FrancophonIA/ELRC3.0 huggingface dataset:
English: Given that the efficacy data from children aged 6 months to 2 years of age is not considered very robust, the CHMP requested, that the Applicant/MAH should give a more detailed instruction in Section 4.2 as to how the treatment effect should be monitored and evaluated.
Slovenian: Ker podatki o učinkovitosti pri otrocih, starih od 6 mesecev do 2 let, niso dovolj robustni je Odbor za zdravila za uporabo v humani medicini (CHMP) zahteval, da predlagatelj/imetnik dovoljenja za promet v poglavju 4.2 navede bolj podrobno navodilo, kako spremljati in vrednotiti učinek zdravljenja.
English: 10 mg film-coated tablets in approximately 4000 adult patients 15 years of age and older 5 mg chewable tablets in approximately 1750 paediatric patients 6 to 14 years of age, and 4 mg chewable tablets in 851 paediatric patients 2 to 5 years of age.
Slovenian: 10 mg filmsko obložene tablete pri približno 4000 odraslih bolnikih, starih 15 let ali več, 5 mg žvečljive tablete pri približno 1750 pediatričnih bolnikih, starih 6 do 14 let, 4 mg žvečljive tablete pri 851 pediatričnih bolnikih, starih 2 do 5 let.
English: Therapy with SINGULAIR in relation to other treatments for asthma.
Slovenian: Zdravljenje z zdravilom SINGULAIR v primerjavi z drugimi načini zdravljenja astme.
English: Simultaneously, the MAH updated module 3 was updated to CTD format in this referral procedure.
Slovenian: Hkrati je med tem napotitvenim postopkom imetnik dovoljenja za promet z zdravilom posodobil modul 3 v format CTD.
English: SINGULAIR is not expected to affect your ability to drive a car or operate machinery.
Slovenian: Ne pričakujemo, da bi zdravilo SINGULAIR vplivalo na sposobnost za vožnjo avtomobila ali upravljanja s stroji.
English: These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors (CysLT) found in the human airway and cause airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment.
Slovenian: Ti pomembni pro-astmatični mediatorji se vežejo na cisteinillevkotrienske receptorje (CysLT), ki jih najdemo v človeških dihalnih poteh, in povzročajo reakcije v dihalnih poteh, vključno z bronhokonstrikcijo, izločanjem sluzi, spremenjeno prepustnostjo žil in kopičenjem eozinofilcev.
English: Always have your child's inhaled rescue medicine for asthma attacks with you.
Slovenian: Pri sebi vedno imejte otrokovo inhalacijsko olajševalno zdravilo za astmatični napad.
English: There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.
Slovenian: Ni podatkov, ki bi pokazali, da se pri sočasni uporabi z montelukastom odmerke peroralnih kortikosteroidov lahko zmanjša.
English: Elimination.
Slovenian: Izločanje.
English: The Applicant/MAH also made reference to an original application concerning the 10 mg film-coated tablet and 5 mg CT, which presents the results of two placebo-controlled clinical studies in more than 1600 adult patients with mild-to-moderate asthma.
Slovenian: Predlagatelj/imetnik dovoljenja za promet je omenil tudi prvotno vlogo za 10 mg filmsko obložene tablete in 5 mg žvečljive tablete, kjer so predstavljeni rezultati dveh s placebom nadzorovanih kliničnih študij pri več kot 1600 odraslih bolnikih z blago do zmerno astmo.
English: In adult and paediatric patients 2 to 14 years of age, montelukast, compared with placebo, decreased peripheral blood eosinophils while improving clinical asthma control.
Slovenian: Pri odraslih in pediatričnih bolnikih, starih 2 do 14 let, je montelukast v primerjavi s placebom zmanjšal število eozinofilcev v periferni krvi, medtem ko je izboljšal nadzor astme.
English: In double-blind, randomised studies it was also shown that the anti-asthmatic effect of montelukast can be shown against exercise-induced asthma in adults.
Slovenian: V dvojno slepih, randomiziranih študijah je bil dokazan antiastmatični učinek montelukasta pri astmi, povzročeni s telesno vadbo pri odraslih.
English: Bulgaria, Cyprus, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Norway, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom: SINGULAIR
Slovenian: To zdravilo je odobreno v naslednjih državah članicah: v Bolgariji, na Cipru, v Estoniji, na Finskem, v Grčiji, na Irskem, na Islandiji, v Italiji, v Latviji, v Litvi, v Luksemburgu, na Malti, v Nemčiji, na Norveškem, na Portugalskem, v Romuniji, v Sloveniji, v Španiji, na Švedskem in v Veliki Britaniji - pod imenom SINGULAIR, v Italiji - pod imenom MONTEGEN.
English: Symptoms of asthma include: Coughing, wheezing, and chest tightness.
Slovenian: Simptomi astme vključujejo: kašljanje, piskanje in stiskanje v prsnem košu.
English: If satisfactory response is not achieved, an additional or different therapy should be considered.
Slovenian: V primeru neustreznega odziva je treba razmisliti o dodatnem ali drugačnem zdravljenju.
English: Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Slovenian: Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Bruselj Belgija
English: Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma.
Slovenian: Montelukast lahko uporabljamo sočasno z drugimi načini zdravljenja, ki se rutinsko uporabljajo za preprečevanje in kronično zdravljenje astme.
English: Nervous system disorders headache headache
Slovenian: Bolezni živčevja glavobol glavobol
English: FEV1 increased from 1.83 L to 2.09 L in the montelukast group and from 1.85 L to 2.14 L in the fluticasone group.
Slovenian: FEV1 se je povečal z 1,83 l na 2,09 l v skupini, ki je prejemala montelukast, in z 1,85 l na 2,14 l v skupini, ki je prejemala flutikazon.
English: • phenytoin (used for treatment of epilepsy)
Slovenian: • fenitoin (za zdravljenje epilepsije)
English: PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 chewable tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 žvečljivih tablet.
English: Cartons of 7, 20, 28 and 30 sachets.
Slovenian: Škatle s 7, 20, 28 in 30 vrečkami.
English: Since 2002, the MRP indications also include the monotherapy of 4 mg paediatric formulations in the treatment of mild asthma in exceptional cases, i.e. when inhaled corticosteroids cannot be used.
Slovenian: Od leta 2002 so indikacije v okviru postopka medsebojnega priznavanja vključevale tudi monoterapijo s 4 mg pediatrično obliko za blago astmo v izjemnih primerih, tj. ko kortikosteroidov za inhaliranje ni možno uporabiti.
English: SINGULAIR may be used in breast-feeding mothers only if it is considered to be clearly essential.
Slovenian: Zdravilo SINGULAIR se pri doječih materah lahko uporablja le, če se oceni, da je to nedvomno nujno.
English: Montelukast should not be abruptly substituted for inhaled or oral corticosteroids.
Slovenian: Z montelukastom se ne sme nenadno zamenjati inhalacijskih ali peroralnih kortikosteroidov.
English: The present referral procedure sought harmonisation of the product information for Singulair 4 mg chewable tablets and 4 mg oral granules with the indications already approved for children 2-5 years old and 6 months to 2 years old in Mutual Recognition Procedures, with Finland acting as the reference member state.
Slovenian: Cilj tega napotitvenega postopka je uskladitev podatkov o zdravilu Singulair 4 mg žvečljive tablete in 4 mg peroralna zrnca z indikacijami, ki so v postopkih medsebojnega priznavanja že odobrene za otroke, stare od 2 do 5 let ter od 6 mesecev do 2 let, pri čemer ima Finska vlogo referenčne države članice.
English: Montelukast was determined not to be phototoxic in mice for UVA, UVB or visible light spectra at doses up to 500 mg/kg/day (approximately >200-fold based on systemic exposure).
Slovenian: Ugotovili so, da montelukast pri miših ni fototoksičen za UVA, UVB ali vidni spekter svetlobe pri odmerkih do 500 mg/kg/dan (približno > 200-kratna sistemska izpostavljenost).
English: Montelukast (5 mg once daily) was shown to exert an anti-asthmatic effect that was larger than the effect obtained with placebo.
Slovenian: Dokazali so, da ima montelukast (5 mg enkrat na dan) antiastmatičen učinek, ki je večji od učinka placeba.
English: Montelukast improved daytime symptoms (including coughing, wheezing, trouble breathing and activity limitation) and nighttime symptoms compared with placebo.
Slovenian: Montelukast je v primerjavi s placebom izboljšal dnevne simptome (vključno s kašljem, kihanjem, težavami pri dihanju in z omejeno aktivnostjo) in nočne simptome.
English: In monkeys, the adverse effects appeared at doses from 150 mg/kg/day (>232-fold the systemic exposure seen at the clinical dose).
Slovenian: Pri opicah so se neželeni učinki pojavili pri odmerkih od 150 mg/kg/dan (> 232-kratna sistemska izpostavljenost pri kliničnem odmerku).
English: • allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, itching, and hives;
Slovenian: • alergijske reakcije vključno z izpuščajem, otekanjem obraza, ustnic, jezika in/ali požiralnika (kar lahko povzroči težave pri dihanju ali požiranju), srbenjem in koprivnico;
English: Women who are pregnant or intend to become pregnant should consult their doctor before taking SINGULAIR.
Slovenian: Nosečnice in ženske, ki nameravajo zanositi, se morajo pred začetkom jemanja zdravila SINGULAIR posvetovati z zdravnikom, ki naj oceni, če lahko jemljejo zdravilo SINGULAIR.
English: When treatment with SINGULAIR is used as add-on therapy to inhaled corticosteroids, SINGULAIR should not be abruptly substituted for inhaled corticosteroids (see section 4.4).
Slovenian: Če se zdravilo SINGULAIR uporablja kot nadaljevanje zdravljenja z inhalacijskimi kortikosteroidi, se z njim ne sme nenadno zamenjati inhalacijskih kortikosteroidov (glejte poglavje 4.4).
English: Montelukast sodium has been used for the add-on treatment (concomitantly with inhaled steroids) and to prevent exercise-induced bronchoconstriction.
Slovenian: Montelukast natrij se uporablja kot dodatno zdravljenje (sočasno s steroidi za vdihavanje) in za preprečevanje bronhokonstrikcije, ki jo povzroči telesna vadba.
English: If you forget to give SINGULAIR to your child
Slovenian: Če ste otroku pozabili dati zdravilo SINGULAIR
English: Coupled with estimates of montelukast oral bioavailability, this indicates that montelukast and its metabolites are excreted almost exclusively via the bile.
Slovenian: Ti rezultati skupaj z ocenami peroralne biološke uporabnosti montelukasta kažejo, da se montelukast in njegovi presnovki izločajo skoraj izključno z žolčem.
English: The PDCO, basing its decision on the GINA paediatric handbook 2006 and expert intervention, concluded that, due to a shortage of clinical data in patients aged 6 months - 2 years with asthma, pharmacokinetic data from patients aged 2-5 years diagnosed with asthma cannot be extrapolated to younger patients aged 6 months- 2 years presenting with the same symptoms.
Slovenian: Odbor za pediatrijo se je odločil na podlagi pediatričnega priročnika GINA 2006 in posredovanja strokovnjakov, da zaradi pomanjkanja kliničnih podatkov pri bolnikih z astmo, starih od 6 mesecev do 2 let, farmakokinetičnih podatkov bolnikov z diagnozo astme, starih od 2 do 5 let, ni možno ekstrapolirati na prej omenjeno populacijo z istimi simptomi.
English: Additionally, while the medicine has been on the market, the following have been reported:
Slovenian: Tekom trženja zdravila pa so poročali še o naslednjih neželenih učinkih:
English: Psychiatric disorders: dream abnormalities including nightmares, hallucinations, insomnia, psychomotor hyperactivity (including irritability, restlessness, agitation including aggressive behaviour, and tremor), depression, suicidal thinking and behaviour (suicidality) in very rare cases.
Slovenian: Psihiatrične motnje: nenormalne sanje vključno z nočnimi morami, halucinacije, nespečnost, psihomotorična hiperaktivnost (vključno z razdražljivostjo, vznemirjenostjo, razburjenostjo z agresivnim obnašanjem in tremorjem), depresija, samomorilne misli in samomorilno vedenje (samomorilnost) v zelo redkih primerih
English: In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported.
Slovenian: Pri astmatikih, ki so se zdravili z montelukastom, so v zelo redkih primerih poročali o kombinaciji simptomov, kot so gripi podobna bolezen, mravljinčenje ali odrevenelost rok in nog, poslabšanje pljučnih simptomov in/ali izpuščaj (Churg-Straussov sindrom).
English: How to store SINGULAIR Further information
Slovenian: Shranjevanje zdravila SINGULAIR Dodatne informacije
English: In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
Slovenian: V študijah medsebojnega delovanja zdravil priporočeni klinični odmerek montelukasta ni imel klinično pomembnih učinkov na farmakokinetiko naslednjih učinkovin: teofilina, prednizona, prednizolona, peroralnih kontraceptivov (etinilestradiol/noretindron 35/1), terfenadina, digoksina in varfarina.
English: In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.
Slovenian: V daljših študijah astme so odrasli bolniki 22 tednov prejemali montelukast v odmerkih do 200 mg/dan, v krajših študijah pa približno en teden do 900 mg/dan, ne da bi imeli klinično pomembne neželene učinke.
English: The Applicant/MAH also made reference to an original application concerning 5 mg CT, which presented the results of a study in 336 paediatric patients (age 6 to 14 years).
Slovenian: Predlagatelj/imetnik dovoljenja za promet je navedel tudi prvotno vlogo za 5 mg žvečljive tablete, kjer so predstavljeni rezultati študije pri 336 otrocih (starih od 6 do 14 let).
English: • SINGULAIR granules are not intended to be dissolved in liquid.
Slovenian: • SINGULAIR zrnca niso namenjena raztapljanju v tekočini.
English: • This medicine is to be given to a child under adult supervision.
Slovenian: • Otrok mora zdravilo vzeti pod nadzorom odraslega.
English: Because montelukast and its metabolites are eliminated by the biliary route, no dose adjustment is anticipated to be necessary in patients with renal impairment.
Slovenian: Ker se montelukast in njegovi presnovki izločajo z žolčem, odmerkov pri bolnikih z ledvično okvaro ni treba prilagajati.
English: Treatment with montelukast inhibited both early- and late-phase bronchoconstriction due to antigen challenge.
Slovenian: Zdravljenje z montelukastom je zaviralo obe - zgodnjo in pozno fazo bronhokonstrikcije zaradi zaviranja reakcije na antigen.
English: Ask your doctor or pharmacist for more information about side effects.
Slovenian: Za več informacij o neželenih učinkih prosite zdravnika ali farmacevta.
English: The oral bioavailability and Cmax are not influenced by a standard meal.
Slovenian: Standardni obrok ne vpliva na peroralno biološko uporabnost in cmax.
English: The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
Slovenian: Najbolj pogosti simptomi, o katerih so poročali pri prekomernem odmerjanju pri odraslih in otrocih, pa so bili bolečine v trebuhu, zaspanost, žeja, glavobol, bruhanje in hiperaktivnost.
English: Montelukast is rapidly absorbed following oral administration.
Slovenian: Montelukast se po peroralni uporabi hitro absorbira.
English: The percentage of patients with an asthma attack (an asthma attack being defined as a period of worsening asthma that required treatment with oral steroids, an unscheduled visit to the doctor's office, an emergency room visit, or hospitalization) was 32.2 in the montelukast group and 25.6 in the fluticasone group; the odds ratio (95% CI) being significant: equal to 1.38 (1.04, 1.84).
Slovenian: Odstotek bolnikov z napadi astme (napad astme definiran kot obdobje poslabšanja astme, ki zahteva zdravljenje s peroralnimi steroidi, nenačrtovan obisk zdravnika, obisk nujne zdravniške pomoči ali zdravljenje v bolnišnici) je bil 32,2 v skupini, ki je prejemala montelukast, in 25,6 v skupini, ki je prejemala flutikazon; razmerje obetov (odds ratio) (95-odstotni IZ) je bilo pomembno: enako 1,38
English: It is not known if montelukast is excreted in human milk.
Slovenian: Ni znano, če se montelukast izloča v materino mleko pri človeku.
English: Try to give SINGULAIR as prescribed.
Slovenian: Zdravilo SINGULAIR poskušajte otroku dajati tako, kot mu je bilo predpisano.
English: Montelukast is extensively metabolized.
Slovenian: Montelukast se v veliki meri presnavlja.
English: Patients with phenylketonuria should take into account that each 4 mg chewable tablet contains phenylalanine in an amount equivalent to 0.674 mg phenylalanine per dose.
Slovenian: Bolniki s fenilketonurijo morajo upoštevati, da vsaka 4 mg žvečljiva tableta vsebuje fenilalanin v količini, ki ustreza 0,674 mg fenilalanina na odmerek.
English: Based on further in vitro results in human liver microsomes, therapeutic plasma concentrations of montelukast do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6.
Slovenian: Nadaljnji rezultati in vitro raziskav kažejo, da terapevtske koncentracije montelukasta v plazmi ne zavirajo citokromov P450 3A4, 2C9, 1A2, 2A6, 2C19 ali 2D6.
English: SINGULAIR as an alternative treatment option to low-dose inhaled corticosteroids for mild, persistent asthma:
Slovenian: Zdravilo Singulair kot alternativa majhnim odmerkom inhalacijskih kortikosteroidov za blago persistentno astmo:
English: However, the Applicant/MAH only seeks to maintain the indication for montelukast as monotherapy in mild to moderate persistent asthma in children aged 2 years to 5 years.
Slovenian: Vendar želi predlagatelj/imetnik dovoljenja za promet za montelukast le ohranitev indikacije kot samostojnega zdravljenja za blago do zmerno perzistentno astmo pri otrocih, starih od 2 do 5 let.
English: The MAH provided harmonised modules 3 in CTD format for Singulair 4 mg granules and 4 mg chewable tablets.
Slovenian: Imetnik dovoljenja za promet je predložil usklajena modula 3 v formatu CTD za zdravili Singulair 4 mg zrnca in 4 mg žvečljive tablete.
English: The results of P910 suggest that with montelukast, as good benefit-risk ratio can be achieved in the treatment of paediatric mild, persistent asthma as with inhaled fluticasone.
Slovenian: Rezultati študije P910 kažejo, da lahko pri zdravljenju blage, perzistentne astme z montelukastom dosežemo dobro razmerje med koristmi in tveganji kakor z flutikazonom za vdihavanje.
English: Nervous system disorders headache headache hyperkinesia
Slovenian: Bolezni živčevja glavobol glavobol hiperkinezija
English: If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each 4-mg chewable tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
Slovenian: Če ima otrok fenilketonurijo (redko dedno motnjo presnove), morate vedeti, da vsaka 4 mg žvečljiva tableta vsebuje fenilalanin (0,674 mg fenilalanina na eno 4 mg žvečljivo tableto).
English: The mean Cmax is 66% higher while mean Cmin is lower than in adults receiving a 10 mg tablet.
Slovenian: Povprečna cmax je 66 % višja , medtem ko je povprečna cmin nižja kot pri odraslih po zaužitju 10 mg tablete.
English: • tiredness, restlessness, agitation including aggressive behaviour, irritability, tremor, depression, suicidal thoughts and actions (in very rare cases), dizziness, drowsiness, hallucinations, dream abnormalities, including nightmares and trouble sleeping, pins and needles/numbness, seizure;
Slovenian: • utrujenost, vznemirjenost, razburjenje z nasilnim vedenjem, razdražljivost, tresenje, depresija, samomorilne misli in samomorilno vedenje (v zelo redkih primerih), omotica, dremavost, halucinacije, nenormalne sanje vključno z nočnimi morami in težavami s spanjem, mravljinčenje/odrevenelost, epileptični napad;
English: Formulations for paediatric use, 4 mg chewable tablets and 4 mg oral granules, have been available since 2000 and 2002, respectively.
Slovenian: Obliki za uporabo pri otrocih, 4 mg žvečljive tablete oziroma 4 mg peroralna zrnca, sta dostopni od leta 2000 oziroma 2002.
English: It is important for your child to continue taking SINGULAIR for as long as your doctor prescribes.
Slovenian: Pomembno je, da otrok zdravilo SINGULAIR jemlje tako dolgo, kot mu to predpiše zdravnik.
English: INSTRUCTIONS ON USE [To be completed nationally]
Slovenian: NAVODILA ZA UPORABO [Izpolniti nacionalno.]
English: • Be sure the child is given the entire spoonful of the granule/food mixture immediately (within
Slovenian: • Bodite pozorni, da otrok takoj (v 15 minutah) zaužije celo žlico mešanico zrnc in hrane.
English: In three active-controlled studies, in nearly 1000 adult patients with mild-to-moderate asthma, the effect of montelukast (10 mg once daily) was shown to be better than that obtained with placebo, but less than that obtained with inhaled beclometasone dipropionate (400 µg/day).
Slovenian: V treh aktivno kontroliranih študijah pri skoraj 1000 odraslih bolnikih z blago do zmerno astmo so dokazali, da je učinek montelukasta (10 mg enkrat dnevno) večji od placeba, vendar manjši od vdihanega beklometazona dipropionata (400 µg/dan).
English: The percentage of days with β-agonist use decreased from 38.0 to 15.4 in the montelukast group, and from 38.5 to 12.8 in the fluticasone group.
Slovenian: Odstotek dni z uporabo agonistov beta se je zmanjšal z 38,0 na 15,4 v skupini, ki je prejemala montelukast, in z 38,5 na 12,8 v skupini, ki je prejemala flutikazon.
English: SINGULAIR should not be used instead of other asthma medications your doctor has prescribed for your child.
Slovenian: Zdravila SINGULAIR ne sme jemati namesto drugih zdravil, ki mu jih je predpisal zdravnik.
English: Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.
Slovenian: Zdravniki morajo biti pozorni na eozinofilijo, vaskulitični izpuščaj, poslabšanje pljučnih simptomov, srčne zaplete in/ali nevropatijo.
English: Montelukast (10 mg once daily at bedtime) was shown to improve respiratory functions, reduce asthma symptoms and beta-agonist use, and to improve quality of life as compared to placebo.
Slovenian: Dokazali so, da montelukast (10 mg enkrat dnevno pred spanjem) v primerjavi s placebom izboljša dihalne funkcije, zmanjša simptome astme in rabo beta-agonista ter izboljša kakovost življenja.
English: In a small study on 27 paediatric patients it was also shown that montelukast seems to protect paediatric patients against exercise-induced bronchoconstriction.
Slovenian: V majhni študiji pri 27 otrocih so ugotovili, da montelukast verjetno ščiti otroke pred bronhokonstrikcijo, ki jo povzroči telesna vadba.
English: PHARMACEUTICAL FORM Granules.
Slovenian: FARMACEVTSKA OBLIKA Zrnca.
English: Mannitol, microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour, aspartame (E951), and magnesium stearate.
Slovenian: • Pomožne snovi so: manitol, mikrokristalna celuloza, hiproloza (E 463), rdeči železov oksid (E 172), premrežen natrijev karmelozat, aroma češnje, aspartam (E 951) in magnezijev stearat.
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling, package leaflet and Module 3.
Slovenian: - predmet napotitvenega postopka je bilo usklajevanje povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo ter modula 3,