FrancophonIA/ELRC3.0 huggingface dataset:
English: Ketorolac, by inhibiting prostaglandin synthesis secondary to ocular surgical insult or direct mechanical stimulation of the iris, may also contribute to the prevention of surgically induced miosis.
Danish: Ved at hæmme prostaglandinsyntese sekundær til øjenkirurgisk insult eller direkte mekanisk stimulation af iris kan ketorolac også bidrage til forebyggelsen af kirurgisk induceret miose.
English: There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac ophthalmic solution in patients who either have a known hypersensitivity to aspirin/NSAIDs, or a past medical history of asthma.
Danish: Der har været indberetninger om bronkospasme eller eksacerbation af astma i forbindelse med brugen af ketorolac oftalmisk opløsning hos patienter, som enten har en kendt overfølsomhed over for aspirin/NSAID'er eller astma i anamnesen.
English: Significant elevations in blood pressure have been reported following instillation of topical ocular phenylephrine.
Danish: Der har været indberetninger om signifikante stigninger i blodtrykket efter instillation af lokal okulær phenylephrin.
English: No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment (see section 5.2).
Danish: Der forventes ikke at være behov for dosisjustering eller særlige overvejelser hos patienter med nedsat nyre- eller leverfunktion (se pkt.
English: It may also cause headache, anxiety, nausea, vomiting, and abnormal rapid heart rhythm.
Danish: Det kan også give anledning til hovedpine, angst, kvalme, opkastning og en unormalt hurtig puls.
English: The safety and efficacy of Omidria has not been evaluated in patients with a history of uveitis, iris trauma, or alpha-adrenergic antagonist use.
Danish: Omidrias sikkerhed og virkning er ikke blevet evalueret hos patienter med uveitis, iristraume eller brug af alfa-adrenerge antagonister i anamnesen.
English: It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias.
Danish: Det kan også medføre hovedpine, angst, kvalme og opkastning samt ventrikulære arytmier.
English: − 4.0 mL of concentrate solution should be injected into a 500 mL bag /bottle of irrigation solution.
Danish: − De 4,0 ml koncentratopløsning skal injiceres i en 500 ml pose/flaske med skylleopløsning.
English: Phenylephrine is an α1-adrenergic receptor agonist and acts as a mydriatic agent by contracting the radial muscle of the iris, dilating the pupil with little or no cycloplegia.
Danish: Phenylephrin er en α1-adrenerg receptoragonist, der fungerer som et mydriatikum ved at kontrahere m. dilator pupillae, hvorved pupillen dilateres med ringe eller ingen cykloplegi.
English: Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic medicinal products.
Danish: Phenylephrin kan potentiere den kardiovaskulære hæmmende virkning, som visse inhalationsanæstetika kan have.
English: There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Der kan forekomme krydsallergi over for acetylsalicylsyre, phenyleddikesyrederivater og andre nonsteroide antiinflammatoriske midler (NSAID'er).
English: The phenylephrine and ketorolac in Omidria act by distinct mechanisms, to maintain intraoperative mydriasis, to prevent intraoperative miosis, and to reduce acute postoperative pain.
Danish: Phenylephrin og ketorolac i Omidria har forskellige virkningsmekanismer til opretholdelse af intraoperativ mydriase, forebyggelse af intraoperativ miose og reduktion af akut postoperativ smerte.
English: Ocular discomfort Eye inflammation Eye irritation
Danish: Okulært ubehag Inflammation af øjet Øjenirritation
English: The medicine is used to keep the pupil dilated (widened) during surgery and to reduce eye pain after the procedure.
Danish: Lægemidlet benyttes til at holde pupillen udvidet under indgrebet og reducere smerterne i øjet efter indgrebet.
English: The Omidria-containing irrigation solution is intended to be used during the surgical procedure in the same manner that the standard irrigation solution would be used.
Danish: Skyllevæsken med Omidria er beregnet til brug under det kirurgiske indgreb på samme måde som standard skyllevæsker ville blive brugt.
English: The elderly population has been studied in clinical studies.
Danish: Der er udført kliniske studier hos ældre patienter.
English: Foreign body sensation in eyes Glare
Danish: Øjenlågssmerte Følelse af fremmedlegeme i øjet
English: Do not store above 25 ˚C.
Danish: Må ikke opbevares ved temperaturer over 25 °C.
English: Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsberetninger (PSUR'er)
English: In a pharmacokinetic study evaluating Omidria, systemic exposure to both phenylephrine and ketorolac was minimal and transient.
Danish: I et farmakokinetisk studie, der evaluerede Omidria, var den systemiske eksponering for både phenylephrin og ketorolac minimal og forbigående.
English: Excipients: citric acid monohydrate, sodium citrate dihydrate, sodium hydroxide/hydrochloric acid (for pH adjustment), water for injection
Danish: Hjælpestoffer: citronsyremonohydrat, natriumcitratdihydrat, natriumhydroxid/saltsyre (til justering af pH), vand til injektionsvæsker
English: The diluted solution is to be used within 6 hours after dilution.
Danish: Den fortyndede opløsning skal bruges inden for 6 timer efter fortynding.
English: N. Ireland
Danish: Nordirland
English: In Study 1, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at the time of cortical clean-up, and 3% of patients in the Omidria group compared to 28% of patients in the placebo group had a pupil constriction ≥2.5 mm (P < 0.0001 in both instances, Chi-Square test).
Danish: I studie 1 havde kun 4 % af patienterne i Omidria-gruppen en pupildiameter < 6 mm på tidspunktet for kortical oprensning sammenlignet med 23 % af patienterne i placebogruppen, og 3 % af patienterne i Omidria-gruppen sammenlignet med 28 % af patienterne i placebogruppen havde en pupilkonstriktion ≥ 2,5 mm (P < 0,0001 i begge tilfælde, khi i anden-test).
English: − The vial should be visually inspected for particulate matter.
Danish: − Hætteglasset skal undersøges visuelt for partikler.
English: Clear, colourless to slightly yellow, sterile concentrate for solution for intraocular irrigation.
Danish: Klart, farveløst til let gulligt sterilt koncentrat til intraokulær skylning, opløsning.
English: Anterior chamber inflammation Conjunctival hyperaemia Corneal oedema Photophobia
Danish: Øjensmerter Inflammation af det anteriore kammer Konjunktival hyperæmi Corneaødem Fotofobi
English: Omidria must not be used:
Danish: Brug ikke Omidria:
English: Only a clear, colourless solution without visible particles should be used.
Danish: Opløsningen må kun anvendes, hvis den er klar og farveløs og uden synlige partikler.
English: Omidria must be administered in a controlled surgical setting by a qualified ophthalmological surgeon experienced in intraocular lens replacement surgery.
Danish: Omidria skal administreres under kontrollerede kirurgiske forhold af en kvalificeret øjenkirurg, der har erfaring med intraokulær linseudskiftningskirurgi.
English: Omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.
Danish: Omidria er indiceret til opretholdelse af intraoperativ mydriase, forebyggelse af intraoperativ miose og nedsættelse af akut postoperativ øjensmerte i forbindelse med intraokulær linseudskiftningskirurgi hos voksne.
English: In a pharmacokinetic study evaluating Omidria, systemic exposure to each of phenylephrine and ketorolac was minimal and transient.
Danish: I et farmakokinetisk studie, hvor Omidria blev evalueret, var den systemiske eksponering for henholdsvis phenylephrin og ketorolac minimal og forbigående.
English: Omidria is used as a solution to rinse the eye (irrigation solution) during surgery to replace the lens.
Danish: Omidria bruges som en væske til at skylle øjnene (skyllevæske) under et kirurgisk indgreb med henblik på udskiftning af linsen.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for de aktive stoffer eller et eller flere af hjælpestofferne anført i pkt.
English: The recommended dose is 4.0 mL of Omidria diluted in 500 mL of irrigation solution administered by intraocular irrigation to the affected eye during surgery.
Danish: Den anbefalede dosis er 4,0 ml Omidria fortyndet med 500 ml skyllevæske administreret som intraokulær skylning af det pågældende øje under indgrebet.
English: What you need to know before Omidria is used
Danish: Det skal du vide, før du begynder at bruge Omidria
English: For dilution instructions, see section 6.6.
Danish: For instruktioner om fortynding, se pkt.
English: After dilution, the solution contains 0.081 mg/mL phenylephrine and 0.023 mg/mL ketorolac.
Danish: Efter fortynding indeholder opløsningen 0,081 mg/ml phenylephrin og 0,023 mg/ml ketorolac.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLESKRIFT <Fritaget fra krav om brailleskrift.>
English: Omidria is not recommended in women of childbearing potential not using contraception.
Danish: Omidria bør ikke anvendes til kvinder i den fertile alder, som ikke anvender antikonception.
English: Intraocular use after dilution.
Danish: Intraokulær anvendelse efter fortynding.
English: The other ingredients are - Citric acid monohydrate - Sodium citrate dihydrate - Sodium hydroxide (to adjust alkalinity level) - Hydrochloric acid (to adjust acidity level) - Water for injection
Danish: Øvrige indholdsstoffer: - citronsyremonohydrat - natriumcitratdihydrat - natriumhydroxid (surhedsregulerende middel) - saltsyre (surhedsregulerende middel) - vand til injektionsvæsker
English: Supplied in a single-use vial designed to deliver 4.0 mL of concentrate for dilution into 500 mL of irrigation solution for ocular use.
Danish: Leveres i et hætteglas til engangsbrug beregnet til at give 4,0 ml koncentrat til fortynding med 500 ml skyllevæske til anvendelse i øjnene.
English: Use within 6 hours of dilution.
Danish: Skal bruges inden for 6 timer efter fortynding.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL DELPAKNING
English: Only a clear, colourless to slightly yellow solution without visible particles should be used.
Danish: Opløsningen må kun anvendes, hvis den er klar, farveløs til let gullig og uden synlige partikler.
English: In Study 2, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at cortical clean-up, and 1% of patients in the Omidria group compared to 27% of patients in the placebo group had a pupil constriction ≥ 2.5 mm (P < 0.0001, Chi-Square test).
Danish: I studie 2 havde kun 4 % af patienterne i Omidria-gruppen en pupildiameter < 6 mm ved kortical oprensning sammenlignet med 23 % af patienterne i placebogruppen, og 1 % af patienterne i Omidria-gruppen sammenlignet med 27 % af patienterne i placebogruppen havde en
English: Omidria should not be used during pregnancy.
Danish: Omidria bør ikke anvendes under graviditet.
English: Intraoperative pupil diameter (mm) change-from-baseline
Danish: Ændring af intraoperativ pupildiameter (mm) fra baseline
English: − No other medicinal products should be added to the prepared irrigation solution.
Danish: − Der må ikke tilsættes andre lægemidler til skyllevæsken.
English: There are no adequate data from the use of phenylephrine hydrochloride or ketorolac trometamol on fertility in humans.
Danish: Der er utilstrækkelige data vedrørende den menneskelige fertilitet ved anvendelse af phenylephrinhydrochlorid eller ketorolactrometamol.
English: Subjects with VAS = 0 at all times Subjects with VAS ≥ 40 at any time
Danish: Forsøgspersoner med VAS = 0 på alle tidspunkter
English: Omidria is indicated for addition to irrigation solution used during intraocular lens replacement procedures only.
Danish: Omidria er kun indiceret som tilsætning til skyllevæske til brug under intraokulære linseudskiftningsindgreb.
English: 6.6 Special precautions for disposal and other handling To prepare Omidria for intraocular irrigation, dilute 4.0 mL of concentrate in 500 mL of standard ophthalmological irrigation solution.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Omidria klargøres til intraokulær skylning ved at fortynde 4,0 ml koncentrat med 500 ml standard oftalmologisk skyllevæske.
English: The use of Omidria during intraocular lens replacement surgery may cause vision to be temporarily affected.
Danish: Brugen af Omidria under intraokulær linseudskiftningskirurgi kan medføre en midlertidig påvirkning af synet (se punkt 4.7).
English: Colourless 5-mL type-1 glass vial closed with a butyl rubber stopper and a polypropylene flip-off cap.
Danish: Farveløst 5 ml hætteglas af type 1-glas med en butylgummiprop og en polypropylen afrivningshætte.
English: After dilution in 500 mL of irrigation solution, the solution contains 0.081 mg/mL of phenylephrine and of 0.023 mg/mL ketorolac.
Danish: Efter fortynding i 500 ml skyllevæske, indeholder opløsningen 0,081 mg/ml phenylephrin og 0,023 mg/ml ketorolac.
English: Anticipated systemic exposure is minimal and transient, however, caution should be used in treating patients with poorly controlled hypertension.
Danish: Der skal dog udvises forsigtighed ved behandling af patienter med dårligt kontrolleret hypertension.
English: − Using aseptic technique, withdraw 4.0 mL of concentrate solution using an appropriate sterile needle.
Danish: − Træk 4,0 ml koncentratopløsning op med en egnet steril nål under anvendelse af aseptisk teknik.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for intraocular irrigation 1 vial.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til intraokulær skyllevæske, opløsning 1 hætteglas.
English: If any of the above applies to you, please inform your doctor.
Danish: Fortæl det til din læge, hvis noget af ovenstående gælder for dig.
English: The solution should be used within 6 hours of preparation.
Danish: Opløsningen skal bruges inden for 6 timer efter klargøring.
English: How Omidria is used
Danish: Sådan skal du bruge Omidria
English: The following warnings and precautions related to topical ophthalmic use of phenylephrine and ketorolac should be considered with the use of Omidria:
Danish: I forbindelse med brugen af Omidria skal der tages højde for nedenstående advarsler og forsigtighedsregler vedrørende lokal oftalmisk anvendelse af phenylephrin og ketorolac: Kardiovaskulære reaktioner
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin, har gjort det for nylig eller påtænker at gøre det. - Det er især vigtigt, at du siger det til lægen, hvis du bruger atropin, som er et lægemiddel,
English: Conjunctival oedema Corneal disorder Mydriasis
Danish: Konjunktivalt ødem Hornhindelidelse Mydriase
English: 6.3 Shelf life
Danish: 6.3 Holdbarhed
English: Each 4.0 mL vial of solution contains 40.6 mg (10.2 mg/mL) of phenylephrine and 11.5 mg (2.88 mg/mL) of ketorolac.
Danish: Hvert 4,0 ml hætteglas med opløsning indeholder 40,6 mg (10,2 mg/ml) phenylephrin og 11,5 mg (2,88 mg/ml) ketorolac.
English: What Omidria is and what it is used for What you need to know before Omidria is used How Omidria is used
Danish: Det skal du vide, før du begynder at bruge Omidria Sådan skal du bruge Omidria Bivirkninger
English: In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean area-under-the curve (AUC) was 0.58 mm [95% confidence interval: 0.48, 0.68] (P < 0.0001).
Danish: I studie 1 var den CMHvægtede middelforskel (Omidria - placebo) i middelarealet under kurven (AUC) 0,58 mm [95 % konfidensinterval: 0,48, 0,68] (P < 0,0001).
English: In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -4.58 mm [95% confidence interval: -6.92, -2.24] (P < 0.001).
Danish: I studie 2 var den CMH-vægtede middelforskel (Omidria - placebo) i middel-AUC -4,58 mm [95 % konfidensinterval: -6,92, -2,24] (P < 0,001).
English: - if you are allergic to phenylephrine or ketorolac or any of the other ingredients of this medicine
Danish: - hvis du er allergisk over for phenylephrin eller ketorolac eller et af de øvrige indholdsstoffer (angivet i punkt 6) - hvis du har en øjenlidelse, som kaldes snævervinklet glaukom.
English: Omidria is not recommended during pregnancy.
Danish: Omidria må ikke anvendes under graviditet.
English: In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -5.20 mm [95% confidence interval: -7.31, -3.09] (P < 0.001).
Danish: I studie 1 var den CMH-vægtede middelforskel (Omidriaplacebo) i middel-AUC -5,20 mm [95 % konfidensinterval: -7,31, -3,09] (P < 0,001).
English: If your eye surgery will involve general anaesthesia, talk to your doctor about this.
Danish: Hvis du skal i fuld narkose under indgrebet, skal du tale med lægen om dette.
English: - Especially, tell your doctor if you are taking atropine, a medicine used to dilate (widen) the pupil of the eye.Taking atropine at the same time as Omidria may increase blood pressure and cause the heart to beat faster in some patients.
Danish: Hvis du bruger atropin, samtidig med at du bliver behandlet med Omidria, kan det føre til forhøjet blodtryk og puls hos visse patienter.
English: Ketorolac is a painkiller that belongs to the group called non-steroidal anti-inflammatory drugs (NSAIDS); it also helps stop the pupil from contracting (getting smaller).
Danish: Ketorolac er et smertestillende middel, som tilhører gruppen, der kaldes nonsteroide antiinflammatoriske lægemidler (NSAID'er).
English: Visual acuity reduced Vitreous floaters Eye pruritus
Danish: Nedsat synsskarphed Mouches volantes Øjenpruritus
English: In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was 0.59 mm [95% confidence interval: 0.49, 0.69] (P < 0.0001).
Danish: I studie 2 var den CMH-vægtede middelforskel (Omidriaplacebo) i middel-AUC 0,59 mm [95 % konfidensinterval: 0,49, 0,69] (P < 0,0001).
English: The following information is intended for healthcare professionals only: To prepare Omidria for intraocular irrigation, dilute 4.0 mL of Omidria concentrate in 500 mL of standard ophthalmological irrigation solution.
Danish: Omidria klargøres til intraokulær skylning ved at fortynde 4,0 ml Omidria-koncentrat med 500 ml standard oftalmologisk skyllevæske.
English: Package leaflet: Information for the user Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Danish: Indlægsseddel: Information til brugeren Omidria 10 mg/ml + 3 mg/ml koncentrat til intraokulær skyllevæske, opløsning phenylephrin/ketorolac
English: Breast-feeding
Danish: BATCHNUMMBER
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation
Danish: LÆGEMIDLETS NAVN Omidria 10 mg/ml + 3 mg/ml koncentrat til intraokulær skyllevæske, opløsning
English: Each 4 mL of solution in the vial contains phenylephrine hydrochloride equivalent to 40.6 mg (10.2 mg/mL) of phenylephrine and ketorolac trometamol equivalent to 11.5 mg (2.88 mg/mL) of ketorolac.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Ét 4 ml hætteglas indeholder phenylephrinhydrochlorid svarende til 40,6 mg (10,2 mg/ml) phenylephrin og ketorolactrometamol svarende til 11,5 mg (2,88 mg/ml) ketorolac.
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: - Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre,
English: AUC change from baseline in pupil diameter (mm) during surgery (Co-primary endpoint) [MeanSD)] Diameter < 6 mm at any time Diameter < 6 mm at cortical clean-up ≥ 2.5 mm pupillary constriction
Danish: AUC-ændring fra baseline i pupildiameter (mm) under indgrebet (co-primært endepunkt) [MiddelSD]
English: One 4 mL vial contains phenylephrine hydrochloride equal to 40.6 mg phenylephrine and ketorolac trometamol equal to 11.5 mg ketorolac.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Ét 4 ml hætteglas indeholder phenylephrinhydrochlorid svarende til 40,6 mg phenylephrin og ketorolactrometamol svarende til 11,5 mg ketorolac.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Omidria 10 mg/ml + 3 mg/ml koncentrat til intraokulær skyllevæske, opløsning phenylephrin/ketorolac
English: Omidria should not be used during breast-feeding.
Danish: Omidria bør ikke anvendes under amning.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Dette lægemiddel skal fortyndes før intraokulær anvendelse.
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Danish: LÆGEMIDLETS NAVN Omidria 10 mg/ml + 3 mg/ml koncentrat til intraokulær skyllevæske, opløsning Phenylephrin/ketorolac
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation Phenylephrine/ketorolac
Danish: LÆGEMIDLETS NAVN Omidria 10 mg/ml + 3 mg/ml koncentrat til intraokulær skyllevæske, opløsning phenylephrin/ketorolac
English: Phenylephrine acts to keep the pupil dilated (widened).
Danish: Phenylephrin virker ved at udvide pupillen.
English: Following dilution do not store above 25 ˚C
Danish: Må ikke opbevares ved temperaturer over 25 °C efter fortynding 6.5 Emballagetype og pakningsstørrelser
English: Concentrate for solution for intraocular irrigation.
Danish: Koncentrat til intraokulær skyllevæske, opløsning.
English: Cross-sensitivity
Danish: Krydsallergi
English: Colourless 5-mL type-I glass vial closed with a butyl rubber stopper and a polypropylene flip-off cap. Each single-use vial is packaged in a cardboard carton.
Danish: Hvert enkelt hætteglas til engangsbrug er pakket i en papkarton.
English: Pain
Danish: Amning
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ikervis on 19 March 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ikervis den 19. marts 2015.
English: Ikervis should be given last.
Danish: Ikervis skal gives sidst.
English: The full EPAR and risk management plan summary for Ikervis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Ikervis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Ikervis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ikervis.
English: Other information about Ikervis
Danish: Andre oplysninger om Ikervis
English: A risk management plan has been developed to ensure that Ikervis is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ikervis anvendes så sikkert som muligt.
English: About 29% (44 of 154) of those given Ikervis responded, compared with 23% (21 of 91) given the vehicle.
Danish: Behandlingen virkede hos ca. 29 % (44 ud af 154) af dem, der fik Ikervis, sammenholdt med 23 % (21 ud af 91) af dem, der fik vehiklet.
English: What is Ikervis and what is it used for?
Danish: Hvad er Ikervis, og hvad anvendes det til?