FrancophonIA/ELRC3.0 huggingface dataset:
English: It might be needed to increase the dose of Remeron, or when these medicines are stopped to lower the dose of Remeron again.
Danish: Det kan være nødvendigt at øge dosis af Remeron, og nedsætte dosis igen, når behandlingen med disse typer medicin stoppes.
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.
Danish: Forsigtighed bør udvises og dosis skal måske nedsættes når mirtazapin administeres sammen med potente CYP3A4 hæmmere, HIV protease hæmmere, azolantimykotikum, erythromycin, cimetidin eller nefazodon.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt] DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN [Udfyldes nationalt] 10.
English: Take care when taking Remeron in combination with:
Danish: Du skal være forsigtig med at tage Remeron samtidig med:
English: • swelling (typically in ankles or feet) caused by fluid retention (oedema)
Danish: • væskeophobning (typisk i ankler og fødder)
English: Drink your prescribed dose of Remeron oral solution in a glass or cup mixed with some water.
Danish: Bland den anbefalede dosis Remeron med vand i et glas eller en kop.
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).
Danish: Hvis psykotiske symptomer, som f.eks. paranoide tanker, forekommer hyppigere eller bliver voldsommere skal du straks kontakte lægen.
English: 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Danish: 30 filmovertrukne tabletter 60 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
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.
Danish: Det kan være nødvendigt at nedsætte dosis af Remeron, og øge dosis igen, når behandlingen med nefazodon stoppes.
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.
Danish: Nogle af symptomerne på dette syndrom er: uforklarlig feber, svedeture, øget hjertefrekvens, diarré, (ukontrollerede) muskelsammentrækninger, kulderystelser, overaktive reflekser, rastløshed, humørsvingninger og bevidstløshed.
English: • monoamine oxidase inhibitors (MAO inhibitors).
Danish: • Monoaminoxidase-hæmmere (MAO-hæmmere).
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.
Danish: Forsigtighed bør udvises, og dosen skal muligvis reduceres ved samtidig administration af mirtazapin og stærke CYP3A4-inhibitorer, HIV-proteaseinhibitorer, azol-svampemidler, erytromycin, cimetidin eller nefazodon.
English: Take special care with Remeron
Danish: Vær ekstra forsigtig med at tage Remeron
English: INFORMATION IN BRAILLE Remeron 45
Danish: INFORMATION I BRAILLE-SKRIFT Remeron 45
English: LIST OF EXCIPIENTS Maltitol liquid
Danish: LISTE OVER HJÆLPESTOFFER Flydende maltitol
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
Danish: 10 filmovertrukne tabletter 20 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 60 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter 200 filmovertrukne tabletter 500 filmovertrukne tabletter
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
Danish: 10 filmovertrukne tabletter 20 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 100 filmovertrukne tabletter 200 filmovertrukne tabletter 500 t filmovertrukne abletter
English: INFORMATION IN BRAILLE Remeron 30
Danish: INFORMATION I BRAILLE-SKRIFT Remeron 30
English: Arthralgia Myalgia Back pain1
Danish: Arthralgi Myalgi Rygsmerter1
English: The average plasma concentration of mirtazapine was about 55 % and 115 %increased respectively.
Danish: Den gennemsnitlige mirtazapin plasmakoncentration var steget hhv. ca. 55 % og 115 %.
English: Using the metering pump to dispense the oral solution The nozzle has two positions and can be turned gently - anti-clockwise (unlocked position) and clockwise (locked position).
Danish: Tuden har to indstillingsmuligheder og kan drejes forsigtigt - mod uret (for at åbne pumpen) og med uret (for at låse pumpen).
English: • Rinse away the liquid that comes out.
Danish: • Den orale opløsning som kommer ud af tuden kasseres.
English: Fig. A.
Danish: Figur A
English: 990 mg/66 ml
Danish: 15 mg/ml Oral opløsning Oral anvendelse 990 mg/66 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of oral solution contains 15 mg mirtazapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml oral opoløsning indeholder 15 mg mirtazapin
English: 45 mg Orodispersible tablets Oral use Mirtazapine REMERON 15 mg 15 mg Film-coated tablets
Danish: 45 mg Smeltetabletter Oral anvendelse MirtazapineMirtazapin IP 15 mg Filmovertrukne tabletter
English: affects 1 to 10 users in 10,000
Danish: forekommer hos 1 til 10 ud af 10.000,00 personer
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).
Danish: • antidepressive midler (f.eks. SSRI'er), venlafaxin og L-tryptophan eller triptans (bruges til behandling af migræne), tramadol (smertestillende), linezolid (antibiotikum), litium (bruges til behandling af visse psykiatriske tilstande) og perikumpræparater - Hypericum perforatum (et naturlægemiddel mod depression).
English: 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.
Danish: Hold et glas med vand under tudens åbning og tryk tuden helt ned indtil den stopper med en fast jævn og fortsat bevægelse (ikke alt for langsom).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister, 30 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort, 30 mg
English: In combination with these medicines Remeron can increase the drowsiness caused by these medicines.
Danish: Remeron kan i kombination med disse typer medicin øge den sløvende virkning af disse.
English: If you develop seizures or your seizures become more frequent, stop taking Remeron and contact your doctor immediately; -liver disease, including jaundice.
Danish: Hvis du begynder at få anfald eller dine anfald bliver hyppigere, skal du stoppe behandlingen med Remeron og straks kontakte lægen.
English: If you have been told by your doctor that you have an intolerance for some sugars, contact your doctor before taking this medicinal product.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: It might be needed to lower the dose of Remeron, or when these medicines are stopped, to increase the dose of Remeron again.
Danish: Det kan være nødvendigt at nedsætte dosis af Remeron, og øge dosis igen, når behandlingen med disse typer medicin stoppes.
English: Oval, biconvex, white and marked with ‘Organon' on one side-and a code on the other side (TZ/7).
Danish: Oval, bikonveks, hvid og mærket med 'Organon' på den ene side og med en kode på den anden side (TZ/7).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister, 45 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort, 45 mg
English: INFORMATION IN BRAILLE Remeron 15
Danish: INFORMATION I BRAILLE-SKRIFT Remeron 15
English: INFORMATION IN BRAILLE Remeron
Danish: INFORMATION I BRAILLE-SKRIFT Remeron
English: Caution should be exercised when co-administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin or nefazodone.
Danish: Forsigtighed bør udvises ved samtidig administration af mirtazapin og stærke CYP3A4-inhibitorer, HIV-proteaseinhibitorer, azol-svampemidler, erytromycin og nefazodon.
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).
Danish: - Som ved SSRI'er kan samtidig administration med andre serotonerge aktive stoffer (L-tryptophan, triptans, tramadol, linezolid, SSRI'er, venlafaxin, litium og perikumpræparater - Hypericum perforatum) desuden føre til en forekomst af serotoninassocierede virkninger (serotoninsyndrom: se afsnit 4.4).
English: HOW TO TAKE REMERON
Danish: SÅDAN SKAL DU TAGE REMERON
English: • feeling dizzy or faint when you stand up suddenly (orthostatic hypotension)
Danish: • svimmelhed og besvimelse, når man rejser sig hurtigt op
English: • feeling elated or emotionally ‘high' (mania)
Danish: • følelse af opstemthed (mani)
English: The cap should be pressed downwards while at the same time rotating it anti-clockwise.
Danish: Tryk låget ned samtidig med at det drejes mod uret.
English: The bottle should be placed on a flat level surface, such as a table top.
Danish: Anvendelse af doseringspumpen til normal dosering Placer flasken på et fladt underlag, f.eks. en bordplade.
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.
Danish: Remeron 45 mg filmovertrukne tabletter er ovale, bikonvekse, hvide og mærket med 'Organon' på den ene side og med 'TZ/7' på den anden side.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister, 15 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort, 15 mg
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. John's Wort - Hypericum perforatum preparations (a herbal remedy for depression).
Danish: • Antidepressiva som serotoningenoptagshæmmere (SSRI'er), venlafaxin og L-tryptophan eller triptaner (til behandling af migræne), tramadol (smertestillende), linezolid (mod infektion), lithium (til behandling af nogle psykiatriske tilstande) og perikon-produkter (et naturprodukt mod depression).
English: Mirtazapine Remeron SolTab 45 mg Orodispersible tablets Oral use Mirtazapine Remeron
Danish: MirtazapineRemeron SolTab 45 mg Smeltetabletter Oral anvendelse Mirtazapine Remeron
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).
Danish: • Øvrige indholdsstoffer: Tablet: majsstivelse, hydroxypropylcellulose, magnesiumstearat, kolloid silica, lactosemonohydrat Filmovertræk: hypromellose, macrogol 8000, titandioxid (E171) Remeron 15 mg filmovertrukne tabletter indeholder også gul jernoxid (E172).
English: 30 mg film-coated tablet:
Danish: 30 mg filmovertrukket tablet:
English: Tablet core: maize starch hyprolose magnesium stearate silica, colloidal anhydrous lactose monohydrate
Danish: Hydroxypropylcellulose Magnesiumstearat Kolloid silica Lactosemonohydrat Filmovertræk:
English: The average plasma concentration of mirtazapine was about 55 %increased.
Danish: Den gennemsnitlige mirtazapin plasmakoncentration var steget ca.
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
Danish: Remeron og tilhørende navne (se Bilag I) 15 mg filmovertrukne tabletter Remeron og tilhørende navne (se Bilag I) 30 mg filmovertrukne tabletter Remeron og tilhørende navne (se Bilag I) 45 mg filmovertrukne tabletter
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
Danish: Gruppe 1 Normalt sunde kontrolpersoner med en glomerulær filtrationshastighed på >80 ml/min./1,73 m2
English: • pain in your joints (arthralgia) or muscles (myalgia)
Danish: • smerter i led og muskler
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Remeron.
Danish: Hvis patienter under 18 år indtager Remeron og hvis nogle af de ovennævnte symptomer opstår eller forværres, skal lægen kontaktes.
English: Also take special care with Remeron
Danish: Vær ekstra forsigtig med at tage Remeron,
English: It should be taken preferably as a single night-time dose before going to bed.
Danish: Remeron bør fortrinsvis indtages som en enkeltdosis ved sengetid.
English: 3 In clinical trials these events occurred statistically significantly more frequently during treatment with placebo than with Remeron.
Danish: 3 I kliniske forsøg forekom disse bivirkninger statistisk signifikant hyppigere under behandlingen med placebo sammenlignet med Remeron.
English: 45 mg film-coated tablet:
Danish: 45 mg filmovertrukket tablet:
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.
Danish: Remeron 15 mg filmovertrukne tabletter er ovale, bikonvekse, gule, med delekærv og mærket med 'Organon' på den ene side og med 'TZ/3' på den anden side.
English: Take out the orodispersible tablet
Danish: Tag smeltetabletten ud
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] Medicinal product subject to medical prescription.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING [Udfyldes nationalt]
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).
Danish: Pakningsstørrelser med Remeron 30 mg filmovertrukne tabletter i blisterkort: 10, 20, 30, 50, 60, 90, 100, 200 og 500 tabletter; 14, 28, 56 og 70 tabletter; Remeron 30 mg filmovertrukne tabletter fås i glas med 250 tabletter (ikke alle pakningsstørrelser er nødvendigvis markedsført).
English: 15 mg film-coated tablet:
Danish: 15 mg filmovertrukket tablet:
English: SPC 4.8 Undesirable Effects
Danish: Produktresumé, afsnit 4.8 Bivirkninger
English: This medicinal product contains maltitol liquid.
Danish: Maltitol Remeron indeholder flydende maltitol.
English: Mirtazapine Mirtazapine orodispergeerbare tabletten
Danish: Mirtazapine Mirtazapine orodispr.geerbare tabletten
English: 15 mg Film-coated tablets
Danish: 15 mg Filmovertrukne tabletter
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).
Danish: Pakningsstørrelser med Remeron 45 mg filmovertrukne tabletter i blisterkort: 10, 20, 30, 50, 100, 200 og 500 tabletter; 14, 28, 56 og 70 tabletter; Remeron 45 mg filmovertrukne tabletter fås i glas med 250 tabletter (ikke alle pakningsstørrelser er nødvendigvis markedsført).
English: • if you have forgotten to take your evening dose, do not take it with the next morning dose; just skip it and continue with your normal morning and evening doses.
Danish: • Hvis du har glemt din aftendosis, skal du ikke tage den sammen med din dosis næste morgen,
English: 1 In clinical trials these events occurred statistically significantly more frequently during treatment with Remeron than with placebo.
Danish: 1 I kliniske forsøg forekom disse bivirkninger statistisk signifikant hyppigere under behandlingen med Remeron sammenlignet med placebo.
English: Oval, biconvex, yellow, scored and marked with ‘Organon' on one side-and a code on the other side (TZ/3).
Danish: Oval, bikonveks, gul, med delekærv og mærket med 'Organon' på den ene side og med en kode på den anden side (TZ/3).
English: Box
Danish: Batch
English: 45 mg Film-coated tablets
Danish: 45 mg Filmovertrukne tabletter
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.
Danish: De 30 mg filmovertrukne tabletter kan fremstilles i følgende pakkestørrelser: 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 90 (9x10), 100 (10x10), 200 (20x10) og 500 (50x10); 14 (2x7), 28 (4x7), 56 (8x7), og 70 (10x7).
English: What Remeron contains
Danish: Remeron indeholder:
English: Mirtazapine Zispin SolTab 45mg orodispersible tablet
Danish: Mirtazapine Zispin SolTab 45mg orodispr.sible tablet
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).
Danish: Pakningsstørrelser med Remeron 15 mg filmovertrukne tabletter i blisterkort: 30, 60, 90 og 100 tabletter; 14, 28, 56 og 70 tabletter; Remeron 15 mg filmovertrukne tabletter fås i glas med 250 tabletter (ikke alle pakningsstørrelser er nødvendigvis markedsført).
English: Oral use Mirtazapine Remeron SolTab 30 mg Orodispersible tablets Oral use
Danish: Oral anvendelse MirtazapineRemeron SolTab 30 mg Smeltetabletter Oral anvendelse
English: Mirtazapine REMERON 45 MG 45 mg Film-coated tablets
Danish: MirtazapineREMERON 45 mg 45 mg Filmovertrukne tabletter
English: 30 mg orodispersible tablet:
Danish: 30 mg smeltetablet:
English: 30 mg Film-coated tablets
Danish: 30 mg Filmovertrukne tabletter
English: Fig. 3.
Danish: Figur 3
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.
Danish: Remeron 30 mg filmovertrukne tabletter er ovale, bikonvekse, rødbrun, med delekærv og mærket med 'Organon' på den ene side og med 'TZ/5' på den anden side.
English: Headache2
Danish: Paræstesi2
English: The clearance of mirtazapine may be decreased as a result of renal or hepatic impairment.
Danish: Mirtazapins clearance kan blive nedsat hos patienter med nyre- eller leverinsufficiens.
English: 30 mg Orodispersible tablets Oral use
Danish: 30 mg Smeltetabletter Oral anvendelse
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.
Danish: De 45 mg filmovertrukne tabletter kan fremstilles I følgende pakkestørrelser: 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 100 (10x10), 200 (20x10) og 500 (50x10); 14 (2x7), 28 (4x7), 56 (8x7), og 70 (10x7).
English: Mirtazapine REMERON 15 MG 15 mg Film-coated tablets
Danish: MirtazapineREMERON 15 mg 15 mg Filmovertrukne tabletter
English: Round, white, standard bevelled-edge, coded with ‘TZ/1' on one side.
Danish: Rund og hvid med skrå kant, mærket med en kode 'TZ/1' på den ene side.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 30 mg mirtazapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 filmovertrukket tablet indeholder 30 mg mirtazapin
English: Round, white, standard bevelled-edge, coded with ‘TZ/2‘ on one side.
Danish: Rund og hvid med skrå kant, mærket med en kode 'TZ/2' på den ene side.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 45 mg mirtazapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 filmovertrukket tablet indeholder 45 mg mirtazapin
English: Each Remeron 30 mg film-coated tablet contains 30 mg of mirtazapine.
Danish: Hver Remeron 30 mg filmovertrukket tablet indeholder 30 mg mirtazapin.
English: Round, white, standard bevelled-edge, coded with ‘TZ/4' on one side.
Danish: Rund og hvid med skrå kant, mærket med en kode 'TZ/4' på den ene side.
English: Remeron 30 mg orodispersible tablets are round, white, standard bevelled-edge tablets coded with ‘TZ/2' on one side.
Danish: Remeron 30 mg smeltetabletter er runde, hvide med en skrå kant og mærket med koden TZ/2 på den ene side.
English: Each Remeron 30 mg orodispersible tablet contains 30 mg of mirtazapine.
Danish: Hver Remeron 30 mg smeltetablet indeholder 30 mg mirtazapin.
English: 15 mg Orodispersible tablets Oral use
Danish: 15 mg Smeltetabletter Oral anvendelse
English: PHARMACEUTICAL FORM AND CONTENTS Orodispersible tablet
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Smeltetablet
English: Oval, biconvex, red-brown, scored and marked with ‘Organon' on one side-and a code on the other side (TZ/5).
Danish: Oval, bikonveks, rødbrun, med delekærv og mærket med 'Organon' på den ene side og med en kode på den anden side (TZ/5).
English: NAME OF THE MEDICINAL PRODUCT Remeron and associated names (see Annex I) 15 mg/ml oral solution [See Annex I - To be completed nationally]
Danish: Remeron og tilhørende navne (se Bilag I) 15 mg/ml oral opløsning [Se Bilag I - Udfyldes nationalt]
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Label on bundle pack, 45 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Etiket på sammenpakning, 45 mg
English: Remeron 15 mg/ml oral solution contains 15 mg mirtazapine per ml solution.
Danish: 15 ml Remeron oral opløsning indeholder 15 mg mirtazapin.
English: 45 mg Orodispersible tablets Oral use
Danish: 45 mg Smeltetabletter Oral anvendelse
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Label on bundle pack, 30 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Etiket på sammenpakning, 30 mg
English: Schmelztabletten
Danish: Indlægsseddel
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 [See Annex I - To be completed nationally]
Danish: Remeron og tilhørende navne (se Bilag I) 15 mg smeltetabletter Remeron og tilhørende navne (se Bilag I) 30 mg smeltetabletter Remeron og tilhørende navne (se Bilag I) 45 mg smeltetabletter [Se bilag I - Udfyldes nationalt]
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 15 mg mirtazapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 filmovertrukket tablet indeholder 15 mg mirtazapin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 45 mg mirtazapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver smeltetablet indeholder 45 mg mirtazapin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 30 mg mirtazapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver smeltetablet indeholder 30 mg mirtazapin
English: Elderly
Danish: Helliniko
English: Remeron 45 mg orodispersible tablets are round, white, standard bevelled-edge tablets coded with ‘TZ/4' on one side.
Danish: Remeron 45 mg smeltetabletter er runde, hvide med en skrå kant og mærket med koden TZ/4 på den ene side.
English: Each Remeron 15 mg film-coated tablet contains 15 mg of mirtazapine.
Danish: Hver Remeron 15 mg filmovertrukket tablet indeholder 15 mg mirtazapin.