FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies, AZOPT was used concomitantly with prostaglandin analogues and timolol ophthalmic preparations without evidence of adverse interactions.
Danish: I kliniske studier, hvor AZOPT øjendråber gives i kombination med prostaglandinanaloger og timolol øjendråber, er der ikke set interaktioner.
English: Some patients were naive to IOP therapy whilst others were on other IOP-lowering medicinal product(s).
Danish: Nogle af patienterne havde aldrig fået glaukom medicin før, mens andre allerede blev behandlet med andre typer IOP-sænkende medicin.
English: Women who may become pregnant are advised to use effective contraception during AZOPT treatment.
Danish: Frugtbare kvinder skal anvende sikker prævention under behandlingen med AZOPT.
English: In plasma, both brinzolamide and Ndesethylbrinzolamide concentrations are low and generally below assay quantitation limits (<7.5 ng/ml).
Danish: Under tilstedeværelse af brinzolamid bindes denne metabolit hovedsagelig til CA-I. I plasma er både brinzolamid og N-desethyl-brinzolamid koncentrationerne lave og ofte under grænseniveauet for bestemmelse for mængden (<7,5 ng/ml).
English: Other medicines and AZOPT
Danish: Brug af anden medicin sammen med AZOPT
English: If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see section 1 What AZOPT is and what it is used for), talk to your doctor.
Danish: Tal med din læge, hvis du bruger andre karboanhydrasehæmmere (acetazolamid eller dorzolamid, se punkt 1 Virkning og anvendelse).
English: The following pack sizes are available: outer cartons containing 1 x 5 ml, 3 x 5 ml and 1 x 10 ml bottles.
Danish: Fås i pakninger, der indeholder: 1 x 5 ml, 3 x 5 ml og 1 x 10 ml flasker.
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan forekomme hos mellem 1 og 100 personer)
English: Uncommon: nasopharyngitis, pharyngitis, sinusitis Not Known: rhinitis
Danish: I henhold til MedDRA v. 15.1 Infektioner og parasitære sygdomme Ikke almindelig: nasopharyngitis, pharyngitis, sinusitis Ikke kendt: rhinitis
English: How to use AZOPT
Danish: Sådan skal du bruge AZOPT
English: BOTTLE LABEL, 5 ml & 10 ml
Danish: FLASKEETIKETTE, 5 ml og 10 ml
English: Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination.
Danish: Orale karboanhydrasehæmmere kan forringe evnen til at udføre opgaver, der kræver mental årvågenhed og/eller fysisk koordination.
English: Manufacturer S.A. Alcon - Couvreur N.V. Rijksweg 14
Danish: S.A. Alcon - Couvreur N.V.
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: Those who had been on previous IOP medicinal product(s) were not required to discontinue their IOP medicinal product(s) until initiation of monotherapy with AZOPT.
Danish: Patienterne blev ikke bedt om at seponere eventuelt IOP-sænkende medicin, før monobehandlingen med AZOPT blev påbegyndt.
English: Uncommon: oesophagitis, diarrhoea, nausea, vomiting, dyspepsia, upper abdominal pain, abdominal discomfort, stomach discomfort, flatulence, frequent bowel movements, gastrointestinal disorder, hypoaesthesia oral, paraesthesia oral, dry mouth
Danish: Ikke almindelig: oesophagitis, diarré, kvalme, opkastning, dyspepsi, øvre abdominalsmerter, abdominalgener, abdominalt ubehag, flatulens, hyppig afføring, gastrointestinale lidelser, oral hypæstesi, oral paræstesi, tør mund
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det til lægen eller apoteketspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: AZOPT is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption.
Danish: AZOPT er et sulfonamid, en karboanhydrase-hæmmer, som absorberes systemisk.
English: - Effects in the eye: corneal swelling, double or reduced vision, abnormal vision, flashes of light in the field of vision, decreased eye sensation, swelling around the eye, increased pressure in eye, damage to the optic nerve.
Danish: • Reaktioner i øjet: hævelse af hornhinden, dobbeltsyn eller nedsat syn, unormalt syn, lysglimt i synsfeltet, nedsat følelse i øjet, hævelse rundt om øjet, øget tryk i øjet, beskadigelse af synsnerven.
English: Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination (see also section 4.4 and section 4.8).
Danish: Orale karboanhydrase-hæmmere kan forringe evnen til at udføre opgaver, der kræver mental årvågenhed og/eller fysisk koordination (se også pkt.
English: Each ml of suspension contains 10 mg brinzolamide.
Danish: Hver ml suspension indeholder 10 mg brinzolamid.
English: Additionally the IOP-reducing effect of AZOPT as adjunctive therapy to the prostaglandin analogue travoprost has been studied.
Danish: Desuden er AZOPTs evne til at sænke det intraokulære tryk (IOP) som supplerende terapi til prostaglandinanalogen travoprost blevet undersøgt.
English: • Use up one bottle before opening the next bottle.
Danish: • Brug kun én flaske ad gangen.
English: After the cap is removed, if tamper evident snap collar is loose, remove before using the product.
Danish: Hvis sikkerhedsringen omkring hætten sidder løst, når flasken åbnes, skal den fjernes, inden præparatet tages i brug.
English: 5 ml 10 ml 3 x 5ml
Danish: 3 x 5 ml
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: Each millilitre contains 10 mg of brinzolamide.
Danish: 1 milliliter indeholder 10 mg brinzolamid.
English: - Effects in the eye: sensitivity to light, inflammation or infection of the conjunctiva, eye swelling, eyelid itching, redness or swelling, deposits in eye, glare, burning sensation, growth on surface of eye, increased pigmentation of the eye, tired eyes, eyelid crusting, or increased tear production.
Danish: • Reaktioner i øjet: lysfølsomhed, betændelseslignende tilstand (inflammation eller infektion) i konjunktiva, hævelse i øjet, kløende, røde eller hævede øjenlåg, aflejringer i øjet, blænding, en brændende fornemmelse, vækst på øjets overflade, øget pigmentering i øjet, trætte øjne, skorper på øjenlåget, øget tåreproduktion.
English: - General side effects: decreased or reduced heart function, a forceful heartbeat that may be rapid or irregular, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased red blood cell count in blood, increased chlorine level in blood, dizziness, difficulty with memory, depression, nervousness, decreased emotional interest, nightmare, generalized weakness, fatigue, feeling abnormal, pain, movement problems, decreased sex drive, male sexual difficulty, cold symptoms, chest congestion, sinus infection, throat irritation, throat pain, abnormal or decreased sensation in mouth, inflammation of the lining of the oesophagus, abdominal pain, nausea, vomiting, upset stomach, frequent bowel movements, diarrhoea, intestinal gas, digestive disorder, kidney pain, muscle pain, muscle spasms, back pain, nose bleeds, runny nose, stuffy nose, sneezing, rash, abnormal skin sensation, itching, smooth skin rash or redness covered by elevated bumps, skin tightness, headache, dry mouth, debris in eye.
Danish: • Generelle bivirkninger: nedsat hjertefunktion, kraftig hjertebanken, som kan være hurtig eller uregelmæssig, langsom hjerterytme (puls), vejrtrækningsproblemer, åndenød, hoste, nedsat antal af røde blodlegemer, øget chloridindhold i blodet, svimmelhed, hukommelsesbesvær, depression, nervøsitet, nedsat følelsesmæssig interesse, mareridt, generel svaghed, træthed, abnorm følelse, smerte, bevægelsesproblemer, nedsat seksualdrift, nedsat potens, forkølelsessymptomer, strammen/trykken for brystet, bihulebetændelse, halsirritation, halssmerter, abnorm eller nedsat følelse i munden, betændelseslignende tilstand (inflammation) af spiserøret, underlivssmerter, kvalme, opkastning, maveuro, hyppig afføring, diaré, luft i maven, fordøjelsesbesvær, nyresmerter, muskelsmerter, muskelkramper, rygsmerter, næseblod, løbende næse, tilstoppet næse, nysen, udslæt, abnorm følelse i huden, kløe, hududslæt eller rødme dækket af eleverede områder, stram hud, hovedpine, mundtørhed, aflejringer i øjet.
English: - Effects in the eye: eyelid abnormality, visual disturbance, corneal disorder, eye allergy, decreased growth or number of eyelashes, eyelid redness.
Danish: • Reaktioner i øjet: unormale øjenlåg, synsforstyrrelser, hornhindelidelser, øjenallergi, nedsat vækst af eller antal af øjenvipper, rødme af øjenlåg.
English: Common: blurred vision, eye irritation, eye pain, foreign body sensation in eyes, ocular hyperaemia Uncommon: corneal erosion, keratitis, punctate keratitis, keratopathy, deposit eye, corneal staining, corneal epithelium defect, corneal epithelium disorder, blepharitis, eye pruritus, conjunctivitis, eye swelling, meibomianitis, glare, photophobiadry eye, allergic conjunctivitis, pterygium, scleral pigmentation, asthenopia, ocular discomfort, abnormal sensation in eye, keratoconjunctivitis sicca, subconjunctival cyst, conjunctival hyperaemia, eyelids pruritus, eye discharge, eyelid margin crusting, lacrimation increased Rare: corneal oedema, diplopia, visual acuity reduced, photopsia, hypoaesthesia eye, periorbital oedema, intraocular pressure increased, optic nerve cup/disc ratio increased Not Known: corneal disorder, visual disturbance, eye allergy, madarosis, eyelid disorder, erythema of eyelid
Danish: Almindelig: sløret syn, øjenirritation, øjensmerter, følelse af fremmedlegeme i øjet, okulær hyperæmi Ikke almindelig: corneaerosion, keratitis, punktformet keratitis, keratopati, aflejring i øjet, korneal staining, defekt i corneaepitelet, lidelse i corneaepitelet, blefaritis, øjenkløe, konjunktivitis, hævelse i øjet, meibomitis, blænding, fotofobi, tørre øjne, allergisk konjunktivitis, pterygium, pigmentering af sclera, astenopi, okulært ubehag, abnorm følelse i øjet, keratokonjunktivitis sicca, subkonjunktival cyste, konjunktival hyperæmi, øjenlågskløe, sekret fra øjet, skorpedannelse på øjenlåget, øget tåreflåd
English: - General side effects: increased allergic symptoms, decreased sensation, tremor, loss or decrease in taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, pain in extremity, skin redness, inflammation, or itching, abnormal liver blood tests, swelling of the extremities, frequent urination, decreased appetite, feeling unwell.
Danish: • Generelle bivirkninger: øgede allergiske symptomer, nedsat følesans, rysten, tab af eller nedsat smagsevne, nedsat blodtryk, øget blodtryk, øget hjerterytme, ledsmerter, astma, smerter i arme og ben, hudrødme, betændelseslignende tilstand (inflammation) eller kløe, unormale levertal i blodprøver, hævede arme og ben, hyppig vandladning, nedsat appetit, utilpashed.
English: (picture 2)
Danish: Figur 2
English: It could infect the drops
Danish: Det kan forurene øjendråberne i flasken.
English: Carbonic anhydrase (CA) is an enzyme found in many tissues of the body, including the eye. Carbonic anhydrase catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid.
Danish: Karboanhydrase katalyserer den reversible reaktion; hydreringen af kuldioxid samt dehydreringen af kulsyre.
English: Each ml of suspension contains 0.1 mg benzalkonium chloride.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver ml suspension indeholder 0,1 mg benzalkoniumchlorid.
English: AZOPT is a carbonic anhydrase inhibitor and, although administered topically, is absorbed systemically.
Danish: AZOPT er en karboanhydrase-hæmmer som absorberes systemisk trods lokal administration.
English: AZOPT was primarily evaluated in concomitant administration with timolol during adjunctive glaucoma therapy.
Danish: AZOPT er primært vurderet som kombinationsterapi af glaukom sammen med timolol.
English: AZOPT is a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically.
Danish: AZOPT øjendråber er en sulfonamidhæmmer af karboanhydrase og absorberes systemisk på trods af lokal administration.
English: Use a single drop as soon as you remember, and then go back to your regular routine.
Danish: Genoptag behandlingen med det samme og fortsæt med den sædvanlige doseringsplan.
English: - General side effects: memory impairment, drowsiness, chest pain, upper respiratory tract congestion, sinus congestion, nasal congestion, dry nose, ringing in ears, hair loss, generalized itching, feeling jittery, irritability, irregular heart rate, body weakness, difficulty sleeping, wheezing, itchy skin rash.
Danish: • Generelle bivirkninger: hukommelsesbesvær, døsighed, brystsmerter, tilstopning af øvre luftveje, tilstoppede bihuler, tilstoppet næse, tørhed i næsen, ringen for ørene, hårtab, generel kløe, nervøsitet, irritabel adfærd, uregelmæssig hjerterytme, svaghedsfornemmelse, søvnbesvær, hvæsende vejrtrækning, kløende hududslæt.
English: Uncommon: pain, chest discomfort, fatigue, feeling abnormal Rare: chest pain, feeling jittery, asthenia, irritability Not Known: peripheral oedema, malaise
Danish: Sjælden: brystsmerter, nervøsitet, asteni, irritabilitet Ikke kendt: perifert ødem, utilpashed
English: Currently available data are described in sections 4.8 and 5.1.
Danish: 4.8 og 5.1.
English: or
Danish: ANDET
English: What AZOPT is and what it is used for What you need to know before you use AZOPT How to use AZOPT
Danish: Det skal du vide, før du begynder at bruge AZOPT Sådan skal du bruge AZOPT Bivirkninger
English: • If you take drops in both eyes, repeat the steps for your other eye.
Danish: • Gentag processen i det andet øje, hvis din læge har foreskrevet det.
English: Uncommon: back pain, muscle spasms, myalgia Not Known: arthralgia, pain in extremity
Danish: Knogler, led, muskler og bindevæv Ikke almindelig: rygsmerter, muskelkramper, myalgi Ikke kendt: artralgi, smerter i ekstremiteterne
English: Uncommon: rash, rash maculo-papular, skin tightness Rare: urticaria, alopecia, pruritus generalised Not Known: dermatitis, erythema
Danish: Sjælden: urticaria, alopeci, generaliseret kløe
English: If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.
Danish: Ved anvendelse sammen med andre øjenpræparater skal der gå mindst 5 minutter mellem instillation af de enkelte præparater.
English: Uncommon: dyspnoea, epistaxis, oropharyngeal pain, pharyngolaryngeal pain, throat irritation, upper airway cough syndrome, rhinorrhoea, sneezing Rare: bronchial hyperreactivity, upper respiratory tract congestion, sinus congestion, nasal congestion, cough, nasal dryness
Danish: Luftveje, thorax og mediastinum Ikke almindelig: dyspnø, hoste, epistaxis, orofaryngeale smerter, faryngolaryngeal smerte, halsirritation, øvre luftvejhoste-syndrom, næseflåd, nysen
English: Not Known: asthma
Danish: Ikke kendt: dermatitis, erytem
English: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain.
Danish: 08320 El Masnou (Barcelona) Spanien
English: LABELLING AND PACKAGE LEAFLET
Danish: ETTIKETTERING OG INDLÆGSSEDDEL
English: 6 OTHER
Danish: Figur 3
English: - The active substance is brinzolamide.
Danish: - Aktivt stof: brinzolamid 10 mg/ml.
English: - Effects in the eye: blurred vision, eye irritation, eye pain, eye discharge, itchy eye, dry eye, abnormal eye sensation, redness of the eye.
Danish: • Reaktioner i øjet: sløret syn, øjenirritation, øjensmerter, pus i øjet, kløen i øjet, tørre øjne,
English: Eye drops, suspension
Danish: Øjendråber, suspension 5 ml
English: Grastofil received a marketing authorisation valid throughout the EU on 18 October 2013.
Danish: Grastofil fik en markedsføringstilladelse med gyldighed i hele EU den 18. oktober 2013.
English: Further information on Grastofil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Grastofil findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Grastofil
Danish: Andre oplysninger om Grastofil
English: Severe neutropenia lasted on average for 1.4 days which compared with 1.6 days and 1.8 days reported in studies using filgrastim found in the literature.
Danish: Alvorlig neutropeni varede i gennemsnit 1,4 dage, sammenholdt med 1,6 dage og 1,8 dage i studier af filgrastim rapporteret i litteraturen.
English: An overview of Grastofil and why it is authorised in the EU
Danish: En oversigt over Grastofil, og hvorfor det er godkendt i EU
English: As for all medicines, data on the use of Grastofil are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Grastofil løbende overvåget.
English: This means that Grastofil is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Grastofil i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: The main measure of effectiveness was the duration of severe neutropenia.
Danish: Virkningen blev hovedsageligt målt på varigheden af alvorlig neutropeni.
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Grastofil is being used for.
Danish: Andre bivirkninger kan forekomme hos mere end 1 ud af 10 patienter, afhængigt af den tilstand, som Grastofil anvendes til.
English: Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.
Danish: Data fra publicerede studier indikerer, at fordelene og sikkerheden ved filgrastim er ens hos både voksne og børn, der får kemoterapi.
English: Grastofil can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.
Danish: Grastofil udleveres kun efter recept, og behandlingen bør ske i samarbejde med et center for kræftbehandling.
English: What measures are being taken to ensure the safe and effective use of Grastofil?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Grastofil?
English: For more information about using Grastofil, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Grastofil, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Grastofil the next day and daily for up to 14 days.
Danish: Patienterne fik kemoterapi på dag 1 i en 3-ugers cyklus og fik derefter en daglig dosis Grastofil i op til 15 dage.
English: What is Grastofil and what is it used for?
Danish: Hvad er Grastofil, og hvad anvendes det til?
English: Side effects reported with Grastofil are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Grastofil vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Grastofil is a ‘biosimilar medicine'.
Danish: Grastofil er et "biosimilært lægemiddel".
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grastofil has been shown to have a comparable quality, safety and effectiveness to Neupogen.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Grastofils og Neupogens kvalitet, sikkerhed og virkning svarer til hinanden.
English: The reference medicine for Grastofil is Neupogen.
Danish: Referencelægemidlet for Grastofil er Neupogen.
English: Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections;
Danish: Neutropeni er en almindelig bivirkning ved kræftbehandling og kan gøre patienterne sårbare over for infektioner
English: Why is Grastofil approved?
Danish: Hvorfor blev Grastofil godkendt?
English: Therefore, the Agency's view was that, as for Neupogen, the benefits of Grastofil are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Grastofil opvejer risiciene, som for Neupogen, og at det kan godkendes til anvendelse i EU.
English: Grastofil is a medicine that stimulates the production of white blood cells and is used:
Danish: Grastofil er et lægemiddel, der stimulerer dannelsen af hvide blodlegemer, og det anvendes til:
English: • to help release cells from the bone marrow in patients who are about to donate blood stem cells for transplant;
Danish: • hjælpe med at frigive celler fra knoglemarven hos patienter, der skal donere blodstamceller med henblik på transplantation
English: The active substance in Grastofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Danish: Det aktive stof i Grastofil, filgrastim, minder meget om det menneskelige protein granulocytkolonistimulerende faktor (G-CSF).
English: Grastofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy (medicines to treat cancer) known to cause neutropenia.
Danish: Grastofil blev undersøgt i et hovedstudie med 120 voksne kvinder med brystkræft, som fik kemoterapi (lægemidler mod kræft), der kan medføre neutropeni.
English: The way Grastofil is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Danish: Administrationsvejen, dosen og varigheden af behandlingen med Grastofil afhænger af den sygdom, som det anvendes til, samt patientens vægt og respons på behandlingen.
English: What are the risks associated with Grastofil?
Danish: Hvilke risici er der forbundet med Grastofil?
English: Studies were also carried out to show that Grastofil produces levels of the active substance in the body that are comparable to the reference medicine, Neupogen.
Danish: Der blev desuden gennemført studier til at påvise, at Grastofil medfører et niveau af det aktive stof i kroppen, som svarer til niveauet for referencelægemidlet (Neupogen).
English: The most common side effects with Grastofil (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Grastofil (der kan forekomme hos mere end 1 ud af 10 patienter) er feber, smerter i muskler og knogler, blodmangel, opkastning og kvalme.
English: The medicine is available in prefilled syringes and is given by injection under the skin or infusion (drip) into a vein.
Danish: Lægemidlet fås som fyldte sprøjter og gives ved injektion under huden eller som infusion (drop) i en blodåre.
English: For the full list of side effects and restrictions with Grastofil, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Grastofil fremgår af indlægssedlen.
English: • to treat persistent neutropenia in patients with advanced human-immunodeficiency-virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Danish: • at behandle vedvarende neutropeni hos patienter med fremskreden hiv-infektion og mindske risikoen for bakterieinfektion, når andre behandlinger ikke er relevante.
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Danish: • at øge niveauet af neutrofiler og mindske risikoen for infektioner hos patienter med neutropeni, som tidligere har haft alvorlige, gentagne infektioner