ ml og 36 µg. h/ ml.
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.
8 µg/ ml og 17 µg/ ml og henholdsvis 34 µg. h/ ml og 68 µg. h/ 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.
Der er ingen akkumulation af doripenem efter flere intravenøse infusioner af enten 500 mg eller 1 g indgivet hver ottende time i 7- 10 dage til patienter med normal nyrefunktion.
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.
Fordeling Den gennemsnitlige binding af doripenem til plasmaproteiner var ca.
Distribution The average binding of doripenem to plasma proteins was approximately 8.1% and is independent of plasma concentrations.
Fordelingsvolumen ved steady state er ca.
The volume of distribution at steady state is approximately 16.8 L, similar to extracellular fluid volume in man.
Doripenem trænger langt ind i flere kropsvæsker og væv, f. eks. livmodervæv, retroperitonealvæske, prostatavæv, galdeblærevæv og urin.
Doripenem penetrates well into several body fluids and tissues, such as uterine tissue, retroperitoneal fluid, prostatic tissue, gallbladder tissue and urine.
Metabolisme Doripenem metaboliseres til en mikrobiologisk inaktiv ringåbnet metabolit hovedsagelig via dehydropeptidase- I.
Metabolism Metabolism of doripenem to a microbiologically inactive ring-opened metabolite occurs primarily via dehydropeptidase-I.
Det er i in vitro- forsøg påvist, at doripenem ikke inhiberer eller inducerer aktivitet i CYP- isoformerne 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 eller 3A4.
In vitro studies have determined that doripenem does not inhibit or induce the activities of CYP isoforms 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 or 3A4.
Eliminering Doripenem elimineres hovedsagelig uforandret gennem nyrerne.
Elimination Doripenem is primarily eliminated unchanged by the kidneys.
15, 9 l/ time.
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.
Gennemsnitlig renal clearance er 10, 3 l/ time.
Mean renal clearance is 10.3 l/hour.
Størrelsen af denne værdi sammen med det signifikante fald i elimineringen af doripenem, som ses ved samtidig indgift af probenecid, tyder på, at doripenem gennemgår glomerulær filtration, tubulær sekretion og reabsorption.
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.
Hos raske unge voksne, som fik en enkelt dosis på 500 mg Doribax, blev 71% og 15% af dosis udskilt med urinen som henholdsvis uforandret aktivt stof og ringåbnet metabolit.
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.
Efter indgift af en enkelt dosis på 500 mg radioaktivt mærket doripenem til raske unge voksne blev mindre end 1% af den samlede radioaktivitet udskilt med fæces.
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.
Doripenems farmakokinetik er lineær over et dosisområde på 500 mg til 1 g ved intravenøs infusion over 1 eller 4 timer.
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.
Nedsat nyrefunktion Efter en enkelt dosis på 500 mg Doribax steg AUC for doripenem 1, 6- gange, 2, 8- gange og 5, 1- gange hos forsøgspersoner med henholdsvis let (CrCl 51- 79 ml/ min), moderat (CrCl 31- 50 ml/ min) og svært nedsat nyrefunktion (CrCl ≤ 30 ml/ min) sammenlignet med raske forsøgspersoner i samme aldersgruppe med normal nyrefunktion (CrCl > 80 ml/ min).
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).
AUC for den mikrobiologisk inaktive ringåbnede metabolit forventes at være betydelig forhøjet hos patienter med svært nedsat nyrefunktion sammenlignet med patienter med en normal nyrefunktion.
AUC of the microbiologically inactive ring-opened metabolite is expected to be considerably increased in patients with severe renal impairment compared with healthy subjects.
4. 2).
Dosage adjustment is necessary in patients with moderate and severe renal impairment (see section 4.2).
8 AUC for doripenem og for den mikrobiologisk inaktive ringåbnede metabolit er væsentligt forhøjet hos patienter, som har behov for hæmodialyse, i forhold til hos raske forsøgspersoner.
AUCs of doripenem and of the microbiologically inactive ring-opened metabolite are substantially increased in patients who require haemodialysis compared with healthy subjects.
I et forsøg, hvor seks hæmodialysepatienter med terminal nyresygdom fik en enkelt dosis på 500 mg doripenem ved intravenøs infusion, blev der elimineret 231 mg doripenem (46% af dosis) i løbet af hæmodialysen på 4 timer.
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).
Nedsat leverfunktion Doripenems farmakokinetik hos patienter med nedsat leverfunktion er ikke fastsat.
Hepatic Impairment The pharmacokinetics of doripenem in patients with hepatic impairment have not been established.
Eftersom doripenem ikke synes at blive metaboliseret i leveren, forventes Doribax 'farmakokinetik ikke at være påvirket af nedsat leverfunktion.
As doripenem does not appear to undergo hepatic metabolism, the pharmacokinetics of Doribax are not expected to be affected by hepatic impairment.
Ældre Alderens betydning for doripenems farmakokinetik blev evalueret hos ældre forsøgspersoner af begge køn (66- 84 år).
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).
Doripenems AUC var 49% højere hos ældre voksne end hos unge voksne.
Doripenem AUC increased 49% in elderly adults relative to young adults.
Disse forandringer blev hovedsagelig tillagt aldersrelaterede forandringer i nyrefunktionen.
These changes were mainly attributed to age-related changes in renal function.
4. 2).
No dosage adjustment is necessary in elderly patients, except in cases of moderate to severe renal insufficiency (see section 4.2).
Køn Kønnets betydning for doripenems farmakokinetik blev evalueret hos raske forsøgspersoner af begge køn.
Gender The effect of gender on the pharmacokinetics of doripenem was evaluated in healthy male and female subjects.
Doripenems AUC var 15% højere hos kvinder end hos mænd.
Doripenem AUC was 15% higher in females compared to males.
Race Racens betydning for doripenems farmakokinetik blev undersøgt i en farmakokinetisk populationsanalyse.
Race The effect of race on doripenem pharmacokinetics was examined through a population pharmacokinetic analysis.
Der blev ikke observeret nogen signifikant forskel i gennemsnitlig doripenem - clearance på tværs af racegrupper, og der kræves derfor ingen dosisjustering på baggrund af race.
No significant difference in mean doripenem clearance was observed across race groups and therefore, no dosage adjustment is recommended for race.
Ikke- kliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi og genotoksicitet.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and genotoxicity.
Kontinuerlig brug hos dyr blev ikke afdækket i disse forsøg på grund af forsøgsdesignet for toksicitet efter gentagne doser samt de farmakokinetiske forskelle i dyr og mennesker.
However, because of the design of the repeat dose toxicity studies and differences in pharmacokinetics in animals and humans, continuous exposure of animals was not assured in these studies.
Der blev ikke observeret nogle reproduktionstoksicitet i forsøg udført i rotter og kaniner.
No reproductive toxicity was observed in studies performed in rats and rabbits.
Relevansen af disse forsøg er dog begrænset, fordi forsøgene blev udført med dosering én gang daglig, hvilket er mindre end en tiendedel af varigheden af den daglige doripenemeksponering i dyr.
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.
6. 3.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3.
9 Opbevaringstid for rekonstituerede opløsninger:
Storage of reconstituted solutions:
Efter rekonstitution med sterilt vand til injektion eller 9 mg/ ml natriumchloridopløsning til injektion (0, 9%) kan Doribax- infusionsvæsken i hætteglasset opbevares i op til 1 time under 30°C før overførsel til og fortynding i infusionsposen.
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.
Efter fortynding i infusionsposen med 9 mg/ ml natriumchloridopløsning til injektion (0, 9%) eller 50 mg/ ml dextroseopløsning til injektion (5%) skal Doribax- infusionsvæske, som opbevares ved kontrolleret stuetemperatur eller i køleskab, indgives i henhold til følgende skema:
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:
Tidsfrister, inden for hvilke rekonstitution, fortynding og infusion skal finde sted for Doribax infusionsvæske, opløsning
9 Time by which reconstitution, dilution and infusion must complete for Doribax infusion solutions
Opløsning opbevaret ved stuetemperatur
Solution stored at
Opløsning opbevaret i køleskab (2- 8°C)
Solution stored in a
9 mg/ ml natriumchloridopløsning til injektion (0, 9%) +
sodium chloride 9 mg/ml (0.9%) solution for injection +
12 timer
temperature 12 hours
72 timer *
refrigerator (2°C-8°C) 72 hours*
50 mg/ ml dextroseopløsning til injektion (5%)
dextrose 50 mg/ml (5%) solution for injection
24 timer *
24 hours *
opbevaring ved stuetemperatur, forudsat at den samlede opbevaringstid i køleskab, tiden til temperering til stuetemperatur og infusionstiden ikke overskrider holdbarhedstiden for opbevaring i køleskab. + 50 mg/ ml dextroseopløsning til injektion (5%) bør ikke bruges til infusioner af varighed på mere end 1 time.
* 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.
Kemisk og fysisk holdbarhed under brug er påvist for de tidsperioder og opløsninger, der er anført i ovenstående tabel.
Chemical and physical in-use stability has been demonstrated for the times and solutions shown in the above Table.
Hvis produktet ikke anvendes straks, er opbevaringstiden og - betingelserne inden anvendelse brugerens ansvar og bør ikke være over 24 timer ved 2- 8°C, medmindre rekonstitution/ fortynding er foretaget under kontrollerede og validerede aseptiske forhold.
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.
6. 3.
For storage conditions of the reconstituted medicinal product, and infusion solutions see section 6.3.
Hætteglas af klart glas på 20 ml (Type I).
Clear 20 ml Type I glass vial.
Lægemidlet leveres i æsker med 10 hætteglas.
The medicinal product is supplied in cartons containing 10 vials.
Klargøring af dosis på 500 mg infusionsvæske, opløsning 1.
Preparation of 500 mg dose of solution for infusion 1.
Tilsæt 10 ml sterilt vand til injektion eller 9 mg/ ml natriumchloridopløsning til injektion (0, 9%) i hætteglasset, og ryst det, til der dannes en suspension.
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.