natgillin/translations-raw huggingface dataset:
Behandlingen bør afbrydes hos patienter, der udvikler epileptiske anfald, eller hvor der ses en øgning i anfaldsfrekvensen. – Leverinsufficiens:
Treatment should be discontinued in any patient who develops seizures, or where there is an increase in seizure frequency – hepatic impairment:
35% nedsat hos patienter med mild til moderat leverinsufficiens, sammenlignet med personer med normal leverfunktion.
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.
55%. – Nyreinsufficiens:
The average plasma concentration of mirtazapine was about 55% increased. – renal impairment:
Den gennemsnitlige mirtazapin plasmakoncentration var steget hhv.
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.
55% og 115%.
The average plasma concentration of mirtazapine was about 55% and 115 %increased respectively.
Der blev ikke fundet signifikante forskelle hos patienter med mild nyreinsufficiens (kreatinin - clearance < 80 ml/ min), sammenlignet med kontrolgruppen. – Hjertesygdomme såsom ledningsforstyrrelser, angina pectoris og nyligt myokardieinfarkt, hvor de sædvanlige forsigtighedsregler bør tages og samtidig medicinindtagelse administreres forsigtigt. – Lavt blodtryk. – Diabetes mellitus:
No significant differences were found in patients with mild renal impairment (creatinine clearance < 80 ml/ min) as compared to the control group. – cardiac diseases like conduction disturbances, angina pectoris and recent myocardial infarction, where normal precautions should be taken and concomitant medicines carefully administered. – low blood pressure. – diabetes mellitus:
Hos patienter med diabetes, kan antidepressiva påvirke den glykæmiske ndocri.
In patients with diabetes, antidepressants may alter glycaemic control.
Dosering af insulin og/ eller orale hypoglykæmiske midler må muligvis justeres og tæt monitorering anbefales.
Insulin and/ or oral hypoglycaemic dosage may need to be adjusted and close monitoring is recommended.
Paranoide idéer kan forstærkes. – Når den depressive fase ved bipolar lidelse behandles, kan den ændre sig til manisk fase.
Like with other antidepressants, the following should be taken into account: – Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified. – When the depressive phase of bipolar disorder is being treated, it can transform into the manic phase.
Patienter med mani/ hypomani i anamnesen bør monitoreres tæt.
Patients with a history of mania/ hypomania should be closely monitored.
Behandling med mirtazapin bør ophøre, såfremt en patient går i manisk fase. – Selvom Remeron ikke er afhængighedsskabende, viser postmarketing erfaringerne, at brat ophør af behandlingen efter langtidsadministration kan medføre seponeringssymptomer.
Mirtazapine should be discontinued in any patient entering a manic phase. – Although Remeron is not addictive, post-marketing experience shows that abrupt termination of treatment after long term administration may sometimes result in withdrawal symptoms.
Som angivet i pkt.
As advised in section 4.2, it is recommended to discontinue treatment with mirtazapine gradually.
4. 2, anbefales det at nedtrappe behandling med mirtazapin gradvist. – Der bør udvises forsigtighed hos patienter med miktionsforstyrrelser såsom prostatahypertrofi og hos patienter med akut snævervinklet glaukom og forhøjet intraokulært tryk (også her er der en lille risiko for problemer under behandling med Remeron på grund af den meget svage anticholinerge aktivitet). – Akatisi/ psykomotorisk uro:
21 – Care should be taken in patients with micturition disturbances like prostate hypertrophy and in patients with acute narrow-angle glaucoma and increased intra-ocular pressure (although there is little chance of problems with Remeron because of its very weak anticholinergic activity). – Akathisia/ psychomotor restlessness:
Anvendelse af antidepressiva er blevet forbundet med udvikling af akatisi, karakteriseret ved subjektiv ubehagelig eller generende uro og behov for ofte at bevæge
The use of antidepressants have been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Hyponatriæmi Hyponatriæmi, sandsynligvis forårsaget af uhensigstsmæssig produktion af antidiuretisk hormon (SIADH), har været rapporteret i meget sjældne tilfælde med mirtazapin.
Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported very rarely with the use of mirtazapine.
Der bør udvises forsigtighed ved behandling af patienter, der har denne risiko, f. eks. ældre patienter eller patienter, der samtidig behandles med medicin kendt for at kunne forårsage hyponatiæmi.
Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatraemia.
4. 5).
Serotonin syndrome Interaction with serotonergic active substances: serotonin syndrome may occur when selective serotonin reuptake inhibitors (SSRIs) are used concomitantly with other serotonergic active substances (see section 4.5).
4. 8).
From post marketing experience it appears that serotonin syndrome occurs very rarely in patients treated with Remeron alone (see section 4.8).
Ældre patienter Ældre patienter er ofte mere følsomme, især hvad angår bivirkninger ved brug af antidepressiva.
Elderly patients Elderly patients are often more sensitive, especially with regard to the undesirable effects of antidepressants.
Saccharose Remeron indeholder sukkerkugler, der indeholder saccharose.
Sucrose Remeron contains sugar spheres, containing sucrose.
Bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose/ galactosemalabsorption og sucrase- isomaltasemangel.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Aspartam Remeron indeholder aspartam som stammer fra phenylalanin.
Aspartame Remeron contains aspartame, a source of phenylalanine.
2, 6 mg, 5, 2 mg og 7, 8 mg phenylalanin.
Each tablet with 15 mg, 30 mg and 45 mg mirtazapine corresponds to 2.6 mg, 5.2 mg and 7.8 mg phenylalanine, respectively.
- Mirtazapin bør ikke administreres samtidig med MAO hæmmere eller inden for to uger efter
- Mirtazapine should not be administered concomitantly with MAO inhibitors or within two
ophør med MAO hæmmer behandling.
weeks after discontinuation of MAO inhibitor therapy.
To uger, inden patienter, der er blevet behandlet med mirtazapin, behandles med MAO hæmmere (se pkt.
In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors (see section 4.3).
4. 3) Som med SSRI’ er, kan samtidig administration med andre serotonerge aktive stoffer (L - tryptophan, triptaner, tramadol, linezolid, SSRI’ er venlafaxine, lithium og perikon- produkter) også føre til tilfælde af serotonin- associerede virkninger (serotonergt syndrom: se pkt.
John’ s Wort – Hypericum perforatum – preparations) may lead to an incidence of serotonin associated effects (serotonin syndrome: see section 4.4).
- Mirtazapin kan øge den sederende egenskab ved benzodiazepiner og andre sedativer (især de
- Mirtazapine may increase the sedating properties of benzodiazepines and other sedatives
fleste former for antipsykotika, antihistamin H1 antagonister, opioider).
(notably most antipsychotics, antihistamine H1 antagonists, opioids).
Der bør udvises forsigtighed i de tilfælde, hvor disse medicinske produkter er udskrevet sammen med mirtazapin.
Caution should be exercised when these medicinal products are prescribed together with mirtazapine.
- Mirtazapin kan øge den CNS- deprimerende effekt af alkohol.
- Mirtazapine may increase the CNS depressant effect of alcohol.
undgå alkoholiske drikke, mens de tager mirtazapin.
advised to avoid alcoholic beverages while taking mirtazapine.
- Hos personer i behandling med warfarin forårsagede mirtazapin doseret med 30 mg en gang
- Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in the
daglig en lille, men statistisk signifikant, øgning i international normaliseret ratio (INR).
international normalized ratio (INR) in subjects treated with warfarin.
- Carbamazapin og phenytoin, som inducerer CYP3A4, medførte at mirtazapin clearance blev ca.
- Carbamazepine and phenytoin, CYP3A4 inducers, increased mirtazapine clearance about
Ca.
twofold, resulting in a decrease in average plasma mirtazapine concentration of 60% and 45%, respectively.
- Samtidig indtagelse af den potente CYP3A4 hæmmer ketoconazol øgede det maksimale
- Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma
40% og 50%.
levels and the AUC of mirtazapine by approximately 40% and 50% respectively.
mirtazapin kan gennemsnitsplasmakoncentrationen af mirtazapin måske stige med mere end 50%.
mirtazapine, the mean plasma concentration of mirtazapine may increase more than 50%.
- Interaktionsstudier indikerede ingen relevante farmakokinetiske ndocrin på samtidig
- Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent
behandling med mirtazapin og paroxetin, amitriptylin, risperidon eller litium.
treatment of mirtazapine with paroxetine, amitriptyline, risperidone or lithium.
5. 3).
Studies in animals have not shown any teratogenic effects of clinical relevance, however developmental toxicity has been observed (see section 5.3).
En beslutning om, hvorvidt amningen skal fortsætte eller stoppe eller om behandlingen med Remeron skal fortsætte eller stoppe, bør være baseret på afvejning af fordelene for barnet ved amning og fordelene af Remeron behandlingen for kvinden.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with Remeron should be made taking into account the benefit of breast- feeding to the child and the benefit of Remeron therapy to the woman.
Selve sygdommen.
Depressed patients display a number of symptoms that are associated with the illness itself.
De mest almindelige, rapporterede bivirkninger der forekom hos mere end 5% af de patienter, der blev behandlet med Remeron i randomiserede, placebo- kontrollerede forsøg (se herunder), er somnolens, sedation, mundtørhed, vægtøgning, øget appetit, svimmelhed og træthed.
The most commonly reported adverse reactions, occurring in more than 5% of patients treated with Remeron in randomized placebo-controlled trials (see below) are somnolence, sedation, dry mouth, weight increased, increase in appetite, dizziness and fatigue.
Bivirkninger ved Remeron.
All randomized placebo-controlled trials in patients (including indications other than major depressive disorder), have been evaluated for adverse reactions of Remeron.
Metaanalysen omfattede 20 forsøg, med en planlagt behandlingsvarighed på op til 12 uger, med 1501 patienter (134 person- år), som anvendte mirtazapin med doser op til 60 mg, og 850 patienter (79 person- år), der anvendte placebo.
The meta-analysis considered 20 trials, with a planned duration of treatment up to 12 weeks, with 1501 patients (134 person years) receiving doses of mirtazapine up to 60 mg and 850 patients (79 person years) receiving placebo.
Forlængede faser i disse forsøg er udelukket for at bevare sammenligneligheden med placebo- behandlingen.
Extension phases of these trials have been excluded to maintain comparability to placebo treatment.
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.
23 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.
Hyppigheden af bivirkninger fra spontan rapportering, for hvilke der ikke blev observeret tilfælde i de randomiserede placebo- kontrollerede patientforsøg med mirtazapin, er klassificeret som ‘ ikke kendt ’.
The frequency of adverse reactions from spontaneous reporting for which no cases in the randomized placebo-controlled patient trials were observed with mirtazapine has been classified as ‘ not known’.
26 Tabel 1.
Table 1.
Organklasse Undersøgelser Blod og lymfesystem
System organ class Investigations
Meget almindelig (≥1/ 10) Vægtøgning1
Very common (≥ 1/ 10) Weight increased1
Almindelig (≥1/ 100 til < 1/ 10)
Common (≥ 1/ 100 to < 1/ 10)
Ikke almindelig (≥1/ 1. 000 til < 1/ 100)
Uncommon (≥ 1/ 1,000 to < 1/ 100)
Hyppighed ikke kendt Knoglemarvsde - pression (granulocytopeni, agranulocytose, aplastisk anæmi trombocytopeni) Eosinofili
Bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia thrombocytopenia) Eosinophilia
Somnolens1, 4 Sedation1, 4 Hovedpine2
Somnolence1, 4 Sedation1, 4 Headache2
Døsighed1 Svimmelhed Tremor
Lethargy1 Dizziness Tremor
Paræstesi2 Uro i benene Synkope
Paraesthesia2 Restless legs Syncope
Myoclonus
Myoclonus
Kvalme3 Diarre2 Opkastning2
Nausea3 Diarrhea2 Vomiting2
Mundødem
Mouth oedema
Vaskulære sygdomme Almene symptomer og reaktioner på administrationsste det
Vascular disorders General disorders and administration site conditions
Ortostatisk hypotension Perifere ødemer1 Træthed
Orthostatic hypotension Oedema peripheral1 Fatigue
Hypotension2
Hypotension2
Forøget serumtrans - aminase aktivitet
Elevations in serum transaminase activities
Livagtige drømme Konfusion Angst2, 5 Søvnløshed3, 5
Abnormal dreams Confusion Anxiety2, 5 Insomnia3, 5
Akatasi, hyperkinesi)
Nightmares2 Mania Agitation2 Hallucinations Psychomotor restlessness (incl. akathisia, hyperkinesia)
Det ndocrine system 1
Endocrine disorders 1
I kliniske forsøg forekom disse bivirkninger statistisk signifikant hyppigere under behandlingen med Remeron sammenlignet med placebo.
In clinical trials these events occurred statistically significantly more frequently during treatment with Remeron than with placebo.
4 N. B. dosisreduktion fører generelt ikke til mindre udtalt somnolens/ sedation, men kan nedsætte den antidepressive virkning.
4 N. B. dose reduction generally does not lead to less somnolence/ sedation but can jeopardize antidepressant efficacy.
5 Ved behandling med antidepressiva generelt, kan angst og søvnløshed (der kan være symptomer på depression) udvikle sig eller blive forværret.
24 5 Upon treatment with antidepressants in general, anxiety and insomnia (which may be symptoms of depression) can develop or become aggravated.
4. 4).
6 Cases of suicidal ideation and suicidal behaviours have been reported during mirtazapine therapy or early after treatment discontinuation (see section 4.4).
Laboratorievurderinger i kliniske forsøg har vist kortvarige stigninger i transaminaser og gammaglutamyltransferaser (bivirkningerne er dog ikke set statistisk signifikant hyppigere med Remeron sammenlignet med placebo).
In laboratory evaluations in clinical trials transient increases in transaminases and gamma- glutamyltransferase have been observed (however associated adverse events have not been reported statistically significantly more frequently with Remeron than with placebo).
Der er rapporteret om påvirkning af centralnervesystemet med desorientering og længerevarende sedation samtidig med takykardi og let hyper - eller hypotension.
Depression of the central nervous system with disorientation and prolonged sedation have been reported, together with tachycardia and mild hyper- or hypotension.
ATC- kode:
Pharmacotherapeutic group: other antidepressants, ATC code:
Mirtazapin er en centralt virkende præsynaptisk α2- antagonist, som øger den centrale noradrenerge og serotonerge neurotransmission.
Mirtazapine is a centrally active presynaptic α 2-antagonist, which increases central noradrenergic and serotonergic neurotransmission.
Øgningen af den serotonerge neurotransmission er specifikt medieret via 5- HT1 receptorer, fordi 5- HT2 og 5- HT3 receptorerne bliver blokeret af mirtazapin.
The enhancement of serotonergic neurotransmission is specifically mediated via 5-HT1 receptors, because 5-HT2 and 5-HT3 receptors are blocked by mirtazapine.
Begge mirtazapins enantiomerer menes at medvirke til den antidepressive virkning, S( +) enantiomeren ved at blokere α2 og 5- HT2 receptorerne, og R (-) enantiomeren ved at blokere 5- HT3 receptorerne.
Both enantiomers of mirtazapine are presumed to contribute to the antidepressant activity, the S(+) enantiomer by blocking α 2 and 5-HT2 receptors and the R(-) enantiomer by blocking 5-HT3 receptors.
Mirtazapins histamin H1- antagonistiske aktivitet er forbundet med de sederende egenskaber.
The histamine H1-antagonistic activity of mirtazapine is associated with its sedative properties.
Efter peroral indtagelse af Remeron absorberes det aktive stof mirtazapin hurtigt og godt (biotilgængelighed ≈ 50%), og maksimale plasmaniveauer nås efter ca.
After oral administration of Remeron, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50%), reaching peak plasma levels after approx. two hours.
Ca.
Binding of mirtazapine to plasma proteins is approx.
85% af mirtazapin bindes til plasmaproteiner.
85%.
Mirtazapin elimineres med en gennemsnitlig halveringstid på 20- 40 timer; der er lejlighedsvis konstateret længere halveringstider på op til 65 timer, og kortere halveringstider er set hos unge mænd.
The mean half-life of elimination is 20-40 hours; longer half-lives, up to 65 hours, have occasionally been recorded and shorter half-lives have been seen in young men.
Steady- state nås efter 3- 4 dage, hvorefter der ikke sker yderligere akkumulation.
Steady state is reached after 3-4 days, after which there is no further accumulation.
In vitro data fra humane levermikrosomer indikerer at cytokrom P450 enzymerne CYP2D6 og CYP1A2 er involveret i dannelsen af 8- hydroxy metabolitten af mirtazapin, og at CYP3A4 er ansvarlig for dannelsen af N- demethyl og N- oxid metabolitterne.
In vitro data from human liver microsomes indicate that cytochrome P450 enzymes CYP2D6 and CYP1A2 are involved in the formation of the 8-hydroxy metabolite of mirtazapine, whereas CYP3A4 is considered to be responsible for the formation of the N-demethyl and N-oxide metabolites.
Mirtazapins clearance kan blive nedsat hos patienter med nyre - eller leverinsufficiens.
The clearance of mirtazapine may be decreased as a result of renal or hepatic impairment.
5. 3 Prækliniske sikkerhedsdata
25 5.3 Preclinical safety data
Ved dobbelt systemisk ekponering sammelignet med maksimum human terapeutisk ekponering var der en stigning i postimplantationstab, et fald i ungernes fødselsvægt og en reduktion i ungernes overlevelse de første tre dage af amningen hos rotter.
At two-fold systemic exposure compared to maximum human therapeutic exposure, there was an increase in post- implantation loss, decrease in the pup birth weights, and reduction in pup survival during the first three days of lactation in rats.
Mirtazapin udviste ikke genotoksicitet i en række tests for genmutation og kromosom - og DNA - skader.
Mirtazapine was not genotoxic in a series of tests for gene mutation and chromosomal and DNA damage.
28 hepatocellulære neoplasmer i et carcinogenicitetsstudie på mus anses for at være artsbestemt, non - genotoksisk respons i forbindelse med langtidsbehandling med høje doser af leverenzyminduktorer.
Thyroid gland tumours found in a rat carcinogenicity study and hepatocellular neoplasms found in a mouse carcinogenicity study are considered to be species-specific, non-genotoxic responses associated with long-term treatment with high doses of hepatic enzyme inducers.
Sukkerkugler Hypromellose Povidon K30 Magnesiumstearat Aminoalkylmethacrylat copolymer E Aspartam (E951) Vandfri citronsyre Crospovidon (type A) Mannitol (E421) Mikrokrystallinsk cellulose Naturlig og kunstig appelsinsmag (No.
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) Natriumbicarbonat
SN027512) sodium hydrogen carbonate
Børnesikret, peel- to- open ubøjeligt og perforeret blisterkort fremstillet af et laminat af aluminiumsfolie og plastikfilm forseglet til et papirbaseret laminat af aluminiumsfolie overtrukket med en varmeforseglet lak.
Child-resistant, peel-to-open, rigid perforated unit dose blister, formed from a laminate of aluminum foil and plastic films sealed to a paper-based laminate of aluminum foil coated with a heat seal lacquer.
Plastikfilmen indeholder:
The plastic films contain:
PVC (polyvinyl chlorid), polyamid og polyester.
PVC (polyvinyl chloride), polyamide and polyester.
Følgende pakningsstørrelser findes for hver styrke:
The following pack sizes are available for each strength:
6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6), 96 (16x6) og 180 (10x18 (3x6)).
6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6) and 96 (16x6) and 180 (10x18 (3x6)) orodispersible tablets.
{Navn og adresse} < {tlf.} > < {fax} >
{Name and address }< {tel }> < {fax }> < {e-mail }>
30 ETIKETTERING
27 LABELLING
31 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre emballage, 15 mg
Outer carton, 15 mg
Remeron og tilhørende navne (se Bilag I) 15 mg smeltetabletter [Se Bilag I – Udfyldes nationalt]
Remeron and associated names (see Annex I) 15 mg orodispersible tablets [See Annex I - To be completed nationally]
Hver smeltetablet indeholder 15 mg mirtazapin
Each orodispersible tablet contains 15 mg mirtazapine
Saccharosekugler og aspartam (E951)
Sugar spheres (containing sucrose) and aspartame (E951)
32 Opbevares utilgængeligt for børn.
29 Keep out of the reach and sight of children.
{Navn og adresse} < {tlf.} > < {fax} > < {e- mail} >
{Name and Address }< {tel }> < {fax }> < {e-mail }>
33 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Etiket på sammenpakning, 15 mg
Label on bundle pack, 15 mg
35 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blisterkort, 15 mg
Blister, 15 mg
RIV
TEAR
36 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre emballage, 30 mg
Outer carton, 30 mg
Remeron og tilhørende navne (se Bilag I) 30 mg smeltetabletter [Se Bilag I – Udfyldes nationalt]
Remeron and associated names (see Annex I) 30 mg orodispersible tablets [See Annex I - To be completed nationally]
Hver smeltetablet indeholder 30 mg mirtazapin
Each orodispersible tablet contains 30 mg mirtazapine
37 Opbevares utilgængeligt for børn.
35 Keep out of the reach and sight of children.
Etiket på sammenpakning, 30 mg
Label on bundle pack, 30 mg
40 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
39 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blisterkort, 30 mg
Blister, 30 mg
Ydre emballage, 45 mg
Outer carton, 45 mg
Remeron Smelt og tilhørende navne (se Bilag I) 45 mg smeltetabletter [Se Bilag I – Udfyldes nationalt]
Remeron and associated names (see Annex I) 45 mg orodispersible tablets [See Annex I - To be completed nationally]
Hver smeltetablet indeholder 45 mg mirtazapin
Each orodispersible tablet contains 45 mg mirtazapine
Opbevares utilgængeligt for børn.
41 Keep out of the reach and sight of children.
Remeron Smelt 45
42 Remeron 45
Etiket på sammenpakning, 45 mg
Label on bundle pack, 45 mg
44 8.
44 7.
Remeron Smelt 45
Remeron 45
Blisterkort, 45 mg
Blister, 45 mg
Remeron Smelt og tilhørende navne (se Bilag I) 45 mg smeltetabletter [Se Bilag I – Udfyldes nationalt]
Remeron and assoicated names (see Annex I) 45 mg orodispersible tablets [See Annex I - To be completed nationally]