natgillin/translations-raw huggingface dataset:
The pharmacokinetics of dexmedetomidine in subjects with severe renal impairment (creatinine clearance <30 ml/min) is not altered relative to healthy subjects.
Farmakokinetika deksmedetomidina pri preiskovancih s hudo ledvično okvaro (očistek kreatinina
N
Starost n
Each 2 ml ampoule contains 200 micrograms of dexmedetomidine.
Ena 2 ml ampula vsebuje 200 mikrogramov deksmedetomidina.
Nausea2, vomiting, dry mouth2 Uncommon: Abdominal distension
navzea2, bruhanje, suha usta2
Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride).
Ena 4 ml viala vsebuje 400 mikrogramov deksmedetomidina (v obliki klorida).
NAME OF THE MEDICINAL PRODUCT Dexdor 100 micrograms/ml concentrate for solution for infusion
IME ZDRAVILA Dexdor 100 mikrogramov/ml koncentrat za raztopino za infundiranje
Symptoms
halucinacije
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
NAVEDBA ENE ALI VEČ UČINKOVIN En ml koncentrata vsebuje deksmedetomidinijev klorid v količini, ki ustreza 100 mikrogramom deksmedetomidina.
Dexdor should be used immediately after dilution.
Po redčenju je treba raztopino uporabiti takoj.
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Dexdor 100 micrograms/ml sterile concentrate dexmedetomidine
IME ZDRAVILA IN POT(I) UPORABE Dexdor 100 µg/ml sterilen koncentrat deksmedetomidin i.v.
Dexdor 100 micrograms/ml concentrate for solution for infusion Dexmedetomidine
Dexdor 100 mikrogramov/ml koncentrat za raztopino za infundiranje deksmedetomidin
Each 2 ml vial contains 200 micrograms of dexmedetomidine.
Ena 2 ml viala vsebuje 200 mikrogramov deksmedetomidina.
Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride).
Ena 2 ml ampula vsebuje 200 mikrogramov deksmedetomidina (v obliki klorida).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULES OR VIALS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).
Ena 2 ml viala vsebuje 200 mikrogramov deksmedetomidina (v obliki klorida).
Volume of Dexdor 100 micrograms/ml concentrate for solution for infusion
Volumen zdravila Dexdor 100 mikrogramov/ml koncentrat za raztopino za infundiranje
Alertness/Sedation Scale ≤4) without need for rescue midazolam was 54% of the patients receiving dexmedetomidine 1 µg/kg and 40% of the patients receiving dexmedetomidine 0.5 µg/kg compared to 3% of patients receiving the placebo.The risk difference in proportion of subjects randomised to dexmedetomidine 1 μg/kg group and dexmedetomidine 0.5 μg/kg group not requiring rescue midazolam was 48% (95% CI: 37 % - 57%) and 40% (95% CI: 28 % - 48%), respectively compared placebo.
Delež bolnikov, pri katerih je bila dosežena ciljna stopnja sedacije (≤ 4 na lestvici opazovalčeve ocene budnosti/sedacije) brez potrebe po rešilnem midazolamu, je bil 54% v skupini, ki je prejemala deksmedetomidin v odmerku 1 μg/kg, in 40% v skupini, ki je prejemala deksmedetomidin v odmerku 0,5 μg/kg, v primerjavi s 3% v skupini, ki je prejemala placebo.
and -2.7 mg (95% CI: -3.3 - -2.1), respectively favouring dexmedetomidine.The median time to first rescue dose was 114 minutes in the dexmedetomidine 1.0 µg/kg group, 40 minutes in the dexmedetomidine 0.5 µg/kg group, and 20 minutes in the placebo group.
Mediani čas do prvega rešilnega odmerka je bil 114 minut v skupini, ki je prejemala 1,0 μg/kg deksmedetomidina, 40 minut v skupini, ki je prejemala 0,5 μg/kg deksmedetomidina, in 20 minut v skupini, ki je prejemala placebo.
Dexmedetomidine treatment should be discontinued in the event of a sustained unexplained fever and is not recommended for use in malignant hyperthermia-sensitive patients.
Uporaba deksmedetomidina ni priporočljiva pri bolnikih, ki so nagnjeni h nastanku maligne hipertermije.
Data in new-born infants (28 - 44 weeks gestation) is very limited and restricted to maintenance doses ≤ 0.2 mcg/kg/h.
- 44. teden gestacije) je zelo malo in so omejeni na vzdrževalne odmerke
The difference in means in dose of rescue midazolam was -1.8 mg (95% CI: -2.7 - -0.86) favouring dexmedetomidine.
Povprečni rešilni odmerek midazolama je bil v skupini z deksmedetomidinom 1,1 mg, v skupini s placebom pa 2,8 mg. Razlika v povprečnem odmerku rešilnega midazolama med skupino, ki je prejemala deksmedetomidin in skupino, ki je prejemala placebo, je bila -1.8 mg (95 % CI: -2.7 - -0.86) v prid skupini z deksmedetomidinom.
The mean body weight associated with these Vss and Cl estimates was 69 kg.
Srednja telesna masa, povezana s temi ocenami Vss in Cl, je bila 69 kg. Plazemska farmakokinetika deksmedetomidina je podobna pri populaciji bolnikov z oddelkov za intenzivno nego po infundiranju >24 ur.
IV
Priloga IV
Dose reduction or discontinuation should be considered in a patient developing signs of myocardial or cerebral ischaemia.
Pri bolnikih, ki kažejo znake miokardne ali možganske ishemije, po potrebi zmanjšajte odmerek zdravila ali prenehajte z njegovim infundiranjem.
Uncommon (affects 1 to 10 users in 1,000) - reduced heart function - swelling of the stomach - thirst - a condition where there is too much acid in the body - low albumin level in blood - shortness of breath - hallucinations - the medicine is not effective enough.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - zmanjšano delovanje srca - otekanje trebuha - žeja
- if you have very low blood pressure which does not respond to treatment.
- če imate nizek volumen krvi, na primer po krvavitvah,
Date of first authorisation: 25 July 2008
Datum prve odobritve: 25. julij 2008
Elderly patients ( 65 years of age)
Starejši bolniki ( 65 let)
● At the request of the European Medicines Agency.
• na zahtevo Evropske agencije za zdravila;
Infusion time a, b
Čas infundiranja a,b
- The treatment course usually lasts 5 to 14 days.
- Zdravljenje običajno traja od 5 do 14 dni.
Solution stored in a refrigerator (2C-8C)
Raztopina, shranjena v hladilniku (2C-8C)
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.
In addition, the patients were allowed to receive specified adjunctive therapies.
Poleg tega so bolniki lahko prejeli določena dodatna zdravljenja.
The first two numbers indicate the month.
Prvi dve številki pomenita mesec, naslednje štiri pa leto.
(see sections 4.2 and 5.1).
(glejte poglavji 4.2 in 5.1).
OTHER SPECIAL WARNING (S) IF NECESSARY
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
The safety and efficacy of Doribax in children aged less than 18 years have not yet been established.
Varnost in učinkovitost zdravila Doribax pri otrocih, mlajših od 18 let, še nista bili dokazani.
Solution stored at room temperature
Raztopina, shranjena pri sobni temperaturi
The interaction had a fast onset.
Medsebojno delovanje se je pojavilo hitro.
Adequate and well controlled studies to establish the safety and efficacy of doripenem in patients with cystic fibrosis have not been conducted.
Ustrezne in dobro nadzorovane študije za potrditev varnosti in učinkovitosti doripenema pri bolnikih s cistično fibrozo niso bile izvedene.
The clinical consequences of such an increase in exposure are unknown.
Klinične posledice povečane izpostavljenosti niso znane.
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Mejne vrednosti minimalne inhibitorne koncentracije (MIC), ki jih je določil Evropski odbor za testiranje občutljivosti na antibiotike (European Committee on Antimicrobial Susceptibility TestingEUCAST), so naslednje:
The information below gives only approximate guidance on the probability as to whether the micro-organism will be susceptible to doripenem or not.
Spodaj navedeni podatki naj vam služijo le kot približno vodilo glede verjetnosti, ali bo mikroorganizem občutljiv za doripenem ali ne.
Inspect the suspension visually for foreign matter.
Suspenzijo vizualno preglejte, ali vsebuje tuje delce.
This medicine is an antibiotic which works by killing different types of bacteria (germs) that cause infections in various parts of the body.
To zdravilo je antibiotik in deluje tako, da ubije različne vrste bakterij (mikrobov), ki povzročajo okužbe na različnih delih telesa.
These changes were mainly attributed to age-related changes in renal function.
Te razlike so pripisali predvsem starostnim spremembam v delovanju ledvic.
● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
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.
Študije in vitro so pokazale, da doripenem ne zavira in ne inducira delovanja izoencimov CYP 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 ali 3A4.
Patients should be carefully monitored during therapy.
Med zdravljenjem je potrebno bolnike skrbno spremljati.
The metabolite lacks target pharmacological activity but other possible pharmacological effects are unknown.
Ta presnovek nima ciljne farmakološke aktivnosti, drugi možni farmakološki učinki pa niso znani.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
● Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
500 mg every 8 hours
500 mg na 8 ur
It is important that you receive treatment with Doribax as long as your doctor feels it is necessary.
Pomembno je, da traja zdravljenje z zdravilom Doribax tako dolgo, kot vaš zdravnik meni, da je potrebno.
These may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening.
To so lahko znaki hude alergijske (anafilaktične) reakcije in so lahko smrtno nevarni.
The impact of age on the pharmacokinetics of doripenem was evaluated in healthy elderly male and female subjects (66-84 years of age).
Vpliv starosti na farmakokinetiko doripenema so ocenili pri zdravih starejših moških in ženskah (starih od 66-84 let).
Doribax should not be given to children or adolescents (under 18 years of age) as there is not enough information to be sure that Doribax can be used safely in children or adolescents.
Zdravila Doribax ne smete dajati otrokom ali mladostnikom (mlajšim od 18 let), ker ni dovolj podatkov o varni uporabi zdravila Doribax pri otrocih ali mladostnikih.
72 hours*
72 ur*
Note: the suspension is not for direct infusion.
Opomba: Suspenzija ni namenjena neposrednemu infundiranju.
Do not take any medicine to treat diarrhoea without first checking with your doctor.
Ne jemljite nobenega zdravila za zdravljenje driske, ne da bi se prej posvetovali s svojim zdravnikom.
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 študij omejen, ker so bile izvedene z enkrat dnevnim odmerjanjem, zaradi česar je bilo trajanje dnevne izpostavljenosti doripenemu pri živalih manjše kot ena desetina.
Adults (including people over 65 years of age) - The usual dose is 500 mg every eight hours.
Odrasli (vključno s starejšimi od 65 let) - Običajen odmerek zdravila je 500 mg na vsakih osem ur.
Doripenem was given for up to 14 days in clinical studies and the safety of longer durations of therapy has not been established.
V kliničnih študijah so doripenem uporabljali največ 14 dni in varnosti pri daljšem trajanju zdravljenja niso ugotavljali.
Frequency categories are defined as follows: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Not known (cannot be
Kategorije pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
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
Vendar zaradi zasnove študij toksičnosti ponavljajočih odmerkov in razlik v farmakokinetiki pri živalih in ljudeh, dolgotrajna izpostavljenost živali v teh študijah ni bila zagotovljena.
The average binding of doripenem to plasma proteins was approximately 8.1% and is independent of plasma concentrations.
Povprečna stopnja vezave doripenema na plazemske beljakovine znaša približno 8,1 % in ni odvisna od njegove plazemske koncentracije.
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.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Prevalenca pridobljene odpornosti pri posameznih bakterijskih vrstah se lahko razlikuje po geografskih območjih in se tudi spreminja s časom, zato je zaželeno, da pridobite lokalne informacije o odpornosti, še posebej pri zdravljenju hudih okužb.
Tell your doctor straight away if you get any of these side effects as you may need urgent medical treatment: - Sudden swelling of your lips, face, throat or tongue, a rash, swallowing or breathing problems.
Svojemu zdravniku nemudoma povejte, če se pri vas pri vas pojavi kateri od omenjenih neželenih učinkov, ker boste lahko potrebovali nujno medicinsko zdravljenje: - nenadno otekanje ustnic, obraza, žrela ali jezika, izpuščaj in težave s požiranjem ali dihanjem.
Storage of reconstituted solutions
Shranjevanje rekonstituiranih raztopin
Doripenem-M-1 had a slow elimination in the patient group and the half-life (and AUC) has not been satisfactorily determined.
Doripenem-M-1 se je slabo izločal v tej skupini bolnikov, razpolovni čas (in AUC) pa ni bil zadovoljivo določen.
Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01DH04.
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, karbapenemi, oznaka ATC: J01DH04.
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same
Če predložitev PSUR in posodobitev RMP sovpadata, se ju lahko predloži istočasno.
Chemical and physical in-use stability has been demonstrated for the times and solutions shown in the
Kemična in fizikalna stabilnost zdravila med uporabo je bila dokazana za čas in vrste raztopin, ki so navedene v zgornji preglednici.
This leaflet was last revised in MM/YYYY
Navodilo je bilo nazadnje revidirano MM/LLLL.
The selection of doripenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria.
Pri izbiri doripenema za zdravljenje pri posameznih bolnikih moramo upoštevati primernost uporabe karbapenemskih protibakterijskih zdravil na podlagi dejavnikov kot so resnost okužbe, prevalenca rezistence na druga primerna protibakterijska zdravila in tveganje pri izbiri karbapenemskih protibakterijskih zdravil.
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.
The study was stopped early based on the recommendation of an independent data monitoring committee.
Na osnovi priporočil neodvisne komisije, ki je spremljala podatke, so študijo predčasno zaključili.
Animal studies are insufficient with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne zadostujejo za oceno vpliva na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Doribax should be made taking into account the benefit of breast-feeding to the child and the benefit of Doribax therapy to the woman.
Odločitev o tem, ali naj ženska nadaljuje/preneha z dojenjem oziroma ali naj nadaljuje/prekine zdravljenje z zdravilom Doribax, je treba sprejeti z upoštevanjem koristi dojenja za otroka in koristi zdravljenja z zdravilom Doribax za mater.
Based on in vitro studies it is not expected that doripenem will inhibit or induce the activities of CYP450.
Na osnovi in vitro študij ni pričakovati, da bi doripenem zaviral ali induciral delovanje CYP450.
Other medicines and Doribax
Druga zdravila in zdravilo Doribax
The effect of race on doripenem pharmacokinetics was examined through a population pharmacokinetic analysis.
Vpliv rase na farmakokinetiko doripenema so proučevali z analizo populacijske farmakokinetike.
Doribax should not be inhaled as it may cause inflammation of the lung (pneumonitis).
Zdravila Doribax se ne sme vdihovati, ker lahko povzroči vnetje pljuč (pneumonitis).
If you are not sure, talk to your doctor, pharmacist or nurse before being given Doribax.
Če niste prepričani, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro, preden prejmete zdravilo Doribax.
Doribax is to be reconstituted and then further diluted (see section 6.6) prior to administration by intravenous infusion over a period of 1 or 4 hours.
Zdravilo Doribax je treba rekonstituirati in nato še dodatno razredčiti (glejte poglavje 6.6), preden ga daste bolniku z intravensko infuzijo v času 1 ali 4 ur.
A study in rats has shown that doripenem and its metabolite are transferred to milk.
Študija pri podganah je pokazala, da doripenem in njegov presnovek prehajata v materino mleko.
The usual treatment duration of doripenem therapy ranges from 5-14 days and should be guided by the severity, site of the infection, infecting pathogen and the patient's clinical response.
Običajno zdravljenje z doripenemom traja od 5-14 dni in je odvisno od resnosti in mesta okužbe, povzročitelja okužbe ter od bolnikovega kliničnega odziva.
What Doribax is and what it is used for
Kaj je zdravilo Doribax in za kaj ga uporabljamo
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.
* species against which activity has been demonstrated in clinical studies species that show natural intermediate susceptibility species with > 50% acquired resistance in one or more Member State ^ all methicillin-resistant staphylococci should be regarded as resistant to doripenem
vrste, proti katerim je bilo dokazano delovanje v kliničnih študijah vrste, ki so naravno intermediarno občutljive z > 50 % pridobljeno odpornostjo v eni ali več državah članicah ^ vse na meticilin rezistentne stafilokoke je treba obravnavati kot odporne na doripenem
Bacteroides fragilis Bacteroides caccae Bacteroides ovatus Bacteroides uniformis Bacteroides thetaiotaomicron Bacteroides vulgatus Bilophila wadsworthia Peptostreptococcus magnus Peptostreptococcus micros Porphyromonas spp.
Bacteroides fragilis* Bacteroides caccae* Bacteroides ovatus Bacteroides uniformis* Bacteroides thetaiotaomicron* Bacteroides vulgatus* Bilophilora wadsworthia Peptostreptococcus magnus Peptostreptococcus micros* Porphyromonas spp.
Powder for solution for infusion (powder for infusion)
prašek za raztopino za infundiranje (prašek za infundiranje)
In patients with mild renal impairment (i.e. creatinine clearance (CrCl) is > 50 to  80 ml/min), no dose adjustment is necessary.
Pri bolnikih z blago ledvično okvaro (očistek kreatinina (CrCl) je > 50 do ≤ 80 ml/min), prilagoditev odmerka ni potrebna.
An interaction with other medicinal products eliminated by renal tubular secretion cannot be excluded.
Interakcij z drugimi zdravili, ki se izločajo s tubulno sekrecijo preko ledvic, ne moremo izključiti.
CRRT: continuous renal replacement therapy; CVVH: continuous venovenous haemofiltration; CVVHDF: continuous venovenous haemodiafiltration; MIC: minimum inhibitory concentration
CRRT (continuous renal replacement therapy): kontinuirano nadomestno zdravljenje končne ledvične odpovedi; CVVH (continuous venovenous haemofiltration): kontinuirana veno-venska hemofiltracija; CVVHDF (continuous venovenous haemodiafiltration): kontinuirana veno-venska hemodiafiltracija; MIC (minimum inhibitory concentration): minimalna inhibitorna koncentracija.
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.
Po potrebi se posvetujte s specialistom, če je lokalna prevalenca odpornosti takšna, da je uporabnost antibiotika vprašljiva vsaj pri nekaterih vrstah okužb.
Pneumonitis with inhalational use
Pneumonitis zaradi uporabe zdravila z inhalacijo
Doribax should not be used during pregnancy unless clearly necessary.
Zdravilo Doribax se v času nosečnosti lahko uporablja le, če je nujno potrebno.
Doribax is supplied in packs of 10 vials.
Zdravilo Doribax je na voljo v pakiranjih po 10 vial.
Your doctor will monitor you for overgrowth and treat you if necessary.
Zdravnik vas bo spremljal, da pri vas ugotovi morebiten razrast mikroorganizmov in vas bo po potrebi ustrezno zdravil.
Mean renal clearance is 10.3 l/hour.
Srednji ledvični očistek doripenema znaša 10,3 l/uro.
If superinfection occurs, appropriate measures should be taken.
Če pride med zdravljenjem do superinfekcije, uvedite ustrezne ukrepe.
Of these, 50% had late-onset VAP (defined as that occurring after five days of mechanical ventilation), 54% had an APACHE (Acute Physiology And Chronic Health Evaluation) II score > 15 and 32% received concomitant aminoglycosides (76% for more than 3 days).
Od tega jih je imelo 50 % pozen pojav pljučnice (opredeljeno kot pojav pljučnice po petih dneh mehanske ventilacije), 54 % jih je imelo oceno APACHE (Acute Physiology And Chronic Health Evaluation) II > 15 in 32 % jih je sočasno prejemalo aminoglikozide (76 % več kot 3 dni).
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%).
Neželeni učinki, ki so vodili do ukinitve zdravila Doribax, so bili navzea (0,1 %), driska (0,1 %), pruritus (0,1 %), glivična okužba vulve (0,1 %), zvišanje vrednosti jetrnih encimov (0,2 %) in izpuščaj (0,2 %).
The effect of gender on the pharmacokinetics of doripenem was evaluated in healthy male and female subjects.
Vpliv spola na farmakokinetiko doripenema so ocenili pri zdravih moških in ženskah.
It is unknown whether doripenem is excreted in human breast milk.
Ni znano, ali se doripenem izloča v materino mleko pri človeku.