FrancophonIA/ELRC3.0 huggingface dataset:
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Slovenian: Povzetek glavnih značilnosti zdravila in Navodilo za uporabo sta posledica zaključka napotitvenega postopka.
English: Section 4.2 Posology and method of administration [This section should be amended to reflect the following wording, as applicable:] <X> should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
Slovenian: Poglavje 4.2 Odmerjanje in način uporabe [Ta del je treba spremeniti tako, da bo odražal naslednje besedilo:] Treba je uporabiti najnižji učinkoviti odmerek zdravila <X> za najkrajše možno trajanje zdravljenja, ki je potrebno za nadzor navzee in bruhanja.
English: o certain antipsychotics (e.g., haloperidol, pimozide, sertindole) o certain antidepressants (e.g., citalopram, escitalopram) o certain antibiotics (e.g. , erythromycin, levofloxacin, moxifloxacin, spiramycin) o certain antifungal agents (e.g., pentamidine) o certain antimalarial agents (in particular halofantrine, lumefantrine) o certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride) o certain antihistaminics (e.g., mequitazine, mizolastine) o certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine) o certain other medicines (e.g., bepridil, diphemanil, methadone) (see section 4.3).
Slovenian: Zdravila, ki podaljšujejo interval QTc o antiaritmiki razreda IA (npr. dizopiramid, hidrokinidin, kinidin) o antiaritmiki razreda III (npr. amiodaron, dofetilid, dronedaron, ibutilid, sotalol) o nekateri antipsihotiki (npr. haloperidol, pimozid, sertindol) o nekateri antidepresivi (npr. citalopram, escitalopram) o nekateri antibiotiki (npr. eritromicin, levofloksacin, moksifloksacin, spiramicin) o nekateri antimikotiki (npr. pentamidin) o nekateri antimalariki (zlasti halofantrin, lumefantrin) o nekatera gastrointestinalna zdravila (npr. cisaprid, dolasetron, prukaloprid) o določeni antihistaminiki (npr. mekitazin, mizolastin) o nekatera zdravila, ki se uporabljajo pri raku (npr. toremifen, vandetanib, vinkamin) o nekatera druga zdravila (npr. bepridil, difemanil, metadon) (glejte poglavje 4.3).
English: Small amounts of domperidone have been detected in breast milk.
Slovenian: V materinem mleku so odkrili majhne količine domperidona.
English: This study included a placebo, an active comparator and a positive control and was conducted in healthy subjects with up to 80 mg per day 10 or 20 mg administered 4 times a day of domperidone.
Slovenian: Študija je vključevala placebo, aktivno primerjalno učinkovino in pozitivno kontrolo in je bila opravljena pri zdravih osebah z do 80 mg domperidona na dan, 10 ali 20 mg 4-krat na dan.
English: In subjects with severe renal insufficiency (creatinine clearance<30 ml/min/1.73m2) the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers.
Slovenian: Pri osebah s hudo okvaro ledvic (očistek kreatinina <30 ml/min/1,73m2) se je razpolovna doba izločanja domperidona podaljšala s 7,4 na 20,8 ur, plazemske koncentracije zdravila pa so bile manjše kot pri zdravih prostovoljcih.
English: Dose modification in mild hepatic impairment is however not needed (see section 5.2).
Slovenian: Sprememba odmerka pri blagi okvari jeter ni potrebna (glejte poglavje 5.2).
English: Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see section 4.8).
Slovenian: Epidemiološke študije so pokazale, da je bil domperidon povezan s povečanim tveganjem hude ventrikularne aritmije ali nenadne srčne smrti (glejte poglavje 4.8).
English: An ECG monitoring could be undertaken, because of the possibility of a heart problem called prolonged QT interval.
Slovenian: Lahko se izvaja spremljanje EKG, saj obstaja možnost težave s srcem, imenovane podaljšanje intervala QT.
English: Adults, and adolescents (12 years of age and older and weighing 35 kg or more) [Tablets (Film-coated, Coated, Scored coated, Effervescent, Chewable), Orodispersible tablets, capsules]
Slovenian: Odrasli in mladostniki (stari 12 ali več let, s telesno maso 35 kg ali več) [Tablete (filmsko obložene, obložene, obložene z razdelilno zarezo, šumeče, žvečljive), orodisperzibilne tablete, kapsule]
English: • depression (e.g., citalopram, escitalopram)
Slovenian: • depresije (npr. citalopram, escitalopram)
English: The elimination half-life of domperidone is prolonged in severe renal impairment.
Slovenian: Razpolovna doba izločanja domperidona je daljša pri hudi ledvični okvari.
English: In the presence of inhibition of the metabolism via CYP3A4 free plasma concentrations of domperidone can rise up to 3-fold.
Slovenian: Ob zaviranju presnove prek CYP3A4 se lahko proste plazemske koncentracije domperidona povečajo do 3-krat.
English: Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.
Slovenian: Motnje ravnovesja elektrolitov (hipokaliemija, hiperkaliemija, hipomagneziemija) ali bradikardija so znane kot stanja, ki povečujejo tveganje za aritmijo.
English: • co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects) (see section 4.5)
Slovenian: • sočasne uporabe z močnimi zaviralci CYP3A4 (ne glede na njihove učinke na podaljšanje QT) (glejte poglavje 4.5)
English: ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Slovenian: Opraviti je treba spremljanje EKG zaradi možnosti podaljšanja intervala QT.
English: If you have used or taken too much {Tradename}, contact your doctor, pharmacist or the poison centre immediately, in particular if a child has taken too much.
Slovenian: Če ste vzeli večji odmerek zdravila X, kot bi smeli Če ste uporabili ali vzeli preveč zdravila {zaščiteno ime zdravila}, se takoj obrnite na zdravnika, farmacevta ali center za zastrupitve, še zlasti, če je preveliki odmerek vzel otrok.
English: Caution should be exercised in case of QTc prolongation risk factors in breast-fed infants.
Slovenian: Previdnost je potrebna v primeru dejavnikov tveganja za podaljšanje interval QTc pri dojenih otrocih.
English: A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors.
Slovenian: Opazili so večje tveganje pri bolnikih, starejših od 60 let, bolnikih, ki jemljejo dnevne odmerke, večje od 30 mg, in pri bolnikih, ki istočasno jemljejo zdravila za podaljšanje QT ali zaviralce CYP3A4.
English: Oral suspension [Appropriate measure device such as dosing cup must be provided with the product, and instructions for use must be included]
Slovenian: [Z zdravilom je treba je zagotoviti ustrezen merilni pripomoček, kot je odmerna posodica, in vključiti je treba navodila za uporabo]
English: Do not take more than three tablets per day.
Slovenian: Ne jemljite več kot 3 tablete na dan.
English: • in patients with moderate or severe hepatic impairment (see section 5.2).
Slovenian: • pri bolnikih z zmerno ali hudo okvaro jeter (glejte poglavje 5.2).
English: Although domperidone's bioavailability is enhanced in normal subjects when taken after a meal, patients with gastro-intestinal complaints should take domperidone 15 - 30 minutes before a meal.
Slovenian: Biološka uporabnost domperidona se poveča, če ga bolniki vzamejo po jedi, vendar je za želeni učinek pri bolnikih s prebavnimi motnjami treba jemati zdravilo 15 do 30 minut pred jedjo.
English: A 2- to 3-fold accumulation of domperidone AUC was observed with repeated four times daily (every 5 hr) dosing of domperidone for 4 days.
Slovenian: Opaženo je bilo 2 do 3-kratno povečanje vrednosti AUC domperidona pri ponavljajočih se 4-dnevnih odmerjanjih domperidona 4krat na dan (vsakih 5 ur).
English: Concomitant use of the following substances requires caution in use Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT-interval prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated as it is a potent CYP3A4 inhibitor).
Slovenian: Sočasna uporaba naslednjih zdravilnih učinkovin zahteva previdnost pri uporabi Previdnost je potrebna pri zdravilih, ki povzročajo bradikardijo in hipokaliemijo, ter pri naslednjih makrolidih, ki so vpleteni v podaljšanje intervala QT: azitromicin in roksitromicin (klaritromicin je kontraindiciran, saj je močan zaviralec CYP3A4).
English: Not known: ventricular arrhythmias, QTc prolongation, Torsade de Pointes, sudden cardiac death (see section 4.4)
Slovenian: Neznana pogostnost: ventrikularne aritmije, podaljšanje interval QTc, »torsade de pointes«, nenadna srčna smrt (glejte poglavje 4.4)
English: Domperidone is rapidly absorbed after oral administration, with peak plasma concentrations occurring at approximately 1 hr after dosing.
Slovenian: Domperidon se po peroralni uporabi hitro absorbira, pri čemer se največja koncentracija v plazmi pojavi približno 1 uro po odmerku.
English: Oral bioavailability is decreased by prior concomitant administration of cimetidine and sodium bicarbonate.
Slovenian: Biološka uporabnost je zmanjšana zaradi predhodne istočasne uporabe cimetidina in natrijevega bikarbonata.
English: In subjects with moderate hepatic impairment (Pugh score 7 to 9, Child-Pugh rating B), the AUC and Cmax of domperidone is 2.9- and 1.5- fold higher, respectively, than in healthy subjects.
Slovenian: Pri osebah z zmerno okvaro jeter (lestvica po Pugh 7 do 9, razred B po Child-Pugh) so vrednosti AUC in Cmax domperidona 2,9- oz. 1,5-krat višje kot pri zdravih osebah.
English: • heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide,
Slovenian: • težav s srcem ali visokega krvnega tlaka (npr. amiodaron, dronedaron, kinidin, dizopiramid,
English: Section 2 ‘What you need to know before you take X ‘ [This section should be amended to include the below wording] Do not take <X>:- if you have a moderate or severe liver disease - if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” - if you have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure).
Slovenian: Ne jemljite zdravila <X>:- če imate zmerno ali hudo bolezen jeter - če vaš EKG (elektrokardiogram) pokaže srčno motnjo, imenovano "podaljšan korigiran interval QT" - če imate ali ste imeli težave, ko srce ne zmore črpati krvi po telesu tako, kot bi moralo (stanje imenujemo srčno popuščanje).
English: Potent CYP3A4 inhibitors (regardless of their QT prolonging effects), i.e : o protease inhibitors o systemic azole antifungals o some macrolides (erythromycin, clarithromycin and telithromycin) (see section 4.3).
Slovenian: Močni zaviralci CYP3A4 (ne glede na njihove učinke na podaljšanja interval QT), in sicer: o zaviralci proteaz o sistemski azolni antimikotiki o nekateri makrolidi (eritromicin, klaritromicin in telitromicin) (glejte poglavje 4.3).
English: • bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin,
Slovenian: • bakterijskih okužb, posebej eritromicin, klaritromicin, telitromicin, moksifloksacin, pentamidin
English: • co-administration with QT-prolonging drugs (see section 4.5)
Slovenian: • sočasne uporabe zdravil, ki podaljšujejo QT (glejte poglavje 4.5)
English: Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of <X> should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced.
Slovenian: Ker je razpolovna doba izločanja pri ponavljajočih se odmerkih domperidona pri hudi ledvični okvari daljša, je treba pogostost odmerjanja zdravila <X> zmanjšati na enkrat ali 2-krat na dan, odvisno od stopnje okvare, in morda zmanjšati odmerek.
English: Ask your doctor for advice before taking this medicine.
Slovenian: Pred uporabo zdravila se posvetujte s svojim zdravnikom.
English: Before taking this medicine contact your doctor if you: - suffer from liver problems (liver function impairment or failure) (see “Do not take this medicinal product”) - suffer from kidney problems (kidney function impairment or failure).
Slovenian: Preden začnete jemati zdravilo se posvetujte z zdravnikom, če: - imate težave z jetri (moteno delovanje ali popuščanje jeter) (glejte »Ne jemljite tega zdravila«) - imate težave z ledvicami (moteno delovanje ali popuščanje ledvic).
English: Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patients with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia (see section 4.3.).
Slovenian: Domperidon je kontraindiciran pri bolnikih z znanimi obstoječimi podaljšanimi intervali prevodnosti srca, zlasti intervala QTc, pri bolnikih s hudimi elektrolitskimi motnjami (hipokaliemija, hiperkaliemija, hipomagneziemija), ali bradikardijo, ali pri bolnikih z obstoječimi srčnimi boleznimi, kot je srčna odpoved zaradi povečanega tveganja za ventrikularno aritmijo (glej poglavje 4.3).
English: The dose should not be doubled to make up for a missed dose.
Slovenian: Ne smejo vzeti dvojnega odmerka, da bi nadoknadili izpuščen odmerek.
English: If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed.
Slovenian: Če načrtovanega odmerka ne vzamejo, naj izpustijo pozabljeni odmerek in nadaljujejo po začrtanem urniku odmerjanja.
English: • allergy (e.g., mequitazine, mizolastine)
Slovenian: • alergije (npr. mekitazin, mizolastin)
English: Effervescent granules 5 mg [Instructions for use must be included]
Slovenian: Šumeča zrnca 5 mg [Treba je vključiti navodila za uporabo]
English: • in patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure (see section 4.4)
Slovenian: • pri bolnikih z znanimi obstoječimi podaljšanimi intervali prevodnosti srca, zlasti intervalom QTc, bolnikih s hudimi elektrolitskimi motnjami ali drugimi srčnimi boleznimi, kot je srčna odpoved (glejte poglavje 4.4)
English: ▼This medicine is subject to additional monitoring.
Slovenian: NAVODILO ZA UPORABO ▼ Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: However, on repeated administration, the dosing frequency should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced.
Slovenian: Pri ponavljajočih se odmerkih pa je treba pogostost odmerjanja zmanjšati na enkrat ali dvakrat na dan, odvisno od stopnje ledvične bolezni, in morda zmanjšati tudi odmerkek.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Slovenian: Dopolnitve ustreznih poglavij Povzetka glavnih značilnosti zdravila in
English: • psychoses (e.g., haloperidol, pimozide, sertindole)
Slovenian: • psihoz (npr. haloperidol, pimozid, sertindol)
English: For repeated administration, the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment.
Slovenian: Pri ponavljajočem se odmerjanju je treba pogostost odmerjanja domperidona zmanjšati na enkrat do dva krat na dan, odvisno od stopnje okvare.
English: [Effervescent granules 10 mg]
Slovenian: [Šumeča zrnca 10 mg]
English: Neonates, infants, children (less than 12 years of age) and adolescents weighing less than 35 kg
Slovenian: Novorojenčki, dojenčki, otroci (stari manj kot 12 let) in mladostniki s telesno maso, manjšo od 35 kg [Peroralna suspenzija/sirup]
English: The usual dose is 10 mg taken up to three times per day, if possible before meals.
Slovenian: Običajni odmerek je 10 mg do 3-krat na dan, če je le mogoče pred obrokom.
English: • fungal infections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole
Slovenian: • glivičnih okužb, kot so azolna protiglivična zdravila, natančneje peroralni ketokonazol, flukonazol ali vorikonazol
English: • gastro-intestinal disorders (e.g., cisapride, dolasetron, prucalopride)
Slovenian: • prebavnih motenj (npr. cisaprid, dolasetron, prukaloprid)
English: Domperidone is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).
Slovenian: Domperidon je kontraindiciran pri bolnikih z zmerno ali hudo okvaro jeter (glejte poglavje 4.3).
English: The usual dose is one tablet taken up to three times per day, if possible before meals.
Slovenian: Običajni odmerek je ena tableta do 3-krat na dan, če je le mogoče pred obroki.
English: Hepatic Impairment <X> is contraindicated in moderate or severe hepatic impairment (see section 4.3).
Slovenian: Zdravilo <X> je kontraindicirano pri zmerni ali hudi okvari jeter (glejte poglavje 4.3).
English: For example, for a child weighing 10 kg, the dose is 2.5 mg and this can be given three times per day to a maximum dose of 7.5 mg per day.
Slovenian: Treba ga je vzeti do 3-krat na dan z največjim dnevnim odmerkom 0,75 mg/kg na dan. Na primer, za otroka, ki tehta 10 kg, znaša odmerek 2,5 mg in ga lahko daste 3-krat na dan do največjega dnevnega odmerka 7,5 mg na dan.
English: However, two previous drug-drug interaction studies showed some evidence of QTc prolongation when domperidone was administered as monotherapy (10 mg 4 times a day).The largest time-matched mean difference of QTcF between domperidone and placebo was 5.4 msec (95 % CI: -1.7 to 12.4) and 7.5 msec (95 % CI: 0.6 to 14.4), respectively.
Slovenian: Največja časovno usklajena povprečna razlika QTcF med domperidonom in placebom je bila 5,4 ms (95 % IZ: -1,7 do 12,4) oz. 7,5 ms (95 % IZ: 0,6 do 14,4).
English: [The paragraph below is to be implemented where the marketing authorisation currently includes relief of the symptoms of nausea and vomiting in children under 12 years of age and adolescents weighing less than 35 kg:]
Slovenian: Eno 30 mg svečko je treba vstaviti v rektum 2-krat na dan. [Spodnji odstavek je treba vključiti le, če dovoljenje za promet trenutno vključuje lajšanje simptomov navzee in bruhanja pri otrocih, mlajših od 12 let, in mladostnikih, ki tehtajo manj kot 35 kg:]
English: In the anesthetized guinea pig model following slow intravenous infusions, there were no effects on QTc at total plasma concentrations of 45.4 ng/mL, which are 3-fold higher than the total plasma levels at in humans at maximum daily dose (10 mg administered 3 times a day).
Slovenian: Zaradi počasnih intravenskih infuzij v anestetiziranem modelu morskega prašička ni bilo nobenih učinkov na interval QTc pri skupni koncentraciji v plazmi 45,4 ng/ml, ki je 3-krat višja od skupnih koncentracij v plazmi pri ljudeh pri največjem dnevnem odmerku (10 mg 3-krat na dan).
English: This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day.
Slovenian: Tveganje je večje pri bolnikih, starejših od 60 let, oziroma ob odmerkih, ki presegajo 30 mg na dan.
English: No teratogenicity was observed in mice and rabbits
Slovenian: Pri miših in kuncih teratogenosti niso ugotovili.
English: [This following wording should be reflected in this section]
Slovenian: [V to poglavje je treba vključiti naslednje besedilo]
English: One or two sachet(s) (containing 5 mg domperidone per sachet) up to three times per day with a maximum dose of 6 sachets per day.
Slovenian: Ena ali dve vrečki (ki vsebujeta 5 mg domperidona na vrečko) do 3-krat na dan z največjim dovoljenim odmerkom 6 vrečk na dan.
English: 10 ml (of 1 mg/ml oral suspension) up to three times per day with a maximum dose of 30 ml per day.
Slovenian: 10 ml (1 mg/ml peroralne suspenzije) do trikrat na dan z največjim dovoljenim odmerkom 30 ml na dan. [Šumeča zrnca 5 mg]
English: One 10 mg tablet up to three times per day with a maximum dose of 30 mg per day.
Slovenian: Eno 10-mg tableto do 3-krat na dan in z največjim dovoljenim odmerkom 30 mg na dan. [orodisperzibilne tablete]
English: While taking domperidone, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, loss of consciousness.
Slovenian: Če imate med jemanjem domperidona motnje srčnega ritma, kot so razbijanje srca ali oteženo dihate, ali če pride do izgube zavesti, se obrnite na svojega zdravnika.
English: Safety margins for prolongation of action potential duration in in vitro experiments on isolated cardiac tissues exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by 45-fold.
Slovenian: Varnostne meje za podaljšanje trajanja akcijskega potenciala v poskusih in vitro na izoliranih srčnih tkivih so bile 45-krat večje od koncentracij proste učinkovine v plazmi pri ljudeh ob dajanju največjega dnevnega odmerka (10 mg 3-krat na dan).
English: In in vivo models the no effect levels for QTc prolongation in dogs and induction of arrhythmias in a rabbit model sensitized for torsade de pointes exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by more than 22-fold and 435-fold, respectively.
Slovenian: V modelih in vivo so ravni brez učinka pri podaljšanju interval QTc pri psih in indukciji aritmij v modelu kuncev, senzibiliziranem za torsade de pointes, bile za več kot 22-krat oz. 435-krat večje od koncentracij proste učinkovine v plazmi pri ljudeh ob dajanju največjega dnevnega odmerka (10 mg 3-krat na dan).
English: <Tablets>, <orodispersible tablets> and <suppositories>are not suitable for children weighing less than 35 kg.
Slovenian: V 24-urnem časovnem obdobju ne dajajte zdravila več kot 3-krat na dan. <Tablete>, <orodisperzivne tablete> in <svečke> niso primerne za otroke, ki tehtajo manj kot 35 kg.
English: Concomitant use of the following substances is not recommended Moderate CYP3A4 inhibitors i.e. diltiazem, verapamil and some macrolides.
Slovenian: Sočasna uporaba naslednjih zdravilnih učinkovin ni priporočjiva: Zmerni zaviralci CYP3A4, t.j.
English: pentamidine (these are antibiotics)
Slovenian: (antibiotiki)
English: Breast-feeding
Slovenian: Dojenje
English: Safety margins in in vitro proarrhythmic models (isolated Langendorff perfused heart) exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by 9- up to 45-fold.
Slovenian: Varnostne meje na proaritmičnih modelih in vitro (perfundirano srce, izolirano po Langendorffu) so za 9- do 45-krat večje od koncentracij proste učinkovine v plazmi pri ljudeh ob dajanju največjega dnevnega odmerka (10 mg 3-krat na dan).
English: In in vitro experiments on isolated cells transfected with hERG and on isolated guinea pig myocytes, exposure ratios ranged between 26 - 47-fold, based on IC50 values inhibiting currents through IKr ion channels in comparison to the free plasma concentrations in humans after administration of the maximum daily dose of 10 mg administered 3 times a day.
Slovenian: V poskusih in vitro na izoliranih celicah, v katere so s transfekcijo vnesli gen hERG, in na izoliranih miocitih morskih prašičkov je bila izpostavljenost od 26- do 47krat večja, kot so bile koncentracije proste učinkovine v plazmi pri ljudeh po dajanju največjega dnevnega odmerka 10 mg (3-krat na dan).
English: Section 1 ‘What X is and what it is used for' [This section should be amended to include the below wording] This medicine is used in adults and in children to treat nausea (feeling sick) and vomiting (being sick).
Slovenian: Poglavje 1 ‘Kaj je zdravilo X in za kaj ga uporabljamo' [V to poglavje je treba vključiti spodnje besedilo]
English: Section 5.2 Pharmacokinetic properties [This section should be amended to include the following wording]
Slovenian: Poglavje 4.6 Plodnost, nosečnost in dojenje [To poglavje je treba spremeniti tako, da bo vsebovalo naslednje besedilo] Dojenje