FrancophonIA/ELRC3.0 huggingface dataset:
English: MAO-inhibitors are therefore relatively contra-indicated with Remeron.
Slovenian: Tako obstaja relativna kontraindikacija pri uporabi zaviralcev monoaminskih oksidaz (MAO) in zdravila Remeron.
English: Table 1 shows the categorized incidence of the adverse reactions, which occurred in the clinical trials statistically significantly more frequently during treatment with Remeron than with placebo, added with adverse reactions from spontaneous reporting.
Slovenian: V preglednici 1 je prikazana pojavnost neželenih učinkov, ki so se v kliničnih preskušanjih pojavljali statistično značilno pogosteje med zdravljenjem z zdravilom Remeron kot pri placebu, razdeljena po organskih sistemih.
English: Increase in appetite1
Slovenian: Preiskave povečanje telesne mase1
English: Remeron and associated names (see Annex I) 15 mg/ml oral solution
Slovenian: Remeron in sorodna imena (glejte Dodatek I) 15 mg/ml peroralna raztopina
English: However, there is a possibility of more serious outcomes (including fatalities) at dosages much higher than the therapeutic dose, especially with mixed overdoses.
Slovenian: Poročali so o depresiji osrednjega živčevja z dezorientacijo in daljšo sedacijo, skupaj s tahikardijo in blago hipertenzijo ali hipotenzijo, mogoči pa so tudi resnejši izidi (vključno s smrtjo) pri odmerkih, ki so veliko večji od terapevtskega odmerka, še posebej pri prevelikem odmerjanju več zdravil hkrati.
English: Treatment should be discontinued in any patient who develops seizures, or where there is an increase in seizure frequency - hepatic impairment: Following a single 15 mg oral dose of mirtazapine, the clearance of mirtazapine was approximately 35 % decreased in mild to moderate hepatically impaired patients, compared to subjects with normal hepatic function.
Slovenian: Pri vseh bolnikih, pri katerih se pojavijo epileptični napadi ali se jim poveča pogostnost epileptičnih napadov, pa je treba zdravilo ukiniti; - jetrno okvaro: pri jemanju enkratnega 15 mg peroralnega odmerka mirtazapina je bil pri bolnikih z blago do zmerno jetrno okvaro njihov očistek zmanjšan za približno 35 % v primerjavi s preiskovanci, ki so imeli normalno delovanje jeter, povprečna plazemska koncentracija mirtazapina pa se je povečala za približno 55 %; - ledvično okvaro: pri jemanju enkratnega 15 mg peroralnega odmerka mirtazapina je bil pri bolnikih z zmerno ledvično okvaro (očistek kreatinina < 40 ml/min) in s hudo ledvično okvaro (očistek kreatinina ≤ 10 ml/min) očistek mirtazapina zmanjšan za približno 30 % do 50 % v primerjavi z normalnimi preiskovanci.
English: 45 mg orodispersible tablet:
Slovenian: 45 mg orodisperzibilna tableta:
English: Make sure these abilities are not affected before you drive or operate machinery.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Remeron lahko vpliva na zbranost ali pozornost, zato se morate pred vožnjo ali upravljanjem s stroji prepričati, da vaše sposobnosti niso zmanjšane.
English: With regard to the chance of suicide, in particular at the beginning of treatment, only a limited quantity of Remeron oral solution should be given to the patient.
Slovenian: Glede na nevarnost samomora, še posebej na začetku zdravljenja, smete bolniku vedno predpisovati omejeno količino peroralne raztopine zdravila Remeron naenkrat.
English: • Common:
Slovenian: • Pogosti:
English: 1 In clinical trials these events occurred statistically significantly more frequently during treatment with Remeron than with placebo.
Slovenian: 1 V kliničnih preskušanjih so se ti učinki pojavljali statistično značilno pogosteje med zdravljenjem z zdravilom Remeron kot pri placebu.
English: Hallucinations Psychomotor restlessness (incl.
Slovenian: halucinacije psihomotorični nemir (vključno akatizija, hiperkinezija)
English: In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors.
Slovenian: V nasprotnem primeru naj pretečeta vsaj dva tedna po zdravljenju z mirtazapinom, pred zdravljenjem z zaviralci monoaminskih oksidaz (MAO).
English: The seal attached to the cap will break first; further pressing and turning will unscrew the cap.
Slovenian: Najprej bo počil obroček na zaporki, pri nadaljnjem pritiskanju in obračanju pa jo boste odvili s stekleničke.
English: • Not known:
Slovenian: • Pogostnost ni znana:
English: 15 mg orodispersible tablet:
Slovenian: 15 mg orodisperzibilna tableta:
English: Orthostatic hypotension
Slovenian: Žilne bolezni ortostatska hipotenzija hipotenzija2
English: For Remeron 15 mg film-coated tablets in blisters the following pack sizes are available: 30, 60, 90 and 100 tablets; 14, 28, 56 and 70 tablets; for Remeron 15 mg film-coated tablets in bottles a pack size of 250 tablets is available (not all pack sizes may be marketed).
Slovenian: Zdravilo Remeron 15 mg filmsko obložene tablete je na voljo v pretisnih omotih v naslednjih velikosti pakiranj: 30, 60, 90 in 100 tablet; 14, 28, 56 in 70 tablet; zdravilo Remeron 15 mg filmsko obložene tablete je na voljo v stekleničkah po 250 tablet (na trgu morda ni vseh navedenih pakiranj).
English: Do not use Remeron after the expiry date which is stated on the carton and the bottle.
Slovenian: Unknown document property name. ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in pretisnem omotu.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Slovenian: To zdravilo vsebuje tekoči maltitol in ga ne smejo jemati bolniki z redkimi dednimi motnjami fruktozne intolerance.
English: INFORMATION IN BRAILLE Remeron
Slovenian: PODATKI V BRAILLOVI PISAVI Remeron
English: When the pump is pressed for the first time it will not discharge the correct quantity of oral solution.
Slovenian: Ko na črpalko prvič pritisnete, iz nje ne bo pritekla pravilna količina peroralne raztopine, zato jo morate najprej pripraviti (napolniti cevko).
English: Remeron 45 mg orodispersible tablets contain 45 mg mirtazapine per orodispersible tablet.
Slovenian: Remeron 45 mg orodisperzibilne tablete vsebujejo 45 mg mirtazapina na orodisprzibilno tableto.
English: 30 mg Tablets
Slovenian: 30 mg Orodisperzibilne tablete
English: 15 mg film-coated tablet:
Slovenian: 15 mg filmsko obložena tableta:
English: 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 90 (9x10), 100 (10x10), 200 (20x10) and 500 (50x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
Slovenian: Zdravilo Remeron 30 mg filmsko obložene tableteje na voljo v pretisnih omotih v naslednjih velikosti pakiranj: 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 90 (9x10), 100 (10x10), 200 (20x10) in 500 (50x10) filmsko obloženih tablet; 14 (2x7), 28 (4x7), 56 (8x7), in 70 (10x7) filmsko obloženih tablet.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Slovenian: Zdravilo Remeron vsebuje sladkorne kroglice, ki vsebujejo saharozo in ga ne smejo jemati bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza- izomaltaze.
English: Remeron 15 mg orodispersible tablets are round, white, standard bevelled-edge tablets coded with ‘TZ/1' on one side.
Slovenian: Remeron 15 mg orodisperzibilne tablete so okrogle, bele, običajne tablete s posnetim robom in z oznako ‘TZ/1‘na eni strani.
English: Remeron 30 mg orodispersible tablets contain 30 mg mirtazapine per orodispersible tablet.
Slovenian: Remeron 30 mg orodisperzibilne tablete vsebujejo 30 mg mirtazapina na orodisprzibilno tableto.
English: 15 mg Tablets
Slovenian: 15 mg Orodisperzibilne tablete
English: Mirtazapine REMERON 15 MG 15 mg Film-coated tablets
Slovenian: MirtazapineREMERON 15 mg 15 mg Filmsko obložene tablete
English: 45 mg Tablets
Slovenian: 45 mg Orodisperzibilne tablete
English: 30 mg film-coated tablet:
Slovenian: 30 mg filmsko obložena tableta:
English: Outer carton and label, 15 mg/ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Zunanja škatla in nalepka, 15 mg/ml
English: Important information about some of the ingredients of Remeron Remeron oral solution contains maltitol liquid.
Slovenian: Unknown document property name. Remeron peroralna raztopina vsebuje tekoči maltitol.
English: 45 mg film-coated tablet:
Slovenian: 45 mg filmsko obložena tableta:
English: Caution should be exercised and the dose may have to be decreased when coadministering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, cimetidine or nefazodone.
Slovenian: Potrebna je previdnost in morda znižanje odmerka mirtazapina pri sočasni uporabi mirtazapina z močnimi zaviralci encima CYP3A4, zaviralci HIV proteaze, azolskimi antimikotiki,eritromicinom, cimetidinom ali nefazodonom.
English: Remeron 30 mg orodispersible tablets are round, white, standard bevelled-edge tablets coded with ‘TZ/2' on one side.
Slovenian: Remeron 30 mg orodisperzibilne tablete so okrogle, bele, običajne tablete s posnetim robom in z oznako ‘TZ/2‘na eni strani.
English: Remeron 30 mg film-coated tablets contain 30 mg mirtazapine per film-coated tablet.
Slovenian: Remeron 30 mg filmsko obložene tablete vsebujejo 30 mg mirtazapina na filmsko obloženo tableto.
English: Each Remeron 30 mg orodispersible tablet contains 30 mg of mirtazapine.
Slovenian: Ena Remeron 30 mg orodisperzibilna tableta vsebuje 30 mg mirtazapina.
English: Remeron 45 mg orodispersible tablets are round, white, standard bevelled-edge tablets coded with ‘TZ/4' on one side.
Slovenian: Remeron 45 mg orodisperzibilne tablete so okrogle, bele, običajne tablete s posnetim robom in z oznako ‘TZ/4‘na eni strani.
English: For Remeron 30 mg film-coated tablets in blisters the following pack sizes are available: 10, 20, 30, 50, 60, 90, 100, 200 and 500 tablets; 14, 28, 56 and 70 tablets; for Remeron 30 mg film-coated tablets in bottles a pack size of 250 tablets is available (not all pack sizes may be marketed).
Slovenian: Zdravilo Remeron 30 mg filmsko obložene tablete je na voljo v pretisnih omotih v naslednjih velikosti pakiranj: 10, 20, 30, 50, 60, 90, 100, 200 in 500 tablet tablet; 14, 28, 56 in 70 tablet; zdravilo Remeron je na voljo v stekleničkah po 250 tablet (na trgu morda ni vseh navedenih pakiranj.)
English: Caution should be exercised and the dose may have to be decreased when co-administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, cimetidine or nefazodone.
Slovenian: Potrebna je previdnost in morda znižanje odmerka mirtazapina pri sočasni uporabi mirtazapina z močnimi zaviralci encima CYP3A4, zaviralci HIV proteaze, azolskimi antimikotiki, eritromicinom, cimetidinom ali nefazodonom.
English: Remeron 45 mg film-coated tablets contain 45 mg mirtazapine per film-coated tablet.
Slovenian: Remeron 45 mg filmsko obložene tablete vsebujejo 45 mg mirtazapina na filmsko obloženo tableto
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle, 30 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja škatla, 30 mg
English: Jaundice Treatment should be discontinued if jaundice occurs.
Slovenian: Zlatenica Če se pri bolniku pojavi zlatenica, je treba z zdravljenjem prekiniti.
English: Each Remeron 30 mg film-coated tablet contains 30 mg of mirtazapine.
Slovenian: Ena Remeron 30 mg filmsko obložena tableta vsebuje 30 mg mirtazapina.
English: For Remeron 45 mg film-coated tablets in blisters the following pack sizes are available: 10, 20, 30, 50, 100, 200 and 500 tablets; 14, 28, 56 and 70 tablets; for Remeron 45 mg film-coated tablets in bottles a pack size of 250 tablets is available (not all pack sizes may be marketed).
Slovenian: Zdravilo Remeron 45 mg filmsko obložene tablete je na voljo v pretisnih omotih v naslednjih velikosti pakiranj: 10, 20, 30, 50, 100, 200 in 500 tablet tablet; 14, 28, 56 in 70 tablet; zdravilo Remeron je na voljo v stekleničkah po 250 tablet (na trgu morda ni vseh navedenih pakiranj.)
English: 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 100 (10x10), 200 (20x10) and 500 (50x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
Slovenian: Zdravilo Remeron 45 mg filmsko obložene tableteje na voljo v pretisnih omotih v naslednjih velikosti pakiranj: 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 100 (10x10), 200 (20x10) in 500 (50x10) filmsko obloženih tablet; 14 (2x7), 28 (4x7), 56 (8x7), in 70 (10x7) filmsko obloženih tablet.
English: However your doctor may suggest you to split your dose of Remeron - once in the morning and once at night-time before you go to bed.
Slovenian: Najbolje je, da zdravilo jemljete v enkratnem odmerku zvečer pred spanjem, vendar vam bo zdravnik lahko svetoval tudi, da dnevni odmerek zdravila razdelite in jemljete en odmerek zjutraj in en odmerek zvečer pred spanjem.
English: Oval, biconvex, white and marked with ‘Organon' on one side-and a code on the other side (TZ/7).
Slovenian: Ovalna, obojestransko izbočena bela tableta z razdelilno zarezo, ki ima na eni strani napis 'Organon', na drugi pa oznako (TZ/7).
English: SPC Section 4.2 Posology and Method of Administration
Slovenian: Povzetek glavnih značilnosti zdravila, razdelek 4.2: Odmerjanje in način uporabe
English: 6.1 List of excipients sugar spheres hypromellose povidone K30 magnesium stearate basic butylated methacrylate copolymer aspartame (E951) citric acid, anhydrous crospovidone (type A) mannitol (E421) microcrystalline cellulose natural and artificial orange flavour (No. SN027512) sodium hydrogen carbonate
Slovenian: Sladkorne kroglice hipromeloza povidon K30 magnezijev stearat bazični butilmetakrilat, kopolimer aspartam (E951) citronska kislina, brezvodna krospovidon (tip A)
English: In this study, subjects were divided into 4 categories using the following cut-off values: Group 1 Normal healthy controls with a glomerular filtration rate (GFR) of >80 ml/min/1.73 m2 Group 2 Mild renal insufficiency with a GFR of 40-79 ml/min/1.73 m2
Slovenian: Skupina 1 Normalni, zdravi posamezniki, pri katerih je hitrost nastajanja ultrafiltrata plazme v ledvičnih glomerulih (GFR) >80 ml/min/1,73 m2
English: LIST OF EXCIPIENTS Maltitol liquid
Slovenian: SEZNAM POMOŽNIH SNOVI Tekoči maltitol
English: • diarrhoea
Slovenian: • letargičnost
English: Mirtazapine REMERON 45 mg 45 mg Film-coated tablets
Slovenian: MirtazapineREMERON 45 mg 45 mg Filmsko obložene tablete
English: Caution should be exercised when co-administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin or nefazodone.
Slovenian: Potrebna je previdnost med sočasno uporabo mirtazapina in močnih zaviralcev CYP3A4, zaviralcev proteaz HIV, azolskih antimikotikov, eritromicina ali nefazodona.
English: There are slight pharmacokinetic differences between oral solution and tablets; although these differences are likely to be of no clinical relevance, care should be taken when switching from tablets to oral solution.
Slovenian: Čeprav te verjetno niso klinično pomembne, pa je potrebna previdnost pri prehodu s tablet na peroralno raztopino.
English: Mirtazapine REMERON 30 MG 30 mg Film-coated tablets
Slovenian: MirtazapineREMERON 30 mg 30 mg Filmsko obložene tablete
English: BEFORE YOU TAKE REMERON
Slovenian: PRED UPORABO ZDRAVILA REMERON
English: LIST OF EXCIPIENTS Lactose monohydrate See leaflet for further information.
Slovenian: SEZNAM POMOŽNIH SNOVI Laktoza monohidrat
English: Abnormal dreams Confusion
Slovenian: Psihiatrične motnje nenormalne sanje zmedenost tesnoba2, 5
English: Each Remeron 45 mg film-coated tablet contains 45 mg of mirtazapine.
Slovenian: Ena Remeron 45 mg filmsko obložena tableta vsebuje 45 mg mirtazapina.
English: 15 mg Film-coated tablets
Slovenian: 15 mg Filmsko obložene tablete
English: 3 In clinical trials these events occurred statistically significantly more frequently during treatment with placebo than with Remeron.
Slovenian: 3 V kliničnih preskušanjih so se ti učinki pojavljali statistično značilno pogosteje med jemanjem placeba kot med zdravljenjem z zdravilom Remeron.
English: Each Remeron 15 mg film-coated tablet contains 15 mg of mirtazapine.
Slovenian: Ena Remeron 15 mg filmsko obložena tableta vsebuje 15 mg mirtazapina.
English: Each Remeron 45 mg orodispersible tablet contains 45 mg of mirtazapine.
Slovenian: Ena Remeron 45 mg orodisperzibilna tableta vsebuje 45 mg mirtazapina.
English: If you stop taking Remeron, do not take MAO inhibitors during the next two weeks either.
Slovenian: Zdravila Remeron tudi ne smete jemati v času dveh tednov po prekinitvi jemanja zaviralcev MAO, ko pa prenehate z jemanjem zdravila Remeron, ne boste smeli jemati zaviralcev MAO še naslednja dva tedna.
English: Each Remeron 15 mg orodispersible tablet contains 15 mg of mirtazapine.
Slovenian: Ena Remeron 15 mg orodisperzibilna tableta vsebuje 15 mg mirtazapina.
English: 45 mg Film-coated tablets
Slovenian: 45 mg Filmsko obložene tablete
English: • If you have forgotten to take your dose of Remeron, do not take the missed dose.
Slovenian: • Če ste pozabili vzeti odmerek zdravila Remeron, ne smete zaužiti izpuščenega odmerka, ampak ga raje preskočite in vzemite naslednji odmerek ob običajnem času.
English: It might be needed to lower the dose of Remeron, or when these medicines are stopped, to increase the dose of Remeron again.
Slovenian: Obvestite svojega zdravnika, če jemljete ta zdravila, da vam bo po potrebi zmanjšal odmerek zdravila Remeron, pa tudi ko jih boste prenehali uporabljati, da vam bo spet povečal odmerek zdravila Remeron.
English: Oval, biconvex, yellow, scored and marked with ‘Organon' on one side-and a code on the other side (TZ/3).
Slovenian: Ovalna, obojestransko izbočena rumena tableta z razdelilno zarezo, ki ima na eni strani napis 'Organon', na drugi pa oznako (TZ/3).
English: Mirtazapine Zispin® oral solution15 mg/ml
Slovenian: Mirtazapine Zispin® oral solution
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle, 15 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja škatla, 15 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle, 45 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja škatla, 45 mg
English: Remeron 15 mg film-coated tablets are oval, biconvex, yellow, scored and coded with 'Organon' on one side and with ‘TZ/3' on the other side.
Slovenian: Zdravilo Remeron 15 mg filmsko obložene tablete so ovalne, obojestransko izbočene, rumene tablete z razdelilno zarezo, ki imajo na eni strani oznako 'Organon', na drugi pa oznako 'TZ/3'.
English: Mirtazapine Remeron 15 mg/ml 15 mg/ml
Slovenian: MirtazapineRemeron 15 mg/ml15 mg/ml Peroralna raztopina
English: Remeron 45 mg film-coated tablets are oval, biconvex, white and coded with ‘Organon' on one side and with ‘TZ/7' on the other side.
Slovenian: Zdravilo Remeron 45 mg filmsko obložene tablete so ovalne, obojestransko izbočene bele tablete z razdelilno zarezo, ki imajo na eni strani napis 'Organon', na drugi pa oznako (TZ/7).
English: Remeron 15 mg/ml oral solution contains 15 mg mirtazapine per ml solution.
Slovenian: Remeron 15 mg/ml peroralna raztopina vsebuje 15 mg mirtazapina na ml raztopine.
English: 30 mg Film-coated tablets
Slovenian: 30 mg Filmsko obložene tablete
English: Round, white, standard bevelled-edge, coded with ‘TZ/1' on one side.
Slovenian: Okrogla, bela, običajna tableta s posnetim robom in z oznako ‘TZ/1‘na eni strani.
English: Hypotension2
Slovenian: hiponatriemija
English: 30 (3x10), 60 (6x10), 90 (9x10) and 100 (10x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
Slovenian: Zdravilo Remeron 15 mg filmsko obložene tableteje na voljo v pretisnih omotih v naslednjih velikosti pakiranj: 30 (3x10), 60 (6x10), 90 (9x10), 100 (10x10), filmsko obloženih tablet; 14 (2x7), 28 (4x7), 56 (8x7), in 70 (10x7) filmsko obloženih tablet.
English: SPC 4.8 Undesirable Effects
Slovenian: Povzetek glavnih značilnosti zdravila, razdelek 4.8: Neželeni učinki
English: It might be needed to lower the dose of Remeron, or when use of nefazodone is stopped, to increase the dose of Remeron again.
Slovenian: Če jemljete nefazodon, obvestite svojega zdravnika o tem, da vam bo po potrebi zmanjšal odmerek zdravila Remeron, pa tudi ko ga boste prenehali uporabljati, da vam bo lahko spet povečal odmerek zdravila Remeron.
English: The bottle containing the oral solution is closed with a child-resistant screw cap and a seal which is broken when the cap is unscrewed.
Slovenian: Steklenička s peroralno raztopino je zaprta z za otroke varno navojno zaporko z obročkom, ki poči pri odvijanju.
English: Box
Slovenian: Serija
English: Remeron 30 mg film-coated tablets are oval, biconvex, red-brown, scored and coded with ‘Organon' on one side and with ‘TZ/5' on the other side.
Slovenian: Zdravilo Remeron 30 mg filmsko obložene tablete so ovalne, obojestransko izbočene rdeče-rjave tablete z razdelilno zarezo, ki imajo na eni strani napis 'Organon', na drugi pa oznako (TZ/5).
English: • if you have forgotten to take both doses, do not attempt to make up for the missed doses.
Slovenian: • Če ste pozabili vzeti oba odmerka, ne skušajte nadomestiti izpuščenih odmerkov, ampak raje oba preskočite in naslednji dan nadaljujte z jemanjem običajnih jutranjih in večernih odmerkov.
English: Phenylketonuria
Slovenian: Peroralna raztopina
English: Activated charcoal or gastric lavage should also be considered.
Slovenian: Presodite, ali je smiselna uporaba aktivnega oglja in izpiranje želodca.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Label on bundle pack, 45 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI Nalepka na omotu, 45 mg
English: Mirtazapine MirtazapinImi Pharma
Slovenian: Mirtazapine Mirtazapin STADA
English: It might be needed to increase the dose of Remeron, or when these medicines are stopped to lower the dose of Remeron again.
Slovenian: Obvestite svojega zdravnika, če jemljete ta zdravila, da vam bo po potrebi povečal odmerek zdravila Remeron, in ponovno ko jih boste prenehali uporabljati, da vam bo zmanjšal odmerek zdravila Remeron.
English: Therefore, the addition of a cross reference to section 4.3 of the SPC in section 4.5 (after the wording related to the interaction with MAOIs) was recommended, in line with the harmonised SPC for SSRIs and in line with the SPC for venlafaxine - a SNRI.
Slovenian: Tako je v skladu z usklajenim povzetkom glavnih značilnosti zdravila za selektivne zaviralce ponovnega privzema serotonina (SSRIs) in povzetka glavnih značilnosti zdravila za venlafaksin - zaviralec privzema serotonina/noradrenalina, dodano navzkrižno sklicevanje na razdelek 4.3 povzetka glavnih značilnost zdravila v razdelku 4.5 (po sestavi besedila v zvezi z medsebojnim delovanjem z zaviralci monoaminskih oksidaz (MAO)).
English: NAME OF THE MEDICINAL PRODUCT Remeron and associated names (see Annex I) 30 mg orodispersible tablets [See Annex I - To be completed nationally]
Slovenian: Remeron in sorodna imena (glejte Dodatek I) 30 mg orodisperzibilne tablete [Glejte Dodatek I - izpolni država članica]
English: Round, white, standard bevelled-edge, coded with ‘TZ/4' on one side.
Slovenian: Okrogla, bela, običajna tablete s posnetim robom in z oznako ‘TZ/4‘na eni strani.
English: The following amendments to the PIL were recommended, in line with the changes made to the SPC.
Slovenian: V skladu s spremembami povzetka glavnih značilnosti zdravila so bile predlagane naslednje dopolnitve navodila za uporabo:
English: Caution should be advised and a closer clinical monitoring is required when these drugs are combined with mirtazapine.
Slovenian: Pri sočasni uporabi teh zdravil in mirtazapina je potrebna posebna pozornost in pozorno klinično spremljanje.
English: Round, white, standard bevelled-edge, coded with ‘TZ/2‘ on one side.
Slovenian: Okrogla, bela, običajna tablete s posnetim robom in z oznako ‘TZ/2‘na eni strani.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking
Slovenian: Zdravnika tudi obvestite, če se pri bolniku, ki je mlajši od 18 let in jemlje zdravilo