FrancophonIA/ELRC3.0 huggingface dataset:
English: 0.2 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a blue polypropylene plunger rod.
Slovenian: 0,2 ml raztopine v: injekcijski brizgi iz prozornega, brezbarvnega, nevtralnega stekla tipa I, opremljeni z injekcijsko iglo in ščitnikom igle, z gumijasto zaporko iz klorobutila in z modrim polipropilenskim batom.
English: 5 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and grey aluminium-plastic cap in a cardboard box.
Slovenian: 5 ml raztopine v viali iz prozornega, brezbarvnega stekla tipa I, zatesnjena z gumijasto zaporko za iglo in sivim aluminijasto-plastičnim pokrovčkom v kartonski škatli.
English: 2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 12 pre-filled syringes with needle guard 24 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 10 pre-filled syringes with UltraSafe Passive needle guard
Slovenian: 2 napolnjeni injekcijski brizgi z varnostno zaščito za iglo 6 napolnjenih injekcijskih brizg z varnostno zaščito za iglo 10 napolnjenih injekcijskih brizg z varnostno zaščito za iglo 12 napolnjenih injekcijskih brizg z varnostno zaščito za iglo 24 napolnjenih injekcijskih brizg z varnostno zaščito za iglo 30 napolnjenih injekcijskih brizg z varnostno zaščito za iglo 2 napolnjeni injekcijski brizgi z UltraSafe Passive varnostno zaščito za iglo 10 napolnjenih injekcijskih brizg z UltraSafe Passive varnostno zaščito za iglo
English: Diluted medicinal product with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose
Slovenian: Zdravilo, razredčeno z raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje ali 5-odstotno glukozo 8 ur
English: 10 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and white aluminium-plastic cap in a cardboard box.
Slovenian: 10 ml raztopine v viali iz prozornega, brezbarvnega stekla tipa I, zatesnjeni z gumijasto zaporko za iglo in bela aluminijasto-plastičnim pokrovčkom v kartonski škatli.
English: Thrombocytopenia and thrombocytosis System Organ
Slovenian: Trombocitopenija in trombocitoza
English: Thrombocytop enia
Slovenian: Trombocitopen ija
English: 0.4 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a yellow polypropylene plunger rod.
Slovenian: 0,4 ml raztopine v: injekcijski brizgi iz prozornega, brezbarvnega, nevtralnega stekla tipa I, opremljeni z injekcijsko iglo in ščitnikom igle, z gumijasto zaporko iz klorobutila in z rumenim polipropilenskim batom.
English: Packs of: - 2, 6, 10, 30, 50 and 90 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Slovenian: Pakiranje po: - 2, 6, 10, 30, 50 in 90 napolnjenih injekcijskih brizg - 2, 6, 10, 12, 24 in 30 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle - 2 in 10 napolnjenih injekcijskih brizg s UltraSafe Passive pripomočkom za zaščito igle
English: Supplied in packs of: - 2, 6, 10, 30, 50 and 90 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Slovenian: Pakirano v škatlah po: - 2, 6, 10, 30, 50 in 90 napolnjenih injekcijskih brizg - 2, 6, 10, 12, 24 in 30 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle - 2 in 10 napolnjenih injekcijskih brizg s UltraSafe Passive pripomočkom za zaščito igle
English: • Inhixa can be given by injection into your vein (intravenous) after certain types of heart attack or operation.
Slovenian: • Po določenih vrstah srčnega infarkta ali operacijah se zdravilo Inhixa lahko injicira v veno
English: Packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 20, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Slovenian: Pakiranje po: - 2, 6, 10, 30 in 50 napolnjenih injekcijskih brizg - 2, 6, 10, 12, 20, 24 in 30 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle - 2 in 10 napolnjenih injekcijskih brizg s UltraSafe Passive pripomočkom za zaščito igle
English: Supplied in packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 20, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Slovenian: Pakirano v škatlah po: - 2, 6, 10, 30 in 50 napolnjenih injekcijskih brizg - 2, 6, 10, 12, 20, 24 in 30 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle - 2 in 10 napolnjenih injekcijskih brizg s UltraSafe Passive pripomočkom za zaščito igle
English: Supplied in packs of: - 1, 2, 6, 10 and 50 pre-filled syringe(s) - 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard
Slovenian: Pakirano v škatlah po: - 1 napolnjena injekcijska brizga in 2, 6, 10, 50 napolnjenih injekcijskih brizg - 2, 6, 10, 20, 50 in 90 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle - 2 in 6 napolnjenih injekcijskih brizg s UltraSafe Passive pripomočkom za zaščito igle
English: Packs of: - 1, 2, 6, 10 and 50 pre-filled syringe(s) - 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard
Slovenian: Pakiranje po: - 1 napolnjena injekcijska brizga in 2, 6, 10, 50 napolnjenih injekcijskih brizg - 2, 6, 10, 20, 50 in 90 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle - 2 in 6 napolnjenih injekcijskih brizg s UltraSafe Passive pripomočkom za zaščito igle
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Slovenian: Intravensko (bolusno) injiciranje - samo za indikacijo akutni STEMI Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: Packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Slovenian: Pakiranje po: - 2, 6, 10, 30 in 50 napolnjenih injekcijskih brizg - 2, 6, 10, 12, 24 in 30 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle - 2 in 10 napolnjenih injekcijskih brizg s UltraSafe Passive pripomočkom za zaščito igle
English: Supplied in packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Slovenian: Pakirano v škatlah po: - 2, 6, 10, 30 in 50 napolnjenih injekcijskih brizg - 2, 6, 10, 12, 24 in 30 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle - 2 in 10 napolnjenih injekcijskih brizg s UltraSafe Passive pripomočkom za zaščito igle
English: No marked changes were observed on an individual level.
Slovenian: Na individualni ravni niso opazili nobene izrazite spremembe.
English: Stir well and drink immediately.
Slovenian: Dobro premešajte in takoj spijte.
English: The AUC was reduced by about 50%.
Slovenian: AUC se je zmanjšal za približno 50 %.
English: The divergences identified at the start of the referral have been resolved.
Slovenian: Razhajanja, opredeljena na začetku napotitvenega postopka, so bila odpravljena.
English: Under these conditions the ability to react may be decreased.
Slovenian: V takih razmerah je zmožnost odzivanja lahko zmanjšana.
English: Descriptions of these effects can be found in other sections.
Slovenian: Opis teh učinkov je v drugih poglavjih.
English: The study duration was 12 weeks
Slovenian: Raziskava je trajala 12 tednov.
English: • Use in children
Slovenian: • Uporaba pri otrocih
English: The safety of PPIs is generally considered high.
Slovenian: Varnost ZPČ se v splošnem šteje za visoko.
English: The efficacy was evaluated after 4 and 8 weeks treatment.
Slovenian: Učinkovitost so vrednotili po 4 in 8 tednih zdravljenja.
English: However lower eradication rates have been achieved with this regimen.
Slovenian: Vendar pa so bile s tem režimom dosežene nižje stopnje eradikacije.
English: 1070 Vienna, Austria
Slovenian: 1070 Vienna, Avstrija
English: The following wording was agreed:
Slovenian: Usklajeno je bilo naslednje besedilo:
English: You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other tasks that demand increased concentration.
Slovenian: Sami ste odgovorni za odločitev, ali ste zmožni voziti ali opravljati dela, pri katerih je potrebna povečana koncentracija.
English: After eight days of repeated administration the reduction is about 85%.
Slovenian: Po osmih dneh ponavljajoče se uporabe je zmanjšanje približno 85-odstotno.
English: A very small statistically significant but clinically irrelevant effect was found.
Slovenian: Ugotovili so zelo majhen, statistično značilen, vendar klinično nepomemben učinek.
English: Your doctor will sometimes prescribe you a different dose and will tell you how long your treatment will last.
Slovenian: Zdravnik vam bo včasih predpisal drugačen odmerek in vam povedal, koliko časa bo trajalo zdravljenje.
English: The clinical trials were all small, open and uncontrolled trials.
Slovenian: Vsa klinična preskušanja so bila majhna, odprta in nekontrolirana prskušanja.
English: France sanofi-aventis
Slovenian: Francija sanofi-aventis
English: In two of the studies, lansoprazole (formulation) was given immediately after a meal.
Slovenian: V dveh izmed njih se je lansoprazol (formulacija) dajal neposredno po obroku.
English: Wyeth AB BOX 1822, 171 24 Solna, Sweden
Slovenian: Wyeth AB BOX 1822, 171 24 Solna, Švedska
English: This medicine is available without prescription.
Slovenian: To zdravilo je na voljo brez recepta.
English: Unless the applicant can show convincing data on satisfactory safety with the exposures obtained, it is recommended that a dose reduction of 50% is made.
Slovenian: Razen če lahko vlagatelj pokaže prepričljive podatke o zadovoljivi varnosti pri doseženih izpostavljenostih, je priporočljivo upoštevati 50 % zmanjšanje odmerka.
English: 4.2 Posology (in special populations)
Slovenian: 4.2 Odmerjanje (pri posebnih populacijah)
English: It is unlikely that the proposed vehicles, even if not of the same brand, would be of such pH and therefore affect the granule coating.
Slovenian: Ni verjetno, da bi predlagani vehikli, tudi če niso iste blagovne znamke, imeli tako pH vrednost in bi posledično vplivali na oblogo zrnc.
English: Frequencies are defined as common (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000).
Slovenian: Pogostnost neželenih učinkov je definirana kot: pogosti (> 1/100, < 1/10); občasni (> 1/1.000, < 1/100); redki (> 1/10.000, < 1/1.000); zelo redki (< 1/10.000).
English: In the third study, no effect of food was observed when the food was taken 30 minutes after administration.
Slovenian: Pri tretji raziskavi niso opazili nobenega učinka hrane, če je bila ta zaužita 30 minut po dajanju zdravila.
English: However, prophylactic treatment should be recommended only for patients at high risk, see SPC for detailed proposal.
Slovenian: Vendar pa se naj profilaktično zdravljenje priporoča le za bolnike z visokim tveganjem, za natančen predlog glejte SPC.
English: However, the magnitude of increase in exposure that is acceptable depends on the available clinical safety data available on the exposures.
Slovenian: Vendar pa je sprejemljiva magnituda povečanja izpostavljenosti odvisna od razpoložljivih kliničnih varnostnih podatkov o izpostavljenosti.
English: Do not stop treatment early because your symptoms have got better.
Slovenian: Zdravljenja ne prekinite predčasno, če se simptomi izboljšajo.
English: The pharmacokinetic data of children and adolescents are summarised under section 5.2.
Slovenian: Farmakokinetični podatki za otroke in mladostnike so povzeti v poglavju 5.2.
English: H-1103 Budapest, Gyomroi ut 19-21 Hungary
Slovenian: H-1103 Budimpešta, Gyomroi ut 19-21 Madžarska
English: 52066 Aachen, Germany
Slovenian: 52066 Aachen, Nemčija
English: This might be attributed to high rates of metronidazole resistence.
Slovenian: To bi bilo mogoče pripisati visokim stopnjam rezistence na metronidazol.
English: If you forget to take a dose, take it as soon as your remember unless it is nearly time for your next dose.
Slovenian: Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, razen če je skoraj čas, ko bi morali vzeti naslednji odmerek.
English: Place the tablet on your tongue and suck gently.
Slovenian: Tableto položite na jezik in nežno sesajte.
English: The factor that would influence the bioavailability the most would be if the granules were mixed with a vehicle of pH>7.
Slovenian: Dejavnik, ki bi najbolj vplival na biološko uporabnost, bi nastopil, če bi bila zrnca zmešana z vehiklom s pH>7.
English: Medicines should not be disposed of via wastewater or household waste.
Slovenian: Zdravil ne smete odstraniti v odpadne vode ali gospodinjske odpadke.
English: 30,400 00040 Pomezia, Roma, Italy
Slovenian: 30,400 00040 Pomezia, Roma, Italija
English: The plasma protein binding is 97%.
Slovenian: Vezava na beljakovine v plazmi je 97-odstotna.
English: In addition the CHMP identified the additional points to be harmonised in the various SPC sections.
Slovenian: Nadalje je CHMP opredelil dodatne točke, ki jih je potrebno uskladiti v različnih poglavjih SPC.
English: Read all the information in this leaflet for guidance.
Slovenian: Preberite vse podatke v tem navodilu za uporabo.
English: The clinical relevance of this is unknown.
Slovenian: Klinični pomen tega ni znan.
English: Via Elio Vittorini 129 00144 Roma, Italy
Slovenian: Via Elio Vittorini 129 00144 Roma, Italija
English: Although all treatments resulted in equivalent AUC of lansoprazole, it has to be noted that the studies were performed with certain brands of the different vehicles.
Slovenian: Čeprav so vsa zdravljenja privedla do ekvivalentnega AUC lansoprazola, je treba omeniti, da so bile raziskave izvedene z določenimi blagovnimi znamkami različnih vehiklov.
English: If you take Agopton on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance.
Slovenian: Če boste zdravilo Agopton jemali daljši čas (več kot 1 leto), vas bo zdravnik verjetno redno pregledoval.
English: If the required daily dose exceeds 120 mg, it should be given in two divided doses.
Slovenian: Če potrebni dnevni odmerek presega 120 mg, ga je treba razdeliti v dva odmerka.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
English: The effects of overdose on lansoprazole in humans are not known (although the acute toxicity is likely to be low) and, consequently, instruction for treatment cannot be given.
Slovenian: Učinki prevelikega odmerjanja lansoprazola pri človeku niso znani (čeprav je akutna toksičnost verjetno majhna), zato ni mogoče dati navodil za zdravljenje.
English: The manufacturer is: <{Name and address}> <{tel}> <{fax}> <{e-mail}>
Slovenian: Izdelovalec: <{Ime in naslov}> <{tel.}> <{faks}> <{e-pošta}> [Izpolni država članica.]
English: Furthermore, at both timepoints, there was a trend for better efficacy of the 30 mg dose.
Slovenian: Nadalje je bilo ob obeh časih vrednotenja mogoče zaznati trend večje učinkovitosti 30 mg odmerka.
English: Taking Agopton with food and drink
Slovenian: Jemanje zdravila Agopton skupaj s hrano in pijačo
English: As regards the relief of symptoms, this was examined in both studies through the use of diary cards and investigator interviews.
Slovenian: Kar se tiče lajšanja simptomov, so ga pri obeh raziskavah preverjali s pomočjo dnevnikov in intervjujev raziskovalcev.
English: Treatment will usually be every day for 7 days.
Slovenian: Zdravljenje ponavadi traja 7 dni vsak dan.
English: Also contains lactose and aspartame.
Slovenian: Vsebuje tudi laktozo in aspartam.
English: Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment.
Slovenian: Bolezen morda še ni povsem pozdravljena in se lahko ponovi, če ne dokončate zdravljenja.
English: Do not crush or chew these capsules or the content of an emptied capsule because this will stop them from working properly.
Slovenian: Kapsul ali njihove vsebine ne zdrobite in jih ne žvečite, ker bo to preprečilo pravilno delovanje.
English: A daily dose of 30 mg should not be exceeded in the elderly unless there are compelling clinical indications.
Slovenian: Dnevni odmerek 30 mg se pri starejših bolnikih ne sme preseči, razen kadar obstajajo nujne klinične indikacije.
English: This is also reflected in the SPC for lansoprazole.
Slovenian: To je razvidno tudi iz SPC za lansoprazol.
English: This is reflected in the SPC.
Slovenian: To je razvidno v SPC.
English: [To be completed nationally - Statement and phone number to be inserted based on national requirement for information on a toxicological service.]
Slovenian: [Izpolni država članica - Izjavo in telefonsko številko vnesite glede na lokalne zahteve o informacijah o toksikološki službi.]
English: Agopton should not be given to children.
Slovenian: Zdravilo Agopton se ne sme dajati otrokom.
English: If you are taking Agopton once a day, try to take it at the same time each day.
Slovenian: Če zdravilo Agopton jemljete enkrat na dan, ga poskusite jemati vsak dan ob istem času.
English: The doctor may have to adjust your dosage.
Slovenian: Morda vam bo moral prilagoditi odmerek.
English: • the Summary of Products Characteristic, Labelling and Package Leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: • Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo, ki jih je predlagalo podjetje, so bili ocenjeni na podlagi predložene dokumentacije in znanstvene razprave v okviru odbora,
English: • Symptomatic gastroesophageal reflux disease (4.1 and 4.2)
Slovenian: • Simptomatska gastroezofagealna refluksna bolezen (4.1 in 4.2)
English: Agopton should be taken at least 30 minutes before food (see section 5.2).
Slovenian: Zdravilo Agopton je treba jemati vsaj 30 minut pred obrokom (glejte poglavje 5.2).
English: Further reductions are not practically possible and data may not allow simulations of PK/PD regarding the increase the dose-interval.
Slovenian: Nadaljnja zmanjšanja praktično niso možna in podatki morda ne dopuščajo simulacije farmakokinetike/farmakodinamike v zvezi s povečanjem odmernega intervala.
English: Relief of symptoms is obtained rapidly.
Slovenian: Simptomi se hitro ublažijo.
English: • 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: • 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: One study of the interaction with phenytoin has been submitted.
Slovenian: Predložena je bila ena raziskava o interakciji s fenitoinom.
English: • Food interaction
Slovenian: • Medsebojno delovanje s hrano
English: To give your medicine the best chance of working, take it at the right time and do not miss a dose.
Slovenian: Da bi zdravilo najbolje delovalo, ga vzemite ob ustreznem času in ne izpustite odmerka.
English: Almirall Prodesfarma, S.A. General Mitre, 151 08022 -Barcelona, Spain
Slovenian: Almirall Prodesfarma, S.A. General Mitre, 151 08022 Barcelona, Španija
English: The treatment duration is most commonly 7 days but sometimes up to 14 days.
Slovenian: Zdravljenje najpogosteje traja 7 dni, včasih pa tudi do 14 dni.
English: It was agreed that the indication should only mention “symptomatic gastroesophageal reflux disease”.
Slovenian: Dogovorjeno je bilo, naj indikacija omenja zgolj »simptomatsko gastroezofagealno refluksno bolezen«.
English: Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough risk/benefit assessment should regularly be performed in these patients.
Slovenian: Zaradi omejenih podatkov o varnosti bolnikov na vzdrževalnem zdravljenju, ki traja dlje kot eno leto, je treba redno preverjati zdravljenje ter temeljito oceniti tveganje in koristi.
English: The usual doses of Agopton for adults are given below.
Slovenian: Običajni odmerki zdravila Agopton za odrasle so navedeni spodaj.
English: Benefit/Risk consideration
Slovenian: Ocenjevanje razmerja med koristmi in tveganji
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF AGOPTON AND ASSOCIATED NAMES
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA AGOPTON IN Z NJIM POVEZANIH IMEN
English: The submitted data for the indication “symptomatic gastroesophageal reflux disease” support this the indication.
Slovenian: Predloženi podatki za indikacijo »simptomatska gastroezofagealna refluksna bolezen« podpirajo to indikacijo.
English: Also contains sucrose and mannitol (E421).
Slovenian: Vsebuje tudi saharozo in manitol (E 421).
English: The evaluation of the symptoms yielded less clear results than for the healing of the ulceration, and the results are inconsistent across the different symptoms/parameters and methods used to assess the symptoms.
Slovenian: Vrednotenje simptomov je podalo manj jasne rezultate kot zdravljenje razjed, rezultati pa pri vrednotenju različnih simptomov oz. parametrov ter metod, uporabljenih za oceno simptomov, niso konsistentni.
English: A study has shown that co-administration of lansoprazole (60 mg once daily) with atazanavir 400 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 90% decrease in AUC and Cmax).
Slovenian: Študija je pokazala, da je sočasna uporaba lansoprazola (60 mg enkrat na dan) in atazanavira 400 mg pri zdravih prostovoljcih povzročila pomembno zmanjšanje izpostavljenosti atazanaviru (približno 90odstotno zmanjšanje vrednosti AUC in Cmax).
English: Seber Portuguesa Farmaceutica, SA Rua Norberto de Oliveira,1a 5 2675-130 Povoa de Santo Adriao, Portugal
Slovenian: Seber Portuguesa Farmaceutica, SA Rua Norberto de Oliveira,1a 5 2675-130 Povoa de Santo Adriao, Portugalska
English: A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).
Slovenian: Opravil bo krvno preiskavo, s katero bo preveril, ali je prisotno zmanjšanje števila belih krvničk (agranulocitoza).
English: Colitis, stomatitis
Slovenian: Kolitis, stomatitis
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with lansoprazole should be made taking into account the benefit of breastfeeding to the child and the benefit of lansoprazole therapy to the woman.
Slovenian: Pri odločitvi, ali nadaljevati ali prekiniti dojenje oziroma ali nadaljevati ali prekiniti zdravljenje z lansoprazolom, je treba upoštevati korist dojenja za otroka in korist zdravljenja z lansoprazolom za žensko.
English: • the scope of the referral was the harmonisation of the Summary of Products Characteristics,
Slovenian: • Namen napotitve je bil usklajevanje Povzetkov glavnih značilnosti zdravila,
English: For the best results from your medicines you should take Agopton at least 30 minutes before food.
Slovenian: Za najboljše rezultate morate zdravilo Agopton jemati vsaj 30 minut pred obrokom.
English: While the results for the two doses of lansoprazole and for misoprostol are very similar, all three treatments were markedly better than placebo and this is confirmed by statistical analysis (p<0.001 for each active vs. placebo comparison).
Slovenian: Medtem ko so bili rezultati za oba odmerka lansoprazola in misoprostol zelo podobni, so se vsi trije načini zdravljenja odrezali bistveno bolje od placeba, kar potrjuje statistična analiza (p<0,001 za vsako učinkovino v primerjavi s placebom).