FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 6-month, controlled, contribution of elements clinical study enrolling 560 patients with openangle glaucoma (including pseudoexfoliation or pigment dispersion component) and/or ocular hypertension who, in the investigator's opinion, were insufficiently controlled on monotherapy or already on multiple IOP-lowering medicinal products, and who had mean baseline diurnal IOP of 26 mmHg, the mean diurnal IOP-lowering effect of SIMBRINZA dosed twice daily was approximately 8 mmHg.
Danish: I et 6-måneders kontrolleret, klinisk studie med bidragselementer, der omfattede 560 patienter med åbenvinklet glaukom (herunder pseudoeksfoliation eller pigmentdispersionselement) og/eller okulær hypertension, der ifølge den forsøgsansvarlige blev utilstrækkelig kontrolleret med monoterapi, eller allerede i behandling med flere IOP-sænkende lægemidler, og som havde en gennemsnitlig baseline døgn-IOP på 26 mmHg, var den gennemsnitlige IOP-sænkende effekt pr. døgn af SIMBRINZA doseret to gange dagligt ca. 8 mmHg.
English: Caution is advised if CYP3A4 inhibitors are given concomitantly.
Danish: Hvis CYP3A4-inhibitorer gives samtidig med brinzolamid, bør man være forsigtig.
English: SIMBRINZA contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses.
Danish: SIMBRINZA indeholder benzalkoniumchlorid, der kan medføre øjenirritation og misfarvning af bløde kontaktlinser.
English: EU/1/14/933/001-002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/933/001-002
English: The recommended dose is one drop in the affected eye or eyes two times a day.
Danish: Den anbefalede dosis er 1 dråbe i de(t) angrebne øje (øjne) 2 gange dagligt.
English: In a 6-month, controlled, non-inferiority clinical study enrolling 890 patients with open-angle glaucoma (including pseudoexfoliation or pigment dispersion component) and/or ocular hypertension who, in the investigator's opinion, were insufficiently controlled on monotherapy or already on multiple IOP-lowering medicinal products, and who had mean baseline diurnal IOP of 26 to 27 mmHg, non-inferiority of SIMBRINZA compared to brinzolamide 10 mg/mL + brimonidine 2 mg/mL dosed concomitantly was demonstrated at all visits throughout the study with respect to mean diurnal IOP reduction from baseline (Table 1).
Danish: I et 6-måneders kontrolleret klinisk non-inferioritetsstudie omfattende 890 patienter med åbenvinklet glaukom (herunder pseudoeksfoliation eller pigmentdispersionselement) og/eller okulær hypertension, der ifølge investigator var utilstrækkeligt kontrolleret med monoterapi eller allerede i behandling med flere IOP-sænkende lægemidler, og som havde en gennemsnitlig baseline døgn-IOP på 26-27 mmHg, blev der påvist non-inferioritet for SIMBRINZA, sammenlignet med brinzolamid på 10 mg/ml + brimonidin på 2 mg/ml givet ved en samtidig dosis, ved alle besøg igennem hele studiet, hvad angik gennemsnitlig døgn-reduktion i IOP fra baseline (tabel 1).
English: Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination in elderly patients.
Danish: Hos ældre patienter kan orale karboanhydrasehæmmere forringe evnen til at udføre opgaver, der kræver mental årvågenhed og/eller fysisk koordination.
English: At the +2 h time point (the time corresponding to the morning efficacy peak) for the primary efficacy visit at Month 3, the percentage of patients with an IOP less than 18 mmHg was 65.6% in the SIMBRINZA group and 63.7% in the Brinzolamide + Brimonidine groups.
Danish: Ved +2 timers tidspunktet (tiden, der svarer til morgen-peakværdien for effekt) for det primære effektbesøg i måned 3 var procentdelen af patienter med en IOP på mindre end 18 mmHg 65,6 % i SIMBRINZA-gruppen og 63,7 % i Brinzolamid + Brimonidin-grupperne.
English: During lactation, the no adverse effect level in the offspring was 5 mg/kg/day.
Danish: Nuleffektniveauet (NOAEL - no observed adverse effect level) var 5 mg/kg/dag hos afkommet i dieperioden.
English: • Effects in the eye: eye surface damage with loss of cells, inflammation of the eyelid, deposits on the eye surface, sensitivity to light, swelling of the eye (affecting the cornea or eyelid), dry eye, eye discharge, watery eye, eyelid redness, abnormal or decreased sensation in eye, tired eye, reduced vision, double vision, product particles in eyes.
Danish: • Reaktioner i øjet: skader på øjets overflade med celletab, betændelseslignende tilstand (inflammation) på øjenlåget, aflejringer på øjets overflade, lysfølsomhed, hævelse af øjet (påvirker hornhinden eller øjenlåget), tørre øjne, sekret fra øjet, tåreflåd, rødmen på øjenlågene, unormal eller nedsat følelse i øjet, trætte øjne, nedsat syn, dobbeltsyn, produktpartikler i øjnene.
English: There are no data on the effect of topical ocular administration of SIMBRINZA on human fertility.
Danish: Der findes ingen tilgængelige data vedrørende topikal, okulær administration af SIMBRINZA og dets påvirkning af fertiliteten hos mennesker.
English: Clinical data on the use of SIMBRINZA adjunctive to travoprost-timolol maleate fixed dose combination eye drops, solution also showed superior IOP-lowering efficacy of SIMBRINZA + travoprost-timolol maleate eye drops compared with the travoprost-timolol maleate alone.
Danish: Kliniske data for brugen af SIMBRINZA i kombination med travopost-timololmaleat kombinationsøjendråber (opløsning) med fast dosis, viste også en bedre IOP-sænkende effekt for SIMBRINZA + travoprost-timololmaleat øjendråber sammenlignet med travopost-timololmaleat øjendråberne alene.
English: In study CQVJ499A2402, SIMBRINZA + travoprost-timolol maleate eye drops demonstrated superior IOPlowering efficacy from baseline compared to Vehicle + travoprost-timolol maleate eye drops after 6 weeks of treatment, with between-treatment difference in model-adjusted mean change from baseline in diurnal IOP of -2.15 mmHg (95% CI, -2.8, -1.5; p-value <0.001).
Danish: I studie CQVJ499A2402 viste SIMBRINZA + travoprost-timololmaleat øjendråber bedre IOP-sænkende effekt fra baseline sammenlignet med vehikel + travoposttimololmaleat øjendråber efter 6 ugers behandling med en forskel mellem behandlingerne i den modeltilrettede gennemsnitlige ændring fra baseline for den gennemsnitlige daglige IOP på -2,15 mmHg (95 % CI, -2,8, -1,5; p-værdi <0,001).
English: Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction(see section 5.1).
Danish: Nedsættelse af forhøjet intraokulært tryk (IOP) hos voksne patienter med åbenvinklet glaukom eller okulær hypertension, for hvem monoterapi giver utilstrækkelig reduktion af IOP (se pkt.
English: You must inform your doctor if you are taking any antidepressant medicines - if you have severe kidney problems - if you have too much acidity in your blood (a condition called hyperchloraemic acidosis) - in babies and infants aged less than 2 years.
Danish: Det er specielt vigtigt at fortælle det til lægen, hvis du bruger medicin mod depression - hvis du har alvorlige nyreproblemer - hvis du lider af for høj surhedsgrad i blodet (en tilstand kaldet "hyperkloræmisk acidose").
English: Patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin) (see section 4.5).
Danish: Patienter, der får antidepressiva, som påvirker den noradrenerge transmission (f.eks. tricykliske antidepressiva og mianserin) (se pkt.
English: In study CQVJ499A2401, SIMBRINZA + PGA (i.e. travoprost, latanoprost, or bimatoprost) demonstrated superior IOP-lowering efficacy from baseline compared to Vehicle + PGA after 6 weeks of treatment, with between-treatment difference in model-adjusted mean change from baseline in diurnal IOP of -3.44 mmHg (95% CI, -4.2, -2.7; p-value <0.001).
Danish: I studie CQVJ499A2401 viste SIMBRINZA + PGA (f.eks. travoprost, latanoprost eller bimatoprost) bedre IOP-sænkende effekt fra baseline sammenlignet med vehikel + PGA efter 6 ugers behandling med en forskel mellem behandlingerne i den model-tilrettede gennemsnitlige ændring fra baseline for den gennemsnitlige daglige IOP på -3,44 mmHg (95 % CI, -4,2, -2,7; p-værdi <0,001).
English: Brimonidine tartrate may cause ocular allergic reactions.
Danish: Brimonidintartrat kan medføre okulære overfølsomhedsreaktioner.
English: SIMBRINZA is contraindicated in patients with severe renal impairment (see section 4.3).
Danish: SIMBRINZA er kontraindiceret hos patienter med svær nyreinsufficiens (se pkt.
English: - The other ingredients are benzalkonium chloride (see section 2 “Wearing contact lensesSIMBRINZA contains benzalkonium chloride”), propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide and purified water.
Danish: 2 ”Brug af kontaktlinser - SIMBRINZA indeholder benzalkoniumchlorid”), propylenglycol, carbomer 974P, borsyre, mannitol, natriumchlorid, tyloxapol, saltsyre og/eller natriumhydroxid og renset vand.
English: 2, myalgia
Danish: 2, myalgi
English: 2, madarosis
Danish: 2, madarose
English: Manufacturer Alcon-Couvreur N.V. Rijksweg 14
Danish: Fremstiller Alcon-Couvreur N.V.
English: Alcon-Couvreur N.V. Rijksweg 14
Danish: Alcon-Couvreur N.V.
English: Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
Danish: Der er rapporteret om syrebaseforstyrrelser ved brug af orale karboanhydrasehæmmere.
English: 2, arrhythmia palpitations
Danish: 2, arytmi palpitationer
English: • General side effects: tremor, decreased sensation, loss of taste, abnormal liver function values as seen in a blood test, swelling of the face, joint pain, frequent urination, chest pain, swelling of the extremities.
Danish: • Generelle bivirkninger: rystelser, nedsat følesans, tab af smagssans, unormale levertal påvist ved en blodprøve, hævelse i ansigtet, ledsmerter, hyppig vandladning, brystsmerter, hævelse af arme og ben.
English: Brimonidine
Danish: Brimonidin
English: SIMBRINZA has not been studied in patients with hepatic impairment and caution is therefore recommended in this population (see section 4.4).
Danish: SIMBRINZA er ikke undersøgt hos patienter med nedsat leverfunktion, og det anbefales derfor at udvise forsigtighed i denne population (se pkt.
English: 2, upper respiratory tract congestion nasal congestion
Danish: 2, kongestion af de øvre luftveje tilstoppet næse
English: How to use SIMBRINZA
Danish: Sådan skal du bruge SIMBRINZA
English: Patients receiving monoamine oxidase (MAO) inhibitor therapy (see section 4.5).
Danish: Patienter, der får monoaminoxidase- (MAO) hæmmere (se pkt.
English: 1 ml of suspension contains 10 mg brinzolamide and 2 mg brimonidine tartrate.
Danish: 1 ml suspension indeholder 10 mg brinzolamid og 2 mg brimonidin-tartrat.
English: Table 1 Comparison of mean diurnal IOP (mmHg) change from baseline - Non-inferiority study
Danish: Non-inferioritetsstudie af ændring fra baseline ved sammenligning af gennemsnitligt døgn-IOP (mmHg)
English: Acid/base disturbances
Danish: Syrebaseforstyrrelser
English: The same type of adverse reactions attributable to oral carbonic anhydrase inhibitors may occur with topical administration.
Danish: De samme typer bivirkninger, som skyldes orale karboanhydrasehæmmere, kan opstå efter topikal administration.
English: 2, pharyngitis
Danish: 2, faryngitis
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: Tell your doctor if you are taking or intend to take any of the following medicines: - medicines to lower blood pressure - heart medicines including digoxin (used to treat heart conditions) - other medicines for glaucoma that also treat altitude sickness known as acetazolamide,
Danish: Informér din læge, hvis du bruger eller overvejer at bruge et eller flere af følgende lægemidler: - blodtrykssænkende lægemidler - hjertemedicin, herunder digoxin (til behandling af hjertesygdomme) - andre lægemidler mod glaukom (grøn stær), som også behandler højdesyge og med betegnelserne acetazolamid, metazolamid og dorzolamid - lægemidler, der kan påvirke stofskiftet, herunder klorpromazin, methylphenidat og reserpin.
English: 1, photopsia
Danish: 1, fotopsi
English: 2, nightmares
Danish: 2, mareridt
English: SIMBRINZA is intended for local action within the eye. Assessment of human ocular exposure at efficacious doses is not feasible.
Danish: Evaluering af human okulær eksponering ved virksomme doser er ikke muligt.
English: Hepatobiliary disorders Not known: liver function test abnormal Skin and subcutaneous tissue disorders
Danish: Ikke kendt: unormale leverfunktionsprøver Hud og subkutane væv Ikke almindelig: kontaktdermatit
English: 1, libido decreased
Danish: 1, nedsat libido
English: , heart rate irregular
Danish: , uregelmæssig puls
English: Twist off the bottle cap. After the cap is removed, if the tamper evident snap collar is loose, remove it before using the medicine.
Danish: Hvis sikkerhedsringen omkring hætten sidder løst, når flasken åbnes første gang, skal den fjernes, inden præparatet tages i brug.
English: 1 mL of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate equivalent to 1.3 mg of brimonidine.
Danish: 1 ml suspension indeholder 10 mg brinzolamid og 2 mg brimonidintartrat svarende til 1,3 mg brimonidin.
English: Patients with severe renal impairment (see section 4.4).
Danish: Patienter med svært nedsat nyrefunktion (se pkt.
English: 3, ocular hyperaemia
Danish: 3, okulær hyperæmi
English: Uncommon: red blood cells decreased
Danish: Ikke kendt: rinitis Blod og lymfesystem Ikke almindelig: nedsat antal røde blodlegemer
English: SIMBRINZA contains brinzolamide, which is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption.
Danish: SIMBRINZA indeholder brinzolamid, som er et sulfonamid, der hæmmer karboanhydrase, og som absorberes systemisk.
English: Uncommon: headache
Danish: Ikke almindelig: smerte
English: 1, abnormal vision
Danish: 1, unormalt syn
English: methazolamide and dorzolamide - medicines that can affect the metabolism, such as chlorpromazine, methylphenidate and reserpine - antiviral, antiretroviral (used to treat Human Immunodeficiency Virus (HIV)) or antibiotic medicines - antiyeast or antifungal medicines - monoamine oxidase (MAO) inhibitors, or antidepressants including amitriptyline, nortriptyline,
Danish: (HIV)) eller antibiotika - lægemidler mod gærsvampe- og svampeinfektioner - monoamin-oxidasehæmmere (MAO) eller medicin mod depression, herunder amitriptylin,
English: SIMBRINZA has not been studied in patients with hepatic impairment; caution should be used in treating such patients (see section 4.2).
Danish: SIMBRINZA øjendråber er ikke undersøgt hos patienter med nedsat leverfunktion, hvorfor der skal udvises forsigtighed ved behandling af disse patienter (se pkt.
English: SIMBRINZA 10 mg/ml + 2 mg/ml eye drops, suspension brinzolamide/brimonidine tartrate
Danish: SIMBRINZA 10 mg/ml + 2 mg/ml øjendråber, suspension brinzolamid/brimonidintartrat
English: - If you get any side effects, talk to your doctor, optometrist (optician) or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: 2, abdominal discomfort diarrhoea
Danish: 2, abdominalt ubehag 1, diarré opkastning 2, kvalme
English: 1, visual acuity reduced
Danish: 1, nedsat synsskarphed øget tåreflåd
English: Ask your optometrist (optician) or pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Rinse your eye with warm water.
Danish: Hvis du har brugt for meget SIMBRINZA, så skyl øjet med lunkent vand.
English: If you wear soft contact lenses, do not use the drops with your lenses in. See section “Wearing contact lenses - SIMBRINZA contains benzalkonium chloride” below).
Danish: Se punktet "Brug af kontaktlinser - SIMBRINZA indeholder benzalkoniumchlorid" nedenfor).
English: 1, conjunctival blanching
Danish: 1, konjunktival bleghed
English: 2, hypoaesthesia
Danish: 2, hypæstesi
English: Talk to your doctor, optometrist (optician) or pharmacist before using SIMBRINZA if you have now or have had in the past: - liver problems - a type of high pressure in the eyes called narrow-angle glaucoma - dry eyes or cornea problems - coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, high or low blood pressure - depression - disturbed or poor blood circulation (such as Raynaud's disease, Raynaud's syndrome or cerebral insufficiency).
Danish: - koronar hjertesygdom (symptomer kan omfatte brystsmerter eller stramhed, åndenød eller kvælningsfornemmelse), hjertesvigt, højt eller lavt blodtryk - depression - forstyrret eller forringet blodomløb (såsom Raynauds sygdom, Raynauds syndrom eller cerebral insufficiens)
English: , depressed mood
Danish: , nedtrykthed
English: 2, flatulence hypoaesthesia oral
Danish: 2, oral hypoæstesi
English: Always use this medicine exactly as your doctor, optometrist (optician) or pharmacist has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens, øjenlægens eller apotekspersonalets anvisning.
English: SIMBRINZA contains two active substances: brinzolamide and brimonidine tartrate.
Danish: SIMBRINZA indeholder 2 aktive indholdsstoffer: brinzolamid og brimonidin-tartrat.
English: 1, corneal deposits (keratic precipitates)
Danish: 2, blefaritis aflejringer i cornea (keratiske udfældninger)
English: 1, asthenopia
Danish: 1, konjunktival sygdom
English: Tell your doctor, optometrist (optician) or pharmacist if you are using, have recently used, or might use any other medicines.
Danish: Brug af anden medicin sammen med SIMBRINZA Fortæl det altid til lægen, øjenlægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Serious adverse reactions following inadvertent ingestion with the brimonidine component of SIMBRINZA by paediatric subjects have been reported.
Danish: Der er rapporteret alvorlige bivirkninger hos pædiatriske patienter efter utilsigtet indtagelse af brimonidin-komponenten i SIMBRINZA.
English: Mean percent IOP reductions from baseline with SIMBRINZA ranged from 25 to 37%.The percentages of patients with an IOP measurement less than 18 mmHg were similar across study visits for the same time point through Month 6 in the SIMBRINZA and Brinzolamide + Brimonidine groups.
Danish: Procentdelene af patienter med en IOP-måling på mindre end 18 mmHg var tilsvarende på tværs af forsøgsbesøg for det samme tidspunkt i måned 6 i SIMBRINZA og Brinzolamid + Brimonidingrupperne.
English: What SIMBRINZA is and what it is used for What you need to know before you use SIMBRINZA How to use SIMBRINZA
Danish: Det skal du vide, før du begynder at bruge SIMBRINZA Sådan skal du bruge SIMBRINZA Bivirkninger
English: What SIMBRINZA contains - The active substances are brinzolamide and brimonidine tartrate.
Danish: SIMBRINZA indeholder: - Aktive stoffer: brinzolamid og brimonidintartrat.
English: SIMBRINZA 10 mg/ml + 2 mg/ml eye drops brinzolamide/brimonidine tartrate
Danish: SIMBRINZA 10 mg/ml + 2 mg/ml øjendråber brinzolamid/brimonidintartrat
English: - If you have any further questions, ask your doctor, optometrist (optician) or pharmacist.
Danish: Er du i tvivl, så spørg lægen, øjenlægen eller apotekspersonalet.
English: 1, motor dysfunction
Danish: Ikke almindelig: hovedpine 1, motorisk dysfunktion
English: Brinzolamide is absorbed through the cornea following topical ocular administration.
Danish: Efter topikal okulær administration absorberes brinzolamid gennem cornea.
English: 2, dry throat
Danish: 2, faryngeale smerter tørhed i halsen
English: 2, ageusia
Danish: 2, ageusi
English: 1, pterygium 2, erythema of eyelid
Danish: 1, pterygium 2, øjenlågserytem 1, meibomianitis
English: • Effects in the eye: allergic conjunctivitis (eye allergy), eye surface inflammation, eye pain, eye discomfort, blurred or abnormal vision, eye redness
Danish: • Reaktioner i øjet: allergisk konjunktivitis (øjenallergi), betændelse i øjets overflade,
English: Brinzolamide is a carbonic anhydrase inhibitor and, although administered topically, is absorbed systemically.
Danish: Brinzolamid er en karboanhydrasehæmmer, der selvom den administreres topikalt, absorberes systemisk.
English: • Trouble breathing
Danish: • Vejrtrækningsbesvær
English: Common: eye allergy 1, keratitis
Danish: Almindelig: øjenallergi
English: 2, throat irritation
Danish: 2, irritabilitet
English: The use of SIMBRINZA is not recommended during breast-feeding.
Danish: SIMBRINZA må ikke anvendes under amning.
English: SIMBRINZA contains brinzolamide, a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically.
Danish: SIMBRINZA indeholder brinzolamid, der er et sulfonamid, som hæmmer karboanhydrase, og selvom det administreres topikalt, absorberes det systemisk.
English: Check with your doctor, optometrist (optician) or pharmacist if you are not sure.
Danish: Spørg lægen, øjenlægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: a
Danish: CI)
English: 1, ocular discomfort
Danish: 1, okulært ubehag 1, sløret syn
English: SIMBRINZA contains brinzolamide, an inhibitor of carbonic anhydrase, and although administered topically, is absorbed systemically.
Danish: SIMBRINZA indeholder brinzolamid, en karboanhydrasehæmmer, der selvom det administreres topikalt, absorberes systemisk.
English: Uncommon: corneal erosion
Danish: Ikke almindelig: hornhindeerosion
English: 1, sneezing Not known: asthma Gastrointestinal disorders Common: dry mouth Uncommon: dyspepsia
Danish: 1, postnasal dryp1, nysen2 Ikke kendt: astma
English: Not known: face oedema
Danish: Ikke kendt: ødem i ansigtet
English: 1, dry eye
Danish: 1, øjensmerte
English: 2, feeling jittery irritability
Danish: 2, unormal fornemmelse nervøsitet
English: Nervous system disorders Common: somnolence
Danish: Almindelig: somnolens
English: Shake well before use.
Danish: Ryst flasken grundigt inden brug.
English: If you use more SIMBRINZA than you should
Danish: Hvis du har brugt for meget SIMBRINZA
English: 1, cough 2, epistaxis
Danish: 2, epistaxis
English: 1, oesophagitis
Danish: 1, øsofagit
English: 2, bronchial hyperactivity 2, pharyngolaryngeal pain
Danish: 2, bronkial hyperaktivitet
English: Figure 1 Mean a diurnal (9 AM, +2 hrs, +7 hrs) IOP change from baseline (mmHg)Contribution of elements study aLeast squares means derived from a statistical model that accounts for study site, 9 AM baseline IOP stratum, and correlated IOP measurements within patient.
Danish: -8,1 (n=346) -8,2 (n=330) Mindste kvadraters metode udledt fra en statistisk model, som tager højde for forsøgsstedet, baseline-IOP-stratum kl. 9.00 og korrelerede IOP-målinger inden for samme patient.
English: 2, vomiting 2, nausea
Danish: 2, diplopi blænding 2, hypæstesi i øjet
English: Uncommon: apathy 2, depression
Danish: Ikke almindelig: apati
English: 2, lacrimation increased
Danish: 2, hævelse af øjet
English: Hepatic impairment
Danish: Psykiske lidelser
English: 2, diplopia glare
Danish: 2, muskelkramper
English: 2, rash maculopapular pruritus generalised
Danish: 2, makulo-papuløst udslæt
English: Zyllt can be given to the following groups of patients:
Danish: Zyllt kan gives til følgende patientgrupper:
English: The European Commission granted a marketing authorisation valid throughout the EU for Zyllt to Krka, d.d., Novo mesto on 28 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Zyllt til Krka, d.d., Novo mesto den 28. september 2009.
English: Other information about Zyllt:
Danish: Andre oplysninger om Zyllt:
English: The Committee recommended that Zyllt be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Zyllt.
English: The full EPAR for Zyllt can be found here.
Danish: Den fuldstændige EPAR for Zyllt findes her.
English: Zyllt clopidogrel EPAR summary for the public
Danish: Zyllt clopidogrel EPAR - sammendrag for offentligheden
English: Zyllt is a ‘generic medicine'.
Danish: Zyllt er et ‘generisk lægemiddel'.