natgillin/translations-raw huggingface dataset:
Selv om disse forskelle sandsynligvis ikke er kliniske relevante bør der udvises forsigtighed, når der skiftes fra tabletter til oral opløsning.
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.
- Produktresuméer, etikettering, indlægsseddel og afsnit 3, som foreslået af indehaverne af markedsføringstilladelsen, er blevet vurderet på grundlag af den indsendte dokumentation og den faglige drøftelse i udvalget anbefaler CHMP en ændring af markedsføringstilladelserne for Remeron og tilknyttede navne (sebilag I).
- the Summaries of Products Characteristic, labelling, package leaflet and Module 3 proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Tabletterne vil hurtigt opløses og kan synkes uden vand.
It will rapidly disintegrate and can be swallowed without water.
Mirtazapine Zispin® Soltab® smeltetabletter
Mirtazapine Zispin® Soltab® orodispersible tablets
Produktresumé, afsnit 4.3 Kontraindikationer
SPC Section 4.3 Contraindications
Opløsningen indtages oralt, opløst i et glas vand.
The solution should be taken orally, in a glass containing some water.
Ca. 85 % af mirtazapin bindes til plasmaproteiner.
Binding of mirtazapine to plasma proteins is approx. 85 %.
Flasken med Remeron oral opløsning er lukket med et forseglet, polypropylen skruelåg med børnesikring.
The supplied bottle with Remeron oral solution is closed with a sealed, polypropylene screw cap which has child-resistant features.
Ud fra følgende betragtninger: - Formålet med indbringelsen af sagen var harmonisering af produktresuméer, etikettering, indlægsseddel og afsnit 3.
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling, package leaflet and Module 3.
Oral anvendelse mirtazapine Remeron
Oral use mirtazapine Remeron
Disse typer medicin kan i kombination med Remeron nedsætte mængden af Remeron i dit blod.
In combination with Remeron these medicines can reduce the amount of Remeron in your blood.
Vigtig information om nogle af de øvrige indholdsstoffer i Remeron Remeron oral opløsning indeholder flydende maltitol.
Important information about some of the ingredients of Remeron Remeron oral solution contains maltitol liquid.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Filmovertrukket tablet
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Fortæl lægen, hvis du bruger en af disse typer medicin.
Inform your doctor if you are using these medicines.
Remeron's udseende og pakningstørrelse
What Remeron looks like and contents of the pack
Tag pumpen ud af plastikposen og sæt den på flasken ved forsigtig at stikke plasticrøret ned i flaskens åbning.
After taking the pump out of the plastic bag it should be fitted onto the bottle by carefully inserting the plastic tube into the bottle opening.
• Tegn på infektioner såsom pludselig, uforklarlig høj feber, ondt i halsen eller sår i munden → Stop behandlingen med Remeron og kontakt straks lægen for at få taget en blodprøve.
• signs of infection such as sudden inexplicable high fever, sore throat and mouth ulcers (agranulocytosis) → Stop taking Remeron and contact your doctor straight away for a blood test.
Kloosterstraat 6, P.O. Box 5340 BH Oss, The Netherlands
Box 20, NL - 5340 BH Oss, The Netherlands
Remeron's virkning og hvad du skal bruge det til Det skal du vide, før du begynder at tage Remeron Sådan skal du tage Remeron Bivirkninger
What Remeron is and what it is used for Before you take Remeron How to take Remeron Possible side effects How to store Remeron Further information
Perifere ødemer1 Træthed
Oedema peripheral1 Fatigue
Remeron indeholder sukkerkugler, der indeholder saccharose.
Remeron contains sugar spheres, containing sucrose.
Der skal udvises forsigtighed, når disse lægemidler ordineres sammen med mirtazapin.
Caution should be exercised when these medicinal products are prescribed together with mirtazapine.
• unormal fornemmelse i huden, som brænden, stikken, kilden og prikken
• abnormal sensation in the skin e.g. burning, stinging, tickling or tingling (paraesthesia)
L-methionin natriumbenzoat (E211) saccharin natrium (E954) citronsyre monohydrat (E330) glycerol (E422) maltitol flydende (E965) mandarin smagsstof No. PHL-132597 (indeholder ethanol) renset vand
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
ATC-kode: N06AX11
Pharmacotherapeutic group: other antidepressants, ATC code: N06AX11
Brug af mirtazapin sammen med monoaminooxidase (MAO) hæmmere (se pkt.
Concomitant use of mirtazapine with monoamine oxidase (MAO) inhibitors (see section 4.5).
Lægen kan dog anbefale, at Remeron tages som to doser - én om morgenen og én om aftenen før sengetid.
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.
180 smeltetabletter
180 orodispersible tablets
Med henvisning til risikoen for selvmord, særligt i starten af behandlingen, bør der kun udleveres en begrænset mængde Remeron filmovertrukne tabletter til patienten.
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.
Med henvisning til risikoen for selvmord, særligt i starten af behandlingen, bør der kun udleveres en begrænset mængde Remeron oral opløsning til patienten.
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.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml Remeron oral opløsning indeholder 15 mg mirtazapin.
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of Remeron oral solution contains 15 mg of mirtazapine.
Når den er låst kan tuden ikke trykkes ned og man kan ikke pumpe opløsningen op.
In the locked position, the nozzle cannot be pressed down and no oral solution can be discharged.
CHMP vurderede desuden, at udskillelsen af mirtazapin kan reduceres hos patienter med moderat til svær nyrebeskadigelse (kreatinin-udskillelse <40 ml/min.).
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).
Derimod skal der gå ca. to uger, før patienter, der behandles med mirtazapin, kan behandles med MAO-inhibitorer (se afsnit 4.3).
In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors (see section 4.3).
Udvikling eller forværring af angst og søvnløshed er blevet rapporteret under behandling med mirtazapin.
Under mirtazapine treatment, development or aggravation of anxiety and insomnia has been reported.
Forsigtighed tilrådes, og der kræves en nærmere klinisk overvågning, når disse lægemidler kombineres med mirtazapin.
Caution should be advised and a closer clinical monitoring is required when these drugs are combined with mirtazapine.
85764 Oberschleißheim Germany
Organon GmbH Mittenheimer Straße 62 85764 Oberschleißheim Germany
Forsigtighed bør udvises og tæt opfølgning er nødvendig når disse aktive stoffer kombineres med mirtazapin.
Caution should be advised and a closer clinical monitoring is required when these active substances are combined with mirtazapine.
• Stil flasken på et fladt underlag.
• Place the bottle on a flat surface.
Remeron og tilhørende navne (se Bilag I) 15 mg/ml oral opløsning
Remeron and associated names (see Annex I) 15 mg/ml oral solution
Remeron 15, 30 og 45 mg filmovertrukne tabletter fås også i HDPE-glas med sikkerhedslåg (LDPE).
Remeron 15, 30 and 45 mg film-coated tablets are also available in HDPE bottles with a tamperevident LDPE cap.
Derimod skal der gå ca. to uger, før patienter, der behandles med mirtazapin, kan behandles med MAO-inhibitorer.
In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors.
Tabel 1 viser den kategoriserede forekomst af bivirkninger, der forekom statistisk signifikant hyppigere i de kliniske forsøg under behandlingen med Remeron sammenlignet med placebo, med tilføjelse af bivirkninger fra spontan rapportering.
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.
Må ikke opbevares over 25 °C
Do not store above 25 °C
Brug ikke Remeron efter den udløbsdato, der står på pakningen og blisterkortet.
Do not use Remeron after the expiry date which is stated on the carton and the blister.
BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDDEL
GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Remeronetabletter indeholder aspartam, en fenylalaninkilde.
Remeron orodispersible tablets contain aspartame, a source of phenylalanine.
Mirtazapins clearance kan være nedsat hos patienter med moderat til svær nyreinsufficiens (kreatininclearance < 40 ml/min).
The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 ml/min).
Gruppe 3 Moderat/udtalt nyreinsufficiens med en glomerulær filtrationshastighed på 10-39 ml/min./1,73 m2
Group 3 Moderate/marked renal insufficiency with a GFR 10-39 ml/min/1.73 m2
→ Stop behandlingen med Remeron og kontakt straks lægen.
→ Stop taking Remeron and tell your doctor straight away.
Selvmord/selvmordstanker eller kliniske forværringer Depression er associeret med en øget risiko for selvmordstanker, selvmutilering og selvmord (selvmordsforsøg).
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suiciderelated events).
For Remeron 15, 30 og 45 mg smeltetabletter er følgende pakningsstørrelser: 6, 18, 30, 48, 90, 96 og 180 smeltetabletter (ikke alle pakningsstørrelser er nødvendigvis markedsført).
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).
Dette forslag blev godkendt af ansøgeren/indehaveren af markedsføringstilladelsen, og problemet blev løst.
This proposal was adopted by the applicant/MAH and the issue was resolved.
Følgende pakningsstørrelser findes for hver styrke: 6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6), 96 (16x6) og 180 (10x18 (3x6)).
The following pack sizes are available for each strength: 6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6) and 96 (16x6) and 180 (10x18 (3x6)) orodispersible tablets.
forekommer hos mindre end 1 ud af 10.000,00 personer
affects less than 1 user in 10,000
Tryk pumpen fast mod flaskens åbning og skru den herefter helt fast.
Press the pump onto the top of the bottle, and turn it clockwise until it clicks tightly into place.
14 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 70 filmovertrukne tabletter
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 70 film-coated tablets
Bivirkninger ved Remeron
Adverse reactions of Remeron
Forberedelse af doseringspumpen
Preparing the metering pump for dosing
15 mg/ml Oral opløsning Oral anvendelse 990 mg/66 ml mirtazapine Remeron
990 mg/66 ml mirtazapine Remeron
Brug ikke Remeron efter den udløbsdato, der står på pakningen og flasken.
Do not use Remeron after the expiry date which is stated on the carton and the bottle.
• Øvrige indholdsstoffer: Sukkerkugler, hypromellose, povidon K30, magnesiumstearat, aminoalkylmethacrylat copolymer E, aspartam (E951), vandfri citronsyre, crospovidon (type A), mannitol (E421), mikrokrystallinsk cellulose, naturlig og kunstig appelsinsmag (No. SN027512), natriumbicarbonat.
• 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.
Hver Remeron 45 mg smeltetablet indeholder 13,95 mg aspartam og 84 mg saccharose.
Each Remeron 45 mg orodispersible tablet contains 13.95 mg aspartame and 84 mg sucrose.
Farmakokinetiske interaktioner - Carbamazepin og phenytoin, som inducerer CYP3A4, medførte, at mirtazapinclearance blev ca. fordoblet, hvilket medførte et fald i den gennemsnitlige mirtazapinkoncentration i plasma på henholdsvis 60 % og 45 %.
Pharmacokinetic interactions - Carbamazepine and phenytoin, CYP3A4 inducers, increased mirtazapine clearance about twofold, resulting in a decrease in average plasma mirtazapine concentration of 60 % and 45 %, respectively.
• Meget sjældne:
• Very rare:
Hver Remeron 15 mg smeltetablet indeholder 4,65 mg aspartam og 28 mg saccharose.
Each Remeron 15 mg orodispersible tablet contains 4.65 mg aspartame and 28 mg sucrose.
Hvert tryk på pumpen giver 15 mg Remeron.
Each time you press the nozzle, the pump dispenses 15 mg of Remeron.
- Når cimetidin (svag inhibitor af CYP1A2, CYP2D6 og CYP3A4) administreres sammen med mirtazapin kan gennemsnitsplasmakoncentrationen af mirtazapin måske stige med mere end 50 %.
- When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with mirtazapine, the mean plasma concentration of mirtazapin may increase more than 50 %.
Stil flasken på et fladt underlag.
Place the bottle on a flat surface.
Brug ikke Remeron efter den udløbsdato, der står på pakningen, blisterkortet eller glasset.
Do not use Remeron after the expiry date which is stated on the carton and the blister or bottle.
Disse typer medicin kan i kombination med Remeron øge mængden af Remeron i dit blod.
In combination with Remeron these medicines can increase the amount of Remeron in your blood.
Vigtig information om nogle af de øvrige indholdsstoffer i Remeron Remeronetabletter indeholder sukkerkugler, der indeholder saccharose.
Important information about some of the ingredients of Remeron Remeron orodispersible tablets contain sugar spheres, containing sucrose.
I henhold til artikel 30, stk. 1, i direktiv 2001/83/EF blev der indbragt en sag med henblik på harmonisering af produktresuméet for Remeron (mirtazapin).
Remeron (mirtazapine) has been referred for the harmonisation of Summary of Product Characteristics, in accordance with Article 30 (1) of Directive 2001/83/EC.
• Almindelige:
• Common:
Efter peroral indtagelse af Remeron absorberes det aktive stof mirtazapin hurtigt og godt (biotilgængelighed ≈ 50 %), og maksimale plasmaniveauer nås efter ca. en time.
After oral administration of Remeron, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50 %), reaching peak plasma levels after approx. one hour.
• Væskeophobning i munden (mundødem)
• swelling in the mouth (mouth oedema)
Povidon K30
Remeron 30
Lægen bør være opmærksom på symptomer som feber, ondt i halsen, stomatitis eller andre tegn på infektion.
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.
• Medicin mod infektioner; medicin mod bakterieinfektioner (såsom erytromycin), medicin mod svampeinfektioner (såsom ketoconazol) og medicin mod HIV/AIDS (såsom HIV proteasehæmmere).
• 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).
forekommer hos mere end 1 ud af 10 personer
affects more than 1 user in 10
- Interaktionsstudier indikerede ingen relevante farmakokinetiske effekter på samtidig behandling med mirtazapin og paroxetin, amitriptylin, risperidon eller litium.
- Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent treatment of mirtazapine with paroxetine, amitriptyline, risperidone or lithium.
Efter peroral indtagelse af Remeron absorberes det aktive stof mirtazapin hurtigt og godt (biotilgængelighed ≈ 50 %), og maksimale plasmaniveauer nås efter ca. to timer.
After oral administration of Remeron, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50 %), reaching peak plasma levels after approx. two hours.
Selvmordstanker og forværring af din depression
Suicide/suicidal thoughts or clinical worsening
Luxembourg Organon Europe B.V.
Luxembourg Organon Europe B.V. Kloosterstraat 6,
Hver Remeron 30 mg smeltetablet indeholder 9,30 mg aspartam og 56 mg saccharose.
Each Remeron 30 mg orodispersible tablet contains 9.30 mg aspartame and 56 mg sucrose.
Figur 4
(Figure 4).
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsortion.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Hver Remeron 30 mg filmovertrukne tablet indeholder 217 mg lactose (som monohydrat).
Each Remeron 30 mg film-coated tablet contains 217 mg lactose (as monohydrate).
Remeron bør ikke anvendes til behandling af børn og unge under 18 år.
Use in children and adolescents under 18 years of age Remeron should not be used in the treatment of children and adolescents under the age of 18 years.
- Interaktionsundersøgelser angiver ikke nogen relevante farmakokinetiske effekter på samtidig behandling med mirtazapin og paroxetin, amitriptylin eller risperidon eller litium.
- Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent treatment of mirtazapine with paroxetine, amitriptyline, or risperidone or lithium.
Med henvisning til risikoen for selvmord, særligt i starten af behandlingen, bør der kun udleveres en begrænset mængde Remeron smeltetabletter til patienten.
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.
2 I kliniske forsøg forekom disse bivirkninger hyppigere under behandlingen med placebo sammenlignet med Remeron, men ikke statistisk signifikant hyppigere.
2 In clinical trials these events occurred more frequently during treatment with placebo than with Remeron, however not statistically significantly more frequently.
Kontakt lægen, når du har fået det bedre.
Once you are feeling better, talk to your doctor.
• Sjældne:
• Rare:
Hver Remeron 15 mg filmovertrukne tablet indeholder 109 mg lactose (som monohydrat).
Each Remeron 15 mg film-coated tablet contains 109 mg lactose (as monohydrate).
Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
Please also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tag den orale opløsning således
Take the oral solution as follows
Mirtazapins clearance kan være nedsat hos patienter med leverinsufficiens.
The clearance of mirtazapine may be decreased in patients with hepatic impairment.
Mirtazapine Mirtazapine 15mg/ml Oral opløsning
Mirtazapine Mirtazapine 15mg/ml Oral Solution
• En kombination af symptomer som uforklarlig feber, sveden, hjertebanken, diarre, (ukontrollerede) muskelsammentrækninger, rysten, overaktive reflekser, rastløshed, humørsvingninger og bevidstløshed.
• a combination of symptoms such as inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness.
• Meget almindelige:
• Very common:
Opbevares i den originale pakning for at beskytte mod lys og fugt
Store in the original package in order to protect from light and moisture
Hvert blisterkort indeholder 6 smeltetabletter.
The blisters contain 6 orodispersible tablets each.
forekommer hos 1 til 10 ud af 100 personer
affects 1 to 10 users in 100
Som ved andre SSRI'er kan samtidig administration med andre serotonerge lægemidlers aktive stoffer (L-tryptophan, triptans, tramadol, linezolid, SSRI'er, venlafaxin, litium og perikumpræparaterHypericum perforatum) desuden føre til en forekomst af serotonin 5-HT-associerede virkninger (serotoninsyndrom: se afsnit 4.3 Kontraindikationer og afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
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).
• Unormal fornemmelse i munden (oral paræstesi)
• abnormal sensations in the mouth (oral paraesthesia)
- Nyreinsufficiens: Efter en oral enkeltdosis på 15 mg mirtazapin til patienter med moderat (kreatinin-clearance < 40 ml/min) og svær (kreatinin-clearance ≤ 10 ml/min) nyreinsufficiens var mirtazapins clearance faldet hhv. ca. 30 % og 50 %, sammenlignet med normale personer.
- renal impairment: Following a single 15 mg oral dose of mirtazapine, in patients with moderate (creatinine clearance <40 ml/min) and severe (creatinine clearance ≤ 10 ml/min) renal impairment the clearance of mirtazapine was about 30 % and 50 % decreased respectively, compared to normal subjects.
- Nyreinsufficiens: Efter en oral enkeltdosis på 15 mg mirtazapin til patienter med moderat (kreatinin-clearance < 40 ml/min) og svær (kreatinin-clearance ≤ 10 ml/min) nyreinsufficiens var mirtazapins clearance faldet hhv. Ca. 30 % og 50 %, sammenlignet med normale personer.
- renal impairment: Following a single 15 mg oral dose of mirtazapine, in patients with moderate (creatinine clearance < 40 ml/min) and severe (creatinine clearance ≤ 10 ml/min) renal impairment the clearance of mirtazapine was about 30 % and 50 % decreased respectively, compared to normal subjects.
- Leverinsufficiens: Efter en oral enkeltdosis på 15 mg mirtazapin var mirtazapins clearance ca. 35 % nedsat hos patienter med mild til moderat leverinsufficiens, sammenlignet med personer med normal leverfunktion.
- 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.
• Øvrige indholdsstoffer: L-methionin, natriumbenzoat (E211), saccharinnatrium (E954), citronsyremonohydrat (E330), glycerol (E422), flydende maltitol (E965), mandarinsmagsstof No. PHL-132597 (indeholder alkohol), renset vand.
• 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.
Remeron indeholder lactose.
This medicinal product contains lactose.
Forslaget blev godkendt af ansøgeren/indehaveren af markedsføringstilladelsen, og spørgsmålet blev således afklaret.
The proposal was adopted by the applicant/MAH and the issue was resolved.
forekommer hos 1 til 10 ud af 1.000,00 personer
affects 1 to 10 users in 1,000
Må ikke opbevares over 30 °C
Do not store above 30 °C
Hver Remeron 45 mg filmovertrukne tablet indeholder 325 mg lactose (som monohydrat).
Each Remeron 45 mg film-coated tablet contains 325 mg lactose (as monohydrate).
Produktresumé, afsnit 4.2 Dosering og indgivelsesmåde
SPC Section 4.2 Posology and Method of Administration
Dosering af oral opløsning
Dosing the oral solution
- Samtidig administration af den stærke CYP3A4-inhibitor ketoconazol øgede maksimumniveauet i plasma og mirtazapins AUC med henholdsvis 40 % og 50 %.
- Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma levels and the AUC of mirtazapine by approximately 40 % and 50 % respectively.