FrancophonIA/ELRC3.0 huggingface dataset:
English: Tablet coating: hypromellose, Macrogol 8000, titanium dioxide (E171) The tablet core of Remeron 15 mg film-coated tablets also contains yellow iron oxide (E172) The tablet coating of Remeron 30 mg film-coated tablets also contain yellow iron oxide (E172) and red iron oxide (E 172).
Slovenian: Filmska obloga tablete: hipromeloza, makrogol 8000, titanov dioksid (E 171) Jedro tablete Remeron 15 mg filmsko obložene tablete vsebuje tudi rumeni železov oksid (E172).
English: Do not store above 25 °C
Slovenian: Shranjujte pri temperaturi do 25 °C
English: Taking your dose of Remeron The pump is used to measure your dose.
Slovenian: Jemanje odmerka zdravila Remeron Črpalko boste uporabljali za merjenje odmerka.
English: HOW TO TAKE REMERON
Slovenian: KAKO JEMATI ZDRAVILO REMERON
English: The bottle should be placed on a flat level surface, such as a table top.
Slovenian: Uporaba odmerne črpalke pri normalnem odmerjanju Stekleničko postavite na ravno plosko površino, na primer na mizo.
English: For Remeron 15, 30 and 45 mg orodispersible tablets the following pack sizes are available: 6, 18, 30, 48, 90, 96 and 180 orodispersible tablets (not all pack sizes may be marketed).
Slovenian: Zdravilo Remeron 15, 30 in 45 mg orodisperzibilne tablete je na voljo v naslednjih velikosti pakiranj: 6, 18, 30, 48, 90, 96 in 180 orodisperzibilnih tablet (na trgu ni vseh navedenih pakiranj.)
English: Fig. 2.
Slovenian: sl. 2.
English: Additionally, the CHMP considered that the clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 ml/min).
Slovenian: Poleg tega je CHMP menil, da je očistek mirtazapina pri bolnikih z zmernimi ali resnimi ledvičnimi obolenji, morda manjši (vrednost kreatinina <40 ml/min).
English: In combination with Remeron these medicines can increase the amount of Remeron in your blood.
Slovenian: Pri kombiniranju z zdravilom Remeron lahko omenjena zdravila povečajo količino Remerona v krvi.
English: In the locked position, the nozzle cannot be pressed down and no oral solution can be discharged.
Slovenian: V zaprtem položaju šobe ne boste mogli potisniti navzdol in iz nje ne bo priteklo nič peroralne raztopine, odprt položaj pa je normalni položaj za odmerjanje peroralne raztopine.
English: • The other ingredients are sugar spheres, hypromellose, povidone K30, magnesium stearate, basic butylated methacrylate copolymer, aspartame (E951), anhydrous citric acid, crospovidone (type A), mannitol (E421), microcrystalline cellulose, natural and artificial orange flavour (No. SN027512) and sodium hydrogen carbonate.
Slovenian: • Pomožne snovi so sladkorne kroglice, hipromeloza, povidon K30, magnezijev stearat, bazični butilmetakrilat kopolimer, aspartam (E951), citronska kislina, brezvodna, krospovidon (tip A), manitol (E421), mikrokristalna celuloza, naravna in umetna pomarančna aroma (št. SN027512), natrijev hidrogenkarbonat.
English: Inappropriate antidiuretic hormone secretion
Slovenian: Bolezni endokrinega sistema neustrezno izločanje antidiuretičnega hormona
English: L-methionine sodium benzoate (E211) saccharin sodium (E954) citric acid monohydrate (E330) glycerol (E422) maltitol liquid (E965) orange tangerine flavour No. PHL-132597 (contains ethanol) purified water
Slovenian: L-metionin natrijev benzoat (E211) natrijev saharinat (E954) citronska kislina, monohidrat (E330) glicerol (E422) tekoči maltitol (E965) aroma pomaranče in mandarine št. PHL-132597 (vsebuje etanol) prečiščena voda
English: Nightmares2
Slovenian: nočne more2
English: Take care when taking Remeron in combination with:
Slovenian: Bodite previdni pri jemanju zdravila Remeron v kombinaciji z naslednjimi zdravili:
English: • muscle twitching or contractions (myoclonus)
Slovenian: • mišični trzaji ali krči (mioklonus)
English: In the postmarketing period with Remeron very rare cases of agranulocytosis have been reported, mostly reversible, but in some cases fatal.
Slovenian: O reverzibilni agranulocitozi so poročali tudi kot o redkem pojavu v kliničnih študijah z zdravilom Remeron, medtem ko so bili v okviru postmarketinških izkušenj z zdravilom Remeron prijavljeni zelo redki primeri večinoma reverzibilne agranulocitoze, ki pa je bila v nekaterih primerih smrtna.
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 70 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 56 filmsko obloženih tablet 70 filmsko obloženih tablet
English: (30 mg film-coated tablets only)
Slovenian: (samo 30 mg filmsko obložene tablete)
English: SPC Section 4.1 Therapeutic Indications
Slovenian: Povzetek glavnih značilnosti zdravila, razdelek 4.1: Terapevtske indikacije
English: Do not take Remeron while you are pregnant.
Slovenian: V času nosečnosti ne uporabljajte zdravila Remeron.
English: Tablet core: maize starch hyprolose magnesium stearate silica, colloidal anhydrous lactose monohydrate
Slovenian: Jedro tablete: koruzni škrob hiproloza magnezijev stearat silicijev dioksid, koloidni, brezvodni laktoza monohidrat
English: Fig. 4.
Slovenian: sl. 4.
English: Suicide/suicidal thoughts or clinical worsening
Slovenian: Misli na samomor in poslabšanje depresije
English: Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported very rarely with the use of mirtazapine.
Slovenian: Pri jemanju mirtazapina so zelo redko poročali o hiponatriemiji, najverjetneje zaradi neustreznega izločanja antidiuretičnega hormona (ADH).
English: With regard to the chance of suicide, in particular at the beginning of treatment, only a limited number of Remeron film-coated tablets should be given to the patient.
Slovenian: Glede na nevarnost samomora, še posebej na začetku zdravljenja, smete bolniku vedno predpisovati omejeno število filmsko obloženih tablet zdravila Remeron naenkrat.
English: Moreover, the CHMP was of the opinion that the mechanism of interaction with MAOIs with mirtazapine is different from SSRIs.
Slovenian: Poleg tega je menil, da je mehanizem medsebojnega delovanja zaviralcev monoaminskih oksidaz (MAO) z mirtazapinom drugačen od selektivnih zaviralcev ponovnega privzema serotonina (SSRIs).
English: You could be more sensitive to the side-effects of antidepressants.
Slovenian: • če sodite med starejše bolnike, saj bi lahko bili bolj občutljivi za neželene učinke antidepresivov.
English: In combination with Remeron these medicines can reduce the amount of Remeron in your blood.
Slovenian: • Pri kombiniranju z zdravilom Remeron lahko omenjena zdravila zmanjšajo njegovo količino v krvi.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [Glejte Dodatek I - izpolni država članica]
English: Each Remeron 30 mg orodispersible tablet contains 9.30 mg aspartame and 56 mg sucrose.
Slovenian: Ena Remeron 30 mg orodisperzibilna tableta vsebuje 9,30 mg aspartama in 56 mg saharoze.
English: Each Remeron 30 mg film-coated tablet contains 217 mg lactose (as monohydrate).
Slovenian: Ena Remeron 30 mg filmsko obložena tableta vsebuje 217 mg laktoze (v obliki monohidrata).
English: Fig. 1.
Slovenian: sl. 1.
English: The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg. Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment.
Slovenian: Učinkovit dnevni odmerek je običajno med 15 in 45 mg; začetni odmerek pa je 15 ali 30 mg.
English: Remeron tablets 15, 30 and 45 mg Remeron orodispersible tablets 15, 30 and 45 mg Remeron oral solution 15 mg/ml
Slovenian: Remeron tablete 15, 30 in 45 mg Remeron orodisperzibilne tablete 15, 30 in 45 mg Remeron peroralna raztopina 15 mg/ml
English: • rash or skin eruptions (exanthema)
Slovenian: • izpuščaj ali kožne spremembe (eksantem)
English: Each Remeron 15 mg film-coated tablet contains 109 mg lactose (as monohydrate).
Slovenian: Ena Remeron 15 mg filmsko obložena tableta vsebuje 109 mg laktoze (v obliki monohidrata).
English: • The other ingredients are L-methionine, sodium benzoate (E211), saccharin sodium (E954), citric acid monohydrate (E330), glycerol (E422), maltitol liquid (E965), orange tangerine flavour No.: PHL-132597 (contains ethanol) and purified water.
Slovenian: • Pomožne snovi so L-metionin, natrijev benzoat (E211), natrijev saharinat (E954), citronska kislina monohidrat (E330), glicerol (E422), tekoči maltitol (E965), aroma pomaranče in mandarine št. PHL-132597 (vsebuje etanol) in prečiščena voda.
English: Do not take Remeron in combination with:
Slovenian: Ne jemljite zdravila Remeron skupaj z naslednjimi zdravili:
English: Caution should be exercised when prescribing to pregnant women.
Slovenian: Vseeno je potrebna previdnost pri jemanju v času nosečnosti.
English: • hyponatraemia
Slovenian: • hiponatriemija
English: Elevations in serum transaminase activities
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišane aktivnosti serumskih transaminaz
English: - When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with mirtazapine, the mean plasma concentration of mirtazapine may increase more than 50 %.
Slovenian: - Med sočasno uporabo cimetidina (šibkega zaviralca CYP1A2, CYP2D6 in CYP3A4) in mirtazapina se plazemska koncentracija mirtazapina lahko poveča za več kot 50 %.
English: Luxembourg Organon Europe B.V. Kloosterstraat 6,
Slovenian: Luksemburg Organon Europe B.V.
English: Macrogol 8000 titanium dioxide (E171) yellow iron oxide (E172) (15 and 30 mg film-coated tablets only) red iron oxide (E172)
Slovenian: hipromeloza makrogol 8000 titanov dioksid (E 171) rumeni železov oksid (E172)
English: Take special care with Remeron
Slovenian: Bodite posebno pozorni pri uporabi zdravila Remeron
English: With regard to the chance of suicide, in particular at the beginning of treatment, only a limited number of Remeron orodispersible tablets should be given to the patient.
Slovenian: Glede na nevarnost samomora, še posebej na začetku zdravljenja, smete bolniku vedno predpisovati omejeno število orodisperzibilnih tablet zdravila Remeron naenkrat.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja eksantem2
English: Each Remeron 45 mg film-coated tablet contains 325 mg lactose (as monohydrate).
Slovenian: Ena Remeron 45 mg filmsko obložena tableta vsebuje 325 mg laktoze (v obliki monohidrata).
English: Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
Slovenian: Pri bolnikih z depresijo se občasno lahko pojavijo misli na samopoškodovanje ali samomor.
English: The cap should be pressed downwards while at the same time rotating it anti-clockwise.
Slovenian: Zaporko pritisnite navzdol in jo hkrati obračajte nasprotno urinemu kazalcu.
English: The tablets should be taken orally.
Slovenian: Tablete naj bolniki jemljejo peroralno.
English: • medicines for infections: medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole) and medicines for HIV/AIDS (such as HIVprotease inhibitors).
Slovenian: • zdravila za zdravljenje okužb: zdravila za zdravljenje bakterijskih okužb (na primer eritromicin), zdravila za zdravljenje glivičnih okužb (na primer ketokonazol) in zdravila za zdravljenje okužbe s HIV in AIDS-a (na primer zaviralci encima proteaze HIV).
English: PHARMACEUTICAL FORM AND CONTENTS Orodispersible tablet
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Orodisperzibilna tableta 180 orodisperzibilnih tablet
English: Nervous system disorders
Slovenian: Odmerjanje peroralne raztopine
English: The proposal was adopted by the applicant/MAH and the issue was resolved.
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom je predlog odbora sprejel in ta zadeva je bila razrešena.
English: Thereafter, each pump will give the correct dose (1 ml containing 15 mg of the active substance mirtazapine).
Slovenian: Ko opravite ta postopek, bo pri vsakem pritisku prišel ven pravilni odmerek (1 ml peroralne raztopine, ki vsebuje 15 mg zdravilne učinkovine mirtazapina).
English: The supplied bottle with Remeron oral solution is closed with a sealed, polypropylene screw cap which has child-resistant features.
Slovenian: Steklenička zdravila Remeron peroralna raztopina je zaprta s polipropilensko navojno zaporko z obročkom oz. pečatom, ki je varna za otroke.
English: - When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with mirtazapine, the mean plasma concentration of mirtazapin may increase more than 50 %.
Slovenian: - Pri sočasnem dajanju cimetidina (šibkega zaviralca CYP1A2, CYP2D6 in CYP3A4) se lahko povprečna vrednost plazemske koncentracije mirtazapina zviša za več kot 50 %.
English: affects more than 1 user in 10
Slovenian: pri več kot 1 od 10 bolnikov
English: Group 3 Moderate/marked renal insufficiency with a GFR 10-39 ml/min/1.73 m2
Slovenian: Skupina 3 Zmerno/izrazito ledvično obolenje s hitrost nastajanja ultrafiltrata plazme v ledvičnih glomerulih 10-39 ml/min/1.73 m2
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Filmsko obložene tablete 250 filmsko obloženih tablet
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of Remeron oral solution contains 15 mg of mirtazapine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml zdravila Remeron peroralna raztopina vsebuje 15 mg mirtazapina.
English: The physician should be alert for symptoms like fever, sore throat, stomatitis or other signs of infection; when such symptoms occur, treatment should be stopped and blood counts taken.
Slovenian: Zdravnik mora biti pozoren na simptome, kot so zvišana telesna temperatura, vnetje žrela, stomatitis ali drugi znaki okužbe.
English: Take your tablets orally.
Slovenian: Tablete jemljite peroralno.
English: Once you are feeling better, talk to your doctor.
Slovenian: Ko se boste začeli počutiti bolje, se pogovorite s svojim zdravnikom, ki bo ocenil, kdaj lahko prenehate z zdravljenjem.
English: Important information about some of the ingredients of Remeron Remeron tablets contain lactose.
Slovenian: Unknown document property name. Remeron tablete vsebujejo laktozo.
English: Remeron may impair concentration and alertness (particularly in the initial phase of treatment).
Slovenian: Lahko namreč zmanjša zbranost in pozornost bolnika, še posebej na začetku zdravljenja.
English: • a combination of symptoms such as inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness.
Slovenian: • skupek simptomov, kot so nepojasnjena zvišana telesna temperatura, potenje, pospešen srčni utrip, driska, (nenadzorovano) krčenje mišic, drgetanje, prekomerno izzivni refleksi, nemir, spremembe razpoloženja in nezavest.
English: INFORMATION IN BRAILLE Remeron 45
Slovenian: PODATKI V BRAILLOVI PISAVI Remeron 45
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets 200 film-coated tablets 500 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 100 filmsko obloženih tablet 200 filmsko obloženih tablet 500 filmsko obloženih tablet
English: Fig. 3.
Slovenian: sl. 3.
English: Remeron and associated names (see Annex I) 15 mg film-coated tablets Remeron and associated names (see Annex I) 30 mg film-coated tablets Remeron and associated names (see Annex I) 45 mg film-coated tablets
Slovenian: Remeron in sorodna imena (glejte Dodatek I) 15 mg filmsko obložene tablete Remeron in sorodna imena (glejte Dodatek I) 30 mg filmsko obložene tablete Remeron in sorodna imena (glejte Dodatek I) 45 mg filmsko obložene tablete
English: 2 In clinical trials these events occurred more frequently during treatment with placebo than with Remeron, however not statistically significantly more frequently.
Slovenian: 2 V kliničnih preskušanjih so se ti učinki pojavljali pogosteje med jemanjem placeba kot med zdravljenjem z zdravilom Remeron, vendar niso bili statistično značilno pogostejši.
English: • Rare:
Slovenian: • Redki:
English: Box 20, NL - 5340 BH Oss, The Netherlands
Slovenian: Organon Europe B.V., Kloosterstraat 6, 5349AB Oss, The Netherlands
English: Do not use Remeron after the expiry date which is stated on the carton and the blister or bottle.
Slovenian: Unknown document property name. ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici, pretisnem omotu in plastenki.
English: - Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma levels and the AUC of mirtazapine by approximately 40 % and 50 % respectively.
Slovenian: - Sočasna uporaba močnega zaviralca encima CYP3A4 ketokonazola je povečala največje plazemske koncentracije mirtazapina in vrednost AUC mirtazapina za približno 40 % oziroma 50 %.
English: 4N.B.
Slovenian: N.V.
English: INFORMATION IN BRAILLE Remeron 30
Slovenian: PODATKI V BRAILLOVI PISAVI Remeron 30
English: SPC Section 4.3 Contraindications
Slovenian: Povzetek glavnih značilnosti zdravila, razdelek 4.3: Kontraindikacije
English: Remeron 15, 30 and 45 mg film-coated tablets are also available in HDPE bottles with a tamperevident LDPE cap.
Slovenian: Zdravilo Remeron 15, 30 in 45 mg filmsko obložene tablete je na voljo tudi v plastenkah iz HDPE z LDPE pokrovčkom, zaščitenim pred odpiranjem.
English: Group 4 Severe renal insufficiency with a GFR <10 ml/min/1.73 m2
Slovenian: Skupina 4 Resno ledvično obolenje s hitrost nastajanja ultrafiltrata plazme v ledvičnih glomerulih <10 ml/min/1.73 m2
English: In addition, as with other SSRIs, co-administration with other serotonergic drugs active substances (L-tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St. John's WortHypericum perforatum - preparations) may lead to an incidence of serotonin 5-HT associated effects (serotonin syndrome: see Section 4.3 Contraindications and section 4.4 Special Warnings and Special Precautions for Use).
Slovenian: Kot pri drugih selektivnih zaviralcih ponovnega privzema serotonina (SSRIs), med sočasno uporabo z drugimi serotonergičnimi zdravilnimi učinkovinami (L-triptofan, triptani, tramadol, linezolid, selektivni zaviralci ponovnega privzema serotonina, venlafaksin, litij in pripravki šentjanževke - Hypericum perforatum) obstaja tveganje za medsebojno delovanje, ki lahko povzroči nastanek s serotoninom 5HT povezanih učinkov (serotoninski sindrom: glejte razdelek 4.3 Kontraindikacije in razdelek 4.4 Posebna opozorila in previdnostni ukrepi pri uporabi).
English: The orodispersible tablets are packed in a child-resistant perforated unit dose blister.
Slovenian: Zdravilo Remeron je pakirano v za otroke varne perforirane pretisne omote za en odmerek.
English: affects less than 1 user in 10,000
Slovenian: pri manj kot 1 od 10.000 bolnikov
English: • Very common:
Slovenian: • Zelo pogosti:
English: Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy.
Slovenian: Mirtazapina ne smete uporabljati sočasno z zaviralci monoaminskih oksidaz (MAO) ali prej kot po preteku dveh tednov zdravljenja z zaviralci monoaminskih oksidaz (MAO).
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 90 film-coated tablets 100 film-coated tablets 200 film-coated tablets 500 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 90 filmsko obloženih tablet 100 filmsko obloženih tablet 200 filmsko obloženih tablet 500 filmsko obloženih tablet
English: • feeling anxious
Slovenian: • občutek tesnobe
English: It is best to take Remeron as a single dose before you go to bed.
Slovenian: Najbolje je, da ga bolnik jemlje v enkratnem odmerku zvečer pred spanjem.
English: Also, do not take Remeron during the two weeks after you have stopped taking MAO inhibitors.
Slovenian: Zdravila Remeron tudi ne smete jemati v času dveh tednov po prekinitvi jemanja zaviralcev MAO, ko pa prenehate z jemanjem zdravila Remeron,
English: INFORMATION IN BRAILLE Remeron 15
Slovenian: PODATKI V BRAILLOVI PISAVI Remeron 15
English: Switching from tablets to oral solution
Slovenian: Prehod s tablet na peroralno raztopino
English: Remeron and associated names (see Annex I) 15 mg orodispersible tablets Remeron and associated names (see Annex I) 30 mg orodispersible tablets Remeron and associated names (see Annex I) 45 mg orodispersible tablets
Slovenian: Remeron in sorodna imena (glejte Dodatek I) 15 mg orodisperzibilne tablete Remeron in sorodna imena (glejte Dodatek I) 30 mg orodisperzibilne tablete Remeron in sorodna imena (glejte Dodatek I) 45 mg orodisperzibilne tablete
English: • antidepressants such as SSRIs, venlafaxine and L-tryptophan or triptans (used to treat migraine), tramadol (a pain-killer), linezolid (an antibiotic), lithium (used to treat some psychiatric conditions) and St. Johns Wort - Hypericum perforatum preparations (a herbal remedy for depression).
Slovenian: • Antidepresivi kot so selektivni zaviralci ponovnega privzema serotonina (SSRIs), venlafaksin in L-triptofan ali triptani (za zdravljenje migrene), tramadol (protibolečinsko sredstvo), linezolid (antibiotik), litij (za zdravljenje nekaterih psihiatričnih stanj) in pripravki iz šentjanževkeHypericum perforatum (zeliščno zdravilo za depresijo).
English: 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Slovenian: 30 filmsko obloženih tablet 60 filmsko obloženih tablet 90 filmsko obloženih tablet 100 filmsko obloženih tablet
English: Bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia thrombocytopenia) Eosinophilia
Slovenian: Bolezni krvi in limfatičnega sistema depresija kostnega mozga (granulocitopenija, agranulocitoza, aplastična anemija, trombocitopenija) eozinofilija
English: Some of the symptoms of this syndrome are: inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness.
Slovenian: Nekateri simptomi tega sindroma so nepojasnjena zvišana telesna temperatura, potenje, pospešen srčni utrip, driska, (nenadzorovano) krčenje mišic, drgetanje, premočni refleksi, nemir, spremembe razpoloženja in nezavest.
English: Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Slovenian: Uporaba zdravila pri otrocih in mladostnikih, mlajših od 18 let Zdravila Remeron ne smete uporabljati za zdravljenje otrok in mladostnikov, ki so mlajši od 18 let, ker so v kliničnih preskušanjih pri otrocih in mladostnikih, zdravljenih z antidepresivi, pogosteje opažali samomorilno vedenje (poskus samomora in samomorilne misli) ter sovražnost (predvsem agresivnost, nasprotovalno vedenje in jezo) kot pri tistih, ki so prejemali placebo.
English: Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with Remeron.
Slovenian: Med zdravljenjem z zdravilom Remeron so poročali o pojavu depresije kostnega mozga, običajno v obliki granulocitopenije ali agranulocitoze.
English: 30 mg orodispersible tablet:
Slovenian: 30 mg orodisperzibilna tableta:
English: In addition, as with SSRIs, co-administration with other serotonergic active substances (Ltryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St. John's WortHypericum perforatum - preparations) may lead to an incidence of serotonin associated effects (serotonin syndrome: see section 4.4).
Slovenian: Poleg tega in tako kot pri selektivnih zaviralcih ponovnega privzema serotonina (SSRI), lahko sočasno jemanje serotoninergičnih zdravilnih učinkovin (l-triptofan, triptani, tramadol, linezolid, SSRI, venlafaksin, litij in šentjanževka-Hypericum perforatum vodi do do nastanka s serotoninom povezanih učinkov (serotoninski sindrom: glejte poglavje 4.4).