FrancophonIA/ELRC3.0 huggingface dataset:
English: CARTON OF UNIT PACK
Danish: YDERKARTON TIL ENKELTPAKNING
English: Patients with symptoms and signs consistent with CM should undergo prompt diagnostic evaluation.
Danish: Patienter med symptomer og tegn i overensstemmelse med kryptokokmeningitis skal straks undersøges med henblik på diagnosticering.
English: Continuation of siponimod therapy in patients with macular oedema has not been evaluated.
Danish: Fortsat behandling med siponimod hos patienter med makulaødem er ikke undersøgt.
English: Your blood pressure will need to be checked regularly.
Danish: Dit blodtryk skal måles regelmæssigt under behandlingen.
English: Women of childbearing potential must use effective contraception during treatment and for at least ten days following the last dose of siponimod (see section 4.4).
Danish: Fertile kvinder skal bruge effektiv kontraception under behandlingen og i mindst ti dage efter den sidste dosis siponimod (se pkt.
English: If PML is suspected, siponimod treatment should be suspended until PML has been excluded.
Danish: Ved mistanke om PML skal behandlingen med siponimod afbrydes midlertidigt, indtil PML er blevet udelukket.
English: • Cases of progressive multifocal leukoencephalopathy (PML) have been reported with another sphingosine 1-phosphate (S1P) receptor modulator.
Danish: • Der er indberettet tilfælde af progressiv multifokal leukoencefalopati (PML) med en anden sphingosin-1-fosfat (S1P)-receptormodulator.
English: • Monitoring requirements at treatment initiation: Prior to initiating treatment: o Perform vitals and baseline ECG prior to the first dose of siponimod in patients with sinus bradycardia (heart rate [HR] <55 bpm), history of first- or second-degree [Mobitz type I] AV block, or a history of myocardial infarction or heart failure (patients with NYHA class I and II).
Danish: • Krav til monitorering ved initiering af behandlingen: Inden initiering af behandling: o Vitale tegn og baseline-EKG måles inden den første dosis af siponimod hos patienter med sinusbradyarytmi (hjertefrekvens [HR] <55 slag/minut), anamnese med AV-blok af 1. eller 2. grad [Mobitz type I] eller myokardieinfarkt eller hjertesvigt i anamnesen (patienter med NYHA-klasse I og II).
English: (listed in section 6).
Danish: Mayzent (angivet i punkt 6).
English: Siponimod therapy should not be initiated in patients with macular oedema until resolution.
Danish: Behandling med siponimod bør ikke initieres hos patienter med makulaødem før resolution.
English: Siponimod is a sphingosine-1-phosphate (S1P) receptor modulator.
Danish: Siponimod er en sphingosin-1-fosfat (S1P)-receptormodulator.
English: % exposure increase versus CYP2C9*1*1
Danish: % stigning i eksponering kontra CYP2C9*1*1
English: Mayzent 2 mg film-coated tablets are pale yellow, round film-coated tablets with the company logo on one side and “II” on the other side.
Danish: Mayzent 2 mg filmovertrukne tabletter er svagt gule, runde filmovertrukne tabletter med virksomhedens logo trykt på den ene side og “II” på den anden side.
English: Concomitant treatment with anti-neoplastic, immune-modulating or immunosuppressive therapies Anti-neoplastic, immune-modulating or immunosuppressive therapies (including corticosteroids) should be co-administered with caution due to the risk of additive immune system effects during such therapy (see section 4.5).
Danish: Samtidig behandling med antineoplastiske, immunmodulerende eller immunsupprimerende midler Der skal udvises forsigtighed ved samtidig behandling med antineoplastiske, immunmodulerende eller immunsupprimerende midler (herunder kortikosteroider) på grund af risikoen for additive virkninger på immunsystemet under en sådan behandling (se pkt.
English: • Women of childbearing potential must use effective contraception during treatment and for at least 10 days following discontinuation of treatment with siponimod.
Danish: • Fertile kvinder skal anvende effektiv kontraception under behandlingen og i mindst 10 dage efter seponering af behandlingen med siponimod.
English: These patients should not receive concomitant phototherapy with UV-B radiation or PUVA-photochemotherapy.
Danish: Disse patienter bør ikke modtage samtidig behandling med UV-B-stråling eller PUVAfotokemoterapi.
English: Packs of 28 film-coated tablets in PA/alu/PVC/alu blisters.
Danish: Pakninger med 28 filmovertrukne tabletter i blistere af PA/alu/PVC/alu.
English: The decrease in heart rate induced by siponimod can be reversed by atropine or isoprenaline.
Danish: Det siponimodinducerede fald i hjertefrekvensen kan reverteres med atropin eller isoprenalin.
English: In patients with a CYP2C9*2*3 or *1*3 genotype, the recommended maintenance dose is 1 mg taken once daily (four tablets of 0.25 mg) (see sections 4.4 and 5.2).
Danish: Hos patienter med en CYP2C9*2*3- eller *1*3-genotype er den anbefalede vedligeholdelsesdosis 1 mg taget en gang dagligt (fire tabletter a 0,25 mg) (se pkt.
English: Titration packs of 12 film-coated tablets in PA/alu/PVC/alu blister in wallet.
Danish: Titreringspakning med 12 filmovertrukne tabletter i en blister af PA/alu/PVC/alu i et omslag.
English: • Patients should report any symptoms of visual impairment immediately to the prescriber during and for up to one month after the end of treatment with siponimod.
Danish: • Patienter skal straks indberette eventuelle symptomer på synsnedsættelse til den ordinerende læge under og i op til 1 måned efter seponering af behandling med siponimod.
English: • Be familiar with the Mayzent Prescribing Information.
Danish: • Sørg altid for at være fortrolig med produktresuméet for Mayzent.
English: In patients with CYP2C9*2*3 or *1*3 genotype, the recommended maintenance dose is 1 mg taken once daily (4 x 0.25 mg) (see above and sections 4.4 and 5.2).
Danish: Hos patienter med en CYP2C9*2*3- eller *1*3-genotype er den anbefalede vedligeholdelsesdosis 1 mg taget en gang dagligt (4 x 0,25 mg) (se ovenfor og pkt.
English: CYP2C9 and CYP3A4 inducers
Danish: CYP2C9- og CYP3A4-induktorer
English: Risk reduction
Danish: Frekvensreduktion
English: The tablets contain soya lecithin.
Danish: Tabletterne indeholder sojalecithin.
English: Also, these patients should not receive concomitant phototherapy with UV-B radiation or PUVA-photochemotherapy.
Danish: Disse patienter må heller ikke modtage samtidig behandling med UV-B-stråling eller PUVA-fotokemoterapi.
English: • Siponimod is contraindicated during pregnancy and in women of childbearing potential not using effective contraception.
Danish: • Siponimod er kontraindiceret under graviditet og til fertile kvinder, som ikke anvender effektiv kontraception.
English: • Be using effective contraception during treatment and for at least 10 days after stopping treatment to avoid pregnancy due to the potential risk of harm to the unborn baby.
Danish: • Bruge effektiv kontraception under behandlingen og i mindst 10 dage efter behandlingens ophør for at undgå graviditet.
English: Dizziness Seizure Tremor
Danish: Svimmelhed Krampeanfald Rystelser
English: Packs of 120 film-coated tablets in PA/alu/PVC/alu blisters.
Danish: Pakninger med 120 filmovertrukne tabletter i blistere af PA/alu/PVC/alu.
English: Titration pack 12 film-coated tablets 120 film-coated tablets
Danish: Titreringspakning 12 filmovertrukne tabletter 120 filmovertrukne tabletter
English: - During pregnancy and in women of childbearing potential not using effective contraception (see sections 4.4 and 4.6).
Danish: - Under graviditet og til fertile kvinder, som ikke anvender effektiv kontraception (se pkt.
English: A case of cryptococcal meningitis (CM) has been reported for siponimod.
Danish: Der er rapporteret om et tilfælde af kryptokokmeningitis for siponimod.
English: When stopping siponimod therapy for planning a pregnancy, the possible return of disease activity should be considered (see section 4.4).
Danish: Ved seponering af behandling med siponimod på grund af planlæggelse af graviditet skal risikoen for tilbagevenden af sygdomsaktivitet overvejes (se pkt.
English: • Macular oedema:
Danish: • Makulaødem:
English: Percentage of patients with 6-month CDP
Danish: Procentdel af forsøgsdeltagere med 6-måneders CDP
English: Percentage of patients with 3-month CDP
Danish: Procentdel af forsøgsdeltagere med 3-måneders CDP
English: Siponimod must not be used in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Danish: Siponimod må ikke anvendes til patienter med svært nedsat leverfunktion (Child-Pugh-klasse C) (se pkt.
English: • Titration pack as wallet containing 12 tablets, and
Danish: • Titreringspakning som omslag med 12 tabletter
English: For 2 mg siponimod given once daily over 10 days, a mean Cmax of 30.4 ng/ml and mean AUCtau of 558 h*ng/ml were observed on day 10.
Danish: Der blev observeret en middel-Cmax på 30,4 ng/ml og et middel-AUCtau på 558 t*ng/ml på dag 10 for 2 mg siponimod administreret en gang dagligt i 10 dage.
English: If necessary, the decrease in heart rate induced by siponimod can be reversed by parenteral doses of atropine or isoprenaline.
Danish: Det af fingolimod inducerede fald i hjertefrekvens kan om nødvendigt reverteres af parenterale doser af atropin eller isoprenalin.
English: • Patients should be instructed to report signs and symptoms of infections immediately to their prescriber during and for up to one month after treatment with siponimod.
Danish: • Patienter skal informere om straks at indberette tegn og symptomer på infektioner til den ordinerende læge under behandlingen og i op til to måneder efter behandling med siponimod.
English: Study A2304 was a randomised, double-blind, placebo-controlled, event and follow-up duration driven, phase III study in patients with SPMS who had documented evidence of progression in the prior 2 years in the absence or independent of relapses, no evidence of relapse in the 3 months prior to study enrolment and with a median Expanded Disability Status Scale (EDSS) score of 3.0 to 6.5 at study entry.
Danish: Patienterne skulle have dokumenteret evidens for progression i de foreudgående 2 år uden eller uafhængigt af attakker, ingen evidens for attakker i 3 måneder forud for inkludering i studiet og en gennemsnitlig EDSS-score (Expanded Disability Status Scale) på 3,0 til 6,5, når de startede i studiet.
English: • Do not initiate siponimod treatment in patients with macular oedema until resolution.
Danish: • Behandling med siponimod må ikke initieres hos patienter med makulaødem før resolution.
English: Initiation of siponimod treatment results in a transient decrease in heart rate (see sections 4.8 and 5.1), and a titration scheme to reach the maintenance dose on day 6 is therefore applied at the start of treatment (see section 4.2).
Danish: 4.8 og 5.1), og der skal derfor anvendes et titreringsskema til at nå vedligeholdelsesdosis på dag 6 efter behandlingsstart (se pkt.
English: Each film-coated tablet contains siponimod fumaric acid equivalent to 2 mg siponimod.
Danish: Hver filmovertrukket tablet indeholder siponimodfumarsyre svarende til 2 mg siponimod.
English: Hazard ratio: 0.69 (95% Cl: 0.53, 0.91); risk reduction: 31%
Danish: Hazard ratio: 0,69 (95 % Cl: 0,53, 0,91); risikoreduktion: 31 %
English: Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported for another sphingosine 1-phosphate (S1P) receptor modulator.
Danish: Der er rapporteret sjældne tilfælde af posteriort reversibelt encefalopatisyndrom (PRES) for en anden sphingosin-1-fosfat (S1P)-receptormodulator.
English: Each film-coated tablet contains siponimod fumaric acid equivalent to 0.25 mg siponimod.
Danish: Hver filmovertrukket tablet indeholder siponimodfumarsyre svarende til 0,25 mg siponimod.
English: Siponimod belongs to a group of medicines called sphingosine-1-phosphate (S1P) receptor modulators.
Danish: Siponimod tilhører en gruppe af lægemidler, som kaldes S1P-receptormodulatorer (S1P = sphingosin-1-fosfat).
English: Pale red, round, biconvex, bevelled-edged film-coated tablet of approximately 6.1 mm diameter with company logo on one side and “T” on the other side.
Danish: Svagt rød, rund, bikonveks, filmovertrukket tablet med skrå kanter og en diameter på ca. 6,1 mm med virksomhedens logo trykt på den ene side og “T” på den anden side.
English: How to take Mayzent
Danish: Sådan skal du tage Mayzent
English: Hazard ratio: 0.63 (95% Cl: 0.47, 0.86); risk reduction: 37%
Danish: Hazard ratio: 0,63 (95 % Cl: 0,47, 0,86); risikoreduktion: 37 %
English: Initiation of siponimod treatment results in a transient decrease in heart rate and may also be associated with atrioventricular conduction delays (see section 4.4).
Danish: Når behandling med siponimod initieres, sker der et forbigående fald i hjertefrekvensen og måske også en forsinkelse af den atrioventrikulære overledning (se pkt.
English: Hazard ratio: 0.74, p=0.0058; (95% Cl: 0.60, 0.92); risk reduction: 26%
Danish: Hazard ratio: 0,74, p=0,0058; (95 % Cl: 0,60; 0,92); risikoreduktion: 26 %
English: If you are taking a beta blocker, such as atenolol or propranolol, your doctor may ask you to temporarily stop your beta-blocker treatment until you have reached your full daily dose of Mayzent.
Danish: Hvis du tager en betablokker som fx atenolol eller propranolol, vil lægen muligvis bede dig om at holde op med behandlingen med betablokkeren midlertidigt, indtil du er oppe på den fulde dagsdosis af Mayzent.lægemidler, der påvirker immunsystemet, som fx kemoterapi, immundæmpende midler eller andre lægemidler til behandling af MS.
English: If PML is suspected, treatment should be suspended until PML has been excluded.
Danish: Behandlingen skal indstilles ved mistanke om PML, indtil PML er blevet udelukket.
English: o If necessary, the decrease in heart rate induced by siponimod can be reversed by parenteral doses of atropine or isoprenaline.
Danish: o Om nødvendigt kan siponimod-induceret fald i hjertefrekvensen reverteres med paranterale doser af atropin eller isoprenalin.
English: Your white blood cell (lymphocyte) count may remain low for up to 3 to 4 weeks after you stop taking Mayzent.
Danish: Mayzent forbliver i kroppen i op til 10 dage efter, at du er stoppet med at tage det. Antallet af hvide blodlegemer (lymfocytter) i dit blod kan forblive lavt i op til 3 til 4 uger efter, at du er holdt op med at tage Mayzent.
English: Intermediate metabolisers CYP2C9*2*2
Danish: Intermediære metabolisatorer CYP2C9*2*2
English: Extensive metabolisers CYP2C9*1*1
Danish: Ekstensive metabolisatorer CYP2C9*1*1
English: o QTc prolongation >500 msec o Severe untreated sleep apnoea o History of symptomatic bradycardia o History of recurrent syncope o Uncontrolled hypertension o Concomitant treatment with class Ia (e.g. quinidine, procainamide) or class III anti-arrhythmic medications, calcium channel blockers (such as verapamil, diltiazem) and other medications (e.g. ivabradine or digoxin)
Danish: o QTc-forlængelse >500 msek o Alvorlig ubehandlet søvnapnø o Symptomatisk bradyarytmi i anamnesen o Tilbagevendende synkope i anamnesen o Ukontrolleret hypertension o Samtidig behandling med antiarytmika klasse Ia (f.eks. kinidin,
English: Pale yellow, round, biconvex, bevelled-edged film-coated tablet of approximately 6.1 mm diameter with company logo on one side and “II” on the other side.
Danish: Svagt gul, rund, bikonveks, filmovertrukket tablet med skrå kanter og en diameter på ca. 6,1 mm med virksomhedens logo trykt på den ene side og “II” på den anden side.
English: The upper bound of the one-sided 95% CI for the ΔΔQTcF at all time points remained below 10 ms. Categorical analysis revealed no treatment-emergent QTc values above 480 ms, no QTc increases from baseline of more than 60 ms and no corrected or uncorrected QT/QTc value exceeded 500 ms.
Danish: Kategorisk analyse afslørede ingen behandlingsrelaterede QTc-værdier over 480 msek., ingen stigninger i QTc i forhold til baseline på mere end 60 msek.
English: Siponimod must not be used in patients with severe hepatic impairment (see section 4.3).
Danish: Siponimod må ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
English: - History of progressive multifocal leukoencephalopathy or cryptococcal meningitis.
Danish: - Progressiv multifokal leukoencefalopati eller kryptokokmeningitis i anamnesen.
English: Hazard ratio: 0.79, p=0.0134; (95% Cl: 0.65, 0.95); risk reduction: 21%
Danish: Hazard ratio: 0,79, p=0,0134; (95 % Cl: 0,65; 0,95); risikoreduktion: 21 %
English: CYP2C9 and CYP3A4 inhibitors
Danish: CYP2C9- og CYP3A4-hæmmere
English: What Mayzent looks like and contents of the pack Mayzent 0.25 mg film-coated tablets are pale red, round film-coated tablets with the company logo on one side and “T” on the other side.
Danish: Udseende og pakningsstørrelser Mayzent 0,25 mg filmovertrukne tabletter er svagt røde, runde filmovertrukne tabletter med virksomhedens logo trykt på den ene side og “T” på den anden side.
English: Specialised pre-natal monitoring will be performed.
Danish: Specialiserede undersøgelser vil blive lavet på dit ufødte barn (prænatal undersøgelse).
English: Titration pack of 12 film-coated tablets
Danish: Titreringspakning med 12 filmovertrukne tabletter
English: TITRATION
Danish: TITRERING
English: Soya lecithin Xanthan gum
Danish: Sojalecithin Xanthangummi
English: • new moles
Danish: • nye modermærker
English: Before initiation of treatment, patients must be genotyped for CYP2C9 to determine their CYP2C9 metaboliser status (see sections 4.4, 4.5 and 5.2).
Danish: Inden behandlingen startes, skal patienten genotypebestemmes for CYP2C9 med henblik på at fastlægge CYP2C9-metaboliseringsstatus (se pkt.
English: During the first 6 days of treatment, if a titration dose is missed on one day treatment needs to be re-initiated with a new titration pack.
Danish: Hvis en titreringsdosis glemmes på en af dagene i løbet af de første 6 dages behandling, skal behandlingen genstartes forfra med en ny titreringspakning.
English: Number of Mayzent 0.25 mg tablets to take
Danish: Så mange Mayzent 0,25 mgtabletter, skal du tage
English: • Summary of Product Characteristics;
Danish: • Produktresumé;
English: On your first day of treatment with Mayzent, therefore, you should not drive or use machines.
Danish: Du bør derfor ikke føre motorkøretøj eller betjene maskiner på din første behandlingsdag med Mayzent.
English: Mayzent 2 mg film-coated tablets siponimod
Danish: Mayzent 2 mg filmovertrukne tabletter siponimod
English: Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), talc, soya lecithin, xanthan gum.
Danish: Tabletovertræk: polyvinylalkohol, titandioxid (E171), rød jernoxid (E172), sort jernoxid (E172), talcum, sojalecithin, xanthangummi.
English: Cases of CM have been reported for another sphingosine 1-phosphate (S1P) receptor modulator.
Danish: Der er rapporteret om tilfælde af kryptokokmeningitis for en anden sphingosin 1-fosfat (S1P)-receptormodulator.
English: Titration pack 12 film-coated tablets
Danish: Titreringspakning 12 filmovertrukne tabletter
English: Mayzent 2 mg film-coated tablets
Danish: Mayzent 2 mg filmovertrukne tabletter
English: Polyvinyl alcohol Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172) Talc
Danish: Polyvinylalkohol Titandioxid (E171) Rød jernoxid (E172) Sort jernoxid (E172) Talcum
English: Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc, soya lecithin, xanthan gum.
Danish: Tabletovertræk: polyvinylalkohol, titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172), talcum, sojalecithin, xanthangummi.
English: Each tablet contains 0.25 mg siponimod (as fumaric acid).
Danish: Hver tablet indeholder 0,25 mg siponimod (som fumarsyre).
English: Each tablet contains 2 mg siponimod (as fumaric acid).
Danish: Hver tablet indeholder 2 mg siponimod (som fumarsyre).
English: In study A2304, basal cell carcinoma was the most common neoplasm and was reported with a similiar incidence in the siponimod 2 mg (1.01%, 12 patients) and placebo (1.23%, 7 patients) groups.
Danish: Det blev rapporteret med samme incidens hos den gruppe, der fik siponimod 2 mg (1,01 %, 12 patienter), og den gruppe, der fik placebo (1,23 %, 7 patienter).
English: • Each tablet contains 2 mg siponimod (as siponimod fumaric acid).
Danish: • Hver tablet indeholder 2 mg siponimod (som siponimodfumarsyre).
English: If you are allergic to peanut or soya, do not use this medicine.
Danish: Brug ikke dette lægemiddel, hvis du er allergisk over for jordnødder eller soja.
English: • If a woman becomes pregnant while on treatment with siponimod, treatment must be discontinued.
Danish: • Behandling med siponimod skal seponeres, hvis en kvinde bliver gravid under behandlingen.
English: Polyvinyl alcohol Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172) Talc
Danish: Polyvinylalkohol Titandioxid (E171) Gul jernoxid (E172) Rød jernoxid (E172) Talcum
English: Mayzent 0.25 mg film-coated tablets
Danish: Mayzent 0,25 mg filmovertrukne tabletter
English: • Each tablet contains 0.25 mg siponimod (as siponimod fumaric acid).
Danish: • Hver tablet indeholder 0,25 mg siponimod (som siponimodfumarsyre).
English: Seizures
Danish: Makulaødem
English: Titration pack
Danish: Titreringspakning
English: Exposure to the sun and protection against the sun Mayzent weakens your immune system.
Danish: Mayzent svækker dit immunsystem.
English: What Mayzent is and what it is used for What you need to know before you take Mayzent How to take Mayzent
Danish: Det skal du vide, før du begynder at tage Mayzent Sådan skal du tage Mayzent Bivirkninger
English: Mayzent 0.25 mg film-coated tablets siponimod
Danish: Mayzent 0,25 mg filmovertrukne tabletter siponimod
English: Liver function test increased
Danish: Forhøjede resultater af leverfunktionsundersøgelser
English: Mayzent 0.25 mg film-coated tablets Mayzent 2 mg film-coated tablets siponimod
Danish: Mayzent 0,25 mg filmovertrukne tabletter Mayzent 2 mg filmovertrukne tabletter siponimod
English: Pregnancy Reminder Card for women of childbearing potential:
Danish: Patientkort specifikt rettet mod graviditet til fertile kvinder:
English: Seizures were reported in 1.7% of patients treated with siponimod compared to 0.4% on placebo in the phase III clinical study in patients with SPMS.
Danish: I det kliniske fase III-studie med patienter med SPMS blev der rapporteret krampeanfald hos 1,7 % af de patienter, der fik behandling med siponimod, sammenlignet med 0,4 % af dem, der fik placebo.
English: Siponimod exposure is therefore approximately 25%, 61%, 91% and 284% higher in CYP2C9*2*2, *1*3, *2*3 and *3*3 subjects, respectively, as compared to *1*1 subjects (see Table 4) (see sections 4.2 and 4.4).
Danish: CYP2C9*2*2, *1*3, *2*3 og *3*3 sammenlignet med patienter med *1*1 (se tabel 4) (se pkt.
English: If you do become pregnant while taking Mayzent, tell your doctor straight away.
Danish: Fortæl det omgående til lægen, hvis du alligevel bliver gravid, imens du tager Mayzent.
English: Reduction in heart rate
Danish: Fald i hjertefrekvensen
English: If you take more Mayzent than you should
Danish: Hvis du har taget for meget Mayzent
English: Bradyarrhythmia
Danish: Bradyarytmi
English: Titration regimen
Danish: Titreringsskema
English: If Mayzent is used during pregnancy, there is a risk of harm to the unborn baby.
Danish: Der er risiko for at skade det ufødte barn, hvis Mayzent tages under graviditet.
English: Mayzent 0.25 mg film-coated tablets Mayzent 2 mg film-coated tablets
Danish: Mayzent 0,25 mg filmovertrukne tabletter Mayzent 2 mg filmovertrukne tabletter
English: problems seeing colours or details (symptoms of macular oedema, which is a swelling in the macular area of the retina at the back of the eye)
Danish: • Synsforstyrrelser, som fx en skygge eller en blind plet midt i synsfeltet, sløret syn, problemer med at se farver eller detaljer (symptomer på makulaødem, som er en hævelse i det makulære område på nethinden bagerst i øjet)
English: Treatment initiation
Danish: Behandlingsdosis
English: • A negative pregnancy test result is required prior to initiation of treatment in women of childbearing potential.
Danish: • Hos kvinder i den fertile alder, skal der foreligge en negativ graviditetstest, inden behandlingen initieres.
English: Heart rate and rhythm
Danish: Hjertefrekvens og hjerterytme