FrancophonIA/ELRC3.0 huggingface dataset:
English: Axumin is indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.
Danish: Axumin er indiceret ved PET-scanning (positronemissionstomografi) til detektion af recidiv af prostatakræft hos voksne mænd ved mistanke om recidiv baseret på forhøjet prostataspecifikt antigen (PSA) i blodet efter primær kurativ behandling.
English: Diagnostic performance of fluciclovine (18F) to detect recurrences has not been investigated in patients with a suspected recurrence based on elevated blood PSA levels after primary radical treatment with a recent positive whole-body bone scintigraphy.
Danish: Diagnosticeringseffektiviteten af fluciclovin (18F) til detektion af recidiv er ikke undersøgt hos patienter med formodet recidiv baseret på forhøjet PSA-niveau i blodet efter primær radikal behandling med nylig positiv helkrops-knoglescintigrafi.
English: - not eat or drink for at least 4 hours before the scan (you can take your usual medicines with small amounts of water).
Danish: - undgå motion i mindst et døgn før Axumin-scanningen - lade være med at spise og drikke i mindst 4 timer inden scanningen (du må dog gerne tage din sædvanlige medicin med lidt vand).
English: MedDRA system organ class
Danish: MedDRA-systemorganklasse Bivirkninger
English: The recommended activity for an adult is 370 MBq fluciclovine (18F).
Danish: Voksne Den anbefalede aktivitet til en voksen patient er 370 MBq fluciclovin (18F).
English: PET images with fluciclovine (18F) should be interpreted visually.
Danish: PET-billeder med fluciclovin (18F) skal fortolkes visuelt.
English: Excipients: sodium citrate, concentrated hydrochloric acid, sodium hydroxide, and water for injections.
Danish: Hjælpestoffer: natriumcitrat, koncentreret saltsyre, natriumhydroxid og vand til injektionsvæsker.
English: After administration of Axumin you should:
Danish: Efter Axumin-scanningen skal du gøre følgende:
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Danish: De sandsynlige fordele ved undersøgelsen skal retfærdiggøre stråleeksponeringen for hver enkelt patient.
English: Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norway Advanced Accelerator Applications, 13005 Marseille, France Nucleis SA, 4000 Liège, Belgium
Danish: Seibersdorf Labor GmbH, 2444 Seibersdorf, Østrig Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norge Advanced Accelerator Applications, 13005 Marseille, Frankrig Nucleis SA, 4000 Liège, Belgien
English: The impact of quantitative/semiquantitative measurement of fluciclovine (18F) uptake as an aid to image interpretation has not been assessed.
Danish: Det er ikke blevet vurderet, om kvantitativ/semikvantitativ måling af fluciclovin (18F)-optagelse kan være en hjælp ved fortolkning af billederne.
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Danish: Axumin er et radioaktivt lægemiddel, der kun er til diagnostisk brug.
English: A PET scan with fluciclovine (18F) should be administered by appropriately qualified healthcare professionals.
Danish: PET-scanning med fluciclovin (18F) skal udføres af specialuddannede sundhedspersoner.
English: GE Healthcare Ltd, Amersham HP7 9LL, UK Advanced Accelerator Applications, 50100, La Almunia-Zaragoza, Spain Advanced Accelerator Applications, 407014, Meldola (FC), Italy Advanced Accelerator Applications, 92210 Saint Cloud, France
Danish: GE Healthcare Ltd, Amersham HP7 9LL, Storbritannien Advanced Accelerator Applications, 50100, Zaragoza, Spanien Advanced Accelerator Applications, 407014, Meldola (FC), Italien Advanced Accelerator Applications, 92210 Saint Cloud, Frankrig
English: Images should only be interpreted by readers trained in the interpretation of PET images with fluciclovine (18F).
Danish: Billederne bør kun fortolkes af specialuddannet personale med erfaring i PET-scanning med fluciclovin (18F).
English: Effect of blood PSA level on the patient-based diagnostic performance of fluciclovine (18F) PET-CT at BED-001 Emory
Danish: Virkning af blod-PSA på den patientbaserede diagnosticeringseffektivitet af PET-CTscanninger med fluciclovin (18F) i BED-001 Emory-studiet
English: Contact your nuclear medicine doctor if you have any questions.
Danish: Spørg den nuklearmedicinske læge, hvis der er noget, du er i tvivl om.
English: Adverse reactions were reported commonly (≥ 1/100 to < 1/10) during clinical trials.
Danish: I kliniske studier er der rapporteret om bivirkninger med frekvensen ”almindelig” (observeret hos ≤ 1/100 til < 1/10 patienter).
English: Please refer to the SmPC [SmPC should be included in the box]
Danish: Læs produktresuméet [produktresuméet skal inkluderes i pakningen].
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SHIELD LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET PÅ AFSKÆRMNING
English: Axumin 3200 MBq/mL solution for injection 10 hours from the time of calibration (ToC)
Danish: Axumin 3200 MBq/ml injektionsvæske, opløsning 10 timer fra tidspunktet for kalibrering (ToC)
English: It is considered unlikely that Axumin will affect your ability to drive or to use machines.
Danish: Axumin påvirker sandsynligvis ikke evnen til færdes sikkert i trafikken eller betjene maskiner.
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Danish: Radioaktive lægemidler skal opbevares i overensstemmelse med national lovgivning vedrørende radioaktive materialer.
English: Axumin 1600 MBq/mL solution for injection 8 hours from the time of calibration (ToC)
Danish: Axumin 1600 MBq/ml injektionsvæske, opløsning 8 timer fra tidspunktet for kalibrering (ToC)
English: Package leaflet: Information for the patient Axumin 1600 MBq/mL solution for injection Axumin 3200 MBq/mL solution for injection fluciclovine (18F) This medicine is subject to additional monitoring.
Danish: Axumin 1600 MBq/ml injektionsvæske, opløsning Axumin 3200 MBq/ml injektionsvæske, opløsning fluciclovin (18F) Dette lægemiddel er underlagt supplerende overvågning.
English: Prostate & prostate bed
Danish: Prostata og prostataleje
English: The Patient-based diagnostic performance of fluciclovine (18F) PET-CT by blood PSA level is shown in Table 2.
Danish: Den patientbaserede diagnosticeringseffektivitet af PET CT-scanninger med fluciclovin (18F) i relation til blod-PSA er vist tabel 2.
English: Image interpretation errors can occur with PET with fluciclovine (18F) (see section 5.1).
Danish: Der kan ske fortolkningsfejl ved PET-scanning med fluciclovin (18F) (se pkt.
English: An additional study BED002 conducted a blinded read of fluciclovine (18F) PET-CT images from the
Danish: I et suppleringsstudie, BED-002, gennemførte 3 eksperter en blindet fortolkning af fluciclovin (18F)baserede PET-CT-billeder fra en undergruppe i BED-001 Emory-studiet.
English: Axumin 1600 MBq/mL solution for injection One vial contains 1 to 10 mL of solution, corresponding to 1600 to 16000 MBq at calibration time.
Danish: Axumin 1600 MBq/ml injektionsvæske, opløsning Et hætteglas indeholder 1-10 ml injektionsvæske, svarende til 1.600-16.000 MBq på tidspunktet for kalibrering.
English: Axumin 3200 MBq/mL solution for injection One vial contains 1 to 10 mL of solution, corresponding to 3200 to 32000 MBq at calibration time.
Danish: Axumin 3200 MBq/ml injektionsvæske, opløsning Et hætteglas indeholder 1-10 ml injektionsvæske, svarende til 3.200-32.000 MBq på tidspunktet for kalibrering.
English: Patient and region based diagnostic performance of fluciclovine 18F PET vs histopathology
Danish: Tabel 1: Patient- og lokationsbaseret diagnostiseringseffektivitet ved PET-scanning med fluciclovin (18F) versus histopatologi
English: Renal/Hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Danish: Nedsat nyre- og leverfunktion Farmakokinetikken er ikke beskrevet hos patienter med nedsat nyre- eller leverfunktion.
English: Axumin 3200 MBq/mL solution for injection fluciclovine (18F)
Danish: Axumin 3200 MBq/ml injektionsvæske, opløsning fluciclovin (18F)
English: How Axumin is used
Danish: Sådan får du Axumin
English: For sodium, see leaflet for further information.
Danish: Med hensyn til natrium, se indlægssedlen.
English: Axumin 1600 MBq/mL solution for injection fluciclovine (18F)
Danish: Axumin 1600 MBq/ml injektionsvæske, opløsning fluciclovin (18F)
English: Axumin may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection by a factor of 8.
Danish: Axumin kan fortyndes op til 8 gange med 0,9 % (9 mg/ml) natriumchlorid-injektionsvæske.
English: The medicinal product may be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection by up to a factor of 8.
Danish: Klargøring Lægemidlet kan fortyndes op til 8 gange med 0,9 % (9 mg/ml) natriumchlorid-injektionsvæske.
English: Each mL of solution contains 7.7 mg of sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på En ml injektionsvæske indeholder 7,7 mg natrium.
English: If you have been given more Axumin than you should
Danish: Hvis du har fået for meget Axumin
English: Axumin 1600 MBq/mL solution for injection Axumin 3200 MBq/mL solution for injection
Danish: Axumin 1600 MBq/ml injektionsvæske, opløsning Axumin 3200 MBq/ml injektionsvæske, opløsning
English: The activity per vial ranges from 1600 MBq to 16000 MBq at the date and time of calibration.
Danish: Aktiviteten pr. hætteglas ligger mellem 1600 MBq og 16000 MBq på datoen og tidspunktet for kalibrering.
English: Advanced Accelerator Applications, 13005 Marseille, France Nucleis SA, 4000 Liège, Belgium
Danish: Advanced Accelerator Applications, 13005 Marseille, Frankrig.
English: Axumin 3200 MBq/mL solution for injection
Danish: Axumin 3200 MBq/ml injektionsvæske, opløsning
English: The activity per vial ranges from 3200 MBq to 32000 MBq at the date and time of calibration (ToC).
Danish: Aktiviteten pr. hætteglas ligger mellem 3.200 MBq og 32.000 MBq på datoen og tidspunktet for kalibrering (ToC).
English: Each multidose vial contains 1 to 10 mL of solution, corresponding to 3200 to 32000 MBq at the date and time of calibration (ToC).
Danish: Et flerdosishætteglas indeholder 1-10 ml injektionsvæske svarende til 3.200-32.000 MBq på datoen og tidspunktet for kalibrering (ToC).
English: The patient-based sensitivity of fluciclovine (18F) was higher than
Danish: Den patientbaserede følsomhed for fluciclovin (18F) var højere end 88,6 % for alle 3 eksperter, mens specificiteten var
English: Each multidose vial contains 1 to 10 mL of solution, corresponding to 1600 to 16000 MBq at the date and time of calibration (ToC).
Danish: Et flerdosishætteglas indeholder 1-10 ml injektionsvæske svarende til 1.600-16.000 MBq på datoen og tidspunktet for kalibrering (ToC).
English: Axumin 1600 MBq/mL solution for injection
Danish: Axumin 1600 MBq/ml injektionsvæske, opløsning
English: The activity per vial ranges from 1600 MBq to 16000 MBq at the date and time of calibration (ToC).
Danish: Aktiviteten pr. hætteglas ligger mellem 1.600 MBq og 16.000 MBq på datoen og tidspunktet for kalibrering (ToC).
English: - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Danish: - Spørg den nuklearmedicinske læge med ansvar for undersøgelsen, hvis der er mere, du vil vide.
English: The PSA value may affect the diagnostic performance of fluciclovine (18F) PET. (see section 5.1, Pharmacodynamic properties).
Danish: Prostataspecifikt antigen (PSA) kan påvirke diagnosticeringseffektiviteten ved PET-scanning med fluciclovin (18F) (se pkt.
English: Pharmacodynamic effects At the chemical concentrations used for diagnostic examinations, fluciclovine (18F) does not appear to have any pharmacodynamic activity.
Danish: Fluciclovin (18F) synes ikke at have nogen farmakodynamisk aktivitet ved de koncentrationer, der anvendes ved diagnostiske undersøgelser.
English: Respiratory thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Parosmi Almene symptomer og reaktioner på administrationsstedet
English: Axumin contains the active ingredient fluciclovine (18F) and is given so that doctors can perform a special type of scan called a PET scan.
Danish: Axumin indgives, så der kan udføres en såkaldt PET-scanning.
English: Each mL of solution for injection contains 3200 MBq of fluciclovine (18F) at date and time of calibration (ToC).
Danish: En ml injektionsvæske indeholder 3200 MBq fluciclovin (18F) på datoen og tidspunktet for kalibrering (ToC).
English: Each mL of solution contains 1600 MBq fluciclovine (18F) at date and time of calibration (ToC).
Danish: En ml injektionsvæske indeholder 1600 MBq fluciclovin (18F) på datoen og tidspunktet for kalibrering (ToC).
English: Each mL of solution for injection contains 1600 MBq of fluciclovine (18F) at date and time of calibration (ToC).
Danish: En ml injektionsvæske, opløsning, indeholder 1600 MBq fluciclovin (18F) på datoen og tidspunktet for kalibrering (ToC).
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: For patient preparation, see section 4.4.
Danish: Forberedelse af patienten er beskrevet i pkt.
English: If the integrity of this vial is compromised, the medicinal product should not be used.
Danish: Lægemidlet må ikke anvendes, hvis hætteglasset er beskadiget.
English: The full EPAR for Clopidogrel Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Clopidogrel Krka findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Krka on 23 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Krka den 23. september 2009.
English: The standard dose is one 75-mg tablet once a day.
Danish: Standarddosen er én 75 mgtablet én gang dagligt.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel Krka.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel Krka.
English: The Agency recommended that Clopidogrel Krka be approved for use in the EU.
Danish: Agenturet anbefalede, at Clopidogrel Krka godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Clopidogrel Krka?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Clopidogrel Krka?
English: This means that Clopidogrel Krka is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel Krka er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Plavix.
English: Clopidogrel Krka is used to prevent problems caused by blood clots in adults who have:
Danish: Clopidogrel Krka anvendes til at forebygge problemer forårsaget af blodpropper hos voksne, som:
English: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel Krka has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: Det Europæiske Lægemiddelagentur (EMA) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Clopidogrel Krka er af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Danish: • har en sygdom kaldet "akut koronart syndrom", når det skal gives sammen med aspirin (et andet lægemiddel, som forebygger blodpropper).
English: Clopidogrel Krka can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel Krka kan påbegyndes mellem få dage og 35 dage efter anfaldet
English: It is not intended to provide practical advice on how to use Clopidogrel Krka.
Danish: Det er ikke en praktisk vejledning i, hvordan Clopidogrel Krka bør anvendes.
English: For more information about treatment with Clopidogrel Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel Krka, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is Clopidogrel Krka and what is it used for?
Danish: Hvad er Clopidogrel Krka, og hvad anvendes det til?
English: Other information about Clopidogrel Krka
Danish: Andre oplysninger om Clopidogrel Krka
English: Therefore, the Agency's view was that, as for Plavix, the benefit outweighs the identified risk.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Plavix.
English: What are the benefits and risks of Clopidogrel Krka?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Krka?
English: Clopidogrel Krka is a ‘generic medicine'.
Danish: Clopidogrel Krka er et "generisk lægemiddel".
English: Clopidogrel Krka can be started between seven days and six months after the stroke;
Danish: Behandling med Clopidogrel Krka kan påbegyndes mellem syv dage og seks måneder efter slagtilfældet
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Danish: Clopidogrel forhindrer blodpladerne i at aggregere ved at forhindre et stof, ADP, i at binde til en særlig receptor på blodpladernes overflade.
English: Clopidogrel Krka is available as tablets containing 75 mg clopidogrel.
Danish: Clopidogrel Krka fås som tabletter, der indeholder 75 mg clopidogrel.
English: Clopidogrel Krka contains the active substance clopidogrel.
Danish: Clopidogrel Krka indeholder det aktive stof clopidogrel.
English: Because Clopidogrel Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Clopidogrel Krka er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For practical information about using Clopidogrel Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Clopidogrel Krka, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Clopidogrel Krka can only be obtained with a prescription.
Danish: Clopidogrel Krka udleveres kun efter recept.
English: Because Clopidogrel Krka is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel Krka er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel Krka have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Clopidogrel Krka.
English: Why is Clopidogrel Krka approved?
Danish: Hvorfor blev Clopidogrel Krka godkendt?
English: The active substance in Clopidogrel Krka, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Krka, clopidogrel, er et blodpladeaggregationshæmmende middel.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Krka is used together with aspirin, the dose of which should not be higher than 100 mg.
Danish: Ved akut koronart syndrom og atrieflimren anvendes Clopidogrel Krka sammen med aspirin.
English: How is Clopidogrel Krka used?
Danish: Hvordan anvendes Clopidogrel Krka?
English: How has Clopidogrel Krka been studied?
Danish: Hvordan blev Clopidogrel Krka undersøgt?
English: How does Clopidogrel Krka work?
Danish: Hvordan virker Clopidogrel Krka?
English: Therefore, in view of available data regarding the joint PASS final study report, the PRAC Rapporteur considered that changes to the conditions of the marketing authorisation were warranted.
Danish: På baggrund af de tilgængelige data vedrørende den endelige rapport for PASS vurderede PRACrapportøren derfor, at ændringerne af betingelserne for markedsføringstilladelsen var berettigede.
English: The joint PASS final study report submitted by the MAHs complies with their obligation to perform a PASS to evaluate the effectiveness of the risk minimisation activities as imposed during the Article 107i procedure EMA/H/A-107i/1357 for cyproterone/ethinylestradiol containing products.
Danish: Med indsendelsen af den endelige rapport for PASS har indehaverne af markedsføringstilladelsen opfyldt deres forpligtelse til at udføre en PASS til vurdering af effektiviteten af risikominimeringstiltagene som pålagt i henhold til artikel 107i under proceduren EMA/H/A-107i/1357 for lægemidler, der indeholder cyproteron/ethinylestradiol.
English: Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner vedrørende resultaterne af undersøgelsen af det lægemiddel/de lægemidler, der indeholder det aktive stof cyproteron/ethinylestradiol, og som vedrører PASS endelige rapport, er CMDh af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der er nævnt ovenfor, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: The MAH(s) should provide a protocol of a PASS within the risk management plan submission, to evaluate the effectiveness of the risk minimisation activities.
Danish: I forbindelse med indsendelsen af risikostyringsplanen forelægger indehaveren af markedsføringstilladelsen en protokol til en sikkerhedsundersøgelse efter markedsføring (PASS) til vurdering af effektiviteten af risikominimeringstiltagene.
English: Renvela received a marketing authorisation valid throughout the EU on 10 June 2009.
Danish: Renvela fik en markedsføringstilladelse med gyldighed i hele EU den 10. juni 2009.
English: Further information on Renvela can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/renvela.
Danish: Yderligere information om Renvela findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/renvela.
English: • adults and children from 6 years of age with chronic (long-term) kidney disease.
Danish: • voksne og børn fra 6-årsalderen med kronisk (langvarig) nyresygdom.
English: • adult patients on dialysis (a technique to remove unwanted substances from the blood);
Danish: • voksne patienter i dialyse (en teknik, hvor uønskede stoffer fjernes fra blodet)
English: Other information about Renvela
Danish: Andre oplysninger om Renvela
English: As for all medicines, data on the use of Renvela are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Renvela løbende overvåget.