FrancophonIA/ELRC3.0 huggingface dataset:
English: Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.
Danish: Der er rapporteret tilfælde af mydriasis efter samtidig anvendelse af oftalmologiske betablokkere og adrenalin (epinephrin).
English: 3, visual impairment
Danish: 3, synsforstyrrelse
English: Carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination (see section 4.4).
Danish: Karboanhydrase-hæmmere kan forringe evnen til at udføre opgaver, der kræver mental årvågenhed og/ eller fysisk koordination (se pkt.
English: This may cause similar adverse reactions as seen with systemic beta-blocking medicinal products.
Danish: Det kan forårsage de samme bivirkninger, som ses ved systemiske betablokkere.
English: Instruct patients to keep the bottle tightly closed when not in use.
Danish: Patienterne skal instrueres i at lukke flasken tæt efter brug.
English: During lactation, the no adverse effect level in the offspring was 5 mg/kg/day.
Danish: Nul-effekt-niveauet (NOAEL: No Observed Adverse Effect Level) viste 5 mg/kg/dag hos afkommet under amning.
English: Infections and infestations Not known: nasopharyngitis
Danish: Ikke kendt: Nasopharyngitis
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er de alvorligste bivirkninger anført først.
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (forekommer hos mellem 1 og 100 behandlede)
English: AZARGA contains brinzolamide, a carbonic anhydrase inhibitor and, although administered topically, is absorbed systemically.
Danish: Azarga indeholder brinzolamid, en karboanhydrase-hæmmer som absorberes systemisk på trods af lokal administration.
English: 3, ageusia dizziness 1, headache
Danish: 3, hypæstesi 3, ageusi svimmelhed 1, hovedpine
English: 1, erythema of eyelid eyelid margin crusting Not known: increased optic nerve cup/disc ratio
Danish: 1, skleral hyperæmi 1, øjenlågserytem skorpedannelse på øjenlågsranden Ikke kendt: øget cup/disc-ratio
English: • Skin: rash, skin redness or inflammation, abnormal or decreased skin sensation, hair loss, rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis.
Danish: • Hud: Hudrødme eller betændelseslignende tilstand (inflammation) i huden, udslæt, unormal eller nedsat følelse i huden, hårtab, hvidligt, sølvfarvet (psoriasis-agtigt) udslæt eller forværring af psoriasis.
English: No effects on male or female fertility are anticipated from the use of AZARGA.
Danish: Anvendelse af Azarga forventes ikke at have nogen effekt på fertiliteten hos mænd eller kvinder.
English: Special caution should be exercised in patients with a history of atopy or anaphylaxis (see section 4.4).
Danish: Der bør udvises særlig forsigtighed hos patienter, der tidligere har haft atopi eller anafylaksi (se pkt.
English: AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension brinzolamide/timolol
Danish: Azarga 10 mg/ml + 5 mg/ml øjendråber, suspension brinzolamid/timolol
English: How to use AZARGA
Danish: Sådan skal du bruge Azarga
English: BOTTLE LABEL
Danish: FLASKEETIKETTE
English: METHOD AND ROUTE OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSSVEJ(E)
English: If you are using other eye drop or eye ointment medicines leave at least 5 minutes between each medicine.
Danish: Hvis du bruger andre øjenlægemidler, så vent mindst 5 minutter mellem Azarga og de andre øjenlægemidler.
English: Other medicines and AZARGA Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: 1, photophobia lacrimation increased 1, scleral hyperaemia
Danish: 1, fotofobi øget tåredannelse
English: In vitro studies show that the metabolism of brinzolamide mainly involves CYP3A4 as well as at least four other isozymes (CYP2A6, CYP2B6, CYP2C8 and CYP2C9).
Danish: N-desethyl-brinzolamid er brinzolamids primære metabolit, der dannes i mennesker, og som ligeledes bindes til CA-I i brinzolamids tilstedeværelse og akkumuleres i RBC. In vitro-studier viser, at metaboliseringen af brinzolamid hovedsageligt inkluderer CYP3A4 såvel som mindst fire andre isozymer (CYP2A6, CYP2B6, CYP2C8 og CYP2C9).
English: 2, somnolence 3, motor dysfunction
Danish: 2, døsighed 3, motorisk dysfunktion 3, amnesi hukommelsessvækkelse
English: Brinzolamide is sequestered in RBCs due to its high affinity binding to CA-II and to a lesser extent to CA-I. Its active N-desethyl metabolite also accumulates in RBCs where it binds primarily to CA-I.
Danish: Dets aktive N-desethyl-metabolit akkumuleres i RBC, hvor det primært bindes til CA-I. Affiniteten af brinzolamid og dets metabolit til RBC og vævs-CA resulterer i lave plasmakoncentrationer.
English: 3, meibomianitis diplopia
Danish: 3, meibomitisis
English: • Bring the bottle tip close to the eye. Use the mirror if it helps.
Danish: • Hold spidsen af flasken tæt hen til øjet.
English: • Gastric: nausea, vomiting, diarrhoea, intestinal gas or abdominal discomfort, inflammation of the throat, dry or abnormal sensation in mouth, indigestion, stomach ache.
Danish: • Mave: Kvalme, opkastning, diarré, luft i maven eller ubehag i maven, halsbetændelse, tør eller unormal følelse i munden, fordøjelsesbesvær, mavesmerter.
English: Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4
Danish: Novartis Europharm Limited Vista Building
English: Studies in animals have shown that following oral administration brinzolamide is excreted in breast milk, see section 5.3.
Danish: Det er ukendt, om brinzolamid udskilles i human mælk, Dyrestudier har påvist, at brinzolamid udskilles i mælk efter oral administration (se pkt.
English: Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.
Danish: Choroidealøsning efter filtreringsprocedurer er indberettet ved samtidig administration af præparater, der nedsætter produktionen af kammervæske (f.eks. timolol, acetazolamid).
English: 1, systemic allergic reactions including angioedema,
Danish: Ikke kendt: Anafylaksi 2, anafylaktisk chok 1, systemisk allergisk reaktion, herunder angioødem 2, lokaliseret og generaliseret udslæt overfølsomhed 1, urticaria
English: • Effects in the eye:corneal erosion (damage to the front layer of the eyeball), Eye surface inflammation with surface damage, inflammation inside the eye, corneal staining, abnormal sensation in the eyes, eye discharge, dry eye, tired eyes, itchy eye, eye redness, eyelid redness.
Danish: • Reaktioner i øjet: hornhindeerosion (skade på øjeæblets yderste lag), betændelse i øjets overflade med skader på overfladen, betændelse indvendigt i øjet, farvning af hornhinden, unormal fornemmelse i øjet, tåreflåd, øjentørhed, trætte øjne, kløende øjne, røde øjne, røde øjenlåg.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 behandlede)
English: 1, eye pruritus 1, foreign body sensation in eyes 1, ocular hyperaemia
Danish: 1, fornemmelse af at have noget i øjet 1, okulær hyperæmi 1, konjunktival hyperæmi
English: Ask your doctor for advice before taking any medicine during breastfeeding.
Danish: Hvis du ammer, skal du spørge din læge eller apoteket til råds, før du bruger nogen form for medicin.
English: 1, asthenia
Danish: 1, smerter
English: Brinzolamide is a potent inhibitor of human carbonic anhydrase II (CA-II), the predominant isoenzyme in the eye. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humour secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport.
Danish: Ved at hæmme karboanhydrase i øjets ciliære processer nedsættes kammervæskesekretionen, formodentlig ved en langsommere dannelse af hydrogencarbonationer, hvilket medfører en reduktion i natrium og væsketransport.
English: 3, increased intraocular pressure
Danish: 3, forhøjet intraokulært tryk 3, aflejringer på øjets overflade
English: Renal and urinary disorders Uncommon: blood urine present Not known: renal pain
Danish: Ikke almindelige: Blod i urinen Ikke kendt: Nyresmerter
English: 3, pollakiuria
Danish: 3, pollakisuri
English: AZARGA 10 mg/ml + 5 mg/ml eye drops brinzolamide/timolol Ocular use
Danish: Azarga 10 mg/ml + 5 mg/ml øjendråber brinzolamid/timolol
English: One ml of suspension contains 10 mg of brinzolamide and 5 mg of timolol (as maleate).
Danish: 1 ml suspension indeholder 10 mg brinzolamid og 5 mg timolol (som maleat).
English: 1, urticaria 2, pruritus
Danish: 2, pruritus
English: Ophthalmic beta-blockers may induce dryness of eyes.
Danish: Oftalmologiske betablokkere kan medføre øjentørhed.
English: When using nasolacrimal occlusion or closing the eyelids, the systemic absorption is reduced.
Danish: Den systemiske absorption kan reduceres ved nasolakrimal okklusion eller ved at lukke øjet.
English: What AZARGA is and what it is used for What you need to know before you use AZARGA How to use AZARGA
Danish: Det skal du vide, før du begynder at bruge Azarga Sådan skal du bruge Azarga Bivirkninger
English: Not known: myalgia
Danish: Ikke kendt: Urticaria
English: 1, ptosis
Danish: 2, ødem
English: 1 ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate).
Danish: 1 ml suspension indeholder 10 mg brinzolamid og 5 mg timolol (som timololmaleat).
English: 3, corneal epithelium defect 3, corneal epithelium disorder
Danish: 4.4), keratopati 3, defekt i korneaepitelet lidelse i korneaepitelet
English: 1, erythema
Danish: 2, udslæt 1, erytem
English: PHARMACOLOGICAL PROPERTIES
Danish: FARMAKOLOGISKE OPLYSNINGER
English: 2, cardio-respiratory distress
Danish: , takykardi 3, øget hjerterytme brystsmerter
English: 3, upper respiratory tract congestion
Danish: 3, halsirritation 3, nasal kongestion kongestion af de øvre luftveje
English: 3, tinnitus
Danish: Ikke kendt: Vertigo 3, tinnitus
English: 3, pain in extremity
Danish: 3, artralgi 3, rygsmerter smerter i ekstremiteterne
English: AZARGA is absorbed systemically and therefore this may occur with topical administration.
Danish: Dette kan også forekomme ved brug af Azarga på grund af den systemiske absorption.
English: 1, abdominal pain diarrhoea 1, dry mouth
Danish: 1, mundtørhed 1, kvalme
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: EVNTUELLE ANDRE SÆRLIGE ADVARSLER
English: • Effects in the eye: eye surface inflammation, blurred vision, signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), eye pain.
Danish: • Reaktioner i øjet: betændelse i øjets overflade, sløret syn, symptomer på øjenirritation (f.eks.
English: • if you have problems with your kidneys.
Danish: • hvis du har nyreproblemer
English: Tabulated summary of adverse reactions
Danish: Skematisk oversigt over bivirkninger
English: 3, eye allergy
Danish: 3, øjenlågslidelse
English: 3, increased blood chloride Immune system disorders Not known: anaphylaxis
Danish: 1, muskelkramper Ikke kendt: Myalgi
English: 2, hypertension
Danish: 2, diarré
English: Choroidal detachment
Danish: Lever og galdeveje
English: Not known: erectile dysfunction
Danish: Ikke kendt: Opkastning
English: 3, alopecia
Danish: 3, diplopi
English: Uncommon: blood potassium increase
Danish: Ikke almindelige: Forhøjet kalium i blodet 1, forhøjet laktatdehydrogenase i blodet
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Ikke kendt: Hypoglykæmi Psykiske forstyrrelser
English: 3, eyelid disorder
Danish: 3, arytmi palpitationer
English: • Twist off the bottle cap. After the cap is removed, if the tamper evident snap collar is loose,
Danish: Hvis sikkerhedsringen omkring hætten sidder løst, når du åbner flasken,
English: • Severe renal impairment.
Danish: • Svært nedsat nyrefunktion.
English: 1, blood lactate dehydrogenase increased adverse reactions observed for Azarga additional adverse reactions observed with timolol monotherapy additional adverse reactions observed with brinzolamide monotherapy
Danish: timolol givet som monoterapi Yderligere bivirkninger, der blev observeret ifm.
English: • Shake well before use.
Danish: • Ryst flasken grundigt inden brug.
English: Psychiatric disorders
Danish: Choroidealøsning
English: , abdominal pain upper
Danish: , øvre abdominalsmerter abdominalsmerter
English: Surgical anaesthesia
Danish: Anæstesi i forbindelse med operation
English: 3, blood pressure increased
Danish: 3, forhøjet koncentration af chlorid i blodet
English: 1, rhinorrhoea Not known: bronchospasm
Danish: Ikke kendt: Bronkospasme
English: Ocular effects
Danish: Okulære virkninger
English: 3, paraesthesia
Danish: 3, paræstesi
English: The European Commission issued a decision on 1 October 2009.
Danish: Europa-Kommissionen traf en afgørelse den 1. oktober 2009.
English: 30 May 2008
Danish: 30. maj 2008
English: London, 14 October 2009 Doc.
Danish: London, den 14. oktober 2009 Dok.
English: Topiramate is not intended for acute treatment.'
Danish: Topiramat er ikke beregnet på akut behandling."
English: The review was carried out under an ‘Article 30' referral1.
Danish: Revurderingen fandt sted inden for rammerne af en indbringelsesprocedure i henhold til artikel 301.
English: The CHMP had considered all available evidence and the various indications already authorised in different Member States.
Danish: CHMP havde taget hensyn til hele den tilgængelige dokumentation og de forskellige indikationer, der allerede er godkendt i de forskellige medlemsstater.
English: It is available as tablets (25 mg, 50 mg, 100 mg and 200 mg) and capsules (15 mg, 25 mg and 50 mg).
Danish: Det fås som tabletter (25 mg, 50 mg, 100 mg og 200 mg) og kapsler (15 mg, 25 mg og 50 mg).
English: The company that markets Topamax is Johnson & Johnson Pharma R & D.
Danish: Den virksomhed, som markedsfører Topamax, er Johnson & Johnson Pharma R & D.
English: Topamax and associated names have been authorised in the EU via national procedures.
Danish: Topamax og tilknyttede navne er godkendt i EU efter nationale procedurer.
English: • in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options.
Danish: • migræneprofylakse hos voksne efter en nøje vurdering af alternative behandlingsmuligheder.
English: What is Topamax?
Danish: Hvad er Topamax?
English: Patients who may be hypersensitive (allergic) to the active substance or to any of the other ingredients should not take Topamax.
Danish: Patienter, som kan være overfølsomme (allergiske) over for det aktive stof eller et af de øvrige indholdsstoffer, må ikke tage Topamax.
English: Topamax is an antiepileptic medicine.
Danish: Topamax er et antiepileptisk lægemiddel.
English: Topamax is also available in the EU under other trade names: Topimax, Epitomax, Topiramat-Cilag, Topiramat-Janssen, Topamax Migräne and Topamac.
Danish: Topamax markedsføres ligeledes i EU under andre handelsnavne: Topimax, Epitomax, TopiramatCilag, Topiramat-Janssen, Topamax Migräne og Topamac.
English: Because these cells are involved in causing seizures and in migraines, reducing their electrical activity helps to reduce the chance of having a seizure or developing a migraine.
Danish: Eftersom disse celler medvirker ved krampeanfald og migræne, er en reduktion af deres elektriske aktivitet med til at mindske risikoen for at få et krampeanfald eller migræne.
English: The exact way in which topiramate, the active substance in Topamax, works is unknown but it is thought to act by interfering with the activity of receptors on nerve cells, which leads to a reduction in electrical transmission.
Danish: Den nøjagtige måde, som topiramat, der er det aktive stof i Topamax, virker på, er ukendt, men det menes at virke ved at gribe ind i receptorernes aktivitet på nervecellerne, hvilket fører til en reduktion i den elektriske transmission.
English: It is used as monotherapy (on its own) or as adjunctive therapy (together with other medicines) to prevent seizures (epileptic fits).
Danish: Det anvendes som monoterapi (alene) eller som tillægsbehandling (sammen med andre lægemidler) for at hindre krampeanfald (epileptiske anfald).
English: Migraine
Danish: Migræne
English: The CHMP harmonised the SPC section on special warnings and included warnings about mood disturbances and depression, suicide and suicidal ideation, and metabolic acidosis (increased acid levels in the body).
Danish: CHMP harmoniserede produktresuméets punkt om særlige advarsler og medtog advarsler om humørsvingninger og depression, selvmord og selvmordstanker samt metabolisk acidose (øget syreniveau i kroppen).
English: Why was Topamax reviewed?
Danish: Hvorfor blev Topamax vurderet igen?
English: The CHMP agreed on a harmonised wording for the indications:
Danish: CHMP godkendte en harmoniseret ordlyd for indikationerne:
English: The new wording highlights the possibility of reduced effectiveness of oral contraceptives in patients taking Topamax.
Danish: Med den nye ordlyd understreges risikoen for reduceret effektivitet af oral kontraception hos patienter, der tager Topamax.
English: The CHMP removed a restriction that was present in some Member States that Topamax monotherapy be used for only newly diagnosed epilepsy.
Danish: CHMP fjernede en restriktion, som var gældende i nogle medlemsstater, nemlig at Topamax monoterapi kun måtte bruges til nyligt diagnosticeret epilepsi.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the different countries where the product is marketed.
Danish: Dette har medført, at lægemidlet blev anvendt på forskellige måder i medlemsstaterne, sådan som det fremgår af forskellene i produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: The Committee also harmonised the SPC section on the interactions of Topamax with other medicines.
Danish: Udvalget harmoniserede ligeledes produktresuméets punkt om Topamax' interaktion med andre lægemidler.
English: The CHMP agreed on a harmonised wording for the contra-indications.
Danish: CHMP godkendte en harmoniseret ordlyd for kontraindikationerne.
English: The initial dose should be of 25 mg a day for one week followed by weekly increases of 25 mg until a beneficial dose is reached.
Danish: Startdosis er 25 mg om dagen i en uge efterfulgt af en ugentlig stigning på 25 mg, indtil der opnås en virkningsfuld dosis.
English: Questions and answers on the referral for Topamax and associated names topiramate tablets and capsules
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Topamax og tilknyttede navne topiramat tabletter og kapsler
English: The Committee did not include a contraindication for the use of Topamax for treating epilepsy in pregnant women or women of childbearing potential who are not using effective methods of contraception.
Danish: Udvalget medtog ikke en kontraindikation for brugen af Topamax til behandling af epilepsi hos gravide og fertile kvinder, som ikke bruger sikre kontraceptionsmetoder.
English: Topamax is also used to prevent migraine headaches.
Danish: Topamax anvendes ligeledes til at forebygge migræne.
English: The main differences concerned the age of children that can be given Topamax, and the medicine's use in monotherapy and conversion to monotherapy.
Danish: De vigtigste forskelle var alderen på børn, der må få Topamax, og lægemidlets brug ved monoterapi og ændring til monoterapi.
English: On 8 May 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Topamax and associated names in the EU and the EEA.
Danish: Den 8. maj 2008 henviste EuropaKommissionen sagen til Udvalget for Humanmedicinske Lægemidler med henblik på harmonisering af markedsføringstilladelserne for Topamax og tilknyttede navne i EU og EØS.
English: The Committee also recommended the initial dose of 100 mg in children aged six years and above.
Danish: Udvalget anbefalede ligeledes en startdosis på 100 mg hos børn over 6 år.
English: • ‘monotherapy in adults, adolescents and children over six years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures;
Danish: • "monoterapi hos voksne, unge og børn over 6 år, som lider af partielle anfald med eller uden sekundær generalisering og primært generaliserede tonisk-kloniske anfald,
English: The European Medicines Agency has completed a review of Topamax and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har foretaget en revurdering af Topamax og tilknyttede navne.
English: • adjunctive therapy in children aged 2 years and above, adolescents and adults for partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome;
Danish: • tillægsbehandling hos børn over 2 år, voksne og unge, som lider af partielle anfald med eller uden sekundær generalisering eller primært generaliserede tonisk-kloniske anfald, og behandling af anfald i forbindelse med Lennox-Gastauts syndrom,
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Topamax and associated names in the European Union (EU) and the European Economic Area (EEA).
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Topamax og tilknyttede navne i Den Europæiske Union (EU) og Det Europæiske Økonomiske Samarbejdsområde (EØS).
English: Advice was included in section 4.6 of the SPC about the risks to the mother and the unborn baby of treatment with Topamax.
Danish: I produktresuméets punkt 4.6 blev der medtaget oplysninger om de risici, som behandling med Topamax udgør for moderen og det ufødte barn.
English: Company responses provided on: 29 Aug 2008, 28 Jan 2009, 19 Mar 2009, 28 May 2009 Opinion date:
Danish: 29. august 2008, 28. januar 2009, 19. marts 2009, 28. maj 2009
English: For monotherapy in adults the CHMP recommended 100 mg to 200 mg a day as the initial dose and a maximum daily dose of 500 mg a day, divided into two doses.
Danish: Som monoterapi hos voksne anbefalede CHMP 100 mg til 200 mg om dagen som startdosis og en maksimal daglig dosis på 500 mg fordelt på to doser.
English: For prevention of migraine in adults, the Committee recommended a total daily dose of 100 mg, divided into two doses.
Danish: Til forebyggelse af migræne hos voksne anbefalede udvalget en total daglig dosis på 100 mg fordelt på to doser.
English: For children aged two years and above, the Committee recommended a dose of 5 to 9 mg per kilogram body weight a day, divided into two doses.
Danish: Til børn over 2 år anbefalede udvalget en dosis på 5 mg til 9 mg pr. kilo kropsvægt om dagen fordelt på to doser.
English: Topamax has been identified as needing harmonisation by the Co-ordination Group on the Mutual Recognition and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentrale procedurer (CMD(h)), at Topamax skulle harmoniseres.
English: For adjunctive therapy, the Committee endorsed a dose range for adults of 200 to 400 mg a day, divided into two doses.
Danish: Som tillægsbehandling godkendte udvalget et dosisinterval til voksne på 200 mg til 400 mg om dagen fordelt på to doser.
English: It is used in patients who have not been treated for this disease before.
Danish: Det anvendes hos patienter, der ikke tidligere har været behandlet for denne sygdom.
English: The most commonly reported side effects are nausea (feeling sick, 6%) and headache (6%).
Danish: De hyppigst indberettede bivirkninger er kvalme (6 %) og hovedpine (6 %).
English: The duration of treatment depends on the patient's condition.
Danish: Behandlingens varighed afhænger af patientens tilstand.