FrancophonIA/ELRC3.0 huggingface dataset:
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the decision to withdraw the application was based on the outcome of the CAT's preliminary assessment.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes resultatet af den foreløbige vurdering i Udvalget For Avancerede Terapier.
English: The cells are then planted on the square inserts, which are used by a surgeon to fill in the spaces on the bone where cartilage has been damaged.
Danish: Cellerne plantes derefter på de firkantede indlæg, der anvendes af kirurgen til at udfylde de steder på knoglen, hvor brusken er beskadiget.
English: The main data submitted by the company came from two published studies involving 126 patients with femoral cartilage defects, which compared Hyalograft C autograft with a surgical technique known as microfracture repair.
Danish: Virksomhedens hoveddokumentation bestod i to publicerede undersøgelser, der omfattede 126 patienter med bruskdefekter i lårbensknoglen, hvor behandling med Hyalograft C autograft blev sammenlignet med en kirurgisk teknik (reparation af mikrofrakturer).
English: This application was withdrawn after the CAT had assessed the initial documentation provided by the company and had formulated a list of questions.
Danish: Ansøgningen blev trukket tilbage, efter at Udvalget For Avancerede Terapier havde vurderet den dokumentation, virksomheden først havde indsendt, og stillet en række spørgsmål.
English: The evaluation of advanced therapy products involves an assessment by the Committee for Advanced Therapies (CAT) before an opinion is adopted by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Produkter til avanceret terapi skal vurderes i Udvalget For Avancerede Terapier, før Udvalget for Lægemidler til Mennesker (CHMP) afgiver en udtalelse.
English: The company had not yet responded to the CAT's questions at the time of the withdrawal.
Danish: Virksomheden havde endnu ikke besvaret spørgsmålene fra udvalget, da ansøgningen blev trukket tilbage.
English: The company informed the EMA that there were no ongoing clinical trials or compassionate use programmes with Hyalograft C autograft at the time of the withdrawal.
Danish: Virksomheden har til EMA oplyst, at der på tilbagetrækningstidspunktet ikke var nogen igangværende kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse med Hyalograft C autograft.
English: officially notified the European Medicines Agency that it wishes to withdraw its application for a marketing authorisation for Hyalograft C autograft, for repairing defects in the cartilage of the femoral condyles and trochlea (the end of the thigh bone that forms part of the knee) caused by sudden or repetitive trauma.
Danish: Officielt Det Europæiske Lægemiddelagentur, at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Hyalograft C autograft til reparation af bruskdefekter efter pludselige eller gentagne skader i knæets femurkondyl og trochlea (den ende af lårbensknoglen, der udgør en del af knæet).
English: Hyalograft C autograft is made from chondrocytes (cartilage cells) taken from the patient and grown outside the body.
Danish: Hyalograft C autograft fremstilles af chondrocytter (bruskceller), der tages fra patienten og dyrkes uden for kroppen.
English: Hyalograft C autograft is an implant consisting of cartilage cells derived from the patient and planted on 2x2 cm square inserts.
Danish: Hyalograft C autograft er et implantat bestående af bruskceller, der er afledt fra patienten selv og plantet på firkantede indlæg med størrelsen 2x2 cm.
English: Hyalograft C autograft is a type of advanced therapy product called a ‘tissue engineered product'.
Danish: Hyalograft C autograft er et lægemiddel til avanceret terapi, som kaldes et “produkt fremstillet ved vævsteknik”.
English: What is Hyalograft C autograft?
Danish: Hvad er Hyalograft C autograft?
English: What was Hyalograft C autograft being evaluated for?
Danish: Hvad blev Hyalograft C autograft vurderet med henblik på?
English: What was the recommendation of the CAT at that time?
Danish: Hvad anbefalede Udvalget For Avancerede Terapier på daværende tidspunkt?
English: Hyalograft C autograft is a ‘combined advanced therapy product' as it incorporates a medical device (the scaffold).
Danish: Hyalograft C autograft er et kombineret lægemiddel til avanceret terapi, da det omfatter medicinsk udstyr (et “stativ” eller “scaffold”).
English: Hyalograft C autograft was being evaluated for use in repairing cartilage defects at the end of the femur (the thigh bone), where the bone forms part of the knee joint.
Danish: Hyalograft C autograft blev vurderet med henblik på anvendelse til korrektion af bruskdefekter i den nederste del af lårbensknoglen på det sted, hvor knoglen danner en del af knæleddet.
English: How does Hyalograft C autograft work?
Danish: Hvordan virker Hyalograft C autograft?
English: It is available as pink, capsule-shaped tablets (75 mg).
Danish: Det fås som lyserøde kapselformede tabletter (75 mg).
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Danish: Dette efterfølges af en standarddosis på 75 mg en gang dagligt i mindst 4 uger (ved myokardieinfarkt med forhøjelse af ST-segmentet) eller i op til 12 måneder (ved non-ST-segment elevation syndrom).
English: B.V. can be started between a few days and 35 days after the attack;
Danish: kan indledes få dage efter anfaldet og indtil 35 dage efter,
English: • patients with peripheral arterial disease (problems with blood flow in the arteries);
Danish: • patienter med perifer arteriesygdom (problemer med blodgennemstrømningen i arterierne),
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 Clopidogrel Teva Pharma B.V.
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 anvendelsesbetingelserne for Clopidogrel Teva Pharma B.V.
English: For more information about treatment with Clopidogrel Teva Pharma B.V., 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 Teva Pharma B.V., kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Danish: • patienter, der lider af ‘akut koronarsyndrom', når patienterne skal indtage det i kombination med aspirin (et andet lægemiddel, som forebygger blodpropper), herunder patienter, der har fået indsat en stent (et kort rør, der anbringes i arterien for at forhindre den i at tillukkes).
English: The standard dose of Clopidogrel Teva Pharma B.V. is one 75-mg tablet once a day, taken with or without food.
Danish: er en 75-mg tablet en gang dagligt taget med eller uden et måltid.
English: This document is a summary of the European public assessment report (EPAR) for Clopidogrel Teva Pharma B.V.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel Teva Pharma B.V.
English: The full EPAR for Clopidogrel Teva Pharma B.V. can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: findes på agenturets websted under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: This means that Clopidogrel Teva Pharma B.V. is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder Plavix.
English: Because Clopidogrel Teva Pharma B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Clopidogrel Teva Pharma B.V. is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Teva Pharma B.V.er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: In acute coronary syndrome, Clopidogrel Teva Pharma B.V. is used together with aspirin and treatment generally starts with a loading dose of four tablets.
Danish: sammen med aspirin, og behandlingen indledes almindeligvis med en initialdosis på fire tabletter.
English: Clopidogrel Teva Pharma B.V. can be used in patients who are having a heart attack with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
Danish: kan anvendes til patienter, som har hjertetilfælde med ‘forhøjelse af STsegmentet' (ST-elevation) (dvs. en unormal visning på elektrokardiogrammet (EKG)), når lægen vurderer, at patienterne kan have gavn af denne behandling.
English: Because Clopidogrel Teva Pharma B.V. is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Clopidogrel Teva Pharma B.V.
English: For genetic reasons, some patients may not be able to convert Clopidogrel Teva Pharma B.V. as effectively as others, which could reduce their response to the medicine.
Danish: Visse patienter er af genetiske årsager måske ikke i stand til at omdanne Clopidogrel Teva Pharma B.V.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Teva Pharma B.V. to Teva Pharma B.V. on 16 June 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Teva Pharma B.V.
English: What are the benefit and risk of Clopidogrel Teva Pharma B.V.?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Teva Pharma B.V.
English: The active substance in Clopidogrel Teva Pharma B.V., clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Teva Pharma B.V., clopidogrel, er en trombocytfunktionshæmmer.
English: Clopidogrel Teva Pharma B.V. is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: The Committee recommended that Clopidogrel Teva Pharma B.V. be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Teva Pharma B.V..
English: Other information about Clopidogrel Teva Pharma B.V.:
Danish: Andre oplysninger om Clopidogrel Teva Pharma B.V.
English: Clopidogrel Teva Pharma B.V. can be given to the following groups of patients:
Danish: kan gives til følgende patientgrupper:
English: Clopidogrel Teva Pharma B.V. can be started between seven days and six months after the stroke;
Danish: kan indledes syv dage efter slagtilfældet og indtil seks måneder efter,
English: What is Clopidogrel Teva Pharma B.V.?
Danish: Hvad er Clopidogrel Teva Pharma B.V.
English: How is Clopidogrel Teva Pharma B.V. used?
Danish: Hvordan anvendes Clopidogrel Teva Pharma B.V.
English: How does Clopidogrel Teva Pharma B.V. work?
Danish: Hvordan virker Clopidogrel Teva Pharma B.V.
English: Why has Clopidogrel Teva Pharma B.V. been approved?
Danish: Hvorfor blev Clopidogrel Teva Pharma B.V.
English: Invented name Strength Pharmaceutical form
Danish: Særnavn Styrker Lægemiddelform
English: Route of administration Packaging Package size
Danish: Emballage Paknings-størrelser EU/1/01/188/001 Fabrazyme 35 mg Pulver til koncentrat til infusionsvæske, opløsning Intravenøs anvendelse Hætteglas
English: Packaging Content (concentration)
Danish: Emballage Indhold (Koncentration)
English: Packaging size
Danish: Pakningsstørrelse
English: Trade name
Danish: Særnavn Styrke
English: Especially tell your doctor:
Danish: Fortæl det især til lægen:
English: Make sure to ask your doctor for advice regarding when you can start your treatment again.
Danish: Sørg for at spørge din læge til råds om, hvornår du kan starte din behandling igen.
English: It particularly effects patients whose kidneys are not working properly.
Danish: Det påvirker især patienter, hvis nyrer ikke fungerer ordentligt.
English: Your kidneys should be checked before you start taking this medicine and at least once every year whilst you are taking it.
Danish: Dine nyrer skal kontrolleres, før du begynder at tage dette lægemiddel og mindst én gang hvert år, mens du tager det.
English: (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: (≥ 1/1000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Gastrointestinal symptomsi,§
Danish: Gastrointestinale symptomeri,§
English: You will need to tell your doctor and stop taking this medicine for a certain period of time and for 2 or more days after depending on how your kidneys are working.
Danish: Du skal fortælle det til lægen og stoppe med at tage dette lægemiddel i et stykke tid og mindst 2 dage derefter, afhængig af hvordan dine nyrer fungerer.
English: Combinations not recommended
Danish: Kombinationer, der frarådes
English: This is a build up of lactic acid in the blood that can cause death.
Danish: Dette er en ophobning af mælkesyre i blodet, som kan medføre dødsfald.
English: In the clinical program, 34.4% of subjects had a history of cardiovascular disease (excluding hypertension) at baseline and 67.9% had hypertension.
Danish: I det kliniske program havde 34,4 % af forsøgspersonerne kardiovaskulær sygdom (eksklusive hypertension) i anamnesen ved baseline, og 67,9 % havde hypertension.
English: • if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink.
Danish: • hvis du har eller senere får kvalme, opkastning eller feber, eller hvis du ikke er i stand til at spise eller drikke.
English: As this medicinal product contains metformin, the treatment must be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia.
Danish: Da dette lægemiddel indeholder metformin, skal behandlingen seponeres 48 timer før elektiv operation med universel, spinal eller epidural anæstesi.
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Danish: Hyppighedskategorier inddeles efter følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig
English: Vulvovaginitis, balanitis and related genital infections*,b,c
Danish: Vulvovaginitis, balanitis og relaterede genitale infektioner*,b,c
English: aRandomized and treated patients with baseline and at least 1 post-baseline efficacy measurement.
Danish: aRandomiserede og behandlede patienter med baselineværdi og mindst 1 effektmåling efter baseline.
English: • if you need to have an injection of a medicine called a contrast agent that contains iodine, for example before an X-ray or scan.
Danish: • hvis du skal have en indsprøjtning med et lægemiddel, der kaldes et kontrastmiddel, som indeholder jod, for eksempel før du skal have taget et røntgenbillede eller skal scannes.
English: Metformin The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Det prospektive randomiserede studie (UKPDS) har fastslået fordelen på langt sigt ved intensiv blodglucosekontrol ved type 2-diabetes.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating anti-hypertensive or diuretic therapy or when starting treatment with a nonsteroidal anti-inflammatory drug (NSAID).
Danish: Der skal udvises særlig omhu i situationer, hvor nyrefunktionen kan blive nedsat, f.eks. ved initiering af antihypertensiv eller diuretisk behandling, eller ved start af behandling med et non-steroidt antiinflammatorisk stof (NSAID).
English: Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Danish: Renal clearance af metformin er > 400 ml/min, hvilket viser, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Danish: hLangvarig behandling med metformin har været associeret med nedsat absorption af vitamin B12, som i meget sjældne tilfælde kan resultere i klinisk signifikant vitamin B12-mangel (f.eks. megaloblastisk anæmi).
English: Difference from placebod
Danish: Forskel fra placebod
English: • if you are going to have an operation under anaesthesia.
Danish: • hvis du skal have foretaget en operation under bedøvelse.
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 4).
Danish: Du skal omgående stoppe med at tage dette lægemiddel og straks kontakte en læge eller nærmeste hospital (se punkt 4).
English: At the usual metformin doses and dosing schedules, steady-state plasma concentrations are reached within 24-48 hours and are generally less than 1 μg/ml.
Danish: Med de almindelige metformindoser og doseringsmåder nås steady-state-plasmakoncentrationer inden for 24-48 timer, og de er i reglen mindre end 1 μg/ml.
English: After administration of a 50 mg [14C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in feces.
Danish: Efter indgivelse af en dosis på 50 mg [14C]-dapagliflozin blev 96 % genfundet, 75 % i urinen og 21 % i afføringen.
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Danish: Kationiske stoffer, som elimineres via sekretion fra nyretubuli (f.eks. cimetidin) kan evt. interagere med metformin ved at konkurrere om fælles transportsystemer i nyretubuli.
English: • if you have a condition called ‘diabetic ketoacidosis', a problem you can get with diabetes.
Danish: - hvis du lider af “diabetisk ketoacidose” - et problem, du kan få med diabetes.
English: The mean steady-state volume of distribution of dapagliflozin was 118 l.
Danish: Det gennemsnitlige steady-state-fordelingsvolumen af dapagliflozin var 118 l.
English: Avoid alcohol, including medicines containing alcohol, while taking this medicine since alcohol may increase the risk of lactic acidosis (see section 4 ‘Possible side effects').
Danish: Undgå alkohol, også medicin der indeholder alkohol, mens du tager dette lægemiddel, da alkohol kan øge risikoen for laktatacidose (se punkt 4 Bivirkninger).
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away.
Danish: Du skal omgående stoppe med at tage dette lægemiddel og straks kontakte en læge eller nærmeste hospital.
English: Cardiovascular death, MI and stroke were observed with a hazard ratio of 0.77 (95% CI: 0.54, 1.10).
Danish: For kardiovaskulær død, MI og slagtilfælde blev der observeret en relativ risiko på 0,77 (95 % CI: 0,54, 1,10).
English: The steady-state inhibition of renal glucose reabsorption and the amount of urinary glucose excretion over a 24-hour period was the same for both dosing regimens.
Danish: Steady-state-hæmningen af renal glucosereabsorption og mængden af udskillelse af glucose i urinen i en periode på 24 timer var den samme for begge doseringsregimer.
English: Urticaria§ Erythema Pruritus§
Danish: Urticaria§ Erytem§ Pruritus§
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Danish: Et studie udført på syv normale, raske frivillige viste, at cimetidin administreret som 400 mg to gange dagligt øgede metformins systemiske eksponering (AUC) med 50 % og Cmax med 81 %.
English: Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are coadministered.
Danish: Tæt monitorering af glykæmisk kontrol, dosisjustering inden for den anbefalede dosering og ændringer i diabetesbehandling skal derfor overvejes ved samtidig administration af kationiske lægemidler, som elimineres via sekretion fra nyretubuli.
English: Blood creatinine increased**,b
Danish: Forhøjet kreatinin i blodet**, b
English: Metformin, one of the active substances in this medicine, can cause a very rare (may affect up to 1 in 10,000 people) but serious side effect called ‘lactic acidosis'.
Danish: Metformin, et af de aktive stoffer i dette lægemiddel, kan forårsage en meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer), men alvorlig bivirkning, der hedder "laktatacidose".
English: Taste disturbance§
Danish: Smagsforstyrrelser §
English: Liver function disorders§ Hepatitis§
Danish: Forstyrrelser i leverfunktionen § Hepatitis§
English: Diuretics, especially loop diuretics, may increase the risk of lactic acidosis due to their potential to decrease renal function.
Danish: Diuretika, især loop-diuretika, kan øge risikoen for laktatacidose på grund af deres potentiale for at nedsætte nyrefunktionen.
English: If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient hospitalised immediately (see section 4.9).
Danish: Hvis der er mistanke om metabolisk acidose, bør behandling med lægemidlet indstilles og patienten indlægges omgående (se pkt.
English: 15% of the dose was excreted as parent drug.
Danish: I afføringen blev ca. 15 % af dosen udskilt som det oprindelige lægemiddel.
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio.
Danish: Diagnostiske laboratoriefund er nedsat blod-pH, plasma-laktatniveauer over 5 mmol/l og en øget anion-gap og laktat/pyruvat-ratio.
English: The safety and efficacy of dapagliflozin in patients with type 1 diabetes have not been established and dapagliflozin should not be used for treatment of patients with type 1 diabetes.
Danish: Dapagliflozins sikkerhed og virkning af hos patienter med type 1-diabetes er ikke klarlagt, og dapagliflozin bør ikke anvendes til patienter med type 1-diabetes.
English: Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Danish: 1Optitrering af insulinregimer (inklusive korttidsvirkende, mellemlangt virkende og basal insulin) var kun tilladt, hvis forsøgspersonerne opfyldte de foruddefinerede FPG-kriterier.