FrancophonIA/ELRC3.0 huggingface dataset:
English: Most subjects were Caucasian (>99%) and male (53%), with a median age of 56 years (28% were ≥65 years).
Danish: De fleste forsøgsdeltagere var kaukasere (> 99 %) og mænd (53 %).
English: • coughing / vomiting up blood
Danish: • ophostning/opkastning af blod
English: Call your doctor or nurse and get medical help right away if you have any unusual signs of bleeding, including:
Danish: - Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: • Cough
Danish: • hoste
English: Pancreatitis has been reported in dabrafenib monotherapy and in combination with trametinib.
Danish: Der er rapporteret pancreatitis hos patienter, som blev behandlet med dabrafenib som monoterapi og i kombination med trametinib.
English: Please refer to the trametinib SmPC for additional information (see section 4.4).
Danish: For yderligere oplysninger henvises til produktresuméet for trametinib (se pkt.
English: Pyrexia Fatigue Chills Asthenia
Danish: Pyreksi Træthed Kulderystelser Asteni
English: BOTTLE LABEL
Danish: ETIKET TIL BEHOLDER
English: Rhabdomyolysis has been reported in patients taking dabrafenib in combination with trametinib (see section 4.8).
Danish: Der er set rabdomyolyse hos patienter, der har fået dabrafenib i kombination med trametinib (se pkt.
English: • Shortness of breath
Danish: • åndenød
English: Check with your doctor, pharmacist or nurse if you are not sure.
Danish: Spørg lægen, sundhedspersonalet eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: • eye pain
Danish: • øjensmerter
English: Trametinib (n=211)
Danish: Dabrafenib trametinib (n = 211)
English: • swelling in the legs
Danish: • hævelse i benene.
English: This may lead to increased risk of non-cutaneous malignancies with dabrafenib exposure (see section 4.8) when RAS mutations are present.
Danish: Eksponering for dabrafenib kan derfor føre til en øget risiko for ikke-kutane maligniteter (se pkt.
English: Please see trametinib SmPC (see section 4.6) when used in combination with trametinib.
Danish: 4.6), når det anvendes i kombination med trametinib.
English: Headache Dizziness
Danish: Median DoR
English: Cutaneous malignancies
Danish: Kutane maligniteter
English: Mucosal inflammation Face oedema
Danish: Palmoplantar erytrodysæstesi-syndrom Hudlæsion
English: Please refer to the trametinib SmPC for additional information.
Danish: For yderligere oplysninger henvises til produktresuméet for trametinib, pkt.
English: • Inflammation of pancreas
Danish: • betændelse i bugspytkirtlen
English: These measures will help to protect the environment.
Danish: Disse forholdsregler vil være med til at beskytte miljøet.
English: In addition, an updated RMP should be submitted:
Danish: Yderligere skal en opdateret RMP indsendes:
English: • At the request of the EMEA.
Danish: • Efter krav fra EMEA
English: Quixidar does not contain any animal products.
Danish: Quixidar indeholder ikke animalske produkter.
English: The mortality benefit shown in the fondaparinux group was maintained until the end of follow-up at Day 180.
Danish: Den mortalitetsgevinst, der blev observeret i fondaparinuxgruppen blev opretholdt til slutningen af opfølgningsperioden ved dag 180.
English: Excretion/Elimination
Danish: Udskillelse/elimination
English: • if you are 75 years old or older.
Danish: • hvis du er 75 år eller ældre.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Danish: • Når ny information modtages, som har indflydelse på den gældende sikkerhedsspecifikation, lægemiddelovervågningsplan eller aktiviteter for risikominimering.
English: This will help to reduce the discomfort at the injection site.
Danish: Dette vil mindske evt. ubehag ved injektionsstedet.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs denne indlægsseddel grundigt inden du begynder at bruge medicinen.
English: Date of latest renewal: 21 March 2007
Danish: Første MT: 21. marts 2002 Fornyelse af MT: 21. marts 2007
English: Over 4874 patients were studied in controlled Phase II and III clinical studies.
Danish: Over 4.874 patienter deltog i kliniske kontrollerede fase II- og fase III-studier.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • Inden for 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering)
English: Like all medicines, Quixidar can cause side effects, although not everybody gets them.
Danish: Quixidar kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Concomitant oral anticoagulation treatment should be initiated as soon as possible and usually within 72 hours.
Danish: Samtidig behandling med perorale antikoagulantia bør indledes snarest muligt og fortrinsvis i løbet af 72 timer.
English: This will activate the automatic needle protection system (picture F).
Danish: Derved aktiveres det automatiske system til beskyttelse af kanylen (fig. F).
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: Ifølge CHMP's retningslinjer for risikohåndteringssystemer i forbindelse med humane lægemidler, skal en opdateret RMP indsendes samtidig med den næste periodiske sikkerhedopdatering (Periodic Safety Update Report, PSUR).
English: This includes medicines you bought without a prescription.
Danish: Dette gælder også medicin, som ikke er købt på recept.
English: Patients with body weight <50 kg are at increased risk of bleeding.
Danish: Patienter med en kropsvægt < 50 kg har en øget blødningsrisiko.
English: If you are pregnant, think you might be, or if you are breast-feeding: → tell your doctor or pharmacist.
Danish: Hvis du er gravid, tror du måske er gravid, eller hvis du ammer: → Fortæl det til din læge eller apoteket.
English: The MAH must ensure that the system of pharmacovigilance, as described in the June 2006 version presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet, som beskrevet i Modul 1.8.1 i juni 2006-versionen af ansøgningsmaterialet til markedsføringstilladelsen er på plads og fungerer, før produktet når markedet, og så længe produktet er markedsført.
English: Rare: allergic reaction
Danish: Sjælden: allergisk reaktion
English: • Do not freeze
Danish: • Må ikke fryses.
English: Some other medicines may affect the way that Quixidar works or be affected by Quixidar.
Danish: Visse andre lægemidler kan påvirke virkningen af Quixidar eller selv blive påvirket af Quixidar.
English: • if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of
Danish: • hvis du er overfølsom (allergisk) over for fondaparinuxnatrium eller et af de øvrige indholdsstoffer.
English: If fondaparinux sodium is added to a 0.9% saline minibag it should ideally be infused immediately, but can be stored at room temperature for up to 24 hours.
Danish: Hvis fondaparinuxnatrium tilsættes en minipose 0,9 % saltopløsning bør infusionen ideelt set gives straks, men den kan opbevares ved stuetemperatur i op til 24 timer.
English: In other studies or in post-marketing experience, rare cases of intracranial / intracerebral and retroperitoneal bleedings have been reported.
Danish: Fra andre forsøg eller efter markedsføring af lægemidlet er der rapporteret sjældne tilfælde af intrakraniel / intracerebral og retroperitoneal blødning.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/
English: Children Quixidar has not been tested in children and adolescents under the age of 17 years.
Danish: Børn Quixidar er ikke undersøgt for børn og unge under 17 år.
English: Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any.
Danish: Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: • if you weigh less than 50 kg. → Tell your doctor if any of these applies to you.
Danish: • hvis du vejer under 50 kg. → Fortæl det til lægen, hvis dette passer på dig.
English: Undesirable effects in patients treated for VTE1
Danish: Bivirkning hos patienter behandlet for VTE 1)
English: BATCH NUMBER Batch {number}
Danish: FREMSTILLERENS BATCHNUMMER Batch {nummer}
English: The primary efficacy endpoint was the composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97.
Danish: Det primære endepunkt for effekt omfattede bekræftet symptomatisk tilbagevendende ikke-fatal VTE og fatal VTE indberettet frem til dag 97.
English: Hold the fold between the thumb and the forefinger during the entire injection (picture D).
Danish: Hold folden mellem tommel- og pegefinger under hele injektionen (fig. D).
English: The average duration of administration in clinical trials was 7 days and the clinical experience from treatment beyond 10 days is limited.
Danish: I kliniske forsøg varede behandlingen i gennemsnit 7 dage, og der er begrænset klinisk erfaring med behandling ud over 10 dage..
English: • if you have a risk of uncontrolled bleeding (haemorrhage) including:
Danish: • om du har risiko for blodtab (ukontrollerede blødninger) på grund af:
English: To treat some types of heart attack, a health professional may give the first dose into a vein (intravenously).
Danish: Til behandling af visse typer af hjerteanfald vil lægen give dig den første dosis i en vene (intravenøst)
English: Do not use Quixidar:
Danish: Brug ikke Quixidar:
English: 10 mg once a day.
Danish: 10 mg daglig.
English: Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3).
Danish: Behandlingen fortsættes i mindst 5 dage, og indtil peroral antikoagulation er tilfredsstillende (INRværdier, international normaliseret ratio, 2-3).
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at udføre de studier og yderligere lægemiddelovervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen, som aftalt i version 1.2 i Risikohåndteringsplan (Risk Management Plan, RMP) anført i Modul 1.8.2 i ansøgningen til markedsføringstilladelsen og efterfølgende CHMP-krav til opdateringer af RMP.
English: Paediatric patients - Fondaparinux has not been investigated in this population.
Danish: Pædiatriske patienter - Fondaparinux er ikke undersøgt i denne patientgruppe.
English: The whole length of the needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; the skin fold should be held throughout the injection.
Danish: Hele nålens længde bør indføres vertikalt i hudfolden der holdes mellem tommel- og pegefinger; hudfolden bør holdes under hele injektionen.
English: Undesirable effects in medical patients
Danish: Bivirkninger hos medicinske patienter
English: Release the plunger and the needle will automatically withdraw from the skin and go back into the security sleeve where it will be locked permanently (picture G).
Danish: Slip stemplet igen, så nålen automatisk trækker sig ud af huden og op i en sikkerhedsmanchet, hvor den fastlåses permanent (fig. G).
English: Quixidar should not be prescribed to pregnant women unless clearly necessary.
Danish: Quixidar bør kun ordineres til gravide kvinder, hvis det er absolut nødvendigt.
English: Remove the cap that protects the plunger by pulling it off (picture B).
Danish: Fjern hætten, som beskytter stemplet, ved at trække den af (fig. B).
English: Don't stop using Quixidar without advice
Danish: Stop ikke med at tage Quixidar uden vejledning
English: The syringes are pre-filled with the exact dose you need.
Danish: Injektionssprøjten indeholder den præcise dosis, som du har behov for.
English: You should inject at about the same time each day.
Danish: Quixidar skal tages på næsten samme tidspunkt hver dag.
English: Quixidar contains a synthetic substance called fondaparinux sodium.
Danish: Quixidar indeholder et syntetisk stof kaldet fondaparinuxnatrium.
English: Important information about some of the ingredients of Quixidar This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Quixidar Denne medicin indeholder mindre end 23 mg natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: How to store Quixidar Further information
Danish: Sådan opbevarer du Quixidar Yderligere oplysninger
English: If you have kidney disease, the dose may be reduced to 1.5 mg once a day.
Danish: Hvis du lider af en nyresygdom, vil din dosis muligvis blive nedsat til 1,5 mg daglig.
English: The primary adjudicated endpoint was a composite of death, myocardial infarction (MI) and refractory ischaemia (RI) within 9 days of randomisation.
Danish: Det primære sammensatte endpoint var død, myokardieinfarkt (MI) og refraktær iskæmi (RI) senest 9 dage efter randomisering.
English: · recent surgery on the brain, spine or eye
Danish: · nylig operation i hjerne, ryg eller øjne.
English: If you get side effects → Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Danish: Hvis du får bivirkninger → Tal med lægen eller apoteket, hvis en bivirkning bliver værre eller generende, eller du får bivirkninger, som ikke er nævnt her.
English: · recent bleeding in the brain (intracranial bleeding)
Danish: · nylig hjerneblødning (intrakraniel blødning).
English: The usual dose is 2.5 mg once a day, injected at about the same time each day.
Danish: Den sædvanlige dosis er 2,5 mg daglig, taget på næsten samme tidspunkt hver dag.
English: What Quixidar is and what it is used for Before you use Quixidar How to use Quixidar Possible side effects
Danish: Quixidars virkning og hvad du skal bruge det til Det skal du vide, før du begynder at bruge Quixidar Sådan skal du bruge Quixidar Bivirkninger
English: • the solution is clear and colourless and doesn't contain particles
Danish: • at opløsningen er klar og farveløs, samt ikke indeholder partikler
English: Hold the body of the syringe firmly in one hand.
Danish: Hold fast i cylinderen med den ene hånd.
English: If they do, you must not use Quixidar.
Danish: Hvis det gør, må du ikke tage Quixidar.
English: In STEMI or UA/NSTEMI patients who are to undergo coronary artery bypass graft (CABG) surgery, fondaparinux where possible, should not be given during the 24 hours before surgery and may be restarted 48 hours post-operatively.
Danish: For STEMI- eller UA/NSTEMI-patienter, som skal have foretaget koronararteriebypass-operation (CABG-operation), bør fondaparinux om muligt ikke gives i de 24 timer umiddelbart før operationen, og det kan genoptages 48 timer efter operationen.
English: 6.6 Special precautions for disposal and other handling The subcutaneous injection is administered in the same way as with a classical syringe.
Danish: 6.6 Regler for destruktion og anden håndtering Den subkutane injektion foretages ligesom med en klassisk injektionssprøjte.
English: Your doctor needs to know before you take Quixidar:
Danish: Din læge behøver at vide dette, før du bruger Quixidar:
English: Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.
Danish: Behandling af ST segment elevations myokardieinfarkt (STEMI) hos patienter, som behandles med fibrinolyse, eller som initielt ikke får andre former for reperfusionsterapi.
English: If you stop the treatment before your doctor told you to, the blood clot may not be treated properly and you may also be at risk of developing a new blood clot in a vein of your leg or in the lung.
Danish: Hvis du stopper behandlingen før det tidspunkt, lægen har sagt, er du ikke behandlet korrekt og der er risiko for, at du får en ny blodprop i en vene i benet eller i lungerne.
English: It is available in packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed).
Danish: Det fås i pakninger med 2, 7, 10 og 20 fyldte injektionssprøjter (det er muligt, at ikke alle pakningsstørrelser markedsføres).
English: Dosing adjustment of fondaparinux is not necessary.
Danish: Dosisjustering af fondaparinux er ikke nødvendig.
English: Low body weight
Danish: Lav kropsvægt
English: WHAT QUIXIDAR IS AND WHAT IT IS USED FOR
Danish: QUIXIDARS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
English: There are limited clinical data available from patients with creatinine clearance less than 30 ml/min.
Danish: Der er kun en begrænset mængde kliniske data tilgængelig for patienter med en kreatininclearance mindre end 30 ml/min.
English: Remove the syringe from the carton and check that:
Danish: Tag injektionssprøjten ud af æsken og check:
English: In the large subgroup of patients undergoing cancer surgery (69% of the patient population), the VTE rate was 4.7% in the fondaparinux group, versus 7.7% in the dalteparin group.
Danish: I den store subgruppe af patienter, som gennemgik cancerkirurgi (69 % af patienterne), var forekomsten af VTE 4,7 % i fondaparinuxgruppen mod 7,7 % i dalteparingruppen.
English: The incidence of symptomatic VTE, including PE was not significantly different between treatment groups.
Danish: Forekomsten af symptomatiske tromboemboliske komplikationer inklusive lungeemboli var ikke signifikant forskellig i behandlingsgrupperne.
English: There are limited data on the use of UFH during non-primary PCI in patients treated with fondaparinux (see section 5.1).
Danish: Der er begrænsede data vedrørende brugen af UFH under ikke-primær PCI til patienter, som også er i behandling med fondaparinux (se pkt.
English: • the syringe has not been opened or damaged
Danish: • at injektionssprøjten ikke tidligere har været åbnet, og ikke er beskadiget
English: Dispose of it as your doctor or pharmacist has instructed.
Danish: Smid den ud, som anvist af din læge eller apotek.
English: • Quixidar is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area.
Danish: • Quixidar gives som en injektion under huden (subkutant) i en hudfold nederst på maven.
English: Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age due to a lack of data on safety and efficacy.
Danish: Børn - Fondaparinux bør ikke anvendes til børn under 17 år p.g.a. manglende dokumentation for sikkerhed og virkning.
English: If you forget to take Quixidar
Danish: Hvis du har glemt at tage Quixidar
English: Do not try to remove this air bubble before making the injection - you may lose some of the medicine if you do.
Danish: Forsøg ikke at fjerne denne luftboble før indsprøjtning - du risikerer at spilde medicinen.
English: This dose may be reduced to 7.5 mg once a day if you have moderate kidney disease.
Danish: Denne dosis kan blive nedsat til 7,5 mg daglig, hvis du lider af en nyresygdom.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: antithrombotic agents.
Danish: FARMAKOLOGISKE EGENSKABER 5.1 Farmakodynamiske egenskaber Farmakoterapeutisk klassifikation: antitrombotiske midler.
English: Take special care with Quixidar: Your doctor needs to know before you take Quixidar:
Danish: Vær ekstra forsigtig med at bruge Quixidar: Din læge behøver at vide dette, før du bruger Quixidar
English: Quixidar is used to treat patients with a blood clot in the blood vessels of their legs (deep vein thrombosis) and/or lungs (pulmonary embolism).
Danish: Quixidar anvendes til at behandle patienter med en blodprop i blodkar i benene (dyb venetrombose) og/eller i lungerne (pulmonær emboli).
English: Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease.
Danish: Forebyggelse af venøse tromboemboliske komplikationer (VTE) hos medicinske patienter, som skønnes at være i højrisikogruppen, og som er immobiliserede på grund af akut sygdom såsom hjerteinsufficiens og/eller akutte respirationssygdomme og/eller akut infektiøs eller inflammatorisk sygdom.
English: Remove the needle guard, by first twisting it and then pulling it in a straight line away from the body of the syringe (picture C).
Danish: Fjern hylstret fra kanylen ved først at dreje det og dernæst trække det direkte væk fra sprøjtens cylinder (fig. C).
English: • after the expiry date stated on the label and carton
Danish: • efter den udløbsdato, der står på pakningen.
English: There are different syringes for the 5 mg, 7.5 mg and 10 mg doses.
Danish: Der er forskellige injektionssprøjter for 5 mg, 7,5 mg og 10 mg dosis.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: BILAG II A. INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: • if you notice that the syringe is damaged
Danish: • hvis du bemærker, at injektionssprøjten er beskadiget
English: Always use Quixidar exactly as your doctor has told you.
Danish: Brug altid Quixidar nøjagtigt efter lægens anvisning.
English: Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
Danish: Intravenøs administration bør ske i en eksisterende intravenøs linje enten direkte eller ved brug af en lille (25 eller 50 ml) minipose med 0,9 % saltopløsning
English: PCI and risk of guiding catheter thrombus
Danish: PCI og risiko for ledekateter-trombose.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorization Holder:
Danish: Indehaveren af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen:
English: The fondaparinux dose (10 mg) in the interaction studies was higher than the dose recommended for the present indications.
Danish: I interaktionsstudier var fondaparinux-dosis (10 mg) højere end anbefalet for de aktuelle indikationer.
English: • leg pain or stomach pain
Danish: • smerte i ben eller mavesmerte
English: If you stop the treatment before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or lung.
Danish: Hvis du stopper behandlingen før det tidspunkt, lægen har sagt, er der risiko for, at du får en blodprop i en vene i benet eller i lungerne.
English: As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone recent surgery (<3 days) and only once surgical haemostasis has been established.
Danish: Hvad angår andre antikoagulantia, bør fondaparinux anvendes med forsigtighed til nyopererede patienter (< 3 dage), og først når der er tilfredsstillende kirurgisk hæmostase.
English: · bleeding disorders
Danish: · Blødersygdomme.
English: There are different syringes for the 2.5 mg and 1.5 mg doses.
Danish: Der er forskellige injektionssprøjter for 2,5 mg og 1,5 mg dosis.
English: The incidence of symptomatic DVT was similar between treatment groups: 6 patients (0.4%) in the fondaparinux group vs 5 patients (0.3%) in the dalteparin group.
Danish: Forekomsten af symptomatisk DVT var den samme i de behandlede grupper, nemlig 6 patienter (0,4 %) i fondaparinuxgruppen over for 5 patienter (0,3 %) i dalteparingruppen.
English: • low number of red blood cells (anaemia)
Danish: • nedsat antal røde blodlegemer (anæmi)