FrancophonIA/ELRC3.0 huggingface dataset:
English: The 30-, 60- and 120-mg tablets also contain yellow ferric oxide (E172, colouring agent) and indigo carmine lake (E132, colouring agent).
Danish: 30, 60 og 120 mg tabletterne indeholder også gul jernoxid (E172, farvestof) og indigocarmin (E132, farvestof).
English: In clinical studies excluding the MEDAL Program Studies, approximately 3100 patients were treated with etoricoxib ≥60 mg daily for 12 weeks or longer.
Danish: Supplerende thrombotiske kardiovaskulære sikkerhedsdata I kliniske undersøgelser, eksklusive undersøgelserne i forbindelse med MEDAL-programmet, blev ca. 3100 patienter behandlet med etoricoxib ≥60 mg dagligt i 12 uger eller længere.
English: Allergic reactions (which may be serious enough to require immediate medical attention) including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, bronchospasm (wheezing or shortness of breath), severe skin reactions, inflammation of the stomach lining or stomach ulcers that can become serious and may lead to bleeding, liver problems, serious kidney problems, severe increase in blood pressure, confusion, seeing, feeling or hearing things that are not there (hallucinations).
Danish: Meget sjældne (forekommer hos færre end 1 ud af 10.000 patienter) Allergiske reaktioner (som kan være alvorlige og kræve øjeblikkelig lægehjælp) herunder nældefeber, hævelse af ansigt, læber, tunge og/eller hals, som kan medføre vejrtræknings- og synkebesvær, sammentrækning af bronkierne (hvæsende vejrtrækning eller kortåndethed), alvorlige hudreaktioner, betændelse i mave- og tarmkanalen eller mavesår, som kan blive alvorligt og kan bløde, leverproblemer, alvorlige nyreproblemer, alvorlig forhøjelse af blodtrykket, forvirring, hallucinationer.
English: Uncommon: blood urea nitrogen increased, creatine phosphokinase increased, haematocrit decreased, haemoglobin decreased, hyperkalaemia, leukocytes decreased, platelets decreased, serum creatinine increased, uric acid increased.
Danish: Ikke almindelig: Øget serum carbamid, øget creatininkinase, fald i hæmatokrit, fald i hæmoglobin, hyperkalæmi, fald i leukocyttal, fald i thrombocyttal, øget serum creatinin, øget urinsyre.
English: Bottles: Keep the container tightly closed in order to protect from moisture.
Danish: Flasker: Hold beholderen tæt tillukket for at beskytte mod fugt.
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl så spørg lægen eller apoteket.
English: The recommended dose is 120 mg once daily.
Danish: Anbefalet dosis er 120 mg én gang dagligt.
English: The dose for OA should not exceed 60 mg daily
Danish: Ved osteoarthrose bør dosis derfor ikke overstige 60 mg dagligt.
English: The dose for RA and ankylosing spondylitis should not exceed 90 mg daily The dose for acute gout should not exceed 120 mg daily, limited to a maximum of 8 days treatment.
Danish: Dosis ved akut arthritis urica bør ikke overstige 120 mg dagligt, og behandlingen bør begrænses til at vare i højst 8 dage.
English: General disorders and administration site conditions: Common: asthenia/fatigue, flu-like disease.
Danish: Almindelige symptomer og reaktioner administrationsstedet: Almindelig: Asteni/træthed, influenzalignende symptomer.
English: The EDGE study included 7111 OA patients treated with a dose of etoricoxib 90 mg daily (1.5 times the dose recommended for OA) or diclofenac 150 mg daily for a mean period of 9.1 months (maximum 16.6 months, median 11.4 months).
Danish: EDGE-undersøgelsen inkluderede 7.111 OA patienter, der blev behandlet med en dosis etoricoxib 90 mg dagligt (1,5 gange den dosis, der anbefales til OA) eller diclofenac 150 mg dagligt i en gennemsnitlig periode på 9,1 måneder (maks.
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
Danish: Patientens behov for symptomlindring samt behandlingsrespons bør reevalueres med jævne mellemrum, især hos patienter med osteoarthrose (se pkt.
English: What <ARCOXIA> contains
Danish: ARCOXIA indeholder:
English: Concomitant administration of etoricoxib with doses of acetylsalicylic acid above those for cardiovascular prophylaxis or with other NSAIDs is not recommended (see sections 5.1 and 4.4.
Danish: Samtidig administration af etoricoxib og doser af acetylsalicylsyre, der er højere end de, der anvendes til kardiovaskulær profylakse eller andre NSAID bør undgås (se pkt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION [To be completed nationally.]
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: The following undesirable effects were reported at an incidence greater than placebo in clinical trials in patients with OA, RA, chronic low back pain or ankylosing spondylitis treated with etoricoxib 30 mg, 60 mg or 90 mg for up to 12 weeks, or in the MEDAL Program studies, or in post-marketing experience:
Danish: Følgende lægemiddelrelaterede bivirkninger er i kliniske undersøgelser, i MEDAL-undersøgelserne eller efter markedsføring rapporteret med højere incidens end for placebo hos patienter med OA, RA kroniske lændesmerter eller ankylosis spondylitis i behandling med etoricoxib 60 mg eller 90 mg i op til 12 uger.
English: Etoricoxib was associated with a statistically significantly lower rate of discontinuations due to hepaticrelated adverse experiences than diclofenac.
Danish: Etoricoxib var associeret med signifikant lavere hyppighed af seponering på grund af leverrelaterede hændelser end diclofenac.
English: Uncommon: proteinuria.
Danish: Ikke almindelig: Proteinuri.
English: Hertfordshire EN11 9BU United Kingdom
Danish: Hertfordshire EN11 9BU
English: While knowledge about effects of multiple sulfotransferases is presently limited and the clinical consequences for many drugs are still being examined, it may be prudent to exercise care when administering etoricoxib concurrently with other drugs primarily metabolised by human sulfotransferases (e.g., oral salbutamol and minoxidil).
Danish: Det er vigtigt at udvise forsigtighed, når etoricoxib administreres samtidig med andre lægemidler, der primært metaboliseres af humane sulfotransferaser (f.eks. oral salbutamol og minoxidil).
English: Merck Sharpe & Dohme Limited Hertford Road
Danish: Storbritannien Merck Sharpe & Dohme Limited, Hertford Road
English: • lithium (a medicine used to treat some types of depression)
Danish: • Lithium (mod depression).
English: The EDGE II study included 4086 RA patients treated with etoricoxib 90 mg daily or diclofenac 150 mg daily for a mean period of 19.2 months (maximum 33.1 months, median 24 months).
Danish: EDGE II undersøgelsen inkluderede 4086 RA-patienter, der blev behandlet med etoricoxib 90 mg dagligt eller diclofenac 150 mg dagligt i en gennemsnitlig periode på 19,2 måneder (maks.
English: Therefore, hypertension should be controlled before treatment with etoricoxib (see section 4.3) and special attention should be paid to blood pressure monitoring during treatment with etoricoxib.
Danish: 4.3), og der bør udvises særlig opmærksomhed på monitorering af blodtrykket under behandling med etoricoxib.
English: The MEDAL Study, was an endpoint driven CV Outcomes study in 17,804 OA and 5,700 RA patients treated with etoricoxib 60 (OA) or 90 mg (OA and RA) or diclofenac 150 mg daily for a mean period of 20.3 months (maximum of 42.3 months, median 21.3 months).
Danish: MEDAL-undersøgelsen var en endpoint-drevet kardiovaskulær outcome-undersøgelse med 17.804 OA og 5.700 RA-patienter, der blev behandlet med etoricoxib 60 mg (OA) eller 90 mg (OA og RA) eller diclofenac 150 mg dagligt i en gennemsnitlig periode på 20,3 måneder (maks.
English: -<ARCOXIA> can be taken with low-dose aspirin.
Danish: ARCOXIA kan tages sammen med acetylsalicylsyre i lave doser.
English: Blisters Store in original package in order to protect from moisture.
Danish: Blister Opbevares i den originale yderpakning for at beskytte mod fugt.
English: • You have a history of stomach bleeding or ulcers.
Danish: • De har tidligere haft maveblødning eller mavesår.
English: Merck Sharp & Dohme - Regulatory Affairs Iceland
Danish: Merck Sharp & DohmeRegulatory Affairs Iceland, Smedeland 8
English: Confirmed Thrombotic Cardiovascular Serious Adverse Events Per-protocol
Danish: Bekræftede trombotiske kardiovaskulære alvorlige hændelser Per-protocol
English: VIANEX S.A.
Danish: Grækenland VIANEX S.A. Tatoiou Street,
English: Blisters: Store in the original package in order to protect from moisture.
Danish: Blister: Opbevares i den originale yderpakning for at beskytte mod fugt.
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs and some selective COX-2 inhibitors during post-marketing surveillance (see section 4.8).
Danish: I forbindelse med brugen af NSAID og nogle selektive COX-2 hæmmere er der efter markedsføringen meget sjældent indberettet alvorlige hudreaktioner, nogle af dem fatale, inklusive exfoliativ dermatitis, Stevens-Johnson syndrom og toksisk epidermisk nekrolyse (se pkt.
English: In the pooled MEDAL Program, 34,701 patients with OA or RA were treated for a mean duration of 17.9 months (maximum 42.3 months, median 16.3 months) with approximately 12,800 patients receiving treatment for more than 24 months.
Danish: 42,3 måneder, median 16,3 måneder), hvor ca. 12.800 patienter fik behandling i mere end 24 måneder.
English: • You have any history of liver or kidney disease.
Danish: • De har tidligere haft lever- eller nyresygdom.
English: • aspirin, the risk of stomach ulcers is greater if you take <ARCOXIA> with aspirin.
Danish: Risikoen for mavesår er større, hvis De tager acetylsalicylsyre sammen med
English: - A direct healthcare professional communication (DHPC) must be sent to all healthcare professionals who prescribe etoricoxib according to national practice.
Danish: - Fagfolk inden for sundhedssektoren, som ordinerer etoricoxib i henhold til den nationale lovgivning, skal underrettes direkte via et ”Direct Healthcare Professional Communication”-brev.
English: especially in high doses, and your doctor will want to check your blood pressure from time to time.
Danish: ARCOXIA kan få blodtrykket til at stige hos nogle personer, især ved høje doser, og lægen vil kontrollere Deres blodtryk regelmæssigt.
English: Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės Luxembourg Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés Malta
Danish: Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės Luxemburg Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés Malta
English: In rats and rabbits, there was a dose dependent increase in post implantation loss at exposures greater than or equal to 1.5 times the human exposure (see sections 4.3 and 4.6).
Danish: Der var imidlertid et fald i embryo/føtal overlevelse ved doser højere eller svarende til 1,5 gange den daglige humandosis (se pkt.
English: The use of etoricoxib, as with any medicinal product known to inhibit cyclooxygenase / prostaglandin synthesis, is not recommended in women attempting to conceive (see sections 4.6, 5.1, and 5.3).
Danish: Etoricoxib kan, ligesom andre lægemidler, som hæmmer cyclooxygenase/prostaglandinsyntesen, ikke anbefales til kvinder, der forsøger at blive gravide (se pkt.
English: The rate of absorption was affected, resulting in a 36% decrease in Cmax and an increase in Tmax by 2 hours.
Danish: Indtagelse af et måltid (højt fedtindhold) har ikke klinisk betydning for absorptionsgraden af en etoricoxibdosis på 120 mg. Absorptionen påvirkedes, resulterende i et 36% fald i Cmax og en øgning i Tmax med 2 timer.
English: Pregnancy and lactation (see sections 4.6 and 5.3).
Danish: 4.6 og 5.3).
English: Uncommon: chest pain.
Danish: Ikke almindelig: Brystsmerter.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE BOTTLE
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: The use of etoricoxib in patients with creatinine clearance <30 ml/min is contra-indicated (see sections 4.3 and
Danish: Anvendelse af etorixocib til patienter med creatininclearance <30 ml/min.
English: Rheumatoid arthritis The recommended dose is 90 mg once a day.
Danish: Rheumatoid arthritis Anbefalet dosis er 90 mg én gang dagligt.
English: • diuretics (water tablets)
Danish: • Vanddrivende midler (diuretika).
English: • You have a history of stroke or mini stroke.
Danish: • De har tidligere haft slagtilfælde eller forbigående iskæmisk anfald.
English: • hormone replacement therapy
Danish: • Hormonbehandling.
English: HOW TO STORE <ARCOXIA>
Danish: SÅDAN OPBEVARER DE ARCOXIA
English: HOW TO TAKE <ARCOXIA>
Danish: SÅDAN SKAL DE TAGE ARCOXIA
English: Hormone Replacement Therapy (HRT): Administration of etoricoxib 120 mg with hormone replacement therapy consisting of conjugated estrogens (0.625 mg PREMARINTM ) for 28 days, increased the mean steady state AUC0-24hr of unconjugated estrone (41%), equilin (76%), and 17-β-estradiol (22%).
Danish: dage, øgede den gennemsnitlige steady-state AUC0-24t af ukonjugeret estron (41 %), equilin (76 %) og 17-ß-østradiol (22 %).
English: Therefore antiplatelet therapies should not be discontinued (see sections above, 4.5 and 5.1.
Danish: Antithrombotisk behandling bør derfor ikke seponeres (se pkt.
English: What <ARCOXIA> looks like and contents of the pack
Danish: ARCOXIAs udseende og pakningsstørrelser
English: When considered separately, the relative risks for confirmed thrombotic cardiovascular serious adverse events with etoricoxib 60 mg or 90 mg compared with diclofenac 150 mg were similar.
Danish: Sammenlignet med diclofenac 150 mg var de relative risici, separat betragtet, for bekræftede thrombotiske kardiovaskulære alvorlige bivirkninger de samme for etoricoxib 60 mg eller 90 mg.
English: 60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 60' on one side and ‘200' on the other.
Danish: 60 mg mørkegrønne, æbleformede, bikonvekse, filmovertrukne tabletter mærket "ARCOXIA 60" på den ene side og "200" på den anden side.
English: Smedeland 8
Danish: Skanstes 13
English: The CHMP recommended the granting of the variation of the Marketing Authorisations for which the summaries of product characteristics, labelling and package leaflets are set out in Annex III and under the conditions set out in Annex IV.
Danish: Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
English: SIA Merck Sharp & Dohme Latvija Skanstes 13
Danish: SIA Merck Sharp & Dohme Latvija,
English: 60 mg Tablets: Dark green, apple-shaped, biconvex tablets <debossed ‘200' on one side and ‘ARCOXIA 60' on the other side>.
Danish: 60 mg tablet: Mørkegrøn, æbleformet, bikonveks tablet med ”200” præget på den ene side og ”ARCOXIA 60” på den anden side.
English: 90 mg white, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 90' on one side and ‘202' on the other.
Danish: 90 mg hvide, æbleformede, bikonvekse, filmovertrukne tabletter mærket "ARCOXIA 90" på den ene side og "202" på den anden side.
English: 30 mg Tablets: Blue-green, apple-shaped biconvex tablets <debossed ‘101' on one side and ‘ACX 30' on the other side>.
Danish: 30 mg tablet: Blågrøn, æbleformet, bikonveks tablet med "101" præget på den ene side og "ACX 30" på den anden side.
English: 120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 120' on one side and ‘204' on the other.
Danish: 120 mg lysegrønne, æbleformede, bikonvekse filmovertrukne tabletter mærket "ARCOXIA 120" på den ene side og "204" på den anden side.
English: 90 mg Tablets: White, apple-shaped, biconvex tablets <debossed ‘202' on one side and ‘ARCOXIA 90' on the other side>.
Danish: 90 mg tablet: Hvid, æbleformet, bikonveks tablet med ”202” præget på den ene side og ”ARCOXIA 90” på den anden side.
English: Uncommon: facial oedema, pruritus, rash.
Danish: Ikke almindelig: Ansigtsødem, pruritus, udslæt.
English: 120 mg Tablets: Pale-green, apple-shaped, biconvex tablets <debossed ‘204' on one side and ‘ARCOXIA 120' on the other side>.
Danish: 120 mg tablet: Lysegrøn, æbleformet, bikonveks tablet med ”204” præget på den ene side og ”ARCOXIA 120” på den anden side.
English: • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: • Tal med lægen eller apoteket hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: Each film coated tablet contains 120 mg etoricoxib.
Danish: Hver filmovertrukken tablet indeholder 120 mg etoricoxib.
English: Each film coated tablet contains 30 mg etoricoxib.
Danish: Hver filmovertrukken tablet indeholder 30 mg etoricoxib.
English: {Name and address} {tel} {fax} {e-mail}
Danish: {Navn og adresse}
English: 30 mg blue-green, apple-shaped, biconvex film coated tablets marked ‘ACX 30' on one side and ‘101' on the other.
Danish: 30 mg blågrønne, æbleformede bikonvekse tabletter mærket "ACX 30" på den ene side og "101" på den anden side.
English: In rabbits, a treatment related increase in cardiovascular malformations was observed at exposure levels below the clinical exposure at the daily human dose (90 mg).
Danish: Hos rotter og kaniner sås ingen embryo/føtal påvirkning ved systemisk optagelse der svarer til, eller er lavere, end den daglige humandosis [90 mg].
English: Ankylosing spondylitis The recommended dose is 90 mg once a day.
Danish: Ankylosis spondylitis Anbefalet dosis er 90 mg én gang dagligt.
English: Uncommon: flushing, cerebrovascular accident
Danish: Ikke almindelig: Rødmen, cerebrovaskulære tilfælde*, forbigående iskæmisk anfald.
English: Each film coated tablet contains 90 mg etoricoxib.
Danish: Hver filmovertrukken tablet indeholder 90 mg etoricoxib.
English: Patients at greatest risk of this response are those with pre-existing significantly impaired renal function,
Danish: Patienter med allerede eksisterende signifikant nedsat nyrefunktion, inkompenseret hjertesvigt eller cirrhose, har størst risiko for dette.
English: (See sections 4.2 and 4.3.)
Danish: 4.3, 4.4, og 5.2).
English: <ARCOXIA (see Annex 1)> 30 mg film-coated tablets <ARCOXIA (see Annex 1)> 60 mg film-coated tablets <ARCOXIA (see Annex 1)> 90 mg film-coated tablets <ARCOXIA (see Annex 1)> 120 mg film-coated tablets [See Annex 1- To be completed nationally]
Danish: ARCOXIA (se Bilag I) 30 mg filmovertrukne tabletter ARCOXIA (se Bilag I) 60 mg filmovertrukne tabletter ARCOXIA (se Bilag I) 90 mg filmovertrukne tabletter ARCOXIA (se Bilag I) 120 mg filmovertrukne tabletter
English: Rate
Danish: Lot
English: Each film coated tablet contains 60 mg etoricoxib.
Danish: Hver filmovertrukken tablet indeholder 60 mg etoricoxib.
English: Elderly
Danish: Slidgigt
English: BEFORE YOU TAKE <ARCOXIA>
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE ARCOXIA
English: This causes swelling (inflammation), pain, tenderness, stiffness and disability.
Danish: Slidgigt er en ledsygdom, der er resultat af en gradvis nedbrydning af den brusk, der fungerer som beskyttelse af knogleenderne, og som resulterer i hævelse (betændelse), smerter, ømhed, stivhed og fysisk invaliditet.
English: Table 1: Rates of Confirmed Thrombotic CV Events (Pooled MEDAL Program) Etoricoxib (N=16819) 25836 PatientYears
Danish: Tabel 1: Hyppighed for bekræftede thrombotiske kardiovaskulære hændelser (Poolet MEDALprogram)
English: • birth control pills
Danish: • P-piller.
English: <ARCOXIA (see Annex 1)> 60 mg film-coated tablets <ARCOXIA (see Annex 1)> 90 mg film-coated tablets <ARCOXIA (see Annex 1)> 120 mg film-coated tablets [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ARCOXIA (se Bilag I) 60 mg filmovertrukne tabletter ARCOXIA (se Bilag I) 90 mg filmovertrukne tabletter ARCOXIA (se Bilag I) 120 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
English: Common: oedema/fluid retention Uncommon: appetite increase or decrease, weight gain.
Danish: Ikke almindelig: Ændring af appetit, vægtøgning.
English: Belgium Merck Sharp and Dohme Chasussée de Waterloo 1135
Danish: Merck Sharp and Dohme Chaussée de Waterloo 1135 B-1180 Brussels Belgium
English: Czech Rep.
Danish: Se pkt.
English: ARCOXIA 30mg, 60mg, 90mg,120mg film-coated tablets
Danish: Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter
English: Further safety data should be provided by ongoing studies.
Danish: Der bør forelægges yderligere sikkerhedsdata fra igangværende undersøgelser.
English: Other information about Afstyla
Danish: Andre oplysninger om Afstyla
English: This is a summary of the European public assessment report (EPAR) for Afstyla.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Afstyla.
English: The full EPAR for Afstyla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Afstyla findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Afstyla's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Afstyla opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The second study involved 83 patients below 12 years of age.
Danish: Den anden undersøgelse omfattede 83 patienter på under 12 år.
English: What is Afstyla and what is it used for?
Danish: Hvad er Afstyla, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Afstyla?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Afstyla?
English: Afstyla lonoctocog alfa
Danish: Afstyla ionoctocog alfa
English: Hypersensitivity (allergic) reactions are common with Afstyla, affecting up to 1 in 10 people.
Danish: Allergiske reaktioner (hypersensitivitetsreaktioner) er almindelige ved Afstyla og forekommer hos op til 1 ud af 10 personer.
English: Why is Afstyla approved?
Danish: Hvorfor blev Afstyla godkendt?
English: The active substance in Afstyla, lonoctocog alfa, is a shorter version of human factor VIII that works in the body in the same way as human factor VIII.
Danish: Det aktive stof i Afstyla, ionoctocog alfa, er en kortere variant af den menneskelige faktor VIII og virker på samme måde i kroppen som den menneskelige faktor VIII.
English: Regarding safety, the reported side effects are in line with those expected for a factor VIII product, although hypersensitivity reactions occurred more frequently with Afstyla.
Danish: Hvad angår sikkerheden, svarer de indberettede bivirkninger til dem, der forventes for et faktor VIII-lægemiddel, skønt overfølsomhedsreaktioner forekom oftere med Afstyla.
English: It is not intended to provide practical advice on how to use Afstyla.
Danish: Det er ikke en praktisk vejledning i, hvordan Afstyla bør anvendes.
English: They may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash over the whole body, headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (rapid heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Danish: De kan bestå i: hævelse af vævet under huden (angioødem), brænden og stikken på indsprøjtningsstedet, kulderystelser, rødmen, kløende udslæt over hele kroppen, hovedpine, helvedesild, for lavt blodtryk (hypotension), sløvhed (letargi), kvalme, rastløshed, for hurtig hjerterytme (takykardi), sammensnørende fornemmelse i brystet, prikkende fornemmelse, opkastning og hvæsende vejrtrækning.
English: Afstyla has been shown to be effective in both preventing and treating bleeding episodes.
Danish: Afstyla er påvist at være effektivt til både at forebygge og behandle blødningsepisoder.
English: What are the risks associated with Afstyla?
Danish: Hvilke risici er der forbundet med Afstyla?