FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Mirtazapine does not significantly inhibit or induce CYP iso-enzymes.
Slovenian: Mirtazapin bistveno ne zavira ali inducira delovanja CYP izo encimov.
English: Even though they have been reported as withdrawal symptoms, it should be realized that these symptoms may be related to the underlying disease.
Slovenian: Četudi so poročali o teh učinkih med odtegnitvenimi simptomi, pa ne smete pozabiti, da so takšni simptomi lahko povezani tudi z bolnikovo osnovno boleznijo.
English: 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).
Slovenian: 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).
English: Each blister contains six tablet pockets, which are separated by perforations.
Slovenian: Vsak pretisni omot vsebuje šest žepkov s po eno tableto, ki so ločeni s perforacijami.
English: 4 N.B. dose reduction generally does not lead to less somnolence/sedation but can jeopardize antidepressant efficacy.
Slovenian: 4Opomba: Zmanjšanje odmerka zdravila običajno ne vodi do zmanjšanja somnolence ali sedacije, lahko pa ogrozi učinkovitost antidepresiva.
English: Mirtazapine displays linear pharmacokinetics within the recommended dose range.
Slovenian: Mirtazapin ima linearno farmakokinetiko v okviru razpona priporočenih odmerkov.
English: Ethanol This medicinal product contains small amounts of ethanol, less than 100 mg per daily dose.
Slovenian: Etanol To zdravilo vsebuje majhne količine etanola, in sicer manj kot 100 mg na dnevni odmerek.
English: • if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is).
Slovenian: • če jemljete ali ste pred kratkim (v obdobju zadnjih dveh tednov) jemali zdravila imenovana zaviralci monoaminooksidaze (MAO)
English: 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.
Slovenian: Občasno so beležili tudi daljše razpolovne dobe, do 65 ur, in pri mladih moških so opažali tudi krajše razpolovne dobe.
English: In order to prevent crushing the orodispersible tablet, do not push against the tablet pocket (Figure A).
Slovenian: Orodisperzibilne tablete ne smete zdrobiti Zdrobitev orodisperzibilne tablete preprečite tako, da ne pritiskate na žepek tablete (slika A).
English: Studies in animals have not shown any teratogenic effects of clinical relevance, however developmental toxicity has been observed (see section 5.3).
Slovenian: Študije pri živalih niso pokazale nikakršnih klinično pomembnih teratogenih učinkov, vendar so opazili posledično toksičnost (glejte poglavje 5.3).
English: 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).
Slovenian: 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).
English: It has practically no anticholinergic activity and, at therapeutic doses, has practically no effect on the cardiovascular system.
Slovenian: Mirtazapin nima praktično nikakršnega antiholinergičnega delovanja in v terapevtskih odmerkih praktično nima učinkov na srce in ožilje.
English: Fig. A.
Slovenian: sl. A.
English: If you stop too early, your depression might come back.
Slovenian: Zdravljenja ne smete ustaviti prezgodaj, ker bi se vam depresija lahko povrnila.
English: Remeron has minor or moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo Remeron ima majhen do zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: 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).
Slovenian: Zdravilo Remeron lahko bolnik jemlje tudi v dveh deljenih odmerkih (en odmerek zjutraj in en odmerek zvečer, pri čemer naj višji odmerek vzame zvečer).
English: Mirtazapine is indicated for episodes of major depression.
Slovenian: Mirtazapin je indiciran za stanje hude depresije.
English: In rare cases these symptoms can be signs of disturbances in blood cell production in the bone marrow.
Slovenian: V redkih primerih so lahko takšni simptomi znak motenj v tvorbi krvnih celic v kostnem mozgu.
English: The frequencies of the adverse reactions from spontaneous reporting are based on the reporting rate of these events in the clinical trials.
Slovenian: Podane pogostnosti neželenih učinkov iz spontanega poročanja temeljijo na pogostnosti njihovega poročanja v kliničnih preskušanjih.
English: Usually you will need to take Remeron until your symptoms of depression have disappeared for 4 to 6 months.
Slovenian: Običajno mora bolnik jemati zdravilo Remeron, dokler ne minejo simptomi depresije za 4 do 6 mesecev.
English: Finally, the referral SPCs were revised in accordance with the European Commission (EC) Guideline on SPC, October 2005.
Slovenian: Pregledani so bili tudi napotitveni povzetki glavnih značilnosti zdravila v skladu s smernicami Evropske Komisije (EK) o povzetkih glavnih značilnosti zdravila, iz oktobra 2005.
English: Extension phases of these trials have been excluded to maintain comparability to placebo treatment.
Slovenian: Faze podaljšanja omenjenih preskušanj niso bile vključene v to metaanalizo, da bi lahko ohranili primerljivost z uporabo placeba.
English: The enhancement of serotonergic neurotransmission is specifically mediated via 5-HT1 receptors, because 5-HT2 and 5-HT3 receptors are blocked by mirtazapine.
Slovenian: Okrepitev serotoninergičnega živčnega prenosa poteka specifično prek delovanja na receptorje 5-HT1, ker so receptorji 5-HT2 in 5-HT3 blokirani pri uporabi mirtazapina.
English: The most likely signs of an overdose of Remeron (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate.
Slovenian: Najverjetnejši znaki prevelikega odmerjanja zdravila Remeron (brez jemanja drugih zdravil ali alkohola) so zaspanost, dezorientacija in pospešen srčni utrip.
English: Present experience concerning overdose with Remeron alone indicates that symptoms are usually mild.
Slovenian: Dosedanje izkušnje s prevelikim odmerjanjem zdravila Remeron kažejo, da so simptomi običajno blagi.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Slovenian: 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.
English: Limited data of the use of mirtazapine in pregnant women do not indicate an increased risk for congenital malformations.
Slovenian: Majhno število podatkov o uporabi mirtazapina pri nosečnicah ne kaže povečanega tveganja za kongenitalne malformacije.
English: This leaflet was last revised/approved in.
Slovenian: Navodilo je bilo zadnjič spremenjeno in odobreno.
English: - 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.
Slovenian: - 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.
English: Do not suddenly stop taking Remeron, even when your depression has lifted.
Slovenian: Zdravljenja ne smete ustaviti prehitro, tudi če se vam je depresija izboljšala.
English: Suicidal ideation6 Suicidal behaviour6
Slovenian: samomorilne misli6
English: 15 mg 1 press 30 mg 2 presses 45 mg 3 presses
Slovenian: Odmerek 15 mg 1 pritisk 30 mg 2 pritiska 45 mg 3 pritiski
English: The applicant/MAH restricted the contra-indication to hypersensitivity only, in accordance with the EC Guideline on SPC, as only absolute contraindications should be mentioned and relative contraindications should move to the warning section 4.3 or section.
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom je kontraindikacije omejil le na preobčutljivost, v skladu z navodili ES o povzetkih glavnih značilnosti zdravil, ki pravijo, da morajo bili navedene le absolutne kontraindikacije, relativne kontraindikacije pa naj bodo navedene v razdelku 4.3 med opozorili ali v drugem razdelku.
English: Importantly, patients with renal impairment and their doctors should be aware of the fact that in subjects with impaired renal function exposure to mirtazapine may be increased and that there is a positive correlation between severity and exposure.
Slovenian: Bolniki z ledvičnimi obolenji in njihovi zdravniki morajo biti pozorni na dejstvo, da je pri bolnikih z ledvičnimi obolenji, izpostavljenost mirtazapinu lahko povečana, ter da obstaja pozitivna korelacija med resnostjo obolenj in izpostavljenostjo.
English: Somnolence1, 4 Sedation1, 4
Slovenian: Bolezni živčevja somnolenca1, 4 sedacija1, 4 glavobol2
English: Cases of overdose should receive appropriate symptomatic and supportive therapy for vital functions.
Slovenian: V primeru prevelikega odmerjanja morate bolniku dati ustrezno simptomatsko zdravljenje in podporno zdravljenje vitalnih funkcij.
English: Patients who are sensitive to phenylalanine are usually aiming for low phenylalanine levels (e.g. through diet), not complete abstinence of this source.
Slovenian: Bolniki, občutljivi na fenilalanin, ponavadi težijo k čim manjšim količinam fenilalanina (to je z ustrezno dieto), ne pa k popolni abstinenci od te snovi.
English: Symptoms of serotonin syndrome may be hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma.
Slovenian: Znaki serotoninskega sindroma so lahko hipertermija, rigidnost, mioklonus, avtonomna nestabilnost z možnimi zelo hitrimi spremembami vitalnih znakov, spremembami psihičnega stanja, ki vključujejo zmedo, razdražljivost in skrajno agitacijo, ki se stopnjuje do delirija in kome.
English: Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatraemia.
Slovenian: Pri bolnikih s povečanim tveganjem, kot so starejši bolniki ali bolniki, ki sočasno jemljejo zdravila, za katera je znano, da povzročajo hiponatriemijo, je potrebna previdnost.
English: • fainting (syncope)
Slovenian: • omedlevica (sinkopa)
English: Press the nozzle down as far as it will go. Use a firm, smooth action - not too slow.
Slovenian: Na šobo pritisnite, dokler gre, trdno in enakomerno in ne prepočasi.
English: It is recommended to discontinue treatment with mirtazapine gradually to avoid withdrawal symptoms (see section 4.4).
Slovenian: Priporočljivo je, da zdravljenje z mirtazapinom prekinete postopoma, s čimer boste preprečili pojav odtegnitvenih simptomov (glejte poglavje 4.4).
English: • shakiness or tremor
Slovenian: • tresenje ali tremor
English: If you are supposed to take your dose twice a day
Slovenian: Če jemljete odmerek zdravila dvakrat na dan:
English: The CHMP was of the opinion that Phenylketonuria, MAO inhibitors, and pathological alterations of blood count are considered absolute contra-indications.
Slovenian: Odbor za zdravila za uporabo v humani medicini je menil, da fenilketonurija, zaviralci monoaminskih oksidaz (MAO) in patološke spremembe krvne slike predstavljajo absolutne kontraindikacije.
English: All randomized placebo-controlled trials in patients (including indications other than major depressive disorder), have been evaluated for adverse reactions of Remeron.
Slovenian: V vseh randomiziranih in s placebom nadzorovanih preskušanjih pri bolnikih (vključno z drugimi indikacijami, ne le za veliko depresijo) so ocenjevali neželene učinke zdravila Remeron.
English: Food intake has no influence on the pharmacokinetics of mirtazapine.
Slovenian: Uživanje hrane ne vpliva na farmakokinetiko mirtazapina.
English: Take out the orodispersible tablet with dry hands and place it on the tongue.
Slovenian: Vzemite ven orodisperzibilno tableto Orodisperzibilno tableto vzemite ven s suhimi rokami in jo položite na jezik.
English: Tear off one tablet pocket
Slovenian: Odtrgajte en žepek
English: If you get a combination of these symptoms, talk to your doctor immediately.
Slovenian: Če se vam pojavi nekaj teh simptomov, se nemudoma posvetujte s svojim zdravnikom.
English: Ask your doctor whether you can breast-feed, while taking Remeron.
Slovenian: Zdravnika vprašajte tudi, ali smete med jemanjem zdravila Remeron dojiti.
English: Major pathways of biotransformation are demethylation and oxidation, followed by conjugation.
Slovenian: Njegova biotransformacija poteka predvsem z demetilacijo in oksidacijo, ki jima sledi konjugacija.
English: Invented Name Strength Pharmaceutical Form Route of administration
Slovenian: INN Izmišljeno ime Jakost Farmacevtska oblika
English: 6 orodispersible tablets 18 orodispersible tablets 30 orodispersible tablets 48 orodispersible tablets 96 orodispersible tablets
Slovenian: 6 orodisperzibilnih tablet 18 orodisperzibilnih tablet 30 orodisperzibilnih tablet 48 orodisperzibilnih tablet 96 orodisperzibilnih tablet
English: As a conclusion to the discussion, the following text was subsequently agreed between the CHMP and the applicant/MAH to include the following: deletion of reference to section 4.3 for serotonin syndrome, deletion of “other” and the addition of “venlafaxine” in the text below.
Slovenian: Razprava se je zaključila s sklepnim dogovorom med CHMP in predlagateljem/imetnikom dovoljenja za promet z zdravilom, o vključitvi naslednjega: izbris reference na razdelek 4.3 za serotoninski sindrom, izbris besede „drugi“ in dodatek „venlafaksin“ v nadaljnje besedilo.
English: • drowsiness or sleepiness
Slovenian: • zaspanost in dremavost
English: In laboratory evaluations in clinical trials transient increases in transaminases and gammaglutamyltransferase have been observed (however associated adverse events have not been reported statistically significantly more frequently with Remeron than with placebo).
Slovenian: Pri laboratorijskih preiskavah v kliničnih preskušanjih so opažali prehodno povečanje vrednosti transaminaz in gama-glutamiltransferaze (vendar s tem povezanih neželenih učinkov niso poročali s statistično značilno večjo pogostnostjo pri zdravilu Remeron kot pri placebu).
English: • epileptic attack (convulsions) → Stop taking Remeron and tell your doctor straight away.
Slovenian: • epileptični napad (konvulzije) → Prenehajte jemati zdravilo Remeron in nemudoma obvestite svojega zdravnika.
English: • yellow colouring of eyes or skin; this may suggest disturbance in liver function (jaundice)
Slovenian: • rumeno obarvanje oči ali kože, ki lahko kaže na motnje delovanja jeter (zlatenica)
English: The metering pump is packed in a sealed plastic bag.
Slovenian: Odmerna črpalka je pakirana v zaprto plastično vrečko.
English: Since it is indicated in the Annex that aspartame, containing a source of phenylalanine may be harmful for people with phenylketonuria (and no comment is included in the Annex that a contraindication should be included in the SPC, such as done for peanut oil), this is not considered to be an absolute contraindication.
Slovenian: Ker je v Dodatku jasno navedeno, da aspartam, ki vsebuje vir fenilalanina, lahko škodi posameznikom z fenilketonurijo (v Dodatku pa ni nobene opombe, da bi v povzetku glavnih značilnosti zdravila to moralo biti navedeno kot kontraindikacija, kot je na primer navedeno za olje arašidov), to pomeni, da ne gre za absolutno kontraindikacijo.
English: This FDA Guidance was superseded in 1998.
Slovenian: Te smernice Urada za živila in zdravila ZDA so bile leta 1998 nadomeščene z drugimi.
English: → Stop taking Remeron and consult your doctor immediately for a blood test.
Slovenian: → Prenehajte jemati zdravilo Remeron in nemudoma obiščite svojega zdravnika, da bo opravil ustrezno krvno preiskavo.
English: United Kingdom Organon Laboratories Ltd, Cambridge Science Park, Milton Road,
Slovenian: Organon Laboratories Ltd, Cambridge Science Park,
English: A single dose of mirtazapine does not result in any acute effect on the pharmacokinetics of lithium at steady state.
Slovenian: En odmerek mirtazapina ne povzroča akutnega učinka na farmakokinetiko litija pri ustaljenem stanju.
English: If psychotic symptoms, such as paranoid thoughts become more frequent or severe, contact your doctor straight away; -manic depression (alternating periods of feeling elated/overactivity and depressed mood).
Slovenian: Če se začnejo psihotični simptomi, na primer paranoidne misli, pojavljati bolj pogosto ali če postanejo bolj izraziti, nemudoma pokličite svojega zdravnika; - manična depresija (izmenjevanje obdobij vznesenosti in prevelike aktivnosti z obdobji depresivnega razpoloženja).
English: Both enantiomers of mirtazapine are presumed to contribute to the antidepressant activity, the S(+) enantiomer by blocking α2 and 5-HT2 receptors and the R(-) enantiomer by blocking 5-HT3 receptors.
Slovenian: Predpostavljajo, da oba enantiomera mirtazapina prispevata k njegovemu antidepresivnemu delovanju, in sicer S(+) enantiomer z blokado receptorjev α2 in 5-HT2, R(-) enantiomer pa z blokado receptorjev 5-HT3.
English: Accordingly hyponatraemia and SIADH are already described under 4.4 Special warnings.
Slovenian: Tako hiponatriemija kot SIADH sta že navedena v razdelku 4.4: Posebna opozorila.
English: The applicant/MAH was therefore asked to provide support for the cut-off at 40 ml/min as the range is normally defined as 30- 50 ml/min (moderate renal impairment).
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom je tako bil naprošen, da zagotovi podporo za presečno vrednost kreatinina 40 ml/min, saj je navadno označen razpon med 30-50 ml/min (pri zmernem ledvičnem obolenju).
English: Remeron oral solution contains small amounts of ethanol (alcohol), less than 100 mg per daily dose.
Slovenian: Remeron peroralna raztopina vsebuje majhne količine etanola (alkohola), in sicer manj kot 100 mg na dnevni odmerek.
English: If you suddenly stop taking Remeron you may feel sick, dizzy, agitated or anxious, and have headaches.
Slovenian: Če boste naglo prenehali z jemanjem zdravila Remeron, boste namreč lahko občutili slabost, omotico, vznemirjenost ali tesnobo in lahko boste imeli glavobole.
English: • inappropriate anti-diuretic hormone secretion
Slovenian: • neustrezno izločanje antidiuretičnega hormona
English: The higher dose should be taken before you go to bed.
Slovenian: Višji odmerek vzemite zvečer pred spanjem.
English: In vitro data from human liver microsomes indicate that cytochrome P450 enzymes CYP2D6 and CYP1A2 are involved in the formation of the 8-hydroxy metabolite of mirtazapine, whereas CYP3A4 is considered to be responsible for the formation of the N-demethyl and N-oxide metabolites.
Slovenian: In vitro podatki za človeške jetrne mikrosome kažejo, da sta pri tvorbi 8-hidroksi presnovka mirtazapina udeležena encima citokroma P450 CYP2D6 in CYP1A2, medtem ko za encim CYP3A4 menijo, da je odgovoren za nastanek N-demetilnih in N-oksidnih presnovkov.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Remeron should be made taking into account the benefit of breastfeeding to the child and the benefit of Remeron therapy to the woman.
Slovenian: Odločitev o tem, ali je bolje prenehati z dojenjem ali ukiniti zdravljenje z zdravilom Remeron, sprejmite po skrbnem razmisleku koristi dojenja za otroka in koristi zdravljenja za mater z zdravilom Remeron.
English: • if you have forgotten to take your morning dose, simply take it together with your evening dose.
Slovenian: • Če ste pozabili vzeti jutranji odmerek zdravila, ga preprosto zaužijte skupaj z večernim odmerkom.
English: - Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in the international normalized ratio (INR) in subjects treated with warfarin.
Slovenian: - Mirtazapin v odmerku 30 mg enkrat na dan je povzročil majhno, a statistično značilno povečanje vrednosti mednarodnega normaliziranega količnika (INR) pri preiskovancih, zdravljenih z varfarinom.
English: - No significant pharmacokinetic interactions are expected between mirtazapine and other psychotropic active substances because most psychotropic active substances are metabolized by multiple cytochrome P450 (CYP) iso-enzymes and one metabolic pathway will compensate for the other in case of inhibition of one or more CYP iso-enzymes.
Slovenian: Med mirtazapinom in drugimi psihotropnimi zdravilnimi učinkovinami se ne pričakuje nobeno pomembnejše medsebojno delovanje, saj večino psihotropnih zdravilnih učinkovin presnavljajo večkratni citokrom P450 (CYP) izo encimi, ena presnovna pot pa v primeru neustreznega delovanja druge le-to nadomesti z enim ali več CYP izo encimi.