FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel BGR 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 BGR er af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: • patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Danish: • patienter, der for nylig har haft et iskæmisk slagtilfælde (et slagtilfælde forårsaget af manglende blodforsyning til en del af hjernen).
English: Clopidogrel BGR is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel BGR anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: The Committee recommended that Clopidogrel BGR be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel BGR.
English: What are the benefits and risks of Clopidogrel BGR?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel BGR?
English: Because Clopidogrel BGR 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: Da Clopidogrel BGR er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
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 stoffet ADP i at binde sig til en særlig receptor på blodpladernes overflade.
English: Clopidogrel BGR can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel BGR kan påbegyndes få dage efter anfaldet og indtil 35 dage efter
English: Other information about Clopidogrel BGR
Danish: Andre oplysninger om Clopidogrel BGR
English: Clopidogrel BGR is a ‘generic medicine'.
Danish: Clopidogrel BGR er et »generisk lægemiddel«.
English: Clopidogrel BGR can be started between seven days and six months after the stroke;
Danish: Behandling med Clopidogrel BGR kan indledes syv dage efter slagtilfældet og indtil seks måneder efter
English: Because Clopidogrel BGR 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 BGR er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: Clopidogrel BGR is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel BGR er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: The active substance in Clopidogrel BGR, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel BGR, clopidogrel, er en trombocytfunktionshæmmer.
English: Why has Clopidogrel BGR been approved?
Danish: Hvorfor blev Clopidogrel BGR godkendt?
English: What is Clopidogrel BGR?
Danish: Hvad er Clopidogrel BGR?
English: How has Clopidogrel BGR been studied?
Danish: Hvordan blev Clopidogrel BGR undersøgt?
English: What is Clopidogrel BGR used for?
Danish: Hvad anvendes Clopidogrel BGR til?
English: How is Clopidogrel BGR used?
Danish: Hvordan anvendes Clopidogrel BGR?
English: How does Clopidogrel BGR work?
Danish: Hvordan virker Clopidogrel BGR?
English: Date of first authorisation: 8 March 2002 Date of latest renewal: 20 March 2007
Danish: Dato for første markedsføringstilladelse: 8. marts 2002 Dato for seneste fornyelse: 20. marts 2007
English: The available medical guidelines should also be taken into account.
Danish: Der skal også tages højde for de gældende medicinske retningslinjer.
English: Additional information on MAS is provided below.
Danish: Der gives yderligere oplysninger om MAS nedenfor.
English: RA: Adults
Danish: RA: Voksne
English: A risk to the newborns/ infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: (Your doctor will have told you what dose you need to use.)
Danish: (Deres læge har på forhånd oplyst Dem om, hvilken dosis, De skal bruge).
English: Elderly population (≥ 65 years)
Danish: Ældre population (≥65 år)
English: Kineret may worsen these conditions; - if you have cancer.
Danish: Kineret kan forværre disse tilstande; hvis De har kræft.
English: - Serious allergic reactions are uncommon.
Danish: - Alvorlige allergiske reaktioner er ikke almindelige.
English: If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible.
Danish: Hvis der opstår MAS, eller der er mistanke om det, skal evaluering og behandling startes snarest muligt.
English: Dose increases may become necessary within 1-2 months based on therapeutic response.
Danish: Øgede doser kan være påkrævet inden for 1-2 måneder baseret på terapeutisk respons.
English: No data are available in children under the age of 8 months.
Danish: Der foreligger ingen data hos børn under 8 måneder.
English: Cytochrome P450 Substrates
Danish: Cytochrom P450-substrater
English: No dose adjustment is required based on age or gender.
Danish: Der er ikke behov for dosisjustering baseret på alder eller køn.
English: This might increase the risk of you getting an infection.
Danish: Det kan øge risikoen for, at De får en infektion.
English: Paediatric population (< 18 years)
Danish: Pædiatrisk population (<18 år)
English: Posology and administration are the same as for adults 18 to 64 years of age.
Danish: Dosering og administration er den samme som for voksne mellem 18 og 64 år.
English: Do not warm Kineret in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Opvarm ikke Kineret på nogen anden måde (De må ikke opvarme i mikrobølgeovn eller i varmt vand).
English: The most suitable places to inject yourself or your child are (See Figure D):
Danish: De bedste steder at give indsprøjtningen til Dem selv eller Deres barn er (se figur D):
English: EU/1/02/203/005 - 1-pack EU/1/02/203/006 - 7-pack EU/1/02/203/007 - 28-pack
Danish: EU/1/02/203/005 - 1-pakning EU/1/02/203/006 - 7-pakning EU/1/02/203/007 - 28-pakning
English: (~35 times the recommended dose in RA) over a 72 hour treatment period.
Danish: (~35 gange den anbefalede dosis til RA) over en 72 timers behandlingsperiode.
English: Pfizer Health AB Mariefredsvägen 37 SE-645 41 Strängnäs Sweden
Danish: Pfizer Health AB Mariefredsvägen 37 SE-645 41 Strängnäs Sverige
English: • A description of the signs of serious infections
Danish: • En beskrivelse af tegnene på alvorlige infektioner
English: Contact your doctor immediately
Danish: De skal kontakte Deres læge med det samme
English: Do not use Kineret if you think it has been frozen.
Danish: Brug ikke Kineret, hvis De har mistanke om, at det har været frosset.
English: • The early signs indicative of MAS
Danish: • De tidlige tegn, der indikerer MAS
English: No overall differences in safety or effectiveness were observed between these patients and younger patients.
Danish: Samlet var der ingen forskel i sikkerhed og effektivitet observeret mellem disse patienter og de yngre patienter.
English: None of these patients had serious infections associated with the neutropenia.
Danish: Ingen af disse patienter havde alvorlige infektioner associeret med neutropeni.
English: • the abdomen (except for the area around the navel)
Danish: • på maven (bortset fra området omkring navlen)
English: Patients with trisomy 21 seem to be overrepresented.
Danish: Det ser ud som om, at patienter med trisomi 21 er overrepræsenteret.
English: - RA: Use of Kineret in children and adolescents with Rheumatoid Arthritis has not been fully investigated and therefore cannot be recommended.
Danish: - RA: Brugen af Kineret hos børn og unge med reumatoid artrit er ikke fuldt undersøgt og kan derfor ikke anbefales.
English: In observations up to 3 years, the serious infection rate remained stable over time.
Danish: Ved observationer i op til 3 år forblev hyppigheden af alvorlige infektioner stabil over tid.
English: The presence of these particles does not affect the quality of the product.
Danish: Disse partikler påvirker ikke produktets kvalitet.
English: Distribution into the cerebrospinal fluid has been demonstrated.
Danish: Fordeling i cerebrospinalvæsken er blevet påvist.
English: Cytokines are proteins made by your body that co-ordinate communication between cells and help control cell activity.
Danish: Cytokiner er proteiner, der dannes i kroppen, og som koordinerer kommunikationen mellem cellerne og hjælper med at kontrollere celleaktiviteten.
English: During an open-label extension phase, switching or add-on treatment with the comparator drug was possible if improvement did not occur within 24 weeks.
Danish: I løbet af en open-label forlængelsesfase var det muligt at skifte eller tilføje behandling med det lægemiddel, der blev sammenlignet med, hvis der ikke opstod forbedring i løbet af 24 uger.
English: Kineret has not been tested in pregnant women.
Danish: Kineret er ikke blevet afprøvet hos gravide kvinder.
English: Upon start or end of Kineret treatment in patients on these types of medicinal products, it may be relevant to consider therapeutic monitoring of the effect or concentration of these products and the individual dose of the medicinal product may need to be adjusted.
Danish: Ved påbegyndelse eller afslutning af Kineret-behandling af patienter, der er i behandling med disse typer af lægemidler, kan det være relevant at overveje terapeutisk monitorering af disse produkters virkning eller koncentration, lige som det kan være nødvendigt at justere den individuelle dosis af lægemidlet.
English: During the 5-year study 14 patients (32.6%) reported 24 serious events.
Danish: I løbet af den 5-årige undersøgelse indberettede 14 patienter (32,6%) 24 alvorlige hændelser.
English: Anakinra is produced by DNA technology using the micro-organism E. coli.
Danish: Anakinra fremstilles med DNA-teknologi ved brug af mikroorganismen E. coli.
English: Non-infectious hepatitis
Danish: Ikke-infektiøs hepatitis
English: RA: The efficacy of Kineret in children with RA (JIA) aged 0 to 18 years has not been established.
Danish: RA: Kinerets virkning hos børn med RA (JIA) i alderen 0 til 18 år er ikke klarlagt.
English: - CAPS: Kineret is not recommended for children younger than 8 months of age because there is no data in this age group.
Danish: - CAPS: Kineret frarådes til børn, der er yngre end 8 måneder, da der ikke findes nogen data for denne aldersgruppe
English: Treatment with Kineret resulted in normalization of body temperature in 18 of 20 patients.
Danish: Behandlingen med Kineret førte til en normalisering af kropstemperaturen hos 18 ud af 20 patienter.
English: Check the appearance of Kineret.
Danish: Kontroller Kinerets udseende.
English: Before you inject Kineret you must do the following:
Danish: Før De injicerer Kineret, skal De gøre følgende:
English: The plasma concentration decreased with no discernible distribution phase and the terminal half-life ranged from 4 to 6 hours.
Danish: Plasmakoncentrationen reduceredes uden nogen klar fordelingsfase, og den terminale halveringstid varierede fra 4 til 6 timer.
English: This was not associated with any clinically significant effects on pharmacokinetics, efficacy, or safety.
Danish: Dette var ikke associeret med nogen klinisk signifikant indvirkning på farmakokinetik, virkning eller sikkerhed.
English: Maintenance dose in severe CAPS (MWS and NOMID/CINCA)
Danish: Vedligeholdelsesdosis ved alvorlig CAPS (MWS og NOMID/CINCA)
English: Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating elderly patients.
Danish: Fordi der generelt er en højere hyppighed af infektioner hos den ældre population, bør der udvises særlig forsigtighed ved behandling af ældre patienter.
English: With the exception of infections and related symptoms that were more frequently reported in patients <2 years of age, the safety profile was similar in all paediatric age groups.
Danish: Med undtagelse af infektioner og relaterede symptomer, der blev indberettet hyppigere for patienter <2 år, var sikkerhedsprofilen ens i alle pædiatriske aldersgrupper.
English: Placebo treatment (n=213) resulted in a decrease of approximately 2.2% in total cholesterol levels at week 2 and 2.3% at week 24.
Danish: Placebobehandling (n = 213) resulterede i et fald i total-kolesterol på cirka 2,2 % ved uge 2 og 2,3 % ved uge 24.
English: Eleven serious events in 4 (9.3%) patients were considered related to Kineret.
Danish: Elleve alvorlige hændelser hos 4 (9,3%) patienter blev betragtet som relateret til Kineret.
English: Your doctor will discuss with you the potential risks of taking Kineret during pregnancy.
Danish: Lægen vil diskutere de mulige risici ved at tage Kineret under graviditeten med Dem.
English: Pharmacokinetic parameters were not substantially different from healthy volunteers, other than a decrease in clearance of approximately 30% in comparison with data from a study with healthy volunteers.
Danish: De farmakokinetiske parametre adskilte sig ikke væsentligt fra raske voksne, bortset fra et fald i clearance på cirka 30% sammenlignet med data fra en undersøgelse med raske frivillige.
English: A similar pattern was seen after 24 weeks Kineret treatment.
Danish: Et tilsvarende mønster sås efter 24 ugers Kineret-behandling.
English: Interactions between Kineret and other medicinal products have not been investigated in formal studies.
Danish: Interaktioner mellem Kineret og andre lægemidler er ikke undersøgt i formelle undersøgelser.
English: Maintenance dose in mild CAPS (FCAS, mild MWS)
Danish: Vedligeholdelsesdosis ved mild CAPS (FCAS, mild MWS)
English: The main objectives of the programme are to provide information on the method of administration, raise awareness on the potential risk of macrophage activation syndrome (MAS) and on the potential risk of serious infections.
Danish: De primære formål for programmet er at oplyse om anvendelsesmåden, øge opmærksomheden på den mulige risiko for makrofag aktiveringsssyndrom (MAS) og den mulige risiko for alvorlige infektioner.
English: This is called a subcutaneous injection.
Danish: Dette kaldes en subkutan injektion.
English: If you have forgotten to take a dose of Kineret, you should contact your doctor to discuss when you should take the next dose.
Danish: Hvis De har glemt at injicere en dosis Kineret, skal De kontakte Deres læge for at diskutere, hvornår De skal injicere næste dosis.
English: Rheumatoid Arthritis (RA)
Danish: Reumatoid artrit (RA)
English: These symptoms are generally mild to moderate and are more common at the start of your treatment.
Danish: Disse symptomer er ofte lette til moderate og forekommer oftest i begyndelsen af behandlingen.
English: When patients are clinically well-controlled, CNS and ophthalmological monitoring may be conducted yearly.
Danish: Når patienter er klinisk velkontrolleret, kan CNS- og oftalmologisk monitorering udføres årligt.
English: If someone else is injecting for you, they can also use the back of your arms.
Danish: Hvis andre injicerer Dem, kan bagsiden af overarmene også anvendes.
English: The risk may be increased in patients with Down's syndrome (trisomy 21).
Danish: Risikoen kan være forhøjet hos patienter med Downs syndrom (trisomi 21).
English: There have been reports of tuberculosis in patients receiving several biological anti-inflammatory treatment regimens.
Danish: Der har været indberetninger om tuberkulose hos patienter, der modtager flere forskellige biologiske, anti-inflammatoriske behandlingsregimer.
English: Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Danish: Find en behagelig og godt oplyst, ren overflade, og placer alt det udstyr, De skal bruge i Deres umiddelbare nærhed.
English: For the purpose of ambulatory use, Kineret may be removed from the refrigerator for 12 hours at temperature not above 25 °C, without exceeding the expiry date.
Danish: Ved ambulant anvendelse kan Kineret være ude af køleskabet i 12 timer ved en temperatur, der ikke overstiger 25 °C, uden at udløbsdatoen overskrides.
English: The majority of CAPS patients in Study 03-AR-0298 developed anakinra anti-drug antibodies.
Danish: De fleste CAPS-patienter i undersøgelsen 03-AR-0298 udviklede anakinra anti-lægemiddel antistoffer.
English: - Headaches.
Danish: - Hovedpine.
English: At the end of this period, the product must not be put back in the refrigerator and must be disposed of.
Danish: Ved overskridelse af denne 12-timers periode må produktet ikke stilles tilbage i køleskabet, og produktet skal bortskaffes.
English: Normally, your body produces a protein that blocks the harmful effects of interleukin-1.
Danish: Normalt producerer kroppen et protein, som blokerer for interleukin-1´s skadelige virkning.
English: Response to treatment should be evaluated after 1 month: In case of persistent systemic manifestations dose may be adjusted in children or continued treatment with Kineret should be reconsidered by the treating physician.
Danish: Responset på behandlingen skal evalueres efter 1 måned: I tilfælde af vedvarende systemiske manifestationer kan dosis justeres hos børn, eller den behandlende læge skal genoverveje en fortsat behandling med Kineret.
English: The dose should be administered at approximately the same time each day.
Danish: Dosis bør indgives på cirka samme tidspunkt hver dag.
English: No dose-limiting toxicities were observed during clinical studies.
Danish: Ingen dosisbegrænsende toksiciteter blev observeret i kliniske studier.
English: Where should you give your injection?
Danish: Hvor skal injektionen gives?
English: RA patients may be at a higher risk (on average 2-3 fold) for the development of lymphoma.
Danish: RA-patienter kan have større risiko (gennemsnitligt 2-3 gange) for at udvikle lymfom.
English: There are limited amount of data from the use of anakinra in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af anakinra til gravide kvinder.
English: Kineret is eliminated by glomerular filtration and subsequent tubular metabolism.
Danish: Kineret elimineres ved glomerulær filtration og efterfølgende tubulær metabolisme.
English: Accordingly, the decrease in clearance is most likely explained by a decrease in renal function in this population.
Danish: Således kan faldet i clearance sandsynligvis forklares med en nedsat nyrefunktion hos denne population.
English: The usual maintenance dose in severe CAPS is 3-4 mg/kg/day, which can be adjusted to a maximum of 8 mg/kg/day.
Danish: Den normale vedligeholdelsesdosis ved alvorlig CAPS er 3-4 mg/kg/dag, som kan justeres til et maksimum på 8 mg/kg/dag.
English: Safety in paediatric RA (JIA) patients
Danish: Sikkerhed hos pædiatriske RA-patienter (JIA)
English: In the severe form of CAPS, long-term treatment improves the systemic inflammatory organ manifestations of the eye, inner ear, and CNS.
Danish: I de alvorlige former af CAPS forbedrer langtidsbehandling de systemiske inflammatoriske organmanifestationer i øjet, det indre øre og CNS.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25 °C) it must either be used within 12 hours or disposed of.
Danish: I det øjeblik en injektionssprøjte tages ud af køleskabet og har nået stuetemperatur (op til 25 °C), skal den anvendes inden for 12 timer eller bortskaffes.
English: X-ray examinations have been undertaken in one clinical study with anakinra.
Danish: Røntgenundersøgelser har været medtaget i en klinisk undersøgelse med anakinra.
English: Decreased acute phase protein levels are noted within the first weeks of treatment.
Danish: De reducerede akutfaseproteinniveauer bemærkes i løbet af de først ugers behandling.
English: In children with inadequate response the dose can be escalated up to 4 mg/kg/day.
Danish: Hos børn med et utilstrækkeligt respons, kan dosis optrappes til 4 mg/kg/dag.
English: If you are not able to set the correct dose, dispose of the syringe and use a new one.
Danish: Hvis De ikke kan indstille den rette dosis, skal De kassere sprøjten og bruge en ny.
English: It is important to tell your doctor if you are pregnant, if you think you may be pregnant or are planning to have a baby.
Danish: Det er vigtigt at fortælle det til lægen hvis De er gravid, har mistanke om, at De er gravid eller planlægger at blive gravid.
English: This would be clinically relevant for CYP450 substrates with a narrow therapeutic index (e.g. warfarin and phenytoin).
Danish: Dette ville være klinisk relevant for CYP450-substratet med et smalt terapeutisk indeks (f.eks. warfarin og phenytoin).
English: Spontaneous mutations in the CIAS1/NLRP3 gene have been identified in a majority of patients with CAPS.
Danish: Spontane mutationer i CIAS1/NLRP3-genet er blevet identificeret hos et flertal af patienter med CAPS.
English: Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors, ATC code: L04AC03
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, interleukinhæmmere, ATC-kode: L04AC03
English: • alcohol wipes or similar; and
Danish: • desinficerende servietter eller lignende, og
English: Kineret was temporarily stopped in one patient, all other patients continued Kineret treatment during the infections.
Danish: Kineret blev midlertidigt seponeret hos én patient, alle øvrige patienter fortsatte Kineret-behandlingen under infektionerne.
English: The risk for developing MAS is increased if you have an infection or if your Still's disease symptoms are poorly controlled.
Danish: Risikoen for at udvikle MAS er øget, hvis De har en infektion, eller hvis Deres symptomer på Stills sygdom er dårligt kontrollerede.
English: The majority (95%) of ISRs were reported as mild to moderate.
Danish: Hovedparten (95%) af reaktionerne blev beskrevet som lette til moderate.
English: No data are available on LDL or HDL cholesterol.
Danish: Der findes ingen data for LDLeller HDL-kolesterol.
English: In addition, postmarketing adverse event reports and published studies constitute supporting data.
Danish: Desuden udgør indberetninger af bivirkninger og publicerede studier efter markedsføring understøttende data.
English: Juvenile rats treated at doses up to 100 times the human dose from day 7 postparturition up to adolescence did not show any signs of adverse effects of the treatment.
Danish: Rotteunger behandlet med doser på op til 100 gange doseringen til mennesker fra dag 7 efter fødslen til adolescens, viste ikke nogen tegn på bivirkninger af behandlingen.
English: The MAH shall ensure that in each Member State where Kineret is marketed, all healthcare professionals and patients/caregivers who are expected to prescribe or use Kineret have access to/are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal i hvert enkelt af de medlemslande, hvor Kineret markedsføres sikre, at alle læger og sundhedspersonale og patienter/plejepersonale, som forventes at ordinere eller anvende Kineret har adgang til/får udleveret følgende uddannelsespakke:
English: At 1 year follow-up, 18 of 20 patients showed at least an adapted ACRpedi 70 response, and 17 of 20 patients reached an adapted ACRpedi 90 response as well as inactive disease.
Danish: Efter 1 års opfølgning viste 18 ud af 20 patienter mindst et adapteret ACRpedi 70-respons, og 17 ud af 20 patienter opnåede et adapteret ACRpedi 90-respons samt inaktiv sygdom.
English: These study data are insufficient to demonstrate efficacy and, therefore, Kineret is not recommended for paediatric use in JIA.
Danish: Disse undersøgelsesdata er ikke tilstrækkelige til at påvise virkning, og pædiatrisk anvendelse af Kineret frarådes derfor i tilfælde af JIA.
English: If you forget to use Kineret
Danish: Hvis De har glemt at bruge Kineret
English: RA: No dose adjustment is required.
Danish: RA: Dosisjustering er ikke nødvendig.