FrancophonIA/ELRC3.0 huggingface dataset:
English: This increase in amoxicillin dose clearly makes this ratio more suitable than the 2:1 ratio and this ratio might be appropriate for some indications in at least some areas.
Slovenian: To povečanje odmerka amoksicilina očitno napravi to razmerje primernejše od razmerja 2:1 in to razmerje je morda primernejše za določene indikacije vsaj na določenih področjih.
English: Some infections (e.g. osteomyelitis) require longer periods of treatment.
Slovenian: Nekatere okužbe (npr. osteomielitis) zahtevajo daljše zdravljenje.
English: In children aged one month and older, the higher dosage is recommended for more severe infections.
Slovenian: Pri otrocih, starih en mesec ali več, je večji odmerek priporočen za hujše okužbe.
English: Intra-abdominal sepsis
Slovenian: Intraabdominalna sepsa
English: This is because the daily dose of amoxicillin delivered by this presentation (750 mg) is insufficient to treat these bacteria.
Slovenian: To je zato, ker je dnevni odmerek amoksicilina, ki ga zagotavlja ta oblika (750 mg) nezadosten za zdravljenje okužbe s temi bakterijami.
English: This suggests that the lower doses of amoxicillin as used in some currently-approved regimens are appropriate.
Slovenian: To kaže, da so nižji odmerki amoksicilina, ki se uporabljajo v nekaterih trenutno odobrenih režimih, primerni.
English: The 2:1 ratio has become a well-established dosing regimen in many countries, and has been the subject of numerous clinical studies, many of them by independent research groups and individuals.
Slovenian: Razmerje 2:1 se je kot režim odmerjanja dobro uveljavilo v številnih državah in je bilo predmet številnih kliničnih študij, veliko le-teh so opravile neodvisne raziskovalne skupine in posamezniki.
English: This section contains detailed information of the conditions and special patient groups where Augmentin should be used with caution.
Slovenian: To poglavje vsebuje podrobne podatke o pogojih in posebnih skupinah bolnikov, pri katerih se mora zdravilo Augmentin uporabljati previdno.
English: In order to provide harmonised dosing recommendations for all countries, a standard dosage and higher dosage are proposed for each formulation, for both adults and children.
Slovenian: Za zagotovitev usklajenih priporočil glede odmerjanja v vseh državah je predlagano standardno in večje odmerjanje za vsako formulacijo tako za odrasle bolnike kot tudi za otroke.
English: • Female genital infections.
Slovenian: • okužbe ženskih spolovil.
English: The CHMP requested the withdrawal of the septicaemia indication in general, since the focus of septicaemia has to be treated sufficiently and therefore this indication is not acceptable.
Slovenian: CHMP je zahteval umik indikacije septikemija na splošno, saj je treba zadostno zdraviti žarišče septikemije, zato ta indikacija ni sprejemljiva.
English: For animal bites, the administration of oral or parenteral antibiotics depends on the depth and severity of the wound and on the time since the bite occurred.
Slovenian: Pri ugrizih živali je uporaba peroralnih ali parenteralnih antibiotikov odvisna od globine in resnosti rane ter od časa, ki je pretekel od ugriza.
English: Empirical antibacterial therapy must provide broad-spectrum coverage of both aerobic and anaerobic pathogens.
Slovenian: Empirična protibakterijska terapija mora zagotoviti širokospektralno pokrivanje tako aerobnih kot tudi anaerobnih patogenov.
English: The recommendations for dosing patients with reduced renal and hepatic function have also been simplified and harmonised.
Slovenian: Priporočila za odmerjanje pri bolnikih z zmanjšanim delovanjem ledvic in jeter so bila ravno tako poenostavljena in usklajena.
English: In addition, only a very small concentration of clavulanic acid (0.12mg/l) is needed to restore susceptibility of these isolates to amoxicillin.
Slovenian: Poleg tega je potrebna zelo majhna koncentracija klavulanske kisline (0,12 mg/l) za obnovitev občutljivosti izolatov za amoksicilin.
English: The CHMP agreed that the available evidence for this indication is not sufficient unless supported by clinical data and deleted this indication for all formulations.
Slovenian: CHMP je menil, da razpoložljivi dokazi za to indikacijo niso zadostni, če jih ne podpirajo klinični podatki, zato je to indikacijo izbrisal iz vseh formulacij.
English: See also section 4.4 regarding prolonged therapy.”
Slovenian: Glejte tudi besedilo o podaljšanem zdravljenju v poglavju 4.4.“
English: The CHMP concluded that the 8:1 ratio is comparable to the 7:1 ratio in terms of efficacy and safety data.
Slovenian: CHMP je menil, da je razmerje 8:1 primerljivo z razmerjem 7:1 v smislu podatkov o učinkovitosti in varnosti.
English: While there are no clinical data on the efficacy in CAP in children, it is considered possible to extrapolate from experience in adults.
Slovenian: Čeprav ni kliničnih podatkov o učinkovitosti pri izvenbolnišnično pridobljeni pljučnici pri otrocih, se šteje, da je možno ekstrapolirati izkušnje pri odraslih.
English: As a daily dose of 375 mg is considered to sufficiently inhibit the sensitive beta-lactamases, the proposed statement was considered to better reflect the situation than mentioning of a maximum daily dose.
Slovenian: Ker se dnevni odmerek 375 mg šteje za zadostnega za zaviranje občutljivih beta laktamaz, se šteje, da predlagana izjava bolje odraža situacijo kot pa omemba največjega dnevnega odmerka.
English: • Acute bacterial sinusitis (adequately diagnosed)
Slovenian: • akutni bakterijski sinusitis (po primerni diagnozi)
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF AUGMENTIN AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA AUGMENTIN IN POVEZANIH IMEN (GLEJTE DODATEK I)
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora.
English: Tonsilitis
Slovenian: Tonzilitis
English: A higher regimen may be appropriate in some indications, and in regions with higher prevalence of resistant organisms, even if the infection is not categorised as ‘severe'.
Slovenian: Večji režim je primeren za določene indikacije in na področjih z višjo pogostnostjo odpornih organizmov, čeprav okužba ni razvrščena kot „huda“.
English: In adults, AOM is rare but the bacteria involved are the same as in children and the therapeutic choices do not differ.
Slovenian: Pri odraslih je akutno vnetje srednjega ušesa redko, vendar so vpletene bakterije enake kot pri otrocih in se terapevtske možnosti ne razlikujejo.
English: Data are lacking to support a specific mention of an acceptable maximal daily dose of clavulanic acid.
Slovenian: Podatkov v podporo posebni omembi sprejemljivega največjega dnevnega odmerka klavulanske kisline ni.
English: At the time, the Augmentin 4:1 ratio was widely used for treating infections in children.
Slovenian: V tistem času je bilo zdravilo Augmentin z razmerjem 4:1 na široko uporabljano za zdravljenje okužb pri otrocih.
English: POSOLOGY IN SPECIAL PATIENT POPULATIONS
Slovenian: ODMERJANJE ZA POSEBNE SKUPINE BOLNIKOV
English: These two ratios allow flexibility of the amoxicillin dosage, whilst delivering an appropriate clavulanic acid unit dose.
Slovenian: Ti dve razmerji omogočata fleksibilnost odmerjanja amoksicilina ob sočasnem vnosu primerne odmerne enote klavulanske kisline.
English: Proposals were made for each sub-section (“Mode of Action” and “Mechanisms of resistance”, “PK/PD relationship” and “Breakpoints”).
Slovenian: Pripravljeni so bili predlogi za vsako podpoglavje („Način delovanja“ in „Mehanizem odpornosti“, „Zveza med farmakokinetiko in farmakodinamiko“ ter „Prelomne točke“).
English: Safety data indicates that prolonged administration does not increase the incidence and severity of side effects compared to shorter therapeutic courses.
Slovenian: Podatki o varnosti kažejo, da podaljšano dajanje ne poveča pojavnosti in resnosti neželenih učinkov v primerjavi s krajšimi terapijami.
English: The CHMP concluded that this general indication is not acceptable as neither amoxicillin/clavulanic acid nor amoxicillin are currently indicated for the treatment of diseases caused by N. gonorrhoeae.
Slovenian: CHMP je zaključil, da ta splošna indikacija ni sprejemljiva, saj niti kombinacija amoksicilin/klavulanska kislina niti amoksicilin trenutno nista indicirana za zdravljenje bolezni, ki jih povzroča N. gonorrhoeae.
English: Resistance to amoxicillin in S. pneumoniae is currently low in a number of Member States, with the majority of MICs ≤ 1 μg/mL.
Slovenian: Odpornost S. pneumoniae proti amoksicilinu je v državah članicah trenutno nizka, večina vrednosti MIC je ≤ 1 μg/mL.
English: Clear clinical signs of infection at operation will require a normal course of intravenous or oral therapy post-operatively.
Slovenian: Očitni klinični znaki okužbe po operaciji zahtevajo normalen potek pooperativne intravenske ali peroralne terapije.
English: A full and comprehensive user testing of the PL was carried out, and the CHMP considered that the two legibility test reports provided, together with the bridging reports, are acceptable.
Slovenian: Opravljeno je bilo popolno in obsežno preskušanje navodila za uporabo pri uporabnikih in CHMP je menil, da sta dve poročili o berljivosti skupaj s premostitvenimi poročili sprejemljivi.
English: The CHMP considered that most acute bronchitis are of viral aetiology and the systematic need for antibiotic treatment is questionable.
Slovenian: CHMP je menil, da je večina akutnih bronhitisov virusnega vzroka, zato je sistematična potreba po antibiotičnem zdravljenju vprašljiva.
English: The benefit/risk assessment conducted by the CHMP has not addressed the use of these products in other markets, where different resistance patterns may apply.
Slovenian: CHMP v oceni razmerja med koristmi in tveganji ni obravnaval uporabe omenjenih zdravil na drugih trgih, ki imajo morda drugačne vzorce odpornosti.
English: Augmentin ES suspension is recommended for dosing at 90/6.4 mg/kg/day in two divided doses at 12-hourly intervals for 10 days.
Slovenian: Zdravilo Augmentin ES suspenzija se priporoča za odmerjanje 90/6,4 mg/kg/dan v dveh razdeljenih odmerkih v 12-urnih časovnih presledkih v obdobju 10 dni.
English: A recommended therapy is amoxicillin/clavulanic acid, especially if no bacteriological markers are available.
Slovenian: Priporočeno zdravljenje je kombinacija amoksicilin/klavulanska kislina, zlasti če niso na voljo bakteriološki označevalci.
English: In order to pre-empt this situation the CHMP stated that:
Slovenian: Za preprečitev te situacije je CHMP izjavil naslednje:
English: The CHMP considered a contraindication for all beta-lactams to be inappropriate and unnecessarily restrictive, potentially excluding the use of several beta-lactams in patients who could receive them safely.
Slovenian: CHMP je štel, da je kontraindikacija za vse beta laktame neprimerna in nepotrebno omejitvena ter da potencialno izključuje uporabo več beta laktamov pri bolnikih, ki bi jih lahko varno prejeli.
English: The time above minimum inhibitory concentration (T>MIC) is one of the major determinants of efficacy for β-lactam antibacterials.
Slovenian: Trajanje nad najmanjšo inhibitorno koncentracijo (T>MIC) je ena od poglavitnih determinant učinkovitosti betalaktamskih protibakterijskih zdravil.
English: • Augmentin ES (Extra Strength) and Sustained Release (SR), developed to meet specific clinical needs related to the occurrence of resistant pathogens.
Slovenian: • Augmentin ES (dodatna jakost) in podaljšano sproščanje (SR), razviti za izpolnjevanje specifičnih kliničnih potreb v zvezi s pojavom odpornih patogenov.
English: The CHMP adopted a harmonised text for this section.
Slovenian: CHMP je sprejel usklajeno besedilo tega poglavja.
English: Amoxicillin/clavulanic acid is not recommended for intra-abdominal sepsis.
Slovenian: Kombinacija amoksicilin/klavulanska kislina ni priporočena za intraabdominalno sepso.
English: This has been shown in in-vitro studies, in-vivo in numerous animal models, and has been confirmed by clinical trial data.
Slovenian: To je bilo dokazano v študijah in vitro, številnih živalskih modelih in vivo ter potrjeno s podatki kliničnih preskušanj.
English: The paediatric recommendations have been harmonised according to weight ranges rather than age, with the sole exception of a lower age limit for very young patients.
Slovenian: Priporočila za otroke so bila usklajena po razponih telesne mase in ne po starosti, pri čemer je edina izjema spodnja starostna omejitev za zelo mlade bolnike.
English: In addition, the number of intermediate penicillin susceptibility strains should also be considered, creating a need for high concentrations of amoxicillin.
Slovenian: Poleg tega je treba upoštevati tudi število sevov z vmesno občutljivostjo za penicilin, zaradi česar se je pojavila potreba po višjih koncentracijah amoksicilina.
English: The data is largely from the extensive published literature and includes comparative data with other antibacterial agents in a range of infections for which Augmentin is indicated.
Slovenian: Podatki izvirajo večinoma iz obsežne objavljene literature in vključujejo primerljive podatke o drugih protibakterijskih zdravilih za številne okužbe, za katere je zdravilo Augmentin indicirano.
English: Augmentin SR plays an important role in the management of infections, particularly in countries and local areas of high levels of S. pneumoniae resistance.
Slovenian: Zdravilo Augmentin SR ima pomembno vlogo pri obravnavi okužb, zlasti v državah in lokalnih področjih z visokimi ravnmi odpornosti pri S. pneumoniae.
English: Therefore any future applications for marketing authorisation for Augmentin presentations should be supported by a discussion of the appropriateness of those specific presentations for the selected Concerned Member States.
Slovenian: Zato je treba vse bodoče vloge za odobritev oblike zdravila Augmentin podpreti z razpravo o primernosti zadevne oblike za izbrano zadevno državo članico.
English: In recent years the MAH has developed a pro-active process for identifying safety signals, consisting of the ongoing review of important individual cases, the review of aggregate adverse event data through the use of disproportional analyses and the review of published medical literature.
Slovenian: V zadnjih letih so imetniki dovoljenj za promet z zdravilom razvili proaktiven proces za identifikacijo varnostnih signalov, ki obsega stalno pregledovanje pomembnih posameznih primerov, pregled združenih podatkov o neželenih učinkih z neproporcionalnimi analizami ter pregled objavljene medicinske literature.
English: In addition, the use of Augmentin should be restricted to indications where both components are needed.
Slovenian: Poleg tega je treba uporabo zdravila Augmentin omejiti na indikacije, kjer sta potrebni obe komponenti.
English: The indications are supported by clinical data, T>MIC values, and publications in peer-reviewed journals.
Slovenian: Indikacije podpirajo klinični podatki, vrednosti T>MIC in objave v strokovno recenziranih revijah.
English: The CHMP agreed, as it should result in a standard daily dose of clavulanic acid for all formulations with 125 mg clavulanic acid per dose.
Slovenian: CHMP se je strinjal, saj bo posledica standardni dnevni odmerek klavulanske kisline za vse formulacije s 125 mg klavulanske kisline na odmerek.
English: The frequency of administration was revised, as it should not be greater than three times a day (every 8 hours), based on the maximum dose for clavulanic acid which should not be exceeded without clear scientific evidence.
Slovenian: Pogostost dajanja je bila popravljena, saj ne sme biti pogostejša od trikrat dnevno (vsakih 8 ur), kar temelji na največjem odmerku klavulanske kisline, ki se ne sme preseči brez jasnih znanstvenih dokazov.
English: • The 8:1 ratio formulations, for general use in the renally-normal population, approved in France only, and associated with their own set of indications.
Slovenian: • Formulacije z razmerjem 8:1 za splošno uporabo pri bolnikih brez okvar delovanja ledvic, odobrene samo v Franciji v povezavi z njihovim lastnim naborom indikacij.
English: Bone infections represent a diagnostic or therapeutic challenge as numerous exogenous and endogenous factors contribute to the onset of bone/joint infection.
Slovenian: Okužbe kosti so diagnostični ali terapevtski izziv, saj k pojavu okužbe kosti/sklepa prispevajo številni eksogeni in endogeni dejavniki.
English: There is no clinical data for children under 1 month of age.
Slovenian: Klinični podatki za otroke, mlajše od 1 meseca, niso na voljo.
English: A text was included in Section 4.4 for all formulations to reiterate that Augmentin should be used with caution in patients with hepatic impairement.
Slovenian: V poglavje 4.4 je bilo za vse formulacije vključeno besedilo, kjer je ponovljeno, da je treba pri bolnikih z okvarjenim delovanjem jeter zdravilo Augmentin uporabljati previdno.
English: The CHMP disagreed as the restriction to three times a day is based on the maximum dose for clavulanic acid which should not be exceeded without clear scientific evidence.
Slovenian: CHMP se ni strinjal, saj omejitev na dajanje trikrat dnevno temelji na največjem odmerku klavulanske kisline, ki se ne sme preseči brez jasnih znanstvenih dokazov.
English: The discussion also focused on treatment duration and the CHMP agreed to amend Section 4.2 of the SPC.
Slovenian: Razprava se je osredotočila tudi na trajanje zdravljenja in CHMP se je strinjal s spremembo poglavja 4.2 povzetka glavnih značilnosti zdravila.
English: Although many pathogens important for urinary tract infections exhibit resistance rates of > 10% towards Augmentin, it is considered a suitable alternative, as all antimicrobial agents with this indication share the problem and the choice of the agent depends on the patient and epidemiological situation.
Slovenian: Čeprav imajo številni patogeni, pomembni pri okužbah sečil, stopnje odpornosti proti zdravilu Augmentin >10 %, se to zdravilo šteje za primerno alternativo, saj imajo vsa protimikrobna zdravila s to indikacijo enako težavo, zato je izbira zdravila odvisna od bolnika in epidemiološke situacije.
English: A Cochrane review concluded that antibiotic treatment in patients with acute bronchitis had a modest beneficial effect not outweighing the side-effects of treatment.
Slovenian: V Cochranovem pregledu so zaključili, da je imelo antibiotično zdravljenje pri bolnikih z akutnim bronhitisom skromen koristen učinek, ki ne odtehta neželenih učinkov zdravljenja.
English: For infections other than acute media otitis, initial antibiotic therapy is not usually recommended.
Slovenian: Za okužbe, kjer ne gre za akutno vnetje srednjega ušesa, začetno antibiotično zdravljenje ponavadi ni priporočeno.
English: The benefit/risk assessment for the series of formulations approved in different Member States was conducted with reference to the existing resistance patterns in those Member States where the product is marketed.
Slovenian: Opravljena je bilo ocena razmerja med koristmi in tveganji za niz formulacij, ki so odobrene v državah članicah z upoštevanjem obstoječih vzorcev odpornosti v državah članicah, kjer je zdravilo v prometu.
English: The CHMP noted the MAH presentation and summary of the different available data of this section and agreed and adopted a harmonised text.
Slovenian: CHMP se je seznanil s predstavitvijo in povzetkom različnih razpoložljivih podatkov, ki so ju za to poglavje predložili imetniki dovoljenj za promet, ter potrdil in sprejel usklajeno besedilo.
English: Intravenous Augmentin is indicated for treatment of infections that are considered to require parenteral therapy because of the seriousness of the infection, or where the patient is unable to tolerate oral therapy.
Slovenian: Intravensko zdravilo Augmentin je indicirano za zdravljenje okužb, za katere se šteje, da zahtevajo parenteralno terapijo zaradi resnosti okužbe, ali kadar bolnik ni zmožen tolerirati peroralne terapije.
English: The PK of the clavulanic acid components are the same as the conventional Augmentin formulations.
Slovenian: Farmakokinetika komponente klavulanska kislina je enaka kot pri običajnih formulacijah zdravila Augmentin.
English: For example, the 250/125 mg tablets are not suitable for use in any EU Member State in which penicillin-insusceptible or penicillin-resistant Streptococcus pneumoniae occur commonly.
Slovenian: Na primer, 250/125 mg tablete so neprimerne za uporabo v vseh državah članicah, kjer se pogosto pojavljajo za penicilin neobčutljivi Streptococcus pneumoniae ali proti penicilinu odporni Streptococcus pneumoniae.
English: Accordingly, metabolic drug interactions affecting the levels of either compound to a significant extent are unlikely to be of clinical significance.
Slovenian: Skladno s tem ni verjetno, da bi bile presnovne interakcije z zdravili, ki bistveno vplivajo na raven katerekoli od obeh spojin, klinično pomembne.
English: The MAH provided comparative and non-comparative clinical studies establishing safety and efficacy and listed the studied indications.
Slovenian: Imetniki dovoljenj za promet z zdravilom so predložili primerjalne in neprimerjalne klinične študije, ki dokazujejo varnost in učinkovitost, ter navedli preučene indikacije.
English: Skin and Soft Tissue Infections
Slovenian: Okužbe kože in mehkih tkiv
English: However, for 1.1 g amoxicillin/clavulanic acid given intravenously three times daily, T>MIC was present for 40% of the dosing interval for pathogens with an MIC of up to 4 μg/mL.
Slovenian: Vendar je bil pri dajanju 1,1 g kombinacije amoksicilina/klavulanske kisline intravensko trikrat dnevno T>MIC prisoten v 40 % odmernega intervala za patogene z MIC do 4 μg/mL.
English: Treatment of recurrent tonsillitis with Augmentin is based on the assumption that betalactamases of other bacteria of the oral cavity excrete their betalactamse in the environment and so inactivate unprotected penicillins.
Slovenian: Zdravljenje ponovitev tonzilitisa z zdravilom Augmentin temelji na predpostavki, da druge bakterije v ustni votlini izločajo lastne beta laktamaze v okolje ter s tem inaktivirajo nezaščitene peniciline.
English: Statements regarding the treatment of elderly patients (>60 years), the possible effect of amoxicillin on glucose tests, Glucose-Galactose Malapsorption and false-positive test results with the Platelia Aspergillus antigen test during treatment were discussed.
Slovenian: Obravnavali so izjave o zdravljenju starostnikov (>60 let), možnih učinkih amoksicilina na določanje glukoze, malabsorpciji glukoze-galaktoze, lažno pozitivnih rezultatih antigenskih testov Platelia Aspergillus med zdravljenjem.
English: Section 4.1 -Therapeutic indications
Slovenian: Poglavje 4.1 - Terapevtske indikacije
English: The IV and oral formulations facilitate switch or sequential therapy from initial intravenous therapy to subsequent oral treatment.
Slovenian: Intravenozna in peroralna formulacija omogočata prehod ali zaporedno zdravljenje z začetnega intravenskega zdravljenja na kasnejše peroralno zdravljenje.
English: No clinical data are available on doses higher than 45/6.4 mg/kg/day in children under 2 years and dosing recommendations in this population can therefore not be made.
Slovenian: Klinični podatki o odmerkih, višjih od 45/6,4 mg/kg/dan pri otrocih, mlajših od 2 let, niso na voljo, zato priporočila za odmerjanje v tej populaciji niso možna.
English: History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid (see section 4.8).”
Slovenian: Anamneza zlatenice/okvarjenega delovanja jeter zaradi kombinacije amoksicilina/klavulanske kisline (glejte poglavje 4.8).“
English: Due to such drug-resistant pathogens, this high-dose formulation could be acceptable for treatment of CAP.
Slovenian: Zaradi takšnih odpornih patogenov je ta visokoodmerna formulacija lahko sprejemljiva za zdravljenje izvenbolnišnično pridobljene pljučnice.