FrancophonIA/ELRC3.0 huggingface dataset:
English: In a postmarketing clinical trial investigating multiple myeloma patients receiving melphalan 200 mg/m2 as conditioning regimen, palifermin administration with four days between the last pre dose and the first post dose did not show a therapeutic benefit in the frequency or duration of severe oral mucositis compared to placebo.
Slovenian: V kliničnem preskušanju v obdobju trženja pri bolnikih z multiplim mielomom, ki so za pripravljalno zdravljenje prejeli melfalan v odmerku 200 mg/m2, uporaba palifermina s 4-dnevnim presledkom med zadnjim odmerkom pred terapijo in prvim odmerkom po njej ni pokazala nobene terapevtske prednosti v primerjavi s placebom, kar zadeva pogostnost ali trajanje hudega oralnega mukozitisa.
English: The conditioning regimen consisted of total body irradiation (TBI), etoposide and cyclophosphamide.
Slovenian: Pripravljalni režim je bil sestavljen iz obsevanja celotnega telesa, etopozida in ciklofosfamida.
English: Each vial contains 6.25 mg of palifermin.
Slovenian: Ena viala vsebuje 6,25 mg palifermina.
English: 6 vials containing powder for solution for injection
Slovenian: 6 vial s praškom za raztopino za injiciranje
English: This dose will be given to you as an intravenous injection (into a vein).
Slovenian: Tak odmerek boste dobili v intravenski injekciji (injekciji v veno).
English: - The other ingredients are mannitol, sucrose, L-histidine, polysorbate 20 and diluted
Slovenian: - Pomožne snovi so manitol, saharoza, L-histidin, polisorbat 20 in razredčena klorovodikova
English: Kepivance left at room temperature for more than 1 hour should be discarded.
Slovenian: Zdravilo Kepivance, ki je bilo na sobni temperaturi več kot 1 uro, morate zavreči.
English: The last three doses should be administered post myeloablative radiochemotherapy; the first of these doses should be administered after, but on the same day of haematopoietic stem cell infusion and at least seven days after the most recent Kepivance administration (see section 4.4).
Slovenian: Prvega od njih je treba aplicirati po infundiranju hematopoetskih matičnih celic, vendar še isti dan in obenem najmanj sedem dni po zadnji prejšnji aplikaciji zdravila Kepivance (glejte poglavje 4.4).
English: KGF receptors are known to be expressed on the lens of the eye. Cataractogenic effects of palifermin cannot be excluded (see section 5.1).
Slovenian: Kataraktogenih učinkov palifermina ni mogoče izključiti (glejte poglavje 5.1).
English: No accumulation of palifermin occurred after 3 consecutive daily doses of 20 and 40 micrograms/kg (healthy volunteers) or 60 micrograms/kg (adult patients) or 40 to 80
Slovenian: Po 3 zaporednih dnevnih odmerkih 20 in 40 mikrogramov/kg (zdravi prostovoljci) oz. 60 mikrogramov/kg (odrasli bolniki) ali 40 do 80 mikrogramov/kg
English: The first three doses should be administered prior to myeloablative therapy, with the third dose 24 to 48 hours before myeloablative radiochemotherapy.
Slovenian: Prve tri odmerke je treba uporabiti pred mieloablacijsko terapijo, in sicer tako, da bolnik dobi tretji odmerek v 24 do 48 urah pred mieloablacijsko radiokemoterapijo.
English: • hand-and-foot skin-reaction (palms of the hands or soles of the feet tingle, become numb,
Slovenian: • reakcija na koži dlani in stopal (na dlaneh ali stopalih se pojavi mravljinčavost/srbečica,
English: Vaginal oedema and vulvovaginal erythema
Slovenian: artralgija vaginalni edem in vulvovaginalni eritem
English: Oral mucosal hypertrophy / Hypertrophy of tongue papillae,Oral mucosal discolouration / Tongue discolouration, Tongue disorder (e.g. redness, bumps), Tongue oedema
Slovenian: Bolezni prebavil hipertrofija ustne sluznice/hipertrofija papil na jeziku, obarvanje ustne sluznice/obarvanje jezika nepravilnosti jezika (npr. pordelost, bule), edem jezika
English: Dose limiting toxicities were observed in 36% (5 of 14) patients receiving 6 doses of 80 micrograms/kg/day administered intravenously over 2 weeks (3 doses preceding and three doses following myeloablative therapy).
Slovenian: Toksične učinke, ki so omejevali odmerek, so zabeležili pri 36 % (5 od 14) bolnikov, ki so dobili 6 odmerkov po 80 mikrogramov/kg/dan intravensko v 2 tednih (3 odmerke pred in 3 odmerke po mieloablacijski terapiji).
English: Kepivance is not recommended in children (0 to 18 years).
Slovenian: Pri otrocih, starih od 0 do 18 let, zdravila Kepivance ne priporočamo.
English: Safety data are based on patients with haematological malignancies enrolled in randomised, placebocontrolled clinical studies, including one pharmacokinetic study, and post marketing experience.
Slovenian: vključenih v randomizirane, s placebom kontrolirane klinične študije, vključno s študijo farmakokinetike, in na podlagi izkušenj v obdobju trženja.
English: The duration between last dose of Kepivance before myeloablative radiochemotherapy and the first dose of Kepivance after myeloablative radiochemotherapy should be at least seven days.
Slovenian: Med zadnjim odmerkom zdravila Kepivance pred mieloablacijsko radiokemoterapijo in prvim odmerkom zdravila Kepivance po mieloablacijski radiokemoterapiji mora preteči najmanj sedem dni.
English: There is no experience with Kepivance doses greater than 80 micrograms/kg/day administered intravenously in patients over 2 weeks (3 doses preceding and 3 doses following myeloablative
Slovenian: Z zdravilom Kepivance ni izkušenj v odmerkih, večjih od 80 mikrogramov/kg/dan, apliciranih intravensko v obdobju 2 tednov (3 odmerki pred in 3 odmerki po mieloablacijski terapiji).
English: Cataractogenic effects of palifermin cannot be excluded following results of ophthalmologic examinations in a subset of patients (n = 66; 14 in the placebo group, 52 in the palifermin group) who were followed for 12 months after the acute phase of the above post-approval study.
Slovenian: Glede na rezultate oftalmološkega pregleda podskupine bolnikov (n = 66; 14 v kontrolni skupini, 52 v skupini, zdravljeni s paliferminom), ki so jih spremljali 12 mesecev po akutni fazi navedene študije po pridobitvi dovoljenja za promet, kataraktogenih učinkov palifermina ni mogoče izključiti.
English: Prior to administration, visually inspect the solution for discolouration and particulate matter before administration, see section 6.6.
Slovenian: Pred aplikacijo morate pregledati, da raztopina ni obarvana in ne vsebuje delcev, glejte poglavje 6.6.
English: Rash, pruritus and erythema Skin hyperpigmentation Palmar-plantar erythrodysaesthesia syndrome (dysaesthesia, erythema, oedema on the palms and soles)
Slovenian: Bolezni kože in podkožja izpuščaj, srbenje in eritem hiperpigmentacija kože sindrom eritrodisestezije dlani in stopal (disestezija, eritem in edem na dlaneh in stopalih)
English: The first of the three doses given after the chemotherapy and radiotherapy must be given at least 7 days after the most recent
Slovenian: Prve tri odmerke po kemoterapiji in radioterapiji morate dobiti najmanj 7 dni po zadnjem dajanju zdravila Kepivance.
English: There was no evidence of a delay in time to haematopoietic recovery in patients who received palifermin as compared to patients who received placebo.
Slovenian: Hematopoetsko okrevanje pri prejemnikih palifermina se v primerjavi s prejemniki placeba ni izkazalo za počasnejše.
English: Median (25th, 75th percentile) days of Median (25th, 75th percentile) days of
Slovenian: Mediana (25., 75. percentil) dni z oralnim mukozitisom 3./4.
English: Patient incidence of WHO Grade 4 oral Median (25th, 75th percentile) days of
Slovenian: Incidenca bolnikov z oralnim mukozitisom 4. stopnje Mediana (25., 75 percentil) dni z oralnim mukozitisom 2./3./4.
English: Once reconstituted, Kepivance contains 5 mg/ml of palifermin.
Slovenian: Zdravilo Kepivance po pripravi vsebuje 5 mg/ml palifermina.
English: Palifermin works in the same way as keratinocyte growth factor (KGF) which is made naturally by
Slovenian: Palifermin deluje enako kot keratinocitni rastni dejavnik (KGF), ki v majhni količini naravno nastaja v človeškem telesu.
English: ** WHO Oral Mucositis Scale: Grade 1 = soreness/erythema; Grade 2 = erythema, ulcers, can eat solids; Grade 3 = ulcers, requires liquid diet only; Grade 4 = alimentation not possible
Slovenian: bolnik lahko uživa čvrsto hrano, 3. stopnja = razjede, potrebna je zgolj tekoča hrana, 4. stopnja = hranjenje ni mogoče
English: Patient Incidence of Febrile Neutropenia 92% 75% * Using Cochran-Mantel-Haenszel (CMH) test stratified for study centre.
Slovenian: mediani (25., 75. percentila) kumulativni odmerek (ekvivalent mg morfina) Incidenca bolnikov s popolno parenteralno prehrano (PPP) Incidenca bolnikov s febrilno nevtropenijo * Z uporabo Cochran-Mantel-Haenszelovega (CMH) testa, stratificirano po študijskem centru.
English: Non-haematological malignancies
Slovenian: Nehematološki malignomi
English: Haematopoietic recovery following PBPC infusion was similar between patients who received Kepivance or placebo, and there were no observed differences in disease progression or survival.
Slovenian: Kepivance in placeba podobno; razlik v napredovanju bolezni ali preživetju niso ugotovili.
English: Kepivance is a growth factor that stimulates the proliferation of KGF receptor expressing epithelial cells.
Slovenian: V zdravilu Kepivance je rastni faktor, ki spodbuja proliferacijo epitelijskih celic z eksprimiranimi receptorji KGF.
English: Palifermin
Slovenian: Dojenje
English: Endogenous KGF is an epithelial cell specific growth factor which is produced by mesenchymal cells and is naturally upregulated in response to epithelial tissue injury.
Slovenian: Endogeni KGF je za epitelijske celice specifičen rastni faktor, ki nastaja v mezenhimskih celicah.
English: The recommended dosage of Kepivance is 60 micrograms/kg/day, administered as an intravenous bolus injection for three consecutive days before and three consecutive days after myeloablative radiochemotherapy for a total of six doses.
Slovenian: Priporočeni odmerek zdravila Kepivance je 60 mikrogramov/kg/dan v intravenski bolusni injekciji, in sicer tri dni zapored pred mieloablacijsko radiokemoterapijo in tri dni zapored po njej, tako da dobi bolnik skupaj šest odmerkov.
English: Approximately dose-linear pharmacokinetics were observed in healthy volunteers after single dose administration up to 250 micrograms/kg.
Slovenian: Pri zdravih prostovoljcih so po uporabi posamičnega odmerka do 250 mikrogramov/kg ugotovili približno z odmerkom linearno farmakokinetiko.
English: Palifermin stimulates the growth of specific cells called epithelial cells that form the tissue lining of your mouth and digestive tract, as well as other tissues such as skin.
Slovenian: Epitelijske celice tvorijo tkivno prevleko v ustih, prebavilih in tudi drugod, npr. na koži.
English: • redness, bumps or swelling of the tongue;
Slovenian: • pordelost, bule ali oteklost jezika, • oteklost (edem) obraza ali ust,
English: • an increase in the thickness in the mouth or tongue;
Slovenian: • zadebelitev ust ali jezika,
English: What Kepivance looks like and contents of the pack Kepivance is a white powder supplied in vials.
Slovenian: Zdravilo Kepivance je bel prašek v vialah.
English: In embryo/foetal development toxicity studies in rats and rabbits, palifermin treatment was associated with developmental toxicity (increased post-implantation loss, reduced litter size, and/or reduced foetal weight) at doses of 500 and 150 micrograms/kg/day, respectively.
Slovenian: V študijah razvojnih toksičnih učinkov pri zarodkih in plodovih podgan in kuncev, je bilo zdravljenje s paliferminom v odmerkih 500 mikrogramov/kg/dan (podgane) oz. 150 mikrogramov/kg/dan (kunci)
English: No adverse developmental effects were observed in rats and rabbits at doses of up to 300 and 60 micrograms/kg/day, respectively.
Slovenian: Pri podganah niso opazili nobenih neugodnih učinkov na razvoj ob odmerkih do 300 mikrogramov/kg/dan, pri kuncih pa do 60 mikrogramov/kg/dan.
English: A randomised, placebo-controlled, double-blind study was conducted post-approval to evaluate the efficacy of palifermin given pre- or pre- and post- chemotherapy (CT).
Slovenian: Randomizirana, s placebom kontrolirana, dvojno slepa študija za oceno učinkovitosti palifermina,
English: Store in the original carton, in order to protect from light.
Slovenian: Shranjujte v originalni škatli, da bo zdravilo zaščiteno pred svetlobo.
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03A F08.
Slovenian: ATC: V03AF08.
English: However, patients treated with chemotherapy and/or radiotherapy are at higher risk of developing secondary tumours some of which may express KGF receptors, and theoretically, be stimulated by KGF receptor ligands.
Slovenian: Nekateri od teh bi lahko imeli eksprimirane receptorje KGF in bi jih teoretično lahko spodbujali ligandi receptorjev KGF.
English: A 3-fold or greater increase in Ki67 staining was observed in buccal biopsies from 3 of 6 healthy subjects given palifermin at 40 micrograms/kg/day intravenously for 3 days, when measured 24 hours after the third dose.
Slovenian: Pri 3 od 6 zdravih preiskovancev, ki so 3 dni dobivali palifermin v odmerku 40 mikrogramov/kg/dan, so z meritvijo 24 ur po 3. odmerku v bukalnih bioptičnih vzorcih ugotovili 3- ali večkraten porast obarvanja Ki67.
English: In studies in rats, no adverse effects on reproductivity/fertility parameters were observed at doses of up to 100 micrograms/kg/day.
Slovenian: Študije na podganah pri odmerkih do 100 mikrogramov/kg/dan niso pokazale neželenih učinkov na parametre razmnoževanja/plodnosti.
English: No gender-related differences were observed in the pharmacokinetics of palifermin.
Slovenian: Farmakokinetika palifermina se med spoloma ni razlikovala.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to
Slovenian: Preobčutljivost na zdravilno učinkovino, katerokoli pomožno snov, navedeno v poglavju 6.1 ali beljakovine, pridobljene iz bakterije Escherichia coli.
English: Dose-dependent epithelial cell proliferation was observed 48 hours post-dosing in healthy subjects given single intravenous doses of 120 to 250 micrograms/kg.
Slovenian: Pri zdravih preiskovancih, ki so dobili en sam intravenski odmerek od 120 do 250 mikrogramov/kg, so 48 ur po odmerku zabeležili od odmerka odvisno proliferacijo epitelijskih celic.
English: • eyelid swelling;
Slovenian: • splošna oteklost (edemi),
English: Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Kepivance Vsebina pakiranja in dodatne informacije
English: Kepivance should not be administered subcutaneously due to poor local tolerability.
Slovenian: Zaradi slabega lokalnega prenašanja zdravila Kepivance ne smete dajati subkutano.
English: Oral mucositis and related clinical sequelae - HSC transplant study Palifermin (60 micrograms/kg/day) n = 106
Slovenian: Oralni mukozitis in sorodne klinične posledice - študija HSC Transplant
English: Powder for solution for injection (powder for injection).
Slovenian: prašek za raztopino za injiciranje (prašek za injekcijo) bel liofiliziran prašek
English: PHARMACEUTICAL PARTICULARS
Slovenian: 5.2 Farmakokinetične lastnosti
English: 1 Kepivance may cause increased lipase and amylase levels in some patients with or without symptoms of abdominal pain or backache.
Slovenian: zvišani amilaza in lipaza v krvi1 1 Zdravilo Kepivance lahko pri nekaterih bolnikih zviša raven lipaze in amilaze.
English: These patient-reported outcomes were highly correlated to the clinician grading of
Slovenian: Ti samoopisani izidi so močno korelirali s klinično razvrstitvijo oralnega mukozitisa po lestvici SZO.
English: NAME OF THE MEDICINAL PRODUCT Kepivance 6.25 mg powder for solution for injection Palifermin
Slovenian: Navodilo za uporabo Kepivance 6,25 mg prašek za raztopino za injiciranje palifermin
English: Post- myeloablative radiochemotherapy:
Slovenian: Pred mieloablacijsko radiokemoterapijo:
English: • tingling of the mouth;
Slovenian: • oteklost ustnic.
English: Days
Slovenian: Otroci
English: After single intravenous doses of 20 to 250 micrograms/kg (healthy volunteers) and 60 micrograms/kg (cancer patients), palifermin exhibited rapid extravascular distribution In patients with haematological malignancies mean Vss was 5 l/kg and mean clearance about 1300 ml/hour/kg with an average terminal half-life of approximately 4.5 hours.
Slovenian: Pri bolnikih s hematološkimi malignomi je bil povprečni Vss 5 l/kg, povprečni očistek okrog 1300 ml/uro/kg in povprečni terminalni razpolovni čas približno 4,5 ure.
English: A total of 27 paediatric patients with leukaemia were randomized to 40, 60 or 80 micrograms/kg/day of palifermin for 3 days pre- and post- hematopoietic stem cell transplantation (HSCT).
Slovenian: Skupno 27 pediatričnih bolnikov z levkemijo so randomizirali v skupine s po 40, 60 in 80
English: Dysgeusia Paraesthesia oral
Slovenian: Bolezni živčevja disgevzija parestezije v ustih
English: Sucrose
Slovenian: EXP
English: NAME OF THE MEDICINAL PRODUCT Kepivance 6.25 mg powder for solution for injection
Slovenian: Kepivance 6,25 mg prašek za raztopino za injiciranje
English: Visually inspect the solution for discolouration and particulate matter before administration.
Slovenian: Pred aplikacijo raztopino preglejte,
English: Kepivance should not be administered if discolouration or particulates are observed.
Slovenian: Če opazite obarvanje ali delce, Kepivanca ne smete aplicirati.
English: In fertility/general reproductive toxicity studies in rats, palifermin treatment was associated with systemic toxicity (clinical signs and/or changes in body weight) and adverse effects on male and female reproductive/fertility parameters at doses greater than or equal to 300 micrograms/kg/day.
Slovenian: spremljali sistemski toksični učinki (klinični znaki in/ali spremembe telesne mase) ter neželeni učinki na reproduktivne parametre/parametre plodnosti samcev in samic.
English: Caution should be used when dosing patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter bodite previdni pri odmerjanju.
English: Detailed information on this medicinal product is available on the website of the European Medicines
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: Polysorbate 20
Slovenian: L-histidin manitol saharoza polisorbat 20
English: Face oedema, oedema mouth
Slovenian: edem, periferni edem, bolečina in pireksija oteklost ustnic, edem vek edem obraza, edem ust
English: For the primary endpoint, which was incidence of cataract development or progression at 12 months (defined as an increase of ≥ 0.3 in the LOCS III score), a greater proportion of subjects experienced cataract development in the palifermin group compared with the placebo group (28.6 % in the placebo group vs 48.1% in the palifermin group).
Slovenian: (opredeljeno kot povečanje ocene po lestvici LOCS III za ≥ 0,3), je v skupini, zdravljeni s paliferminom, prišlo do razvoja katarakte pri večjem deležu preiskovancev kot v kontrolni skupini
English: Lip swelling, eyelid oedema
Slovenian: OVOJNINAH NALEPKA NA VIALI
English: Ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Preden začnete jemati to zdravilo, se posvetujte s svojim zdravnikom ali farmacevtom.
English: None were considered serious in nature.
Slovenian: Noben se ni obravnaval kot resen.
English: open here
Slovenian: odprite tukaj
English: There may be new information.
Slovenian: Morda bo vsebovalo nove informacije.
English: Date of first authorisation: 18 July 2014 Date of latest renewal: 25 March 2019
Slovenian: Datum prve odobritve: 18. julij 2014 Datum zadnjega podaljšanja: 25. marec 2015
English: These symptoms are not really flu, see below.
Slovenian: Ti simptomi niso prava gripa, glejte spodaj.
English: This is normal and will not affect your dose.
Slovenian: To je normalno in ne vpliva na vaš odmerek.
English: Research Triangle Park, NC 27709-4627 USA
Slovenian: Research Triangle Park, NC 27709-4627
English: DK-3400 Hillerød
Slovenian: DK-3400 Hillerød Danska
English: 17% previously treated
Slovenian: 17 % predhodno zdravljeni
English: For more information see section 5.1.
Slovenian: Za več informacij glejte poglavje 5.1.
English: - Contact a doctor immediately.
Slovenian: - se takoj posvetujte z zdravnikom.
English: Experience with exposure during the second and third trimester is very limited.
Slovenian: Izkušnje z izpostavljenostjo v drugem in tretjem trimesečju so omejene.
English: Clinical experience in patients aged above 65 years is limited.
Slovenian: Klinične izkušnje pri bolnikih, starih več kot 65 let, so omejene.
English: • Record the date and location of each injection.
Slovenian: • Zabeležite datum in lokacijo vsakega injiciranja.
English: Amount (micrograms)
Slovenian: Količina (mikrogrami)
English: - Serious allergic reaction
Slovenian: - Resne alergijske reakcije
English: Results for this study are shown in Table 3.
Slovenian: Rezultati te študije so prikazani v preglednici 3.
English: This includes any medicines obtained without a prescription.
Slovenian: To vključuje tudi katero koli zdravilo, ki ste ga dobili brez recepta.
English: 125 (full dose)
Slovenian: 125 (polni odmerek)
English: Do not make changes unless your doctor tells you.
Slovenian: Ne spreminjajte ničesar, če vam tako ne naroči zdravnik.
English: The pack contains 3 inner cartons.
Slovenian: Pakiranje vsebuje 3 notranje škatle.
English: Treatment can then continue with the next scheduled dose as planned.
Slovenian: Zdravljenje se naj nadaljuje z naslednjim načrtovanim odmerkom.
English: The start and end of flu-like symptoms are different for every patient.
Slovenian: Začetek in konec gripi podobnih simptomov sta pri vsakem bolniku drugačna.
English: This regular schedule helps to deliver the treatment as evenly as possible.
Slovenian: Ta redni režim zagotavlja, da zdravilo prejemate kar najbolj enakomerno.
English: The majority of enzyme elevations were <3 times the upper limit of normal (ULN).
Slovenian: Večina povečanja encimov je bila < 3-kratna zgornja meja normalne vrednosti (ULN, upper limit of normal).
English: Everyone has their own set of MS symptoms.
Slovenian: Vsak bolnik z MS ima svoj skupek simptomov.
English: The study design and patient demographics are presented in Table 2.
Slovenian: Zasnova študije in demografski podatki bolnikov so predstavljeni v preglednici 2.
English: - Contact a doctor for advice.
Slovenian: - se za nasvet obrnite na zdravnika.
English: Patients who failed previous MS treatment were not included in the study.
Slovenian: Bolniki, pri katerih predhodno zdravljenje MS ni bilo uspešno, niso bili vključeni v študijo.
English: Results in this subgroup were consistent with those in the overall population.
Slovenian: Rezultati te podskupine so bili skladni z rezultati celotne populacije.
English: At very high doses, anovulatory and abortifacient effects were observed in animals.
Slovenian: Pri zelo visokih odmerkih so pri živalih opazili anovulacijske in abortivne učinke.
English: The incidence of the adverse reactions below are expressed according to the following categories:
Slovenian: Incidenca spodnjih neželenih učinkov je izražena po naslednjih kategorijah:
English: This medicine is used to treat relapsing-remitting multiple sclerosis (MS) in adults aged 18 or over.
Slovenian: To zdravilo se uporablja za zdravljenje recidivne-remitentne multiple skleroze (MS) pri odraslih, starih 18 let ali več.
English: Interferons are natural substances made in the body to help protect from infections and diseases.
Slovenian: Interferoni so snovi, ki v telesu nastajajo naravno, in pomagajo pri obrambi pred okužbami in boleznimi.
English: Neutralising antibodies have the potential to reduce clinical efficacy.
Slovenian: Nevtralizirajoča protitelesa potencialno lahko zmanjšajo klinično učinkovitost.
English: Speak to your doctor or pharmacist about how much to take and how long to take it.
Slovenian: Pogovorite se z zdravnikom ali farmacevtom o tem, koliko tega zdravila lahko vzamete in kako dolgo ga lahko jemljete.