FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare acute renal failure, oligurial/anuria, polyuria, urine discoloration (harmless and should not be confused with haematuria) The role of TIENAM in changes in renal function is difficult to assess, since factors predisposing to pre-renal azotemia or to impaired renal function usually have been present.
Slovenian: Redki akutna odpoved ledvic, oligurija/anurija, poliurija, obarvanje urina (neškodljivo in se ga ne sme zamenjati za hematurijo) Vlogo zdravila TIENAM pri spremembah delovanja ledvic je težko oceniti, ker so bili običajno prisotni dejavniki, ki povečujejo nagnjenost k predrenalni azotemiji ali okvari delovanja ledvic.
English: Interaction with valproic acid
Slovenian: Medsebojno delovanje z valprojsko kislino
English: • Hypersensitivity to any other carbapenem antibacterial agent
Slovenian: Preobčutljivost za kakšno drugo karbapenemsko protibakterijsko zdravilo.
English: 20 ml Type I glass vials.
Slovenian: 20 ml viale iz stekla tipa I
English: Hepatic function should be closely monitored during treatment with imipenem/cilastatin due to the risk of hepatic toxicity (such as increase in transaminases, hepatic failure and fulminant hepatitis).
Slovenian: Med zdravljenjem z imipenemom/cilastatinom je treba natančno kontrolirati delovanje jeter, ker obstaja tveganje hepatotoksičnih učinkov (npr. zvišanja transaminaz, odpovedi jeter in fulminantnega hepatitisa).
English: TIENAM has not been studied in pregnant women.
Slovenian: Zdravilo TIENAM pri nosečnicah ni raziskano.
English: Patients with creatinine clearances of 5 ml/min/1.73 m2 should not receive TIENAM unless haemodialysis is instituted within 48 hours.
Slovenian: Bolniki z očistkom kreatinina od 5 ml/min/1,73 m2 ne smejo dobiti zdravila TIENAM, razen če se hemodializa ne začne v 48 urah.
English: Furthermore, due to the limited susceptibility of specific pathogens associated with e.g. bacterial skin and soft-tissue infections, to imipenem/cilastatin, caution should be exercised.
Slovenian: Poleg tega je potrebna previdnost zaradi majhne občutljivosti specifičnih patogenov, povezanih z npr. bakterijskimi okužbami kože in mehkih tkiv, za imipenem/cilastatin.
English: Clinical data are insufficient to recommend the use of TIENAM in children under 1 year of age or paediatric patients with impaired renal function (serum creatinine >2 mg/dl).
Slovenian: Kliničnih podatkov ni dovolj, da bi priporočali uporabo zdravila TIENAM pri otrocih, mlajših od 1 leta, ali pediatričnih bolnikih z okvarjenim delovanjem ledvic (kreatinin v serumu >2 mg/dl).
English: If you stop using TIENAM
Slovenian: Če ste prenehali jemati zdravilo TIENAM
English: Discontinuation of therapy with imipenem/cilastatin and the administration of specific treatment for Clostridium difficile should be considered.
Slovenian: V poštev pride prenehanje zdravljenja z imipenemom/cilastatinom in uporaba specifičnega zdravljenja, usmerjenega proti Clostridium difficile.
English: Approximately 70-80% of the dose of cilastatin was recovered unchanged in the urine as cilastatin within 10 hours of administration of TIENAM.
Slovenian: Približno 70 do 80% odmerka cilastatina se je v urin izločilo nespremenjenega v obliki cilastatina v 10 urah po uporabi zdravila TIENAM.
English: Approximately 10% was found as the Nacetyl metabolite, which has inhibitory activity against dehydropeptidase comparable to that of cilastatin.
Slovenian: Približno 10% se ga je pojavilo v obliki N-acetilnega presnovka, ki zavira dehidropeptidazo podobno kot cilastatin.
English: Long term studies in animals have not been performed to evaluate carcinogenic potential of imipenemcilastatin.
Slovenian: Dolgoročnih študij za oceno kancerogenega potenciala kombinacije imipenem/cilastatin na živalih ni bilo.
English: Symptoms of overdose that can occur are consistent with the adverse reaction profile; these may include seizures, confusion, tremors, nausea, vomiting, hypotension, bradycardia.
Slovenian: Simptomi prevelikega odmerjanja, ki se lahko pojavijo, se skladajo s profilom neželenih učinkov; lahko vključujejo napade krčev, zmedenost, tremor, navzeo, bruhanje, hipotenzijo in bradikardijo.
English: Inherently resistant species: Gram positive aerobes: Enterococcus faecium Gram negative aerobes: Some strains of Burkholderia cepacia (formerly Pseudomonas cepacia) Legionella spp.
Slovenian: Inherentno odporne vrste: Grampozitivni aerobi: Enterococcus faecium Gram negativno aerobes: Nekateri sevi Burkholderia cepacia (prej Pseudomonas cepacia) Legionella spp.
English: Similarly, the most frequently reported local adverse reactions were phlebitis/thrombophlebitis (3.1%), pain at the injection site (0.7%), erythema at the injection site (0.4%) and vein induration (0.2%).
Slovenian: Podobno so bili najpogosteje poročani lokalni neželeni učinki flebitis/tromboflebitis (3,1%), bolečina ne mestu injiciranja (0,7%), eritem na mestu injiciranja (0,4%) in induracija vene (0,2%).
English: HOW TO USE TIENAM
Slovenian: KAKO UPORABLJATI ZDRAVILO TIENAM
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship Similar to other beta-lactam antibacterial agents, the time that imipenem concentrations exceed the MIC (T>MIC) has been shown to best correlate with efficacy.
Slovenian: Razmerje med farmakokinetiko in farmakodinamiko (FK/FD) Podobno kot velja za druga betalaktamska protibakterijska zdravila, se je tudi za imipenem pokazalo, da čas, ko koncentracija imipenema presega MIC (t >MIC ) najbolje kolerira z njegovo učinkovitostjo.
English: Shake well and transfer the resulting mixture to the infusion solution container.
Slovenian: Dobro pretresite in dobljeno mešanico prenesite v vsebnik z raztopino za infundiranje.
English: Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Slovenian: Zdravljenje bolnikov z bakteriemijo, povezano s katero od navedenih okužb, ali če obstaja sum, da je povezana s katero od njih.
English: Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see section 6.2 and 6.3): 0.9% sodium chloride.
Slovenian: Vsebino ene viale je treba prenesti v 100 ml ustrezne raztopine za infundiranje (glejte poglavji 6.2 in 6.3): 0,9 % raztopino natrijevega klorida.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom .
English: Common increases in serum transaminases, increases in serum alkaline phosphatase
Slovenian: Pogosti zvišanje serumskih transaminaz, zvišanje serumske alkalne fosfataze
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for infusion
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za raztopino za infundiranje
English: CNS adverse reactions such as myoclonic activity, confusional states, or seizures have been reported, especially when recommended doses based on renal function and body weight were exceeded.
Slovenian: Poročali so o neželenih učinkih na osrednje živčeve, kot so mioklonična aktivnost, stanja zmedenosti ali napadi krčev, zlasti če so bili prekoračeni priporočeni odmerki na podlagi delovanja ledvic in telesne mase.
English: When doses of imipenem-cilastatin sodium (approximately 100/100 mg/kg/day or approximately 3 times the usual recommended daily human intravenous dose) were administered to pregnant cynomolgus monkeys at an intravenous infusion rate which mimics human clinical use, there was minimal maternal intolerance (occasional emesis), no maternal deaths, no evidence of teratogenicity, but an increase in embryonic loss relative to control groups (see section 4.6).
Slovenian: Če so odmerke imipenema//-natrijeve soli cilastatina (približno 100/100 mg/kg/dan ali približno 3-kratni običajni priporočeni dnevni intravenski odmerek za človeka) uporabili pri nosečih opicah cynomolgus v intravenski infuziji s hitrostjo, ki posnema klinično uporabo pri človeku, je bila intoleranca mater minimalna (občasno bruhanje), ni bilo maternalnih smrti in nobenih znakov teratogenosti, ugotovili pa so večjo izgubo zarodkov v primerjavi s kontrolno skupino (glejte poglavje 4.4).
English: In clinical trials including 1,723 patients treated with imipenem/cilastatin intravenous the most frequently reported systemic adverse reactions that were reported at least possibly related to therapy were nausea (2.0%), diarrhoea (1.8%), vomiting (1.5%), rash (0.9%), fever (0.5%), hypotension (0.4%), seizures (0.4%) (see section 4.4), dizziness (0.3%), pruritus (0.3%), urticaria (0.2%), somnolence (0.2%).
Slovenian: V kliničnih preskušanjih pri 1.723 bolnikih, intravensko zdravljenih z imipenemom/cilastatinom, so bili najpogosteje poročani sistemski neželeni učinki, navedeni kot vsaj možno povezani z zdravljenjem, navzea (2,0%), driska (1,8%), bruhanje (1,5%), izpuščaj (0,9%), zvišana telesna temperatura (0,5%), hipotenzija (0,4%), napadi krčev (0,4%) (glejte poglavje 4.4), omotica (0,3%), srbenje (0,3%), urtikarija (0,2%) in zaspanost (0,2%).
English: Take special care with TIENAM
Slovenian: Bodite posebno pozorni pri jemanju zdravila TIENAM
English: Very rare cyanosis, tachycardia, palpitations
Slovenian: Zelo redki cianoza, tahikardija, palpitacije
English: Animal studies showed that the toxicity produced by imipenem, as a single entity, was limited to the kidney.
Slovenian: Študije na živalih so pokazale, da so toksični učinki imipenema, uporabljenega samega, omejeni na ledvice.
English: Due to the limited extent of hepatic metabolism of imipenem, its pharmacokinetics are not expected to be affected by hepatic impairment.
Slovenian: Zaradi majhnega obsega presnove imipenema v jetrih ni pričakovati, da bi okvara jeter vplivala na njegovo farmakokinetiko.
English: 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.
Slovenian: Če je lokalna prevalenca odpornosti takšna, da je uporabnost tega zdravila vsaj pri nekaterih vrstah okužb vprašljiva, je treba poiskati nasvet strokovnjaka.
English: There are some side effects associated with this product (such as seeing, hearing, or feeling something that is not there, dizziness, sleepiness, and a spinning sensation) that may affect some patients' ability to drive or operate machinery (see section 4).
Slovenian: S tem zdravilom je povezanih nekaj neželenih učinkov (kot so videnje, slišanje ali občutenje stvari, ki jih ni, omotica, zaspanost in vrtoglavica), ki lahko pri nekaterih bolnikih poslabšajo njihovo sposobnost upravljanja vozil in strojev (glejte poglavje 4).
English: • Imipenem 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 hydrolysing beta-lactamases.
Slovenian: Imipenem je stabilen proti hidrolizi z večino betalaktamaz, vključno s penicilinazami in cefalosporinazami, ki jih tvorijo grampozitivne in gramnegativne bakterije, z izjemo razmeroma redkih betalaktamaz, ki hidrolizirajo karbapeneme.
English: The usual dose for children one year of age or older is 15/15 or 25/25 mg/kg/dose every 6 hours.
Slovenian: Običajen odmerek za otroke, stare eno leto ali več, je 15/15 ali 25/25 mg/kg/odmerek na vsakih 6 ur.
English: Patients with a creatinine clearance of ≤5 ml/min/1.73 m2
Slovenian: Bolniki z očistkom kreatinina ≤5 ml/min/1,73 m2
English: Cilastatin is a specific inhibitor of dehydropeptidase-I enzyme and effectively inhibits metabolism of imipenem so that concomitant administration of imipenem and cilastatin allows therapeutic antibacterial levels of imipenem to be attained in both urine and plasma.
Slovenian: Cilastatin je specifičen zaviralec encima dehidropeptidaze-I in učinkovito zavre presnovo imipenema; sočasna uporaba imipenema in cilastatina tako omogoča, da imipenem doseže terapevtsko protibakterijsko koncentracijo v urinu in plazmi.
English: Very rare aggravation of myasthenia gravis, headache
Slovenian: Zelo redki poslabšanje miastenije gravis, glavobol
English: Very rare vertigo, tinnitus
Slovenian: Zelo redki vrtoglavica, tinitus
English: It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of imipenem/cilastatin (see section 4.8).
Slovenian: Na to diagnozo je treba pomisliti pri vseh bolnikih, ki med uporabo imipenema/cilastatina ali po njej dobijo drisko (glejte poglavje 4.8).
English: A teratology study in pregnant cynomolgus monkeys given imipenem-cilastatin sodium at doses of 40/40 mg/kg/day (bolus intravenous injection) resulted in maternal toxicity including emesis, inappetence, body weight loss, diarrhoea, abortion, and death in some cases.
Slovenian: V teratološki študiji pri nosečih opicah cynomolgus, ki so dobivale imipenem/natrijevo sol cilastatina v odmerkih 40/40 mg/kg/dan (bolusna intravenska injekcija), so se pojavili toksični učinki pri materah; obsegali so bruhanje, pomanjkanje apetita, hujšanje, drisko, splav in v nekaterih primerih smrt.
English: Co-administration of cilastatin with imipenem in a 1:1 ratio prevented the nephrotoxic effects of imipenem in rabbits and monkeys.
Slovenian: Sočasna uporaba cilastatina in imipenema v razmerju 1:1 je pri kuncih in opicah preprečila nefrotoksične učinke imipenema.
English: Mode of action TIENAM consists of two components: imipenem and cilastatin sodium in a 1:1 ratio by weight.
Slovenian: Način delovanja Zdravilo TIENAM vsebuje dve učinkovini: imipenem in natrijevo sol cilastatina v razmerju mase 1:1.
English: Greece: Primaxin
Slovenian: Grčija: Primaxin
English: Central nervous system
Slovenian: Osrednje živčevje
English: The remainder of the administered dose was recovered in the urine as antibacterially inactive metabolites, and faecal elimination of imipenem was essentially nil.
Slovenian: Preostanek uporabljenega odmerka se je pojavil v urinu v obliki protibakterijsko neaktivnih presnovkov, odstranjevanja imipenema v blatu pa praktično ni.
English: Each dose of 500 mg/500 mg should be given by intravenous infusion over 20 to 30 minutes.
Slovenian: Vsak odmerek 500 mg/500 mg je treba dati v intravenski infuziji v obdobju 20 do 30 minut.
English: In healthy elderly volunteers (65 to 75 years of age with normal renal function for their age), the pharmacokinetics of a single dose of TIENAM 500 mg/500 mg administered intravenously over 20 minutes were consistent with those expected in subjects with slight renal impairment for which no dose alteration is considered necessary.
Slovenian: Pri zdravih starejših prostovoljcih (starih od 65 do 75 let in z normalnim delovanjem ledvic za njihovo starost) se farmakokinetika enkratnega odmerka zdravila TIENAM 500 mg/500 mg, danega intravensko v 20 minutah, sklada s farmakokinetiko oseb z rahlo okvaro ledvic, pri katerih prilagoditev odmerka ni potrebna.
English: 500 mg/500 mg every 6 hours OR 1000 mg/1000 mg every 8 hours OR every 6 hours
Slovenian: 500 mg/500 mg vsakih 6 ur ALI 1.000 mg/1.000 mg vsakih 8 ur ALI vsakih 6 ur.
English: Before initiating therapy with TIENAM, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta-lactams and other allergens (see section 4.3).
Slovenian: Pred uvedbo zdravljenja z zdravilom TIENAM je treba natančno poizvedeti, ali je bolnik kdaj v preteklosti imel preobčutljivostno reakcijo na karbapeneme, peniciline, cefalosporine, druge betalaktamske antibiotike ali druge alergene (glejte poglavje 4.3).
English: Very rare gastro-enteritis
Slovenian: Zelo redki gastroenteritis
English: The concomitant use of imipenem/cilastatin and valproic acid/sodium valproate is not recommended (see section 4.5).
Slovenian: Sočasna uporaba imipenema/cilastatina in valprojske kisline oz. natrijevega valproata ni priporočljiva (glejte poglavje 4.5).
English: Rare anaphylactic reactions
Slovenian: Redki anafilaktične reakcije
English: • Infection affecting the lungs (pneumonia)
Slovenian: • okužbo pljuč (pljučnico)
English: Rare agranulocytosis
Slovenian: Redki agranulocitoza
English: Commonly susceptible species: Gram-positive aerobes: Enterococcus faecalis Staphylococcus aureus (Methicillin-susceptible)*
Slovenian: Pogosto občutljive vrste: Grampozitivni aerobi: Enterococcus faecalis Staphylococcus aureus (občutljiv za meticilin)*
English: 3 Susceptibility of staphylococci to carbapenems is inferred from the cefoxitin susceptibility.
Slovenian: 3 Sklepanje o občutljivosti stafilokokov za karbapeneme temelji na občutljivosti za cefoksitin.
English: Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see Incompatibility and After reconstitution): 0.9% sodium chloride.
Slovenian: Vsebino ene viale je treba prenesti v 100 ml ustrezne raztopine za infundiranje (glejte: Inkompatibilnost in Po pripravi): 0,9 % raztopino natrijevega klorida.
English: The lowered valproic acid levels can lead to inadequate seizure control; therefore, concomitant use of imipenem and valproic acid/sodium valproate is not recommended and alternative antibacterial or anti-convulsant therapies should be considered (see section 4.4).
Slovenian: Zmanjšanje koncentracije valprojske kisline lahko povzroči neustrezno obvladanje napadov krčev, zato sočasna uporaba imipenema in valprojske kisline oz. natrijevega valproata ni priporočljiva in je treba razmisliti, če ne bi uporabili drugih protibakterijskih ali antiepileptičnih zdravil (glejte poglavje 4.4).
English: * A further proportionate reduction in dose administered must be made for patients with a body weight
Slovenian: * Dodatno sorazmerno zmanjšanje uporabljenega odmerka je potrebno pri bolnikih s telesno maso < 70 kg.
English: Imipenem, also referred to as N-formimidoyl-thienamycin, is a semi-synthetic derivative of thienamycin, the parent compound produced by the filamentous bacterium Streptomyces cattleya.
Slovenian: Imipenem (N-formimidoil-tienamicin) je pol-sintezni derivat tienamicina, matične spojine, ki jo izdeluje filamentozna bakterija Streptomyces cattleya.
English: It is recommended that infections suspected or proven to be due to less susceptible bacterial species (such as Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic patients with a fever) should be treated with 25/25 mg/kg administered every 6 hours.
Slovenian: Priporočeno je, da se pri okužbah, za katere obstaja sum oz. za katere je dokazano, da jih povzročajo manj občutljive vrste bakterij (kot je Pseudomonas aeruginosa), in zelo hudih okužbah (npr. pri nevtropeničnih bolnikih z zvišano telesno temperaturo) bolnike zdravi z odmerki 25/25 mg/kg vsakih 6 ur.
English: The dose recommendations for TIENAM represent the quantity of imipenem/cilastatin to be administered.
Slovenian: Priporočila za odmerjanje zdravila TIENAM pomenijo količino imipenema/cilastatina, ki jo je treba uporabiti.
English: If CNS symptoms continue, the dose of TIENAM should be decreased or discontinued.
Slovenian: Če se simptomi s strani osrednjega živčevja nadaljujejo, je treba odmerek zdravila TIENAM zmanjšati ali uporabo zdravila prekiniti.
English: Non-clinical data reveal no special hazard for humans based on repeated dose toxicity and genotoxicity studies.
Slovenian: Predklinični podatki na osnovi študij toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: TIENAM is to be reconstituted and further diluted (see section 6.2, 6.3 and 6.6) prior to administration.
Slovenian: Zdravilo TIENAM je treba pred uporabo pripraviti in nato razredčiti (glejte poglavja 6.2, 6.3 in 6.6).
English: SPECIAL STORAGE CONDITIONS Do not store above 25C
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 C.
English: However, there are some side effects (such as hallucination, dizziness, somnolence, and vertigo) associated with this product that may affect some patients' ability to drive or operate machinery (see section 4.8).
Slovenian: Vendar lahko nekateri neželeni učinki, povezani s tem zdravilom (kot so halucinacije, omotica, zaspanost in vrtoglavica), pri nekaterih bolnikih vplivajo na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
English: • Complicated skin and soft tissue infections
Slovenian: • zapleteno okužbo kože in mehkih tkiv
English: Multiple dosing has no effect on the pharmacokinetics of either imipenem or cilastatin, and no accumulation of imipenem/cilastatin was observed (see section 4.2).
Slovenian: Večkratno odmerjanje ne vpliva ne na farmakokinetiko imipenema ne na farmakokinetiko cilastatina in kopičenja imipenema/cilastatina niso opazili (glejte poglavje 4.2).
English: TIENAM and associated names (see Annex I) 500 mg/500 mg powder for solution for infusion [See Annex I - To be completed nationally]
Slovenian: TIENAM in z njim povezana imena (glejte Dodatek I) 500 mg/500 mg prašek za raztopino za infundiranje [Glejte Dodatek I - izpolni država članica]
English: For patients with normal renal function (creatinine clearance of >70 ml/min/1.73 m2), the recommended dose regimens are:
Slovenian: Za bolnike z normalnim delovanjem ledvic (očistek kreatinina > 70 ml/min/1,73 m2) so priporočene sheme odmerjanja:
English: Common diarrhoea, vomiting, nausea Medicinal product-related nausea and/or vomiting appear to occur more frequently in granulocytopenic patients than in nongranulocytopenic patients treated with TIENAM
Slovenian: Pogosti driska, bruhanje, navzea Kaže, da se z zdravilom povezana navzea in/ali bruhanje med zdravljenjem z zdravilom TIENAM pogosteje pojavita pri granulopeničnih kot pri negranulopeničnih bolnikih.
English: Hence close adherence to recommended dose schedules is urged especially in these patients (see section 4.2).
Slovenian: Zato je treba še zlasti pri teh bolnikih natančno upoštevati priporočene razporede odmerkov (glejte poglavje 4.2).
English: Therefore, your doctor will decide whether you should use TIENAM while breast-feeding.
Slovenian: Zato bo zdravnik presodil, ali naj med obdobjem dojenja prejemate zdravilo TIENAM.
English: Clinical data are insufficient to recommend dosing for paediatric patients with renal impairment (serum creatinine > 2 mg/dl).
Slovenian: Kliničnih podatkov ni dovolj, da bi bilo mogoče priporočiti odmerjanje za otroke z okvaro ledvic (kreatinin v serumu > 2 mg/dl).
English: TIENAM should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the foetus.
Slovenian: Zdravila TIENAM se med nosečnostjo ne sme uporabljati, razen če zdravnik presodi, da možna korist upravičuje možno tveganje za plod.
English: TIENAM may be used in the management of patients with low white blood cell counts, who have fever that is suspected to be due to a bacterial infection.
Slovenian: Zdravilo TIENAM se lahko uporablja za zdravljenje bolnikov, ki imajo majhno število belih krvnih celic in zvišano telesno temperaturo, za katero sumimo, da je posledica bakterijske okužbe.
English: Cilastatin sodium is a competitive, reversible and specific inhibitor of dehydropeptidase-I, the renal enzyme which metabolizes and inactivates imipenem.
Slovenian: Natrijeva sol cilastatina je kompetitiven, reverzibilen in specifičen zaviralec dehidropeptidaze-I, ledvičnega encima, ki presnovi in inaktivira imipenem.
English: For paediatric patients ≥1 year of age, the recommended dose is 15/15 or 25/25 mg/kg/dose administered every 6 hours.
Slovenian: Za pediatrične bolnike, stare ≥1 leto, je priporočeni odmerek 15/15 ali 25/25 mg/kg/odmerek, uporabljen na 6 ur.
English: Each dose >500 mg/500 mg should be infused over 40 to 60 minutes.
Slovenian: Vsak odmerek > 500 mg/500 mg je treba infundirati v obdobju od 40 do 60 minut.