natgillin/translations-raw huggingface dataset:
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. 
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.
Some side effects are more likely to occur than others. 
Nekateri neželeni učinki se pojavljajo pogosteje kot drugi.
In reproductive toxicity studies in rats and rabbits no teratogenic effects were observed. 
V študijah reprodukcijske toksičnosti pri podganah in kuncih niso opažali nobenih teratogenih učinkov.
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. 
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.
→ 2 to 4 weeks after you have started taking Remeron, talk to your doctor about how this medicine has affected you. 
→ 2 do 4 tedne po začetku jemanja zdravila Remeron se pogovorite s svojim zdravnikom o tem, kako zdravilo vpliva na vas.
Mirtazapine was not genotoxic in a series of tests for gene mutation and chromosomal and DNA damage. 
Mirtazapin ni bil genotoksičen v vrsti testov na genske mutacije in kromosomske in DNA poškodbe.
As advised in section 4.2, it is recommended to discontinue treatment with mirtazapine gradually. 
Kot svetujemo v poglavju 4.2, je torej priporočljivo, da zdravljenje z mirtazapinom prekinete postopoma.
The use of aspartame as presented in these amounts in Remeron orodispersible tablets is not an absolute contraindication. 
Predstavljena uporaba aspartama v navedenih količinah v zdravilu Remeron orodisperzibilnih tabletah, ni absolutna kontraindikacija.
Tear off one tablet pocket along the dotted lines (Figure 1). 
Odtrgajte en žepek po perforirani črti (slika 1).
The CHMP considered that the proposed wording under bullet point a and b were acceptable. 
Odbor za zdravila za uporabo v humani medicini je menil, da je predlagano besedilo za točki a in b sprejemljivo.
Steady state is reached after 3-4 days, after which there is no further accumulation. 
Stanje dinamičnega ravnovesja je doseženo po 3 do 4 dneh, potem pa več ni nadaljnjega kopičenja zdravila.
Animal studies and limited human data have shown excretion of mirtazapine in breast milk only in very small amounts. 
Študije pri živalih in omejeni podatki za človeka so pokazali, da se mirtazapin izloča v materino mleko le v zelo majhnih količinah.
• if you have previously had thoughts about killing or harming yourself. 
• če ste že kdaj razmišljali o samomoru ali samopoškodovanju,
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF REMERON AND ASSOCIATED NAMES (SEE ANNEX I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA REMERON IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Pharmacotherapeutic group: other antidepressants, ATC code: N06AX11 
Farmakoterapevtska skupina: Drugi antidepresivi, Oznaka ATC: N06AX11
Mirtazapine has an elimination half-life of 20-40 hours and therefore Remeron is suitable for once daily administration. 
Mirtazapin ima razpolovno dobo od 20 do 40 ur, zato je zdravilo Remeron primerno za jemanje enkrat na dan.
If there is no response within a further 2-4 weeks, then treatment should be stopped. 
Če v naslednjih 2 do 4 tednih zdravljenja ni nobenega odziva, z zdravljenjem prekinite.
Pathological alterations of blood count 
Patološke spremembe krvne slike
While rare, these symptoms most commonly appear after 4-6 weeks of treatment. 
Pojavljajo se redko, najpogosteje pa jih opazimo po 4 do 6 tednih zdravljenja.
In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response. 
Pri starostnikih naj poteka povečevanje odmerka pod strogim nadzorom, da boste lahko dosegli zadovoljiv in varen odziv.
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking. 
Poleg tega tudi ni dolgoročnih podatkov o varnosti zdravila za otroke in mladostnike kar zadeva rast, zorenje ter kognitivni in vedenjski razvoj.
- Although Remeron is not addictive, post-marketing experience shows that abrupt termination of treatment after long term administration may sometimes result in withdrawal symptoms. 
- Čeprav Remeron ne povzroča zasvojenosti, pa postmarketinške izkušnje kažejo, da lahko nagla prekinitev zdravljenja po dolgotrajnem jemanju zdravila včasih povzroči pojav odtegnitvenih simptomov.
It will rapidly disintegrate and can be swallowed without water. 
Hitro bo razpadla in jo boste lahko pogoltnili brez vode.
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 
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.
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. 
Dolgoročna varnost zdravila Remeron glede rasti, zorenja ter kognitivnega in vedenjskega razvoja pri tej starostni skupini še ni dokazana.
When to take Remeron → Take Remeron at the same time each day. 
Kdaj jemati zdravilo → Zdravilo Remeron jemljite ob istem času vsak dan.
If treatment with such medicinal product is discontinued, it may be necessary to reduce the mirtazapine dose. 
Če se zdravljenje s takšnimi zdravili preneha, utegne biti potrebno zmanjšanje odmerka mirtazapina.
This procedure is given in symbolic instructions on the top of the screw cap. 
Ta postopek je simbolično prikazan na vrhu navojne zaporke.
- 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, 
- 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,
Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines in the following list. 
Obvestite svojega zdravnika ali farmacevta, če jemljete (ali nameravate jemati) katero od zdravil iz spodnjega seznama.
Sugar spheres (containing sucrose) and aspartame (E951) See leaflet for further information. 
SEZNAM POMOŽNIH SNOVI Sladkorne kroglice (ki vsebujejo saharozo) in aspartam (E951) Za dodatne informacije glejte priloženo navodilo.
The possible side effects of Remeron are listed below and can be divided as: 
Možni neželeni učinki zdravila Remeron so našteti v nadaljevanju in jih lahko razdelimo na naslednje kategorije:
WHAT REMERON IS AND WHAT IT IS USED FOR Remeron is one of a group of medicines called antidepressants. 
KAJ JE ZDRAVILO REMERON IN ZA KAJ GA UPORABLJAMO Remeron sodi v skupino zdravil, ki jih imenujemo antidepresivi.
However, the CHMP did not consider this explanation acceptable and requested that the applicant/MAH should argue why these contraindications are not absolute. 
Za CHMP ta razlaga ni bila sprejemljiva in je od predlagatelja/imetnika dovoljenja za promet z zdravilom zahteval pojasnilo, zakaj navedene kontraindikacije niso absolutne.
• vivid dreams 
• žive sanje
• urge to move 
• potreba po premikanju.
• if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Remeron. 
• če ste alergični na (preobčutljivi za) mirtazapin ali katerokoli sestavino zdravila Remeron.
Inform your doctor if you are using this medicine. 
Obvestite svojega zdravnika, če jemljete to zdravilo.
However, caution should be exercised when used during pregnancy. 
Kljub temu pa je potrebna posebna previdnost pri uporabi v času nosečnosti.
The CHMP considered this explanation to be acceptable and the issue was resolved. 
Za CHMP je bila ta razlaga sprejemljiva in tako je bila ta zadeva razrešena.
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). 
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).
The plastic films contain: PVC (polyvinyl chloride), polyamide and polyester. 
Plastična folija vsebuje PVC (polivinilklorid), poliamid in poliester.
Some people become less resistant to infection because Remeron can cause a temporary shortage of white blood cells (granulocytopenia). 
Nekateri ljudje na primer postanejo manj odporni na okužbe, ker lahko zdravilo Remeron povzroči začasno pomanjkanje belih krvničk (granulocitopenija).
In case of combination it is advised that a doctor monitors your blood carefully. 
V primeru kombiniranja teh dveh zdravil je priporočljivo, da zdravnik natančno spremlja stanje vaše krvi.
(Figure 4). 
(sl 4).
You can take Remeron with or without food. 
Zdravilo Remeron lahko jemljete s hrano ali brez.
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 
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.
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. 
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.
From post marketing experience it appears that serotonin syndrome occurs very rarely in patients treated with Remeron alone (see section 4.8). 
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).
The Annex explicitly mentions those excipients that require to be mentioned as a contraindication (e.g. hypersensitivity to peanut or soya oil). 
Dodatek izrecno navaja pomožne snovi, ki morajo biti navedene kot kontraindikacije (to je preobčutljivost na olje arašidov ali sojino olje).
Mania Agitation2 
manija vznemirjenost2
• medicines to prevent blood clotting such as warfarin. 
• zdravila za preprečevanje strjevanja krvi, na primer varfarin.
The nozzle has two positions - locked and open. 
Šobo obrnite v odprt položaj Šoba ima dva položaja - zaprtega in odprtega.
You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. 
Morda bi bilo koristno, če za težave z depresijo ali anksioznostjo poveste sorodniku ali dobremu prijatelju in ga prosite, da prebere to navodilo.
Further the recommendations by the Pharmacovigilance Working Party with respect to the core SPC for antidepressants were implemented. 
Uporabljena so bila tudi priporočila delovne skupine za farmakovigilanco v zvezi z osnovnim povzetkom glavnih značilnosti zdravila za antidepresive.
Hence it is proposed not to include MAO-inhibitors as absolute contraindication in section 4.3. 
Tako se predlaga, da se zaviralcev monoaminskih oksidaz (MAO) ne vključi v razdelek 4.3 kot absolutno kontraindikacijo.
Remeron can increase the effects of warfarin on the blood. 
Remeron lahko okrepi učinke varfarina na kri.
Remeron oral solution contains 0.3 % v/v ethanol. 
Remeron peroralna raztopina vsebuje 0,3 % v/v etanola.
The histamine H1-antagonistic activity of mirtazapine is associated with its sedative properties. 
Antagonistično delovanje mirtazapina na histaminske receptorje H1 je povezano z njegovimi sedativnimi lastnostmi.
Please also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
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. 
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.
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). 
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).
Usually Remeron will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better. 
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.
The applicant/MAH argued that, according to the Guideline on SPC (October 2005) contraindications “arising from the presence of certain excipients (under reference to the Guideline on excipients in the label and package leaflet of medicinal products for human use)” should be included. 
Predlagatelj/imetnik dovoljenja za promet z zdravilom je zatrjeval, da je v skladu s smernicami za povzetek glavnih značilnosti zdravila (oktober 2005), kontraindikacije „nastale zaradi prisotnosti določenih pomožnih snovi (upoštevajoč referenčne smernice o pomožnih snoveh pri označevanju in navodilih za uporabo zdravil za uporabo v humani medicini)“ potrebno vključiti.
Mirtazapine does not significantly inhibit or induce CYP iso-enzymes. 
Mirtazapin bistveno ne zavira ali inducira delovanja CYP izo encimov.
Even though they have been reported as withdrawal symptoms, it should be realized that these symptoms may be related to the underlying disease. 
Četudi so poročali o teh učinkih med odtegnitvenimi simptomi, pa ne smete pozabiti, da so takšni simptomi lahko povezani tudi z bolnikovo osnovno boleznijo.
In Section 4.2 Posology and method of administration of the SPC, the CHMP considered that the sentence “Treatment should preferably be continued until the patient has been completely symptomfree for 4-6 months” should be replaced by “Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.” (in accordance with the wording of other antidepressants). 
V razdelku 4.2 Odmerjanje in način uporabe v povzetku glavnih značilnosti zdravila, je CHMP predlagal, da se stavek „Zdravljenje naj se nadaljuje dokler je bolnik brez simptomov v obdobju 4 do 6 mesecev“, zamenja s stavkom „Zdravljenje bolnikov z depresijo naj poteka dovolj dolgo, in sicer vsaj šest mesecev, za zagotovitev, da pri bolnikih ni več simptomov“ (v skladu z besedili drugih antidepresivov).
Each blister contains six tablet pockets, which are separated by perforations. 
Vsak pretisni omot vsebuje šest žepkov s po eno tableto, ki so ločeni s perforacijami.
4 N.B. dose reduction generally does not lead to less somnolence/sedation but can jeopardize antidepressant efficacy. 
4Opomba: Zmanjšanje odmerka zdravila običajno ne vodi do zmanjšanja somnolence ali sedacije, lahko pa ogrozi učinkovitost antidepresiva.
Mirtazapine displays linear pharmacokinetics within the recommended dose range. 
Mirtazapin ima linearno farmakokinetiko v okviru razpona priporočenih odmerkov.
Ethanol This medicinal product contains small amounts of ethanol, less than 100 mg per daily dose. 
Etanol To zdravilo vsebuje majhne količine etanola, in sicer manj kot 100 mg na dnevni odmerek.
• if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is). 
• če jemljete ali ste pred kratkim (v obdobju zadnjih dveh tednov) jemali zdravila imenovana zaviralci monoaminooksidaze (MAO)
The mean half-life of elimination is 20-40 hours; longer half-lives, up to 65 hours, have occasionally been recorded and shorter half-lives have been seen in young men. 
Občasno so beležili tudi daljše razpolovne dobe, do 65 ur, in pri mladih moških so opažali tudi krajše razpolovne dobe.
In order to prevent crushing the orodispersible tablet, do not push against the tablet pocket (Figure A). 
Orodisperzibilne tablete ne smete zdrobiti Zdrobitev orodisperzibilne tablete preprečite tako, da ne pritiskate na žepek tablete (slika A).
Studies in animals have not shown any teratogenic effects of clinical relevance, however developmental toxicity has been observed (see section 5.3). 
Študije pri živalih niso pokazale nikakršnih klinično pomembnih teratogenih učinkov, vendar so opazili posledično toksičnost (glejte poglavje 5.3).
In rare cases Remeron can also cause a shortage of red and white blood cells, as well as blood platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia). 
V redkih primerih lahko zdravilo Remeron povzroči tudi pomanjkanje rdečih in belih krvničk ali krvnih ploščic (aplastična anemija), samo pomanjkanje krvnih ploščic (trombocitopenija) ali pa celo povečanje števila belih krvničk (eozinofilija).
It has practically no anticholinergic activity and, at therapeutic doses, has practically no effect on the cardiovascular system. 
Mirtazapin nima praktično nikakršnega antiholinergičnega delovanja in v terapevtskih odmerkih praktično nima učinkov na srce in ožilje.
Fig. A. 
sl. A.
If you stop too early, your depression might come back. 
Zdravljenja ne smete ustaviti prezgodaj, ker bi se vam depresija lahko povrnila.
Remeron has minor or moderate influence on the ability to drive and use machines. 
Zdravilo Remeron ima majhen do zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Remeron may also be given in two divided doses (once in the morning and once at night-time, the higher dose should be taken at night). 
Zdravilo Remeron lahko bolnik jemlje tudi v dveh deljenih odmerkih (en odmerek zjutraj in en odmerek zvečer, pri čemer naj višji odmerek vzame zvečer).
Mirtazapine is indicated for episodes of major depression. 
Mirtazapin je indiciran za stanje hude depresije.
In rare cases these symptoms can be signs of disturbances in blood cell production in the bone marrow. 
V redkih primerih so lahko takšni simptomi znak motenj v tvorbi krvnih celic v kostnem mozgu.
The frequencies of the adverse reactions from spontaneous reporting are based on the reporting rate of these events in the clinical trials. 
Podane pogostnosti neželenih učinkov iz spontanega poročanja temeljijo na pogostnosti njihovega poročanja v kliničnih preskušanjih.
Usually you will need to take Remeron until your symptoms of depression have disappeared for 4 to 6 months. 
Običajno mora bolnik jemati zdravilo Remeron, dokler ne minejo simptomi depresije za 4 do 6 mesecev.
Finally, the referral SPCs were revised in accordance with the European Commission (EC) Guideline on SPC, October 2005. 
Pregledani so bili tudi napotitveni povzetki glavnih značilnosti zdravila v skladu s smernicami Evropske Komisije (EK) o povzetkih glavnih značilnosti zdravila, iz oktobra 2005.
Extension phases of these trials have been excluded to maintain comparability to placebo treatment. 
Faze podaljšanja omenjenih preskušanj niso bile vključene v to metaanalizo, da bi lahko ohranili primerljivost z uporabo placeba.
The enhancement of serotonergic neurotransmission is specifically mediated via 5-HT1 receptors, because 5-HT2 and 5-HT3 receptors are blocked by mirtazapine. 
Okrepitev serotoninergičnega živčnega prenosa poteka specifično prek delovanja na receptorje 5-HT1, ker so receptorji 5-HT2 in 5-HT3 blokirani pri uporabi mirtazapina.
The most likely signs of an overdose of Remeron (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate. 
Najverjetnejši znaki prevelikega odmerjanja zdravila Remeron (brez jemanja drugih zdravil ali alkohola) so zaspanost, dezorientacija in pospešen srčni utrip.
Present experience concerning overdose with Remeron alone indicates that symptoms are usually mild. 
Dosedanje izkušnje s prevelikim odmerjanjem zdravila Remeron kažejo, da so simptomi običajno blagi.
Additionally in Section 4.5 of the SPC, the CHMP considered it sufficient to state that Lithium and mirtazapine showed no pharmacokinetic interactions (last paragraph section 4.5) without further specifications. 
CHMP je poleg tega menil, da v razdelku 4.5 povzetka glavnih značilnosti zdravila zadostuje le navedba, da sočasna uporaba litija in mirtazapina ni pokazala nobenih farmakokinetičnih medsebojnih delovanj (zadnji odstavek razdelka 4.5), brez nadaljnjih opredelitev.
The meta-analysis considered 20 trials, with a planned duration of treatment up to 12 weeks, with 1501 patients (134 person years) receiving doses of mirtazapine up to 60 mg and 850 patients (79 person years) receiving placebo. 
V metaanalizo so vključili 20 preskušanj z načrtovano dolžino zdravljenja do 12 tednov, pri čemer je 1501 bolnikov (134 oseb x let) prejemalo odmerke mirtazapina do 60 mg, 850 bolnikov (79 oseb x let) pa je prejemalo placebo.
To investigate the impact of renal impairment on the pharmacokinetics of mirtazapine, the applicant/MAH made reference to a clinical trial that was designed specifically for that purpose (trial 22503). 
Predlagatelj/imetnik dovoljenja za promet se je pri preučitvi učinkovanja ledvičnih obolenj na farmakokinetiko mirtazapina skliceval na klinično preskušanje, ki je bilo zasnovano posebej s tem namenom (preskušanje 22503).
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. 
Če pa se na podlagi kliničnih potreb kljub temu odločite, da boste takega bolnika zdravili z zdravilom Remeron, ga morate pozorno spremljati, da boste lahko ugotovili morebiten pojav samomorilnih simptomov.
Limited data of the use of mirtazapine in pregnant women do not indicate an increased risk for congenital malformations. 
Majhno število podatkov o uporabi mirtazapina pri nosečnicah ne kaže povečanega tveganja za kongenitalne malformacije.
This leaflet was last revised/approved in. 
Navodilo je bilo zadnjič spremenjeno in odobreno.
- Akathisia/psychomotor restlessness: The use of antidepressants have been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. 
- Akatizija/psihomotorični nemir: Jemanje antidepresivov je povezano z razvojem akatizije, označene s subjektivno neprijetnim ali mučnim nemirom in potrebo po gibanju, pogosto spremljano z nezmožnostjo sedenja ali mirnega stanja.
Do not suddenly stop taking Remeron, even when your depression has lifted. 
Zdravljenja ne smete ustaviti prehitro, tudi če se vam je depresija izboljšala.
Suicidal ideation6 Suicidal behaviour6 
samomorilne misli6
15 mg 1 press 30 mg 2 presses 45 mg 3 presses 
Odmerek 15 mg 1 pritisk 30 mg 2 pritiska 45 mg 3 pritiski