FrancophonIA/ELRC3.0 huggingface dataset:
English: Rhabdomyolysis has been reported in patients taking trametinib alone or in combination with dabrafenib.
Slovenian: Pri bolnikih, ki so prejemali trametinib samostojno ali v kombinaciji z dabrafenibom, je bila opisana rabdomioliza.
English: Dehydration
Slovenian: Pogosti dehidracija
English: palpitations and chest pain.
Slovenian: • izkašljevanje/bruhanje krvi.
English: It is recommended that patients receiving treatment with trametinib monotherapy or in combination with dabrafenib have liver function monitored every four weeks for 6 months.
Slovenian: Bolnikom, ki prejemajo trametinib v monoterapiji ali v kombinaciji z dabrafenibom, je 6 mesecev priporočljivo kontrolirati delovanje jeter na štiri tedne, kasneje pa se delovanje jeter lahko spremlja v skladu s kliničnimi indikacijami (glejte poglavje 4.4).
English: Disorders associated with visual disturbance, including RPED and RVO, may occur with trametinib as monotherapy and in combination with dabrafenib.
Slovenian: Med zdravljenjem s trametinibom, bodisi v monoterapiji ali v kombinaciji z dabrafenibom, lahko pride do težav, povezanih z motnjami vida, vključno z odstopom mrežničnega pigmentnega epitelija (RPED) in zaporo mrežnične vene (RVO).
English: Skin fissures
Slovenian: Ploščatocelični karcinom kože
English: Oedema peripheral Pyrexia
Slovenian: Občasni rabdomioliza
English: Haemorrhagic events, including major haemorrhagic events and fatal haemorrhages, have occurred in patients taking trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Slovenian: Pri bolnikih, ki so jemali trametinib, bodisi v monoterapiji ali v kombinaciji z dabrafenibom, je prihajalo do krvavitev, med katerimi so bile tudi večje krvavitve in krvavitve, zaradi katerih so bolniki umrli (glejte poglavje 4.8).
English: No dose modification of dabrafenib is required when trametinib is taken in combination with dabrafenib for cases of ILD or pneumonitis.
Slovenian: Če bolnik v kombinaciji z dabrafenibom jemlje trametinib, v primeru intersticijske bolezni pljuč ali pnevmonitisa odmerka dabrafeniba ni treba prilagajati.
English: Always take Mekinist exactly as your doctor, nurse or pharmacist has told you.
Slovenian: Pri jemanju zdravila Mekinist natančno upoštevajte navodila zdravnika, medicinske sestre ali farmacevta.
English: Face oedema Mucosal inflammation Asthenia
Slovenian: Pogosti okužba sečil celulitis folikulitis paronihija pustulozen izpuščaj
English: 100 mg twice daily
Slovenian: 100 mg dvakrat na dan drugo znižanje odmerka
English: 13.8d (11.0, NR)
Slovenian: 10,2d (7,5; ND)
English: The bottle contains a desiccant.
Slovenian: Plastenka vsebuje sušilo.
English: Please refer to dabrafenib SmPC for information on method of administration when given in combination with trametinib.
Slovenian: Za informacije o načinu uporabe dabrafeniba pri jemanju v kombinaciji s trametinibom glejte povzetek glavnih značilnosti zdravila za dabrafenib.
English: Hazard Ratio (95% CI)
Slovenian: Razmerje ogroženosti (95-odstotni IZ)
English: Hepatic adverse reactions have been reported in clinical trials with trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Slovenian: V kliničnih preskušanjih s trametinibom, bodisi v monoterapiji ali v kombinaciji z dabrafenibom, so poročali o jetrnih neželenih učinkih (glejte poglavje 4.8).
English: NR
Slovenian: NO
English: Please see the dabrafenib SmPC.
Slovenian: Glejte povzetek glavnih značilnosti zdravila za dabrafenib.
English: Most subjects had LDH ≤ULN (67%), ECOG performance status of 0 (70%), and visceral disease (78%) at baseline.
Slovenian: (70 %) in zasevke v visceralnih organih (78 %).
English: • Feeling sick (nausea), being sick (vomiting)
Slovenian: • slabost v želodcu (siljenje na bruhanje), bruhanje
English: Myocarditis
Slovenian: Neznana pogostnost miokarditis
English: • usually over 90 minutes
Slovenian: • običajno v času 90 minut.
English: Date of first authorisation: 25 October 2005 Date of latest renewal: 25 October 2010
Slovenian: Datum prve odobritve: 25. oktober 2005 Datum zadnjega podaljšanja: 25. oktober 2010
English: If you are already taking rifabutin,
Slovenian: Če že jemljete rifabutin,
English: Children (< 18 years)
Slovenian: Otroci (< 18 let)
English: Not known: frequency cannot be estimated from the available data
Slovenian: Neznana pogostnost: ni mogoče oceniti iz razpoložljivih podatkov
English: • being completely or partially unable to talk
Slovenian: • popolna ali delna nezmožnost govorjenja
English: However, this was not a prospective, randomised controlled study and so all comparisons with the external control group should be viewed with caution.
Slovenian: Vendar to ni bila prospektvina, randomizirana in kontrolirana študija, zato je treba vse primerjave z zunanjo kontrolno skupino previdno obravnavati.
English: After first opening the container: 4 weeks
Slovenian: Po prvem odprtju vsebnika: 4 tedne
English: • have or have ever had liver problems.
Slovenian: • če imate ali ste kdaj imeli težave z jetri.
English: pCav: predicted Cav
Slovenian: pCav: predvidena Cav
English: Includes other less common species or species unknown
Slovenian: Vključuje druge manj pogoste vrste ali neznane vrste
English: d: All randomised e: All treated
Slovenian: d: Vsi randomizirani e: Vsi zdravljeni
English: EUCAST ECOFF values:
Slovenian: EUCAST ECOFF vrednosti:
English: The clinical significance of this finding is unknown.
Slovenian: Klinični pomen tega izsledka ni znan.
English: Recommended dose according to indication Indication
Slovenian: Priporočeno odmerjanje glede na indikacijo Indikacija
English: External control group
Slovenian: Zunanja kontrolna skupina
English: • Tablets may be taken with or without food.
Slovenian: • Tablete lahko vzamete s hrano ali brez nje.
English: These medicines include:
Slovenian: Med takšnimi zdravili so:
English: Elderly ( 65 years)
Slovenian: Starostniki ( 65 let)
English: • inability to sleep (insomnia)
Slovenian: • nezmožnost zaspati (nespečnost)
English: • mental problems such as hearing voices or seeing things that are not there
Slovenian: • duševne motnje, na primer slišanje glasov ali videnje stvari, ki jih ni
English: Manufacturer SP Labo N.V.
Slovenian: SP Labo N.V.
English: Unopened container: 3 years
Slovenian: Neodprt vsebnik: 3 leta
English: Variations of colour within this range do not affect the quality of the product.
Slovenian: Sprememba barve v tem območju ne vpliva na kakovost zdravila.
English: • If you have any suspension left in a bottle more than four weeks after it was first opened, you should not use this medicine.
Slovenian: • Če vam več kot štiri tedne po prvem odprtju stekleničke v njej ostane še nekaj suspenzije, tega zdravila ne smete več uporabljati.
English: The critical ratio for subjects with Aspergillus infections was ~200.
Slovenian: Kritično razmerje za osebe, okužene z Aspergillusom, je bilo ~200.
English: • reduced feeling of sensitivity especially on the skin
Slovenian: • zmanjšana občutljivost, zlasti na koži
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Slovenian: Ker boste zdravilo dobivali pod natančnim zdravniškim nadzorom, ni verjetno, da bi bil kakšen odmerek pozabljen.
English: In general, exposures tended to be higher in the older patients (7 to <18 years) than in younger patients (2 to <7 years).
Slovenian: Na splošno so bile izpostavljenosti večinoma višje pri starejših bolnikih (7 do < 18 let) kot pri mlajših bolnikih (2 do < 7 let).
English: Recommended dose and length of treatment
Slovenian: Priporočeni odmerek in trajanje zdravljenja
English: Fixed-time period
Slovenian: Določeno časovno obdobje
English: • Once prepared, the product should be used immediately.
Slovenian: • Ko je zdravilo pripravljeno, ga je treba uporabiti takoj.
English: • swelling of the face or tongue
Slovenian: • oteklost obraza ali jezika
English: • If you forget a dose, take it as soon as you remember it.
Slovenian: • Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
English: • Swallow the tablet whole with some water.
Slovenian: • Tableto zaužijte celo z nekaj vode.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below:
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so navedena spodaj:
English: The ECOFF values for posaconazole, which distinguish the wild type population from isolates with acquired resistance, have been determined by EUCAST methodology.
Slovenian: ECOFF vrednosti za posakonazol, ki razlikujejo populacijo divjega tipa od izolatov s pridobljeno odpornostjo, so bile določene po metodologiji EUCAST.
English: Patients with glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Prophylaxis in AML and HSCT Study 5615
Slovenian: Profilaksa pri AML in HSCT Študija 5615
English: The total subject population had a mean age of 51 years (range = 18-82 years), 95 % were White, the major ethnicity was not Hispanic or Latino (92 %), and 55 % were male.
Slovenian: Povprečna starost celotne populacije je bila 51 let (razpon 18-82 let), 95 % je bilo belcev, največja etnična skupina ni bila hispanskega oziroma latinskega porekla (92 %), 55 % je bilo moških.
English: INFORMATION IN BRAILLE
Slovenian: INFORMACIJE V BRAILLOVI PISAVI
English: EU/1/05/320/002 24 tablets EU/1/05/320/003 96 tablets
Slovenian: EU/1/05/320/002 24 tablet EU/1/05/320/003 96 tablet
English: An increased effect on the QTc interval cannot be ruled out.
Slovenian: Večjega vpliva na interval QTc ni mogoče izključiti.
English: The oral suspension must be shaken well before use.
Slovenian: Peroralno suspenzijo je treba pred uporabo dobro pretresti.
English: Dose adjustment of calcium channel blockers may be required.
Slovenian: Morda bo potrebna prilagoditev odmerka zaviralcev kalcijevih kanalčkov.
English: Unbound concentrations were not determined and it cannot be excluded that there is a larger increase in unbound posaconazole exposure than the observed 60 % increase in total AUC.
Slovenian: Koncentracije nevezanega posakonazola niso bile določene in ni mogoče izključiti možnosti, da pride do večjega povečanja izpostavljenosti nevezanemu posakonazolu od opaženega 60 % povečanja celokupne AUC.
English: Electrocardiogram evaluation
Slovenian: Ocena elektrokardiograma
English: Schering-Plough Labo N.V., Industriepark 30, Zone A, BE-2220 Heist-op-den-Berg, Belgium
Slovenian: Schering-Plough Labo N.V., Industriepark 30, Zone A, BE-2220 Heist-op-den-Berg, Belgija
English: Clinical outcomes were compared with those in an external control group derived from a retrospective review of medical records.
Slovenian: Klinične izide so primerjali z izidi zunanje kontrolne skupine, ki so jih dobili na osnovi retrospektivnega pregleda zdravstvene dokumentacije.
English: • Concomitant use with medicinal products known to prolong the QTc interval (other than those mentioned in section 4.3).
Slovenian: • sočasna uporaba z zdravili, za katera je znano, da podaljšajo interval QTc (razen tistih, ki so omenjena v poglavju 4.3).
English: • abnormal dreams, or difficulty sleeping
Slovenian: • nenormalne sanje, težave s spanjem
English: • problems with co-ordination or balance
Slovenian: • težave z usklajenostjo gibov (koordinacijo) ali ravnotežjem
English: EXP Any product remaining four weeks after opening the bottle should be discarded.
Slovenian: EXP Zdravilo, ki preostane štiri tedne po odprtju stekleničke, zavrzite.
English: • develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine.
Slovenian: • če se pojavita huda driska ali bruhanje, kajti lahko zmanjšata učinkovitost tega zdravila.
English: Safety data in the elderly are limited.
Slovenian: Podatkov o varnosti pri starejših bolnikih je malo.
English: Children Noxafil should not be used in children (17 years of age and younger).
Slovenian: Otroci Zdravila Noxafil se ne sme uporabljati pri otrocih (starih 17 let ali manj).
English: No overall differences in safety were observed between the geriatric patients and younger patients; therefore, no dosage adjustment is recommended for geriatric patients.
Slovenian: V celoti niso ugotovili razlik v varnosti med geriatričnimi bolniki in mlajšimi bolniki, zato geriatričnim bolnikom odmerka ni treba prilagoditi.
English: • high or low blood sugar levels
Slovenian: • visoka ali nizka koncentracija sladkorja v krvi
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: 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); not known (cannot be estimated from the available data).
Slovenian: V okviru organskih sistemov so neželeni učinki navedeni z naslednjimi kategorijami pogostnosti: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Noxafil with food and drink
Slovenian: Zdravilo Noxafil skupaj s hrano in pijačo
English: • if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na posakonazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Any products not listed in the table above should not be coadministered with Noxafil through the same intravenous line (or cannula).
Slovenian: Zdravil, ki niso navedena na zgornjem seznamu, se ne sme dajati skupaj z zdravilom Noxafil po isti intravenski liniji (ali kanili).
English: • However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule.
Slovenian: • Če pa je že skoraj čas za naslednji odmerek, preskočite izpuščeni odmerek in nadaljujte jemanje po svojem običajnem urniku.
English: TreatmentInvasive Aspergillosis Study 0041
Slovenian: Zdravljenjeinvazivna aspergiloza Študija 0041
English: Your doctor will monitor your response and condition to determine how long Noxafil needs to be given and whether any change is needed to your daily dose.
Slovenian: Zdravnik bo spremljal vaš odziv in stanje in tako ugotovil, kako dolgo morate jemati zdravilo Noxafil in ali je potrebna kakšna sprememba dnevnega odmerka.
English: The pharmacokinetics and safety data from Study 5615 were bridged to the existing data (including efficacy data) with the oral suspension.
Slovenian: S podatki o farmakokinetiki in varnosti iz študije 5615 je bila opravljena premostitev na obstoječe podatke (vključno s podatki o učinkovitosti), pridobljene s peroralno suspenzijo.
English: This medicinal product is for single use only and any unused solution should be discarded.
Slovenian: Zdravilo je samo za enkratno uporabo in vso neporabljeno raztopino je treba zavreči.
English: Overall efficacy of posaconazole oral suspension at the end of treatment for invasive aspergillosis in comparison to an external control group Posaconazole oral suspension
Slovenian: Skupna učinkovitost peroralne suspenzije posakonazola ob koncu zdravljenja invazivne aspergiloze v primerjavi z zunanjo kontrolno skupino Peroralna suspenzija posakonazola
English: Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy.
Slovenian: Zvišane vrednosti testov delovanja jeter so bile običajno reverzibilne po prenehanju zdravljenja, v nekaterih primerih pa so se normalizirale že brez prekinitve zdravljenja.
English: Study 5520 enrolled a total of 279 subjects, including 268 receiving at least one dose of posaconazole concentrate for solution for infusion.
Slovenian: Študija 5520 je zajela skupno 279 preiskovancev, vključno z 268, ki so dobili vsaj en odmerek posakonazola v koncentratu za raztopino za infundiranje.
English: Five of these patients had chromoblastomycosis due to Fonsecaea pedrosoi and 4 had mycetoma, mostly due to Madurella species.
Slovenian: Pet od teh bolnikov je imelo kromoblastomikozo zaradi okužbe s Fonsecaea pedrosoi, 4 pa so imeli micetom, večinoma zaradi okužbe z Madurella spp.
English: No safety data are available for administration > 28 days.
Slovenian: Podatkov o varnosti za več kot 28-dnevno uporabo ni.
English: Noxafil gastro-resistant tablets may be taken with or without food (see section 5.2).
Slovenian: Zdravilo Noxafil gastrorezistentne tablete je mogoče jemati s hrano ali brez nje (glejte poglavje 5.2).
English: The external control group included 86 patients treated with available therapy (as above) mostly at the same time and at the same sites as the patients treated with posaconazole.
Slovenian: V zunanji kontrolni skupini je bilo 86 bolnikov, zdravljenih z razpoložljivimi zdravili (kot navedeno zgoraj), večinoma ob istem času in na istih mestih kot bolniki, zdravljeni s posakonazolom.
English: In both prophylaxis studies, aspergillosis was the most common breakthrough infection.
Slovenian: V obeh študijah profilaktične uporabe zdravila je bila aspergiloza najpogostejša prebijajoča okužba.
English: • blurred vision, sensitivity to light
Slovenian: • zamegljen vid, občutljivost za svetlobo
English: The clinical response rates from the above study are shown in the Table 4 below.
Slovenian: Odstotki kliničnega odziva iz zgornje študije so prikazane v Preglednici 4 v nadaljevanju.
English: Noxafil can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them:
Slovenian: Zdravilo Noxafil se lahko uporablja pri odraslih bolnikih za zdravljenje naslednjih vrst glivnih okužb, kadar druga protiglivna zdravila niso učinkovala ali ste jih morali nehati jemati:
English: you will need a blood test and you will need to look out for some possible side effects of rifabutin.
Slovenian: boste morali opraviti preiskavo krvi in biti pozorni na nekatere možne neželene učinke rifabutina.
English: • Noxafil is for single use.
Slovenian: • Zdravilo Noxafil je samo za enkratno uporabo.
English: In the fasting state, AUC increased less than in proportion to dose above 200 mg.
Slovenian: Na tešče se je vrednost AUC povečala manj kot bi bilo sorazmerno odmerku nad 200 mg.
English: Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin).
Slovenian: Spremljanje bolnika mora vključevati laboratorijsko oceno delovanja jeter (še posebej jetrne teste in določanje bilirubina).
English: Please return the bottle containing any leftover suspension to your pharmacist.
Slovenian: Stekleničko z morebitno preostalo suspenzijo vrnite v lekarno.
English: Clinical success rate was defined as the number of cases assessed as having a clinical response (cure or improvement) divided by the total number of cases eligible for analysis.
Slovenian: Klinična uspešnost je bila opredeljena kot število primerov, pri katerih so ocenili pozitiven klinični odziv (ozdravitev ali izboljšanje stanja), deljeno s skupnim številom primerov, ki so bili primerni za analizo.
English: What Noxafil is and what it is used for
Slovenian: Kaj je zdravilo Noxafil in za kaj ga uporabljamo
English: • having a blind or dark spot in your field of vision
Slovenian: • pojav slepe ali temne pege v vidnem polju
English: • having problems thinking or talking, having jerking movements, especially in your hands that you cannot control
Slovenian: • težave z razmišljanjem ali govorjenjem, trzajoči gibi, zlasti trzajoči gibi rok, ki jih ne morete obvladovati
English: Prevention of serious Fungal Infections
Slovenian: Preprečevanje resnih glivnih okužb
English: Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Slovenian: Odpornost na zdravilo je opredeljena kot napredovanje okužbe ali brez izboljšanja po najmanj 7-dnevnem predhodnem zdravljenju s terapevtskimi odmerki učinkovitega antimikotičnega zdravila.
English: The primary efficacy variable was the clinical success rate (defined as cure or improvement) after 14 days of treatment.
Slovenian: Primarni parameter učinkovitosti je bil odstotek klinične uspešnosti (opredeljena kot ozdravitev ali izboljšanje stanja) po 14 dneh zdravljenja.
English: There is no information on the effect of alcohol on posaconazole.
Slovenian: Ni podatkov o vplivu alkohola na posakonazol.
English: FLU = fluconazole; ITZ = itraconazole; POS = posaconazole.
Slovenian: FLU = flukonazol; ITZ = itrakonazol; POS = posakonazol.
English: Therefore, in subsequent studies posaconazole was administered via central venous catheter.
Slovenian: Zato so v poznejših študijah posakonazol dajali po centralnem venskem katetru.
English: EU/1/05/320/004 1 vial
Slovenian: EU/1/05/320/004 1 viala
English: Particular caution is advised in such cases where posaconazole is administered peripherally, as the recommended infusion time of 30 minutes may further increase Cmax.
Slovenian: Posebna previdnost se priporoča v primerih, ko se posakonazol uporablja po periferni poti, kajti zaradi priporočenega časa infundiranja (30 minut) se Cmax lahko dodatno poveča.
English: If you have missed a dose, take it as soon as you remember and then carry on as before.
Slovenian: Če ste izpustili odmerek zdravila, ga zaužijte takoj, ko se spomnite, in potem nadaljujte z jemanjem zdravila kot prej.
English: Posaconazole must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Slovenian: Posakonazola se ne sme uporabljati pri nosečnicah, razen če korist za mater očitno odtehta možno tveganje za plod.
English: Posaconazole has a distribution volume of 261 L, indicating extravascular distribution.
Slovenian: Volumen porazdelitve posakonazola je 261 l, kar kaže na zunajžilno porazdelitev.
English: Do not switch between taking Noxafil tablets and Noxafil oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.
Slovenian: Ne preidite na jemanje Noxafil tablet, če jemljete Noxafil peroralno suspenzijo, in obratno, ne da bi se posvetovali z zdravnikom ali farmacevtom, saj lahko pride do pomanjkanja učinkovitosti ali povečanega tveganja za neželene učinke.
English: • pituitary gland not working properly - this may cause low blood levels of some hormones that affect the function of the male or female sex organs
Slovenian: • nepravilno delovanje žleze hipofize - to lahko povzroči nizko koncentracijo nekaterih hormonov, ki vplivajo na delovanje moških ali ženskih spolnih organov
English: 2, rue Louis Pasteur F-14200 Hérouville St Clair France
Slovenian: 2, rue Louis Pasteur F-14200 Hérouville St Clair Francija
English: 5 % dextrose in water 0.9 % sodium chloride 0.45 % sodium chloride 5 % dextrose and 0.45 % sodium chloride 5 % dextrose and 0.9 % sodium chloride 5 % dextrose and 20 mEq KCl
Slovenian: 5 % glukoza v vodi 0,9 % natrijev klorid 0,45 % natrijev klorid 5 % glukoza in 0,45 % natrijev klorid 5 % glukoza in 0,9 % natrijev klorid 5 % glukoza in 20 mEq KCl
English: Reproduction, peri- and postnatal development studies were conducted in rats.
Slovenian: Pri podganah so bile opravljene študije razmnoževanja ter peri- in post-natalnega razvoja.
English: The microbiological data suggest that posaconazole is active against Rhizomucor, Mucor, and Rhizopus; however the clinical data are currently too limited to assess the efficacy of posaconazole against these causative agents.
Slovenian: Mikrobiološki podatki kažejo, da je posakonazol učinkovit proti vrstam Rhizomucor, Mucor in Rhizopus; vendar je kliničnih podatkov trenutno premalo, da bi lahko ocenili učinkovitost posakonazola proti tem povzročiteljem okužb.
English: Steady-state is attained following 7 to 10 days of multiple-dose administration.
Slovenian: Stanje dinamičnega ravnovesja je doseženo po 7 do 10 dneh dajanja večkratnih odmerkov.
English: 105 mL oral suspension
Slovenian: 105 ml peroralna suspenzija