FrancophonIA/ELRC3.0 huggingface dataset:
English: Contact your doctor immediately if you notice any of the following side effects occuring during combination treatment with other medicines: - chest pain or persistent cough; changes in the way your heart beats; fainting, - confusion, feeling depressed; suicidal thoughts or aggressive behaviour, attempt suicide, thoughts about threatening the life of others, - feelings of numbness or tingling, - trouble sleeping, thinking or concentrating, - severe stomach pain; black or tar-like stools; blood in stool or urine; lower back or side pain, - painful or difficult urination, - severe bleeding from your nose, - fever or chills beginning after a few weeks of treatment, - problems with your eyesight or hearing, - severe skin rash or redness.
Danish: Kontakt straks din læge, hvis du oplever nogle af følgende bivirkninger, der kan forekomme under kombinationsbehandling med andre lægemidler: - brystsmerter eller vedvarende hoste, ændringer i måden dit hjerte slår på, besvimelse, - forvirring, nedtrykthed, selvmordstanker eller aggressiv opførsel, selvmordforsøg, tanker om at true andre på livet, - følelsesløshed eller prikkende fornemmelse, - besvær med at sove, tænke eller koncentrere dig, - kraftige mavesmerter, sort eller tjærelignende afføring, blod i afføring eller urin, smerter i nederste del af ryggen eller siden, - alvorlig blødning fra din næse, - feber eller kulderystelser begyndende efter nogle få ugers behandling, - problemer med synsevnen eller hørelsen, - kraftigt hududslæt eller rødme.
English: Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence, disturbance in attention, poor quality of sleep
Danish: Hyperkinesi, tremor, dysfoni, paræstesi, hypoæstesi, hyperæstesi, nedsat koncentration, døsighed, opmærksomhedsforstyrrelser, dårlig søvnkvalitet
English: For complete information be sure to read the “How to use” section of the Package Leaflet for the other medicines used in combination with Ribavirin Teva Pharma B.V..
Danish: For fuldstændig information læs afsnittet ”Sådan skal du bruge” i indlægssedlen for de andre lægemidler, du tager sammen med Ribavirin Teva Pharma B.V..
English: Thrombocytopenia, lymphadenopathy
Danish: Trombocytopeni, lymfadenopati
English: Peripheral ischaemia*
Danish: Perifer iskæmi٭
English: • Ribavirin (800 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week) (n = 511).
Danish: • Ribavirin (800 mg/dag) + peginterferon alfa-2b (1,5 mikrogram/kg/uge) (n = 511).
English: Wheezing, nasal discomfort
Danish: Hiven efter vejret, nasalt ubehag
English: Hypothyroidism, hyperthyroidism
Danish: Hypotyreoidisme, hypertyreoidisme
English: HCV/HIV Co-infection
Danish: Samtidig infektion med HCV/hiv
English: Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin Teva Pharma B.V. (see sections 4.3, 4.4 and 5.3).
Danish: Den yderste forsigtighed skal udvises for at undgå graviditet hos partnere til mandlige patienter, der tager Ribavirin Teva Pharma B.V.
English: Laboratory values for HCV/HIV co-infected patients
Danish: Laboratorieværdier for samtidig infektion med HCV/hiv
English: Please refer to the corresponding Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Ribavirin Teva Pharma B.V in combination with other medicinal products.
Danish: Der henvises til SmPC for de antiretrovirale lægemidler, der skal tages samtidig med HCV-behandling for bevidsthed om og håndtering af toksicitet, der er specifik for det enkelte produkt samt for potentiale for overlappende toksicitet med Ribavirin Teva Pharma B.V.
English: Ribavirin Teva Pharma B.V. has no or negligible influence on the ability to drive and use machines; however, other medicinal products used in combination may have an effect.
Danish: påvirker ikke eller kun i ubetydelig grad evnen til at føre bil og betjene maskiner; andre lægemidler anvendt i kombination kan imidlertid have en negativ virkning.
English: Table 6 Adverse reactions very commonly, commonly and uncommonly reported during clinical trials in children and adolescents with ribavirin in combination with interferon alfa-2b or peginterferon alfa-2b
Danish: Tabel 6 Meget almindelige, almindelige og ikke almindelige bivirkninger rapporteret i kliniske undersøgelser af ribavirin i kombination med interferon alfa-2b eller peginterferon alfa-2b i børn og unge
English: Fatigue, rigors, pyrexia, influenza like illness, asthenia, irritability
Danish: Træthed, rigor, feber, influenzalignende sygdom, astheni, irritabilitet
English: Chest pain, chest discomfort, peripheral oedema, malaise, feeling abnormal, thirst
Danish: Brystsmerter, ubehag i brystet, perifere ødemer, utilpashed, unormal fornemmelse, tørst
English: From pre-treatment to end of long-term follow up among children treated for 24 or 48 weeks, height for age percentiles decreased 1.3 and 9.0 percentiles, respectively.
Danish: Blandt de børn, der blev behandlet i 24 eller 48 uger, reduceredes percentilen for alderen henholdsvis 1,3 og 9,0 percentiler fra før behandling til afslutning af langtidsopfølgningen.
English: Please refer to the corresponding SmPC of medicinal products used in combination with ribavirin for further dosage recommendations on co-administration.
Danish: Der henvises til SmPC'erne for de lægemidler, der anvendes i kombination med ribavirin, for yderligere anbefalinger vedrørende dosering ved samtidig administration.
English: d: Ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg. Carrat F, Bani-Sadr F, Pol S et al. JAMA 2004; 292(23): 2839-2848.
Danish: d: Ribavirin-dosis var 800 mg for patienter < 60 kg, 1.000 mg for patienter 60-75 kg, og 1.200 mg for patienter > 75 kg.
English: Reminder: Please read the “Warnings and precautions” section of the Package Leaflet for the other medicines used in combination with Ribavirin Teva Pharma B.V. before you begin combination treatment.
Danish: Læs afsnittet ”Advarsler og forsigtighedsregler” i indlægssedlen for de andre lægemidler, du tager sammen med Ribavirin Teva Pharma B.V, før du begynder kombinationsbehandlingen.
English: SPECIAL STORAGE CONDITIONS
Danish: SÆRLIGE OPBEVARINGSBETINGELSER 10.
English: Renal failure*, renal insufficiency*
Danish: Nyresvigt*, nyreinsufficiens٭
English: Please refer to the corresponding SmPC of medicinal products used in combination with Ribavirin Teva Pharma B.V. for contraindications specific to these products.
Danish: Der henvises til SmPC'erne for de lægemidler, der anvendes i kombination med Ribavirin Teva Pharma B.V., for oplysninger om kontraindikationer, der er specifikke for disse præparater.
English: Fungal infection, bacterial infection, pulmonary infection, nasopharyngitis, pharyngitis streptococcal, otitis media, sinusitis, tooth abscess, influenza, oral herpes, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
Danish: Svampeinfektion, bakterieinfektion, lungeinfektion, nasofaryngitis, streptokokinfektion i svælget, otitis media, sinuitis, tandbylder, influenza, oral herpes, herpes simplex, urinvejsinfektion, vaginitis, gastroenteritis
English: Please refer to the corresponding SmPC of medicinal products used in combination with Ribavirin Teva Pharma B.V. for discontinuation or dose modification recommendations.
Danish: Der henvises til SmPC'erne for de lægemidler, der anvendes i kombination med Ribavirin Teva Pharma B.V., for anbefalinger vedrørende behandlingsafbrydelse eller dosisjustering.
English: Multiple-dose pharmacokinetic properties for ribavirin and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 10.
Danish: Flerdosis farmakokinetiske egenskaber for ribavirin og interferon alfa-2b hos børn og unge med kronisk hepatitis C i alderen 5 til 16 år er opsummeret i Tabel 10. Farmakokinetikken for ribavirin og interferon alfa-2b (dosis-normaliseret) er ens hos voksne og børn eller unge.
English: Ulcerative colitis*
Danish: Colitis ulcerosa٭
English: The decision to treat should be made on a case by case basis (see section 4.4).
Danish: Beslutning om at behandle bør tages individuelt fra patient til patient (se pkt.
English: Chest pain, oedema, pain, feeling cold
Danish: Brystsmerter, ødem, smerte, kuldefølelse
English: This medicine in combination with peginterferon alfa-2b or interferon alfa-2b may also cause: dark, cloudy or abnormally coloured urine, difficulty breathing, changes in the way your heart beats, chest pain, pain down left arm, jaw pain, loss of consciousness, loss of use, drooping or loss of power of facial muscles, loss of feeling sensation, loss of vision.
Danish: Dette lægemiddel i kombination med peginterferon alfa-2b eller interferon alfa-2b kan også bevirke: - mørk, grumset eller unormalt farvet urin, - vejrtrækningsproblemer, ændringer i den måde dit hjerte slår, brystsmerte, smerte i venstre arm,
English: Table 1 Ribavirin Teva Pharma B.V. dose based on body weight when used in combination with interferon alfa-2b in paediatric patients
Danish: Ribavirin Teva Pharma B.V.-dosis baseret på legemsvægt i kombination med interferon alfa-2b hos pædiatriske patienter Patientvægt (kg)
English: delusions, upper and lower respiratory tract infection, inflammation of the pancreas, severe rashes which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes (erythema multiforme, Stevens Johnson syndrome), toxic epidermal necrolysis (blistering and peeling of the top layer of skin).
Danish: Dette forårsager svær anæmi, og symptomer herpå omfatter usædvanlig træthed og mangel på energi, - vrangforestilling, øvre og nedre luftvejsinfektion, - betændelse i bugspytkirtlen, - kraftigt udslæt, som kan optræde i forbindelse med blærer i mund, næse, øjne og andre slimhindemembraner (erythem muliforme, Stevens Johnson syndrom), toksisk epidermal nekrolyse (blæredannelse og afskalning af det øverste lag af huden).
English: In the cases in which no specific dose recommendation is made, the following dose should be used: Patient weight: < 75 kg =1,000 mg and > 75 kg = 1,200 mg.
Danish: Patientens vægt < 75 kg = 1.000 mg og > 75 kg = 1.200 mg.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Ribavirin Teva Pharma B.V., skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Each tablet contains 400 mg of ribavirin
Danish: Hver tablet indeholder 400 mg ribavirin
English: Ribavirin Teva Pharma B.V. is available in different pack sizes containing 14, 28, 42, 56, 84, 112, 140 or 168 tablets.
Danish: fås i forskellige pakningsstørrelser indeholdende 14, 28, 42, 56, 84, 112, 140 eller 168 tabletter.
English: Suicidal ideation, psychosis, aggressive behaviour, confusion, agitation, anger, mood altered, abnormal behaviour nervousness, sleep disorder, decreased libido, apathy, abnormal dreams, crying,
Danish: Selvmordstanker, psykose, aggresiv opførsel, forvirring, uro, vrede, humørændring, unormal adfærd, nervøsitet, søvnforstyrrelser, nedsat libido, apati, abnorme drømme, gråd
English: Suicidal ideation, aggression, confusion, affect liability, behaviour disorder, agitation, somnambulism, anxiety, mood altered, restlessness, nervousness, sleep disorder, abnormal dreaming, apathy
Danish: Selvmordstanker, aggression, forvirring, påvirke ansvarlighed, unormal opførsel, uro, søvngængeri, angst, humørændring, rastløshed, nervøsitet, søvnforstyrrelser, abnorme drømme, apati
English: Fatigue, rigors, pyrexia, influenza-like illness, asthenia, malaise, irritability
Danish: Træthed, rigor, feber, influenzalignende sygdom, asteni, utilpashed, irritabilitet
English: Each film-coated tablet contains 200 mg of ribavirin.
Danish: Hver filmovertrukket tablet indeholder 200 mg ribavirin.
English: Headache, dizziness
Danish: Hovedpine, svimmelhed
English: The combination of Ribavirin Teva Pharma B.V. with interferon alfa-2b is used to treat adult patients with chronic hepatitis C, who have previously responded to treatment with an alpha interferon alone, but whose condition has recurred.
Danish: med interferon alfa-2b anvendes i behandlingen af voksne patienter med kronisk hepatitis C (HCV) infektion, som tidligere har responderet på behandling med et alfa interferon alene, men hvor sygdommen er vendt tilbage.
English: The following other side effects have also been reported with the combination of this medicine and an alpha interferon product: abnormal thoughts, hearing or seeing images that are not present, altered mental status, disorientation, angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing), stroke (cerebrovascular events), Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction), constant cough, eye problems including damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye and cotton wool spots (white deposits on the retina), enlarged abdominal area, heartburn, trouble having bowel movement or painful bowel movement, acute hypersensitivity reactions including urticaria (hives), bruises, intense pain in a limb, leg or thigh pain, loss of range of motion, stiffness, sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands).
Danish: De følgende bivirkninger er også blevet rapporteret ved kombination af dette lægemiddel og et alfa interferon-produkt: - unormale tanker, høre og se ting som ikke er til stede, ændret mental status, desorientering, - angioødem (hævede hænder, fødder, ankler, ansigt, læber, mund eller hals, hvilket gør det svært at synke eller trække vejret), slagtilfælde (cerebrovaskulær hændelse), - Vogt-Koyanagi-Harada syndrom (en autoimmun inflammatorisk sygdom, der påvirker øjne, hud og membraner i øret, hjerne og rygmarv), - sammentrækning af bronkierne og anafylaksi (en alvorlig allergisk reaktion, der rammer hele kroppen), vedvarende hoste, - øjenproblemer herunder beskadigelse af nethinden, obstruktion af arterien i nethinden, inflammation af den optiske nerve, hævelse af øjet og nethinde-ekksudater (hvid aflejring på nethinden), - forstørret mave, halsbrand, problemer med tarmbevægelser eller smertefulde tarmbevægelser, - akutte overfølsomhedsreaktioner herunder urticaria (nældefeber), blå mærker, intens smerte i arme og/eller ben, smerter i ben eller lår, indskrænket bevægelsesområde, stivhed, sarcoidosis (en sygdom karakteriseret ved vedvarende feber, vægttab, ømme og hævede led, hudlæsion og hævede kirtler).
English: Teva Pharma, S.L.U Tél: +(34) 91 387 32 80
Danish: Tél: +(34) 91 387 32 80
English: seizure (convulsions) pneumonia, rheumatoid arthritis, kidney problems, dark or bloody stools, intense abdominal pain sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands), vasculitis.
Danish: - anfald (kramper), - lungebetændelse, - reumatoid arthrit, nyreproblemer, - mørk eller blodig afføring, intense mavesmerter, - sarcoidose (en sygdom karakteriseret ved længerevarende feber, vægttab, ledsmerte og
English: Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, night sweats, hyperhidrosis, dermatitis, acne, furuncule, erythema, urticaria, skin disorder, bruise, sweating increased, abnormal hair texture, nail disorder*
Danish: Psoriasis, forværret psoriasis, eksem, lysoverfølsomhedsreaktion, makulopapuløst udslæt, erytematøst udslæt, nattesved, hyperhidrose, dermatitis, akne, furunkulose, erytem, urticaria, hudlidelse, blå mærker, øget svedtendens, unormal hårstruktur, neglelidelse٭
English: Adult patients: Ribavirin Teva Pharma B.V. is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA (see section 4.4).
Danish: er indiceret i kombination med interferon alfa-2b til behandling af voksne patienter med tidligere ubehandlet, kronisk hepatitis C af alle typer, med undtagelse af genotype 1, uden leverdekompensation, med forhøjet alaninaminotransferase (ALAT) og som er positive med hensyn til hepatitis C-viral ribonukleinsyre (HCV-RNA) (se pkt.
English: Contents of the pack and other information What Ribavirin Teva Pharma B.V. contains
Danish: Pakningsstørrelser og yderligere oplysninger Ribavirin Teva Pharma B.V.
English: Each tablet contains 200 mg of ribavirin
Danish: Hver tablet indeholder 200 mg ribavirin
English: Haemoglobin levels dropped below 10 g/dL in up to 14 % of adult patients and 7 % of children and adolescents treated with ribavirin in combination with either peginterferon alfa-2b or interferon alfa-2b.
Danish: Hæmoglobinværdierne faldt til under 10 g/dl hos op til 14 % voksne patienter og 7 % børn og unge behandlet med ribavirin i kombination med enten peginterferon alfa-2b eller interferon alfa-2b.
English: Please refer to the corresponding SmPC of medicinal products used in combination with ribavirin for discontinuation or dose modification recommendations.
Danish: Der henvises til SmPC'erne for de lægemidler, der anvendes i kombination med ribavirin, for anbefalinger vedrørende behandlingsafbrydelse eller dosisjustering.
English: Enuresis, micturition disorder, urinary incontinence, proteinuria
Danish: Ufrivillig vandladning, ændret vandladningsfrekvens, urininkontinens, proteinuri
English: Ribavirin in combination with interferon alfa-2b
Danish: Ribavirin i kombination med interferon alfa-2b
English: Ulcerative stomatitis, stomatitis, mouth ulceration, colitis, upper right quadrant pain, dyspepsia, gastroesophageal reflux*, glossitis, cheilitis, abdominal distension, gingival bleeding, gingivitis, loose stools, tooth disorder, constipation, flatulence
Danish: Ulcerøs stomatitis, stomatitis, mundsår, colitis, smerte i højre øvre kvadrant, dyspepsi, gastro-øsofageal refluks٭, glossitis, keilit, abdominal udspiling, gingivalblødning, gingivitis, løse afføringer, tandlidelse, obstipation, flatulens
English: Ribavirin in combination with peginterferon alfa-2b
Danish: Ribavirin i kombination med peginterferon alfa-2b
English: Amnesia, memory impairment, syncope, migraine, ataxia,, paraesthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, hypertonia, somnolence, disturbance in attention, tremor, dysgeusia
Danish: Amnesi, svigtende hukommelse, synkope, migræne, ataksi, tremor, paræstesi, dysfoni, tab af smagssans, hypoæstesi, hyperæstesi, hypertoni, somnolens, opmærksomhedsforstyrrelser, tremor, smagsforstyrrelser
English: Retinal haemorrhages*, retinopathies (including macular oedema)*, retinal artery occlusion*, retinal vein occlusion*, optic neuritis*, papilloedema*, loss of visual acuity or visual field*, retinal exudates*
Danish: Blødninger i nethinden٭, retinopati (herunder macula ødem)٭, nethindearterieokklusion٭, nethindeveneokklusion٭, optisk neuropati٭, papilødem٭, synstab eller tab af synsfelt٭, nethinde-ekssudater٭
English: Please read the “Possible side effects” section of the Package Leaflet for the other medicines used in combination with Ribavirin Teva Pharma B.V..
Danish: Læs venligst afsnittet “Bivirkninger” i indlægssedlen for de andre lægemidler, du tager sammen med Ribavirin Teva Pharma B.V.
English: Please refer to the corresponding SmPC of medicinal products that are used in combination with ribavirin for additional undesirable effects reported with these products.
Danish: Der henvises til SmPC'erne for de lægemidler, der anvendes i kombination med ribavirin, vedrørende yderligere bivirkninger rapporteret i forbindelse med disse præparater.
English: A decrease in haemoglobin levels to < 10 g/dL was observed in up to 14 % of adult patients and 7 % of children and adolescents treated with ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials.
Danish: Et fald i hæmoglobinniveau til < 10 g/dl blev set hos op til 14 % af voksne patienter og hos 7 % af børn og unge behandlet med ribavirin i kombination med peginterferon alfa-2b eller interferon alfa-2b i kliniske undersøgelser.
English: 1,200 mg/day) d + peginterferon alfa-2b (100 or 150c µg/week)
Danish: 1.200 mg/dag)d peginterferon alfa-2b (100 eller
English: Each film-coated tablet contains 400 mg of ribavirin.
Danish: Hver filmovertrukket tablet indeholder 400 mg ribavirin.
English: In combination with peginterferon alfa-2b
Danish: I kombination med peginterferon alfa-2b
English: The exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Danish: Til trods for at den nøjagtige mekanisme stadig mangler at blive belyst, er der set forværring af anæmi som følge af ribavirin, når zidovudin er en del af de lægemidler, der anvendes til behandling af hiv.
English: Table 5 Adverse reactions reported during clinical trials or following the marketing use of ribavirin with pegylated interferon alfa-2b or interferon alfa-2b
Danish: Bivirkninger set i kliniske undersøgelser og efter markedsføring af ribavirin med pegyleret interferon alfa-2b- eller interferon alfa-2b
English: Mouth ulceration, stomatitis ulcerative, stomatitis, aphthous stomatitis, dyspepsia, cheilosis, glossitis, gastroesophageal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder, stomach discomfort, oral pain
Danish: Mundsår, ulcerøs stomatitis, stomatitis, aftøs stomatitis, dyspepsi, keilit, glossitis, gastroøsofageal refluks, rektal lidelse, gastrointestinal lidelse, obstipation, løse afføringer, tandpine, tandlidelse, abdominalt ubehag, oral smerte
English: No data are available regarding dose modification for paediatric patients with renal impairment (see sections 4.2 and 5.2).
Danish: Der foreligger ingen data vedrørende dosisjustering hos pædiatriske patienter med nedsat nyrefunktion (se pkt.
English: Antacid
Danish: Antacida
English: Adult patients: Ribavirin Teva Pharma B.V. is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed (see section 5.1).
Danish: er indiceret i kombination med interferon alfa-2b til behandling af voksne patienter med kronisk hepatitis C, der tidligere har responderet (med normalisering af ALAT ved behandlingsafslutningen) på interferon alfa-monoterapi, men som efterfølgende har fået tilbagefald (se pkt.
English: Tabulated list of adverse reactions in paediatric population Reported adverse reactions listed in Table 6 are based on experience from the two multicentre children and adolescents clinical trials using ribavirin with interferon alfa-2b or peginterferon alfa-2b.
Danish: Rapporterede bivirkninger i Tabel 6 er baseret på erfaring fra de to multicenter kliniske undersøgelser med børn og unge i behandling med ribvirin med interferon alfa-2b eller peginterferon alfa-2b..
English: Each Ribavirin Teva Pharma B.V. tablet contains 400 mg of ribavirin For the full list of excipients, see section 6.1.
Danish: Hver Ribavirin Teva Pharma B.V.-tablet indeholder 400 mg ribavirin Alle hjælpestoffer er anført under pkt.
English: Rarely reported side effects (may affect up to 1 in 1,000 people):
Danish: Sjældent rapporterede bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer):
English: Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Danish: Konjunktivitis, øjensmerter, abnormt syn, tårekirtellidelse
English: p valueb
Danish: pværdib