FrancophonIA/ELRC3.0 huggingface dataset:
English: Tél/Tel: +32-(0)2-535 63 11
Danish: Luxembourg/Luxemburg Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11
English: • Prior to usage, the unopened vial may be stored at room temperature (below 25°C) for up to
Danish: • Før brug kan det uåbnede hætteglas opbevares ved stuetemperatur (under 25 °C) i op til
English: • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),
Danish: • nedsat syn på grund af makulaødem sekundært til retinal veneokklusion (RVO)
English: Holding the syringe with the needle pointing up, check the syringe for bubbles.
Danish: Kontroller, om det er bobler i injektionssprøjten, ved at holde injektionssprøjten med kanylen pegende opad.
English: Prior to usage, the unopened blister of Eylea may be stored at room temperature (below 25°C) for up to 24 hours.
Danish: Før brug kan den uåbnede blister med Eylea opbevares ved stuetemperatur (under 25 °C) i op til 24 timer.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose = 2 mg/50 microlitres Extractable content = 4 mg/100microlitres
Danish: Ekstraherbar mængde = 4 mg/100 mikroliter
English: Vitreous floaters, Vitreous detachment, Injection site pain, Foreign body sensation in eyes, Lacrimation increased, Eyelid oedema,
Danish: Iridocyklitis, Linseuklarheder, Corneaepiteldefekt, Irritation på injektionsstedet, Unormal fornemmelse i øjet, Irritation af øjenlåget, Lysvej i forreste kammer,
English: weeks to 8 weeks through week 48.
Danish: Reduktionen blev opretholdt til og med uge 48.
English: NAME OF THE MEDICINAL PRODUCT Eylea 40 mg/ml solution for injection in pre-filled syringe.
Danish: LÆGEMIDLETS NAVN Eylea 40 mg/ml injektionsvæske, opløsning, i fyldt injektionssprøjte.
English: Solution for injection in pre-filled syringe
Danish: MÆRKNING PÅ BLISTER Fyldt injektionssprøjte
English: Visual acuity reduced, Conjunctival haemorrhage, Eye pain
Danish: Nedsat visus, Konjunktival blødning, Øjensmerter
English: List of side effects reported
Danish: Liste over bivirkninger
English: BCVA as covariate.
Danish: Doseri ngslinj e
English: • Prior to usage, the unopened blister may be stored at room temperature (below 25°C) for up to
Danish: • Før brug kan den uåbnede blister opbevares ved stuetemperatur (under 25 °C) i op til 24 timer.
English: A,C)
Danish: A)
English: Mean change in BCVA as measured by ETDRS E letter score from Baseline
Danish: Gennemsnitlig ændring i BCVA målt ved ETDRS Ebogstavsscoring fra baseline
English: NAME OF THE MEDICINAL PRODUCT Eylea 40 mg/ml solution for injection in a vial.
Danish: LÆGEMIDLETS NAVN Eylea 40 mg/ml injektionsvæske, opløsning, i et hætteglas.
English: The ALTAIR study was conducted in Japanese patients with treatment naïve wet AMD, showing similar outcomes to the VIEW studies using 3 initial monthly Eylea 2 mg injections, followed by one injection after a further 2 months, and then continued with a treat-and-extend regimen with variable treatment intervals (2- week or 4- week adjustments) up to a maximum 16 week interval according to pre-specified criteria.
Danish: Derefter blev der fortsat med en gradvis forlængelse af behandlingsintervallet (treat and extend regimen) med variable behandlingsintervaller (justeringer på 2 eller 4 uger) til et maksimalt 16 ugers interval ifølge de præspecificerede kriterier.
English: Prior to use, the unopened blister may be stored at room temperature (below 25°C) for up to 24 hours.
Danish: Før brug kan den uåbnede blisterpakning opbevares ved stuetemperatur (højst 25 °C) i op til 24 timer.
English: Pharmacodynamic effects wet AMD
Danish: Farmakodynamisk virkning
English: Mean change in BCVA B) as measured by ETDRS letter score from baseline (SD) B) Difference in LS mean C,D,E) (95% CI) Proportion of patients with ≥15 letters gain from baseline Weighted difference D,F) (95% CI)
Danish: Gennemsnitlig ændring i BCVAC) målt ved ETDRSC) bogstavs-score fra baseline (SD) Forskel i LS-gennemsnitA,C,D,E) (95 % CI) p-værdi p < 0,0001
English: Proportion of patients with ≥ 15 letters gain from baseline
Danish: Andel af patienter med en forbedring på ≥ 15 bogstaver fra baseline
English: Proportion of patients with≥15 letters gain from baseline
Danish: Andel af patienter med en forbedring på ≥15 bogstaver fra baseline
English: LOCF: Last Observation Carried Forward
Danish: PRN med forlængede monitoreringsinterval
English: Vial for single use only.
Danish: Hætteglas kun til engangsbrug.
English: Prior to use, the unopened vial may be stored at room temperature (below 25°C) for up to 24 hours.
Danish: Før brug kan det uåbnede hætteglas opbevares ved stuetemperatur (højst 25°C) i op til 24 timer.
English: EMEA/459391/2008-EN
Danish: EMEA/459391/2008-DA
English: The CVMP Opinion was adopted on 13 February 2008 and the subsequent Commission Decision on 2 April 2008.
Danish: CVMP's udtalelse blev vedtaget den 13. februar 2008 og den efterfølgende afgørelse truffet af Europa-Kommissionen den 2. april 2008
English: The gel is applied on the skin and its indications are:
Danish: Gelen smøres på huden, og dens indikationer er:
English: Compagel Gel for Horses is a generic product.
Danish: Compagel gel til heste er et generisk produkt.
English: In June 2007 a mutual recognition procedure started with Germany as Reference Member State and 5 Concerned Member States.
Danish: I juni 2007 blev en gensidig anerkendelsesprocedure indledt med Tyskland som referencemedlemsstat og med 5 berørte medlemsstater.
English: The CVMP started the referral procedure during its meeting of 15-17 January 2008.
Danish: CVMP indledte indbringelsesproceduren på sit møde den 15.-17. januar 2008.
English: The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.
Danish: Sagen blev indbragt for koordineringsgruppen for gensidig anerkendelse og decentraliserede procedurer, CMD(v) og efterfølgende for CVMP.
English: The objections from France and Sweden should not prevent the granting of a marketing authorisation.
Danish: De indsigelser, som Frankrig og Sverige rejste, bør ikke forhindre udstedelse af en markedsføringstilladelse.
English: No differences between the two products have been identified that would justify different conclusions on the safety and efficacy.
Danish: Der er ikke identificeret forskelle mellem de to produkter, der kunne berettige forskellige konklusioner med hensyn til sikkerhed og virkning.
English: Having considered the referral notification and responses of the applicant, the CVMP concluded that all concerned member states in the mutual recognition procedure agreed that Compagel Gel for Horses is essentially similar to Tensolvet 50000.
Danish: Efter at have overvejet indbringelsesanmeldelsen og ansøgerens svar konkluderede CVMP, at alle berørte medlemsstater i proceduren for gensidig anerkendelse var enige om, at Compagel gel til heste i det væsentlige ligner Tensolvet 50000.
English: Compagel Gel for Horses contains heparin sodium, levomenthol and hydroxyethyl salicylates.
Danish: Compagel gel til heste indeholder heparinnatrium, levomenthol og hydroxyethylsalicylat.
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR COMPAGEL GEL FOR HORSES
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 33, STK. 4 VEDRØRENDE COMPAGEL GEL TIL HESTE
English: Therefore, the absence of efficacy documentation does not present a potential serious risk to animal health.
Danish: Den manglende dokumentation for virkning udgør derfor ikke en potentiel alvorlig risiko for dyresundheden.
English: France and Sweden could not agree to the granting of a marketing authorisation as they considered there were potential serious risks to animal health.
Danish: Frankrig og Sverige kunne ikke godkende udstedelsen af en markedsføringstilladelse, da de vurderede, at der var alvorlige potentielle risici for dyresundheden.
English: • To accelerate the absorption of infiltrates (e.g. postoperative swelling, penile paralysis).
Danish: • Fremskyndelse af absorptionen af infiltrater (f.eks. postoperativ hævelse, penisparalyse).
English: The Marketing Authorisation Holder was requested to provide a copy of the dossier and, in view of the concerns raised by France and Sweden, to indicate and to substantiate where necessary any differences between Compagel Gel for Horses and the reference product that could justify different conclusions on the safety or efficacy for the two products.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at fremskaffe en kopi af dossieret og i betragtning af de betænkeligheder, som Frankrig og Sverige havde rejst, at angive og om nødvendigt at dokumentere eventuelle forskelle mellem Compagel gel til heste og referencelægemidlet, som kunne retfærdiggøre forskellige konklusioner med hensyn til de to produkters sikkerhed eller virkning.
English: France and Sweden considered that due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
Danish: Frankrig og Sverige fandt, at det på grund af manglende dokumentation for virkning ikke kan antages, at lægemidlet er effektivt, og at dette som sådan udgør en potentiel alvorlig risiko for dyrs sundhed.
English: In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of the compositions that there are no differences between Compagel Gel for Horses and the reference product that could justify different conclusions on the safety and efficacy.
Danish: Som svar på spørgsmålene indsendte ansøgeren dossieret og anførte på grundlag af en sammenligning af sammensætningerne, at der ingen forskelle er mellem Compagel gel til heste og referencelægemidlet, som kunne retfærdiggøre forskellige konklusioner med hensyn til sikkerhed og virkning.
English: contusion, bruising, inflammation of the joint capsule (synovitis), muscle rupture, after nerve block anaesthesia, after paravenous injection.
Danish: kvæstelse, stød, inflammation i ledkapsel (synovitis), muskelsprængning, efter nerveblokanæstesi,
English: • Haematoma, tendinitis, tendovaginitis, bursitis, capped hock, saddle sore, sprain, torsion,
Danish: • Haematoma, tendinitis, tendovaginitis, bursitis, piphas, sadeltrykning, forstuvning, forvridning,
English: • To treat inflammations of superficial veins (e.g. phlebitis, thrombophlebitis, infusion thrombophlebitis).
Danish: • Behandling af inflammationer i overfladiske vener (f.eks. flebitis, tromboflebitis,
English: Under these conditions the applicant is exempted from submitting further preclinical or clinical data on efficacy of the
Danish: omstændigheder er ansøgeren fritaget for at indsende yderligere prækliniske eller kliniske data vedrørende det foreslåede produkts virkning og kan rejse krav om de samme terapeutiske indikationer som de, der gælder for referenceproduktet.
English: Bottle (LDPE) oval
Danish: Flaske (LDPE) oval
English: Bottle (LDPE)
Danish: Flaske (LDPE)
English: Bottle (LDPE) round
Danish: Flaske (LDPE) rund
English: Date of latest renewal: 20 December 2012
Danish: Dato for seneste fornyelse: 20. december 2012
English: SN {number} [serial number]
Danish: SN {nummer} [serienummer]
English: One year later, the child's development remained normal.
Danish: Et år senere var barnets udvikling indenfor normalområdet.
English: Other published data support these conclusions.
Danish: Andre publiserede data supporterer disse konklusioner.
English: 3 for men.
Danish: 3 for mænd.
English: NN {number} [national reimbursement number or other national number identifying the medicinal product]
Danish: NN {nummer} [nationalt refusionsnummer eller andet nationalt nummer, der identificerer lægemidlet]
English: It is particularly important that you tell your doctor if you are taking or have recently taken:
Danish: Det er særligt vigtigt, at du fortæller det til din læge, hvis du tager eller for nylig har taget:
English: 2NN Three-year follow-up-study
Danish: 2NN Tre-års follow-up studie
English: Race - White - Black - Asian - Other
Danish: Race - Hvid - Farvet - Asiatisk - Andet
English: - Other**
Danish: - Andet**
English: There are no adequate and well-controlled studies in pregnant women.
Danish: Der findes ingen fyldestgørende, gennemkontrollerede studier, hvori der indgår gravide.
English: Such reactions can be life-threatening.
Danish: Sådanne reaktioner kan være livstruende.
English: These excipients can cause allergic reactions over time.
Danish: Disse hjælpestoffer kan forårsage allergiske reaktioner over tid.
English: ** Based on Cochran's statistic with continuity correction for the variance calculation
Danish: ** Baseret på Cochrane-statistik med kontinuitetskorrektion for beregning af varians.
English: ** Includes American Indians/Alaska natives and Hawaiian/Pacific islanders.
Danish: ** Omfatter amerikanske indianere/first nation people fra Alaska og øboer fra Hawaii og Stillehavet.
English: 25 and above
Danish: 25 og derover
English: To date no other relevant epidemiological data are available.
Danish: Indtil videre er der ingen øvrige relevante epidemiologiske data tilgængelige.
English: HIV-1 subtype
Danish: Hiv-1-undertype
English: ND = Not Determined, ↑ = Increased, ↓ = Decreased,  = No Effect
Danish: ND = non-detekterbar, ↑ = øget, ↓ = Formindsket,  = Ingen effekt
English: Open the bottle.
Danish: Åbn flasken.
English: Region - North America
Danish: Region - Nordamerika
English: Therefore, you may continue to develop infections and other illnesses associated with HIV infection.
Danish: Derfor vil du muligvis fortsat få infektioner og andre sygdomme fremkaldt af hiv-infektionen.
English: Virologic failure - Never suppressed through week 48 - Rebound
Danish: Virologisk svigt - Ikke på noget tidspunkt undertrykt til og med uge 48 - Rebound
English: Other enzymes may be involved in the metabolism.
Danish: Andre enzymer er muligvis involveret i metaboliseringen.
English: Patients should be intensively monitored during the first 18 weeks of treatment.
Danish: Patienter bør monitoreres intensivt de første 18 uger af behandlingen.
English: 43.8 and above
Danish: 43,8 og derover
English: One case of massive accidental overdose in a newborn was reported.
Danish: Et tilfælde af massiv overdosis hos et nyfødt barn er rapporteret.
English: Close monitoring of anticoagulation levels is warranted.
Danish: Tæt monitorering af antikoagulationsniveauer er nødvendig.
English: In these cases, more frequent liver monitoring is required.
Danish: I disse tilfælde er oftere levermonitorering påkrævet.
English: Cases of jaundice have been reported.
Danish: Tilfælde af gulsot er blevet rapporteret.
English: These reactions occur mainly in the first 18 weeks of treatment with Viramune.
Danish: Disse reaktioner opstår primært i de første 18 uger af behandlingen med Viramune.
English: Your doctor will test for these changes.
Danish: Lægen vil holde øje med disse forandringer.
English: If you need a higher dose, repeat steps 4-5 above.
Danish: Hvis du skal bruge en højere dosis så gentag punkt 3-4 herover.
English: 6.6 Special precautions for disposal and other handling Instructions for administration:
Danish: 6.6 Regler for bortskaffelse og anden håndtering Vejledning for administration:
English: Discontinued medicinal product prior to week 48
Danish: Fik seponeret lægemidlet før uge 48
English: Gender - Male - Female
Danish: Køn - Mænd - Kvinder
English: Lactose (as monohydrate)
Danish: Lactose (som monohydrat)
English: Hypersensitivity (allergic) reactions can occur.
Danish: Overfølsomhedsreaktioner (allergiske) kan forekomme.
English: Interferons (pegylated interferons alfa 2a and alfa 2b)
Danish: Interferoner (pegyleret interferon alfa 2a og alfa 2b)
English: This is therefore an important period which requires close monitoring by your doctor.
Danish: Det er derfor en vigtig periode, hvor det kræves, at du følges nøje af din læge.
English: Viramune oral suspension can be taken by children of all age groups.
Danish: Viramune oral suspension kan tages af børn i alle aldre.
English: Based on the data available so far, this has not been shown to affect the therapeutic response.
Danish: Hidtil har tilgængelige data ikke vist, at dette påvirker det terapeutiske respons.
English: These can become severe and even life threatening.
Danish: Sådanne reaktioner kan blive alvorlige og endog livstruende.
English: Contact your doctor if you notice changes in body fat (see section 4 “Possible side effects”).
Danish: Kontakt din læge, hvis du opdager ændringer i kropsfedt (se under punkt 4 ”Bivirkninger”).
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er bevis for forværring af leversygdom hos disse patienter bør afbrydelse af eller ophør med behandlingen overvejes.
English: Interaction has not been studied.
Danish: Interaktion er ikke undersøgt.
English: Numerous studies have been performed examining the use of Viramune in regards to perinatal transmission, most notably HIVNET 012.
Danish: Utallige studier er udført for at undersøge brugen af Viramune i forhold til perinatal transmission, især HIVNET 012.
English: Careful monitoring of paediatric patients is especially warranted, particularly in the first 18 weeks of treatment, since these patients may be less likely than adults to notice, or report, skin reactions.
Danish: Omhyggelig monitorering af pædiatriske patienter er specielt berettiget, særligt i de første 18 uger af behandlingen, da disse patienter formodentlig i mindre grad end voksne bemærker eller rapporterer hudreaktioner.
English: Turn the bottle upside down and gently draw out the required amount of Viramune oral suspension.
Danish: Vend flasken på hovedet og udtag forsigtigt den nødvendige mængde Viramune oral suspension.
English: There is at present little information on the effects of Viramune overdose.
Danish: Der er på nuværende tidspunkt kun få oplysninger om virkningerne af Viramune ved overdosering.
English: ANTIVIRALS FOR CHRONIC HEPATITIS B AND C Adefovir
Danish: ANTIVIRALE MIDLER TIL KRONISK HEPATITIS B OG C Adefovir
English: Greater than 80 % of the radioactivity in urine was made up of glucuronide conjugates of hydroxylated metabolites.
Danish: Mere end 80 % af radioaktiviteten i urinen består af glucuronid konjugater af hydroxylerede metabolitter.
English: There were no significant differences in demographic and baseline characteristics between the treatment groups.
Danish: Der var ingen signifikante forskelle i demografiske og baseline karakteristika mellem behandlingsgrupperne.
English: It is important that the entire measured dose of Viramune oral suspension is administered.
Danish: Det er vigtigt, at hele den opmålte mængde Viramune oral suspension indtages.
English: Also, both dosing regimens were effective in reducing the viral load.
Danish: Desuden var begge doseringsregimer effektive til at nedsætte det viral belastning.
English: The use of Viramune has not been evaluated within a specific study on PEP, especially in term of treatment duration and therefore, is strongly discouraged.
Danish: Brugen af Viramune er ikke blevet evalueret ved et specifikt studie på PEP, specielt med henblik på behandlingsvarighed, og frarådes derfor kraftigt.
English: Female patients showed a 13.8 % lower clearance of nevirapine than did male patients.
Danish: De kvindelige patienter viste en 13,8 % lavere clearance af nevirapin end de mandlige patienter.
English: The clinical relevance of these data in European populations has not been established.
Danish: Den kliniske relevans af disse data i den europæiske population er ikke klarlagt.
English: Interferons have no known effect on CYP 3A4 or 2B6.
Danish: Interferoner har ingen kendt effekt på CYP3A4 eller 2B6.
English: Medicinal products by therapeutic areas
Danish: Lægemidler efter terapeutiske områder
English: The recommended oral doses for paediatric patients based upon their weight are described in the table below.
Danish: Den anbefalede orale dosis til pædiatriske patienter baseret på deres vægt fremgår af tabellen nedenfor.
English: Reverse transcriptase is an enzyme that HIV needs in order to multiply.
Danish: Revers transkriptase er et enzym, som hiv har brug for for at kunne formere sig.
English: The recommended weight-based paediatric dose is dependent upon the patient's age, with different recommended doses for children from 3 to < 8 years of age and children 8 years or older.
Danish: Den anbefalede vægtbaserede pædiatriske dosis afhænger af patientens alder, idet de anbefalede doser til børn fra 3 til < 8 år og børn på 8 år eller derover er forskellige.
English: Overall, there was a comparable incidence of symptomatic hepatic events among men and women enrolled in VERxVE.
Danish: Samlet set var incidensen af symptomatiske hepatiske hændelser blandt mænd og kvinder, der var inkluderet i VERxVE, ens.
English: There was also accumulation of nevirapine hydroxy-metabolites in plasma.
Danish: Der var også akkumulering af nevirapin-hydroxy-metabolitter i plasma.
English: ANTACIDS Cimetidine
Danish: ANTACIDA Cimetidin
English: Changes of body fat may occur in patients receiving combination antiretroviral therapy.
Danish: Ændringer af fordelingen af kropsfedt kan forekomme hos patienter, som modtager antiretroviral kombinationsbehandling.
English: As Viramune must always be taken together with other HIV antiretroviral medicines, you should follow the instructions for your other medicines carefully.
Danish: Da Viramune altid skal tages sammen med andre hiv-antiretrovirale lægemidler, bør du nøje følge instruktionerne for de andre lægemidler.
English: • have a body surface area of 1.17 m2 or above according to the Mosteller formula.
Danish: • har et legemsoverfladeareal på 1,17 m2 eller højere i henhold til Mosteller-formlen
English: The denominator 1,068 includes 55 patients who stopped treatment during the lead in phase and two patients randomized but never treated with randomized dose.
Danish: Inkluderet i 1.068 er 55 patienter, der stoppede behandlingen i optrapningsfasen, og to randomiserede patienter, som aldrig blev behandlet med randomiseringsdosen.
English: Make sure that the adapter is fitted tightly.
Danish: Vær sikker på, at adaptoren sidder godt fast.
English: Insert the syringe into the adapter.
Danish: Sæt sprøjten i adaptoren.
English: Sodium hydroxide (for pH-adjustment) Purified water
Danish: Natriumhydroxid ( til pH justering) Renset vand
English: The maximum volume which can be measured with the dispensing syringe is 5 ml and therefore steps 3-5 must be repeated for dose volumes greater than 5 ml.
Danish: Maksimum volumen, som kan afmåles med dispenseringssprøjten, er 5 ml og derfor skal trin 3-5 gentages ved dosisvolumen på mere end 5 ml.
English: As the regimen of nevirapine plus efavirenz did not have additional efficacy and caused more adverse events than each medicinal product separately, this regimen is not recommended.
Danish: Da regimet med nevirapin og efavirenz ikke viste yderligere effekt og forårsagede flere bivirkninger end hvert lægemiddel for sig, kan dette regime ikke anbefales.
English: Lipids, Change from baseline Changes from baseline in fasting lipids are shown in Table 4.
Danish: Lipider, ændring i forhold til baseline Ændringer i fastende lipider i forhold til baseline, er vist i tabel 4.
English: ANALGESICS/OPIOIDS Methadone Individual Patient Dosing
Danish: ANALGETIKA/OPIOIDER Methadon individuel dosering
English: Of these 50 patients, 28 developed resistance to efavirenz and 39 developed resistance to etravirine (the most frequently emergent resistance mutation being Y181C).
Danish: Af disse 50 patienter udviklede 28 resistens over for efavirenz, og 39 udviklede resistens over for etravirin (den hyppigst opståede resistensmutation var Y181C).
English: The plasma nevirapine concentrations observed were within the range observed in adults and the remainder of the paediatric population, but were more variable between patients, particularly in the second month of age.
Danish: Plasmakoncentrationen af nevirapin var inden for det område, som er set hos voksne og den resterende pædiatriske population, men var mere variable i mellem patienterne, især dem på to måneder.