FrancophonIA/ELRC3.0 huggingface dataset:
English: Levviax should not be used by breast-feeding women.
Slovenian: Ustreznih podatkov za ljudi ni. Doječe ženske ne smejo uporabljati zdravila Levviax.
English: • pimozide (psychiatric problems) - if you have severely impaired renal function and/or severely impaired hepatic function, do not take Levviax while taking other medicines containing any of the following active substances:
Slovenian: - če imate hudo okvaro ledvic in/ali hudo okvaro jeter, ne jemljite zdravila Levviax skupaj z zdravili, ki vsebujejo katero od naslednjih zdravilnih učinkovin: - ketokonazol (antimikotično zdravljenje) - zdravilo imenovano proteazni inhibitor (zdravljenje okužbe s HIV).
English: Microcrystalline cellulose Povidone K25
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Jedro tablete: mikrokristalna celuloza povidon K25 premrežen natrijev karmelozat magnezijev stearat
English: Cholestatic jaundice
Slovenian: hepatitis holestatski ikterus
English: Diarrhoea Nausea, vomiting, gastrointestinal pain, flatulence
Slovenian: Bolezni kože in podkožja izpuščaj, urtikarija, pruritus ekcem multiformni eritem
English: • a medicine called protease inhibitor (HIV treatment) Refer also to section “Taking other medicines”.
Slovenian: Glejte tudi poglavje "Jemanje drugih zdravil".
English: BEFORE YOU TAKE LEVVIAX
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO LEVVIAX
English: • if you are a young adult.
Slovenian: • če ste mlajša odrasla oseba.
English: Drink the mixture all at once.
Slovenian: Mešanico popijte vso naenkrat.
English: In each subgroup 10 subjects were included.
Slovenian: V vsaki podskupini je bilo 10 posameznikov.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Slovenian: {Ime in naslov } <{tel.}> <{fax}> <{e-mail}>
English: The pump is now ready for use.
Slovenian: Črpalka je zdaj pripravljena za uporabo.
English: Therefore the following wording was recommended:
Slovenian: Tako se priporoča naslednja ubeseditev:
English: The recommended dose is the same as that for adults.
Slovenian: Priporočeni odmerek je enak kot pri odraslih.
English: The general wording on absence of interactions should not be included.
Slovenian: Splošnega besedila o neprisotnosti medsebojnih delovanj ni treba vključiti.
English: This is most likely to occur within the first few weeks of treatment.
Slovenian: To se najverjetneje pojavi v prvih dveh tednih zdravljenja.
English: You are advised not to drink any alcohol.
Slovenian: Svetujemo, da sploh ne pijete alkohola.
English: Do not use the bottle more than 6 weeks after opening.
Slovenian: Stekleničke ne smete uporabljati več kot 6 tednov po odprtju.
English: 2 years Shelf life after first opening of the bottle: 6 weeks
Slovenian: 2 leti Rok uporabnosti po prvem odprtju stekleničke: 6 tednov.
English: The low number of post-marketing reports does not justify this either.
Slovenian: Majhno število poročil po začetku trženja tega prav tako ne upravičuje.
English: If you still don't feel better, your doctor may prescribe a higher dose.
Slovenian: Če se še vedno ne počutite bolje, vam bo zdravnik morda predpisal večji odmerek.
English: When it is locked, no liquid will come out.
Slovenian: Ko je zaprta, ven ne priteče nič tekočine.
English: Fatal cases mostly concerned patients with an age above 65.
Slovenian: Pri smrtnih primerih je šlo večinoma za bolnike, stare nad 65 let.
English: The warning at section 4.5 seems sufficient for its purpose.
Slovenian: Opozorilo v razdelku 4.5 ustrezno zadostuje svojemu namenu.
English: Your doctor may advise you to increase your dose after a few days to the amount that is best for you (between 15 and 45 mg per day).
Slovenian: Zdravnik vam bo morda svetoval, da čez nekaj dni povečate odmerek do količine, ki vam najbolj ustreza (od 15 do 45 mg na dan).
English: cannot be estimated from the available data
Slovenian: iz razpoložljivih podatkov ocena ni mogoča
English: Make a note of the date of opening of the bottle.
Slovenian: Zapišite si datum odprtja stekleničke.
English: 167 77 Athens, Greece
Slovenian: 167 77 Athens,
English: Your doctor will tell you how to decrease the dose gradually.
Slovenian: Vaš zdravnik vam bo povedal, kako naj postopno zmanjšujete odmerek zdravila.
English: Treatment of episodes of major depression.
Slovenian: Zdravljenje epizod velike depresije.
English: The majority of withdrawal reactions are mild and self-limiting.
Slovenian: Odtegnitvene reakcije so večinoma blage in omejene.
English: The CHMP considered that the addition of “in adults” was not acceptable.
Slovenian: Odbor za zdravila za uporabo v humani medicini je menil, da dodatek „pri odraslih“ ni sprejemljiv.
English: Preparation of the bottle
Slovenian: Priprava stekleničke
English: For consistency, the CHMP considered that these undesirable effects should also be stated under 4.8 (Undesirable Effects).
Slovenian: Zaradi doslednosti je CHMP predlagal, da se ti neželeni učinki navedejo tudi v razdelku 4.8 (Neželeni učinki).
English: In that case, talk to your doctor again after another 2 to 4 weeks.
Slovenian: V tem primeru se ponovno pogovorite z njim po dodatnih 2 do 4 tednih zdravljenja.
English: These symptoms can be avoided by stopping gradually.
Slovenian: Tem simptomom se lahko izognete s postopnim ukinjanjem zdravila.
English: Immeuble Optima 10 rue Godefroy 92821 PUTEAUX Cedex France
Slovenian: Immeuble Optima 10 rue Godefroy 92821 PUTEAUX Cedex
English: The usual starting dose is 15 or 30 mg every day.
Slovenian: Običajen začetni odmerek je 15 ali 30 mg vsak dan.
English: You may need to press the nozzle more than once to get the dose your doctor has prescribed (see picture).
Slovenian: Nekateri bolniki morajo na šobo pritisniti več kot enkrat, da dobijo odmerek, ki jim ga je predpisal zdravnik (glejte sliko).
English: It is important that, during the first few weeks of the treatment, you talk with your doctor about the effects of Remeron:
Slovenian: Pomembno je, da se v času prvih nekaj tednov zdravljenja posvetujete s svojim zdravnikom o učinkih zdravila Remeron:
English: • Rinse away the liquid that comes out.
Slovenian: • Sperite tekočino, ki priteče ven.
English: In addition, the most recent EU Guideline was only established in 1994 (Note for Guidance on the evaluation on the pharmacokinetics of medicinal products in patients with impaired renal function, CHMP/EWP/225/02).
Slovenian: Poleg tega so bile tudi najsodobnejše smernice EU oblikovane šele leta 1994 (Smernice za vrednotenje farmakokinetike zdravil pri bolnikih z omejenim ledvičnim delovanjem, CHMP/EWP/225/02).
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Slovenian: Pri bolnikih, pri katerih se razvijejo ti simptomi, bi bilo povečanje odmerka lahko škodljivo.
English: • Hold a glass or cup under the nozzle (see picture).
Slovenian: • Pod šobo postavite kozarec ali skodelico (glejte sliko).
English: -seizures (epilepsy).
Slovenian: - epileptični napadi (epilepsija).
English: It is therefore proposed to keep this warning in the corresponding section, section 4.4.
Slovenian: Tako se predlaga, da se to opozorilo navede v ustreznem razdelku 4.4.
English: In very rare cases these can be signs of serotonin syndrome.
Slovenian: V zelo redkih primerih so to lahko znaki serotoninskega sindroma.
English: Pour a little water into a glass or cup, and hold it under the nozzle.
Slovenian: Nalijte malo vode v kozarec ali skodelico in ga oz. jo držite pod šobo.
English: If your doctor has prescribed Remeron for a patient under 18 and you want to discuss this, please go back to your doctor.
Slovenian: Če je zdravnik predpisal zdravilo Remeron bolniku, ki je mlajši od 18 let, in se želite pogovoriti o tem, ga ponovno obiščite.
English: - low blood pressure.
Slovenian: • nizek krvni tlak
English: • sleeping problems
Slovenian: • težave s spanjem
English: The demethyl metabolite is pharmacologically active and appears to have the same pharmacokinetic profile as the parent compound.
Slovenian: Demetilni presnovek je farmakološko aktiven in videti je, da ima enak farmakokinetični profil kot matična spojina.
English: You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Slovenian: Prosite ga lahko tudi, da naj vas opozori, če meni, da se je depresija ali anksioznost poslabšala ali ga skrbijo spremembe v vašem vedenju.
English: The oral solution should not be mixed with fluids other than water.
Slovenian: Peroralne raztopine ne smemo mešati z drugimi tekočinami razen z vodo.
English: The Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product (EMEA/CHMP/QWP/396951/2006) and the above mentioned guideline (CHMP/463/00) indicate which excipients and information should appear in the labelling.
Slovenian: Smernice o pomožnih snoveh v dokumentaciji za predložitev vloge za dovoljenje za promet z zdravilom (EMEA/CHMP/QWP/396951/2006) in prej navedena smernica (CHMP/463/00) jasno določajo, katere pomožne snovi in podatki morajo biti navedeni pri označevanju.
English: Some side effects are more likely to occur than others.
Slovenian: Nekateri neželeni učinki se pojavljajo pogosteje kot drugi.
English: In reproductive toxicity studies in rats and rabbits no teratogenic effects were observed.
Slovenian: V študijah reprodukcijske toksičnosti pri podganah in kuncih niso opažali nobenih teratogenih učinkov.
English: Aspartame may be/is considered contraindicated in infants, but mirtazapine is not to be used in this age category and, consequently, requires no further warning.
Slovenian: Aspartam je/je lahko kontraindiciran pri dojenčkih, vendar pa mirtazapin ni namenjen za uporabo v tej starostni kategoriji ter tako posledično ne potrebuje dodatnega opozorila.
English: → 2 to 4 weeks after you have started taking Remeron, talk to your doctor about how this medicine has affected you.
Slovenian: → 2 do 4 tedne po začetku jemanja zdravila Remeron se pogovorite s svojim zdravnikom o tem, kako zdravilo vpliva na vas.
English: Mirtazapine was not genotoxic in a series of tests for gene mutation and chromosomal and DNA damage.
Slovenian: Mirtazapin ni bil genotoksičen v vrsti testov na genske mutacije in kromosomske in DNA poškodbe.
English: As advised in section 4.2, it is recommended to discontinue treatment with mirtazapine gradually.
Slovenian: Kot svetujemo v poglavju 4.2, je torej priporočljivo, da zdravljenje z mirtazapinom prekinete postopoma.
English: Maistraatinportti 2 00240 Helsinki, Finland
Slovenian: Oy Organon Ab Maistraatinportti 2 00240 Helsinki, Finland
English: The use of aspartame as presented in these amounts in Remeron orodispersible tablets is not an absolute contraindication.
Slovenian: Predstavljena uporaba aspartama v navedenih količinah v zdravilu Remeron orodisperzibilnih tabletah, ni absolutna kontraindikacija.
English: Tear off one tablet pocket along the dotted lines (Figure 1).
Slovenian: Odtrgajte en žepek po perforirani črti (slika 1).
English: The CHMP considered that the proposed wording under bullet point a and b were acceptable.
Slovenian: Odbor za zdravila za uporabo v humani medicini je menil, da je predlagano besedilo za točki a in b sprejemljivo.
English: Steady state is reached after 3-4 days, after which there is no further accumulation.
Slovenian: Stanje dinamičnega ravnovesja je doseženo po 3 do 4 dneh, potem pa več ni nadaljnjega kopičenja zdravila.
English: Animal studies and limited human data have shown excretion of mirtazapine in breast milk only in very small amounts.
Slovenian: Študije pri živalih in omejeni podatki za človeka so pokazali, da se mirtazapin izloča v materino mleko le v zelo majhnih količinah.
English: • if you have previously had thoughts about killing or harming yourself.
Slovenian: • če ste že kdaj razmišljali o samomoru ali samopoškodovanju,
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF REMERON AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA REMERON IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: Pharmacotherapeutic group: other antidepressants, ATC code: N06AX11
Slovenian: Farmakoterapevtska skupina: Drugi antidepresivi, Oznaka ATC: N06AX11
English: Mirtazapine has an elimination half-life of 20-40 hours and therefore Remeron is suitable for once daily administration.
Slovenian: Mirtazapin ima razpolovno dobo od 20 do 40 ur, zato je zdravilo Remeron primerno za jemanje enkrat na dan.
English: If there is no response within a further 2-4 weeks, then treatment should be stopped.
Slovenian: Če v naslednjih 2 do 4 tednih zdravljenja ni nobenega odziva, z zdravljenjem prekinite.
English: Pathological alterations of blood count
Slovenian: Patološke spremembe krvne slike
English: While rare, these symptoms most commonly appear after 4-6 weeks of treatment.
Slovenian: Pojavljajo se redko, najpogosteje pa jih opazimo po 4 do 6 tednih zdravljenja.
English: In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response.
Slovenian: Pri starostnikih naj poteka povečevanje odmerka pod strogim nadzorom, da boste lahko dosegli zadovoljiv in varen odziv.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Slovenian: Poleg tega tudi ni dolgoročnih podatkov o varnosti zdravila za otroke in mladostnike kar zadeva rast, zorenje ter kognitivni in vedenjski razvoj.
English: - Although Remeron is not addictive, post-marketing experience shows that abrupt termination of treatment after long term administration may sometimes result in withdrawal symptoms.
Slovenian: - Čeprav Remeron ne povzroča zasvojenosti, pa postmarketinške izkušnje kažejo, da lahko nagla prekinitev zdravljenja po dolgotrajnem jemanju zdravila včasih povzroči pojav odtegnitvenih simptomov.
English: It will rapidly disintegrate and can be swallowed without water.
Slovenian: Hitro bo razpadla in jo boste lahko pogoltnili brez vode.
English: Given the very low incidence of the most serious condition, i.e. agranulocytosis (independent from the question of causality or whether it surpasses the background incidence), this is not an absolute contraindication and should not be included in section 4.3
Slovenian: Upoštevajoč zelo majhno pojavnost najresnejših stanj, to je agranulocitoza (neodvisno od vprašanja vzročnosti ali če presega pojavnost iz preteklosti), to ni absolutna kontraindikacija in ne zahteva vključitve v razdelek 4.3.
English: Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Remeron in this age group have not yet been demonstrated.
Slovenian: Dolgoročna varnost zdravila Remeron glede rasti, zorenja ter kognitivnega in vedenjskega razvoja pri tej starostni skupini še ni dokazana.
English: When to take Remeron → Take Remeron at the same time each day.
Slovenian: Kdaj jemati zdravilo → Zdravilo Remeron jemljite ob istem času vsak dan.
English: If treatment with such medicinal product is discontinued, it may be necessary to reduce the mirtazapine dose.
Slovenian: Če se zdravljenje s takšnimi zdravili preneha, utegne biti potrebno zmanjšanje odmerka mirtazapina.
English: This procedure is given in symbolic instructions on the top of the screw cap.
Slovenian: Ta postopek je simbolično prikazan na vrhu navojne zaporke.
English: - the Summaries of Products Characteristic, labelling, package leaflet and Module 3 proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - so bili povzetki glavnih značilnosti zdravila, označevanja, navodil za uporabo in moduli 3, ki so jih predlagali imetniki dovoljenj za promet z zdravilom ovrednoteni na podlagi predložene dokumentacije in strokovne razprave v Odboru,
English: Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines in the following list.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete (ali nameravate jemati) katero od zdravil iz spodnjega seznama.
English: Sugar spheres (containing sucrose) and aspartame (E951) See leaflet for further information.
Slovenian: SEZNAM POMOŽNIH SNOVI Sladkorne kroglice (ki vsebujejo saharozo) in aspartam (E951) Za dodatne informacije glejte priloženo navodilo.
English: The possible side effects of Remeron are listed below and can be divided as:
Slovenian: Možni neželeni učinki zdravila Remeron so našteti v nadaljevanju in jih lahko razdelimo na naslednje kategorije:
English: WHAT REMERON IS AND WHAT IT IS USED FOR Remeron is one of a group of medicines called antidepressants.
Slovenian: KAJ JE ZDRAVILO REMERON IN ZA KAJ GA UPORABLJAMO Remeron sodi v skupino zdravil, ki jih imenujemo antidepresivi.
English: However, the CHMP did not consider this explanation acceptable and requested that the applicant/MAH should argue why these contraindications are not absolute.
Slovenian: Za CHMP ta razlaga ni bila sprejemljiva in je od predlagatelja/imetnika dovoljenja za promet z zdravilom zahteval pojasnilo, zakaj navedene kontraindikacije niso absolutne.
English: • vivid dreams
Slovenian: • žive sanje
English: • urge to move
Slovenian: • potreba po premikanju.
English: • if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Remeron.
Slovenian: • če ste alergični na (preobčutljivi za) mirtazapin ali katerokoli sestavino zdravila Remeron.
English: Inform your doctor if you are using this medicine.
Slovenian: Obvestite svojega zdravnika, če jemljete to zdravilo.
English: However, caution should be exercised when used during pregnancy.
Slovenian: Kljub temu pa je potrebna posebna previdnost pri uporabi v času nosečnosti.
English: The CHMP considered this explanation to be acceptable and the issue was resolved.
Slovenian: Za CHMP je bila ta razlaga sprejemljiva in tako je bila ta zadeva razrešena.
English: As explained in the referral application dossier, animal studies have shown that mirtazapine induces only a small and temporary increase in noradrenalin and serotonin levels in the hippocampus (data available on request).
Slovenian: Obrazložitev v dokumentaciji za napotitev navaja, da so študije pri živalih pokazale, da mirtazapin povzroča le majhno in začasno povečanje ravni noradrenalina in serotonina pri hippocampusih (podatki na razpolago na zahtevo).
English: The plastic films contain: PVC (polyvinyl chloride), polyamide and polyester.
Slovenian: Plastična folija vsebuje PVC (polivinilklorid), poliamid in poliester.
English: Some people become less resistant to infection because Remeron can cause a temporary shortage of white blood cells (granulocytopenia).
Slovenian: Nekateri ljudje na primer postanejo manj odporni na okužbe, ker lahko zdravilo Remeron povzroči začasno pomanjkanje belih krvničk (granulocitopenija).
English: In case of combination it is advised that a doctor monitors your blood carefully.
Slovenian: V primeru kombiniranja teh dveh zdravil je priporočljivo, da zdravnik natančno spremlja stanje vaše krvi.
English: (Figure 4).
Slovenian: (sl 4).
English: You can take Remeron with or without food.
Slovenian: Zdravilo Remeron lahko jemljete s hrano ali brez.
English: The CHMP considered that the explanations provided appear scientifically sound and justified, noting that the aspartame content of the product is adequately addressed in the proposed form
Slovenian: CHMP je preučil posredovane obrazložitve ter menil, da so le-te znanstveno dobro utemeljene ter da je v predlagani obliki vsebnost aspartama v zdravilu ustrezno označena.
English: The nozzle should be pressed in a firm, smooth, continuous action (not too slowly) all the way down until it stops, holding a glass containing some water under the opening of the nozzle.
Slovenian: Pritiskajte na šobo trdno, enakomerno in neprekinjeno (vendar ne prepočasi) vse do konca, da se ustavi, in pri tem držite kozarec z nekaj vode pod odprtino šobe.
English: From post marketing experience it appears that serotonin syndrome occurs very rarely in patients treated with Remeron alone (see section 4.8).
Slovenian: Na podlagi postmarketinških izkušenj pa je videti, da se serotoninski sindrom zelo redko pojavlja pri bolnikih, ki jemljejo samo zdravilo Remeron (glejte poglavje 4.8).
English: The Annex explicitly mentions those excipients that require to be mentioned as a contraindication (e.g. hypersensitivity to peanut or soya oil).
Slovenian: Dodatek izrecno navaja pomožne snovi, ki morajo biti navedene kot kontraindikacije (to je preobčutljivost na olje arašidov ali sojino olje).
English: Mania Agitation2
Slovenian: manija vznemirjenost2
English: • medicines to prevent blood clotting such as warfarin.
Slovenian: • zdravila za preprečevanje strjevanja krvi, na primer varfarin.
English: The nozzle has two positions - locked and open.
Slovenian: Šobo obrnite v odprt položaj Šoba ima dva položaja - zaprtega in odprtega.
English: You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Slovenian: Morda bi bilo koristno, če za težave z depresijo ali anksioznostjo poveste sorodniku ali dobremu prijatelju in ga prosite, da prebere to navodilo.
English: Further the recommendations by the Pharmacovigilance Working Party with respect to the core SPC for antidepressants were implemented.
Slovenian: Uporabljena so bila tudi priporočila delovne skupine za farmakovigilanco v zvezi z osnovnim povzetkom glavnih značilnosti zdravila za antidepresive.
English: Hence it is proposed not to include MAO-inhibitors as absolute contraindication in section 4.3.
Slovenian: Tako se predlaga, da se zaviralcev monoaminskih oksidaz (MAO) ne vključi v razdelek 4.3 kot absolutno kontraindikacijo.
English: Remeron can increase the effects of warfarin on the blood.
Slovenian: Remeron lahko okrepi učinke varfarina na kri.
English: Remeron oral solution contains 0.3 % v/v ethanol.
Slovenian: Remeron peroralna raztopina vsebuje 0,3 % v/v etanola.
English: The histamine H1-antagonistic activity of mirtazapine is associated with its sedative properties.
Slovenian: Antagonistično delovanje mirtazapina na histaminske receptorje H1 je povezano z njegovimi sedativnimi lastnostmi.
English: Please also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: The CHMP considered that a contraindication is acceptable, given the marginal influence on noradrenaline and serotonin levels and the post-marketing experience available to date.
Slovenian: CHMP je menil, da je kontraindikacija sprejemljiva, upoštevajoč mejni vpliv na raven noradrenalina in serotonina ter razpoložljive podatke o izkušnjah iz poročil po začetku trženja.
English: This should be taken into account when prescribing Remeron to this category of patients, particularly with severe hepatic impairment, as patients with severe hepatic impairment have not been investigated (see section 4.4).
Slovenian: To je treba upoštevati pri predpisovanju zdravila Remeron tej skupini bolnikov, še posebej pri hudi jetrni okvari, ker niso proučevali bolnikov s hudo jetrno okvaro (glejte poglavje 4.4).
English: Usually Remeron will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better.
Slovenian: Kdaj lahko pričakujete, da se boste začeli počutiti bolje Običajno začne zdravilo Remeron delovati po 1 do 2 tednih in po 2 do 4 tednih se boste lahko začeli počutiti bolje.