FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is one capsule (i.e. 290 micrograms of linaclotide) taken orally once a day.
Danish: Den sædvanlige dosis er en kapsel (dvs. 290 mikrogram linaclotid) oralt en gang dagligt.
English: What Constella contains - The active substance is linaclotide.
Danish: Constella indeholder - Aktivt stof: linaclotid.
English: Constella has not been studied in patients who have renal impairment.
Danish: Constella er ikke blevet undersøgt hos patienter, som har nedsat leverfunktion.
English: The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry.
Danish: Beholderen indeholder en eller flere forseglede tørrekapsler med silicagel for at holde kapslerne tørre.
English: Linaclotide is rarely detectable in plasma and is not metabolised by liver cytochrome P450 enzymes, therefore, hepatic impairment would not be expected to affect the metabolism or clearance of the parent drug or its metabolite.
Danish: Linaclotid kan kun sjældent detekteres i plasma og metaboliseres ikke af lever cytomkrom P450-enzymer, og nedsat leverfunktion forventes derfor ikke at påvirke metabolismen eller clearance af modersubstansen eller dens metabolit.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/801/005 Multipack: 112 (4 packs of 28) capsules 13.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/801/001/005 Multipakning: 112 (4 pakker a 28) kapsler 13.
English: No dose adjustments are required for patients with hepatic or renal impairment (see section 5.2).
Danish: Det er ikke nødvendigt at foretage dosisjustering for patienter med nedsat nyre- eller leverfunktion (se pkt.
English: Straining (5-point ordinal scale) *p<0.0001, linaclotide vs placebo.
Danish: *p<0,0001, linaclotid vs. placebo.
English: Do not store above 30C Keep the bottle tightly closed in order to protect from moisture
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 ºC Hold beholderen tæt tillukket for at beskytte mod fugt
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING SINGLE BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE, DER INDEHOLDER EN ENKELT BEHOLDER
English: Linaclotide is metabolised locally within the gastrointestinal tract to its active primary metabolite, destyrosine.
Danish: Linaclotid metaboliseres lokalt i mave-tarmkanalen til dets primære metabolit, des-tyrosin.
English: Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
Danish: Constella er indiceret til voksne til symptomatisk behandling af moderat til svær irritabel tyktarm med obstipation (IBS-C).
English: Constella is available in packs containing 10, 28 or 90 capsules and in multipacks of 112 capsules comprising 4 cartons, each containing 28 capsules.
Danish: Constella fås i pakninger, der indeholder 10, 28 eller 90 kapsler og i multipakninger med 112 kapsler, der består af 4 æsker, der hver indeholder 28 kapsler.
English: • low level of potassium in your blood
Danish: • Lavt kaliumniviau i blodet
English: They are packaged in a white, high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant screw cap, together with one or more desiccant canisters containing silica gel.
Danish: De er pakket i en hvid, HDPE (high density polyethylen) beholder med en sikkerhedsforsegling og et børnesikret skruelåg samt en eller flere tørrekapsler med silicagel.
English: For age related information, please see sections 4.2., 4.4., and 4.8.
Danish: 4.2, 4.4 og 4.8.
English: Blood bicarbonate decreased
Danish: Reduceret bicarbonat i blodet
English: Printing ink: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171) and black iron oxide (E172).
Danish: Påtrykningsblæk: shellac, propylenglykol, koncentreret ammoniakopløsning, kaliumhydroxid, titandioxid (E171) og sort jernoxid (E172).
English: What Constella looks like and contents of the pack The capsules are white to off-white-orange opaque hard capsules marked “290” with grey ink.
Danish: Kapslerne er hvide til off white-orange uigennemsigtige kapsler mærket ”290” med gråt blæk.
English: Change from baseline Mean
Danish: Ændring i forhold til baseline Middel
English: 10 capsules 28 capsules 90 capsules METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: 10 kapsler 28 kapsler 90 kapsler ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug Oral anvendelse SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: Diarrhoea is normally short lived; however, if you experience severe or prolonged diarrhoea (passing frequent or watery stools for 7 days or more) and feel lightheaded, dizzy or faint, stop taking Constella and contact your doctor.
Danish: Hvis du imidlertid oplever svær eller langvarig diarré (hyppig eller vandig afføring i 7 dage eller derover) og føler dig svimmel, omtåget eller mat, skal du holde op med at tage Constella og kontakte lægen.
English: Multipack : 112 (4 packs of 28) capsules METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: Multipakning: 112 (4 pakker a 28) kapsler ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug Oral anvendelse SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: How Constella works
Danish: Sådan virker Constella
English: Stool consistency (BSFS Score)
Danish: Afføringens konsistens (BSFS-score) Pressen (5-punkts ordinalskala)
English: Capsule shell Titanium dioxide (E 171) Gelatin
Danish: Kapselskal Titandioxid (E171) Gelatine
English: EU/1/12/801/001 10 capsules EU/1/12/801/002 28 capsules EU/1/12/801/004 90 capsules
Danish: EU/1/12/801/001 10 kapsler EU/1/12/801/002 28 kapsler EU/1/12/801/004 90 kapsler
English: Pack sizes: 10, 28 or 90 capsules and multipacks containing 112 (4 packs of 28) capsules.
Danish: Pakningsstørrelser: 10, 28 eller 90 kapsler og multipakninger, der indeholder 112 (4 pakker a 28) kapsler.
English: Constella 290 micrograms hard capsules linaclotide
Danish: Constella 290 mikrogram hårde kapsler linaclotid
English: The capsule should be taken at least 30 minutes before a meal (see section 4.5).
Danish: Kapslen bør indtages mindst 30 minutter før et måltid (se pkt.
English: Each capsule contains 290 micrograms of linaclotide.
Danish: Hver kapsel indeholder 290 mikrogram linaclotid.
English: Capsule shell: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatin.
Danish: Kapselskal: rød jernoxid (E172), titandioxid (E171), gul jernoxid (E172) og gelatine.
English: EU/1/12/801/005 Multipack: 112 (4 packs of28) capsules
Danish: EU/1/12/801/005 Multipakning: 112 (4 pakker a 28) kapsler
English: An IBS degree of relief responder was a patient that was considerably or completely relieved for at least 50% of the treatment period; an abdominal pain/discomfort responder was a patient that had an improvement of 30% or more for at least 50% of the treatment period.
Danish: En respondent med abdominal(t) smerte/ubehag var en patient, der oplevede en forbedring på 30 % eller derover i mindst 50 % af behandlingsperioden.
English: White high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant closure, together with one or more desiccant canisters containing silica gel.
Danish: Hvid, HDPE (high-density polyethylen) beholder med en sikkerhedsforsegling og en børnesikret lukning samt en eller flere tørrekapsler med silicagel.
English: Linaclotide has not been studied in patients with chronic inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis; therefore it is not recommended to use Constella in these patients.
Danish: Linaclotid er ikke blevet undersøgt hos patienter med kroniske inflammatoriske sygdomme i mavetarmkanalen, såsom Crohns sygdom og colitis ulcerosa.
English: Unopened bottle for 28, 90 and multipack containing 112 (4 packs of 28) capsules: 3 years.
Danish: Uåbnet beholder med 28, 90 og multipakning med 112 (4 pakker a 28) kapsler: 3 år.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug Oral anvendelse SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: Taking Constella in the fed condition produced more frequent and looser stools, as well as more gastrointestinal adverse events, than when taking it under fasting conditions (see section 5.1).
Danish: Indtagelse af Constella efter et måltid medførte hyppigere og løsere afføringer samt flere gastrointestinale bivirkninger end i fastende tilstand (se pkt.
English: - Laxatives.
Danish: - Afføringsmidler.
English: What you need to know before you take Constella Do not take Constella - if you are allergic to linaclotide or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for linaclotid eller et af de øvrige indholdsstoffer i Constella (angivet i punkt 6).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON CONTAINING SINGLE 28 CAPSULE BOTTLES (MULTIPACK) WITHOUT BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDVENDIG ÆSKE, DER INDEHOLDER ENKELTBEHOLDERE MED 28 KAPSLER (MULTIPAKNING)
English: Flatulence Abdominal distension
Danish: Abdominal smerte Flatulens Abdominal udspiling
English: Hypersensitivity to linaclotide or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for linaclotid eller over for et eller flere af hjælpestofferne anført i pkt.
English: Linaclotide is rarely detectable in plasma, therefore, renal impairment would not be expected to affect clearance of the parent compound or its metabolite.
Danish: Nedsat nyrefunktion forventes derfor ikke at påvirke clearance af modersubstansen eller dens metabolit.
English: Study 2 shows that 37% of the patients treated with linaclotide compared with 19% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and 55% of the patients treated with linaclotide compared with 42% of the patients treated with placebo showed response to abdominal pain/discomfort (p=0.0002).
Danish: Efter 12 ugers behandling viste studie 2, at 37 % af de patienter, som blev behandlet med linaclotid, udviste et respons på IBS-lindring (p<0,0001) sammenlignet med 19 % af de patienter, som blev behandlet med placebo, og 55 % af de patienter, som blev behandlet med linaclotid, udviste respons på abdominal(t) smerte/ubehag (p=0,0002) sammenlignet med 42 % af de patienter, som blev behandlet med placebo.
English: If you have not experienced improvement in your symptoms after 4 weeks of treatment, you should contact your doctor.
Danish: Tal med lægen, hvis du ikke oplever en bedring af symptomerne efter 4 ugers behandling.
English: By attaching to this receptor, it blocks the sensation of pain and allows liquid to enter from the body into the gut, thereby loosening the stools and increasing your bowel movements.
Danish: Det absorberes ikke i kroppen, men hæfter sig på en receptor på tarmens overflade, som hedder guanylat cyclase C. Ved at hæfte sig til denne receptor, blokerer den så smertefornemmelsen, og giver væske mulighed for at løbe fra kroppen ind i tarmen, hvorved afføringen bliver løsere og hyppigere.
English: How to take Constella
Danish: Sådan skal du tage Constella
English: For the 26 weeks data, study 1 shows that 37% and 54% of the patients treated with linaclotide compared with 17% and 36% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and abdominal pain/discomfort (p<0.0001) respectively.
Danish: Efter 26 uger viste studie 1, at 37 % og 54 % af de patienter, som blev behandlet med linaclotid, havde respons på henholdsvis IBS-lindring (p<0,0001) og abdominal(t) smerte/ubehag (p<0,0001) sammenlignet med 17 % og 36 % af de patienter, som blev behandlet med placebo.
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end l ud af 10 patienter)
English: For the 12 weeks data, study 1 shows that 39% of the patients treated with linaclotide compared with 17% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and 54% of the patients treated with linaclotide compared with 39% of the patients treated with placebo showed response to abdominal pain/discomfort (p<0.0001).
Danish: Efter 12 uger viste studie 1, at 39 % af de patienter, som blev behandlet med linaclotid, havde et respons på IBS-lindring (p<0,0001) sammenlignet med 17 % af de patienter, som blev behandlet med placebo, og 54 % af de patienter, som blev behandlet med linaclotid, havde respons på abdominal(t)
English: EU/1/12/801/001 10 capsules
Danish: EU/1/12/801/001 10 kapsler
English: NAME OF THE MEDICINAL PRODUCT Constella 290 micrograms hard capsules linaclotide
Danish: LÆGEMIDLETS NAVN Constella 290 mikrogram hårde kapsler.
English: Red iron oxide (E172) Yellow iron oxide (E172)
Danish: Rød jernoxid (E172) Gul jernoxid (E172)
English: EU/1/12/801/004 90 capsules
Danish: EU/4/12/801/004 90 kapsler
English: Marketing Authorisation Holder Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
Danish: Indehaver af markedsføringstilladelsen Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE BEHOLDER
English: Because of the higher risk of diarrhoea seen in the clinical trials (see section 4.8), special attention should be given to these patients and the treatment benefitrisk ratio should be carefully and periodically assessed.
Danish: 4.8), bør disse patienter overvåges nøje, og behandlingens benefit/risk-forhold bør vurderes omhyggeligt og regelmæssigt.
English: • feeling bloated
Danish: • oppustet fornemmelse
English: In one clinical study (study 1), 804 patients were treated with Constella 290 micrograms or placebo once daily for 26 weeks.
Danish: Effekten af linaclotid er dokumenteret i to randomiserede, dobbeltblinde, placebokontrollerede fase 3 kliniske studier hos patienter med IBS-C. I et af disse kliniske studier (studie 1) blev 802 patienter behandlet med Constella, 290 mikrogram, eller placebo 1 gang dagligt i 26 uger.
English: EU/1/12/801/002 28 capsules
Danish: EU/2/12/801/002 28 kapsler
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines: Some medicines may not work as effectively if you have severe or prolonged diarrhoea, such as: - Oral contraceptives.
Danish: Nogle lægemidler virker muligvis ikke lige så godt, hvis du har svær eller langvarig diarré, såsom: - P-piller.
English: Trial Week
Danish: 12 uger Middel
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter)
English: For the full list of excipients, see section 6.1.
Danish: For aldersrelateret information, se pkt.
English: Slovenská republika Allergan SK s.r.o.
Danish: Allergan SK s.r.o.
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 290 micrograms of linaclotide
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 290 mikrogram linaclotid.
English: If you take more Constella than you should
Danish: Hvis du har taget for meget Constella
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Allergan Pharmaceuticals International Limited
English: Responders
Danish: TILLADELSEN
English: • wind
Danish: • Luft i maven
English: Name and address of the manufacturer responsible for batch release Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
English: • feeling bloated,
Danish: • Følelse af svimmelhed
English: Faecal incontinence Defecation urgency Lower gastrointestinal haemorrhage including haemorrhoidal haemorrhage and rectal haemorrhage Nausea
Danish: Fækal inkontinens Defækationstrang Blødning i den nedre del af mavetarm-kanalen, inkl.
English: 290 µg Placebo
Danish: constella 290 mcg
English: Lactation
Danish: Opkastning
English: • stomach or abdominal pain,
Danish: • Mave- eller underlivssmerter
English: • rectal bleeding
Danish: • Blødning fra endetarmen
English: EU/1/12/801/001 EU/1/12/801/002 EU/1/12/801/004 EU/1/12/801/005
Danish: EU/1/12/801/005
English: Abdominal pain
Danish: Baseline Middel
English: --1 Live aroA gene deleted Escherichia coli, type O78, strain EC34195 - 5.2x106 - 9.1x108 CFU* * Colony forming units when grown on tryptic soy agar plates.
Danish: --1 Levende Escherichia coli der aroA-genet er fjernet, type O78, stamme EC34195 - 5,2 x 106 til 9,1 x 108 Kolonidannende enheder
English: Strength Pharmaceutical form Target species
Danish: Særnavn Styrke Lægemiddel¬ form
English: EU (MA) number
Danish: Markedsføringstill adelsens nummer (numre)
English: 12 (3 x 4) pre-filled pens (multipack)
Danish: 12 (3x4) fylde penne (multipakning)
English: 4 pre-filled pens
Danish: 4 fyldte penne
English: 12 (3 x 4) pre-filled syringes (multipack)
Danish: 12 (3x4) fyldte injektionssprøjter (multipakning)
English: MA (EU) number (Invented) name
Danish: EU nummer
English: The first event of each category is included in the analysis.
Danish: Den første hændelse i hver kategori er inkluderet i analysen.
English: ABOUT YOUR TREATMENT
Danish: OM DIN BEHANDLING
English: Note: A subject can be included in multiple sub-categories if he/she had an event for those categories.
Danish: Bemærk: En person kan være inkluderet i flere underkategorier, hvis han/hun havde en hændelse i disse kategorier.
English: 0.004 (for superiority)
Danish: 0,004 (for superioritet)
English: The t½ for oral administration is 10 - 14 hours.
Danish: T½ for oral administration er 10 - 14 timer.
English: n Number of Events
Danish: n Antal hændelser
English: Experience with overdose cases is very limited.
Danish: Erfaringen fra tilfælde med overdosering er meget begrænset.
English: The formula is as follows:
Danish: Formlen er den følgende:
English: a A subject can be represented in multiple rows.
Danish: a En person kan være repræsenteret i flere rækker.
English: The absolute bioavailability is approximately 62%.
Danish: Den absolutte biotilgængelighed er ca. 62 %.
English: Roteas is used in adults to:
Danish: Roteas anvendes til voksne til at:
English: How much to take
Danish: Hvor meget skal du tage?
English: In some cases the bleeding may not be obvious.
Danish: Blødningen kan i nogle tilfælde ikke ses tydeligt.
English: Recombinant factor VIIa (r-FVIIa) can also be considered.
Danish: Rekombinant faktor VIIa (r-FVIIa) kan også overvejes.
English: Superiority testing was performed on the ITT Overall Study Period.
Danish: Superioritetstests blev udført på den samlede studieperiode for ITT.
English: If you need to have an operation:
Danish: Hvis du skal opereres:
English: - if you have a mechanical heart valve
Danish: - hvis du har en mekanisk hjerteklap
English: PATIENT INFORMATION Patient name:
Danish: PATIENTOPLYSNINGER Patientnavn:
English: The treatment duration was from 3 months up to 12 months, determined by the investigator based on the patient's clinical features.
Danish: Behandlingsvarigheden var fra 3 måneder op til 12 måneder, hvilket var bestemt af investigatoren baseret på patientens kliniske udtryk.
English: In case of emergency, please contact: Name:
Danish: I nødstilfælde bedes du kontakte: Navn:
English: Table 2: Switching
Danish: Tabel 2: Skift
English: There is no information on its use in children and adolescents.
Danish: Der er ingen information om anvendelse til børn og unge.
English: Exposure to the other metabolites is less than 5%.
Danish: Eksponeringen for andre metabolitter er under 5 %.
English: Please talk to your doctor if you experience any unusual symptoms.
Danish: Kontakt lægen, hvis du oplever usædvanlige symptomer.
English: • rifampicin, an antibiotic
Danish: • rifampicin, et antibiotikum
English: Your doctor may decide to keep you under closer observation or change your medicine.
Danish: Lægen kan beslutte at holde dig under nøje observation eller ændre din medicin.
English: Your doctor may change your anticoagulant treatment as follows:
Danish: Din læge kan ændre din behandling med antikoagulantia på følgende måde:
English: TREATMENT INFORMATION (To be completed by physician)
Danish: BEHANDLINGSOPLYSNINGER (Udfyldes af lægen)
English: How to take the tablet Swallow the tablet, preferably with water.
Danish: Sådan skal du tage tabletten Slug tabletten, helst med vand.
English: If you are taking any of the following:
Danish: Hvis du tager nogle af følgende:
English: Steady state concentrations are achieved within 3 days.
Danish: Der opnås steady-statekoncentrationer i løbet af 3 dage.
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention:
Danish: Bivirkningerne er klassificeret efter systemorganklasse og hyppighed med følgende konvention:
English: Phone number, practice stamp:
Danish: Telefonnummer, stempel for praksis:
English: There is a decreasing event rate at increasing CrCL in both treatment groups.
Danish: Der er en faldende hændelsesrate ved stigende CrCl i begge behandlingsgrupper.
English: • Use of coagulation tests and their interpretation
Danish: • Anvendelse af koagulationstests og tolkning heraf
English: Tell your doctor immediately if you have taken too many Roteas tablets.
Danish: Fortæl det straks til din læge, hvis du har taget for mange tabletter med Roteas.
English: Patients with active cancer
Danish: Patienter med aktiv cancer
English: Please keep this card with you at all times.
Danish: Du bør altid have dette kort på dig.
English: It is therefore important to be aware of the possible signs and symptoms of bleeding and to speak to your doctor immediately if you experience any of the following:
Danish: Det er derfor vigtigt at være opmærksom på de mulige tegn og symptomer på blødning, og straks tale med lægen, hvis du oplever et eller flere af følgende:
English: Blood type: Other medications/conditions:
Danish: Blodtype: Andre lægemidler/sygdomme:
English: - if you have an increased risk of bleeding, as could be the case if you have any of the following conditions:
Danish: - hvis du har en øget blødningsrisiko, hvilket kunne være tilfældet, hvis du har en af følgende tilstande:
English: • Anaemia (low levels of red blood cells)
Danish: • Anæmi (lavt niveau af røde blodlegemer)
English: Menstrual bleeding may be intensified and/or prolonged.
Danish: Menstruationsblødningen kan være kraftigere og/eller forlænget.
English: This was not considered clinically relevant.
Danish: Dette blev ikke anset for klinisk relevant.
English: Food increases peak exposure to a varying extent, but has minimal effect on total exposure.
Danish: Mad øger den maksimale eksponering i varierende grad, men det har en minimal virkning på den totale eksponering.