FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies in hypertensive patients, Riprazo had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Danish: I kliniske studier af hypertensive patienter havde Riprazo ingen klinisk signifikant virkning på total kolesterol, HDL-kolesterol, fastende triglycerider,
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema which in some cases was associated with the administration of other medicines known to cause angioedema, including RAAS blockers (ACEIs or ARBs).
Danish: Et antal af disse patienter havde en anamnese med angioødem eller symptomer, der tydede på angioødem, som i nogle tilfælde havde efterfulgt brug af anden medicin, der er kendt for at forårsage angioødem, inklusive RAAS-blokkere (ACE-hæmmere eller ARB'er).
English: Following intravenous administration, the mean plasma clearance is
Danish: Efter intravenøs administration er den gennemsnitlige
English: Uncommon (may affect up to 1 in 100 people): Skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects below), kidney problems including acute renal failure (severely decreased urine output), swelling of hands, ankles or feet (peripheral oedema), severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, fever), low blood pressure, palpitations, cough, itching, itchy rash
Danish: Ikke almindelige bivirkninger (forekommer hos op til 1 ud af 100 patienter): Hududslæt (dette kan også være symptomer på en overfølsomhedsreaktion eller angioødem - se ”Sjældne” bivirkninger herunder), nyreproblemer inklusive akut nyresvigt (svært nedsat urinproduktion), hævede hænder, ankler eller fødder (væskeansamlinger), alvorlige hudreaktioner (toksisk epidermal nekrolyse og/eller bivirkninger fra slimhinden i munden - rød hud, blæredannelse omkring læber, øjne eller mund, hudafskalning, feber), lavt blodtryk, hjertebanken, hoste, kløe, kløende udslæt (nældefeber), forhøjet
English: Angiotensin II causes blood vessels to tighten, which increases the blood pressure.
Danish: AngiotensinII får blodkarrene til at trække sig sammen, hvilket øger blodtrykket.
English: If pregnancy is detected during therapy, Riprazo should be discontinued accordingly.
Danish: Hvis der opstår graviditet under behandlingen, skal Riprazo
English: In the majority of patients aged 65 years or older, the 300 mg dose of Riprazo shows no additional benefit in reducing blood pressure compared to the 150 mg dose.
Danish: Hos størstedelen af patienter på 65 år og derover giver en dosis på 300 mg af Riprazo ikke ekstra nedsat blodtryk sammenlignet med en dosis på 150 mg.
English: - if you have diabetes mellitus or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.
Danish: - hvis du har diabetes eller nedsat nyrefunktion, og du behandles med nogen af følgende typer lægemidler, som bruges til at behandle for højt blodtryk: en ”angiotensin-konverteringsenzym (ACE)-hæmmer”, som fx enalapril, lisinopril, ramipril osv.
English: These include potassiumsparing diuretics, potassium supplements.
Danish: Dette gælder også kaliumbesparende diuretika og kaliumtilskud.
English: Hypersensitivity reactions including anaphylactic reactions have also been reported in post-marketing experience (see section 4.4).
Danish: Der er også blevet indberettet overfølsomhedsreaktioner inklusive anafylaktiske reaktioner efter markedsføring (se pkt.
English: Combination therapy studies are available for Riprazo added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol.
Danish: Der er undersøgelser af kombinationsbehandling tilgængelige, hvor Riprazo er kombineret med diuretikummet hydrochlorthiazid, calciumantagonisten amlodipin og betablokkeren atenolol.
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [NYHA] functional class III-IV).
Danish: Aliskiren bør anvendes med forsigtighed til patienter med svært hjertesvigt (New York Heart
English: Do not take Riprazo if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).
Danish: Du må ikke tage Riprazo, hvis du samtidig er i behandling med ciclosporin (medicin, der bruges til organtransplantation for at undgå afstødning af organet eller det kan bruges til andre tilstande, fx gigt eller hudeksem), itraconazol (medicin, der bruges til behandling af svampeinfektioner) eller quinidin (medicin, som bruges til at korrigere hjerterytmen).
English: Skin and subcutaneous tissue disorders Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome, toxic epidermal necrolysis (TEN) and oral mucosal
Danish: Svære kutane bivirkninger inklusive Stevens-Johnsons syndrom, toksisk epidermal nekrolyse (TEN) og bivirkninger fra
English: Special caution is necessary in patients with a hypersensitivity predisposition.
Danish: Der bør udvises særlig forsigtighed hos patienter disponeret for allergi.
English: Riprazo is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Danish: Riprazo anbefales ikke til patienter med stærkt nedsat nyrefunktion (glomerulær filtrationsrate (GFR) < 30 ml/min./1,73 m2).
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i
English: Rare (may affect up to 1 in 1,000 people): Severe allergic reaction (anaphylactic reaction), allergic reactions (hypersensitivity) and angioedema (the symptoms of which can include difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, hands and feet, eyes, lips and/or tongue, dizziness), increased level of creatinine in the blood, red skin (erythema).
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter): Alvorlige allergiske reaktioner (anafylaktisk reaktion), allergiske reaktioner (overfølsomhed) og angioødem (symptomerne kan være besvær med at trække vejret eller med at synke, udslæt, kløe, nældefeber, hævet ansigt, hænder og fødder, øjenomgivelser, læber og/eller tunge eller svimmelhed), forhøjet indhold af kreatinin i blodet,
English: - History of angioedema with aliskiren.
Danish: - Angioødem forårsaget af aliskiren i anamnesen.
English: Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of this medicine.
Danish: Du skal sørge for at finde ud af, hvordan du reagerer på dette lægemiddel, før du kører bil, betjener maskiner eller udfører andre aktiviteter, som kræver koncentration.
English: The combination of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR
Danish: Kombination af aliskiren og ARB'er eller ACE-hæmmere er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (GFR
English: Anaphylactic reactions have been observed during treatment with aliskiren from post-marketing experience (see section 4.8).
Danish: Der er set anafylaktiske reaktioner ved behandling med aliskiren efter markedsføring (se pkt.
English: - The active substance is aliskiren (as hemifumarate) 150 mg. - The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol, microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
Danish: - Aktivt stof: aliskiren (som hemifumarat) 150 mg. - Øvrige indholdsstoffer: crospovidon, hypromellose, magnesiumstearat, macrogol, mikrokrystallinsk cellulose, povidon, kolloid vandfri silica, talcum, titandioxid (E171), sort jernoxid (E172), rød jernoxid (E172).
English: - The active substance is aliskiren (as hemifumarate) 300 mg. - The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol, microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
Danish: - Aktivt stof: aliskiren (som hemifumarat) 300 mg. - Øvrige indholdsstoffer: crospovidon, hypromellose, magnesiumstearat, macrogol, mikrokrystallinsk cellulose, povidon, kolloid vandfri silica, talcum, titandioxid (E171), sort jernoxid (E172), rød jernoxid (E172).
English: When administered with atorvastatin, steady-state Riprazo AUC and Cmax increased by 50%.
Danish: Ved samtidig administration med atorvastatin steg AUC og Cmax for Riprazo ved steady state med 50 %.
English: Caution should therefore be exercised when prescribing aliskiren to patients with a history of angioedema, and such patients should be closely monitored during treatment (see section 4.8) especially at the beginning of the treatment.
Danish: Der skal derfor udvises forsigtighed, når aliskiren udskrives til patienter med angioødem i anamnesen, og disse patienter skal følges tæt under behandlingen, især i
English: - one of the following classes of medicines used to treat high blood pressure: an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.
Danish: - en af følgende typer medicin, som anvendes til at behandle for højt blodtryk: en ”angiotensin-konverteringsenzym (ACE)-hæmmer, som fx enalapril, lisinopril, ramipril osv.
English: The increased incidence of non-fatal stroke was greater in patients with
Danish: Forekomsten af ikke-letal apopleksi var højere
English: In patients with marked volume- and/or salt-depletion (e.g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Riprazo.
Danish: Symptomatisk hypotension kan forekomme hos patienter med markant væske- og/eller natriummangel (fx patienter, som får høje doser af diuretika) efter initiering af behandling med Riprazo.
English: Consequently, no adjustment of the initial dose of aliskiren is required in patients with mild
Danish: Derfor er justering af initialdosen af aliskiren ikke nødvendig hos patienter med let til svært nedsat leverfunktion.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på
English: Common (may affect up to 1 in 10 people): Diarrhoea, joint pain (arthralgia), high level of potassium
Danish: Bivirkninger: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 patienter): Diarré, ledsmerter, højt
English: - if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue):
Danish: - hvis du har oplevet følgende former for angioødem (svært ved at trække vejret eller synke eller har haft hævet ansigt, hænder og fødder, øjenomgivelser, læber og/eller tunge): angioødem når du har taget aliskiren.
English: EXPIRY DATE
Danish: Udløbsdatoen
English: When administered with atorvastatin (80 mg), steady-state aliskiren (300 mg) AUC and Cmax increased by 50%.
Danish: Ved samtidig administration af aliskiren (300 mg) og atorvastatin (80 mg) blev AUC og Cmax for aliskiren øget med 50 % ved steady state.
English: Riprazo is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Danish: Riprazo er tilgængelig i pakninger, der indeholder 7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
English: As for any medicine that acts directly on the RAAS, Riprazo should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Danish: Riprazo bør, som andre præparater, der virker direkte på RAAS, ikke anvendes under 1. trimester i graviditeten (se pkt.
English: Other inducers of P-gp (St. John's wort) might decrease the bioavailability of Riprazo.
Danish: Andre P-gp-induktorer (perikon) kan muligvis nedsætte Riprazos biotilgængelighed.
English: 2) and is not recommended in other patients (see sections 4.3, 4.4 and 5.1).
Danish: 2) og frarådes til andre patienter (se pkt.
English: Talk to your doctor before taking Riprazo: - if you are taking a diuretic (a type of medicine also known as “water” tablets which increases the amount of urine you produce).
Danish: - hvis du tager et diuretikum (kaldes også vanddrivende tabletter, som øger den mængde urin, du
English: PSURs
Danish: Talcum
English: Tabulated list of adverse reactions:
Danish: Liste over bivirkninger i tabelform:
English: In post-marketing experience, angioedema or angioedema-like reactions have been reported when aliskiren was co-administered with ACEIs and/or ARBs (see section 4.8).
Danish: Angioødem eller angioødem-lignende reaktioner er set efter markedsføring, når aliskiren administreres sammen med ACE-hæmmere og/eller ARB'er (se pkt.
English: Dual blockade of the renin-angiotensin-aldosterone system by combining aliskiren with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) is therefore not recommended.
Danish: Dobbelt hæmning af renin-angiotensin-aldosteronsystemet ved kombination af aliskiren med en angiotensin-konverteringsenzym (ACE)-hæmmer eller en
English: Riprazo 300 mg film-coated tablets Aliskiren
Danish: Riprazo 300 mg filmovertrukne tabletter Aliskiren
English: Riprazo 150 mg film-coated tablets
Danish: Riprazo 150 mg filmovertrukne tabletter
English: Riprazo 150 mg film-coated tablets Aliskiren
Danish: Riprazo 150 mg filmovertrukne tabletter Aliskiren
English: You may need to stop Riprazo.
Danish: Hvis du har glemt at tage Riprazo
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Riprazo til dig personligt.
English: P-glycoprotein (P-gp) potent inhibitors
Danish: - P-gp-substrater og svage P-gp-hæmmere
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Danish: YDRE KARTON TIL MULTPAKNING (INKLUSIV BLÅ BOKS) MED PA/ALU/PVCBLISTERKORT
English: Riprazo 300 mg film-coated tablets
Danish: Riprazo 300 mg filmovertrukne tabletter
English: Severe allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, dizziness.
Danish: Kontakt din læge med det samme, hvis du oplever noget af følgende: Alvorlige allergiske reaktioner med symptomer som fx udslæt, kløe, hævet ansigt, læber eller tunge, svært ved trække vejret, svimmelhed.
English: What Riprazo looks like and contents of the pack Riprazo 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Danish: Riprazo 150 mg filmovertrukne tabletter er lyse pink, udadbuede, runde tabletter, præget med ”IL” på den ene side og ”NVR” på den anden side.
English: Furosemide
Danish: Nyrearteriestenose
English: What Riprazo looks like and contents of the pack Riprazo 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Danish: Riprazo 300 mg filmovertrukne tabletter er lyserøde, udadbuede, ovale tabletter, præget med ”IU” på den ene side og ”NVR” på den anden side.
English: INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Danish: KARTON TIL DELPAKNING (UDEN BLÅ BOKS) MED PA/ALU/PVC-BLISTERKORT
English: - if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).
Danish: Bruges også til andre tilstande fx gigt eller hudeksem), itraconazol (medicin, der bruges til behandling af svampeinfektioner) eller quinidin (medicin, som bruges til at korrigere hjerterytmen).
English: The most common adverse reaction is
Danish: Det primære endepunkt var en
English: - If you get any side effects, talk to your doctor or pharmacist.
Danish: - Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får
English: • A description and timelines for the new observational study on incidence of colorectal hyperplasia in aliskiren-treated patients.
Danish: • en beskrivelse og tidslinjer for et nyt observationsstudie om forekomsten af kolorektal
English: Medicinal product subject to medical prescription.
Danish: Lægemidler, som påvirker serumkalium
English: No adjustment of the initial dosage of Riprazo is required in patients with mild to moderate renal impairment (see sections 4.2 and 4.4).
Danish: Det er ikke nødvendigt at justere initialdosen af Riprazo hos patienter med let til moderat nedsat nyrefunktion (se pkt.
English: As for other medicinal products acting on the renin-angiotensin system, caution should be exercised when aliskiren is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (eg.
Danish: Som for andre lægemidler, der virker på renin-angiotensin-systemet, skal der udvises forsigtighed, når aliskiren gives til patienter, der er prædisponerede for renal dysfunktion som hypovolæmi (fx pga. blodtab, alvorlig og vedvarende diarré, vedvarende opkastning), hjertelidelse, leverlidelse, diabetes mellitus eller nyrelidelse.
English: EU/1/07/409/007 84 film-coated tablets (3x28) EU/1/07/409/009 98 film-coated tablets (2x49) EU/1/07/409/010 280 film-coated tablets (20x14)
Danish: EU/1/07/409/011-020 EU/1/07/409/031-040
English: Concomitant use of Riprazo with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Danish: Samtidig brug af Riprazo og ARB'er eller ACE-hæmmere er kontraindiceret hos patienter med nedsat nyrefunktion (GFR < 60 ml/min./1,73 m2) (se pkt.
English: Respiratory, thoracic and mediastinal disorders
Danish: Silica, kolloid vandfri Hypromellose Macrogol
English: - Hereditary or idiopathic angioedema.
Danish: Anafylaktisk reaktioner og angioødem
English: This includes any possible side
Danish: I nogle tilfælde opstod dette som en del af en
English: Concomitant use of Riprazo with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see
Danish: Samtidig brug af Riprazo og ARB'er eller ACE-hæmmere er kontraindiceret hos patienter med nedsat nyrefunktion (GFR < 60 ml/min./1,73 m
English: - The concomitant use of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m 2) (see sections 4.2, 4.4, 4.5 and
Danish: - Anvendelse af aliskiren sammen med ARB'er eller ACE-hæmmere er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min./1,73 m 2) (se pkt.
English: If any of these affect you severely, tell your doctor.
Danish: Fortæl det til din læge, hvis nogle af disse bivirkninger påvirker dig alvorligt.
English: EU/2/08/088/004 Acticam 5 mg/ml solution for injection
Danish: EU/2/08/088/004 Acticam 5 mg/ml Injektionsvæske, Opløsning
English: Dogs and cats sc/iv
Danish: Hunde og katte Subkutan eller intravenøs injection
English: Glass vial
Danish: Farveløse Hætteglas
English: Invented Name
Danish: Ikke relevant
English: You should usually receive your infusion once every 3 weeks.
Danish: Du vil normalt få din infusion én gang hver tredje uge.
English: Treatment should be resumed according to the guidelines in Table 2.
Danish: Behandlingen bør genoptages i henhold til retningslinjerne i tabel
English: This medicine should not been used if there are any signs of particles.
Danish: Dette lægemiddel skal ikke anvendes, hvis der er tegn på partikler.
English: In the absence of other compatibility studies this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke er foretaget andre forligelighedsstudier, må dette lægemiddel ikke blandes med andre lægemidler.
English: if you have recently received or are about to receive a vaccine against yellow fever.
Danish: hvis du for nylig er blevet eller snart skal vaccineres mod gul feber.
English: Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Reconstituted and infusion solutions: The product should be used immediately.
Danish: Rekonstituerede opløsninger og infusionsopløsninger: Produktet skal anvendes med det samme.
English: The reporting rates shown are according to CTCAE version 3.0.
Danish: De viste indberetningsfrekvenser er i henhold til CTCAE version 3.0.
English: * Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Danish: Definition af hyppighed: Meget almindelig - ≥ 10 %; Almindelig - > 5 % og < 10 %.
English: Between patient variability in clearance is moderate at 19.3 %.
Danish: Der er en moderat variation i clearance blandt patienter på 19,3 %.
English: Sienkiewicza 25, Kutno, 99-300, Poland
Danish: Sienkiewicza 25, Kutno, 99-300 Polen eller
English: Unopened vial 2 years.
Danish: Ubrudt hætteglas 2 år.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 July 2016
Danish: Dato for første markedsføringstilladelse: 22. juli 2016.
English: Particular attention should be paid to these patients and caution exercised with use of other radiosensitising agents.
Danish: Der bør udvises særlig opmærksomhed ved disse patienter, og der bør udvises forsigtighed ved brug af andre radiosensibiliserende stoffer.
English: Your doctor will use this body surface area to work out the right dose for you.
Danish: Din læge vil bruge legemsoverfladearealet til at bestemme den rette dosis til dig.
English: Frequency estimate: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and not known (cannot be estimated from available data).
Danish: Estimeret hyppighed: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Pregnant women must avoid contact with cytostatic medicinal product.
Danish: Gravide kvinder skal undgå kontakt med cytostatiske lægemidler.
English: Any diarrhoea requiring hospitalisation (irrespective of grade) or grade 3 or 4 diarrhoea.
Danish: Enhver diarré der kræver indlæggelse (uanset grad) eller diarré af grad 3 eller 4.
English: If concomitant administration of NSAIDs is necessary, patients should be monitored closely for toxicity, especially myelosuppression and gastrointestinal toxicity.
Danish: Hvis samtidig administration af NSAID-præparater er nødvendig, skal patienterne monitoreres nøje for toksicitet, især myelosuppression og gastrointestinal toksicitet.
English: Not known: frequency cannot be estimated from the available data Lower limb swelling with pain and redness Increased urine output
Danish: Ikke kendt: hyppigheden kan ikke estimeres udfra forhåndenværende data Hævelse i de nedre lemmer med smerte og rødme Øget urinproduktion
English: Pemetrexed can have genetically damaging effects.
Danish: Pemetrexed kan have genetisk skadelig effekt.
English: If you are pregnant, , think you may be pregnant or are planning to have a baby, tell your doctor.
Danish: Hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du fortælle det til din læge.
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS.
Danish: Den uafhængige evaluering af patienternes skanninger, bekræftede investigatorens vurdering af PFS.