FrancophonIA/ELRC3.0 huggingface dataset:
English: HOW TO USE MERONEM
Slovenian: KAKO UPORABLJATI ZDRAVILO MERONEM
English: - the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
Slovenian: - obseg napotitvenega postopka je bil uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo,
English: The amount of liquid that you need is shown in the table below: Dose of Meronem Amount of ‘Water for Injections' needed for dilution 500 mg (milligrams) 10 ml (milliliters) 1 g (gram)
Slovenian: Količina "vode za injekcije", potrebna za razredčenje 500 mg (miligramov) 10 ml (mililitrov) 1 g (gram)
English: Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8).
Slovenian: Obstajajo redka poročila o napadih med zdravljenjem s karbapenemi, vključno z meropenemom (glejte poglavje 4.8).
English: The CHMP finally agreed the following indication:
Slovenian: Odbor CHMP se je končno strinjal z naslednjo indikacijo:
English: There are no established dose recommendations for patients receiving peritoneal dialysis.
Slovenian: Za bolnike na peritonealni dializi ni oblikovanih priporočil za odmerjanje.
English: Do not stop having Meronem until your doctor tells you to.
Slovenian: Če ste prenehali uporabljati zdravilo Meropenem Ne nehajte uporabljati zdravila Meronem, dokler vam tega ne naroči zdravnik.
English: As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy.
Slovenian: Iz previdnosti se je uporabi meropenema med nosečnostjo bolje izogniti.
English: Slowly push the plunger of the syringe to give the antibiotic steadily over about 5 minutes.
Slovenian: Počasi potiskajte bat brizge, da boste antibiotik enakomerno dajali približno 5 minut.
English: "CANA" SA Pharmaceutical laboratories
Slovenian: CANA Pharmaceutical Laboratories Societe Anonyme
English: A dose is usually given every 8 hours.
Slovenian: Odmerek se po navadi uporabi na 8 ur.
English: However you may receive a dose less often if your kidneys do not work very well.
Slovenian: Če pa vam ledvice ne delujejo dobro, boste odmerek morda dobili manj pogosto.
English: The CHMP agreed with the following information added by the MAH in section 4.3 of the SPC on hypersensitivity to any other carbapenem antibacterial agent and severe hypersensitivity (eg anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (eg penicillins or cephalosporins).
Slovenian: CHMP se je strinjal, da imetnik dovoljenja za promet z zdravilom doda naslednje informacije v poglavje 4.3 povzetka glavnih značilnosti zdravila, ki se navezujejo na prekomerno občutljivost za katera koli druga karbapenemska protibakterijska zdravila in na hudo preobčutljivost (npr. anafilaktična reakcija, huda reakcija kože) za katero koli drugo vrsto betalaktamskih protibakterijskih sredstev (npr. penicilini ali cefalosporini).
English: Animal studies indicate that meropenem is well tolerated by the kidney.
Slovenian: Študije na živalih kažejo dobro ledvično prenašanje meropenema.
English: In summary, the CHMP harmonised the posology, for both adults and adolescents, and children over 50 kg body weight of 500 mg or 1 g (to be administered every 8 hours) and for children from 3 months (and under) to 11 years of age and up to 50 kg body weight a dose of 10 or 20 mg/kg (administered every 8 hours) for the following indications: Pneumonia , including community acquired pneumonia and nosocomial pneumonia Complicated urinary tract infections Complicated intra-abdominal infections Intra- and post-partum infections (for adults only) Complicated skin and skin tissue infections
Slovenian: CHMP je v povzetku uskladil odmerjanje zdravila za odrasle, mladostnike in otroke s telesno maso nad 50 kg, pri katerih se uporablja 500 mg ali 1 g zdravila (ki se daje vsakih 8 ur), ter za otroke od 3 mesecev do 11 let starosti in s telesno maso do 50 kg, pri katerih se uporablja odmerek od 10 do 20 mg/kg (ki se daje vsakih 8 ur) za naslednje indikacije: pljučnica, vključno z izvenbolnišnično pridobljeno pljučnico in bolnišnično pridobljeno pljučnico, zapletene okužbe sečil, zapletene intraabdominalne okužbe, okužba med porodom in po njem (samo za odrasle), zapletene okužbe kože in kožnih tkiv.
English: The usual dose is between 10 mg and 40 mg of Meronem for each kilogram (kg) that the child weighs.
Slovenian: Po navadi je odmerek od 10 do 40 mg zdravila Meronem na kilogram (kg) otrokove telesne mase.
English: Hold the syringe upright, with the needle pointing upwards.
Slovenian: Držite brizgo pokonci in tako, da je igla obrnjena navzgor.
English: Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs).
Slovenian: Meropenem zavre sintezo bakterijske celične stene grampozitivnih in gramnegativnih bakterij z vezavo na penicilin vežoče beljakovine (PBP - penicillin-binding proteins) in tako deluje baktericidno.
English: • Meronem is a white to light yellow powder for solution for injection or infusion in vial.
Slovenian: • Zdravilo Meronem je bel do svetlo rumen prašek za raztopino za injiciranje ali infundiranje v viali.
English: The CHMP noted that EU countries themselves do not consider that CLSI breakpoints are required in addition to the EUCAST breakpoints.
Slovenian: CHMP je navedel, da države EU ne menijo, da so poleg prelomnih točk testiranja občutljivosti za protimakrobna zdravila (EUCAST) potrebne tudi prelomne točke Inštituta za klinične in laboratorijske standarde (CLSI).
English: Once you have finished giving the antibiotic, remove the syringe and use a flush as recommended by your doctor or nurse.
Slovenian: Ko končate dajanje antibiotika, brizgo odstranite in opravite izpiranje, kot vam je naročil zdravnik ali medicinska sestra 4.
English: It was therefore accepted by the CHMP that the severity of the general condition of the patients and treatment outcome are sufficiently different to prevent the extrapolation of efficacy in VAP from the efficacy in HAP.
Slovenian: Odbor CHMP je zaradi tega sprejel, da sta resnost splošnega stanja bolnikov in izid zdravljenja dovolj različna, da onemogočata ekstrapolacijo učinkovitosti pri pljučnici, povezani z ventilatorjem, iz učinkovitosti pri zunajbolnišnični pljučnici.
English: EUCAST clinical MIC breakpoints for meropenem (2009-06-05, v 3.1) Organism
Slovenian: Klinične mejne vrednosti MIK za meropenem po EUCAST (5. 6. 2009, različica 3.1) Organizem občutljiv (O) (mg/l)
English: • if you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meronem
Slovenian: • če ste alergični (preobčutljivi) na meropenem ali katerokoli sestavino zdravila Meronem (naštete so v poglavju 6, Dodatne informacije).
English: Slovak Republic: Meronem 500mg i.v.
Slovenian: Slovaška: Meronem 500mg i.v.
English: Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem.
Slovenian: Probenecid tekmuje z meropenemom za aktivno tubulno sekrecijo in tako zavira ledvično izločanje meropenema.
English: Uncommon urticaria
Slovenian: Občasni urtikarija
English: The CHMP considered that co-administration of probenecid and meropenem is not expected to have clinical consequences, in view of the limited increase.
Slovenian: Odbor CHMP je menil, da se ob upoštevanju omejenega povečanja za sočasno dajanje probenecida in meropenema ne pričakuje kliničnih posledic.
English: Section 6.5 - Nature and contents of container
Slovenian: Poglavje 6.5 - Vrsta ovojnine in vsebina
English: Giving Meronem through a port or central line 1.
Slovenian: Dajanje zdravila Meronem skozi nastavek ali centralni kanal 1.
English: There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection.
Slovenian: Malo je podatkov o varnosti, ki pri otrocih podpirajo dajanje odmerka 40 mg/kg v intravenski bolusni injekciji.
English: MIC summary data for the common lung pathogens in patients with CF isolated from two studies were also presented.
Slovenian: Predstavljen je bil tudi povzetek podatkov o MIC za splošne pljučne povzročitelje bolezni pri bolnikih s cistično fibrozo, ki so jih izolirali iz dveh študij.
English: • Changes in blood tests, including tests that show how well your liver is working.
Slovenian: • Spremembe v izvidih preiskav krvi, vključno s preiskavami delovanja ledvic.
English: The AUC of the microbiologically inactive ring opened metabolite was also considerably increased in patients with renal impairment.
Slovenian: Bolnikom z okvaro ledvic se občutno poveča tudi AUC mikrobiološko neaktivnega presnovka z razklenjenim obročem.
English: The intravenous formulation was well tolerated in animal studies.
Slovenian: Živali v študijah so intravensko obliko dobro prenašale.
English: Driving and using machines No studies on the effect on the ability to drive and use machines have been performed.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
English: You must then hold both the syringe and the vial and turn the vial upside down.
Slovenian: Potem morate prijeti brizgo in vialo ter vialo obrniti na glavo.
English: • Sudden onset of a severe rash or blistering or peeling skin.
Slovenian: • Nenaden pojav hudega izpuščaja, mehurjev na koži ali lupljenja kože.
English: Adequate clinical trial data to conduct a robust benefit assessment is sparse in CF, but two recent studies evaluating meropenem in combination with tobramycin were discussed by the MAH, one of which remains one of the largest trials undertaken in CF. An improvement in lung function is also evident from meropenem-treated CF patients from two compassionate use programs discussed by the MAH.
Slovenian: Ustrezni podatki kliničnega preskusa za izvajanje robustnega ovrednotenja koristi so pri cistični fibrozi redki, vendar je imetnik dovoljenja za promet z zdravilom kljub temu razpravljal o dveh nedavnih študijah, v katerih so ovrednotili meropenem v kombinaciji z učinkovino tobramicin, pri tem pa ena od obeh študij ostaja eden od največjih preskusov pri cistični fibrozi.
English: Keeping the end of the needle in the liquid, pull back the plunger and draw all the liquid in the vial into the syringe.
Slovenian: Konica igle mora biti v tekočini; potegnite bat nazaj in izvlecite vso tekočino iz viale v brizgo.
English: Gram-positive anaerobes
Slovenian: Grampozitivni anaerobi
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem (see section 4.8).
Slovenian: Zato je na to diagnozo treba pomisliti pri vseh bolnikih, ki med uporabo meropenema ali po njej dobijo drisko (glejte poglavje 4.8).
English: Since the original MAA application, 2 further clinical studies have been conducted in approximately 1050 patients, of which approximately 520 patients received meropenem.
Slovenian: Od izvirne vloge za odobritev dovoljenja za promet z zdravilom so izvedli še dve dodatni klinični študiji pri približno 1 050 bolnikih, od katerih jih je približno 520 prejemalo meropenem.
English: Meronem and associated names (see Annex I) 1 g Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
Slovenian: Meronem in povezana imena (glejte Dodatek I) 1 g Ena viala vsebuje meropenem trihidrat, kolikor ga ustreza 1 g brezvodnega meropenema.
English: For all indications no dose adjustment was considered to be necessary in hepatically impaired patients and in the elderly with normal renal function or creatinine clearance values above 50ml/min, for all indications.
Slovenian: Menil je, da za vse indikacije pri bolnikih s poslabšanim delovanjem jeter in za starostnike z normalno jetrno funkcijo ali vrednostmi kreatininskega očistka nad 50 ml/min, ni potrebno nikakršno prilagajanje odmerka.
English: Dose to be administered every 8 hours
Slovenian: Odmerek, ki ga je treba uporabiti na 8 ur
English: United Kingdom AstraZeneca UK Limited 600 Capability Green Luton
Slovenian: Velika Britanija AstraZeneca UK Limited 600 Capability Green Luton
English: the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Meronem and associated names (see Annex I).
Slovenian: CHMP je priporočil dopolnitev dovoljenj(a) za promet z zdravilom Meronem in z njim povezanih imen (glejte dodatek I), katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
English: Meronem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection
Slovenian: Zdravilo Meronem se lahko uporablja za zdravljenje nevtropeničnih bolnikov s povišano telesno temperaturo, za katero se domneva, da je posledica bakterijske okužbe
English: There was increased evidence of abortions at 500 mg/kg in a preliminary study in monkeys.
Slovenian: V preliminarni študiji na opicah so pri odmerku 500 mg/kg ugotovili povečanje splavov.
English: Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
Slovenian: Pred začetkom zdravljenja z meropenemom je treba natančno poizvedeti, ali je bolnik kdaj imel preobčutljivostno reakcijo na betalaktamske antibiotike.
English: Section 4.4 - Special warnings and precautions for use
Slovenian: Poglavje 4.4 - Posebna opozorila in varnostni ukrepi
English: It should also be noted that considerations for pneumonia are the same for adults and for children.
Slovenian: Poleg tega je treba dodati, da so premisleki glede pljučnice enaki za odrasle in za otroke.
English: 3 Susceptibility of staphylococci to meropenem is inferred from the methicillin susceptibility.
Slovenian: 3 O občutljivosti stafilokokov za meropenem sklepajo na podlagi občutljivosti za meticilin.
English: For broncho-pulmonary infections in cystic fibrosis the CHMP agreed with the MAH proposal for the dosage regimen including the posology 2g/8h in adults and adolescents and children over 50 kg body weight, and 40 mg/kg q8h in children from 3 months (and under) to 11 years of age and up to 50 kg body weight, as higher doses are specifically requested in the treatment of infections due to Acinetobacter or P. aeruginosa.
Slovenian: V primeru bronhopulmonalne okužbe pri cistični fibrozi se je CHMP strinjal z imetnikom dovoljenja za promet z zdravilom glede predloga za režim odmerjanja, ki vključuje odmerjanje 2 g vsakih 8 h pri odraslih, mladostnikih in otrocih s telesno maso nad 50 kg ter 40 mg/kg vsakih 8 h za otroke od 3 mesecev (in mlajših) do 11 let starosti s telesno maso do 50 kg, ker so pri zdravljenju okužb zaradi bakterij Acinetobacter ali P. aeruginosa izrecno potrebni večji odmerki.
English: 500 mg/10 ml for injection or variable concentration for infusion
Slovenian: 500 mg/10 ml za injiciranje ali različne koncentracije za infuzijo
English: Remove the cap on the port or line, clean the end of the line with an alcohol wipe and allow it to dry.
Slovenian: Odstranite zaporko nastavka ali kanala, očistite konec kanala z alkoholnim zložencem in pustite, da se posuši.
English: 14122 Iraklio Attikis Greece
Slovenian: GR-141 22 Iraklion Attikis, Grčija
English: Common inflammation, pain
Slovenian: Pogosti vnetje, bolečina
English: Limited safety data are available to support the 2 g intravenous bolus or the corresponding paediatric 40 mg/kg bolus
Slovenian: V podporo odmerka 2 g za intravenski bolus ali 40 mg/kg za ustrezni pediatrični bolus so na voljo omejeni podatki o varnosti
English: There were AUC increases of 2.4 fold in patients with moderate impairment (CrCL 33-74 ml/min), 5 fold in severe impairment (CrCL 4-23 ml/min) and 10 fold in haemodialysis patients (CrCL <2 ml/min) when compared to healthy subjects (CrCL >80 ml/min).
Slovenian: V primerjavi z zdravimi osebami (očistek kreatinina > 80 ml/min) se je AUC povečala za 2,4-krat pri bolnikih z zmerno okvaro ledvic (očistek kreatinina 33-74 ml/min), 5-krat pri bolnikih s hudo okvaro (očistek kreatinina 4-23 ml/min) in 10-krat pri bolnikih na hemodializi (očistek kreatinina < 2 ml/min).
English: Section 6.6 - Special precautions for disposal and other handling
Slovenian: Poglavje 6.6 - Posebni varnostni ukrepi za odstranjevanje zdravila in ravnanje z njim
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection or infusion.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek za raztopino za injiciranje ali infundiranje.
English: Meronem 1g prasek za raztopino za injiciranje ali infundiranje
Slovenian: Meronem 1g prašek za raztopino za injiciranje ali infundiranje
English: No reports of adverse events associated with inhaled or nebulised meropenem have been received by the MAH.
Slovenian: Imetnik dovoljenja za promet z zdravilom ni prejel nobenih poročil o neželenih učinkih, ki so povezani z inhaliranim meropenemom ali meropenemom, ki se pripravi z nebulatorjem.
English: It was noted that considerations are the same for adults and children.
Slovenian: Ugotovili so, da so premisleki enaki za odrasle in za otroke.
English: Comparison showed consistent pharmacokinetics between the doses and half-lives similar to those observed in adults in all but the youngest subjects (<6 months t1/2 1.6 hours).
Slovenian: Primerjava je pri vseh razen najmlajših preiskovancih (< 6 mesecev t1/2 1,6 ure) pokazala konsistentno farmakokinetiko med odmerki in razpolovnimi časi, podobno tisti pri odraslih.
English: There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes.
Slovenian: Med meropenemom in učinkovinami iz kinolonske, aminoglikozidne, makrolidne in tetraciklinske skupine ni navzkrižne odpornosti na podlagi cilja.
English: 10 or 20 mg/kg
Slovenian: 10 ali 20 mg/kg
English: Remove the needle from the syringe and throw the needle away carefully in your sharps bin.
Slovenian: Odstranite iglo z brizge in iglo previdno odvrzite v vsebnik za ostre odpadke.
English: Oral anti-coagulants
Slovenian: Peroralni antikoagulansi
English: Meronem 500 mg 674 mg powder in a 20 ml Type 1 glass vial with stopper (grey halobutilic rubber with an aluminium cap Meronem 1 g 1348 mg powder in a 30 ml Type 1 glass vial with stopper (grey halobutilic rubber with an aluminium cap)
Slovenian: 674 mg praška v 20-ml viali iz stekla tipa 1 z zamaškom (iz sive halobutilne gume z aluminijasto zaporko).
English: • Acute bacterial meningitis
Slovenian: • akutnega bakterijskega meningitisa.
English: Your doctor will decide whether you should use Meropenem.
Slovenian: Zdravnik bo odločil, ali naj dobite zdravilo Meronem.
English: The CHMP agreed to add the following statement in section 4.2 of the SPC:
Slovenian: CHMP se je strinjal z dodatkom spodnjega besedila v poglavju 4.2 povzetka glavnih značilnosti zdravila:
English: 1g/20 ml (not marketed)
Slovenian: 1g/20 ml (se ne trži)
English: In particular the sub-section specific for neonates was appreciated.
Slovenian: Še posebej dobro je sprejel podpoglavje, ki se nanaša na nedonošenčke.
English: Meropenem is cleared by haemodialysis and haemofiltration.
Slovenian: Meropenem se odstrani s hemodializo in hemofiltracijo.
English: Gram-negative anaerobes
Slovenian: Gramnegativni anaerobi
English: Severe hypersensitivity (eg anaphylactic reaction, severe skin reaction) to any other type of betalactam antibacterial agent (e.g. penicillins or cephalosporins).
Slovenian: Huda preobčutljivost (npr. anafilaktična reakcija, huda kožna reakcija) na katerokoli drugo betalaktamsko protimikrobno zdravilo (npr. na peniciline ali cefalosporine).
English: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7
Slovenian: AstraZeneca Österreich GmbH,
English: • Complicated intra-abdominal infections
Slovenian: • zapletenih intraabdominalnih okužb,
English: Broncho-pulmonary infections in cystic fibrosis
Slovenian: Bronhopulmonalne okužbe pri cistični fibrozi
English: Meronem 500 mg: This medicinal product contains approximately 2.0 mEq of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.
Slovenian: Meronem 500 mg: Zdravilo vsebuje približno 2,0 mEq natrija na 500-mg odmerek.
English: MIC summary data for the common meningitis pathogens isolated from the clinical studies presented in the original MAA.
Slovenian: Podatki povzetka o MIC za splošne patogene meningitisa so izolirani iz kliničnih študij, predstavljenih v izvirni vlogi za odobritev dovoljenje za promet z zdravilom.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Injekcija
English: Meronem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Slovenian: Meropenem se lahko uporablja za zdravljenje nevtropeničnih bolnikov z zvišano telesno temperaturo, če obstaja sum, da je vzrok zvišane temperature bakterijska okužba.
English: No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.
Slovenian: Starejšim bolnikom z normalnim delovanjem ledvic ali očistkom kreatinina nad 50 ml/min odmerka ni treba prilagoditi.
English: Limited post-marketing experience indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction.
Slovenian: Maloštevilne postmarketinške izkušnje kažejo, da se v primeru pojava neželenih učinkov po prevelikem odmerjanju ti učinki skladajo s profilom neželenih učinkov, opisanem v poglavju 4.8.
English: • Intra- and post-partum infections
Slovenian: • intrapartalnih in postpartalnih okužb,
English: There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection.
Slovenian: Malo je podatkov o varnosti, ki podpirajo dajanje 2-g odmerka v intravenski bolusni injekciji.
English: The following wording was therefore agreed by the CHMP:
Slovenian: Zaradi tega se je odbor CHMP strinjal z naslednjim besedilom:
English: • Severe rash, itching or hives on the skin.
Slovenian: • Hudega izpuščaja, srbenja ali koprivnice na koži.
English: • Lung and bronchial infections in patients suffering from cystic fibrosis
Slovenian: • Okužbe pljuč in bronhusov pri bolnikih s cistično fibrozo
English: Haemodialysis will remove meropenem and its metabolite.
Slovenian: Hemodializa odstrani meropenem in njegov presnovek.
English: Dose adjustment is recommended for patients with moderate and severe renal impairment (see section 4.2).
Slovenian: Bolnikom z zmerno in hudo okvaro ledvic je priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
English: • Inflammation of the bowel with diarrhoea.
Slovenian: • Vnetje črevesa z drisko.
English: Section 6.1 - List of excipients
Slovenian: Poglavje 6.1 - Seznam pomožnih snovi
English: Intra- and post-partum infections
Slovenian: Intrapartalne in postpartalne okužbe
English: Meronem 1.0 g: This medicinal product contains approximately 4.0 mEq of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.
Slovenian: Meronem 1,0 g: Zdravilo vsebuje približno 4,0 mEq natrija na 1,0-g odmerek.
English: There have been many reports of increases in the anti-coagulant effects of orally administered anti coagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents.The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (international normalised ratio) is difficult to assess.
Slovenian: Tveganje se lahko razlikuje glede na osnovno okužbo, starost in splošno stanje bolnika, tako da je težko oceniti, kolikšen je vpliv antibiotika na povečanje INR (internacionalnega normaliziranega razmerja).