FrancophonIA/ELRC3.0 huggingface dataset:
English: Select a different injection site from the one you used on the previous day to help the skin to recover after the injection.'
Danish: Vælg et andet injektionssted end det, du har brugt den foregående dag, så huden kan komme sig efter injektionen.
English: No studies have been performed to evaluate the mutagenic potential of caplacizumab, as such tests are not relevant for biologicals.
Danish: Der er ikke udført studier for at evaluere caplacizumabs mutagenpotentiale, da sådanne tests ikke er relevante for biologiske lægemidler.
English: No impact on clinical efficacy was observed and no serious adverse events were found to be associated with these ADA responses.
Danish: Der blev ikke observeret nogen indvirkning på klinisk effekt, og ingen alvorlige bivirkninger viste sig at være associeret med disse ADA-reaktioner.
English: The reconstituted solution is clear, colourless, or slightly yellowish.
Danish: Den rekonstituerede opløsning er klar, farveløs eller let gullig.
English: INFORMATION IN BRAILLE Cablivi
Danish: INFORMATION I BRAILLESKRIFT Cablivi
English: Your doctor will decide if it can be postponed or if you should stop Cablivi before your surgery or dental treatment.
Danish: Din læge vil beslutte, om det kan udsættes, eller om du skal stoppe med Cablivi før din operation eller tandbehandling.
English: • If the kit was not stored at room temperature, allow the vial and the syringe to reach room temperature (15°C - 25°C) by letting them stand at room temperature for a few minutes.
Danish: • Hvis kittet ikke blev opbevaret ved stuetemperatur, skal hætteglasset og injektionssprøjten nå stuetemperatur (15 °C-25 °C) ved at lade dem stå ved stuetemperatur i et par minutter.
English: Patients or caregivers may inject the medicinal product after proper training in the subcutaneous injection technique.
Danish: Patienter og omsorgspersoner kan injicere lægemidlet efter oplæring i teknikken med subkutan injektion.
English: If a recurrence occurred while on study drug treatment, patients were switched to open-label caplacizumab.
Danish: Hvis en tilbagevendende episode opstod mens patienterne var i behandling med studiemedicinen, blev de skiftet til open-label caplacizumab.
English: While experience with the use of caplacizumab in the elderly is limited, there is no evidence to suggest that dose adjustment or special precautions are needed for elderly patients (see section 5.2).
Danish: Selv om erfaringen med brugen af caplacizumab hos ældre er begrænset, er der ingen evidens, der antyder, at dosisjustering eller særlige forholdsregler er nødvendige for ældre patienter (se pkt.
English: Step 1 - Cleaning
Danish: Trin 1 - Rengøring
English: • Make sure you have a disposal container at hand.
Danish: • Sørg for, at du har en affaldsbeholder ved hånden.
English: In studied populations; gender, age, blood group and race did not affect the pharmacokinetics of caplacizumab.
Danish: I undersøgte populationer påvirkede køn, alder, blodgruppe og race ikke caplacizumabs farmakokinetik.
English: The first dose of Cablivi is to be administered as an intravenous injection.
Danish: Den første dosis Cablivi skal administreres som intravenøs injektion.
English: • Hold this skin fold during the entire injection.
Danish: • Hold fast i hudfolden under hele injektionen.
English: All clinical studies with caplacizumab demonstrated rapid decreases in RIPA and/or RICO levels after the start of the treatment, with recovery to baseline levels within 7 days of discontinuation.
Danish: Alle kliniske studier med caplacizumab påviste hurtige fald i RIPA- og/eller RICO-niveauer efter behandlingsstart med genopretning til baseline niveauer inden for 7 dage efter ophør.
English: Active clinically significant bleeding
Danish: Aktiv, klinisk signifikant blødning
English: In healthy volunteers receiving 10 mg caplacizumab subcutaneoulsy once daily, the maximum concentration was observed at 6-7 hours post-dose and steady-state was reached following the first administration, with minimal accumulation.
Danish: Hos raske frivillige, der fik 10 mg caplacizumab subkutant en gang dagligt, blev den maksimale koncentration observeret 6-7 timer efter dosis, og steady state blev nået efter den første administration med minimal akkumulering.
English: The most frequent adverse reactions in clinical trials were epistaxis, headache and gingival bleeding.
Danish: De mest almindelige bivirkninger i kliniske studier var epistaxis, hovedpine og gingival blødning.
English: • first dose - 1 vial injected into a vein by a healthcare professional - the medicine will be given before starting plasma exchange
Danish: • første dosis - 1 hætteglas indsprøjtet i en blodåre af sundhedspersonale - lægemidlet vil blive givet før start af plasmaudskiftning
English: Avoid foaming.
Danish: Undgå skumdannelse.
English: The safety and efficacy of caplacizumab in the paediatric population have not yet been established.
Danish: Sikkerheden og effekten af caplacizumab i den pædiatriske population er endnu ikke klarlagt.
English: The results indicated exposure to caplacizumab in dams and, to a much lesser extent, foetuses, with no reported effects on foetal development.
Danish: Resultaterne indikerede eksponering for caplacizumab hos mødrene og i meget mindre grad fostrene, uden rapporterede virkninger på fostrets udvikling.
English: The t1/2 of caplacizumab is, therefore, concentrationand target level-dependent.
Danish: t1/2 for caplacizumab er derfor koncentrations- og målniveauafhængig.
English: • have a bleeding disorder such as haemophilia.
Danish: • har en blødningsforstyrrelser som f.eks. hæmofili.
English: Step 12 - Administration
Danish: Trin 12 - Administration
English: Step 11 - Prepare injection site for injection under the skin
Danish: Trin 11 - Klargør injektionsstedet til injektion under huden
English: Take care that the adapter does not come away from the vial.
Danish: Sørg for, at adapteren ikke løsnes fra hætteglasset.
English: In the clinical development program, caplacizumab has been administered daily for up to 65 days.
Danish: I det kliniske udviklingsprogram blev caplacizumab givet dagligt i op til 65 dage.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with caplacizumab in one or more subsets of the paediatric population with aTTP (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med caplacizumab i en eller flere undergrupper af den pædiatriske population med aTTP (se pkt.
English: Treatment with caplacizumab resulted in a statistically significant reduction in time to platelet count response (p<0.01).
Danish: Behandling med caplacizumab resulterede i en statistisk signifikant reduktion af tiden til blodpladetalrespons (p<0,01).
English: In this case, your doctor or healthcare provider will train you or your caregiver on how to use Cablivi.
Danish: I sådanne tilfælde vil din læge eller sundhedspersonale træne dig eller din omsorgsperson i at bruge Cablivi.
English: Cablivi contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder under 1 mmol natrium (23 mg) pr. dosis, dvs. det er stort set ”natriumfrit”.
English: Upon repeated administration of caplacizumab, a decrease of 30-50% in von Willebrand factor antigen levels was observed in clinical studies, reaching a maximum within 1-2 days of treatment.
Danish: Efter gentagen administration af caplacizumab blev der observeret et fald på 30-50 % i von Willebrand faktor-antigen niveauer i kliniske studier med et maksimum inden for 1-2 dages behandling.
English: Caplacizumab is a humanised bivalent Nanobody that consists of two identical humanised building blocks (PMP12A2hum1), genetically linked by a three-alanine linker, targeting the A1-domain of von Willebrand factor and inhibiting the interaction between von Willebrand factor and platelets.
Danish: Caplacizumab er en humaniseret bivalent Nanobody, der består af to identiske humaniserede byggesten (PMP12A2hum1), der er genetisk forbundet af en tre-alanin linker, målrettet mod A1domænet af von Willebrand faktor og hæmmer interaktionen mellem von Willebrand faktor og blodplader.
English: • subsequent doses: - 1 vial once daily as a subcutaneous injection (under the skin of the belly) - the subcutaneous injection will be given after each daily plasma exchange - after the daily plasma exchange finishes, your treatment with Cablivi will continue for at least 30 days with injection of 1 vial once daily.
Danish: • efterfølgende doser - 1 hætteglas dagligt som subkutan injektion (under maveskindet) - den subkutane injektion vil blive givet efter hver daglig plasmaudskiftning - når den daglige plasmaudskiftning er afsluttet, vil din behandling med Cablivi fortsætte i mindst 30 dage med injektion af 1 hætteglas dagligt.
English: Subsequent doses are to be administered via subcutaneous injection in the abdomen.
Danish: Efterfølgende doser skal administreres som subkutane injektioner i abdomen.
English: Cablivi can be intravenously administered by connecting the prepared syringe to standard Luer locks of IV lines or using a suitable needle.
Danish: Cablivi kan administreres intravenøst ved at forbinde den klargjorte injektionssprøjte til standard Luer lock af IV linjer eller med en egnet kanyle.
English: If more than 12 hours have passed since the dose should have been given, do not take the missed dose, but inject the next dose at the usual time.
Danish: Hvis der er gået mere end 12 timer siden dosis skulle have været givet, må du ikke tage den manglende dosis, men du skal injicere næste dosis til sædvanlig tid.
English: If at the end of this period there is evidence of unresolved immunological disease, it is recommended to optimise the immunosupression regimen and continue daily subcutaneous administration of 10 mg of caplacizumab until the signs of underlying immunological disease are resolved (e.g. sustained normalisation of ADAMTS13 activity level).
Danish: Hvis der ved afslutningen af denne periode er evidens for uafklaret immunologisk sygdom, anbefales det at optimere immunsuppressionsregimenet og fortsætte med daglig subkutan administration af 10 mg caplacizumab, indtil tegnene på underliggende immunologisk sygdom er løst (f.eks. vedvarende normalisering af ADAMTS13 aktivitetsniveau).
English: • Remove the plastic packaging from the adapter by holding the vial with one hand, pressing the sides of the adapter packaging with your other hand, and then lifting the packaging upwards.
Danish: • Fjern plastikemballagen fra adapteren ved at holde hætteglasset med den ene hånd, trykke på siderne af adapteremballagen med den anden hånd og løft derefter emballagen opad.
English: • Make sure the kit package is complete.
Danish: • Kontrollér at kitpakningen er komplet.
English: • bleed excessively during treatment.
Danish: • bløder kraftigt under behandling.
English: In this study, 145 patients experiencing an episode of aTTP were randomised (72 to caplacizumab and to 73 placebo).
Danish: I dette studie blev 145 patienter, der oplevede en episode af aTTP, randomiseret (72 til caplacizumab og 73 til placebo).
English: The reduced von Willebrand factor antigen and FVIII:C levels were transient and returned to baseline upon cessation of treatment.
Danish: De reducerede von Willebrand faktor-antigen og FVIII:C niveauer var forbigående og vendte tilbage til baseline efter ophør af behandling.
English: • bleeding in brain as evidenced by severe headache of rapid onset, vomiting, decreased level of consciousness, fever, sometimes seizures and neck stiffness or neck pain
Danish: • blødning i hjernen set ved hurtigt opstået svær hovedpine, opkastning, nedsat bevidsthedsniveau, feber, undertiden krampeanfald og nakkestivhed eller nakkesmerter
English: In the clinical studies of patients with TTP, those with renal impairment did not show additional risk of adverse events.
Danish: I de kliniske studier med patienter med TTP, viste patienter med nedsat nyrefunktion ikke yderligere risiko for bivirkninger.
English: • injection site reactions: rash, itching and bleeding
Danish: • reaktioner på injektionsstedet: Udslæt, kløe og blødning
English: Higher levels of von Willebrand factor antigen, such as in patients with aTTP, increase the fraction of drug-target complex retained in the circulation.
Danish: Højere niveauer af von Willebrand faktor-antigen, som f.eks. hos patienter med aTTP, øger fraktionen af lægemiddelmålkompleks bevaret i kredsløbet.
English: No formal study with caplacizumab has been conducted in patients with severe acute or chronic hepatic impairment and no data regarding the use of caplacizumab in these populations are available.
Danish: Der er ikke udført noget formelt studie med caplacizumab hos patienter med svært akut eller kronisk nedsat leverfunktion, og der er ingen tilgængelig data vedrørende brugen af caplacizumab i disse populationer.
English: • Clean the exposed rubber stopper using one of the alcohol pads provided and allow it to dry for a few seconds.
Danish: • Rengør den frigjorte gummiprop med en af de medfølgende alkoholservietter og lad den tørre et par sekunder.
English: If more than 12 hours have passed since the dose was to have been given, the missed dose should NOT be administered and the next dose should be administered per the usual dosing schedule.
Danish: Hvis der er gået mere end 12 timer siden dosis skulle have været givet, må den glemte dosis IKKE administreres, og den næste dosis skal administreres ifølge det normale doseringsskema.
English: Treatment with Cablivi is started by a doctor experienced in blood disorders.
Danish: Behandling med Cablivi igangsættes af en læge, der har erfaring med blodsygdomme.
English: In this double-blind, placebo-controlled study, patients with an episode of aTTP were randomised 1:1 to receive either caplacizumab or placebo in addition to daily plasma exchange and immunosuppression.
Danish: I dette dobbeltblindede, placebokontrollerede studie blev patienter med en episode af aTTP randomiseret 1:1 til enten at få caplacizumab eller placebo ud over daglig plasmaudskiftning og immunsuppression.
English: It is unknown whether caplacizumab is excreted in human milk.
Danish: Det er ukendt, om caplacizumab udskilles i human mælk.
English: Dyspnoea, Haemoptysis*
Danish: Dyspnø, hæmoptyse*
English: • Allow the vial with connected syringe to stand on the surface for 5 minutes at room temperature to allow the solution to completely dissolve.
Danish: • Lad hætteglasset med tilsluttet injektionssprøjte stå på overfladen i 5 minutter ved stuetemperatur, for at lade opløsningen blive helt opløst.
English: The MAH shall ensure that in each Member State where Cablivi is marketed, all patients/carers who are expected to use Cablivi are provided with the following patient alert card which shall contain the following key message:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle patienter/omsorgspersoner, der forventes at anvende Cablivi, i hvert medlemsland, hvor Cablivi markedsføres, får udleveret patientadvarselskortet, som skal indeholde følgende vigtige besked:
English: The intravenous bolus injection of Cablivi given at the start of the treatment must be administered by a health care professional.
Danish: Den intravenøse bolusinjektion med Cablivi, der gives i starten af behandlingen, skal administreres af sundhedspersonalet.
English: Your doctor will advise you whether to discontinue breastfeeding or not use Cablivi, considering the benefit of breastfeeding to the baby and the benefit of Cablivi to you.
Danish: Din læge vil rådgive dig om, hvorvidt du skal stoppe med at amme eller ikke bruge Cablivi, hvor fordelen af at amme barnet og fordelen af Cablivi for dig tages i betragning.
English: Do not shake it.
Danish: Det må ikke rystes.
English: • Check the solution for particles.
Danish: • Kontroller opløsningen for partikler.
English: • water for injections in a pre-filled syringe to dissolve the powder After dissolving the powder in the solvent, the solution is clear, colourless or slightly yellowish.
Danish: • vand til injektionsvæske i en fyldt injektionssprøjte til at opløse pulveret Efter opløsning af pulveret i solvensen er opløsningen klar, farveløs eller let gullig.
English: • a white powder for solution for injection in a glass vial, and
Danish: • et hvidt pulver til injektionsvæske, opløsning i et glashætteglas, og
English: Cerebral infarction
Danish: Cerebral infarkt
English: Cablivi has no or negligible influence on the ability to drive and use machines.
Danish: Cablivi påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Due to a potential increased risk of bleeding, use of Cablivi in patients with underlying coagulopathies (e.g. hemophilia, other coagulation factor deficiencies) is to be accompanied by close clinical monitoring.
Danish: På grund af en potentiel risiko for blødning skal brugen af Cablivi hos patienter med underliggende koagulopati (f.eks. hæmofili, andre koagulationsdefekter) ledsages af tæt klinisk monitorering.
English: • Gently pinch the cleaned skin between your thumb and forefinger to make a fold.
Danish: • Knib forsigtigt den rensede hud mellem din tommelfinger og pegefinger, så der kommer en fold.
English: Also tell your doctor if you are using an anticoagulant medicine such as vitamin K antagonists, rivaroxaban, or apixaban which treat blood clots or anti-platelet agents, such as aspirin, or low molecular weight heparin which prevent blood clots.
Danish: Fortæl også din læge, hvis du bruger et blodfortyndende lægemiddel som f.eks. vitamin K antagonister, rivaroxaban eller apixaban, som behandler blodpropper, eller trombocytfunktionshæmmende midler som f.eks. aspirin eller lavmolekylært heparin, som forebygger blodpropper.
English: • Holding the syringe in your hand, break off the white cap with your other hand.
Danish: • Hold injektionssprøjten i den ene hånd og knæk den hvide hætte af med den anden hånd.
English: • Do not use the syringe if this white cap is missing, loose or damaged.
Danish: • Brug ikke injektionssprøjten, hvis den hvide hætte mangler, sidder løst eller er beskadiget.
English: Then, slowly push the plunger until a small amount of liquid comes out of the needle.
Danish: Tryk derefter langsomt på stemplet, indtil der kommer lidt væske ud af kanylen.
English: Patients treated with caplacizumab were 1.55 times more likely to achieve platelet count response at any given time point, compared to patients treated with placebo.
Danish: Patienter, der blev behandlet med caplacizumab, var 1,55 gange mere tilbøjelige til at opnå blodpladetalrespons på et hvilket som helst tidspunkt sammenlignet med patienter, der blev behandlet med placebo.
English: Name and address of the manufacturer responsible for batch release Ablynx NV
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Ablynx NV
English: Pharmacokinetics in patients with aTTP were investigated upon single intravenous and repeated subcutaneous injections.
Danish: Farmakokinetikken hos patienter med aTTP blev undersøgt ved en enkelt intravenøs og gentagne subkutane injektioner.
English: Leave the adapter in its opened plastic packaging.
Danish: Lad adapteren blive i den åbne plastikemballage.
English: If at the end of this treatment period there was evidence of persistent underlying disease activity (indicative of an imminent risk for recurrence), treatment could be extended weekly for a maximum of 4 weeks, together with optimisation of immunosuppression.
Danish: Hvis der i slutningen af denne behandlingsperiode var evidens for vedvarende underliggende sygdomsaktivitet (indikation af en imminent risiko for tilbagevendende episode) kan behandlingen forlænges ugentligt i maksimalt 4 uger sammen med optimering af immunsuppression.
English: Pharmacokinetics of caplacizumab appear as non-dose proportional, as characterized by targetmediated disposition.
Danish: Caplacizumabs farmakokinetik fremstår som ikke-dosisproportional, som karakteriseret ved målmedieret disposition.
English: • Carefully remove the needle protection cap from the needle and throw it away.
Danish: • Fjern forsigtigt beskyttelseshætten fra kanylen og smid den væk.
English: • Prepare a clean flat surface for placing the kit package.
Danish: • Klargør en ren, flad overflade til at lægge kitpakningen på.
English: • Go to step 10 to inject caplacizumab under the skin of the belly.
Danish: • Gå til trin 10 for at injicere caplacizumab under maveskindet.
English: If emergency surgery is needed, the use of von Willebrand Factor concentrate could be considered to correct hemostasis.
Danish: Hvis akut kirurgi bliver nødvendig, kan brugen af von Willebrand Factor koncentrat overvejes for at korrigere hæmostase.
English: • are using anti-platelet agents such as aspirin, or low molecular weight heparin (which prevent blood clots).
Danish: • bruger trombocytfunktionshæmmende midler som f.eks. aspirin, eller lavmolekylært heparin (som forebygger blodpropper).
English: • Insert the full length of the needle into the skin fold at an angle as shown in the illustration.
Danish: • Indfør hele kanylens længde i hudfolden i en vinkel som vist på illustrationen.
English: • are using anticoagulants such as vitamin K antagonists , rivaroxaban, apixaban (which treat blood clots).
Danish: • bruger blodfortyndende midler som f.eks. vitamin K antagonister, rivaroxaban og apixaban (som behandler blodpropper).
English: If at the end of this treatment period there were was evidence of ongoing underlying disease, open-label treatment with caplacizumab could be extended weekly for a maximum of 4 weeks, together with optimisation of immunosuppression.
Danish: Hvis der ved afslutningen af denne behandlingsperiode var evidens for igangværende underliggende sygdom, kunne open-label behandling med caplacizumab forlænges ugentligt i maksimalt 4 uger sammen med optimering af immunsuppression.
English: If needed, the use of von Willebrand Factor concentrate could be considered to correct hemostasis.
Danish: Om nødvendigt kan brugen af von Willebrand Factor koncentrat overvejes for at korrigere hæmostase.
English: Cablivi may be stored at a temperature not above 25 °C for a single period of up to 2 months, but not beyond the expiry date.
Danish: Cablivi kan opbevares ved en temperatur på højest 25 °C i en enkelt periode på op til 2 måneder, men ikke efter udløbsdatoen.
English: Do not use Cablivi
Danish: Brug ikke Cablivi
English: Content:
Danish: Indhold:
English: No patients treated with caplacizumab (0/72) were refractory to treatment (defined as absence of platelet count doubling after 4 days of standard treatment and elevated LDH) compared to three patients treated with placebo (3/73).
Danish: Ingen patienter, der blev behandlet med caplacizumab (0/72), var refraktære over for behandling (defineret som mangel på fordobling af antallet af blodplader efter 4 dages standardbehandling og forhøjet LDH) sammenlignet med tre patienter, der blev behandlet med placebo (3/73).
English: Treatment with Cablivi should be initiated and supervised by physicians experienced in the management of patients with thrombotic microangiopathies.
Danish: Behandling med Cablivi bør startes og overvåges af læger med erfaring i behandling af patienter med trombotisk mikroangiopati.
English: Treatment with caplacizumab reduced the mean number of days of plasma exchange, the volume of plasma used, the mean length of Intensive Care Unit stay and the mean length of hospitalization during the study drug treatment period.
Danish: Behandling med caplacizumab reducerede det gennemsnitlige antal dage med plasmaudskiftning, volumen af anvendt plasma, den gennemsnitlige længde af ophold på intensivafdelingen og den gennemsnitlige længde af hospitalsindlæggelse under behandlingsperioden med studiemedicin.
English: The pharmacokinetics of caplacizumab were determined using a population pharmacokinetic analysis on pooled pharmacokinetic data.
Danish: Caplacizumabs farmakokinetik blev fastsat ved hjælp af en populationsfarmakokinetisk analyse på poolede farmakokinetiske data.