FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Spedra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Spedra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Spedra is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Spedra anvendes så sikkert som muligt.
English: The dose may be adjusted if necessary; lower doses may be needed in patients with liver problems or who are taking certain other medicines.
Danish: Dosis kan om nødvendigt tilpasses: Det kan være nødvendigt med en lavere dosis til patienter, der har leverproblemer eller er i behandling med visse andre lægemidler.
English: What is Spedra and what is it used for?
Danish: Hvad er Spedra, og hvad anvendes det til?
English: However, the fact that it was not compared directly with other medicines in its class made it hard to evaluate its potential place in treating erectile dysfunction.
Danish: Det forhold, at det ikke blev sammenlignet direkte med andre lægemidler af samme klasse, gjorde det dog vanskeligt at vurdere dets mulige plads i behandlingen af rejsningsproblemer.
English: Spedra was more effective than placebo in all studies.
Danish: Spedra var mere effektivt end placebo i alle undersøgelserne.
English: What measures are being taken to ensure the safe and effective use of Spedra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Spedra?
English: Why is Spedra approved?
Danish: Hvorfor blev Spedra godkendt?
English: Spedra is available as tablets (50, 100 and 200 mg) and can only be obtained with a prescription.
Danish: Spedra leveres som tabletter (50, 100 og 200 mg) og udleveres kun efter recept.
English: The Committee therefore considered that Spedra's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Udvalget fandt derfor, at fordelene ved Spedra overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
English: For Spedra to be effective, sexual stimulation is required.
Danish: For at Spedra skal virke effektivt, kræves seksuel stimulation.
English: Regarding its safety, side effects were similar to other medicines of its class.
Danish: Hvad sikkerheden angår, er de fleste bivirkninger sammenlignelige med bivirkningerne af andre lægemidler af samme klasse.
English: Other information about Spedra
Danish: Andre oplysninger om Spedra:
English: By blocking the breakdown of cGMP, Spedra enhances its effect on erectile function.
Danish: Ved at blokere nedbrydningen af cGMP øger Spedra dets virkning på rejsningen.
English: What are the risks associated with Spedra?
Danish: Hvilke risici er der forbundet med Spedra?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spedra, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Spedra, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Spedra must not be taken with certain other medicines including nitrates (a type of medicine used for angina) or medicines that strongly reduce the breakdown of Spedra in the body.
Danish: Spedra må ikke tages sammen med visse andre lægemidler, herunder nitrater (en type lægemiddel mod angina) eller lægemidler, der kraftigt hæmmer nedbrydningen af Spedra i kroppen.
English: An additional study involving 440 adults with erectile dysfunction was also carried out, where Spedra was taken approximately 15 minutes before sexual activity.
Danish: Der blev desuden gennemført en undersøgelse med 440 voksne med erektil dysfunktion, hvor Spedra blev taget ca. 15 minutter før seksuel aktivitet.
English: Sexual stimulation is still needed to produce an erection.
Danish: Der kræves stadig seksuel stimulation for at frembringe en rejsning.
English: The active ingredient in Spedra, avanafil, belongs to a group of medicines called phosphodiesterasetype-5 (PDE5) inhibitors.
Danish: Det aktive stof i Spedra, avanafil, tilhører lægemiddelgruppen fosfodiesterase-5-hæmmere (PDE-5hæmmere).
English: It is not intended to provide practical advice on how to use Spedra.
Danish: Det er ikke en praktisk vejledning i, hvordan Spedra bør anvendes.
English: The improvement in assessment score was about 5 to 7 points more than with placebo.
Danish: Bedringen i bedømmelsesscore var cirka 5-7 point større end med placebo.
English: The recommended dose is 100 mg, taken approximately 15 to 30 minutes before sexual activity; patients should not take more than one dose a day.
Danish: Den anbefalede dosis er 100 mg taget ca. 15-30 minutter før seksuel aktivitet; der bør ikke tages mere end én dosis dagligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Spedra was more effective than placebo in allowing successful intercourse.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Spedra var mere effektivt end placebo til at muliggøre vellykket samleje.
English: Spedra has been studied in three main studies involving over 3,400 men with erectile dysfunction.
Danish: Spedra var genstand for tre hovedundersøgelser, hvori der deltog 3 400 mænd med rejsningsproblemer.
English: The main measures of effectiveness in all three studies were the percentage of erections that lasted long enough for successful intercourse, the percentage of successful vaginal penetrations, and the change in an assessment score for erectile function.
Danish: I alle tre undersøgelser blev virkningen hovedsagelig bedømt på den procentdel af rejsningerne, der varede tilstrækkeligt længe til vellykket samleje, den procentdel, der muliggjorde indtrængen i skeden, og ændringen i score for bedømmelse af rejsningsfunktionen.
English: The percentage of successful attempts was about 28% with Spedra at a dose of 200 mg and about 25% with a dose of 100 mg, compared with 14% with placebo.
Danish: Procentdelen af vellykkede samlejeforsøg var på ca. 28 % med Spedra ved en dosis på 200 mg og på ca. 25 % ved en dosis på 100 mg, sammenlignet med 14 % med placebo.
English: The medicine also produced about 20% more successful vaginal penetrations than placebo.
Danish: Lægemidlet frembragte også 20 % flere vellykkede indtrængninger i skeden end placebo.
English: Spedra is a medicine used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Danish: Spedra er et lægemiddel, der anvendes til voksne mænd med rejsningsproblemer (impotens, erektil dysfunktion), som ikke kan få eller opretholde tilstrækkelig rejsning til tilfredsstillende seksuel aktivitet.
English: It must also not be used by patients who have severely reduced liver or kidney function, or who have had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischaemic optic neuropathy, NAION) that can be triggered by this class of medicines.
Danish: Det må desuden ikke anvendes til patienter med svært nedsat lever- eller nyrefunktion eller nedsat syn på grund af forringet blodtilførsel til øjennerven (ikke-arteritisk anterior iskæmisk opticusneuropati, NAION) som kan fremkaldes af denne gruppe af lægemidler.
English: In these studies, which lasted for 12 weeks, different doses of Spedra taken approximately 30 minutes before sexual activity were compared with placebo (a dummy tablet).
Danish: I disse undersøgelser, der varede i 12 uger, blev forskellige doser af Spedra taget ca. 30 minutter før seksuel aktivitet sammenlignet med placebo (en virkningsløs tablet).
English: The medicine must not be used by patients with certain serious heart or circulatory problems, including those who have had a heart attack, stroke, or serious arrhythmia (irregularity of the heart rhythm) in the last six months and those who have unstable angina (a severe type of chest pain), angina during sexual intercourse, heart failure, or high or low blood pressure.
Danish: Lægemidlet må ikke anvendes af patienter med visse alvorlige hjerte-karsygdomme, herunder dem, der inden for de seneste seks måneder har haft hjerteanfald, slagtilfælde eller svær arytmi (uregelmæssig hjerterytme), eller dem, der har ustabil angina (en svær form for hjertekrampe), angina (hjertekrampe) under samleje, hjertesvigt eller for højt eller for lavt blodtryk.
English: For more information about treatment with Spedra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Spedra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: How is Spedra used?
Danish: Hvordan anvendes Spedra?
English: The results of the first study showed that Spedra taken approximately 30 minutes before sexual activity at a dose of 100 or 200 mg increased the percentage of successful attempts at intercourse from about 13% before treatment to about 57%, whereas placebo only increased it to 27%.
Danish: Den første undersøgelse viste, at Spedra taget ca. 30 minutter før seksuel aktivitet i en dosis på 100 eller 200 mg øgede procentdelen af vellykkede samlejeforsøg fra ca. 13 % før behandlingen til cirka 57 %, hvorimod placebo kun medførte en forøgelse til 27 %.
English: For practical information about using Spedra, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Spedra, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Spedra, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Spedra fremgår af indlægssedlen.
English: Doctors should consider the potential risks of sexual activity for the heart in men who have heart disease before prescribing Spedra.
Danish: I forbindelse med mænd med hjertesygdom skal lægen overveje de mulige risici ved seksuel aktivitet, før Spedra ordineres.
English: What benefits of Spedra have been shown in studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Spedra?
English: The most common side effects with Spedra (which may affect up to 1 in 10 people) are headache, flushing (reddening of the skin) and nasal congestion; back pain has also been reported and may affect up to 1 in 100 people.
Danish: De hyppigste bivirkninger ved Spedra (som kan forekomme hos op til 1 ud af 10 patienter) er hovedpine, rødme og tilstoppet næse.
English: The first study involved men from the general population, but because certain conditions associated with erectile dysfunction might affect response to treatment the second study looked mainly at men who had erectile dysfunction and diabetes, and the third was in men who had erectile dysfunction after surgery on the prostate gland.
Danish: Derfor omfattede den anden undersøgelse hovedsagelig mænd med rejsningsproblemer og sukkersyge, mens den tredje undersøgelse omfattede mænd med rejsningsproblemer efter operation på blærehalskirtlen.
English: Spedra may be taken with or without food.
Danish: Spedra kan tages i forbindelse med et måltid, men kan også tages alene.
English: This allows blood to flow into the corpora, producing the erection.
Danish: Derved åbnes der for blodtilførslen til svulmelegemerne, så der fremkommer en rejsning.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Danish: Under normal seksuel stimulation dannes der cGMP i penis.
English: How does Spedra work?
Danish: Hvordan virker Spedra?
English: You may need to read it again.
Danish: Du får måske brug for at læse den igen.
English: The safety was considered sufficiently shown.
Danish: Sikkerheden blev betragtet som tilstrækkeligt påvist.
English: Your symptoms may reoccur.
Danish: Dine symptomer kan genopstå
English: This was considered appropriate.
Danish: Dette blev betragtet som passende.
English: - If you suffer from asthma.
Danish: • Hvis du lider af astma..
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs hele denne indlægsseddel omhyggeligt, inden du begynder at tage dette lægemiddel
English: The period to onset of response cannot be assessed.
Danish: Perioden indtil respons kan ikke fastsættes.
English: Pharmacovigilance reporting, mainly from Sweden and Spain, does not indicate any new safety issues.
Danish: Lægemiddelovervågning, hovedsagelig fra Sverige og Spanien, indikerer ingen nye sikkerhedsproblemer.
English: Benefit/risk assessment
Danish: Vurdering af benefit/risk forhold
English: The absolute bioavailability is unknown.
Danish: Den absolutte biotilgængelighed er ukendt.
English: Two Cochrane reviews indicate efficacy but in the second review the conclusion are more hesitant.
Danish: To Cochrane bedømmelser indikerer effekt, men i den anden bedømmelse er konklusionen mere tøvende.
English: From animal studies only insufficient data are available.
Danish: Der findes kun utilstrækkelige data fra dyreforsøg.
English: These indicate efficacy even if modest.
Danish: Disse indikerer effekt om end beskeden.
English: The open, comparative study by Qiu 2005 did not identify any efficacy differences between the two formulations.
Danish: Det åbne sammenlignende forsøg gennemført af Qiu i 2005 identificerede ikke nogle forskelle i effekt mellem de to formuleringer.
English: The following have been reported:
Danish: Følgende er rapporteret:
English: The distribution volume is approximately 5 litres and the half-life after intravenous administration is approximately 2 hours.
Danish: Distributionsvolumen er ca. 5 liter, og halveringstiden efter intravenøs indgift er ca. 2 timer.
English: The safety in all the performed studies covering thousands of patients is reassuring and was comparable to placebo.
Danish: Sikkerheden i alle de gennemførte forsøg, der involverede tusinde patienter, er betryggende og kunne sammenlignes med placebo.
English: The applicant provided bibliographical data from a number of studies.
Danish: Ansøgeren fremskaffede biografiske data fra et antal forsøg.
English: When it comes to relative benefit and risk assessment, the influence of publication bias may be less.
Danish: Når det gælder vurdering af relativt benefit/risk forhold, kan påvirkning af publikationsbias være mindre.
English: Additional information on special populations.
Danish: Yderligere oplysninger til særlige befolkningsgrupper:
English: The applicant nonetheless mainly referred to the two large and long-term studies by Reginster and Pavelka.
Danish: Ansøgeren refererede ikke desto mindre hovedsagelig til de to store og langvarige forsøg, der var gennemført af Reginster og Pavelka.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: BILAG 1 LISTE AF NAVNE, LÆGEMIDDELFORM, STYRKE AF LÆGEMIDLET, ADMINISTRATIONSVEJ, ANSØGER, INDEHAVER AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSLANDENE
English: NAME OF THE MARKETING AUTHORISATION HOLDER Navamedic ASA
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Navamedic ASA
English: Approximately 38% of an intravenous dose is excreted in the urine as unchanged substance.
Danish: Ca. 38% af en intravenøs dosis udskilles uomdannet med urinen.
English: Different views on glucosamine, due to different interpretations of regulatory/legal systems have resulted in glucosamine being classified as a medicinal product in many regions of the world, including some Member States.
Danish: Forskellige meninger vedrørende glucosamin har på grund af forskellige fortolkninger af regulerende/lovmæssige systemer resulteret i, at glucosamin er blevet klassificeret som et lægemiddel mange steder i verden, herunder i nogle medlemsstater.
English: Children and Adolescents
Danish: Børn og unge:
English: Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer.
Danish: Symptomlindring (især smertelindring) mærkes måske først efter adskillige ugers behandling, og i nogle tilfælde varer det endnu længere.
English: Many published reviews, national therapy recommendations and other publications have discussed and evaluated the robustness of efficacy data.
Danish: Mange publicerede bedømmelser, nationale anbefalinger vedrørende behandling samt andre publikationer har drøftet og evalueret pålideligheden af effektdataene.
English: Overall the safety profile is favourable with mainly mild gastrointestinal symptoms reported.
Danish: Overordnet er sikkerhedsprofilen gunstig med hovedsagelig milde gastrointestinale symptomer indberettet.
English: Glucomed is not recommended for use in children and adolescents below the age of 18, due to lack of data on safety and efficacy.
Danish: Glucomed anbefales ikke til børn og unge under 18 år, p.g.a. mangel på data vedrørende sikkerhed og effekt.
English: The tablets should be swallowed together with some water or other suitable liquid.
Danish: Tabletterne skal sluges med vand eller anden passende væske.
English: Since 1980 many clinical studies of glucosamine have been performed, with varying scientific relevance and quality.
Danish: Siden 1980 er der gennemført mange kliniske forsøg med glucosamin af varierende videnskabelig relevans og kvalitet.
English: Glucosamine is considered to be an simple substance with a high solubility, and therefore, a comparative bioavailability study was not considered necessary for an approval.
Danish: Glucosamin betragtes som et simpelt stof med høj opløselighed, og derfor blev et sammenlignende biotilgængelighedsforsøg ikke betragtet som nødvendigt med henblik på at opnå godkendelse.
English: For both studies the results are statistically significant for the WOMAC scale (Reginster) and for WOMAC and Lequesne scale (Pavelka) at 3 years.
Danish: For begge forsøg er resultaterne statistisk signifikante for WOMAC skalaen (Reginster) og for WOMAC og Lequesne skalaen (Pavelka) ved tre år.
English: D-glucosamine has low acute toxicity.
Danish: D-glucosamin har lav akut toksicitet.
English: Sporadic, spontaneous cases of hypercholesterolaemia have been reported, but causality has not been established.
Danish: Der er blevet rapporteret om sporadiske, spontane tilfælde af hyperkolesterolæmi, men årsagssammenhængen er ikke fastslået.
English: 13 C 1327 Lysaker Norway
Danish: 13 C N-1327 Lysaker Norge
English: No specific studies have been performed in the elderly, but according to clinical experience dosage adjustment is not required when treating otherwise healthy, elderly patients.
Danish: Der er ikke foretaget særlige undersøgelser med ældre, men ud fra klinisk erfaring er det ikke nødvendigt med dosisjustering ved behandling af ældre, der i øvrigt er raske.
English: Store below 30˚C
Danish: Opbevares under 30˚C
English: These two studies use authorised glucosamine-containing medicinal products, are long-term 3-years placebo-controlled studies, include an appropriate number of patients with appropriate inclusion criteria and look at relevant endpoints.
Danish: Disse to forsøg anvender godkendte lægemidler indeholdende glucosamin, er langvarige treårige placebokontrollerede forsøg, omfatter et passende antal patienter med passende inklusionskriterier og ser på relevante endepunkter.
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg på apoteket hvad du skal gøre ved medicin, der ikke længere er nødvendig.
English: ATC code: M01AX05
Danish: ATC-kode: M 01 AX 05.
English: No curative or disease-modifying treatment exists, apart from surgery with arthroplasty.
Danish: Der findes ingen helbredende eller sygdomsændrende behandling bortset fra artroplastik.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF GLUCOMED AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF GLUCOMED OG TILKNYTTEDE NAVNE (se Bilag I)
English: Driving and using machines:
Danish: Bilkørsel og betjening af maskiner
English: Dose selection in this bibliographical application is made from experience from other related glucosamine products and the dose and posology chosen is the same as used in almost all performed studies.
Danish: Valg af dosis i denne bibliografiske ansøgning er foretaget ud fra erfaring fra andre relaterede glucosaminprodukter, og den valgte dosering og indgivelsesmåde er den samme som det, der blev anvendt i næsten alle gennemførte forsøg.
English: Pharmacovigilance surveillance has resulted in some reports indicating a potential interaction with warfarin, and hence a warning has been added in the SPC text.
Danish: Lægemiddelovervågning har resulteret i nogle indberetninger, der indikerer en potentiel interaktion med warfarin, og der er derfor indført en advarsel i teksten i produktresumeet.
English: In addition the applicant was asked to justify the proposed dose and posology, to characterise the safety profile, including a discussion of reported adverse drug reactions (ADRs), to justify the relevance of literature considering that the formulations of glucosamine sulphate (as the sodium chloride complex) used in the cited literature differ from the concerned application formulation and whether the differences in formulation will alter the efficacy and safety of the product, to elucidate the possibility of interactions with other medicinal products, and finally to show a positive risk/benefit profile of glucosamine hydrochloride in the intended indication.
Danish: Desuden blev ansøgeren bedt om at berettige den foreslåede dosering og indgivelsesmåde, at karakterisere sikkerhedsprofilen, herunder en drøftelse af indberettede bivirkninger (ADR'er), at retfærdiggøre relevansen af litteraturen i lyset af at de formuleringer af glucosaminsulfat (som natriumchlorid kompleks), der er anvendt i den citerede litteratur, er forskellige fra den aktuelle formulering i ansøgningen, og hvorvidt forskellene i formulering vil ændre effekten og sikkerheden af produktet med henblik på at belyse muligheden for interaktioner med andre medicinske produkter og endelig at vise, at glucosaminhydrochlorid har en positiv risk/benefit profil i den påtænkte indikation.
English: Concurrent treatment with glucosamine may increase the absorption and serum concentration of tetracyclines, but the clinical relevance of this interaction is probably limited.
Danish: Samtidig behandling med glucosamin kan forøge absorptionen og serumkoncentrationen af tetracykliner, men den kliniske relevans af denne interaktion er sandsynligvis begrænset.
English: Taking Glucomed with food and drink You can take the tablets with or without food.
Danish: Hvordan man tager Glucomed sammen med mad og drikkevarer Du kan tage Glucomed med eller uden mad.
English: Glucosamine is a relatively small molecule (molecular mass 179), which is easily dissolved in water and soluble in hydrophilic organic solvents.
Danish: Glucosamin er et relativt lille molekyle (molekylærmasse 179), som let opløses i vand, og det er opløselig i hydrofile, organiske opløsningsmidler.
English: If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be re-evaluated.
Danish: Hvis der ikke ses symptomlindring efter 2-3 måneder, skal fortsat behandling med glucosamin genovervejes.
English: The safety profiles are, however, inferior to glucosamine.
Danish: Sikkerhedsprofilen er imidlertid inferiør til glucosamin.
English: Keep the bottle or blister tightly closed.
Danish: Hold glasset eller blisterpakningen tæt lukket.
English: 1250 mg glucosamine once daily for relief of symptoms.
Danish: 1250 mg glucosamin en gang daglig til symptomlindring.