FrancophonIA/ELRC3.0 huggingface dataset:
English: To be taken twice daily for children from 4 years of age weighing less than 40 kg Weight Starting dose: 0.1 ml/kg
Slovenian: Odmerki pri samostojnem zdravljenju, pri otrocih od 4. leta starosti, ki tehtajo manj kot 40 kg(1), ki jih je treba vzeti dvakrat na dan: Telesna masa
English: 10.5 ml (105 mg) 14 ml (140 mg)
Slovenian: 10,5 ml (105 mg)
English: Lacosamide UCB contains sorbitol, sodium, sodium methyl parahydroxybenzoate and aspartame Sorbitol (a type of sugar): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Zdravilo Lakozamid UCB vsebuje sorbitol, natrij, natrijev metilparahidroksibenzoat in aspartam
English: Using Lacosamide UCB with other antiepileptic medicines - Children and adolescents with a body weight of 20 to under 30 kg - This is for information only.
Slovenian: Uporaba zdravila Lakozamid UCB skupaj z drugimi antiepileptiki - otroci in mladostniki, ki tehtajo od 20 kg do manj kot 30 kg - to navodilo je le informativno.
English: To be used twice daily for children and adolescents from 4 years of age weighing 40 kg to under 50 kg: Weight Starting dose: 0.1 ml/kg
Slovenian: Uporaba dvakrat na dan za otroke in mladostnike od 4. leta starosti, ki tehtajo od 40 do manj kot 50 kg:
English: A maximum dose of 250 mg/day is recommended for paediatric patients weighing 50 kg or more and for adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease.
Slovenian: Za pediatrične bolnike, ki tehtajo 50 kg ali več, in pri odraslih bolnikih z resnimi motnjami v delovanju ledvic (CLCR ≤ 30 ml/min) ali s končno ledvično odpovedjo je največji priporočen odmerek 250 mg/dan.
English: How quickly will the treatment start to work?
Slovenian: Kako hitro bo zdravljenje začelo delovati?
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Tega zdravila se ne sme mešati z drugimi zdravili, razen tistih, ki so omenjena v poglavju 6.6.
English: Maintenance dose: 6 months.
Slovenian: Vzdrževalni odmerek: 6 mesecev.
English: Ten of these patients were concomitantly receiving diuretics.
Slovenian: Deset izmed teh bolnikov je sočasno prejemalo diuretike.
English: Your condition should start to clear up within a few days - some women notice an improvement in one day.
Slovenian: Vaše stanje se mora začeti izboljševati v nekaj dneh - nekatere ženske zaznajo izboljšanje v enem dnevu.
English: Additional data were available from a compassionate use study.
Slovenian: Dodatni podatki so bili na voljo iz študije sočutne uporabe.
English: Percent of recommended dose
Slovenian: Odstotek priporočenega odmerka
English: Data from one study were not interpretable due to changes in formulation pathway through the study.
Slovenian: Podatkov ene študije ni bilo mogoče interpretirati zaradi sprememb formulacije med študijo.
English: Usually at least 6 to 8 weeks.
Slovenian: Običajno najmanj 6 do 8 tednov.
English: 2 to 4 weeks, tinea pedis may require treatment for up to 6 weeks
Slovenian: 2 do 4 tedne, pri tinea pedis bi lahko bilo potrebnih do 6 tednov zdravljenja
English: However, growth rates may vary widely in individuals, and by age.
Slovenian: Vendar pa je hitrost rasti lahko pri posameznikih zelo različna in odvisna tudi od starosti.
English: The clinical significance of results obtained in these studies is unknown.
Slovenian: Klinični pomen rezultatov teh študij ni znan.
English: 100% after each dialysis
Slovenian: 100 % po vsaki dializi
English: 14 days
Slovenian: 14 dni
English: S = Susceptible, R = Resistant
Slovenian: S = Občutljive, R = Odporne
English: Creatinine clearance (ml/min)
Slovenian: Očistek kreatinina (ml/min)
English: Consequently, reduction of the dose is needed.
Slovenian: Posledično je potrebno zmanjšanje odmerka.
English: Patients should have their blood pressure monitored continuously.
Slovenian: Pri bolnikih je treba stalno spremljati krvni tlak.
English: Glass vials: 5 years.
Slovenian: Steklene viale: 5 let.
English: Swallow the capsule whole with a glass of water.
Slovenian: Kapsulo pogoltnite celo, s kozarcem vode.
English: Make sure your doctor knows if you are taking any of the following medicines:
Slovenian: Poskrbite za to, da bo vaš zdravnik vedel, če jemljete katerokoli izmed naslednjih zdravil:
English: Up to 28 days.
Slovenian: Do 28 dni.
English: Shake well for 1 to 2 minutes to obtain a homogenous suspension.
Slovenian: Temeljito stresajte 1 do 2 minuti, da dobite homogeno suspenzijo.
English: 7 to 21 days.
Slovenian: 7 do 21 dni.
English: These pharmacokinetic parameter values are higher than analogous values reported for normal young male volunteers.
Slovenian: Te vrednosti farmakokinetičnih parametrov so večje kot ustrezne vrednosti, o katerih so poročali za normalne mlade prostovoljce moškega spola.
English: Although no specific incompatibilities have been noted, mixing with any other medicinal products prior to infusion is not recommended.
Slovenian: Čeprav posebnih inkompatibilnosti niso zabeležili, pa mešanje s katerimkoli drugim zdravilom pred infundiranjem ni priporočljivo.
English: The distribution volume in this age group was about 950 ml/kg.
Slovenian: Volumen porazdelitve v tej starostni skupini je bil okrog 950 ml/kg.
English: From a microbiological point of view, the dilutions should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba razredčene raztopine uporabiti takoj.
English: The dilution is to be made under aseptic conditions.
Slovenian: Razredčevanje je treba opraviti v aseptičnih razmerah.
English: Children to 11 years old
Slovenian: Otroci stari do 11 let
English: It is best to take your capsules at the same time each day.
Slovenian: Najbolje je, da kapsulo vzamete vsak dan ob istem času.
English: A few people develop allergic reactions although serious allergic reactions are rare.
Slovenian: Pri majhnem številu ljudi pride do pojava alergijskih reakcij, čeprav so resne alergijske reakcije redke.
English: It was shown not to be superior to griseofulvin and the overall success rate was less than 20%.
Slovenian: Izkazalo se je, da ni učinkovitejši od grizeofulvina, celotna ocena uspešnosti pa je znašala manj kot 20 %.
English: Any unused suspension should be not be used after this date and should be returned to your pharmacist.
Slovenian: Neuporabljene suspenzije ne smete uporabljati po tem datumu in jo je treba vrniti vašemu farmacevtu.
English: ≤50 (no dialysis) Regular dialysis
Slovenian: ≤50 (brez dialize) Redna dializa
English: After successful treatment of long-term chronic infections, nails occasionally remain disfigured.
Slovenian: Po uspešnem zdravljenju dolgotrajnih kroničnih okužb včasih nohti ostanejo izmaličeni.
English: Intravenous infusion should be administrated at a rate not exceeding 10 ml/minute.
Slovenian: Intravensko infuzijo je treba dati s hitrostjo, ki ne presega 10 ml/minuto.
English: After this initial loading dose, the daily dose (according to indication) should be based on the following table:
Slovenian: Po tem začetnem polnilnem odmerku mora dnevni odmerek (glede na indikacijo) temeljiti na naslednji razpredelnici:
English: As with similar infections in adults, the duration of treatment is based on the clinical and mycological response.
Slovenian: Kot pri podobnih okužbah pri odraslih, trajanje zdravljenja temelji na kliničnem in mikološkem odzivu.
English: This medicine will be given by your doctor or nurse as a slow injection (infusion) into your vein.
Slovenian: To zdravilo vam bo dal vaš zdravnik ali medicinska sestra v obliki počasnega injiciranja (infuzije) v vašo veno.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ° C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če se jih ne uporabi takoj, je za obdobje med uporabo in stanje pred uporabo odgovoren uporabnik, običajno pa ne sme biti daljše od 24 ur pri temperaturi 2 do 8 ° C, razen če razredčevanje ni potekalo v nadzorovanih in validiranih aseptičnih pogojih.
English: If it is almost time for your next dose, do not take the dose that you missed.
Slovenian: Če je že skoraj čas za naslednji odmerek, ne vzemite odmerka, ki ste ga pozabili vzeti.
English: Therefore caution should be exercised when using these combinations and the patients should be carefully monitored.
Slovenian: Zato je pri uporabi teh kombinacij potrebna previdnost, bolnike pa je treba natančno spremljati.
English: For older children, the suspension may be put in a spoon and drunk by the child.
Slovenian: Pri starejših otrocih je suspenzijo mogoče dati na žlico, otrok pa jo popije.
English: Your condition should start to clear up within a few days but it may take up to a week.
Slovenian: Vaše stanje se mora začeti izboljševati v nekaj dneh, lahko pa je za to potreben tudi en teden.
English: Taking Diflucan with food and drink
Slovenian: Jemanje zdravila Diflucan skupaj s hrano in pijačo
English: Initial dose may be used on the first day to achieve steady state levels more rapidly
Slovenian: Začetni odmerek se lahko uporabi prvi dan, da se hitreje dosežejo ravni v stanju dinamičnega ravnotežja
English: Mechanism(s) of resistance
Slovenian: Mehanizem(mi) odpornosti
English: They are for use only for organisms that do not have specific breakpoints.
Slovenian: Uporabljajo se samo za organizme, ki nimajo specifičnih mejnih koncentracij.
English: It is best to take medicine at the same time each day.
Slovenian: Najbolje je, da zdravilo vzamete vsak dan ob istem času.
English: Susceptibility in vitro
Slovenian: Občutljivost in vitro
English: This should be taken into account if you have diabetes.
Slovenian: To je treba upoštevati, če imate sladkorno bolezen.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Slovenian: Ker boste to zdravilo prejemali pod skrbnim zdravniškim nadzorom, je malo verjetno, da bi odmerek izpustili.
English: If you forget to take a dose, take it as soon as you remember.
Slovenian: Če ste pozabili vzeti odmerek, ga vzemite takoj ko se spomnite.
English: Instructions are provided in a section of this leaflet for healthcare professionals.
Slovenian: Navodila za to se nahajajo v tistem poglavju tega navodila, ki je namenjeno zdravstvenim delavcem.
English: Once opened, any unused infusion should be discarded.
Slovenian: Ko je bilo enkrat odprto, je treba vso neporabljeno infuzijo zavreči.
English: For younger children, the medicinal product may be given directly into the mouth from the syringe.
Slovenian: Pri mlajših otrocih je zdravilo mogoče dati iz brizge neposredno v usta.
English: Sometimes doses are increased up to 800 mg
Slovenian: Včasih se odmerki povečajo na do 800 mg
English: Pharmacokinetic data were assessed for 113 paediatric patients from 5 studies; 2 single-dose studies, 2 multiple-dose studies, and a study in premature neonates.
Slovenian: Farmakokinetične podatke so ocenili za 113 pediatričnih bolnikov iz 5 študij; 2 študiji sta bili študiji posamičnih odmerkov, 2 študiji večkratnih odmerkov in 1 študija pri nedonošenčkih.
English: The usual adult dose should be given.
Slovenian: Uporabiti je treba običajen odmerek za odrasle.
English: In general, the recommended duration of therapy for candidemia is for 2 weeks after first negative blood culture result and resolution of signs and symptoms attributable to candidemia.
Slovenian: Na splošno priporočeni čas trajanja zdravljenja pri kandidemiji znaša 2 tedna po prvem negativnem rezultatu preverjanja krvne kulture in po izginotju znakov in simptomov, ki bi jih bilo mogoče pripisati kandidemiji.
English: There are some medicines that may interact with Diflucan.
Slovenian: Obstaja nekaj zdravil, pri katerih lahko pride do medsebojnega delovanja z zdravilom Diflucan.
English: Regrowth of fingernails and toenails normally requires 3 to 6 months and 6 to 12 months, respectively.
Slovenian: Za to, da nohti na prstih rok in nog ponovno zrastejo, je običajno potrebno 3 do 6 mesecev, oziroma 6 do 12 mesecev.
English: AIDS patients are more prone to the development of severe cutaneous reactions to many medicinal products.
Slovenian: Bolniki z aidsom so bolj nagnjeni k hudim kožnim reakcijam na številna zdravila.
English: Treatment of fluconazole should be immediately discontinued and the patient should consult a physician.
Slovenian: Zdravljenje s flukonazolom je treba takoj prekiniti, bolnik pa se mora posvetovati z zdravnikom.
English: This combination should be avoided (see section 4.4).
Slovenian: Tej kombinaciji se je treba izogibati (glejte poglavje 4.4).
English: The disturbances in parturition were reflected by a slight increase in the number of still-born pups and decrease of neonatal survival at these dose levels.
Slovenian: Motnje kotenja so se odražale v majhnem povečanju števila mrtvorojenih mladičev in zmanjšanju neonatalnega preživetja pri teh ravneh odmerkov.
English: Cytochrome P450
Slovenian: Citokrom P450
English: C. glabrata shows a wide range of susceptibility while C. krusei is resistant to fluconazole.
Slovenian: C. glabrata izkazuje široko območje občutljivosti, medtem ko je C. krusei odporna na flukonazol.
English: Plasticised PVC bag.
Slovenian: Plastificirana vrečka iz PVC.
English: Contact your doctor or your nearest hospital casualty department at once.
Slovenian: Nemudoma se posvetujte s svojim zdravnikom ali z oddelkom za nujno zdravniško pomoč najbližje bolnišnice.
English: The dose will be based on the child's weight in kilograms.
Slovenian: Odmerek bo temeljil na otrokovi telesni masi v kilogramih.
English: Instructions to make up the suspension:
Slovenian: Navodila za pripravo suspenzije:
English: In clinical studies, there is an almost 1:1 linear relationship between the AUC and the dose of fluconazole.
Slovenian: V kliničnih študijah je prisotno skoraj 1:1 linearno razmerje med AUC in odmerkom flukonazola.
English: Furthermore, it was shown in healthy volunteers that fluconazole delayed the elimination of fentanyl significantly.
Slovenian: Poleg tega so pri zdravih prostovoljcih ugotovili, da flukonazol pomembno upočasni izločanje fentanila.
English: Distribution The apparent volume of distribution approximates to total body water.
Slovenian: Navidezni volumen porazdelitve je približno tolikšen kot skupna količina vode v telesu.
English: Add a small quantity of still water and shake it vigorously.
Slovenian: Dodajte majhno količino vode brez mehurčkov in močno stresajte.
English: Treatment of infections requiring multiple dosing should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided.
Slovenian: Zdravljenje okužb, pri katerih je potrebno večkratno odmerjanje zdravila, je treba nadaljevati, dokler klinični parametri ali laboratorijske preiskave ne pokažejo, da je aktivna glivična okužba izzvenela.
English: On transferring from the intravenous to the oral route, or vice versa, there is no need to change the daily dose.
Slovenian: Pri prehodu z intravenske na peroralno uporabo, ali obratno, dnevnega odmerka ni potrebno spreminjati.
English: Treatment should be continued until infected nail is replaced (uninfected nail grows in).
Slovenian: Zdravljenje je treba nadaljevati dokler namesto okuženega nohta ne zraste drug noht (vraste se neokužen noht).
English: Check with your doctor or nurse if you are not sure why you are being given Diflucan.
Slovenian: Preverite s svojim zdravnikom ali medicinsko sestro, če ne veste natančno čemu prejemate zdravilo Diflucan.
English: Depending on the severity of the disease
Slovenian: Odvisno od izrazitosti obolenja
English: Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram.
Slovenian: Nekateri azoli, tudi flukonazol, so bili povezani s podaljšanjem intervala QT na elektrokardiogramu.
English: Dermatological reactions
Slovenian: Dermatološke reakcije
English: Where there is no evidence of renal impairment, normal dose recommendations should be adopted.
Slovenian: Če ni znakov okvare ledvic, se je treba držati priporočil za običajno odmerjanje.
English: It is recommended that your pharmacist makes up Diflucan powder for oral suspension before giving it to you.
Slovenian: Priporočljivo je, da farmacevt pripravi zdravilo Diflucan prašek za peroralno suspenzijo preden vam ga izda.
English: There is also a direct though imperfect relationship between the AUC or dose and a successful clinical response of oral candidosis and to a lesser extent candidaemia to treatment.
Slovenian: Obstaja tudi neposredno čeprav nepopolno razmerje med AUC ali odmerkom in uspešnim kliničnim odzivom kandidoze v ustih ter v manjšem obsegu odzivom kandidemije na zdravljenje.
English: Patients should be warned about the potential for dizziness or seizures (see section 4.8) while taking Diflucan and should be advised not to drive or operate machines if any of these symptoms occur.
Slovenian: Bolnike je treba opozoriti na možnost pojava omotice ali konvulzij (glejte poglavje 4.8) med jemanjem zdravila Diflucan in jim svetovati, da ne vozijo ali upravljajo s stroji, če pride do pojava katerega od teh simptomov.
English: Point the syringe at the inside of the cheek; release the suspension slowly into the child's mouth (Figure 3).
Slovenian: Brizgo usmerite na notranjo stran lica; suspenzijo počasi sprostite v otrokova usta (slika 3).
English: Open the bottle (safety cap);
Slovenian: Plastenko odprite (varnostni pokrovček);
English: - tinea unguium (onychomycosis)
Slovenian: - tinea unguium (onihomikoza)
English: 1 to 3 weeks
Slovenian: 1 do 3 tedne
English: For the 175 ml bottle: (Applicable only if marketed in your country) 1.
Slovenian: Za 175 ml plastenko: (Smiselno le v primeru, če se nahaja na trgu v vaši državi) 1.
English: Therefore, Diflucan should not be used for tinea capitis.
Slovenian: Zato se zdravila Diflucan ne sme uporabljati za zdravljenje tinea capitis.
English: Plasticised PVC bags: 18 months.
Slovenian: Plastificirane vrečke iz PVC: 18 mesecev.
English: Use in children less than 2 weeks old:
Slovenian: Uporaba pri otrocih, mlajših od 2 tedna:
English: Fungal strains which have developed one or more of these resistance mechanisms are known to exhibit high minimum inhibitory concentrations (MICs) to fluconazole which impacts adversely efficacy in vivo and clinically.
Slovenian: Za glivične seve, ki so razvili enega ali več teh mehanizmov odpornosti, je znano, da izkazujejo visoke minimalne inhibitorne koncentracije (MIK) za flukonazol, ki neugodno vplivajo na učinkovitost in vivo in klinično.
English: The effect of fluconazole on other medicinal products
Slovenian: Vpliv flukonazola na druga zdravila
English: 1 bottle - 150 ml
Slovenian: 1 steklenička - 150 ml
English: Somnolence, insomnia
Slovenian: Somnolenca, nespečnost
English: There is a risk of developing carbamazepine toxicity.
Slovenian: Obstaja tveganje za pojav toksičnih učinkov karbamazepina.
English: The dose should be based on the nature and severity of the fungal infection.
Slovenian: Odmerek mora temeljiti na naravi in izrazitosti glivične okužbe.
English: Current available data for other paediatric indications are described in section 4.8.
Slovenian: Trenutno razpoložljivi podatki za ostale pediatrične indikacije so opisani v poglavju 4.8.
English: Depending on the extent and duration of the induced neutropenia (see Adults posology)
Slovenian: Odvisno od obsega in trajanja izzvane nevtropenije (glejte Odmerjanje pri odraslih)
English: How to take Diflucan”).
Slovenian: Kako jemati zdravilo Diflucan").
English: Measure 66 ml of still water and add the water to the bottle.
Slovenian: Odmerite 66 ml vode brez mehurčkov in vodo dodajte v plastenko.
English: Neonates excrete fluconazole slowly.
Slovenian: Novorojenčki izločajo flukonazol počasi.
English: The reduced dose and/or frequency of voriconazole and fluconazole that would eliminate this effect have not been established.
Slovenian: Zmanjšanega odmerka in/ali pogostosti dajanja vorikonazola, ki bi izničil ta učinek, niso ugotavljali.
English: These reports included seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant treatment that may have been contributory.
Slovenian: Ta poročila so vključevala resno bolne bolnike z več dejavniki tveganja, npr. strukturno boleznijo srca, elektrolitskimi motnjami in sočasno uporabo zdravil, kar je lahko pripomoglo k temu učinku.
English: A 20 ml measuring cup is also provided.
Slovenian: Priložena je tudi 20 ml merilna skodelica.
English: Thus, multiple dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.
Slovenian: Glede na to je malo verjetno, da bi večkratno odmerjanje flukonazola v teh odmerkih vplivalo na učinkovitost kombiniranega peroralnega kontraceptiva.
English: Recommendations
Slovenian: Priporočila
English: Turn the bottle with the syringe upside down and withdraw the quantity of suspension prescribed by the doctor (Figure 2).
Slovenian: Plastenko z brizgo obrnite tako, da se zgornji del nahaja spodaj in izvlecite količino suspenzije, ki jo je predpisal zdravnik (slika 2).
English: No studies have been performed on the effects of Diflucan on the ability to drive or use machines.
Slovenian: Študije o vplivih zdravila Diflucan na sposobnost za vožnjo in upravljanje s stroji niso bile opravljene.
English: Fluconazole may be infused through an existing line with one of the above listed fluids.
Slovenian: Flukonazol se lahko infundira s katero od omenjenih tekočin po obstoječi liniji.
English: The maximum adult daily dose should not be exceeded in children (see section 4.2) 4.
Slovenian: Pri otrocih se ne sme preseči največjega dnevnega odmerka za odrasle (glejte poglavje 4.2) 4.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the human exposure indicating little relevance to clinical use.
Slovenian: Učinke v predkliničnih študijah so opažali le pri izpostavljanjih, ki so znatno presegala izpostavljenost pri ljudeh, kar nakazuje majhen pomen za klinično uporabo.
English: Safety and efficacy for genital candidiasis indication in paediatric population has not been established.
Slovenian: Varnost in učinkovitost za indikacijo genitalna kandidoza pri pediatrični populaciji ni bila dokazana.
English: Of a radioactive dose, only 11% is excreted in a changed form in the urine.
Slovenian: Samo 11 % radioaktivno označenega odmerka se v spremenjeni obliki izloči v urin.
English: Current available safety data for other paediatric indications are described in section 4.8.
Slovenian: Trenutno razpoložljivi podatki o varnosti za ostale pediatrične indikacije so opisani v poglavju 4.8.
English: Elevated fentanyl concentration may lead to respiratory depression.
Slovenian: Povečana koncentracija fentanila lahko privede do depresije dihanja.
English: Plasma concentrations are proportional to dose.
Slovenian: Koncentracija v plazmi je sorazmerna odmerku.
English: The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucination and paranoid behaviour).
Slovenian: Simptomi morebitnega prevelikega odmerjanja so lahko stanja, ko slišite, vidite, občutite in si zamišljate stvari, ki v resnici ne obstajajo (halucinacije in paranoidno obnašanje).
English: Diflucan may affect your liver.
Slovenian: Zdravilo Diflucan lahko vpliva na vaša jetra.
English: The marks on the syringe are shown in ml.
Slovenian: Merilne oznake na brizgi so navedene v ml.
English: Doctors sometimes prescribe different doses to these.
Slovenian: Zdravniki včasih predpišejo odmerke, ki se razlikujejo od navedenih.
English: Remove the syringe from the bottle;
Slovenian: Odstranite brizgo s plastenke;
English: Breast-feeding may be maintained after a single use of a standard dose 200 mg fluconazole or less.
Slovenian: Z dojenjem je mogoče nadaljevati po enkratni uporabi običajnega odmerka 200 mg flukonazola ali manj.