FrancophonIA/ELRC3.0 huggingface dataset:
English: In cases of fluconazole associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of patient has been observed.
Slovenian: V primerih s flukonazolom povezane hepatotoksičnosti očitne povezanosti s celokupnim dnevnim odmerkom, trajanjem zdravljenja, spolom ali starostjo bolnika niso opazili.
English: If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: The pharmacokinetics of fluconazole has not been studied in paediatric population with renal insufficiency (for “Term newborn infants” who often exhibit primarily renal immaturity please see below).
Slovenian: Farmakokinetike flukonazola pri pediatrični populaciji z ledvično insuficienco niso raziskovali (za »normalno donošene otroke«, pri katerih je pogosto prisotna primarna nezrelost ledvic, glejte v nadaljevanju).
English: 200 mg to 400 mg 11 months up to 24 months or longer depending on the patient.
Slovenian: 200 mg do 400 mg 11 mesecev do 24 mesecev ali dlje, odvisno od bolnika.
English: During concomitant treatment with fluconazole and warfarin the prothrombin time was prolonged up to 2-fold,
Slovenian: Med sočasnim zdravljenjem s flukonazolom in varfarinom se je protrombinski čas podaljšal do 2-kratno,
English: A. = Non-species related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species.
Slovenian: A. = Mejne koncentracije, ki niso povezane z vrsto, so določili predvsem na temelju PK/PD podatkov in so neodvisne od porazdelitev MIK pri specifičnih vrstah.
English: Diflucan is administered as a single daily dose.
Slovenian: Zdravilo Diflucan se daje v enkratnem dnevnem odmerku.
English: For paediatric patients with impaired renal function, see dosing in “Renal impairment”.
Slovenian: Za pediatrične bolnike z okvaro ledvic glejte odmerjanje pri “Okvara ledvic”.
English: Important information about some of the ingredients of Diflucan
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Diflucan
English: - Glass vials: Do not freeze.
Slovenian: - Steklene viale: Ne zamrzujte.
English: Male rats treated with 5 and 10 mg/kg/day had an increased incidence of hepatocellular adenomas.
Slovenian: Pri podganjih samcih, ki so dobivali 5 ali 10 mg/kg/dan, je bila pogostnost pojavljanja hepatocelularnih adenomov večja.
English: Fluconazole clearance is proportional to creatinine clearance.
Slovenian: Očistek flukonazola je sorazmeren očistku kreatinina.
English: Glycerol may cause headache, stomach upset, and diarrhoea.
Slovenian: Glicerol lahko povzroči glavobol, želodčne težave in diarejo.
English: • Invasive candidiasis.
Slovenian: • Invazivne kandidoze.
English: For the 60 ml bottle:
Slovenian: Za 60 ml plastenko:
English: Increased tacrolimus levels have been associated with nephrotoxicity.
Slovenian: Zvišano raven takrolimusa povezujejo z nefrotoksičnostjo.
English: Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding and your doctor will decide whether you should be given Diflucan.
Slovenian: Povejte svojemu zdravniku, če ste noseči, poskušate zanositi, ali dojite, vaš zdravnik pa bo odločil, ali smete prejeti zdravilo Diflucan.
English: Fluconazole in standard doses and short-term treatments should not be used in pregnancy unless clearly necessary.
Slovenian: Flukonazola se v običajnih odmerkih in pri kratkotrajnem zdravljenju ne sme uporabljati med nosečnostjo, razen če ni to nujno potrebno.
English: Oral use after reconstitution.
Slovenian: Peroralna uporaba po rekonstituciji.
English: The maximum dose for children is 400 mg daily (see section “3.
Slovenian: Največji odmerek za otroke znaša 400 mg na dan (glejte poglavje "3.
English: Common side effects which affect 1 to 10 users in 100 are listed below:
Slovenian: Pogosti neželeni učinki, ki prizadenejo 1 do 10 uporabnikov izmed 100 so navedeni spodaj:
English: If concomitant therapy is necessary, the patient should be observed for symptoms of myopathy and rhabdomyolysis and creatinine kinase should be monitored.
Slovenian: Če je potrebno sočasno zdravljenje, je treba bolnika opazovati glede pojava simptomov miopatije in rabdomiolize ter spremljati raven kreatin-kinaze.
English: 50 mg once daily 2 to 4 weeks
Slovenian: 50 mg enkrat na dan 2 do 4 tedne
English: Dose adjustment of carbamazepine may be necessary depending on concentration measurements/effect.
Slovenian: Potrebna je lahko prilagoditev odmerka karbamazepina glede na meritve koncentracije in učinka.
English: Ciclosporin: Fluconazole significantly increases the concentration and AUC of ciclosporin.
Slovenian: Ciklosporin: Flukonazol pomembno poveča koncentracijo in AUC ciklosporina.
English: Similarly cure is less likely for infections caused by strains with a higher fluconazole MIC.
Slovenian: Skladno s tem je ozdravitev manj verjetna pri okužbah, ki so jih povzročili sevi z višjo MIK flukonazola.
English: 200 mg to 400 mg Treatment should start several days before the anticipated onset of neutropenia and continue for 7 days after recovery from neutropenia after the neutrophil count rises above 1000 cells per mm3.
Slovenian: Zdravljenje se mora začeti nekaj dni pred pričakovanim nastopom nevtropenije in se mora nadaljevati 7 dni po okrevanju od nevtropenije, po tem, ko se število nevtrofilcev dvigne nad 1000 celic na mm3.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single use only.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Samo za enkratno uporabo.
English: Infants, toddlers and children (from 28 days to 11 years old): Indication
Slovenian: Dojenčki, majhni otroci in otroci (v starosti od 28 dni do 11 let): Indikacija
English: Fluconazole in high dose and/or in prolonged regimens should not be used during pregnancy except for potentially life-threatening infections.
Slovenian: Flukonazola se v velikih odmerkih in/ali pri dolgotrajnem zdravljenju ne sme uporabljati med nosečnostjo, razen v primeru potencialno smrtno nevarnih okužb.
English: A 175 ml bottle contains 67.1 g of powder for oral suspension.
Slovenian: 175 ml plastenka vsebuje 67,1 g praška za peroralno suspenzijo.
English: Diflucan is used in adults to treat infections caused by fungi.
Slovenian: Zdravilo Diflucan se uporablja pri odraslih za zdravljenje okužb, ki jih povzročajo glivice.
English: Limited data are available in patients with hepatic impairment, therefore fluconazole should be administered with caution to patients with liver dysfunction (see sections 4.4 and 4.8).
Slovenian: Na voljo so omejeni podatki pri bolnikih z okvaro jeter, zato je treba flukonazol pri bolnikih z zmanjšanim delovanjem jeter uporabljati previdno (glejte poglavji 4.4 in 4.8).
English: Oral contraceptives: Two pharmacokinetic studies with a combined oral contraceptive have been performed using multiple doses of fluconazole.
Slovenian: Peroralni kontraceptivi: Opravili so dve študiji farmakokinetike kombiniranih peroralnih kontraceptivov ob sočasni uporabi večkratnih odmerkov flukonazola.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Slovenian: Opomba: Spodnja različica povzetka glavnih značilnosti zdravila, besedila ovojnine in navodila za uporabo je veljavna v času sklepa komisije.
English: Undesirable effects
Slovenian: MOŽNI NEŽELENI UČINKI
English: Important information about some of the ingredients of Diflucan This medicine contains a small amount of lactose (milk sugar).
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Diflucan To zdravilo vsebuje majhno količino laktoze (mlečni sladkor).
English: Fluconazole 50 mg daily given up to 28 days has been shown not to effect testosterone plasma concentrations in males or steroid concentration in females of child-bearing age.
Slovenian: Za flukonazol v odmerku 50 mg na dan, ki so ga dajali v obdobju do 28 dni, so ugotovili, da ne vpliva na koncentracije testosterona v plazmi pri moških ali na koncentracijo steroidov pri ženskah v rodni dobi.
English: Ninety percent steady state levels are reached by day 4-5 with multiple once daily dosing.
Slovenian: Devetdesetodstotna koncentracija v stanju dinamičnega ravnovesja je dosežena do 4. ali 5. dne večkratnega odmerjanja enkrat na dan.
English: - It comes in either a glass vial containing a total of 50 mg, 100 mg, 200 mg or 400 mg fluconazole or 1, 5, 10 and 20 plasticised PVC bag(s) containing a total of 200 mg or 400 mg fluconazole.
Slovenian: - Na voljo je bodisi v stekleni viali, ki vsebuje skupno 50 mg, 100 mg, 200 mg ali 400 mg flukonazola ali pa v 1, 5, 10 in 20 plastificirani(h) vrečki(ah) iz PVC, ki vsebujejo skupno 200 mg ali 400 mg flukonazola.
English: The patient should be informed of suggestive symptoms of serious hepatic effect (important asthenia, anorexia, persistent nausea, vomiting and jaundice).
Slovenian: Bolnika je treba poučiti o simptomih resnih učinkov na jetra (zlasti o asteniji, anoreksiji, perzistentni navzei, bruhanju in zlatenici).
English: Calcium channel blockers: Certain calcium channel antagonists (nifedipine, isradipine, amlodipine, verapamil and felodipine) are metabolized by CYP3A4.
Slovenian: Zaviralci kalcijevih kanalčkov: Nekateri zaviralci kalcijevih kanalčkov (nifedipin, isradipin, amlodipin, verapamil in felodipin) se presnavljajo s CYP3A4.
English: Although not specifically studied, fluconazole has the potential to increase the systemic exposure of other NSAIDs that are metabolized by CYP2C9 (e.g. naproxen, lornoxicam, meloxicam, diclofenac).
Slovenian: Čeprav tega niso posebej raziskali, lahko flukonazol poveča sistemsko izpostavljenost drugim nesteroidnim protivnetnim zdravilom, ki se presnavljajo s CYP2C9 (npr. naproksenu, lornoksikamu, meloksikamu, diklofenaku).
English: Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding.
Slovenian: Povejte svojemu zdravniku, če ste noseči, poskušate zanositi ali dojite.
English: - Treatment and prophylaxis of recurrent vaginal candidiasis (4 or more episodes a year)
Slovenian: - Zdravljenje in preprečevanje ponovitev vaginalne kandidoze (4 ali več epizod na leto)
English: The long plasma elimination half-life provides the basis for single dose therapy for vaginal candidiasis, once daily and once weekly dosing for other indications.
Slovenian: Dolg razpolovni čas izločanja iz plazme omogoča zdravljenje vaginalne kandidoze z enim samim odmerkom in odmerjanje enkrat na teden pri drugih indikacijah.
English: After three hours of haemodialysis session, around 50% of fluconazole is eliminated from blood.
Slovenian: Po treh urah izvajanja hemodialize se iz krvi odstrani približno 50 % flukonazola.
English: One 180 ml amber Type III glass bottle with threaded aluminum caps.
Slovenian: Ena 180 ml steklenička iz rjavega stekla tipa III z navojnim pokrovčkom iz aluminija.
English: If patients with invasive/systemic fungal infections develop rashes, they should be monitored closely and fluconazole discontinued if bullous lesions or erythema multiforme develop.
Slovenian: Če se pri bolnikih z invazivnimi/sistemskimi glivičnimi okužbami pojavi izpuščaj, jih je treba skrbno spremljati in z uporabo flukonazola prenehati, če se pojavijo bulozne spremembe ali multiformni eritem.
English: This combination may be used with a dose adjustment of sirolimus depending on the effect/concentration measurements.
Slovenian: To kombinacijo je mogoče uporabljati ob prilagoditvi odmerka sirolimusa glede na učinek oz. izmerjene koncentracije.
English: Reconstituted suspension: Store below 30°C, do not freeze.
Slovenian: Rekonstituirana suspenzija: Shranjujte pri temperaturi do 30 °C, ne zamrzujte.
English: This medicinal product contains 0.154 mmol sodium per ml.
Slovenian: To zdravilo vsebuje 0,154 mmolov natrija v enem ml.
English: Fluconazole is removed by haemodialysis and to a lesser extent by peritoneal dialysis.
Slovenian: Flukonazol se odstrani s hemodializo, v manjšem obsegu pa s peritonealno dializo.
English: Depending on the site of the infection 50 mg once daily, 150 mg once weekly, 300 to 400 mg once weekly for 1 to 4 weeks (Athlete's foot may be up to 6 weeks, for nail infection treatment until infected nail is replaced)
Slovenian: Odvisno od mesta okužbe 50 mg enkrat na dan, 150 mg enkrat na teden, 300 do 400 mg enkrat na teden v obdobju 1 do 4 tednov (pri glivicah med prsti na nogah (atletovo stopalo) zdravljenje lahko traja do 6 tednov, pri okužbi nohtov pa tako dolgo, dokler okuženega nohta ne nadomesti nov noht)
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Slovenian: Za razmere pri shranjevanju za uporabo pripravljenega zdravila glejte poglavje 6.3.
English: The pattern and incidence of adverse reactions and laboratory abnormalities recorded during paediatric clinical trials are comparable to those seen in adults.
Slovenian: Vzorec in incidenca neželenih učinkov in laboratorijskih nepravilnosti, zabeležena med kliničnimi preskušanji pri otrocih, sta primerljiva tistim pri odraslih.
English: Concomitant use of the following other medicinal products cannot be recommended:
Slovenian: Sočasna uporaba naslednjih zdravil ni priporočljiva:
English: Fluconazole also exhibits activity in vitro against Cryptococcus neoformans and Cryptococcus gattii as well as the endemic moulds Blastomyces dermatiditis, Coccidioides immitis, Histoplasma capsulatum and Paracoccidioides brasiliensis.
Slovenian: Flukonazol in vitro kaže aktivnost tudi proti Cryptococcus neoformans in Cryptococcus gattii, pa tudi proti endemičnim plesnim Blastomyces dermatiditis, Coccidioides immitis, Histoplasma capsulatum in Paracoccidioides brasiliensis.
English: High skin concentration of fluconazole, above serum concentrations, are achieved in the stratum corneum, epidermis-dermis and eccrine sweat.
Slovenian: Visoko koncentracijo v koži, ki presega koncentracijo v serumu, doseže flukonazol v stratum corneum, epidermisu-dermisu in ekrinem znoju.
English: - Do not use the medicine if you notice signs of deterioration such as unusual odour, product discoloration, visible particles or crystallisation.
Slovenian: - Zdravila ne uporabljajte, če zaznate znake kvarjenja kot so npr. neobičajen vonj, sprememba barve zdravila, vidni delci ali kristalizacija.
English: The maximum dose for children is 400 mg daily.
Slovenian: Največji odmerek za otroke je 400 mg na dan.
English: Adolescents (from 12 to 17 years old):
Slovenian: Mladostniki (v starosti od 12 do 17 let):
English: 3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day)
Slovenian: 3 mg na kg telesne mase (prvi dan se lahko uporabi 6 mg na kg telesne mase)
English: In addition, creatinine clearance (74 ml/min), the percent of medicinal product recovered unchanged in urine (0-24 h, 22%) and the fluconazole renal clearance estimates (0.124 ml/min/kg) for the elderly were generally lower than those of younger volunteers.
Slovenian: Poleg tega so očistek kreatinina (74 ml/min), odstotek zdravila, ki so ga v nespremenjeni obliki ugotovili v urinu (0-24 ur, 22%) in ocene glede ledvičnega očistka flukonazola (0,124 ml/min/kg) pri starejših bili na splošno manjši od ustreznih vrednosti pri mladih prostovoljcih.
English: Any remaining suspension should be discarded 28 days after reconstitution.
Slovenian: Neuporabljeno suspenzijo je treba zavreči 28 dni po rekonstituciji.
English: Glass vials: Do not freeze.
Slovenian: Steklene viale: Ne zamrzujte.
English: Patients on regular dialysis should receive 100% of the recommended dose after each dialysis; on nondialysis days, patients should receive a reduced dose according to their creatinine clearance.
Slovenian: Bolniki, pri katerih se redno izvaja dializa, morajo dobiti 100 % priporočenega odmerka po vsaki dializi; v dneh, ko se dializa ne izvaja, morajo bolniki dobivati zmanjšan odmerek, glede na njihov očistek kreatinina.
English: If you forget to take Diflucan
Slovenian: Če ste pozabili vzeti zdravilo Diflucan
English: Follow the dose prescribed by your doctor (either adults or children posology).
Slovenian: Držite se odmerka, ki ga je predpisal vaš zdravnik (bodisi da gre za odmerjanje, ki velja za odrasle ali za otroke).
English: Peak plasma concentrations in the fasting state occur between 0.5 and 1.5 hours post-dose.
Slovenian: Do največjih koncentracij v plazmi na tešče pride od 0,5 do 1,5 ure po odmerku.
English: One study at a 200 mg daily dose of fluconazole failed to demonstrate a prolongation in QTc interval.
Slovenian: Ena študija, v kateri so uporabljali dnevni odmerek 200 mg flukonazola, ni odkrila podaljšanja intervala QTc.
English: 6.6 Special precautions for disposal and other handling Do not use the medicinal product if you notice signs of deterioration such as unusual odour, product discoloration, visible particles or crystallization.
Slovenian: 6.6 Navodila za pripravo in ravnanje z zdravilom Zdravila ne uporabljajte, če zaznate znake kvarjenja kot so npr. neobičajen vonj, sprememba barve zdravila, vidni delci ali kristalizacija.
English: Patients with kidney problems
Slovenian: Bolniki z ledvičnimi težavami
English: - A measuring cup is also provided to measure the correct dose .
Slovenian: - Da bi lahko namerili pravilen odmerek je dodana merilna skodelica.
English: Its primary mode of action is the inhibition of fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis.
Slovenian: Njegov najpomembnejši način delovanja je zaviranje demetilacije 14 alfa-lanosterola, ki poteka s posredovanjem citokroma P-450, pri glivicah; to je nujna stopnja pri biosintezi ergosterola v glivicah.
English: Administration of a loading dose (on day 1) of twice the usual daily dose enables plasma levels to approximate to 90% steady-state levels by day 2.
Slovenian: Uporaba začetnega odmerka (1. dan), ki je dvakrat tolikšen kot običajni dnevni odmerek, omogoča, da se koncentracija v plazmi do 2. dne približa 90 % koncentracije v stanju dinamičnega ravnovesja.
English: Voriconazole: (CYP2C9 and CYP3A4 inhibitor): Coadministration of oral voriconazole (400 mg Q12h for 1 day, then 200 mg Q12h for 2.5 days) and oral fluconazole (400 mg on day 1, then 200 mg Q24h for 4 days) to 8 healthy male subjects resulted in an increase in Cmax and AUCτ of voriconazole by an average of 57% (90% CI: 20%, 107%) and 79% (90% CI: 40%, 128%), respectively.
Slovenian: Vorikonazol: (zaviralec CYP2C9 in CYP3A4): Sočasna peroralna uporaba vorikonazola o (400 mg vsakih 12 ur 1. dan, nato 200 mg vsakih 12 ur, 2 dni in pol) in flukonazola (400 mg na 1. dan, nato 200 mg vsakih 24 ur 4 dni) pri 8 zdravih moških osebah je v povprečju povečala Cmax vorikonazola za 57 % (90 % IZ: 20 %, 107 %) in AUCτ za 79 % (90 % IZ: 40 %, 128 %).
English: Fluconazole is largely excreted in the urine; forced volume diuresis would probably increase the elimination rate.
Slovenian: Ker se flukonazol v veliki meri izloča v urin, bi forsirana volumska diureza verjetno pospešila izločanje.
English: Mucosal thrush and throat infections caused by Candida - dose and duration depends on the severity of the infection and on where the infection is located
Slovenian: S kandido povzročene glivične okužbe sluznic in okužbe grla - odmerek in trajanje zdravljenja sta odvisna od stopnje izraženosti okužbe in od tega, na katerem mestu se okužba nahaja
English: During concomitant treatment with fluconazole and warfarin the prothrombin time was prolonged up to 2-fold, probably due to an inhibition of the warfarin metabolism through CYP2C9.
Slovenian: Med sočasnim zdravljenjem s flukonazolom in varfarinom se je protrombinski čas podaljšal do 2-kratno, verjetno zaradi zavrtja presnove varfarina prek CYP2C9.
English: Such cases may require alternative antifungal therapy.
Slovenian: V takih primerih bi utegnilo biti potrebno drugačno protiglivično zdravljenje.
English: In vitro, fluconazole displays antifungal activity against most clinically common Candida species (including C. albicans, C. parapsilosis, C. tropicalis).
Slovenian: In vitro flukonazol kaže protiglivično aktivnost proti večini klinično običajnih vrst Candida (vključujoč C. albicans, C. parapsilosis, C. tropicalis).
English: Longer periods depending on both the severity of infection or underlying immune compromisation and infection
Slovenian: Daljša obdobja zdravljenja so odvisna tako od izrazitosti okužbe kot od prisotne stopnje oslabelosti imunskega sistema in okužbe.
English: Dose reduction of zidovudine may be considered.
Slovenian: Potrebno je lahko zmanjšati odmerek zidovudina.
English: Diflucan can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence (see section 4.4).
Slovenian: Zdravilo Diflucan lahko uporabljamo za vzdrževalno zdravljenje za preprečevanje ponovitve kriptokoknega meningitisa pri otrocih z visokim tveganjem za ponovitev bolezni (glejte poglavje 4.4).
English: At a dose of 50 mg once daily, the concentration of fluconazole after 12 days was 73 µg/g and 7 days after cessation of treatment the concentration was still 5.8 µg/g.
Slovenian: Ob odmerku 50 mg enkrat na dan je koncentracija flukonazola po 12 dneh znašala 73 mikrogramov/g, 7 dni po prenehanju zdravljenja pa je bila koncentracija še vedno 5,8 mikrogramov/g.
English: Ask your doctor or pharmacist for advice before taking any medicines.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
English: The evidence for efficacy of fluconazole in the treatment of cryptococcosis of other sites (e.g. pulmonary and cutaneous cryptococcosis) is limited, which prevents dosing recommendations.
Slovenian: Dokazi o učinkovitosti flukonazola za zdravljenje kriptokokoze drugih mest (npr. kriptokokoza pljuč in kriptokokoza kože) so omejeni, zato ni mogoče dati priporočil o odmerjanju.
English: Diflucan is formulated in sodium chloride 9 mg/ml (0.9%) solution for infusion, each 200 mg (100 ml bottle) containing 15 mmol each of Na+ and C1-.
Slovenian: Zdravilo Diflucan je raztopljen v raztopini natrijevega klorida 9 mg/ml (0.9%) za infundiranje, pri čemer vsakih 200 mg (100 ml steklenička) vsebuje 15 mmolov Na+ kot Cl- ionov.
English: Concentration of fluconazole in nails after 4 months of 150 mg once-a-week dosing was 4.05 µg/g in healthy and 1.8 µg/g in diseased nails; and, fluconazole was still measurable in nail samples 6 months after the end of therapy.
Slovenian: Koncentracija flukonazola v nohtih po 4 mesecih uporabe 150 mg odmerkov enkrat na teden je znašala 4,05 mikrogramov/g v zdravih nohtih in 1,8 mikrogramov/g v obolelih nohtih; flukonazol pa je še vedno bilo mogoče izmeriti v vzorcih nohtov 6 mesecev po koncu zdravljenja.
English: Fertility Fluconazole did not affect the fertility of male or female rats (see section 5.3)
Slovenian: Plodnost Flukonazol ni vplival na plodnost podganjih samcev ali samic (glejte poglavje 5.3).
English: Glycerol may cause headache, stomach upset, and diarrhoea (see section 4.8).
Slovenian: Glicerol lahko povzroči glavobol, težave z želodcem in drisko (glejte poglavje 4.8).
English: Tap the bottle to release the powder.
Slovenian: Rahlo potrkajte po plastenki, da se prašek razrahlja.
English: SPECIAL STORAGE CONDITIONS (Glass vials) Do not freeze.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE (Steklene viale) Ne zamrzujte.
English: It will not be diluted further.
Slovenian: Raztopine ni treba dodatno redčiti.
English: With coadministration, serum phenytoin concentration levels should be monitored in order to avoid phenytoin toxicity.
Slovenian: Med sočasno uporabo je treba preverjati koncentracije fenitoina v serumu, da bi se izognili toksičnim učinkom fenitoina.