FrancophonIA/ELRC3.0 huggingface dataset:
English: Study 1 randomised patients undergoing elective surgeries/procedures under monitored anaesthesia care and local/regional anaesthesia to receive a loading infusion of dexmedetomidine either 1 µg/kg (n=129) or 0.5 µg/kg (n=134), or placebo (normal saline; n=63) given over 10 minutes and followed by a maintenance infusion started at 0.6 µg/kg/h.
Slovenian: Študija 1: randomizirani bolniki, na katerih so opravili elektivne operacije/posege pod nadzirano anestezijsko oskrbo in lokalno/regionalno anestezijo, so prejeli udarno infuzijo deksmedetomidina, bodisi v odmerku 1 μg/kg (n=129) bodisi v odmerku 0,5 μg/kg (n=134),
English: The cardiovascular effects depend on the dose; with lower infusion rates the central effects dominate leading to decrease in heart rate and blood pressure.
Slovenian: Srčno-žilni učinki so odvisni od odmerka - pri manjših hitrostih infundiranja prevladujejo centralni učinki, kar vodi do zmanjšanja srčne frekvence in krvnega tlaka, pri večjih odmerkih pa prevlada učinek periferne vazokonstrikcije, kar vodi do povečanja sistemske žilne upornosti in krvnega tlaka, medtem ko je bradikardni učinek dodatno poudarjen.
English: Inhibition of CYP enzymes including CYP2B6 by dexmedetomidine has been studied in human liver microsome incubations.
Slovenian: Pri inkubaciji mikrosomov v človeških jetrih so preučili inhibicijo encimov CYP, vključno s CYP2B6,
English: Dexmedetomidine treated patients had more frequent hypotension and bradycardia but less tachycardia than those receiving midazolam and more frequent tachycardia but similar hypotension to propofoltreated patients.
Slovenian: V primerjavi tako s propofolom kot z midazolamom so bolnike tudi lažje zbudili in so bili ti bolj kooperativni ter so lažje povedali, ali imajo bolečine ali ne. Bolniki, zdravljeni z deksmedetomidinom, so imeli pogosteje hipotenzijo in bradikardijo, vendar manj tahikardije od tistih, ki so prejemali midazolam, ter pogosteje tahikardijo in podobno pogosto hipotenzijo kot bolniki, zdravljeni s propofolom.
English: Plasma pharmacokinetics of dexmedetomidine is similar in the ICU population following infusion >24 h. The estimated pharmacokinetic parameters are: t1/2 approximately 1.5 hours, Vss approximately 93 litres and Cl approximately 43 l/h.
Slovenian: Ocenjeni farmakokinetični parametri so: t1/2 približno 1,5 ure, Vss približno 93 litrov in Cl približno 43 l/h.
English: Dexdor should be administered by healthcare professionals skilled in the management of patients requiring intensive care.
Slovenian: Zdravilo Dexdor smejo uporabljati le zdravstveni delavci, ki so izurjeni za zdravljenje bolnikov na intenzivni negi.
English: Patients should be advised to refrain from driving or other hazardous tasks and where possible to avoid the use of other agents that may sedate (e.g, benzodiazepines, opioids, alcohol) for a suitable period of time based on observed effects of dexmedetomidine, the procedure, concomitant medications, the age and the condition of the patient.
Slovenian: Če je mogoče, naj se za določeno časovno obdobje, odvisno od opaženih učinkov deksmedetomidina, opravljenega posega, sočasnega zdravljenja, starosti in stanja bolnika, izognejo uporabi drugih sredstev, ki lahko povzročajo sedativne učinke (npr. benzodiazepinov, opioidov, alkohola).
English: Resuscitation was required in isolated cases of severe overdose resulting in cardiac arrest.
Slovenian: V redkih primerih hudega prevelikega odmerjanja, ki so vodili do zastoja srca, je bilo potrebno oživljanje.
English: Very common (affects more than 1 user in 10) - slow heart rate - low or high blood pressure - change in breathing pattern or stopping breathing.
Slovenian: - nizek ali visok krvni tlak - sprememba v dihalnem vzorcu ali prenehanje dihanja
English: Dexdor is diluted and it is given to you as an infusion (drip) into your veins.
Slovenian: Zdravilo Dexdor je razredčeno in ga boste prejeli v obliki (kapalne) infuzije v veno.
English: Polyuria
Slovenian: poliurija
English: Dexdor should be administered only by health care professionals skilled in the anaesthetic management of patients in the operating room or during diagnostic procedures.
Slovenian: Zdravilo Dexdor smejo aplicirati samo zdravstveni delavci, izurjeni za anesteziološko obravnavo bolnikov med operativnimi ali diagnostičnimi posegi.
English: Containers
Slovenian: Vsebniki
English: Caution should be exercised when administering dexmedetomidine to elderly patients.
Slovenian: Pri dajanju deksmedetomidina starejšim bolnikom je potrebna previdnost.
English: How to store Dexdor
Slovenian: Shranjevanje zdravila Dexdor
English: Dexmedetomidine exhibits a two-compartment disposition model.
Slovenian: Model porazdelitve deksmedetomidina je dvoprostorni.
English: Adverse reactions Metabolism and nutrition disorders Common:
Slovenian: Presnovne in prehranske motnje Pogosti:
English: Dexdor should not be given as a bolus dose and in the ICU a loading dose is not recommended.
Slovenian: Zdravila Dexdor se ne sme uporabljati v bolusnem odmerku, na oddelkih za intenzivno nego pa ni priporočljiv udarni odmerek.
English: Dexmedetomidine plasma protein binding is decreased in subjects with hepatic impairment compared with healthy subjects.
Slovenian: V primerjavi z zdravimi preiskovanci je stopnja vezave deksmedetomidina na plazemske beljakovine zmanjšana pri preiskovancih z jetrno okvaro.
English: Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
Slovenian: En ml koncentrata vsebuje deksmedetomidinijev klorid v količini, ki ustreza 100 mikrogramom deksmedetomidina.
English: In case the required concentration is 4 micrograms/ml:
Slovenian: V primeru, da je potrebna koncentracija 4 mikrograme/ml:
English: In case the required concentration is 8 micrograms/ml:
Slovenian: V primeru, da je potrebna koncentracija 8 mikrogramov/ml:
English: Sedation of adult ICU (Intensive Care Unit) patients
Slovenian: Sedacija na oddelkih za intenzivno nego pri odraslih bolnikih:
English: A lower starting infusion rate should be considered for frail patients.
Slovenian: Pri oslabelih bolnikih po potrebi uporabite manjšo začetno hitrost infundiranja.
English: Dexdor should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Zdravilo Dexdor je treba pred uporabo vizualno pregledati, da ugotovite morebitne delce in obarvanje.
English: ICU sedation.
Slovenian: - Navodilo shranite.
English: Each 10 ml vial contains 1000 micrograms of dexmedetomidine.
Slovenian: Ena 10 ml viala vsebuje 1000 mikrogramov deksmedetomidina.
English: Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Slovenian: Ena 4 ml viala vsebuje 400 mikrogramov deksmedetomidina.
English: Transient hypertension has been observed primarily during the loading dose in association with the peripheral vasoconstrictive effects of dexmedetomidine and a loading dose is not recommended in
Slovenian: Predvsem pri uporabi udarnega odmerka v povezavi s perifernimi vazokonstriktornimi učinki deksmedetomidina so opazili prehodno hipertenzijo, zato uporaba udarnega odmerka za sedacijo na oddelkih za intenzivno nego ni priporočljiva.
English: The difference in means in dose of rescue midazolam in dexmedetomidine 1 μg/kg and dexmedetomidine 0.5 μg/kg group compared to placebo was -3.1 mg (95% CI: -3.8 - -2.5)
Slovenian: Razlika v povprečnem odmerku rešilnega midazolama med skupino, ki je prejemala deksmedetomidin v odmerku 1 μg/kg, in skupino, ki je prejemala placebo, je bila -3,1 mg (95 % IZ: -3,8 - -2,5) v prid skupini z deksmedetomidinom.
English: No dose adjustment is required for patients with renal impairment.
Slovenian: Ledvična okvara Pri bolnikih z ledvično okvaro običajno ni potrebna nikakršna prilagoditev odmerka.
English: Withdrawal syndrome, hyperthermia Uncommon: Drug ineffective, thirst
Slovenian: odtegnitveni sindrom, hipertermija
English: Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).
Slovenian: Ena 10 ml viala vsebuje 1000 mikrogramov deksmedetomidina (v obliki klorida).
English: The pharmacokinetics of dexmedetomidine in subjects with severe renal impairment (creatinine clearance <30 ml/min) is not altered relative to healthy subjects.
Slovenian: Farmakokinetika deksmedetomidina pri preiskovancih s hudo ledvično okvaro (očistek kreatinina
English: Hrvatska Malta România Orion Oyj
Slovenian: Orion Oyj
English: N
Slovenian: Starost n
English: Each 2 ml ampoule contains 200 micrograms of dexmedetomidine.
Slovenian: Ena 2 ml ampula vsebuje 200 mikrogramov deksmedetomidina.
English: Nausea2, vomiting, dry mouth2 Uncommon: Abdominal distension
Slovenian: navzea2, bruhanje, suha usta2
English: Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride).
Slovenian: Ena 4 ml viala vsebuje 400 mikrogramov deksmedetomidina (v obliki klorida).
English: NAME OF THE MEDICINAL PRODUCT Dexdor 100 micrograms/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Dexdor 100 mikrogramov/ml koncentrat za raztopino za infundiranje
English: Symptoms
Slovenian: halucinacije
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En ml koncentrata vsebuje deksmedetomidinijev klorid v količini, ki ustreza 100 mikrogramom deksmedetomidina.
English: Dexdor should be used immediately after dilution.
Slovenian: Po redčenju je treba raztopino uporabiti takoj.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Dexdor 100 micrograms/ml sterile concentrate dexmedetomidine
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Dexdor 100 µg/ml sterilen koncentrat deksmedetomidin i.v.
English: Dexdor 100 micrograms/ml concentrate for solution for infusion Dexmedetomidine
Slovenian: Dexdor 100 mikrogramov/ml koncentrat za raztopino za infundiranje deksmedetomidin
English: Each 2 ml vial contains 200 micrograms of dexmedetomidine.
Slovenian: Ena 2 ml viala vsebuje 200 mikrogramov deksmedetomidina.
English: Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride).
Slovenian: Ena 2 ml ampula vsebuje 200 mikrogramov deksmedetomidina (v obliki klorida).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULES OR VIALS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Age
Slovenian: Lot
English: Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).
Slovenian: Ena 2 ml viala vsebuje 200 mikrogramov deksmedetomidina (v obliki klorida).
English: Volume of Dexdor 100 micrograms/ml concentrate for solution for infusion
Slovenian: Volumen zdravila Dexdor 100 mikrogramov/ml koncentrat za raztopino za infundiranje
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Dexmedetomidine treatment should be discontinued in the event of a sustained unexplained fever and is not recommended for use in malignant hyperthermia-sensitive patients.
Slovenian: Uporaba deksmedetomidina ni priporočljiva pri bolnikih, ki so nagnjeni h nastanku maligne hipertermije.
English: Data in new-born infants (28 - 44 weeks gestation) is very limited and restricted to maintenance doses ≤ 0.2 mcg/kg/h.
Slovenian: - 44. teden gestacije) je zelo malo in so omejeni na vzdrževalne odmerke
English: The difference in means in dose of rescue midazolam was -1.8 mg (95% CI: -2.7 - -0.86) favouring dexmedetomidine.
Slovenian: 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.
English: The mean body weight associated with these Vss and Cl estimates was 69 kg.
Slovenian: 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.
English: IV
Slovenian: Priloga IV
English: Dose reduction or discontinuation should be considered in a patient developing signs of myocardial or cerebral ischaemia.
Slovenian: Pri bolnikih, ki kažejo znake miokardne ali možganske ishemije, po potrebi zmanjšajte odmerek zdravila ali prenehajte z njegovim infundiranjem.
English: 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.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - zmanjšano delovanje srca - otekanje trebuha - žeja
English: - if you have very low blood pressure which does not respond to treatment.
Slovenian: - če imate nizek volumen krvi, na primer po krvavitvah,
English: Date of first authorisation: 25 July 2008
Slovenian: Datum prve odobritve: 25. julij 2008
English: Elderly patients ( 65 years of age)
Slovenian: Starejši bolniki ( 65 let)
English: ● At the request of the European Medicines Agency.
Slovenian: • na zahtevo Evropske agencije za zdravila;
English: Infusion time a, b
Slovenian: Čas infundiranja a,b
English: - The treatment course usually lasts 5 to 14 days.
Slovenian: - Zdravljenje običajno traja od 5 do 14 dni.
English: Solution stored in a refrigerator (2C-8C)
Slovenian: Raztopina, shranjena v hladilniku (2C-8C)
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.3.
English: In addition, the patients were allowed to receive specified adjunctive therapies.
Slovenian: Poleg tega so bolniki lahko prejeli določena dodatna zdravljenja.
English: The first two numbers indicate the month.
Slovenian: Prvi dve številki pomenita mesec, naslednje štiri pa leto.
English: (see sections 4.2 and 5.1).
Slovenian: (glejte poglavji 4.2 in 5.1).
English: OTHER SPECIAL WARNING (S) IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: The safety and efficacy of Doribax in children aged less than 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Doribax pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: Solution stored at room temperature
Slovenian: Raztopina, shranjena pri sobni temperaturi
English: The interaction had a fast onset.
Slovenian: Medsebojno delovanje se je pojavilo hitro.
English: Adequate and well controlled studies to establish the safety and efficacy of doripenem in patients with cystic fibrosis have not been conducted.
Slovenian: Ustrezne in dobro nadzorovane študije za potrditev varnosti in učinkovitosti doripenema pri bolnikih s cistično fibrozo niso bile izvedene.
English: The clinical consequences of such an increase in exposure are unknown.
Slovenian: Klinične posledice povečane izpostavljenosti niso znane.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Slovenian: 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:
English: The information below gives only approximate guidance on the probability as to whether the micro-organism will be susceptible to doripenem or not.
Slovenian: Spodaj navedeni podatki naj vam služijo le kot približno vodilo glede verjetnosti, ali bo mikroorganizem občutljiv za doripenem ali ne.
English: Inspect the suspension visually for foreign matter.
Slovenian: Suspenzijo vizualno preglejte, ali vsebuje tuje delce.
English: This medicine is an antibiotic which works by killing different types of bacteria (germs) that cause infections in various parts of the body.
Slovenian: To zdravilo je antibiotik in deluje tako, da ubije različne vrste bakterij (mikrobov), ki povzročajo okužbe na različnih delih telesa.
English: These changes were mainly attributed to age-related changes in renal function.
Slovenian: Te razlike so pripisali predvsem starostnim spremembam v delovanju ledvic.
English: ● 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
Slovenian: • 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).
English: 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.
Slovenian: Študije in vitro so pokazale, da doripenem ne zavira in ne inducira delovanja izoencimov CYP 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 ali 3A4.
English: Patients should be carefully monitored during therapy.
Slovenian: Med zdravljenjem je potrebno bolnike skrbno spremljati.
English: The metabolite lacks target pharmacological activity but other possible pharmacological effects are unknown.
Slovenian: Ta presnovek nima ciljne farmakološke aktivnosti, drugi možni farmakološki učinki pa niso znani.
English: 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.
Slovenian: ● 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.
English: 500 mg every 8 hours
Slovenian: 500 mg na 8 ur
English: It is important that you receive treatment with Doribax as long as your doctor feels it is necessary.
Slovenian: Pomembno je, da traja zdravljenje z zdravilom Doribax tako dolgo, kot vaš zdravnik meni, da je potrebno.
English: These may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening.
Slovenian: To so lahko znaki hude alergijske (anafilaktične) reakcije in so lahko smrtno nevarni.
English: The impact of age on the pharmacokinetics of doripenem was evaluated in healthy elderly male and female subjects (66-84 years of age).
Slovenian: Vpliv starosti na farmakokinetiko doripenema so ocenili pri zdravih starejših moških in ženskah (starih od 66-84 let).
English: 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.
Slovenian: 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.
English: 72 hours*
Slovenian: 72 ur*
English: Note: the suspension is not for direct infusion.
Slovenian: Opomba: Suspenzija ni namenjena neposrednemu infundiranju.
English: Do not take any medicine to treat diarrhoea without first checking with your doctor.
Slovenian: Ne jemljite nobenega zdravila za zdravljenje driske, ne da bi se prej posvetovali s svojim zdravnikom.
English: 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.
Slovenian: 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.
English: Adults (including people over 65 years of age) - The usual dose is 500 mg every eight hours.
Slovenian: Odrasli (vključno s starejšimi od 65 let) - Običajen odmerek zdravila je 500 mg na vsakih osem ur.
English: Doripenem was given for up to 14 days in clinical studies and the safety of longer durations of therapy has not been established.
Slovenian: V kliničnih študijah so doripenem uporabljali največ 14 dni in varnosti pri daljšem trajanju zdravljenja niso ugotavljali.
English: 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
Slovenian: 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).
English: 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
Slovenian: Vendar zaradi zasnove študij toksičnosti ponavljajočih odmerkov in razlik v farmakokinetiki pri živalih in ljudeh, dolgotrajna izpostavljenost živali v teh študijah ni bila zagotovljena.
English: The average binding of doripenem to plasma proteins was approximately 8.1% and is independent of plasma concentrations.
Slovenian: Povprečna stopnja vezave doripenema na plazemske beljakovine znaša približno 8,1 % in ni odvisna od njegove plazemske koncentracije.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.