FrancophonIA/ELRC3.0 huggingface dataset:
English: In very rare cases Remeron alone or the combination of Remeron with these medicines, can lead to a so-called serotonin syndrome.
Slovenian: V zelo redkih primerih lahko samostojna uporaba zdravila Remeron ali njegovo kombiniranje s temi zdravili vodi do pojava t.i. serotoninskega sindroma.
English: The low number of post-marketing reports suggests that this interaction does not occur frequently and do not warrant any change to the location in the SPC where the warning for concomitant use of Remeron with MAO-Is is provided.
Slovenian: Majhno število poročil po začetku trženja kaže, da do teh medsebojnih delovanj ne prihaja pogosto in da ta ne zahtevajo spremembe mesta navajanja v povzetku glavnih značilnosti zdravila, kjer je navedeno opozorilo glede hkratne uporabe zdravila Remeron in zaviralcev monoaminskih oksidaz (MAO).
English: Patients should therefore be advised to avoid alcoholic beverages while taking mirtazapine.
Slovenian: Bolnikom je zato treba svetovati, naj ne pijejo alkoholnih pijač med jemanjem mirtazapina.
English: Remeron (mirtazapine) has been referred for the harmonisation of Summary of Product Characteristics, in accordance with Article 30 (1) of Directive 2001/83/EC.
Slovenian: Zdravilo Remeron (mirtazapin) je bilo v skladu s členom 30 (1) Direktive 2001/83/ES napoteno v postopek uskladitve povzetkov glavnih značilnosti zdravila.
English: monitoring for signs of beginning serotonergic overstimulation maintained is warranted.
Slovenian: Zagotoviti je treba ustrezno natančen nadzor znakov nastajajoče čezmerne serotonergične stimulacije.
English: • pain in your joints (arthralgia) or muscles (myalgia)
Slovenian: • bolečine v sklepih (artralgija) ali mišicah (mialgija)
English: In rare cases Remeron can cause disturbances in the production of blood cells (bone marrow depression).
Slovenian: V redkih primerih lahko zdravilo Remeron povzroči motnje v tvorbi krvnih celic (depresija kostnega mozga).
English: Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and
Slovenian: Previdno odluščite prekrivno folijo od vogala, označenega s puščico (sliki 2 in 3).
English: • if you have forgotten to take your evening dose, do not take it with the next morning dose; just skip it and continue with your normal morning and evening doses.
Slovenian: • Če pa ste pozabili vzeti večerni odmerek, ga ne vzemite z naslednjim jutranjim odmerkom, ampak ga raje preskočite in nadaljujte z jemanjem običajnih jutranjih in večernih odmerkov.
English: At two-fold systemic exposure compared to maximum human therapeutic exposure, there was an increase in postimplantation loss, decrease in the pup birth weights, and reduction in pup survival during the first three days of lactation in rats.
Slovenian: V primerjavi z največjo izpostavljenostjo pri terapevtski uporabi na človeku so pri dvojnem sistemskem izpostavljanju pri podganah opazili povečanje poimplantacijskih izgub zarodkov, zmanjšanje porodne teže mladičev in slabše preživetje mladičev v prvih treh dneh laktacije.
English: Like with other antidepressants, the following should be taken into account: - Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified.
Slovenian: Kot pri drugih antidepresivih je treba upoštevati naslednje: - Pri predpisovanju antidepresivov bolnikom s shizofrenijo ali drugimi psihotičnimi motnjami lahko nastopi poslabšanje psihotičnih simptomov in okrepijo se jim lahko paranoidne misli.
English: This should be taken into account when prescribing Remeron to this category of patients (see section 4.4).
Slovenian: To je potrebno upoštevati pri predpisovanju zdravila Remeron bolnikom v tej kategoriji (glejte razdelek 4.4).
English: If so, you must talk to your doctor as soon as you can before taking Remeron.
Slovenian: se morate čimprej posvetovati s svojim zdravnikom, še preden začnete jemati zdravilo Remeron.
English: If you start feeling elated or over-excited, stop taking Remeron and contact your doctor immediately; -diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines); -eye disease, such as increased pressure in the eye (glaucoma); -difficulty in passing water (urinating), which might be caused by an enlarged prostate.
Slovenian: Če se začnete počutiti vzneseno ali zelo vznemirjeno, prenehajte jemati zdravilo Remeron in nemudoma pokličite svojega zdravnika; - sladkorna bolezen (v tem primeru bo lahko potrebna prilagoditev odmerka insulina ali katerega drugega zdravila za sladkorno bolezen); - očesne bolezni, na primer zvišan očesni tlak (glavkom); - težave pri odvajanju vode (uriniranju), ki jih lahko povzroči povečana prostata.
English: This medicinal product is authorised in the Member States of the EEA under the following names: [not applicable for art 30 referral]
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: [ne velja za navedbo art. 30]
English: - Mirtazapine may increase the sedating properties of benzodiazepines and other sedatives (notably most antipsychotics, antihistamine H1 antagonists, opioids).
Slovenian: - Mirtazapin lahko poveča sedativne učinke benzodiazepinov in drugih sedativov (najbolj antipsihotikov, H1 antihistaminskih antagonistov, opioidov).
English: Preparing the Remeron metering pump for use Before you take Remeron, you need to fit the pump onto the bottle.
Slovenian: Priprava odmerne črpalke zdravila Remeron za uporabo Preden zaužijete zdravilo Remeron, morate na stekleničko postaviti črpalko.
English: In section 4.1 Therapeutic Indications of the SPC, the CHMP considered that the indication should be amended to: Episodes of major depression (or treatment of episodes of major depression) in accordance with the wording agreed for this indication for other products of which the SPC is harmonised in Europe.
Slovenian: CHMP je predlagal spremembo indikacije v razdelku 4.1 povzetka glavnih značilnosti zdravila v: Epizode hude depresije (ali zdravljenje epizod huje depresije) v skladu z besedilom, dodgovorjenim za to označevanje za druga zdravila, katerih povzetki glavnih značilnosti zdravila so v Evropi usklajeni.
English: If jaundice occurs, stop taking Remeron and contact your doctor immediately; -kidney disease; -heart disease, or low blood pressure; -schizophrenia.
Slovenian: Če se pojavi zlatenica, prenehajte jemati zdravilo Remeron in nemudoma pokličite svojega zdravnika; - ledvična bolezen; - srčna bolezen ali nizek krvni tlak; - shizofrenija.
English: A meta-analysis of placebocontrolled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Slovenian: Metaanaliza s placebom nadzorovanih kliničnih preskušanj antidepresivov pri odraslih bolnikih s psihiatričnimi motnjami je pokazala, da pri bolnikih, mlajših od 25 let, pri uporabi antidepresivov obstaja večje tveganje za pojav samomorilnega vedenja kot pri uporabi placeba.
English: Binding of mirtazapine to plasma proteins is approx. 85 %.
Slovenian: Vezava mirtazapina na plazemske beljakovine je približno 85-%.
English: The nozzle can then be released and the pump is ready for the following dose.
Slovenian: Potem lahko prenehate pritiskati in črpalka bo spet pripravljena za naslednji odmerek.
English: The applicant/MAH argues that it does not have data from clinical trials evaluating interactions between MAO inhibitors (MAO-Is) and mirtazapine.
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom je zatrjeval, da nima podatkov iz kliničnih preskušanj za vrednotenje medsebojnega delovanja med zaviralci monoaminskih oksidaz (MAO -Is) in mirtazapinom.
English: Remeron is used to treat depressive illness.
Slovenian: Uporabljamo ga za zdravljenje depresije.
English: Mirtazapine is a centrally active presynaptic α2-antagonist, which increases central noradrenergic and serotonergic neurotransmission.
Slovenian: Mirtazapin je presinaptični antagonist receptorjev α2 s centralnim delovanjem, ki v osrednjem živčevju okrepi noradrenergični in serotoninergični živčni prenos.
English: The following sections of the Product Information were addressed during this harmonisation procedure.
Slovenian: V postopku uskladitve je bilo največ pozornosti namenjene naslednjim delom informacij o zdravilu.
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Slovenian: Zavedati se morate tudi, da je pri jemanju zdravil iz te skupine pri bolnikih, ki so mlajši od 18 let, prisotno povečano tveganje za neželene učinke, na primer poskus samomora, samomorilne misli in sovražnost (predvsem agresivnost, nasprotovalno vedenje in jeza).
English: • medicines for epilepsy such as carbamazepine and phenytoin; medicines for tuberculosis such as rifampicin.
Slovenian: • zdravila za epilepsijo, na primer karbamazepin in fenitoin ter zdravila za tuberkulozo, na primer rifampicin.
English: 5 Upon treatment with antidepressants in general, anxiety and insomnia (which may be symptoms of depression) can develop or become aggravated.
Slovenian: 5 Med zdravljenjem z antidepresivi na splošno se lahko pri bolnikih pojavita ali poslabšata tesnoba in nespečnost (ki sta lahko simptoma depresije).
English: During the last PSUR period (01 Sep 2004 to 01 Sep 2007), 36 cases of hyponatraemia and 8 cases of SIADH were reported for mirtazapine (Remeron).
Slovenian: V času zadnjega periodičnega poročila o varnosti zdravila (1. september 2004 do 1. september 2007) je pri uporabi mirtazapina (Remeron) bilo sporočenih 36 primerov hiponatriemije in 8 primerov sindroma neustreznega izločanja antidiuretičnega hormona (SIADH).
English: A warning concerning the use during pregnancy and the possible risk of withdrawal effects on the newborn were recommended to be included in the PIL.
Slovenian: Priporočeno je bilo, da se v navodilo za uporabo vključi opozorilo o uporabi zdravila v času nosečnosti in možni učinki ob prenehanju jemanja zdravila na novorojenčka.
English: If you are taking Remeron and you become pregnant or you plan to get pregnant, ask your doctor whether you may continue taking Remeron.
Slovenian: Če ste med jemanjem zdravila Remeron zanosili ali načrtujete nosečnost, se posvetujte s svojim zdravnikom, ki vam bo povedal, ali ga lahko še naprej jemljete.
English: • swelling (typically in ankles or feet) caused by fluid retention (oedema)
Slovenian: • otekanje (običajno na gležnjih ali stopalih), ki ga povzroča zastajanje tekočine v telesu (edem)
English: • feeling dizzy or faint when you stand up suddenly (orthostatic hypotension)
Slovenian: • občutek omotičnosti ali vrtoglavice ob naglem vstajanju (ortostatska hipotenzija)
English: Use in children and adolescents under 18 years of age Remeron should normally not be used for children and adolescents under 18 years.
Slovenian: Uporaba zdravila pri otrocih in mladostnikih, mlajših od 18 let Zdravila Remeron običajno ne bi smeli uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: Blisters containing 7 and 10 film-coated tablets are available.
Slovenian: Na voljo so pretisni omoti s po 7 in 10 filmsko obloženimi tabletami.
English: The supplied metering pump is packed in a sealed polyethylene bag.
Slovenian: Priložena merilna črpalka je pakirana v zaprto polietilensko vrečko.
English: The nozzle should be turned gently anti-clockwise until it cannot be turned any further (about one-quarter turn); the pump is then ready for use.
Slovenian: Šobo previdno obračajte nasprotno smeri urinega kazalca, dokler se ne ustavi (na približno eni četrtini obrata), potem je pripravljena za uporabo.
English: Despite this, your doctor may prescribe Remeron for patients under 18 because he/she decides that this is in their best interests.
Slovenian: Kljub temu pa bo zdravnik lahko predpisal zdravilo Remeron tudi bolniku, ki je mlajši od 18 let, če presodi, da je to najbolj primerno zanj.
English: The clearance of mirtazapine may be decreased in patients with hepatic impairment.
Slovenian: Očistek mirtazapina je lahko zmanjšan pri bolnikih z jetrno okvaro.
English: With regards to the pathological alterations of blood count, the CHMP considered that proposed wording is acceptable, based on the meta-analysis report provided in the applicant/MAH's responses.
Slovenian: Odbor za zdravila za uporabo v humani medicini je v zvezi s patološkimi spremembami krvne slike izrazil mnenje, da je na podlagi predloženih poročil meta-analiz v odgovorih predlagatelja/imetnika dovoljenja za promet z zdravilom, predlagano besedilo sprejemljivo.
English: The referral was triggered by the applicant and aims to harmonise major areas of discrepancy between the EU member states, with regard to the Summary of Product Characteristics (SPCs), Package Leaflets (PLs), labelling and Module 3 of the following products containing the active substance mirtazapine:
Slovenian: Napotitev je vložil predlagatelj, s ciljem uskladiti glavna neskladja med državami članicami EU v zvezi s povzetki glavnih značilnosti zdravila, navodili za uporabo, označevanji in modulom 3 navedenih zdravil, ki vsebujejo zdravilno učinkovino mirtazapin:
English: What Remeron is and what it is used for Before you take Remeron How to take Remeron Possible side effects How to store Remeron Further information
Slovenian: Kaj je zdravilo Remeron in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Remeron Kako jemati zdravilo Remeron Možni neželeni učinki
English: The tablet will rapidly disintegrate and can be swallowed without water.
Slovenian: Tableta bo hitro razpadla in jo lahko bolnik pogoltne brez vode.
English: Despite this, in special cases your doctor may prescribe Remeron for you because it may be in the best interest of you and your child.
Slovenian: Kljub temu opozorilu vam vaš zdravnik v posebnih primerih, kadar je to v vašem in interesu vašega otroka, lahko predpiše zdravilo Remeron.
English: Mirtazapine is extensively metabolized and eliminated via the urine and faeces within a few days.
Slovenian: Mirtazapin se obsežno presnovi in se v nekaj dneh izloči s sečem in z blatom.
English: As at a higher dose of mirtazapine a more pronounced effect can not be excluded, it is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine.
Slovenian: Pri višjih odmerkih mirtazapina ni mogoče izključiti bolj izraženega učinka zdravila, zato je priporočljivo, da v primeru sočasnega zdravljenja z varfarinom in mirtazapinom redno spremljate vrednost INR pri bolniku.
English: Under mirtazapine treatment, development or aggravation of anxiety and insomnia has been reported.
Slovenian: Tudi med zdravljenjem z mirtazapinom so poročali o pojavu ali poslabšanju tesnobe in nespečnosti.
English: The tablets should be taken orally, with fluid, and swallowed without chewing.
Slovenian: Tablete naj bolniki jemljejo peroralno, po potrebi s tekočino, in naj jih pogoltnejo brez žvečenja.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light and moisture
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
English: It may be harmful for patients with phenylketonuria.
Slovenian: Zdravilo je torej lahko škodljivo za bolnike s fenilketonurijo.
English: System organ class
Slovenian: Razvrstitev po organskih sistemih
English: The half-life of elimination is sufficient to justify once-a-day dosing.
Slovenian: Razpolovna doba izločanja je zadosti dolga, da dovoljuje odmerjanje zdravila enkrat na dan.
English: When carbamazepine or any other inducer of hepatic metabolism (such as rifampicin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased.
Slovenian: Po dodatku karbamazepina ali kakšnega drugega induktorja presnove v jetrih (npr. rifampicina) terapiji z mirtazapinom utegne biti potrebno povečanje odmerka mirtazapina.
English: Removing the screw cap from the bottle
Slovenian: Odstranjevanje navojne zaporke s stekleničke
English: The blisters contain 6 orodispersible tablets each.
Slovenian: Pretisni omoti vsebujejo vsak po 6 orodisperzibilnih tablet.
English: Each tablet with 15 mg, 30 mg and 45 mg mirtazapine corresponds to 2.6 mg, 5.2 mg and 7.8 mg phenylalanine, respectively.
Slovenian: Ena tableta s 15 mg, 30 mg, 45 mg mirtazapina vsebuje po 2,6 mg, 5,2 mg in 7,8 mg fenilalanina.
English: Bottles contain 250 film-coated tablets.
Slovenian: Plastenke vsebujejo po 250 filmsko obloženih tablet.
English: Swallow your prescribed dose of Remeron without chewing, with some water or juice.
Slovenian: Predpisani odmerek zdravila Remeron pogoltnite brez žvečenja, z malo vode ali soka.
English: Finally, the cimetidine interaction study should be included in section 4.5.
Slovenian: Študija medsebojnega delovanja s cimetidinom naj bo vključena v razdelek 4.5: Farmakokinetično medsebojno delovanje .
English: 1 bottle containing 66 ml
Slovenian: 1 steklenička s 66 ml raztopine.
English: Cambridge, CB4 0FL
Slovenian: Milton Road, Cambridge, CB4 0FL United Kingdom
English: Among the various reported withdrawal symptoms, dizziness, agitation, anxiety, headache and nausea are the most frequently reported.
Slovenian: Med različnimi prijavljenimi odtegnitvenimi simptomi so bili najpogostejši omotica, vznemirjenost, tesnoba, glavobol in slabost.
English: Caution should be exercised when these medicinal products are prescribed together with mirtazapine.
Slovenian: Pri predpisovanju teh zdravil skupaj z mirtazapinom je torej potrebna previdnost.
English: Concomitant use of mirtazapine with monoamine oxidase (MAO) inhibitors (see section 4.5).
Slovenian: Sočasna uporaba mirtazapina in zaviralcev monoaminooksidaze (MAO) (glej poglavje 4.5).
English: Remeron contains aspartame, a source of phenylalanine.
Slovenian: Zdravilo Remeron vsebuje aspartam, ki je vir fenilalanina.
English: Not known:
Slovenian: Neznano:
English: This proposal was adopted by the applicant/MAH and the issue was resolved.
Slovenian: Ta predlog je predlagatelj/imetnik dovoljenja za promet z zdravilom sprejel in tako je bila zadeva razrešena.
English: Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used for Parkinson's disease).
Slovenian: Med zaviralce MAO sodijo na primer moklobemid in tranilcipromin (oba sta antidepresiva) ter selegilin (ki ga uporabljamo za zdravljenje Parkinsonove bolezni).
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling, package leaflet and Module 3.
Slovenian: - je napotitev obsegala uskladitev povzetkov glavnih značilnosti zdravil, označevanja, navodil za uporabo in modulov 3;
English: Whereas
Slovenian: Če ste,
English: In combination with these medicines Remeron can increase the drowsiness caused by these medicines.
Slovenian: Pri sočasni uporabi z navedenimi zdravili lahko Remeron okrepi zaspanost, ki jo povzročajo ta zdravila.
English: If you have been told by your doctor that you have an intolerance for some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je vaš zdravnik povedal, da ne prenašate nekaterih sladkorjev (na primer laktoze), se posvetujte z njim pred jemanjem tega zdravila.
English: If you stop taking Remeron → Only stop taking Remeron in consultation with your doctor.
Slovenian: Če ste prenehali jemati zdravilo Remeron → Zdravilo Remeron lahko prenehate jemati le po posvetu z zdravnikom.
English: To open the nozzle, turn it anticlockwise as far as it will go (about one-quarter turn).
Slovenian: Šobo lahko odprete z obračanjem nasprotno smeri urinega kazalca, dokler gre (približno eno četrtino obrata).
English: Remeron are orodispersible tablets.
Slovenian: Remeron so orodisperzibilne tablete.
English: Children and adolescents under the age of 18 years Remeron should not be used in children and adolescents under the age of 18 years (see section 4.4).
Slovenian: Otroci in mladostniki, mlajši od 18 let Zdravila Remeron ne smete uporabljati pri otrocih in mladostnikih, ki so mlajši od 18 let (glejte poglavje
English: Careful dosing as well as regular and close monitoring is necessary in patients with: - epilepsy and organic brain syndrome: Although clinical experience indicates that epileptic seizures are rare during mirtazapine treatment, as with other antidepressants, Remeron should be introduced cautiously in patients who have a history of seizures.
Slovenian: Bolezni in stanja, pri katerih je potreben nadzor Natančno odmerjanje in redno ter skrbno spremljanje je potrebno pri bolnikih z: - epilepsijo in sindromom organske prizadetosti možganov; čeprav klinične izkušnje kažejo, da so epileptični napadi redki med zdravljenjem z mirtazapinom in tudi pri jemanju drugih antidepresivov.
English: Insomnia3, 5
Slovenian: nespečnost3, 5
English: • abnormal sensation in the skin e.g. burning, stinging, tickling or tingling (paraesthesia)
Slovenian: • nenormalni občutki po koži, npr. občutek pečenja, zbadanja, žgečkanja ali mravljincev (parestezije)
English: If you develop seizures or your seizures become more frequent, stop taking Remeron and contact your doctor immediately; -liver disease, including jaundice.
Slovenian: Če se vam pojavijo epileptični napadi oziroma če postanejo ti bolj pogosti, prenehajte jemati zdravilo Remeron in nemudoma pokličite svojega zdravnika; - jetrna bolezen, vključno z zlatenico.
English: Pharmacodynamic interactions - Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy.
Slovenian: Farmakodinamične interakcije - Mirtazapina ne smete uporabljati sočasno z zaviralci MAO ali v času dveh tednov po prekinitvi zdravljenja z zaviralcem MAO.
English: Patients should avoid the performance of potentially dangerous tasks, which require alertness and good concentration, such as driving a motor vehicle or operating machinery, at any time when affected.
Slovenian: Kadarkoli bolnik opazi, da zdravilo vpliva nanj, se mora torej izogibati opravljanju potencialno nevarnem delu, pri katerem je potrebna pozornost in dobra koncentracija, na primer vožnji motornega vozila ali upravljanju s stroji.
English: - Mirtazapine may increase the CNS depressant effect of alcohol.
Slovenian: - Mirtazapin lahko poveča depresivne učinke alkohola na osrednje živčevje.
English: Each time you press the nozzle, the pump dispenses 15 mg of Remeron.
Slovenian: Vsakič ko pritisnete na šobo, bo črpalka odmerila 15 mg zdravila Remeron.
English: • Press the nozzle down as far as it will go, three times.
Slovenian: • Trikrat pritisnite na šobo, do konca.
English: Organon (Ireland) Limited, PO Box 2857,
Slovenian: Organon (Ireland) Limited, PO Box 2857, Drynam Road, Swords, Co. Dublin, Ireland
English: Drink your prescribed dose of Remeron oral solution in a glass or cup mixed with some water.
Slovenian: Predpisani odmerek zdravila Remeron peroralna raztopina popijte iz kozarca ali skodelice, zmešanega z nekaj vode.
English: • thoughts of harming or killing yourself → Contact your doctor or go to a hospital straight away.
Slovenian: • potreba po samopoškodovanju ali samomorilne misli → Nemudoma obvestite svojega zdravnika ali pojdite v bolnišnico.
English: Child-resistant, peel-to-open, rigid perforated unit dose blister, formed from a laminate of aluminum foil and plastic films sealed to a paper-based laminate of aluminum foil coated with a heat seal lacquer.
Slovenian: Za otroke varni trdi perforirani pretisni omoti z enotnimi odmerki, ki se odpirajo z odluščenjem folije in so izdelani iz laminata z aluminijevo in plastično folijo, zavarjeno na laminat iz aluminijeve folije s papirno osnovo, ki je prevlečen s toplotno skrčljivim lakom.