FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of roflumilast 250 micrograms once-daily was tested in 16 patients with mild to moderate hepatic impairment classified as Child-Pugh A and B. In these patients, the total PDE4 inhibitory activity was increased by about 20% in patients with Child-Pugh A and about 90% in patients with Child-Pugh B. Simulations suggest dose proportionality between roflumilast 250 and 500 micrograms in patients with mild and moderate hepatic impairment.
Slovenian: Farmakokinetiko roflumilasta v odmerku 250 mikrogramov enkrat na dan so preizkusili pri 16 bolnikih z blago do zmerno jetrno okvaro stopnje Child-Pugh A in B. V tej skupini bolnikov je bilo skupno inhibitorno delovanje na PDE4 povečano za približno 20 % pri bolnikih s stopnjo Child-Pugh A in za približno 90 % pri bolnikih s stopnjo Child-Pugh B. Za bolnike z blago in zmerno jetrno okvaro simulacije kažejo sorazmernost z velikostjo odmerkov roflumilast 250 in 500 mikrogramov.
English: The recommended dose is one 500 micrograms tablet once daily.
Slovenian: Priporočeni odmerek je ena tableta 500 mikrogramov enkrat na dan.
English: Libertek tablets contain lactose.
Slovenian: Zdravilo Libertek vsebuje laktozo.
English: • Summary of Product Characteristics and Patient Information Leaflet for Libertek
Slovenian: • Povzetek glavnih značilnosti zdravila in navodilo za uporabo zdravila Libertek
English: If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure.
Slovenian: Če ste vzeli večji odmerek zdravila Libertek, kot bi smeli Če ste vzeli več tablet kot bi smeli, se lahko pojavijo naslednji simptomi: glavobol, slabost, driska, omotica, udarjanje srca, vrtoglavica, vlažna in hladna koža ter nizek krvni tlak.
English: Upon in vitro stimulation of human neutrophils, monocytes, macrophages or lymphocytes, roflumilast and roflumilast N-oxide suppress the release of inflammatory mediators e.g. leukotriene B4, reactive oxygen species, tumor necrosis factor α, interferon γ and granzyme B.
Slovenian: N-oksid po in vitro stimulaciji človeških nevtrofilcev, monocitov, makrofagov ali limfocitov inhibirata sproščanje vnetnih mediatorjev, npr. levkotriena B4, reaktivnih vrst kisika, tumorje nekrotizirajočega faktorja α, interferona γ in grancima B.
English: (i.e. focal haemorrhages, haemosiderin deposits and lympho-histiocytic cell infiltration in the right atria in dogs, and decreased blood pressure and increased heart rate in rats, guinea pigs and dogs).
Slovenian: fokalne krvavitve, depoziti hemosiderina in infiltracija limfo-histiocitnih celic v desnem atriju psov, znižan krvni tlak in povišana frekvenca srca pri podganah, morskih prašičkih in psih).
English: Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Slovenian: Zdravilo Libertek je indicirano za vzdrževalno zdravljenje hude oblike kronične obstruktivne pljučne bolezni (KOPB) (FEV1 po bronhodilatatorju manjši od 50 % pričakovane vrednosti), povezane s kroničnim bronhitisom, pri odraslih bolnikih z anamnezo pogostih poslabšanj bolezni kot dopolnilo zdravljenju z bronhodilatatorji.
English: In clinical studies and post-marketing experience, rare instances of suicidal thinking and behaviour (including suicide) were reported.
Slovenian: V kliničnih študijah in med spremljanjem zdravila po pridobitvi dovoljenja za promet so poročal or redkih primerih samomorilnih misli in vedenja (vključno s samomorom).
English: Libertek is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Slovenian: Zdravilo Libertek uporabljamo za vzdrževalno zdravljenje KOPB pri odraslih, ki so v preteklosti imeli pogosta poslabšanja simptomov KOPB in imajo kronični bronhitis.
English: What Libertek contains - The active substance is roflumilast.
Slovenian: Kaj vsebuje zdravilo Libertek - Zdravilna učinkovina je roflumilast.
English: Post-bronchodilator FEV1 showed a clinically significant improvement in favour of Roflumilast by 56 mL over placebo (95% CI: 38, 73 mL).
Slovenian: Vrednost FEV1 po bronhodilatatorju kaže na klinično pomembno izboljšanje v korist roflumilasta nad placebom za 56 ml (95 % interval zaupanja: 38, 73 ml).
English: In the two six-month studies, pre-bronchodilator FEV1 was significantly improved by 49 ml (primary endpoint, p<0.0001) beyond the bronchodilator effect of concomitant treatment with salmeterol in study M2-127 and by 80 ml (primary endpoint, p<0.0001) incremental to concomitant treatment with tiotropium in study M2-128.
Slovenian: V teh dveh šestmesečnih študijah se je FEV1 pred bronhodilatatorjem statistično pomembno izboljšal za 49 ml (primarni klinični izid, p < 0,0001) preko bronhodilatatorskega učinka sočasnega zdravljenja s salmeterolom v študiji M2-127 in za 80 ml (primarni klinični izid, p < 0,0001) preko učinka sočasnega zdravljenja s tiotropijem v študiji M2-128.
English: Libertek is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Slovenian: Zdravilo Libertek je kontraindicirano pri bolnikih z zmerno ali hudo okvaro jeter (Child-Pugh B ali C).
English: A total of 1935 patients were randomised to double-blind medication and approximately 70% were also using a long-acting muscarinic antagonist (LAMA) through the course of the trial.
Slovenian: Na dvojno slepo zdravljenje je bilo vsega skupaj randomiziranih 1.935 bolnikov, približno 70 % bolnikov pa je med preskušanjem uporabljalo tudi dolgodelujoče antagoniste muskarinskih receptorjev (LAMA).
English: Roflumilast is a PDE4 inhibitor, a non-steroid, anti-inflammatory active substance designed to target both the systemic and pulmonary inflammation associated with COPD.
Slovenian: Roflumilast je inhibitor PDE4, nesteroidna protivnetna zdravilna učinkovina, zasnovana tako, da učinkuje na sistemsko in pljučno vnetje, povezano s KOPB.
English: Libertek may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Slovenian: Zdravilo Libertek lahko jemljete skupaj z drugimi zdravili za zdravljenje KOPB, kot so inhalacijski ali peroralni bronhodilatatorji.
English: The rate (per patient per year) of moderate exacerbations (requiring intervention with systemic glucocorticosteroids) or severe exacerbations (resulting in hospitalisation and/or leading to death) after 1 year was 1.142 with roflumilast and 1.374 with placebo corresponding to a relative risk reduction of 16.9% (95%CI: 8.2% to 24.8%) (primary endpoint, p=0.0003).
Slovenian: Pogostnost (na bolnika na leto) zmernih poslabšanj (ki so zahtevala uporabo sistemskih glukokortikoidov) ali resnih poslabšanj (ki so imela za posledico sprejem v bolnišnico in/ali so povzročila smrt) po 1 letu je znašala 1,142 za roflumilast in 1,374 za placebo, kar pomeni zmanjšanje relativnega tveganja za 16,9 % (95 % interval zaupanja: 8,2 % do 24,8 % (primarni klinični izid, p = 0,0003).
English: In the subgroup of patients with history of frequent exacerbations (at least 2 exacerbations during the last year), the rate of exacerbations was 1.526 with roflumilast and 1.941 with placebo corresponding to a relative risk reduction of 21.3% (95%CI: 7.5% to 33.1%).
Slovenian: V podskupini bolnikov z anamnezo pogostih poslabšanj (vsaj 2 poslabšanji v preteklem letu) je pogostnost poslabšanj znašala 1,526 ob roflumilastu in 1,941 ob placebu, kar pomeni zmanjšanje relativnega tveganja za 21,3 % (95 % interval zaupanja: 7,5 % do 33,1 %).
English: Warnings and precautions Talk to your doctor or pharmacist before taking Libertek
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Libertek se posvetujte z zdravnikom ali s farmacevtom.
English: If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended to discontinue treatment with Libertek.
Slovenian: Če bolniki trpijo zaradi novih ali zaradi poslabšanja psihiatričnih simptomov ali če se ugotovi pojav samomorilnih misli ali poskus samomora, je priporočljivo prekiniti zdravljenje z zdravilom Libertek.
English: That Libertek may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Slovenian: Da zdravilo Libertek lahko povzroči izgubo telesne mase in, da se morajo redno tehtati ter beležiti svojo telesno maso na opozorilno kartico za bolnika.
English: Libertek contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Slovenian: Zdravilo Libertek vsebuje zdravilno učinkovino roflumilast, ki je protivnetno zdravilo, imenovano zaviralec fosfodiesteraze 4.
English: How to store Libertek
Slovenian: Kako jemati zdravilo Libertek
English: Libertek contains lactose
Slovenian: Zdravilo Libertek vsebuje laktozo
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g..multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Libertekshould not be initiated or should be stopped in these patients.
Slovenian: Pomanjkanje izkušenj pri bolnikih z okužbo HIV ali aktivnim hepatitisom, z resnimi imunološkimi boleznimi (npr. multiplo sklerozo, eritematoznim lupusom, multifokalno leukoencefalopatijo) ali na zdravljenju z imunosupresivnimi zdravili (razen kratkotrajnega zdravljenja s sistemskimi kortikosteroidi) in zdravila Libertekse pri teh bolnikih ne sme uvajati oz. ga je treba ukiniti.
English: A total of 2,690 patients were included and randomized in two supportive 1-year studies (M2-111 and M2-112).
Slovenian: V dve podporni enoletni študiji (M2-111 in M2-112) je bilo vključeno in randomizirano skupno 2.690 bolnikov.
English: Posology The recommended dose is 500 micrograms (one tablet) roflumilast once daily.
Slovenian: Odmerjanje Priporočen odmerek je 500 mikrogramov (ena tableta) roflumilasta enkrat na dan.
English: Libertek is not recommended in patients with a history of depression associated with suicidal thinking or behaviour.
Slovenian: Zdravilo Libertek ni priporočljivo za bolnike z anamnezo depresije, ki je bila povezana s samomorilnimi mislimi ali vedenjem.
English: Vomiting Gastro-esophageal reflux disease Dyspepsia
Slovenian: Bolezni prebavil gastritis bruhanje gastroezofagealna refluksna bolezen dispepsija hematohezija zaprtost
English: In study RO-2455-404-RD when compared with the overall population, the total PDE4 inhibitory activity determined from ex vivo unbound fractions was found to be 15% higher in patients ≥75 years of age, and 11% higher in patients with baseline body weight <60 kg (refer to section 4.4).
Slovenian: V študiji RO-2455-404-RD je bilo na osnovi ex vivo nevezanih frakcij ugotovljeno, da je skupno inhibitorno delovanje na PDE4 v primerjavi s splošno populacijo pri bolnikih, starih ≥ 75 let, večje za 15 % in pri bolnikih z izhodiščno telesno maso, manjšo od 60 kg, večje za 11 % (glejte poglavje 4.4).
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C should not take roflumilast (see section 4.3).
Slovenian: Bolniki z zmerno ali hudo jetrno okvaro stopnje Child-Pugh B ali C roflumilast ne smejo jemati (glejte poglavje 4.3).
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Libertek (see section 4.3).
Slovenian: Bolniki z zmerno ali hudo okvaro jeter stopnje Child-Pugh B ali C zdravila Libertek ne smejo jemati (glejte poglavje 4.3).
English: More patients in the roflumilast group (27.6%) than placebo (19.8%) withdrew study medication due to any reason (risk ratio: 1.40; 95%CI: 1.19 to 1.65).
Slovenian: V študiji je bilo zdravljenje zaradi katerega koli razloga prekinjeno pri več bolnikov v skupini z roflumilastom (27,6 %) kot v skupini s placebom (19,8 %) (razmerje tveganja: 1,40; 95 % interval zaupanja: 1,19 do 1,65).
English: Due to lack of relevant experience, treatment with roflumilast should not be initiated or existing treatment with roflumilast should be stopped in patients with severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma), or patients being treated with immunosuppressive medicinal products (i.e.: methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids).
Slovenian: Zaradi pomanjkanja ustreznih izkušenj se zdravljenja z roflumilastom ne sme začeti oz. je potekajoče zdravljenje z roflumilastom treba prekiniti pri bolnikih z resnimi boleznimi imunskega sistema (npr. okužbo s HIV, multiplo sklerozo, eritematoznim lupusom, progresivno multifokalno levkoencefalopatijo), resnimi akutnimi infekcijskimi boleznimi, rakom (razen bazalnoceličnega karcinoma) ali bolnikih na imunosupresivnih zdravilih (t.j.
English: Common side effects (may affect up to 1 in 10 people) - diarrhoea, nausea, stomach ache - weight decrease, decreased appetite - headache
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - driska, siljenje na bruhanje, bolečina v trebuhu - zmanjšanje telesne mase, zmanjšan apetit - glavobol
English: - The other ingredients are: - Core: lactose monohydrate, maize starch, povidone (K90), magnesium stearate, - Coating: hypromellose, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow (E172).
Slovenian: - Obloga: hipromeloza, makrogol 4000, titanov dioksid (E171) in rumeni železov oksid (E172).
English: Rescue medicinal products Libertek is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Slovenian: Zdravila za prvo pomoč Zdravilo Libertekni indicirano kot zdravilo za prvo pomoč pri zdravljenju akutnih bronhospazmov.
English: What Libertek looks like and contents of the pack Libertek 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Slovenian: Libertek 500 mikrogramov filmsko obložene tablete so rumene barve, v obliki črke D in imajo na eni strani izbočeno črko “D”.
English: It is important to continue taking Libertek for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.
Slovenian: Zaradi vzdrževanja normalnega delovanja pljuč je pomembno, da nadaljujete z jemanjem zdravila Libertek tako dolgo, kot vam je predpisal zdravnik, tudi če nimate simptomov.
English: Libertek 500 micrograms tablets roflumilast
Slovenian: Libertek 500 mikrogramov tablete roflumilast
English: Thus, roflumilast treatment is not recommended in patients receiving strong cytochrome P450 enzyme inducers.
Slovenian: Pri bolnikih, ki se zdravijo z močnimi zaviralci encima citokroma P450, uporaba roflumilasta tako ni priporočljiva.
English: - If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
English: These findings consisted mainly of gastrointestinal findings (i.e. vomiting, increased gastric secretion, gastric erosions, intestine inflammation) and cardiac findings
Slovenian: bruhanje, povečano izločanje želodčne kisline, želodčne erozije, vnetje črevesja) in težave s srcem (t.j.
English: Libertek 500 micrograms film-coated tablets
Slovenian: Libertek 500 mikrogramov filmsko obložene tablete
English: (LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Slovenian: Zdravljenje z zdravilom Libertek ni priporočljivo, če imate eno ali več naslednjih bolezni: - resne bolezni imunskega sistema, kot so okužba s HIV, multipla skleroza (MS), eritematozni lupus (EL) ali progresivna multifokalna levkoencefalopatija (PML), - resne akutne infekcijske bolezni, kot sta tuberkuloza ali akutni hepatitis, - raka (razen bazalnoceličnega karcinoma- počasi napredujoča oblika kožnega raka), - resno okvaro srčne funkcije.
English: Libertek 500 micrograms film-coated tablets roflumilast
Slovenian: Libertek 500 mikrogramov filmsko obložene tablete roflumilast
English: You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with Libertek.
Slovenian: V prvih tednih zdravljenja z zdravilom Libertek boste morda imeli drisko, slabost, bolečine v trebuhu ali glavobol.
English: A.
Slovenian: IZ
English: Method of administration
Slovenian: Analizni model
English: Tremor Vertigo Dizziness
Slovenian: Okvara jeter
English: Gastrointestinal disorders Diarrhoea
Slovenian: Bolezni imunskega sistema preobčutljivost angioedem
English: Final study report by 31/03/2021
Slovenian: Končno poročilo o študijido
English: This will reduce the risk of possible problems.
Slovenian: Tako boste zmanjšali tveganje za morebitne težave.
English: • if you are pregnant, think you might be pregnant or are planning to become pregnant
Slovenian: • če ste noseči, mislite, da bi lahko bili noseči, ali če nameravate zanositi;
English: Symptoms of these reactions include:
Slovenian: Med simptomi teh reakcij so:
English: Repeat steps 4 to 6 to rinse the inside of the vial.
Slovenian: Ponovite korake od 4 do 6, da boste sprali notranjost viale.
English: Maximum dose: 6 g per day.
Slovenian: Največji odmerek: 6 g na dan.
English: • positive Coomb's test.
Slovenian: • pozitiven Coombsov test.
English: S=susceptible, R=resistant.
Slovenian: S = občutljivi (susceptible), R = odporni (resistant)
English: See (‘Conditions you need to look out for') in section 4.
Slovenian: Glejte "Stanja, na katera morate biti pozorni" v poglavju 4.
English: If you are having tests:
Slovenian: Če morate opraviti preiskave:
English: Streptococcus A, B, C and G
Slovenian: Streptococcus A, B, C in G
English: Approximate cefuroxime concentration (mg/mL)**
Slovenian: Približna koncentracija cefuroksima (mg/ml)**
English: Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms:
Slovenian: Odpornost bakterij na cefuroksim je lahko posledica enega ali več od naslednjih mehanizmov:
English: This may have significance in the interference in clinical laboratory tests in humans.
Slovenian: To je morda pomembno pri vplivu na klinične laboratorijske preiskave pri človeku.
English: Check that the powder has dissolved, and that the bag has no leaks.
Slovenian: Preverite, da se je prašek raztopil in da vrečka ne pušča.
English: Zinacef is an antibiotic used in adults and children.
Slovenian: Zdravilo Zinacef je antibiotik, ki se uporablja pri odraslih in otrocih.
English: • Intra-abdominal infections (see section 4.4).
Slovenian: • intraabdominalne okužbe (glejte poglavje 4.4);
English: (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
Slovenian: (To so lahko znaki Stevens-Johnsonovega sindroma ali toksične epidermalne nekrolize.)
English: Dispose of the empty Monovial safely.
Slovenian: Prazno monovialo varno zavrzite.
English: No carcinogenicity studies have been performed; however, there is no evidence to suggest carcinogenic potential.
Slovenian: Študije kancerogenosti niso bile izvedene, vendar ni izsledkov, ki bi nakazovali kancerogeni potencial.
English: In many areas, ESBL detection and characterization is recommended or mandatory for infection control purposes.
Slovenian: Na številnih območjih je odkrivanje in karakterizacija ESBL priporočljiva ali obvezna zaradi obvladovanja okužb.
English: These may affect up to 1 in 100 people:
Slovenian: Pojavijo se lahko pri največ 1 od 100 oseb:
English: Amount of water to be added (ml)
Slovenian: Količina dodane vode (ml)
English: • severe allergic reaction.
Slovenian: • huda alergijska reakcija.
English: France - Zinnat
Slovenian: Francija - Zinnat
English: It works by killing bacteria that cause infections.
Slovenian: Deluje tako, da uniči bakterije, ki povzročajo okužbe.
English: The following convention has been utilised for the classification of frequency: very common ≥ 1/10; common ≥ 1/100 to < 1/10, uncommon ≥ 1/1,000 to < 1/100; rare ≥ 1/10,000 to < 1/1,000; very rare < 1/10,000 and not known (cannot be estimated from the available data).
Slovenian: Pri razvrstitvi pogostnosti je bil upoštevan naslednji dogovor: zelo pogosti  1/10, pogosti  1/100 do < 1/10, občasni  1/1.000 do < 1/100, redki  1/10.000 do < 1/1.000, zelo redki < 1/10.000 in ni znano (ni mogoče oceniti iz razpoložljivih podatkov).
English: If you have a kidney problem, your doctor may change your dose.
Slovenian: Če imate težave z ledvicami, vam bo zdravnik morda spremeni odmerek.
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 (MIK), ki jih je postavil EUCAST (European Committee on Antimicrobial Susceptibility Testing), so:
English: • to prevent infections during surgery.
Slovenian: • preprečevanje okužb med operacijami.
English: "click" is heard.
Slovenian: dokler ne zaslišite "klik".
English: Holding it upright, fill the vial to approximately two-thirds capacity by squeezing the bag several times.
Slovenian: Držite vialo pokonci in jo napolnite do približno dveh tretjin, tako da vrečko večkrat stisnete.
English: As necessary, expert advice should be sought when the local prevalence of resistance is known and the utility of the agent in at least some types of infections is questionable.
Slovenian: Glede na potrebe je treba poiskati nasvet strokovnjaka, če je lokalna prevalenca odpornosti znana in je uporabnost tega zdravila vprašljiva pri vsaj nekaterih vrstah okužb.
English: Zinacef is usually be given by a doctor or nurse.
Slovenian: Zdravilo Zinacef vam bo ponavadi dal zdravnik ali medicinska sestra.
English: Zinacef should be prescribed to pregnant women only if the benefit outweighs the risk.
Slovenian: Zdravilo Zinacef se sme nosečnicam predpisati le, če korist odtehta tveganje.
English: • the skin and soft tissue
Slovenian: • kože in mehkih tkiv;
English: Your doctor will consider the benefit of treating you with Zinacef against the risk to your baby.
Slovenian: Zdravnik bo upošteval koristi zdravljenja z zdravilom Zinacef za vas v primerjavi s tveganjem za vašega otroka.
English: Concomitant use with oral anticoagulants may give rise to increased international normalised ratio (INR).
Slovenian: Sočasna uporaba s peroralnimi antikoagulanti lahko še dodatno zviša internacionalno normalizirano razmerje (INR).
English: Compatibility
Slovenian: Kompatibilnost
English: This side effect is more likely if you take Zinacef for a long time.
Slovenian: Ta neželeni učinek je verjetnejši, če zdravilo Zinacef uporabljate dolgo časa.
English: The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data for calculating incidence are not available.
Slovenian: Kategorije pogostnosti neželenih učinkov, ki so navedeni v nadaljevanju, temeljijo na ocenah, saj za večino neželenih učinkov ni na voljo primernih podatkov za izračun.
English: Other side effects Other side effects have occurred in a very small number of people but their exact frequency is unknown:
Slovenian: Drugi neželeni učinki so se pojavili pri zelo majhnem številu bolnikov, njihova natančna pogostnost pa ni znana:
English: Due to its spectrum of activity, cefuroxime is not suitable for the treatment of infections caused by Gramnegative non-fermenting bacteria (see section 5.1).
Slovenian: Zaradi svojega spektra delovanja cefuroksim ni primeren za zdravljenje okužb, ki jih povzročajo nefermentirajoče po Gramu negativne bakterije (glejte poglavje 5.1).
English: Interference with diagnostic tests
Slovenian: Vpliv na diagnostične preiskave