FrancophonIA/ELRC3.0 huggingface dataset:
English: Lixiana 15 mg: Each tablet contains 15 mg edoxaban (as tosilate).
Danish: Lixiana 15 mg: Hver tablet indeholder 15 mg edoxaban (som tosilat).
English: Lixiana 60 mg film-coated tablets are yellow, round-shaped (10.5 mm diameter) and debossed with “DSC L60” on one side.
Danish: Lixiana 60 mg filmovertrukne tabletter er gule, runde (10,5 mm i diameter) og præget med ”DSC L60 ” på den ene side.
English: Package leaflet: Information for the user Lixiana 15 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Lixiana 15 mg filmovertrukne tabletter Lixiana 30 mg filmovertrukne tabletter Lixiana 60 mg filmovertrukne tabletter
English: Discontinue Lixiana and start the parenteral anticoagulant at the time of the next scheduled dose of Lixiana.
Danish: Seponer Lixiana, og start parenteral antikoagulation på tidspunktet for den næste planlagte dosis Lixiana.
English: Lixiana 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side.
Danish: Lixiana 30 mg filmovertrukne tabletter er lyserøde, runde (8,5 mm i diameter) og præget med ”DSC L30 ”på den ene side.
English: Subjects in the edoxaban treatment group received 30 mg once daily if one or more of the following clinical factors were present: moderate renal impairment (CrCL 3050 mL/min), low body weight (≤ 60 kg) or concomitant use of specific P-gp inhibitors.
Danish: Forsøgspersonerne i edoxaban-behandlingsgruppen fik 30 mg en gang dagligt, hvis en eller flere af følgende kliniske faktorer var til stede: moderat nedsat nyrefunktion (CrCl 30-50 ml/min.
English: Lixiana 30 mg: Each tablet contains 30 mg edoxaban (as tosilate).
Danish: Lixiana 30 mg: Hver tablet indeholder 30 mg edoxaban (som tosilat).
English: NAME OF THE MEDICINAL PRODUCT Lixiana 60 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Danish: LÆGEMIDLETS NAVN Lixiana 60 mg filmovertrukne tabletter edoxaban NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Daiichi-Sankyo (logo) UDLØBSDATO
English: NAME OF THE MEDICINAL PRODUCT Lixiana 30 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Danish: LÆGEMIDLETS NAVN Lixiana 30 mg filmovertrukne tabletter edoxaban NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Daiichi-Sankyo (logo) UDLØBSDATO
English: NAME OF THE MEDICINAL PRODUCT Lixiana 15 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Danish: LÆGEMIDLETS NAVN Lixiana 15 mg filmovertrukne tabletter edoxaban NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Daiichi-Sankyo (logo) UDLØBSDATO
English: Lixiana 60 mg: Each tablet contains 60 mg edoxaban (as tosilate).
Danish: Lixiana 60 mg: Hver tablet indeholder 60 mg edoxaban (som tosilat).
English: Lixiana 30 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172).
Danish: Lixiana 30 mg: hypromellose (E464), macrogol 8000, titandioxid (E171), talcum, carnaubavoks, jernoxid, rød (E172).
English: EU/1/15/993/020 56 film-coated tablets
Danish: EU/1/15/993/020 56 filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Lixiana 60 mg film-coated tablets edoxaban
Danish: LÆGEMIDLETS NAVN Lixiana 60 mg filmovertrukne tabletter edoxaban
English: Lixiana 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Danish: Lixiana 15 mg: Tabletkerne: mannitol (E421), pregelatineret stivelse, crospovidon, hydroxypropylcellulose, magnesiumstearat (E470b).
English: NAME OF THE MEDICINAL PRODUCT Lixiana 15 mg film-coated tablets edoxaban
Danish: LÆGEMIDLETS NAVN Lixiana 15 mg filmovertrukne tabletter edoxaban
English: NAME OF THE MEDICINAL PRODUCT Lixiana 30 mg film-coated tablets edoxaban
Danish: LÆGEMIDLETS NAVN Lixiana 30 mg filmovertrukne tabletter edoxaban
English: Lixiana 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Danish: Lixiana 60 mg: Tabletkerne: mannitol (E421), pregelatineret stivelse, crospovidon, hydroxypropylcellulose, magnesiumstearat (E470b).
English: Lixiana 60 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide yellow (E172).
Danish: Lixiana 60 mg: hypromellose (E464), macrogol 8000, titandioxid (E171), talcum, carnaubavoks, jernoxid, gul (E172).
English: Lixiana 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172), iron oxide yellow (E172).
Danish: Lixiana 15 mg: hypromellose (E464), macrogol 8000, titandioxid (E171), talcum, carnaubavoks, jernoxid, rød (E172), jernoxid, gul (E172).
English: EU/1/15/993/007 56 film-coated tablets
Danish: EU/1/15/993/007 56 filmovertrukne tabletter
English: EU/1/15/993/011 98 film-coated tablets
Danish: EU/1/15/993/011 98 filmovertrukne tabletter
English: Lixiana 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Danish: Lixiana 30 mg: Tabletkerne: mannitol (E421), pregelatineret stivelse, crospovidon, hydroxypropylcellulose, magnesiumstearat (E470b).
English: EU/1/15/993/019 30 film-coated tablets
Danish: EU/1/15/993/019 30 filmovertrukne tabletter
English: EU/1/15/993/017 14 film-coated tablets
Danish: EU/1/15/993/017 14 filmovertrukne tabletter
English: Table 7: Number of Major Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Danish: Tabel 7: Antal større blødningshændelser pr. kreatininclearance-kategori i ENGAGE AFTIMI 48, sikkerhedsanalyse under behandlinga CrClundergruppe (ml/min.)
English: For patients currently on a 30 mg dose (for one or more of the following clinical factors: moderate to severe renal impairment (CrCL 15 - 50 mL/min), low body weight, or use with certain P-gp inhibitors), administer a Lixiana dose of 15 mg once daily together with an appropriate VKA dose.
Danish: Til patienter, der aktuelt får en 30 mg dosis (ved én eller flere af følgende kliniske faktorer: moderat til svært nedsat nyrefunktion (CrCl 15 - 50 ml/min.
English: EU/1/15/993/006 30 film-coated tablets
Danish: EU/1/15/993/006 30 filmovertrukne tabletter
English: EU/1/15/993/021 60 film-coated tablets
Danish: EU/1/15/993/021 60 filmovertrukne tabletter
English: EU/1/15/993/022 84 film-coated tablets
Danish: EU/1/15/993/022 84 filmovertrukne tabletter
English: EU/1/15/993/004 14 film-coated tablets
Danish: EU/1/15/993/004 14 filmovertrukne tabletter
English: Lixiana administration should be discontinued if severe haemorrhage occurs (see sections 4.8 and 4.9).
Danish: Hvis der forekommer svær blødning, skal administration af Lixiana seponeres (se pkt.
English: EU/1/15/993/008 60 film-coated tablets
Danish: EU/1/15/993/008 60 filmovertrukne tabletter
English: EU/1/15/993/024 98 film-coated tablets
Danish: EU/1/15/993/024 98 filmovertrukne tabletter
English: EU/1/15/993/010 90 film-coated tablets
Danish: EU/1/15/993/010 90 filmovertrukne tabletter
English: EU/1/15/993/023 90 film-coated tablets
Danish: EU/1/15/993/023 90 filmovertrukne tabletter
English: EU/1/15/993/002 10 film-coated tablets
Danish: EU/1/15/993/002 10 filmovertrukne tabletter
English: EU/1/15/993/005 28 film-coated tablets
Danish: EU/1/15/993/005 28 filmovertrukne tabletter
English: EU/1/15/993/018 28 film-coated tablets
Danish: EU/1/15/993/018 28 filmovertrukne tabletter
English: EU/1/15/993/009 84 film-coated tablets
Danish: EU/1/15/993/009 84 filmovertrukne tabletter
English: In patients with end stage renal disease (ESRD) (CrCL < 15 mL/min) or on dialysis, the use of Lixiana is not recommended (see sections 4.4 and 5.2).
Danish: Hos patienter med nyresygdom i slutstadiet (end stage renal disease, ESRD) (CrCl < 15 ml/min.)
English: If you take more Lixiana than you should
Danish: Hvis du har taget for meget Lixiana
English: EU/1/15/993/003 10 film-coated tablets
Danish: EU/1/15/993/003 10 filmovertrukne tabletter
English: What Lixiana looks like and contents of the pack Lixiana 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side.
Danish: Lixiana 15 mg filmovertrukne tabletter er orange, runde (6,7 mm i diameter) og præget med ”DSC L15 ”på den ene side.
English: Lixiana 30 mg film-coated tablets
Danish: Lixiana 15 mg filmovertrukne tabletter Lixiana 30 mg filmovertrukne tabletter Lixiana 60 mg filmovertrukne tabletter
English: In patients with mild renal impairment (CrCL > 50 - 80 mL/min), the recommended dose is 60 mg Lixiana once daily.
Danish: Hos patienter med let nedsat nyrefunktion (CrCl > 50 - 80 ml/min.)
English: In patients with severe hepatic impairment Lixiana is not recommended (see sections 4.4 and 5.2).
Danish: Hos patienter med svært nedsat leverfunktion bør Lixiana ikke anvendes (se pkt.
English: Lixiana is not recommended in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Danish: Lixiana bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
English: Haemodialysis
Danish: • Mavesmerter
English: The application was at day 177 when the company withdrew.
Danish: Ansøgningen var på dag 177, da virksomheden trak den tilbage.
English: It was to be available as tablets (75 mg).
Danish: Det skulle have været leveret som kapsler (75 mg).
English: Ref. EMEA/254399/2009
Danish: ref. EMEA/410302/2009 EMEA/H/C/1052
English: This reduces the risk of a blood clot forming and helps prevent another heart attack or stroke.
Danish: Dette mindsker risikoen for, at der dannes blodpropper og medvirker til at forebygge endnu et hjerteanfald eller slagtilfælde.
English: Questions and answers on the withdrawal of the marketing authorisation application for Clopidogrel Teva Pharma clopidogrel
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Clopidogrel Teva Pharma clopidogrel
English: It was to be used in patients who had recently had a myocardial infarction (heart attack) or an ischaemic stroke (non-bleeding stroke), or in patients with peripheral arterial disease (problems with blood flow in the arteries).
Danish: Det skulle have været anvendt til patienter, som inden for den seneste tid havde haft et myocardieinfarkt (hjerteanfald) eller et iskæmisk slagtilfælde (slagtilfælde uden blødning), eller til patienter med perifer arteriesygdom (problemer med blodgennemstrømningen i arterierne).
English: When the blood clots, this is due to special cells in the blood called platelets sticking together (aggregating).
Danish: Når blodet koagulerer, skyldes det, at særlige celler i blodet kaldet trombocytter klæber sammen (aggregerer).
English: This stops the platelets becoming ‘sticky'.
Danish: Det forhindrer trombocytterne i at blive ‘klæbende'.
English: This means that Clopidogrel Teva Pharma was intended to be similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at det var hensigten, at Clopidogrel Teva Pharma skulle være identisk med et ”referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Plavix.
English: Because Clopidogrel Teva Pharma was developed as a generic medicine, the company presented the results of studies carried out to investigate whether it is ‘bioequivalent' to the reference medicine.
Danish: Fordi Clopidogrel Teva Pharma blev udviklet som et generisk lægemiddel, fremlagde virksomheden resultaterne af undersøgelser, som er udført for at undersøge, hvorvidt det er ‘bioækvivalent' med referencelægemidlet.
English: Clopidogrel Teva Pharma was expected to be used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel Teva Pharma forventedes anvendt til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Danish: Clopidrogel forhindrer trombocytterne i at aggregere ved at forhindre et stof, ADP, i at binde sig til en særlig receptor på overfladen af disse.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Clopidogrel Teva Pharma could not have been approved for the prevention of atherothrombotic events in patients who have had myocardial infarction, ischaemic stroke or who have established peripheral arterial disease.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Clopidogrel Teva Pharma ikke kunne være blevet godkendt til forebyggelse af aterotrombotiske hændelser hos patienter, som havde haft myocardieinfarkt eller iskæmisk slagtilfælde, eller som havde påvist perifer arteriesygdom.
English: Clopidogrel Teva Pharma was developed as a ‘generic medicine'.
Danish: Clopidogrel Teva Pharma blev udviklet som et ‘generisk lægemiddel'.
English: What is Clopidogrel Teva Pharma?
Danish: Hvad er Clopidogrel Teva Pharma?
English: At this point in time, the CHMP was of the opinion that Clopidogrel Teva Pharma could not be considered a generic medicine of Plavix, the reference medicinal product.
Danish: På dette tidspunkt var CHMP af den opfattelse, at Clopidogrel Teva Pharma ikke kunne anses for at være et generisk lægemiddel af Plavix, referencelægemidlet.
English: Clopidogrel Teva Pharma is expected to work in the same way as the reference medicine, Plavix.
Danish: Clopidogrel Teva Pharma forventes at virke på samme måde som referencelægemidlet Plavix.
English: Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Teva Pharma er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: The active substance in Clopidogrel Teva Pharma and in Plavix, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Teva Pharma og i Plavix, clopidogrel, er en trombocytaggregationshæmmer.
English: The CHMP concluded that the studies presented did not provide enough evidence to show that Clopidogrel Teva Pharma was bioequivalent to the reference medicine Plavix.
Danish: CHMP konkluderede, at de fremlagte undersøgelsesresultater ikke i tilstrækkelig grad dokumenterede, at der var påvist bioækvivalens mellem Clopidogrel Teva Pharma og referencelægemidlet Plavix.
English: On 22 April 2009, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Clopidogrel Teva Pharma, for the prevention of atherothrombotic events in patients who have myocardial infarction, ischaemic stroke or established peripheral arterial disease.
Danish: officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Clopidogrel Teva Pharma til forebyggelse af aterotrombotiske hændelser hos patienter, som har myocardieinfarkt, iskæmisk slagtilfælde eller påvist perifer arteriesygdom.
English: What was Clopidogrel Teva Pharma expected to be used for?
Danish: Hvad forventedes Clopidogrel Teva Pharma anvendt til?
English: How is Clopidogrel Teva Pharma expected to work?
Danish: Hvordan forventes Clopidogrel Teva Pharma at virke?
English: This overview was last updated in 10-2018.
Danish: Denne oversigt blev sidst ajourført i 10-2018.
English: The effectiveness of Strensiq was also generally supported by several additional small studies.
Danish: Effektiviteten af Strensiq blev derudover generelt understøttet af flere supplerende små studier.
English: Strensiq received a marketing authorisation valid throughout the EU on 28 August 2015.
Danish: Strensiq fik en markedsføringstilladelse med gyldighed i hele EU den 28. august 2015.
English: Strensiq has been authorised under ‘exceptional circumstances'.
Danish: Strensiq er godkendt under "særlige omstændigheder".
English: Strensiq has been studied in one main study in 13 children between 6 and 12 years of age.
Danish: Strensiq er blevet anvendt i én hovedundersøgelse hos 13 børn mellem 6 og 12 år.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu308594.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/medicines/human/orphan-designations/eu308594.
English: As for all medicines, data on the use of Strensiq is continuously monitored.
Danish: Som for alle lægemidler, bliver data vedrørende brug af Strensiq løbende overvåget.
English: This is because it has not been possible to obtain complete information about Strensiq due to the rarity of the disease.
Danish: Det skyldes, at ikke har været muligt at indhente fyldestgørende oplysninger om Strensiq, fordi sygdommen er sjælden.
English: In the historical controls, most children did not experience similar improvements in their joints or gain in height over a comparable period of time.
Danish: Blandt de historiske kontroller fik størstedelen af børnene ikke tilsvarende forbedringer i deres led eller højdevækst i løbet af et sammenligneligt tidsrum.
English: The study also looked at other measures of effectiveness such as growth in height.
Danish: I studiet blev der også registreret andre mål for virkningen, såsom højdevækst.
English: The Agency noted that hypophosphatasia is a serious and life-threatening disease for which no treatment is authorised.
Danish: Udvalget bemærkede, at hypofosfatasi er en alvorlig, livstruende sygdom, som der ikke findes nogen godkendt behandling for.
English: What is Strensiq and what is it used for?
Danish: Hvad er Strensiq, og hvad anvendes det til?
English: Further information on Strensiq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Strensiq
Danish: Yderligere information om Strensiq findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Strensiq
English: An overview of Strensiq and why it is authorised in the EU
Danish: En oversigt over Strensiq, og hvorfor det er godkendt i EU
English: As the amount given depends on the patient's bodyweight, the doctor will need to adjust the dose as the patient's weight changes, particularly in growing children.
Danish: Da mængden, der gives, afhænger af patientens kropsvægt, vil lægen være nødt til løbende at tilpasse dosis efter patientens vægt, navnlig hos børn i voksealderen.
English: X-rays of children given Strensiq were also compared with similar x-rays available from 16 children who had not received Strensiq (‘historical controls').
Danish: Røntgenbilleder af børn, der fik Strensiq, blev desuden sammenlignet med tilsvarende røntgenbilleder fra 16 børn, der ikke havde fået Strensiq ("historiske kontroller").
English: Other information about Strensiq
Danish: Andre oplysninger om Strensiq
English: For more information about using Strensiq, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Strensiq, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Strensiq?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Strensiq?
English: Side effects reported with Strensiq are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Strensiq vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Although the main study was small and did not directly compare Strensiq with another treatment or with untreated patients, the Agency considered that the improvement seen in the bones and the apparent growth was relevant.
Danish: Selv om hovedstudiet var lille og ikke direkte sammenlignede Strensiq med en anden behandling eller med ubehandlede patienter, fandt CHMP, at den konstaterede bedring i patienternes knogler og tilsyneladende vækst var relevant.
English: The most common side effects with Strensiq (which may affect more than 1 in 10 people) are headache, erythema (reddening of the skin), pain in arms and legs, fever, irritability, injection site reactions (such as pain, rash and itching) and contusion (bruising).
Danish: De hyppigste bivirkninger ved Strensiq (som kan forekomme hos op til 1 ud af 10 personer) er hovedpine, rødme af huden (erytem), smerter i arme og ben, feber, irritabilitet, reaktioner på injektionsstedet (såsom smerter, udslæt og kløe) og blå mærker (kontusioner).
English: Regarding safety, injection site reactions and other side effects were considered manageable with the recommendations in place.
Danish: Vedrørende sikkerheden fandt udvalget, at virkningerne på injektionsstedet og andre bivirkninger kunne håndteres med de gældende anbefalinger.
English: The European Medicines Agency decided that Strensiq's benefits are greater than its risks and it be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Strensiq opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The enzyme ‘tissue non-specific alkaline phosphatase' (ALP) plays a key role in creating and maintaining healthy bones, and managing calcium and phosphate in the body.
Danish: Enzymet "ikkevævsspecifik alkalisk fosfatase" (ALP) spiller en vigtig rolle i at skabe og opretholde raske knogler og regulere calcium og fosfat i kroppen.
English: Hypophosphatasia is rare, and Strensiq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 December 2008.
Danish: Hypofosfatasi er sjælden, og Strensiq blev udpeget som "lægemiddel til sjældne sygdomme" den 3. december 2008.
English: It is given by injection under the skin either six times a week (in a dose of 1 mg per kilogram bodyweight) or three times a week (in a dose of 2 mg/kg).
Danish: Det gives ved injektion under huden enten seks gange ugentligt (i en dosis på 1 mg/kg legemsvægt) eller tre gange ugentligt (i en dosis på 2 mg/kg).
English: Additional data from an extension of this study in children aged 13 to 18 years confirmed the initial results.
Danish: De indledende resultater bekræftedes af yderligere data fra en forlængelse af dette studie hos børn i alderen 13 til 18 år.
English: Strensiq is a medicine used long-term to treat patients with hypophosphatasia that started in childhood.
Danish: Strensiq er et lægemiddel til langsigtet behandling af patienter med hypofosfatasi, der er begyndt i barndommen.
English: This study showed that children given Strensiq had an improvement in their joint structure as demonstrated by x-rays and most of them seemed to gain in height.
Danish: Studiet viste, at børn, der fik Strensiq, fik forbedret strukturen af deres led, således som dette fremgik af røntgenbilleder, og størstedelen syntes at opnå højdevækst.
English: Why is Strensiq authorised in the EU?
Danish: Hvorfor blev Strensiq godkendt i EU?
English: Since Strensiq has been authorised under exceptional circumstances, the company that markets Strensiq will set up a registry of patients with hypophosphatasia to collect information on the disease and on the long-term safety and effectiveness of Strensiq.
Danish: Da Strensiq er godkendt under særlige omstændigheder, skal virksomheden, der markedsfører Strensiq, oprette et register over patienter med hypofosfatasi for at indsamle oplysninger om sygdommen og om Strensiqs langsigtede sikkerhed og virkning.
English: The main measure of effectiveness of the medicine was the improvement in x-ray appearance of the wrists and knee joints before and after treatment with Strensiq.
Danish: Lægemidlets virkning blev hovedsagelig bedømt på forbedringen i udseendet af håndled og knæled på røntgen før og efter behandlingen med Strensiq.
English: What are the risks associated with Strensiq?
Danish: Hvilke risici er der forbundet med Strensiq?