FrancophonIA/ELRC3.0 huggingface dataset:
English: There was no increase in systemic exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below.
Danish: Hos individer med Child-Pugh score på 7 eller derunder er der ikke set en øgning i systemisk eksponering af rosuvastatin.
English: Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
Danish: Homozygot familiær hyperkolesterolæmi, som supplement til diæt og anden lipidsænkende behandling
English: ANNEX III AMENDED SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE
Danish: BILAG III PRODUKTRESUME
English: Musculoskeletal, connective tissue and bone disorders Common: myalgia
Danish: Skeletmuskulaturpåvirkninger: Der er rapporteret om påvirkninger af skeletmuskulaturen, fx myalgi,
English: - renal impairment
Danish: - nyreinsufficiens
English: This dose can be continued for up to 13 weeks.
Danish: Denne dosis kan fastholdes i op til 13 uger.
English: Patients should avoid alcohol before, during and after taking Circadin.
Danish: Patienter bør undgå at drikke alkohol inden, under og efter, at de har taget Circadin.
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: irritability, nervousness, restlessness, insomnia, abnormal dreams, anxiety, migraine, lethargy (lack of energy), psychomotor hyperactivity (restlessness with increased activity), dizziness, somnolence (sleepiness), hypertension (high blood pressure), abdominal pain (stomach ache), dyspepsia (heartburn), mouth ulcers, dry mouth, hyperbilirubinaemia (high blood levels of bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes), dermatitis (skin inflammation), night sweats, pruritus (itching), rash, dry skin, pain in the extremities (arms and legs), symptoms of the menopause, asthenia (weakness), chest pain, glycosuria (sugar in the urine), proteinuria (protein in the urine), abnormal liver function tests and increased weight.
Danish: Bivirkninger er sjældne hos patienter, der behandles med Circadin, men de mest almindelige bivirkninger (som ses hos mellem 1 og 10 patienter ud af 1 000) er irritabilitet, nervøsitet, rastløshed, søvnløshed, abnorme drømme, angst, migræne, apati (mangel på energi), psykomotorisk hyperaktivitet (rastløshed i forbindelse med øget aktivitet), svimmelhed, somnolens (døsighed), hypertension (forhøjet blodtryk), mavepine, dyspepsi (halsbrand), mundsår, mundtørhed, hyperbilirubinæmi (forhøjede niveauer i blodet af bilirubin, som er et nedbrydningsprodukt fra røde blodlegemer, og som kan medføre, at huden og det hvide i øjnene bliver farvet gul), dermatitis (hudbetændelse), svedeture om natten, kløe, udslæt, tør hud, smerter i ekstremiteterne (arme og ben), symptomer på overgangsalder, kraftesløshed, brystsmerter, glykosuri (sukker i urinen), proteuniri (protein i urinen), abnorme leverfunktionsprøver og vægtforøgelse.
English: The patients assessed the severity of their symptoms using a standard questionnaire.
Danish: Patienterne vurderede sværhedsgraden af deres symptomer ved brug af et standardiseret spørgeskema.
English: It is available as white prolongedrelease tablets (2 mg).
Danish: Det leveres som hvide depottabletter (2 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Circadin to Rad Neurim Pharmaceuticals EEC Limited on 29 June 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Circadin til Rad Neurim Pharmaceuticals EEC Limited den 29. juni 2007.
English: ‘Primary' means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.
Danish: ”Primær” betyder, at der ikke er påvist nogen årsag til søvnløsheden, herunder heller ingen medicinske, psykologiske eller miljømæssige årsager.
English: This document is a summary of the European Public Assessment Report (EPAR) for Circadin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Circadin.
English: When the results of all three studies were looked at together, 32% of the patients taking Circadin (86 out of 265) reported a significant improvement in symptoms after three weeks, compared with 19% of those taking placebo (51 out of 272).
Danish: Når resultaterne af alle tre undersøgelser blev taget under ét, indberettede 32 % af de patienter, der tog Circadin (86 ud af 265), en betydelig forbedring i symptomerne efter tre uger, sammenlignet med 19 % af de patienter, der tog placebo (51 ud af 272).
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 Circadin.
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 Circadin.
English: Circadin can cause drowsiness, so it should be used with caution if this could pose a risk to safety, including in people who need to drive or use machines.
Danish: Circadin kan medføre døsighed, så det skal anvendes med forsigtighed, hvis dette kan medføre en sikkerhedsrisiko, herunder af personer, som skal køre bil eller betjene maskiner.
English: The recommended dose of Circadin is one tablet a day, taken one to two hours before bedtime and after food.
Danish: Den anbefalede dosis Circadin er én tablet daglig, taget én til to timer inden sengetid og efter indtagelse af mad.
English: Other information about Circadin:
Danish: Andre oplysninger om Circadin:
English: An additional study compared the effects of Circadin and placebo for up to six months.
Danish: En yderligere undersøgelse sammenlignede virkningerne af Circadin og placebo i op til seks måneder.
English: For more information about treatment with Circadin, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Circadin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Circadin is a medicine that contains the active substance melatonin.
Danish: Circadin er et lægemiddel, der indeholder det aktive stof melatonin.
English: Circadin should not be used in people who may be hypersensitive (allergic) to melatonin or any of the other ingredients.
Danish: Circadin bør ikke anvendes til personer, der kan være overfølsomme (allergiske) over for melatonin eller andre af indholdsstofferne.
English: The CHMP decided that, although Circadin has only been shown to have a small effect in a relatively small number of patients, its benefits are greater than its risks.
Danish: CHMP besluttede, at selv om det er blevet påvist, at Circadin kun har en begrænset virkning hos et relativt begrænset antal patienter, opvejer fordelene ved Circadin risiciene.
English: Circadin was more effective than placebo at improving quality of sleep and the patients' ability to function normally on the following day.
Danish: Circadin var mere effektivt end placebo til at forbedre patienternes søvnkvalitet samt evne til at fungere normalt den følgende dag.
English: The additional study showed that Circadin was more effective than placebo for at least 13 weeks.
Danish: Den yderligere undersøgelse viste, at Circadin var mere effektivt end placebo i mindst 13 uger.
English: Older people may produce less melatonin, leading to the development of insomnia.
Danish: Ældre mennesker producerer sommetider mindre melatonin, hvilket fører til udvikling af søvnløshed.
English: Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night.
Danish: Niveauet af melatonin i blodet øges normalt efter mørkets frembrud og topper midt på natten.
English: The active substance in Circadin, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland.
Danish: Det aktive stof i Circadin, melatonin, er et naturligt forekommende hormon, der normalt produceres af en kirtel i hjernen, som kaldes pinealkirtlen.
English: Melatonin is involved in co-ordinating the body's sleep cycle by acting on cells in specific areas of the brain and helping to bring about sleep.
Danish: Melatonin medvirker til at koordinere kroppens søvncyklus via indvirkning på celler i bestemte områder af hjernen og medvirker til at frembringe søvn.
English: The Committee recommended that Circadin be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Circadin.
English: The full EPAR for Circadin can be found here.
Danish: Den fuldstændige EPAR for Circadin findes her.
English: Because Circadin tablets release melatonin slowly over a few hours, they mimic the natural production of melatonin in the body.
Danish: Da Circadin-tabletter frigiver melatonin langsomt over nogle få timer, efterligner de den naturlige produktion af melatonin i kroppen.
English: Circadin has been compared with placebo (a dummy treatment) in three main studies involving a total of 681 patients aged over 55 years with primary insomnia.
Danish: Circadin blev sammenlignet med placebo (en virkningsløs behandling) i tre hovedundersøgelser af i alt 681 patienter over 55 år med primær søvnløshed.
English: The main measure of effectiveness was the number of patients who reported a significant improvement in their quality of sleep and ability to function normally on the following day, after three weeks of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, der efter tre ugers behandling berettede om en betydelig forbedring i deres søvnkvalitet samt deres evne til at fungere normalt den følgende dag.
English: By replacing the hormone, Circadin increases blood levels of melatonin, helping them to sleep.
Danish: Ved at erstatte det naturlige hormon øger Circadin niveauet af melatonin i blodet, og dette hjælper personen til at kunne sove.
English: Circadin is used on its own for the short-term treatment of primary insomnia (poor quality of sleep) in patients aged 55 years or over.
Danish: Circadin anvendes alene ikke sammen med andre sovemidler til korttidsbehandling af primær søvnløshed (dårlig søvnkvalitet) hos patienter i alderen 55 år eller derover.
English: Why has Circadin been approved?
Danish: Hvorfor blev Circadin godkendt?
English: What is the risk associated with Circadin?
Danish: Hvilken risiko er der forbundet med Circadin?
English: ‘Prolonged-release' means that melatonin is released slowly from the tablet over a few hours.
Danish: At tabletterne kaldes depottabletter betyder, at stoffet melatonin langsomt frigives fra tabletten over nogle få timer.
English: For the full list of all side effects reported with Circadin, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Circadin fremgår af indlægssedlen.
English: What is Circadin?
Danish: Hvad er Circadin?
English: What benefit has Circadin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Circadin?
English: How has Circadin been studied?
Danish: Hvordan blev Circadin undersøgt?
English: What is Circadin used for?
Danish: Hvad anvendes Circadin til?
English: How is Circadin used?
Danish: Hvordan anvendes Circadin?
English: How does Circadin work?
Danish: Hvordan virker Circadin?
English: Do not pass it on to others.
Danish: Lad være med at give det til andre.
English: · Risk Management Plan (RMP) Not applicable.
Danish: · Risikostyringsplan (RMP) Ikke relevant.
English: However, due to high inter-subject variability, these differences were not statistically significant.
Danish: På grund af høj interpersonvariabilitet er disse forskelle imidlertid ikke statistisk signifikate.
English: Do not use nitrates to treat your chest pain.
Danish: Tag ikke nitrater til at behandle dine smerter i brystet.
English: In vitro studies
Danish: In vitro studier
English: The safety and efficacy of sildenafil was maintained in long-term studies.
Danish: Sikkerhed og effekt af sildenafil var fastholdt i langtidsundersøgelser.
English: Use in adults
Danish: Anvendelse hos voksne
English: These reports included dizziness and light-headedness, but not syncope.
Danish: Disse rapporter omfattede svimmelhed og uklarhed, men ikke synkope.
English: There are no adequate and well-controlled studies in pregnant or breast-feeding women.
Danish: Der foreligger ingen velkontrollerede studier hos gravide eller ammende kvinder.
English: Elderly Dosage adjustments are not required in elderly patients (≥ 65 years old).
Danish: Dosisjustering er ikke nødvendig hos ældre (≥ 65 år).
English: In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
Danish: I kliniske undersøgelser blev sildenafil administreret til mere end 8.000 patienter mellem 19 og 87 år.
English: - If you have recently had a stroke or a heart attack, or if you have low blood pressure.
Danish: - hvis du for nyligt har haft slagtilfælde eller hjerteanfald, eller hvid du har lavt blodtryk.
English: The amount of time Sildenafil Actavis takes to work varies from person to person, but it normally takes between half an hour and one hour.
Danish: Den tid det tager for Sildenafil Actavis at virke varierer fra person til person, men det tager normalt mellem ½ og 1 time.
English: Due to the nitrate component it has the potential to result in a serious interaction with sildenafil.
Danish: På grund af nitratkomponenten har det potentiale for at medføre alvorlig interaktion med sildenafil.
English: Certain patients have experienced these symptoms when taking sildenafil with alpha-blockers.
Danish: Visse patienter har oplevet disse symptomer, når de tager sildenafil sammen med alfa-blokkere.
English: Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine.
Danish: Det bør tages i betragtning, at de fleste af de mænd, men ikke alle, der fik disse bivirkninger, havde hjerteproblemer, før de tog denne medicin.
English: Date of latest renewal: 4 September 2014
Danish: Dato for første markedsføringstilladelse: 10 december 2009 Dato for seneste fornyelse: 4 september 2014
English: Use in patients taking other medicinal products
Danish: Anvendelse hos patienter, som tager andre lægemidler
English: Nicorandil is a hybrid of potassium channel activator and nitrate.
Danish: Nicorrandil er en hybrid af kaliumkanalaktivator og nitrat.
English: Further information on clinical trials
Danish: Yderligere oplysninger om kliniske undersøgelser
English: See 4.2 for information on paediatric use.
Danish: 4.2 for oplysninger om pædiatrisk anvendelse).
English: Because not all adverse reactions are reported the frequencies of these reactions cannot be reliably determined.
Danish: Da det ikke er alle bivirkninger, der er rappoteret, kan frekvensen af disse bivirkninger ikke bestemmes pålideligt.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via det nationale rapporteringssystem anført i Appendiks V
English: Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.
Danish: Derfor bør sildenafil kun administreres til disse patienter efter omhyggeligt at have opvejet fordele mod risici.
English: This is consistent with ritonavir's marked effects on a broad range of P450 substrates.
Danish: Dette er i overenstemmelse med ritonavirs udtalte effekt på et bredt udvalg af P450-substrater.
English: It is not possible to determine whether these events were directly related to sildenafil.
Danish: Det er ikke muligt at bestemme, om disse bivirkninger er direkte relateret til sildenafil.
English: If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.
Danish: Hvis priapisme ikke behandles med det samme, kan det resultere i beskadigelse af penisvæv og permanent impotens
English: The side effects reported in association with the use of sildenafil are usually mild to moderate and of a short duration.
Danish: De bivirkninger, der er rapporteret i forbindelse med brug af sildenafil, er som regel milde til moderate og af kort varighed.
English: - If you have a deformity of your penis or Peyronie's Disease.
Danish: knoglemarvskræft (multipelt myelom) - hvis du har en deformitet af penis eller Peyronies sygdom.
English: Sildenafil Actavis with food and drink and alcohol Sildenafil Actavis can be taken with or without food.
Danish: Brug af Sildenafil Actavis sammen med mad og drikke og alkohol Sildenafil Actavis kan tages sammen med mad eller uden mad.
English: Periodic Safety Update Reports
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR)
English: The maximum recommended dose is 100 mg.
Danish: Den anbefalede maximale dosis er 100 mg.
English: In addition, the frequency of medically important adverse reactions reported from post-marketing experience is included as not known.
Danish: Derudover er frekvensen af klinisk vigtige bivirkninger rapporteret efter markedsføring angivet som ikke kendt.
English: - Chest pains - this occurs uncommonly If this occurs during or after intercourse Get in a semi-sitting position and try to relax.
Danish: - Smerter i brystet - dette ses ikke almindeligt Hvis dette sker under eller efter samleje Sæt dig op i en tilbagelænet stilling og prøv at slappe af.
English: If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.
Danish: Hvis du får en erektion, som varer længere end 4 timer, bør du straks kontakte lægen.
English: If you feel that the effect of Sildenafil Actavis is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du føler, at virkningerne af Sildenafil Actavis er for kraftige eller for svage, bør du tale med din læge eller apotek herom.
English: You should not take Sildenafil Actavis more than once a day.
Danish: Du bør ikke tage Sildenafil Actavis mere end 1 gang dagligt.
English: If you experience any of the following serious side effects stop taking Sildenafil Actavis and seek medical help immediately:
Danish: Hvis du oplever nogen af de følgende alvorlige bivirkninger, skal du stoppe med at tage Sildenafil Actavis og øjeblikkeligt søge lægehjælp:
English: Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.
Danish: Derfor kan hæmmere af disse isoenzymer reducere sildenafil-clearance, og induktorer af disse isoenzymer kan øge sildenafil-clearance.
English: Sildenafil Actavis will only help you to get an erection if you are sexually stimulated.
Danish: Sildenafil Actavis vil kun hjælpe dig med at få en erektion, hvis du bliver seksuelt stimuleret.
English: In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken Sildenafil Actavis and when you did.
Danish: I tilfælde af en alvorlig hændelse, bør du fortælle lægen, apotekspersonalet eller sundhedspersonalet, at du har taget Sildenafil Actavis, og hvornår du har taget det.
English: Your doctor should carefully check whether your heart can take the additional strain of having sex. - If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).
Danish: Din læge skal omhyggeligt undersøge, om dit hjerte kan tåle den ekstra anstrengelse, det er at have sex. - hvis du for tiden har mavesår eller blødningsforstyrrelser (som f.eks. hæmofili).
English: 6.6 Special precautions for disposal No special requirements.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Ingen særlige forholdsregler.
English: In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)).
Danish: I tabellen nedenfor er alle medicinske vigtige bivirkninger, som er opstået i kliniske studier med en hyppighed større end placebo, anført efter organklasse og frekvens (meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000)).
English: A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Danish: Sygdomshistorie bør gennemgås, og en fysisk undersøgelse bør foretages for at stille diagnosen erektil dysfunktion og mulige underliggende årsager skal fastslås, før farmakologisk behandling overvejes.
English: At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11.
Danish: Ved den maksimale anbefalede dosis er der over 80-gange så stor selektivitet over for PDE1 og mere end 700-gange over for PDE2, 3, 4, 7, 8, 9, 10 og 11.
English: Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.
Danish: Før initiering af nogen som helst form for behandling af erektil dysfunktion bør lægen undersøge patienternes kardiovaskulære tilstand, da der er en vis kardial risiko forbundet med seksuel aktivitet.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet, der indeholder sildenafil, i alle undergrupper af den pædiatriske population for behandling af erektil dysfunktion (se pkt.
English: - If you have a severe heart or liver problem.
Danish: - hvis du har alvorlige hjerte- eller leverproblemer.
English: If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Sildenafil Actavis.
Danish: Hvis du tager medicin, som kaldes proteasehæmmere, for eksempel til behandling af HIV, kan din læge starte behandlingen på den laveste dosis Sildenafil Actavis (25 mg).
English: In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased.
Danish: I enkeltdosisundersøgelser med frivillige forsøgspersoner med doser op til 800 mg er bivirkningerne de samme, som ses efter lavere doser, men incidensrater og sværhedsgrader var forhøjede.
English: Rare (³ 1/10000 and
Danish: Sjælden (³ 1/10.000 og
English: Given sildenafil peak plasma concentrations of approximately 1 µM after recommended doses, it is unlikely that Sildenafil Actavis will alter the clearance of substrates of these isoenzymes.
Danish: Med sildenafils maksimale plasmakoncentration på ca. 1 µM efter anbefalede doser,er det usandsynligt, af Sildenafil Actavis vil ændre clearance af substrater af disse isoenzymer.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og reproduktions- og udviklingstoksicitet.
English: Film-coat:
Danish: Filmovertræk:
English: You should take Sildenafil Actavis about one hour before sexual activity.
Danish: Sildenafil Actavis bør tages ca. 1 time inden seksuel aktivitet.