FrancophonIA/ELRC3.0 huggingface dataset:
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter fortynding af lægemidlet: Se pkt.
English: In controlled clinical trials, the most commonly reported serious adverse reactions were anaphylaxis, which occurred at a frequency of 6.5% (8/123) in patients treated with 8 mg every 2 weeks; infusion reactions, which occurred at a frequency of 26% and gout flares, which were more common during the first 3 months of treatment.
Danish: I kontrollerede kliniske undersøgelser var de hyppigst indberettede bivirkninger anafylaksi, der forekom med en hyppighed på 6,5 % (8/123) hos patienter, der blev behandlet med 8 mg hver 2. uge, infusionsreaktioner, der forekom med en hyppighed på 26 %, og akutte anfald af artritis urica, der forekom oftere i de første tre måneder af behandlingen.
English: Pegloticase 8 mg every 2 weeks Pegloticase 8 mg every 4 weeks Placebo
Danish: GOUT3 2 pegloticase, 8 mg hver 2. uge pegloticase, 8 mg hver 4. uge placebo
English: Uncommon: Exacerbation of congestive heart failure
Danish: Ikke almindelig: eksacerbation af venstresidig hjerteinsufficiens
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Danish: Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelserne
English: - if you are currently taking other medicines to lower your uric acid level - if you have been told you have heart failure - if you have ever been told you have an enzyme deficiency that causes anaemia - if you weigh over 100 kg - if you have been treated with KRYSTEXXA before
Danish: - hvis du får anden urinsyresænkende medicin - hvis du har fået at vide, at du har hjertesvigt - hvis du nogensinde har fået at vide, at du har en enzymmangel, der medfører blodmangel
English: A total of 32% (27 of 85) of patients treated with KRYSTEXXA 8 mg every 2 weeks had a creatinine clearance of ≤62.5 ml/min.
Danish: Hos i alt 32 % (27 af 85) af de patienter, der blev behandlet med KRYSTEXXA, var kreatininclearance ≤62,5 ml/min.
English: Very common side effects (may affect more than 1 in 10 people): hives, skin rash, itchy, dry or irritated skin, nausea
Danish: Meget almindelige bivirkninger (forekommer hos mere end 1 ud af 10 behandlede): nældefeber, udslæt, kløende, tør eller af irriteret hud, kvalme.
English: The most common signs and symptoms of generalised infusion reactions were: hives, shortness of breath, redness in the face, sweating, chest discomfort or pain, chills, and high blood pressure.
Danish: De mest almindelige tegn og symptomer på almene infusionsreaktioner var: nældefeber, kortåndethed, rødme af ansigtet, svedtendens, ubehag eller smerter i brystregionen, kulderystelser og højt blodtryk.
English: Lower response rates were observed in patients over 100 kg BW; however, confounding factors in a small sample size make it unclear if in patients over 100 kg BW the dose was optimal to achieve an effect.
Danish: Pga. lille patient antal i denne gruppe samt andre interagerende faktorer var det dog uklart, om de pågældende patienter med legemsvægt over 100 kg fik optimal dosis med henblik på virkning.
English: In clinical trials, 91% of patients who experienced an infusion-related reaction had a serum uric acid level above 6 mg/dl (360 μmol/L) due to the development of anti-pegloticase antibodies.
Danish: Af de patienter, der fik en infusionsreaktion i de kliniske undersøgelser, havde 91 % serumurinsyre over 0,360 mmol/l (6 mg/dl) som følge af udvikling af anti-pegloticase-antistoffer.
English: KRYSTEXXA should not be administered if two consecutive levels above 6 mg/dl (360 µmol/L) have been measured (see section 4.4).
Danish: KRYSTEXXA bør ikke gives, hvis der to på hinanden følgende gange er målt over 0,360 mmol/l (6 mg/dl) (se pkt.
English: Infusion-related reactions / Anaphylaxis
Danish: Infusionsbetingede reaktioner/anafylaksi
English: KRYSTEXXA 8 mg concentrate for solution for infusion is supplied in 2 ml glass vials containing 1 ml concentrate.
Danish: KRYSTEXXA, koncentrat til infusionsvæske, opløsning, 8 mg, fås i 2 ml hætteglas af glas, der indeholder 1 ml koncentrat.
English: Anti-PEG antibodies also developed in 41% of patients treated with KRYSTEXXA 8 mg every 2 weeks.
Danish: Desuden udvikledes der anti-PEG-antistoffer hos 41 % af de patienter, der blev behandlet med KRYSTEXXA, 8 mg hver 2. uge.
English: The solution should be used within 4 hours of dilution (see section 6.6).
Danish: Opløsningen skal bruges senest 4 timer efter fortynding (se pkt.
English: The most common signs and symptoms of systemic infusion reactions are: urticaria, dyspnoea, flushing, hyperhidrosis, chest discomfort or pain, chills, and hypertension.
Danish: De hyppigste tegn og symptomer på systemiske infusionsreaktioner er: urticaria, dyspnø, rødme, hyperhidrose, ubehag eller smerter i brystet, kulderystelser og hypertension.
English: The most common signs and symptoms of local infusion reactions are: erythema, pruritus, and rash.
Danish: De hyppigste tegn og symptomer på lokale infusionsreaktioner er: erytem, pruritus og udslæt.
English: Other medicines and KRYSTEXXA
Danish: Brug af anden medicin sammen med KRYSTEXXA
English: Each vial contains 8 mg of pegloticase (8 mg/ml concentrate).
Danish: Hvert hætteglas indeholder 8 mg pegloticase (koncentrat, 8/mg/ml).
English: • tightness of the throat, hoarse voice or trouble swallowing
Danish: • sammensnøring af halsen, hæs stemme eller synkebesvær
English: KRYSTEXXA should be given to you by a doctor or nurse experienced in the treatment of severe chronic gout in a healthcare centre.
Danish: Den læge eller sygeplejerske, der behandler dig med KRYSTEXXA, bør have erfaring fra et behandlingscenter i behandling af svær kronisk urinsyregigt.
English: It is therefore recommended that patients given repeat infusions of KRYSTEXXA after a treatment interruption be monitored carefully.
Danish: Derfor anbefales nøje overvågning af patienter, der efter forudgående afbrydelse af behandlingen får gentaget infusion med KRYSTEXXA.
English: In clinical trials, anti-pegloticase antibodies (IgM and IgG) developed in 89% of patients treated with KRYSTEXXA 8 mg every 2 weeks and 15% in the placebo group.
Danish: I de kliniske undersøgelser udvikledes anti-pegloticase-antistoffer (IgM og IgG) hos 89 % af de patienter, der blev behandlet med KRYSTEXXA, 8 mg hver 2. uge, og hos 15 % i placebogruppen.
English: In the clinical studies, 34% (29 of 85) of patients treated with KRYSTEXXA 8 mg every 2 weeks were 65 years of age and older and 12% (10 of 85) were 75 years of age and older.
Danish: Af de patienter, der fik KRYSTEXXA, 8 mg hver 2. uge, i de kliniske undersøgelser, var 34 % (29 af 85) over 65 år, og 12 % (10 af 85) var over 75 år.
English: Disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections
Danish: Dinatriumhydrogenphosphatdihydrat, natriumdihydrogenphosphatdihydrat, natriumklorid, vand til injektionsvæsker.
English: Your doctor may prescribe medicines to reduce the likelihood of gout flares after starting KRYSTEXXA.
Danish: Lægen vil muligvis ordinere medicin, der mindsker sandsynligheden for, at du får akutte anfald af urinsyregigt, efter at du er begyndt at få KRYSTEXXA.
English: As shown in Table 3 at Month 6, the percentage of patients who achieved complete tophus response (defined as 100% resolution of at least one target tophus, without the appearance of any new tophi or any progression of existing tophi) was 29.0% in patients treated with 8 mg pegloticase every 2 weeks compared to 6.9% in placebo patients excluding patients with missing data, who were considered as a failure.
Danish: Som det ses af tabel 3, var der i måned 6 fuldstændig tophus-respons hos 29,0 % af de patienter, der fik KRYSTEXXA, 8 mg hver 2. uge, sammenholdt med 6,9 % hos patienter på placebo (idet der ved fuldstændig tophus-respons forstås 100 % opløsning af mindst én mål-tophus uden dannelse af nye tophi eller progression af eksisterende tophi).
English: Most infusion-related reactions have been observed after loss of therapeutic response due to the development of anti-pegloticase antibodies, i.e. when serum uric acid values were above 6 mg/dl (360 µmol/L).
Danish: De fleste infusionsrelaterede reaktioner er iagttaget efter tab af behandlingsrespons forårsaget af udvikling af anti-pegloticase-antistoffer, dvs. ved serumurinsyre over 0,360 mmol/l (6 mg/dl) Serumurinsyre skal derfor kontrolleres før hver infusion.
English: Package Leaflet: Information for the user KRYSTEXXA 8 mg concentrate for solution for infusion
Danish: Indlægsseddel: Information til brugeren KRYSTEXXA, 8 mg, koncentrat til infusionsvæske, opløsning pegloticase
English: Grounds recommending the variation to the terms of the Marketing Authorisation
Danish: Begrundelser for at anbefale ændring af betingelserne for markedsføringstilladelsen
English: Common side effects (may affect up to 1 in 10 people): high blood sugar levels, vomiting, joint swelling, flu-like symptoms
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 behandlede): forhøjet blodsukker, opkastning, hævede led, influenzalignende symptomer.
English: In clinical trials, the mean plasma uric acid (PUA) levels fell to 0.7 mg/dl approximately 24 hours following the first dose of pegloticase in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with a mean PUA of 8.2 mg/dl in the placebo-treated patients.
Danish: I de kliniske forsøg faldt den gennemsnitlige plasmaurinsyre (PUA) til 0,041 mmol/l (0,7 mg/dl) ca. 24 timer efter den første dosis af pegloticase hos patienter, der fik KRYSTEXXA, 8 mg hver 2. uge, sammenholdt med en gennemsnitlig PUA på 0,48 mmol/l (8,2 mg/dl) hos placebobehandlede patienter.
English: There were no effects on the fertility of male or female rats.
Danish: Der var ingen indvirkning på fertiliteten at han- eller hunrotter.
English: Based on similar efficacy and safety profiles of pegloticase in patients with creatinine clearance below and above 50 ml/min, no dose adjustment is required for patients with renal impairment (see section 5.2).
Danish: Virknings- og sikkerhedsprofilen af pegloticase er den samme hos patienter med kreatininclearance under og over 50 ml/min.
English: No formal studies were conducted to examine the effects of hepatic impairment.
Danish: Der er ikke udført formelle undersøgelser af virkningerne af leverinsufficiens.
English: The maximum dose that has been administered as a single intravenous dose during clinical studies was 12 mg. A post-marketing report documented administration of the contents of 2 vials (16 mg) without any adverse reaction related to KRYSTEXXA administration.
Danish: Efter markedsføring blev der indberettet et tilfælde, hvor indholdet af to hætteglas (16 mg) KRYSTEXXA blev administreret uden optræden af uønskede reaktioner.
English: fluids, additional glucocorticoids or antihistamines, or following discontinuation of the infusion and with epinephrine for anaphylactic reactions.
Danish: Andre svandt med støttende behandling med intravenøs væske, supplerende glukokortikoider eller antihistaminer eller efter ophør af infusionen samt med adrenalin mod anafylaktiske reaktioner.
English: Haemolysis and/or Methemoglobinemia
Danish: Hæmolyse og/eller methæmoglobinæmi
English: The most common signs and symptoms of local infusion reactions were: redness at the injection site, itching, and rash.
Danish: De mest almindelige tegn og symptomer på lokale infusionsreaktioner var: rødme på injektionsstedet, kløe og udslæt.
English: KRYSTEXXA, once diluted with 250 ml of sodium chloride solution, 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%), is administered as an intravenous infusion over no less than 2 hours, at a flow rate of approximately 2 ml/minute.
Danish: Efter fortynding af KRYSTEXXA med 250 ml natriumkloridopløsning 4,5 mg/ml (0,45 %) eller 9 mg/ml (0,9 %) administreres det som en intravenøs infusion i løbet af mindst 2 timer med en infusionshastighed på ca. 2 ml/minut.
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Danish: Denne indlægsseddel blev senest godkendt i {MM/ÅÅÅÅ\}.
English: KRYSTEXXA should be discontinued if 2 consecutive levels above 6 mg/dl have been measured.
Danish: KRYSTEXXA bør seponeres, hvis der to på hinanden følgende gange måles over 0,360 mmol/l
English: Your doctor will test your blood to measure uric acid levels before each dose to make sure that you should continue receiving KRYSTEXXA.
Danish: Før hver dosis vil lægen undersøge dit blod for indholdet af urinsyre for at sikre, at du skal fortsætte med at få KRYSTEXXA.
English: KRYSTEXXA 8 mg concentrate for solution for infusion pegloticase
Danish: KRYSTEXXA, 8 mg, koncentrat til infusionsvæske, opløsning pegloticase
English: Responders maintained PUA values < 6 mg/dl throughout the 6-month treatment period.
Danish: Hos responderende patienter var PUA-værdien < 0,360 mmol/l (< 6 mg/dl) i hele den 6 måneders behandlingsperiode.
English: KRYSTEXXA contains 4.2 mg sodium per dose which means it is essentially sodium free.
Danish: KRYSTEXXA indeholder 4,2 mg natrium pr. dosis.
English: This compared with flare rates of 41%and 67% in the same groups in the subsequent 3 months, and gout flares were infrequent in patients that received pegloticase 8 mg every 2 weeks for over one year.
Danish: I de efterfølgende tre måneder forekom akutte artritis urica-anfald hos 41 % og 67 % i de samme grupper, og hos patienter, der fik pegloticase, 8 mg hver 2. uge, i over et år, var sådanne anfald ikke almindelige.
English: Not known: Haemolysis
Danish: Ikke kendt: hæmolyse
English: As shown in Table 2, a greater proportion of patients treated with KRYSTEXXA 8 mg every 2 weeks were responders as compared to patients receiving placebo.
Danish: Som vist i tabel 2 var responsandelen større hos patienter, der fik KRYSTEXXA, 8 mg hver 2. uge, end i placebogruppen.
English: • 1 ml of KRYSTEXXA should be injected into a single 250 ml bag of sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) solution for injection or infusion.
Danish: • 1 ml KRYSTEXXA injiceres i en enkelt 250 ml pose med natriumklorid, 4,5 mg/ml (0,45 %) eller 9 mg/ml (0,9 %) injektionsvæske eller infusionsvæske.
English: If you stop taking KRYSTEXXA, and then are treated again, you may be at increased risk of infusion reactions, including severe acute allergic reactions (anaphylaxis) so your doctor will monitor you carefully when you restart treatment.
Danish: Hvis du holder op med at få KRYSTEXXA og derefter genoptager behandlingen, kan der være øget risiko for infusionsreaktioner, herunder svære akutte overfølsomhedsreaktioner (anafylaksi).
English: Disodium hydrogen phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride
Danish: Dinatriumhydrogenphosphatdihydrat Natriumdihydrogenphosphatdihydrat Natriumklorid
English: KRYSTEXXA 8 mg concentrate for solution for infusion
Danish: KRYSTEXXA, 8 mg, koncentrat til infusionsvæske, opløsning
English: The following information is intended for healthcare professionals only: KRYSTEXXA must be prepared as follows:
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale:
English: In clinical trials, the percentage of patients that had flares in the first 3 months was 75% in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with 54% in placebo-treated patients.
Danish: I de kliniske undersøgelser forekom akutte anfald af artritis urica i de første tre måneder hos 75 % af de patienter, der blev behandlet med KRYSTEXXA, 8 mg hver 2. uge, sammenholdt med 54 % af de placebobehandlede.
English: Physical and chemical stability of KRYSTEXXA diluted in 250 ml sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) has been demonstrated for 4 hours at 2°C to 8°C and at room temperature (20°C to 25°C), if the solution is prepared as described in section 6.6.
Danish: 6.6 er KRYSTEXXA påvist at være fysisk og kemisk stabil ved fortynding i 250 ml natriumklorid, 4,5 mg/ml (0,45 %) og 9 mg/ml (0,9 %), gennem 4 timer ved 2 °C til 8 °C samt ved rumtemperatur (7 °C til 25 °C).
English: KRYSTEXXA does not need to be discontinued because of a gout flare.
Danish: Behandlingen med KRYSTEXXA behøver ikke afbrydes ved akutte anfald af artritis urica.
English: How KRYSTEXXA is administered
Danish: Hvordan KRYSTEXXA gives
English: Before starting the treatment and especially before monitoring the serum uric acid levels, patients should discontinue oral urate-lowering medication and not institute therapy with oral urate-lowering medication while taking KRYSTEXXA (see section 4.4).
Danish: Før behandlingen påbegyndes og især før kontrol af urinsyreniveauerne i serum, bør oral uratsænkende medicin være seponeret.
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: - Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre,
English: From the nonclinical studies, the elimination of pegloticase is via renal/urinary excretion.
Danish: De ikke-kliniske undersøgelser viser, at pegloticase udskilles renalt.
English: Acute gouty attacks (gout flare)
Danish: Akutte anfald af artritis urica
English: Do not use this medicine if you notice any particles or discolouration in the diluted solution.
Danish: Brug ikke KRYSTEXXA, hvis den fortyndede opløsning indeholder partikler eller er misfarvet.
English: Annex IV Scientific conclusions and grounds recommending the variation to the terms of the Marketing Authorisation
Danish: Videnskabelige konklusioner og begrundelser, der anbefaler en ændring af betingelserne for
English: Each vial contains 8 mg of pegloticase (8 mg/ml concentrate)
Danish: Hvert hætteglas indeholder 8 mg pegloticase (koncentrat,
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Spørg lægen eller på apoteket eller sundhedspersonalet, hvis du er i tvivl om brugen af lægemidlet.
English: Also, high titres of anti-pegloticase antibodies and infusion-related reactions showed a tendency to occur in a greater proportion of patients in this weight group (see section 4.8).
Danish: I denne vægtgruppe var der desuden tendens til øget forekomst af høj titer af anti-pegloticase-antistoffer og infusionsrelaterede reaktioner (se pkt.
English: How KRYSTEXXA works
Danish: Sådan virker KRYSTEXXA
English: The Pain scores using a visual analogue scale were 44.2 at baseline vs. 28.4 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 53.9 vs. 57.2 in the placebo group (p≤0.001).
Danish: Smertescore på en visuel analog skala var 44,2 ved baseline mod 28,4 i uge 25 for patienter behandlet med pegloticase, 8 mg hver 2. uge.
English: Sustained decrease in plasma uric acid below the solubility concentration of 6 mg/dl was observed for more than 12 days with single doses of 8 mg and 12 mg.
Danish: Ved enkeltdoser på 8 mg og 12 mg iagttoges et vedholdende (mere end 12 dage) fald i plasmaurinsyre til under opløseligheden på 0,360 mmol/l (6 mg/dl).
English: • 1 ml of KRYSTEXXA should be injected into a single 250 ml bag of sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) solution for injection for infusion.
Danish: • 1 ml KRYSTEXXA injiceres i en enkelt 250 ml pose med natriumklorid, 4,5 mg/ml (0,45 %)
English: The HAQ-PGA scores were 42.4 at baseline vs. 27.1 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 51.6 vs. 53.4 in the placebo group (p≤0.001).
Danish: HAQ-PGA-scoren var 42,4 ved baseline mod 27,1 i uge 25 for patienter behandlet med pegloticase, 8 mg hver 2. uge.
English: Monitoring of serum uric acid level is required prior to each infusion.
Danish: Før hver infusion skal serumurinsyre måles.
English: • The other ingredients are disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride and water for injections.
Danish: • De øvrige indholdsstoffer er dinatriumhydrogenphosphatdihydrat,
English: The HAQ-DI scores were 1.1 at baseline vs. 0.84 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 1.2 vs. 1.3 in the placebo group (p≤0.01).
Danish: HAQ-DI-scoren var 1,1 ved baseline mod 0,84 i uge 25 for patienter behandlet med KRYSTEXXA, 8 mg hver 2. uge.
English: Common: Vomiting
Danish: Almindelig: hævede led
English: Uncommon side effects: (may affect up to 1 in 100 people): worsening of a type of heart disease called congestive heart failure, skin infection, elevated potassium levels in the blood Frequency not known (cannot be estimated from available data): destruction of red blood cells If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Ualmindelige bivirkninger (forekommer hos op til 1 ud af 100 behandlede): forværring af hjertesvigt med væskeophobning, hudinfektioner, forhøjet kaliumindhold i blodet.
English: The mean PUA at baseline was 9.8 mg/dl. Seventy-one percent (71%) of patients had baseline tophi.
Danish: 71 % af patienterne havde tophi ved baseline.
English: p-Value2
Danish: pværdi2
English: Very common: Gout flare
Danish: Meget almindelig: akutte anfald af artritis urica
English: Metabolism and nutrition disorders Common: Hyperglycaemia Cardiac disorders
Danish: Ikke almindelig: hyperkaliæmi
English: Breast-feeding
Danish: Mave-tarmkanalen
English: Solution for infusion
Danish: Injektionsvæske, pløsning
English: vials (glass)
Danish: 100 IE/ml
English: EU/1/97/030/053 Insuman Infusat 100 IU/ml
Danish: EU/1/97/030/095 Insuman Rapid 100 IE/ml
English: EU/1/97/030/203 Insuman Implantable
Danish: EU/1/97/030/054 Insuman Infusat
English: Filamentous haemagglutinin, adsorbed 25 micrograms Pertactin, adsorbed
Danish: Filamentøs hæmagglutinin, adsorberet 25 mikrogram Pertactin, adsorberet
English: Pertussis toxoid, adsorbed
Danish: Pertussistoksoid, adsorberet
English: 1 pre-filled syringe + 2 separate needles
Danish: 1 fyldt injektionssprøjte + 2 separate kanyler
English: Recombinant Hepatitis B surface antigen (S protein), adsorbed Inactivated type 1 Poliovirus Inactivated type 2 Poliovirus Inactivated type 3 Poliovirus
Danish: Rekombinant hepatitis B overfladeantigen (S protein), adsorberet
English: Invented name Strength Pharmaceutical
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage
English: Diphtheria toxoid, adsorbed Tetanus toxoid, adsorbed
Danish: Tetanustoksoid, adsorberet
English: 1 pre-filled syringe (glass) + 1 separate needle
Danish: 1 fyldt injektionssprøjte + 1 separat kanyle
English: Content
Danish: r l g
English: The European Commission granted a marketing authorisation valid throughout the EU for Copalia on 16 January 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Copalia den 16. januar 2007.
English: Other information about Copalia
Danish: Andre oplysninger om Copalia
English: This is a summary of the European public assessment report (EPAR) for Copalia.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Copalia.
English: The full EPAR for Copalia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Copalia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Copalia is taken by mouth as one tablet once a day with some water.
Danish: Copalia tages oralt som en tablet en gang dagligt med vand.
English: Copalia amlodipine / valsartan
Danish: Copalia amlodipin/valsartan
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Copalia.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Copalia skal anvendes.